[Title 21 CFR ]
[Code of Federal Regulations (annual edition) - April 1, 2008 Edition]
[From the U.S. Government Printing Office]



[[Page i]]

          

          21


          Part 500 to 599

                         Revised as of April 1, 2008


          Food and Drugs
          



________________________

          Containing a codification of documents of general 
          applicability and future effect

          As of April 1, 2008
          With Ancillaries
                    Published by
                    Office of the Federal Register
                    National Archives and Records
                    Administration
                    A Special Edition of the Federal Register

[[Page ii]]

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                            Table of Contents



                                                                    Page
  Explanation.................................................       v

  Title 21:
          Chapter I--Food and Drug Administration, Department 
          of Health and Human Services (Continued)                   3
  Finding Aids:
      Material Approved for Incorporation by Reference........     593
      Table of CFR Titles and Chapters........................     595
      Alphabetical List of Agencies Appearing in the CFR......     613
      List of CFR Sections Affected...........................     623

[[Page iv]]





                     ----------------------------

                     Cite this Code: CFR
                     To cite the regulations in 
                       this volume use title, 
                       part and section number. 
                       Thus, 21 CFR 500.23 refers 
                       to title 21, part 500, 
                       section 23.

                     ----------------------------

[[Page v]]



                               EXPLANATION

    The Code of Federal Regulations is a codification of the general and 
permanent rules published in the Federal Register by the Executive 
departments and agencies of the Federal Government. The Code is divided 
into 50 titles which represent broad areas subject to Federal 
regulation. Each title is divided into chapters which usually bear the 
name of the issuing agency. Each chapter is further subdivided into 
parts covering specific regulatory areas.
    Each volume of the Code is revised at least once each calendar year 
and issued on a quarterly basis approximately as follows:

Title 1 through Title 16.................................as of January 1
Title 17 through Title 27..................................as of April 1
Title 28 through Title 41...................................as of July 1
Title 42 through Title 50................................as of October 1

    The appropriate revision date is printed on the cover of each 
volume.

LEGAL STATUS

    The contents of the Federal Register are required to be judicially 
noticed (44 U.S.C. 1507). The Code of Federal Regulations is prima facie 
evidence of the text of the original documents (44 U.S.C. 1510).

HOW TO USE THE CODE OF FEDERAL REGULATIONS

    The Code of Federal Regulations is kept up to date by the individual 
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    To determine whether a Code volume has been amended since its 
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EFFECTIVE AND EXPIRATION DATES

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OMB CONTROL NUMBERS

    The Paperwork Reduction Act of 1980 (Pub. L. 96-511) requires 
Federal agencies to display an OMB control number with their information 
collection request.

[[Page vi]]

Many agencies have begun publishing numerous OMB control numbers as 
amendments to existing regulations in the CFR. These OMB numbers are 
placed as close as possible to the applicable recordkeeping or reporting 
requirements.

OBSOLETE PROVISIONS

    Provisions that become obsolete before the revision date stated on 
the cover of each volume are not carried. Code users may find the text 
of provisions in effect on a given date in the past by using the 
appropriate numerical list of sections affected. For the period before 
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1963, 1964-1972, 1973-1985, or 1986-2001 published in seven separate 
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INCORPORATION BY REFERENCE

    What is incorporation by reference? Incorporation by reference was 
established by statute and allows Federal agencies to meet the 
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to materials already published elsewhere. For an incorporation to be 
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This material, like any other properly issued regulation, has the force 
of law.
    What is a proper incorporation by reference? The Director of the 
Federal Register will approve an incorporation by reference only when 
the requirements of 1 CFR part 51 are met. Some of the elements on which 
approval is based are:
    (a) The incorporation will substantially reduce the volume of 
material published in the Federal Register.
    (b) The matter incorporated is in fact available to the extent 
necessary to afford fairness and uniformity in the administrative 
process.
    (c) The incorporating document is drafted and submitted for 
publication in accordance with 1 CFR part 51.
    Regulations containing properly approved incorporations by reference 
in this volume are listed in the Finding Aids at the end of their CFR 
volume.
    What if the material incorporated by reference cannot be found? If 
you have any problem locating or obtaining a copy of material listed in 
the Finding Aids of this volume as an approved incorporation by 
reference, please contact the agency that issued the regulation 
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the material is not available, please notify the Director of the Federal 
Register, National Archives and Records Administration, Washington DC 
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the revision dates of the 50 CFR titles.

[[Page vii]]


REPUBLICATION OF MATERIAL

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    Raymond A. Mosley,
    Director,
    Office of the Federal Register.
    April 1, 2008.







[[Page ix]]



                               THIS TITLE

    Title 21--Food and Drugs is composed of nine volumes. The parts in 
these volumes are arranged in the following order: Parts 1-99, 100-169, 
170-199, 200-299, 300-499, 500-599, 600-799, 800-1299 and 1300-end. The 
first eight volumes, containing parts 1-1299, comprise Chapter I--Food 
and Drug Administration, Department of Health and Human Services. The 
ninth volume, containing part 1300 to end, includes Chapter II--Drug 
Enforcement Administration, Department of Justice, and Chapter III--
Office of National Drug Control Policy. The contents of these volumes 
represent all current regulations codified under this title of the CFR 
as of April 1, 2008.

    For this volume, Jonn V. Lilyea was Chief Editor. The Code of 
Federal Regulations publication program is under the direction of 
Michael L. White, assisted by Ann Worley.


[[Page 1]]



                        TITLE 21--FOOD AND DRUGS




                  (This book contains parts 500 to 599)

  --------------------------------------------------------------------
                                                                    Part

chapter i--Food and Drug Administration, Department of 
  Health and Human Services (Continued).....................         500

[[Page 3]]



CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)




  --------------------------------------------------------------------


  Editorial Note: Nomenclature changes to chapter I appear at 69 FR 
13717, Mar. 24, 2004, and 69 FR 18803, Apr. 9, 2004.

         SUBCHAPTER E--ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS
Part                                                                Page
500             General.....................................           5
501             Animal food labeling........................          15
502             Common or usual names for nonstandardized 
                    animal foods............................          32
509             Unavoidable contaminants in animal food and 
                    food-packaging material.................          33
510             New animal drugs............................          37
511             New animal drugs for investigational use....          49
514             New animal drug applications................          53
515             Medicated feed mill license.................          88
516             New animal drugs for minor use and minor 
                    species.................................          93
520             Oral dosage form new animal drugs...........         117
522             Implantation or injectable dosage form new 
                    animal drugs............................         244
524             Ophthalmic and topical dosage form new 
                    animal drugs............................         325
526             Intramammary dosage forms...................         352
529             Certain other dosage form new animal drugs..         359
530             Extralabel drug use in animals..............         365
556             Tolerances for residues of new animal drugs 
                    in food.................................         371
558             New animal drugs for use in animal feeds....         389
564             [Reserved]

570             Food additives..............................         529
571             Food additive petitions.....................         536
573             Food additives permitted in feed and 
                    drinking water of animals...............         541
579             Irradiation in the production, processing, 
                    and handling of animal feed and pet food         560
582             Substances generally recognized as safe.....         561

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584             Food substances affirmed as generally 
                    recognized as safe in feed and drinking 
                    water of animals........................         585
589             Substances prohibited from use in animal 
                    food or feed............................         586
590-599         [Reserved]

[[Page 5]]



         SUBCHAPTER E_ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS



PART 500_GENERAL--Table of Contents




Subpart A [Reserved]

         Subpart B_Specific Administrative Rulings and Decisions

Sec.
500.23 Thermally processed low-acid foods packaged in hermetically 
          sealed containers.
500.24 Emergency permit control.
500.25 Anthelmintic drugs for use in animals.
500.26 Timed-release dosage form drugs.
500.27 Methylene blue-containing drugs for use in animals.
500.29 Gentian violet for use in animal feed.
500.30 Gentian violet for animal drug use.
500.35 Animal feeds contaminated with Salmonella microorganisms.
500.45 Use of polychlorinated biphenyls (PCB's) in the production, 
          handling, and storage of animal feed.
500.46 Hexachlorophene in animal drugs.
500.50 Propylene glycol in or on cat food.

               Subpart C_Animal Drug Labeling Requirements

500.51 Labeling of animal drugs; misbranding.
500.52 Use of terms such as ``tonic'', ``tone'', ``toner'', or 
          ``conditioner'' in the labeling of preparations intended for 
          use in or on animals.
500.55 Exemption from certain drug-labeling requirements.

            Subpart D_Requirements for Specific Animal Drugs

500.65 Epinephrine injection 1:1,000 in 10-milliliter containers for 
          emergency treatment of anaphylactoid shock in cattle, horses, 
          sheep, and swine.

 Subpart E_Regulation of Carcinogenic Compounds Used in Food-Producing 
                                 Animals

500.80 Scope of this subpart.
500.82 Definitions.
500.84 Conditions for approval of the sponsored compound.
500.86 Marker residue and target tissue.
500.88 Regulatory method.
500.90 Waiver of requirements.
500.92 Implementation.

    Authority: 21 U.S.C. 321, 331, 342, 343, 348, 351, 352, 353, 360b, 
371.

    Source: 40 FR 13802, Mar. 27, 1975, unless otherwise noted.

Subpart A [Reserved]



         Subpart B_Specific Administrative Rulings and Decisions



Sec. 500.23  Thermally processed low-acid foods packaged in hermetically 

sealed containers.

    The provisions of part 113 of this chapter shall apply to the 
manufacture, processing or packing of low-acid foods in hermetically 
sealed containers, and intended for use as food for animals.

[61 FR 37681, July 19, 1996]



Sec. 500.24  Emergency permit control.

    The provisions of part 108 of this chapter shall apply to the 
issuance of emergency control permits for the manufacturer or packer of 
thermally processed low-acid foods packaged in hermetically sealed 
containers, and intended for use as food for animals.

[61 FR 37681, July 19, 1996]



Sec. 500.25  Anthelmintic drugs for use in animals.

    (a) The Commissioner of Food and Drugs has determined that, in order 
to assure that anthelmintic drugs, including animal feeds bearing or 
containing such drugs, which do not carry the prescription statement are 
labeled to provide adequate directions for their effective use, labeling 
of these anthelmintic drugs shall bear, in addition to other required 
information, a statement that a veterinarian should be consulted for 
assistance in the diagnosis, treatment, and control of parasitism.
    (b) The label and any labeling furnishing or purporting to furnish 
directions for use, shall bear conspicuously the following statement: 
``Consult your veterinarian for assistance in the diagnosis, treatment, 
and control of parasitism.''

[[Page 6]]

    (c) For drugs covered by approved new animal drug applications, the 
labeling revisions required for compliance with this section may be 
placed into effect without prior approval, as provided for in Sec. 
514.8(c)(3) of this chapter. For drugs listed in the index, the labeling 
revisions required for compliance with this section may be placed into 
effect without prior granting of a request for a modification, as 
provided for in Sec. 516.161(b)(1) of this chapter.
    (d) Labeling revisions required for compliance with this section 
shall be placed into effect by February 25, 1975, following which, any 
such drugs that are introduced into interstate commerce and not in 
compliance with this section will be subject to regulatory proceedings.

[40 FR 13802, Mar. 27, 1975, as amended at 71 FR 74782, Dec. 13, 2006; 
72 FR 69120, Dec. 6, 2007]



Sec. 500.26  Timed-release dosage form drugs.

    (a) Drugs are being offered in dosage forms that are designed to 
release the active ingredients over a prolonged period of time. There is 
a possibility of unsafe overdosage or ineffective dosage if such 
products are improperly made and the active ingredients are released at 
one time, over too short or too long a period of time, or not released 
at all. Drugs marketed in this form, which are referred to by such terms 
as timed-release, controlled-release, prolonged-release, sustained-
release, or delayed-release drugs, are regarded as new animal drugs 
within the meaning of section 201(v) of the Federal Food, Drug, and 
Cosmetic Act.
    (b) Timed-release dosage form animal drugs that are introduced into 
interstate commerce are deemed to be adulterated within the meaning of 
section 501(a)(5) of the act and subject to regulatory action, unless 
such animal drug is the subject of an approved new animal drug 
application, or listed in the index, as required by paragraph (a) of 
this section.
    (c) The fact that the labeling of this kind of drug may claim 
delayed, prolonged, controlled, or sustained-release of all or only some 
of the active ingredients does not affect the new animal drug status of 
such articles. A new animal drug application or index listing is 
required in any such case.
    (d) New animal drug applications for timed-release dosage form 
animal drugs must contain, among other things, data to demonstrate 
safety and effectiveness by establishing that the article is 
manufactured using procedures and controls to ensure release of the 
total dosage at a safe and effective rate. Data submitted in the new 
animal drug application must demonstrate that the formulation of the 
drug and the procedures used in its manufacture will ensure release of 
the active ingredient(s) of the drug at a safe and effective rate and 
that these release characteristics will be maintained until the 
expiration date of the drug. When the drug is intended for use in food-
producing animals, data submitted must also demonstrate that, with 
respect to possible residues of the drug, food derived from treated 
animals is safe for consumption.

[42 FR 8635, Feb. 11, 1977, as amended at 60 FR 38480, July 27, 1995; 72 
FR 69120, Dec. 6, 2007]



Sec. 500.27  Methylene blue-containing drugs for use in animals.

    (a) New information requires a re- evaluation of the status of drugs 
containing methylene blue (tetramethylthionine chloride) for oral use in 
cats or dogs.
    (1)(i) It has been demonstrated that two orally administered urinary 
antiseptic-antispasmodic preparations that contained methylene blue 
cause Heinz body hemolytic anemia in cats when used according to label 
directions. The specific cause of the reaction was determined to be the 
methylene blue contained in the preparations. The reaction can be severe 
enough to cause death of treated animals.
    (ii) The Heinz body hemolytic anemia reaction to methylene blue has 
also been demonstrated in dogs under laboratory conditions. The precise 
mechanism by which methylene blue produces the characteristic 
erythrocytic inclusion bodies (Heinz bodies) and associated hemolytic 
anemia is unclear.
    (2) The effectiveness of orally administered methylene blue as a 
urinary antiseptic is open to question. It appears that following oral 
administration,

[[Page 7]]

methylene blue is poorly and erratically absorbed and also slowly and 
erratically excreted in the urine. Studies in the dog indicate it is 
excreted in the urine essentially as leukomethylene blue stabilized in 
some manner. Methylene blue itself is stepwise demethylated in alkaline 
solutions (alkaline urine being a frequent consequence of urinary 
infection) to Azure B, Azure A, and Azure C. The antiseptic efficacy of 
all of these excretion products is unsubstantiated.
    (3) In view of the foregoing, the Commissioner has concluded that 
animal drugs containing methylene blue for oral use in cats or dogs are 
neither safe nor generally recognized as effective within the meaning of 
section 201(v) of the act and are therefore considered new animal drugs. 
Accordingly, all prior formal and informal opinions expressed by the 
Food and Drug Administration that such drugs are ``not new drugs'' or 
``no longer new drugs'' are hereby revoked.
    (b) Animal drugs that contain methylene blue for oral use in cats or 
dogs and not the subject of an approved new animal drug application 
(NADA) are deemed to be adulterated under the provisions of section 
501(a) (5) and/or (6) and/or misbranded under section 502(a) of the act 
and subject to regulatory action as of April 10, 1978.
    (c) Sponsors of animal drugs that contain methylene blue for oral 
use in cats or dogs and not the subject of an approved new animal drug 
application (NADA) may submit an application in conformity with Sec. 
514.1 of this chapter. Such applications will be processed in accordance 
with section 512 of the act. Submission of an NADA will not constitute 
grounds for continued marketing of this drug substance until such 
application is approved.
    (d) New animal drug applications required by this regulation 
pursuant to section 512 of the act shall be submitted to the Food and 
Drug Administration. Center for Veterinary Medicine, Office of New 
Animal Drug Evaluation (HFV-100), 7500 Standish Pl., Rockville, MD 
20855.

[43 FR 9803, Mar. 10, 1978; 43 FR 12310, Mar. 24, 1978, as amended at 54 
FR 18279, Apr. 28, 1989; 57 FR 6475, Feb. 25, 1992; 60 FR 38480, July 
27, 1995]



Sec. 500.29  Gentian violet for use in animal feed.

    The Food and Drug Administration has determined that gentian violet 
is not generally recognized as safe for use in animal feed and is a food 
additive subject to section 409 of the Federal Food, Drug, and Cosmetic 
Act (the act), unless it is intended for use as a new animal drug, in 
which case it is subject to section 512 of the act. The Food and Drug 
Administration has determined that gentian violet is not prior 
sanctioned for any use in animal feed.

[56 FR 40506, Aug. 15, 1991]



Sec. 500.30  Gentian violet for animal drug use.

    The Food and Drug Administration (FDA) has determined that gentian 
violet is not generally recognized as safe and effective for any 
veterinary drug use in food animals and is a new animal drug subject to 
section 512 of the Federal Food, Drug, and Cosmetic Act. FDA has 
determined that gentian violet is not exempted from new animal drug 
status under the ``grandfather'' provisions of the Drug Amendments of 
1962 (21 U.S.C. 342).

[56 FR 40507, Aug. 15, 1991]



Sec. 500.35  Animal feeds contaminated with Salmonella microorganisms.

    (a) Investigations by the Food and Drug Administration, the Centers 
for Disease Control of the U.S. Public Health Service, the Animal Health 
Division of the Agricultural Research Service, U.S. Department of 
Agriculture, and by various State public health agencies have revealed 
that processed fish meal, poultry meal, meat meal, tankage, and other 
animal byproducts intended for use in animal feed may be contaminated 
with Salmonella bacteria, an organism pathogenic to man and animals. 
Contamination of these products may occur through inadequate heat 
treatment of the product during its processing or through 
recontamination of the heat-treated product during a time of improper 
storage or handling subsequent to processing.
    (b) Articles used in food for animals are included within the 
definition of

[[Page 8]]

food in section 201(f) of the Federal Food, Drug, and Cosmetic Act. 
Further, Salmonella contamination of such animal feeds having the 
potentiality for producing infection and disease in animals must be 
regarded as an adulterant within the meaning of section 402(a) of the 
act. Therefore, the Food and Drug Administration will regard as 
adulterated within the meaning of section 402(a) of the act shipments of 
the following when intended for animal feed and encountered in 
interstate commerce and found upon examination to be contaminated with 
Salmonella microorganisms: Bone meal, blood meal, crab meal, feather 
meal, fish meal, fish solubles, meat scraps, poultry meat meal, tankage, 
or other similar animal byproducts, or blended mixtures of these.

[40 FR 13802, Mar. 27, 1975, as amended at 54 FR 18279, Apr. 28, 1989]



Sec. 500.45  Use of polychlorinated biphenyls (PCB's) in the production, 

handling, and storage of animal feed.

    (a) Polychlorinated biphenyls (PCB's) represent a class of toxic 
industrial chemicals manufactured and sold under a variety of trade 
names, including: Aroclor (United States); Phenoclor (France); Colphen 
(Germany); and Kanaclor (Japan). PCB's are highly stable, heat 
resistant, and nonflammable chemicals. Industrial uses of PCB's include, 
or did include in the past, their use as electrical transformer and 
capacitor fluids, heat transfer fluids, hydraulic fluids, plasticizers, 
and in formulations of lubricants, coatings, and inks. Their unique 
physical and chemical properties and widespread, uncontrolled industrial 
applications have caused PCB's to be a persistent and ubiquitous 
contaminant in the environment, causing the contamination of certain 
foods. In addition, incidents have occurred in which PCB's have directly 
contaminated animal feeds as a result of industrial accidents (leakage 
or spillage of PCB fluids from plant equipment). These accidents in turn 
cause the contamination of food intended for human consumption (meat, 
milk, and eggs). Investigations by the Food and Drug Administration have 
revealed that heat exchange fluids for certain pasteurization equipment 
used in processing animal feed contain PCB's. Although heat exchange 
fluids in such equipment are considered to be in closed systems, leakage 
has occurred that resulted in direct contamination of animal feed with 
PCB's and subsequently resulted in the transfer of PCB's to human food 
produced by animals consuming the contaminated feed. The use of PCB-
containing coatings on the inner walls of silos has resulted in the 
contamination of silage which has in turn caused PCB residues in the 
milk of dairy cows consuming the contaminated silage. Since PCB's are 
toxic chemicals, the PCB contamination of food as a result of these and 
other incidents represent a hazard to public health. It is therefore 
necessary to place certain restrictions on the industrial uses of PCB's 
in the production, handling, and storage of animal feed.
    (b) The following special provisions are necessary to preclude 
accidental PCB contamination of animal feed:
    (1) Coatings or paints for use on the contact surfaces of feed 
storage areas may not contain PCB's or any other harmful or deleterious 
substances likely to contaminate feed.
    (2) New equipment or machinery for handling or processing feed in or 
around an establishment producing animal feed shall not contain PCB's.
    (3) On or before Sept. 4, 1973, the management of establishments 
producing animal feed shall:
    (i) Have the heat exchange fluid used in existing equipment or 
machinery for handling and processing feed sampled and tested to 
determine whether it contains PCB's, or verify the absence of PCB's in 
such formulations by other appropriate means. On or before Sept. 4, 
1973, any such fluid formulated with PCB's must to the fullest extent 
possible commensurate with current good manufacturing practices, be 
replaced with a heat exchange fluid that does not contain PCB's.
    (ii) Eliminate to the fullest extent possible commensurate with 
current good manufacturing practices from the animal feed producing 
establishment any PCB-containing lubricants for equipment or machinery 
used for handling or processing animal feed.

[[Page 9]]

    (iii) Eliminate to the fullest extent possible commensurate with 
current good manufacturing practices from the animal feed producing 
establishment any other PCB-containing materials, whenever there is a 
reasonable expectation that such materials could cause animal feed to 
become contaminated with PCB's either as a result of normal use or as a 
result of accident, breakage, or other mishap.
    (iv) The toxicity and other characteristics of fluids selected as 
PCB replacements must be adequately determined so that the least 
potentially hazardous replacement should be used. In making this 
determination with respect to a given fluid, consideration should be 
given to (a) its toxicity; (b) the maximum quantity that could be 
spilled onto a given quantity of food before it would be noticed, taking 
into account its color and odor; (c) possible signaling devices in the 
equipment to indicate a loss of fluid, etc.; (d) and its environmental 
stability and tendency to survive and be concentrated through the food 
chain. The judgment as to whether a replacement fluid is sufficiently 
non-hazardous is to be made on an individual installation and operation 
basis.
    (c) For the purpose of this section, the provisions do not apply to 
electrical transformers and condensers containing PCB's in sealed 
containers.
    (d) For the purpose of this section, the term animal feed includes 
all articles used for food or drink for animals other than man.



Sec. 500.46  Hexachlorophene in animal drugs.

    (a) The Commissioner of Food and Drugs has determined that there are 
no adequate data to establish that animal drugs containing 
hexachlorophene are safe and effective for any animal use other than in 
topical products for use on non-food-producing animals as part of a 
product preservative system at a level not to exceed 0.1 percent; that 
there is no information on the potential risk to humans from exposure to 
hexachlorophene by persons who apply animal products containing the drug 
at levels higher than 0.1 percent; and that there is likewise no 
information on human exposure to animals on which these animal drugs 
have been used and no information on possible residues of 
hexachlorophene in edible products of food-producing animals treated 
with new animal drugs that contain any quantity of hexachlorophene.
    (b) Animal drugs containing hexachlorophene for other than 
preservative use on non-food-producing animals at levels not exceeding 
0.1 percent are considered new animal drugs and shall be the subject of 
new animal drug applications (NADA's).
    (c) Any person currently marketing animal drugs that contain 
hexachlorophene other than as part of a product preservative system for 
products used on non-food-producing animals at a level not exceeding 0.1 
percent shall submit a new animal drug application, supplement an 
existing application, or reformulate the product by September 29, 1977. 
Each application or supplemental application shall include adequate data 
to establish that the animal drug is safe and effective. If the animal 
drug is currently subject to an approved new animal drug application, 
each reformulation shall require an approved supplemental application. 
The interim marketing of these animal drugs may continue until the 
application has been approved, until it has been determined that the 
application is not approvable under the provisions of Sec. 514.111 of 
this chapter, or until an existing approved application has been 
withdrawn.
    (d) After September 29, 1977, animal drugs that contain 
hexachlorophene other than for preservative use on non-food-producing 
animals at a level not exceeding 0.1 percent that are introduced into 
interstate commerce shall be deemed to be adulterated within the meaning 
of section 501(a)(5) of the act (21 U.S.C. 351(a)(5)) unless such animal 
drug is the subject of a new animal drug application submitted pursuant 
to paragraph (c) of this section. Action to withdraw approval of new 
animal drug applications will be initiated if supplemental new animal 
drug applications have not been submitted in accordance with this 
section.
    (e) New animal drug applications submitted for animal drugs 
containing hexachlorophene for use in or on food-

[[Page 10]]

producing animals shall include adequate data to assure that edible 
products from treated animals are safe for human consumption under the 
labeled conditions of use.

[42 FR 33725, July 1, 1977; 42 FR 37975, July 26, 1977]



Sec. 500.50  Propylene glycol in or on cat food.

    The Food and Drug Administration has determined that propylene 
glycol in or on cat food is not generally recognized as safe and is a 
food additive subject to section 409 of the Federal Food, Drug, and 
Cosmetic Act (the act). The Food and Drug Administration also has 
determined that this use of propylene glycol is not prior sanctioned.

[61 FR 19544, May 2, 1996]



               Subpart C_Animal Drug Labeling Requirements



Sec. 500.51  Labeling of animal drugs; misbranding.

    (a) Among the representations on the label or labeling of an animal 
drug which will render the drug misbranded are any broad statements 
suggesting or implying that the drug is not safe and effective for use 
when used in accordance with labeling direction, or suggesting or 
implying that the labeling does not contain adequate warnings or 
adequate directions for use. Such statements include, but are not 
limited to:
    (1) Any statement that disclaims liability when the drug is used in 
accordance with directions for use contained on the label or labeling.
    (2) Any statement that disclaims liability when the drug is used 
under ``abnormal'' or ``unforeseeable'' conditions.
    (3) Any statement limiting the warranty for the products to a 
warranty that the drug in the package contains the ingredients listed on 
the label.
    (b) This regulation is not intended to prohibit any liability 
disclaimer that purports to limit the amount of damages or that sets 
forth the legal theory under which damages are to be recovered.
    (c) Any person wishing to obtain an evaluation of an animal drug 
liability disclaimer under this regulation may submit it to Division of 
Compliance, (HFV-230), Center for Veterinary Medicine, Food and Drug 
Administration, 7500 Standish Pl., Rockville, MD 20855. A supplemental 
NADA providing appropriately revised labeling shall be submitted for any 
approved new animal drug the labeling of which is not in compliance with 
this regulation.

[41 FR 8473, Feb. 27, 1976, as amended at 54 FR 18279, Apr. 28, 1989; 57 
FR 6475, Feb. 25, 1992]



Sec. 500.52  Use of terms such as ``tonic'', ``tone'', ``toner'', or 

``conditioner'' in the labeling of preparations intended for use in or on 

animals.

    (a) The use of terms such as tonic, tone, toner, and similar terms 
in the labeling of a product intended for use in or on animals implies 
that such product is capable of a therapeutic effect(s) and causes such 
a product to be a drug within the meaning of section 201(g) of the 
Federal Food, Drug, and Cosmetic Act. The unqualified use of such terms 
in a product's labeling fails to provide adequate directions and 
indications for use of such product and causes it to be misbranded 
within the meaning of section 502(a) and (f)(1) of the act. The terms 
tonic, tone, toner, and similar terms may be used in labeling only when 
appropriately qualified so as to fully inform the user regarding the 
intended use(s) of the product.
    (b) The unqualified use of the term conditioner and similar terms in 
the labeling of a product intended for use in or on animals implies that 
such product is capable of a therapeutic effect(s) and causes such a 
product to be a drug within the meaning of section 201(g) of the act. 
The unqualified use of such terms in a product's labeling fails to 
provide adequate directions and indications for use of such product and 
causes it to be misbranded within the meaning of section 502(a) and 
(f)(1) of the act. The term conditioner and similar terms may be used in 
labeling only when appropriately qualified so as to fully inform the 
user regarding the intended use(s) of the product. A product labeled as 
a ``conditioner'' or with a similar term can be either a food or drug 
depending upon the manner in

[[Page 11]]

which the term is qualified in the labeling to reflect the product's 
intended use.
    (c) An article so qualified as to be represented as a drug must be 
the subject of an approved new animal drug application unless the use of 
the article under the conditions set forth in its labeling is generally 
recognized as safe and effective among experts qualified by scientific 
training and experience to evaluate the safety and effectiveness of 
animal drugs.



Sec. 500.55  Exemption from certain drug-labeling requirements.

    (a) Section 201.105(c) of this chapter provides that in the case of 
certain drugs for which directions, hazards, warnings, and use 
information are commonly known to practitioners licensed by law, such 
information may be omitted from the dispensing package. Under this 
proviso, the Commissioner of Food and Drugs will offer an opinion, upon 
written request, stating reasonable grounds therefore on a proposal to 
omit such information from the dispensing package.
    (b) The Commissioner of Food and Drugs has considered submitted 
material covering a number of drug products and has offered the opinion 
that the following drugs when intended for those veterinary uses for 
which they are now generally employed by the veterinary medical 
profession, should be exempt from the requirements of Sec. 201.105(c) 
of this chapter, provided that they meet the conditions prescribed in 
this paragraph. Preparations that are not in dosage unit form (for 
example, solutions) will be regarded as meeting the conditions with 
respect to the maximum quantity of drug per dosage unit if they are 
prepared in a manner that enables accurate and ready administration of a 
quantity of drug not in excess of the stated maximum per dosage unit:

Atropine sulfate. As an injectable for cattle, goats, horses, pigs, and 
sheep, not in excess of 15 milligrams per dosage unit; as an injectable 
for cats and dogs, not in excess of 0.6 milligram per dosage unit.
Barbital sodium. For oral use in cats and dogs, not in excess of 300 
milligrams per dosage unit.
Epinephrine injection. 1:1,000. For cats, dogs, cattle, goats, horses, 
pigs, and sheep (except as provided in Sec. 500.65).
Morphine sulfate. As an injectable for dogs, not in excess of 15 
milligrams per dosage unit.
Pentobarbital sodium. For oral use in cats and dogs, not in excess of 
100 milligrams per dosage unit.
Phenobarbital sodium. For oral use in cats and dogs, not in excess of 
100 milligrams per dosage unit.
Procaine hydrochloride injection. Containing not in excess of 2 percent 
procaine hydrochloride, with or without epinephrine up to a 
concentration of 1:50,000. For use in cats, dogs, cattle, goats, horses, 
pigs, and sheep.
Thyroid. For oral use in dogs, not in excess of 60 milligrams per dosage 
unit.



            Subpart D_Requirements for Specific Animal Drugs



Sec. 500.65  Epinephrine injection 1:1,000 in 10-milliliter containers for 

emergency treatment of anaphylactoid shock in cattle, horses, sheep, and 

swine.

    (a) Anaphylactoid reactions in cattle, horses, sheep, and swine 
occur occasionally from the injection of antibiotics, bacterins, and 
vaccines. Adequate directions for use of these antibiotics, bacterins, 
and vaccines can generally be written for use by the laity and thus are 
available to livestock producers. Epinephrine injection is effective for 
the treatment of anaphylactoid reactions in animals and would be of 
value in saving lives of animals if it were readily available at the 
time of administration of the causative agents. In connection with this 
problem the Food and Drug Administration has obtained the views of the 
Advisory Committee on Veterinary Medicine, and other experts, and has 
concluded that adequate directions for over-the-counter sale of 
epinephrine injection 1:1,000 can be prepared.
    (b) In view of the above, the Commissioner of Food and Drugs has 
concluded that it is in the public interest to make epinephrine 
injection 1:1,000 available for sale without a prescription provided 
that it is packaged in vials not exceeding 10 milliliters and its label 
bears, in addition to other required information, the following 
statements in a prominent and conspicuous manner: ``For emergency use 
only in treating

[[Page 12]]

anaphylactoid shock. Usual Dosage: Cattle, horses, sheep, and swine--1 
cubic centimeter per 100 pounds of body weight. Inject subcutaneously''.
    (c) The labeling must also bear a description of the symptoms of 
anaphylactoid shock including glassy eyes, increased salivation, 
grinding of the teeth, rapid breathing, muscular tremors, staggering 
gait, and collapse with death following. These symptoms may appear 
shortly after injection of a bacterin, vaccine, or antibiotic.



 Subpart E_Regulation of Carcinogenic Compounds Used in Food-Producing 
                                 Animals

    Source: 52 FR 49586, Dec. 31, 1987, unless otherwise noted.



Sec. 500.80  Scope of this subpart.

    (a) The Federal Food, Drug, and Cosmetic Act requires that sponsored 
compounds intended for use in food-producing animals be shown to be safe 
and that food produced from animals exposed to these compounds be shown 
to be safe for consumption by people. The statute prohibits the use in 
food-producing animals of any compound found to induce cancer when 
ingested by people or animals unless it can be determined by methods of 
examination prescribed or approved by the Secretary (a function 
delegated to the Commissioner of Food and Drugs) that no residue of that 
compound will be found in the food produced from those animals under 
conditions of use reasonably certain to be followed in practice. This 
subpart identifies the steps a sponsor of a compound shall follow to 
secure the approval of the compound. FDA guidance documents contain the 
procedures and protocols FDA recommends for the implementation of this 
subpart. These guidance documents are available from the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852. Requests for these guidance 
documents should be identified with Docket No. 1983D-0288.
    (b) If FDA concludes on the basis of the threshold assessment that a 
sponsor shall conduct carcinogenicity testing on the sponsored compound, 
FDA will also determine whether and to what extent the sponsor shall 
conduct carcinogenicity testing on metabolites of the sponsored 
compound. The bioassays that a sponsor conducts must be designed to 
assess carcinogenicity and to determine the quantitative aspects of any 
carcinogenic response.
    (c) If FDA concludes on the basis of the threshold assessment or at 
a later time during the approval process that the data show that the 
sponsored compound and its metabolites should not be subject to this 
subpart, FDA will continue to consider the compound for approval under 
the general safety provisions of the act for risks other than cancer.
    (d) This subpart does not apply to essential nutrients.

[52 FR 49586, Dec. 31, 1987, as amended at 59 FR 14365, Mar. 28, 1994; 
62 FR 66983, Dec. 23, 1997; 65 FR 56480, Sept. 19, 2000; 67 FR 78174, 
Dec. 23, 2002; 68 FR 24879, May 9, 2003; 69 FR 17292, Apr. 2, 2004]



Sec. 500.82  Definitions.

    (a) The definitions and interpretations contained in section 201 of 
the act apply to those terms when used in this subpart.
    (b) The following definitions apply to this subpart:
    Act means the Federal Food, Drug, and Cosmetic Act (sections 201-
901, 52 Stat. 1040 et seq. as amended (21 U.S.C. 301-392)).
    Essential nutrients means compounds that are found in the tissues of 
untreated, healthy target animals and not produced in sufficient 
quantity to support the animal's growth, development, function, or 
reproduction, e.g., vitamins, essential minerals, essential amino acids, 
and essential fatty acids. These compounds must be supplied from 
external sources.
    FDA means the Food and Drug Administration.
    Limit of detection (LOD) means the lowest concentration of analyte 
that can be confirmed by the approved regulatory method.
    Marker residue means the residue selected for assay whose 
concentration is in a known relationship to the concentration of the 
residue of carcinogenic concern in the last tissue to deplete to its 
Sm.

[[Page 13]]

    Preslaughter withdrawal period or milk discard time means the time 
after cessation of administration of the sponsored compound at which no 
residue is detectable in the edible product using the approved 
regulatory method (i.e., the marker residue is below the LOD).
    Regulatory method means the aggregate of all experimental procedures 
for measuring and confirming the presence of the marker residue of the 
sponsored compound in the target tissue of the target animal.
    Rm means the concentration of the marker residue in the 
target tissue when the residue of carcinogenic concern is equal to 
Sm.
    Residue means any compound present in edible tissues of the target 
animal which results from the use of the sponsored compound, including 
the sponsored compound, its metabolites, and any other substances formed 
in or on food because of the sponsored compound's use.
    Residue of carcinogenic concern means all compounds in the total 
residue of a demonstrated carcinogen excluding any compounds judged by 
FDA not to present a carcinogenic risk.
    Sm means the concentration of residue in a specific 
edible tissue corresponding to a maximum lifetime risk of cancer in the 
test animals of 1 in 1 million.
    So means the concentration of the test compound in the 
total diet of test animals that corresponds to a maximum lifetime risk 
of cancer in the test animals of 1 in 1 million. For the purpose of this 
subpart, FDA will also assume that this So will correspond to 
the concentration of residue of carcinogenic concern in the total human 
diet that represents no significant increase in the risk of cancer to 
people.
    Sponsor means the person or organization proposing or holding an 
approval by FDA for the use of a sponsored compound.
    Sponsored compound means any drug or food additive or color additive 
proposed for use, or used, in food-producing animals or in their feed.
    Target animals means the production class of animals in which a 
sponsored compound is proposed or intended for use.
    Target tissue means the edible tissue selected to monitor for 
residues in the target animals, including, where appropriate, milk or 
eggs.
    Test animals means the species selected for use in the toxicity 
tests.
    Threshold assessment means FDA's review of data and information 
about a sponsored compound to determine whether chronic bioassays in 
test animals are necessary to resolve questions concerning the 
carcinogenicity of the compound.

[52 FR 49586, Dec. 31, 1987, as amended at 67 FR 78174, Dec. 23, 2002]



Sec. 500.84  Conditions for approval of the sponsored compound.

    (a) On the basis of the results of the chronic bioassays and other 
information, FDA will determine whether any of the substances tested are 
carcinogenic.
    (b) If FDA concludes that the results of the bioassays do not 
establish carcinogenicity, then FDA will not subject the sponsored 
compound to the remainder of the requirements of this subpart.
    (c) For each sponsored compound that FDA decides should be regulated 
as a carcinogen, FDA will analyze the data from the bioassays using a 
statistical extrapolation procedure.
    (1) For each substance tested in separate bioassays, FDA will 
calculate the concentration of the residue of carcinogenic concern that 
corresponds to a maximum lifetime risk to the test animal of 1 in 1 
million. FDA will designate the lowest value obtained as So. 
Because the total diet is not derived from food-producing animals, FDA 
will make corrections for food intake. FDA will designate as 
Sm the concentration of residue in a specific edible tissue 
corresponding to a maximum lifetime risk of cancer in test animals of 1 
in 1 million.
    (2) From the appropriate residue chemistry data FDA will calculate 
the Rm as described in Sec. 500.86(c). The sponsor must 
provide a regulatory method in accordance with Sec. 500.88(b). FDA will 
calculate the LOD of the method from data submitted by the sponsor under 
Sec. 500.88. The LOD must be less than or equal to Rm.

[[Page 14]]

    (3) FDA will conclude that the provisions of this subpart are 
satisfied when no residue of the compound is detectable (that is, the 
marker residue is below the LOD) using the approved regulatory method 
under the conditions of use of the sponsored compound, including any 
required preslaughter withdrawal period or milk discard time.

[52 FR 49586, Dec. 31, 1987, as amended at 67 FR 78174, Dec. 23, 2002]



Sec. 500.86  Marker residue and target tissue.

    (a) For each edible tissue, the sponsor shall measure the depletion 
of the residue of carcinogenic concern until its concentration is at or 
below Sm.
    (b) In one or more edible tissues, the sponsor shall also measure 
the depletion of one or more potential marker residues until the 
concentration of the residue of carcinogenic concern is at or below 
Sm.
    (c) From these data, FDA will select a target tissue and a marker 
residue and designate the concentration of marker residue 
(Rm) that the regulatory method must be capable of measuring 
in the target tissue. FDA will select Rm such that the 
absence of the marker residue in the target tissue above Rm 
can be taken as confirmation that the residue of carcinogenic concern 
does not exceed Sm in each of the edible tissues and, 
therefore, that the residue of carcinogenic concern in the diet of 
people does not exceed So.
    (d) When a compound is to be used in milk- or egg-producing animals, 
milk or eggs must be the target tissue in addition to the tissue 
selected to monitor for residues in the edible carcass.

(Approved by the Office of Management and Budget under control number 
0910-0228)



Sec. 500.88  Regulatory method.

    (a) The sponsor shall submit for evaluation and validation a 
regulatory method developed to monitor compliance with FDA's operational 
definition of no residue.
    (b) The regulatory method must be able to confirm the identity of 
the marker residue in the target tissue at a minimum concentration 
corresponding to the Rm. FDA will determine the LOD from the 
submitted analytical method validation data.
    (c) FDA will publish in the Federal Register the complete regulatory 
method for ascertaining the marker residue in the target tissue in 
accordance with the provisions of sections 409(c)(3)(A), 512(d)(1)(I), 
and 721(b)(5)(B) of the act.

(Approved by the Office of Management and Budget under control number 
0910-0228)

[52 FR 49586, Dec. 31, 1987, as amended at 67 FR 78174, Dec. 23, 2002]



Sec. 500.90  Waiver of requirements.

    In response to a petition or on the Commissioner's own initiative, 
the Commissioner may waive, in whole or in part, the requirements of 
this subpart except those provided under Sec. 500.88. A petition for 
this waiver may be filed by any person who would be adversely affected 
by the application of the requirements to a particular compound. The 
petition shall explain and document why the requirements from which a 
waiver is requested are not reasonably applicable to the compound, and 
set forth clearly the reasons why the alternative procedures will 
provide the basis for concluding that approval of the compound satisfies 
the requirements of the anticancer provisions of the act. If the 
Commissioner determines that waiver of any of the requirements of this 
subpart is appropriate, the Commissioner will state the basis for that 
determination in the regulation approving marketing of the sponsored 
compound.

(Approved by the Office of Management and Budget under control number 
0910-0228)



Sec. 500.92  Implementation.

    (a) This subpart E applies to all new animal drug applications, food 
additive petitions, and color additive petitions concerning any compound 
intended for use in food-producing animals (including supplemental 
applications and amendments to petitions).
    (b) This subpart E also applies in the following manner to compounds 
already approved:
    (1) For those compounds that FDA determines may induce cancer when 
ingested by man or animals, i.e., suspect

[[Page 15]]

carcinogens, Sec. Sec. 500.80(b), 500.82, and 500.90 apply.
    (2) For those compounds that FDA determines have been shown to 
induce cancer when ingested by man or animals, Sec. Sec. 500.82 through 
500.90 apply.



PART 501_ANIMAL FOOD LABELING--Table of Contents




                      Subpart A_General Provisions

Sec.
501.1 Principal display panel of package form animal food.
501.2 Information panel of package for animal food.
501.3 Identity labeling of animal food in package form.
501.4 Animal food; designation of ingredients.
501.5 Animal food; name and place of business of manufacturer, packer, 
          or distributor.
501.8 Labeling of animal food with number of servings.
501.15 Animal food; prominence of required statements.
501.17 Animal food labeling warning statements.
501.18 Misbranding of animal food.

          Subpart B_Specific Animal Food Labeling Requirements

501.22 Animal foods; labeling of spices, flavorings, colorings, and 
          chemical preservatives.

Subparts C-E [Reserved]

       Subpart F_Exemptions From Animal Food Labeling Requirements

501.100 Animal food; exemptions from labeling.
501.103 Petitions requesting exemptions from or special requirements for 
          label declaration of ingredients.
501.105 Declaration of net quantity of contents when exempt.
501.110 Animal feed labeling; collective names for feed ingredients.

    Authority: 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342, 343, 
348, 371.

    Source: 41 FR 38619, Sept. 10, 1976, unless otherwise noted.



                      Subpart A_General Provisions



Sec. 501.1  Principal display panel of package form animal food.

    The term principal display panel as it applies to food in package 
form and as used in this part, means the part of a label that is most 
likely to be displayed, presented, shown, or examined under customary 
conditions of display for retail sale. The principal display panel shall 
be large enough to accommodate all the mandatory label information 
required to be placed thereon by this part with clarity and 
conspicuousness and without obscuring design, vignettes, or crowding. 
Where packages bear alternate principal display panels, information 
required to be placed on the principal display panel shall be duplicated 
on each principal display panel. For the purpose of obtaining uniform 
type size in declaring the quantity of contents for all packages of 
substantially the same size, the term area of the principal display 
panel means the area of the side or surface that bears the principal 
display panel, which area shall be:
    (a) In the case of a rectangular package where one entire side 
properly can be considered to be the principal display panel side, the 
product of the height times the width of that side;
    (b) In the case of a cylindrical or nearly cylindrical container, 40 
percent of the product of the height of the container times the 
circumference;
    (c) In the case of any otherwise shaped container, 40 percent of the 
total surface of the container: Provided, however, That where such 
container presents an obvious principal display panel such as the top of 
a triangular or circular package, the area shall consist of the entire 
top surface. In determining the area of the principal display panel, 
exclude tops, bottoms, flanges at tops and bottoms of cans, and 
shoulders and necks of bottles or jars. In the case of cylindrical or 
nearly cylindrical containers, information required by this part to 
appear on the principal display panel shall appear within that 40 
percent of the circumference which is most likely to be displayed, 
presented, shown, or examined under customary conditions of display for 
retail sale.

[[Page 16]]



Sec. 501.2  Information panel of package for animal food.

    (a) The term information panel as it applies to packaged food means 
that part of the label immediately contiguous and to the right of the 
principal display panel as observed by an individual facing the 
principal display panel with the following exceptions:
    (1) If the part of the label immediately contiguous and to the right 
of the principal display panel is too small to accommodate the necessary 
information or is otherwise unusable label space, e.g., folded flaps or 
can ends, the panel immediately contiguous and to the right of this part 
of the label may be used.
    (2) If the package has one or more alternate principal display 
panels, the information panel is immediately contiguous and to the right 
of any principal display panel.
    (3) If the top of the container is the principal display panel and 
the package has no alternate principal display panel, the information 
panel is any panel adjacent to the principal display panel.
    (b) All information required to appear on the label of any package 
of food pursuant to Sec. Sec. 501.4, 501.5, 501.8 and 501.17 shall 
appear either on the principal display panel or on the information 
panel, unless otherwise specified by regulations in this chapter.
    (c) All information appearing on the principal display panel or the 
information panel pursuant to this section shall appear prominently and 
conspicuously, but in no case may the letters and/or numbers be less 
than \1/16\ inch in height unless an exemption pursuant to paragraph (f) 
of this section is established. The requirements for conspicuousness and 
legibility shall include the specifications of Sec. Sec. 501.15 and 
501.105(h) (1) and (2).
    (1) Packaged foods are exempt from the type size requirements of 
this paragraph: Provided, That:
    (i) The package is designed such that it has a surface area that can 
bear an information panel and/or an alternate principal display panel.
    (ii) The area of surface available for labeling on the principal 
display panel of the package as this term is defined in Sec. 501.1 is 
less than 10 square inches.
    (iii) The label information includes a full list of ingredients in 
accordance with regulations in this part.
    (iv) The information required by paragraph (b) of this section 
appears on the principal display panel or information panel label in 
accordance with the provisions of this paragraph (c) except that the 
type size is not less than \3/64\ inch in height.
    (2) Packaged foods are exempt from the type size requirements of 
this paragraph: Provided, That:
    (i) The package is designed such that it has a single obvious 
principal display panel as this term is defined in Sec. 501.1 and has 
no other available surface area for an information panel or alternate 
principal display panel.
    (ii) The area of surface available for labeling on the principal 
display panel of the package as this term is defined in Sec. 501.1 is 
less than 12 square inches and bears all labeling appearing on the 
package.
    (iii) The label information includes a full list of ingredients in 
accordance with regulations in this part.
    (iv) The information required by paragraph (b) of this section 
appears on the single, obvious principal display panel in accordance 
with the provisions of this paragraph (c) except that the type size is 
not less than \1/32\ inch in height.
    (3) Packaged foods are exempt from the type size requirements of 
this paragraph: Provided, That:
    (i) The package is designed such that it has a total surface area 
available to bear labeling of less than 12 square inches.
    (ii) The label information includes a full list of ingredients in 
accordance with regulations in this part.
    (iii) The information required by paragraph (b) of this section 
appears on the principal display panel or information panel label in 
accordance with the provisions of this paragraph (c) except that the 
type size is not less than \1/32\ inch in height.
    (d) All information required to appear on the principal display 
panel or on the information panel pursuant to this section shall appear 
on the same panel unless there is insufficient space. In determining the 
sufficiency of the available space, any vignettes, design,

[[Page 17]]

and other nonmandatory label information shall not be considered. If 
there is insufficient space for all of this information to appear on a 
single panel, it may be divided between these two panels except that the 
information required pursuant to any given section or part shall all 
appear on the same panel. A food whose label is required to bear the 
ingredient statement on the principal display panel may bear all other 
information specified in paragraph (b) of this section on the 
information panel.
    (e) All information appearing on the information panel pursuant to 
this section shall appear in one place without other intervening 
material.
    (f) If the label of any package of food is too small to accommodate 
all of the information required by Sec. Sec. 501.4, 501.5, 501.8, and 
501.17, the Commissioner may establish by regulation an acceptable 
alternative method of disseminating such information to the public, 
e.g., a type size smaller than one-sixteenth inch in height, or labeling 
attached to or inserted in the package or available at the point of 
purchase. A petition requesting such a regulation, as an amendment to 
this paragraph shall be submitted pursuant to part 10 of this chapter.

[41 FR 38619, Sept. 10, 1976, as amended at 42 FR 4716, Jan. 25, 1977; 
42 FR 15675, Mar. 22, 1977]



Sec. 501.3  Identity labeling of animal food in package form.

    (a) The principal display panel of a food in package form shall bear 
as one of its principal features a statement of the identity of the 
commodity.
    (b) Such statement of identity shall be in terms of:
    (1) The name now or hereafter specified in or required by any 
applicable Federal law or regulation; or, in the absence thereof,
    (2) The common or usual name of the food; or, in the absence 
thereof,
    (3) An appropriately descriptive term, or when the nature of the 
food is obvious, a fanciful name commonly used by the public for such 
food.
    (c) Where a food is marketed in various optional forms (whole, 
slices, diced, etc.), the particular form shall be considered to be a 
necessary part of the statement of identity and shall be declared in 
letters of a type size bearing a reasonable relation to the size of the 
letters forming the other components of the statement of identity; 
except that if the optional form is visible through the container or is 
depicted by an appropriate vignette, the particular form need not be 
included in the statement. This specification does not affect the 
required declarations of identity under definitions and standards for 
foods promulgated pursuant to section 401 of the act.
    (d) This statement of identity shall be presented in bold type on 
the principal display panel, shall be in a size reasonably related to 
the most prominent printed matter on such panel, and shall be in lines 
generally parallel to the base on which the package rests as it is 
designed to be displayed.
    (e) Under the provisions of section 403(c) of the Federal Food, 
Drug, and Cosmetic Act, a food shall be deemed to be misbranded if it is 
an imitation of another food unless its label bears, in type of uniform 
size and prominence, the word imitation and, immediately thereafter, the 
name of the food imitated.
    (1) A food shall be deemed to be an imitation and thus subject to 
the requirements of section 403(c) of the act if it is a substitute for 
and resembles another food but is nutritionally inferior to that food.
    (2) A food that is a substitute for and resembles another food shall 
not be deemed to be an imitation provided it meets each of the following 
requirements:
    (i) It is not nutritionally inferior to the food for which it 
substitutes and which it resembles.
    (ii) Its label bears a common or usual name that complies with the 
provisions of Sec. 502.5 of this chapter and that is not false or 
misleading, or in the absence of an existing common or usual name, an 
appropriately descriptive term that is not false or misleading. The 
label may, in addition, bear a fanciful name which is not false or 
misleading.
    (3) A food for which a common or usual name is established by 
regulation (e.g., in a standard of identity pursuant to section 401 of 
the act, in a common or usual name regulation and may, in

[[Page 18]]

addition, bear a fanciful name which is not false or misleading, and 
established pursuant to part 502 of this chapter), and which complies 
with all of the applicable requirements of such regulation(s), shall not 
be deemed to be an imitation.
    (4) Nutritional inferiority includes:
    (i) Any reduction in the content of an essential nutrient that is 
present in a measurable amount.
    (ii) If the Commissioner concludes that a food is a substitute for 
and resembles another food but is inferior to the food imitated for 
reasons other than those set forth in this paragraph, he may propose 
appropriate revisions to this regulation or he may propose a separate 
regulation governing the particular food.
    (f) A label may be required to bear the percentage(s) of a 
characterizing ingredient(s) or information concerning the presence or 
absence of an ingredient(s) or the need to add an ingredient(s) as part 
of the common or usual name of the food pursuant to part 502 of this 
chapter.

[41 FR 38619, Sept. 10, 1976, as amended at 42 FR 14091, Mar. 15, 1977; 
54 FR 18279, Apr. 28, 1989]



Sec. 501.4  Animal food; designation of ingredients.

    (a) Ingredients required to be declared on the label of a food, 
including foods that comply with standards of identity that require 
labeling in compliance with this part 501, except those exempted by 
Sec. 501.100, shall be listed by common or usual name in descending 
order of predominance by weight on either the principal display panel or 
the information panel in accordance with the provisions of Sec. 501.2.
    (b) The name of an ingredient shall be a specific name and not a 
collective (generic) name, except that:
    (1) Spices, flavorings, colorings and chemical preservatives shall 
be declared according to the provisions of Sec. 501.22.
    (2) An ingredient which itself contains two or more ingredients and 
which has an established common or usual name, conforms to a standard 
established pursuant to the Meat Inspection or Poultry Products 
Inspection Acts by the U.S. Department of Agriculture, or conforms to a 
definition and standard of identity established pursuant to section 401 
of the Federal Food, Drug, and Cosmetic Act, shall be designated in the 
statement of ingredients on the label of such food by either of the 
following alternatives:
    (i) By declaring the established common or usual name of the 
ingredient followed by a parenthetical listing of all ingredients 
contained therein in descending order of predominance except that, if 
the ingredient is a food subject to a definition and standard of 
identity established in this subchapter E, only the ingredients required 
to be declared by the definition and standard of identity need be 
listed; or
    (ii) By incorporating into the statement of ingredients in 
descending order of predominance in the finished food, the common or 
usual name of every component of the ingredient without listing the 
ingredient itself.
    (3) Skim milk, concentrated skim milk, reconstituted skim milk, and 
nonfat dry milk may be declared as skim milk or nonfat milk.
    (4) Milk, concentrated milk, reconstituted milk, and dry whole milk 
may be declared as milk.
    (5) Bacterial cultures may be declared by the word cultured followed 
by the name of the substrate, e.g., made from cultured skim milk or 
cultured buttermilk.
    (6) Sweetcream buttermilk, concentrated sweetcream buttermilk, 
reconstituted sweetcream buttermilk, and dried sweetcream buttermilk may 
be declared as buttermilk.
    (7) Whey, concentrated whey, reconstituted whey, and dried whey may 
be declared as whey.
    (8) Cream, reconstituted cream, dried cream, and plastic cream 
(sometimes known as concentrated milkfat) may be declared as cream.
    (9) Butteroil and anhydrous butterfat may be declared as butterfat.
    (10) Dried whole eggs, frozen whole eggs, and liquid whole eggs may 
be declared as eggs.
    (11) Dried egg whites, frozen egg whites, and liquid egg whites may 
be declared as egg whites.
    (12) Dried egg yolks, frozen egg yolks, and liquid egg yolks may be 
declared as egg yolks.

[[Page 19]]

    (13) A livestock or poultry feed may be declared by a collective 
name listed in Sec. 501.110 if it is an animal feed within the meaning 
of section 201(w) of the act and meets the requirements for the use of a 
collective name as prescribed in Sec. 501.110 for certain feed 
ingredients.
    (14) [Reserved]
    (15) When all the ingredients of a wheat flour are declared in an 
ingredient statement, the principal ingredient of the flour shall be 
declared by the name(s) specified in Sec. Sec. 137.105, 137.200, 
137.220, 137.225 of this chapter, i.e., the first ingredient designated 
in the ingredient list of flour, or bromated flour, or enriched flour, 
or self-rising flour is flour, white flour, wheat flour, or plain flour; 
the first ingredient designated in the ingredient list of durum flour is 
durum flour; the first ingredient designated in the ingredient list of 
whole wheat flour, or bromated whole wheat flour is whole wheat flour, 
graham flour, or entire wheat flour; and the first ingredient designated 
in the ingredient list of whole durum wheat flour is whole durum wheat 
flour.
    (c) When water is added to reconstitute, completely or partially, an 
ingredient permitted by paragraph (b) of this section to be declared by 
a class name, the position of the ingredient class name in the 
ingredient statement shall be determined by the weight of the 
unreconstituted ingredient plus the weight of the quantity of water 
added to reconstitute that ingredient, up to the amount of water needed 
to reconstitute the ingredient to single strength. Any water added in 
excess of the amount of water needed to reconstitute the ingredient to 
single strength shall be declared as water in the ingredient statement.

[41 FR 38619, Sept. 10, 1976, as amended at 42 FR 14091, Mar. 15, 1977; 
60 FR 38480, July 27, 1995]



Sec. 501.5  Animal food; name and place of business of manufacturer, packer, 

or distributor.

    (a) The label of a food in packaged form shall specify conspicuously 
the name and place of business of the manufacturer, packer, or 
distributor.
    (b) The requirement for declaration of the name of the manufacturer, 
packer, or distributor shall be deemed to be satisfied, in the case of a 
corporation, only by the actual corporate name, which may be preceded or 
followed by the name of the particular division of the corporation. In 
the case of an individual, partnership, or association, the name under 
which the business is conducted shall be used.
    (c) Where the food is not manufactured by the person whose name 
appears on the label, the name shall be qualified by a phrase that 
reveals the connection such person has with such food; such as 
``Manufactured for ------------,'' ``Distributed by ------------,'' or 
any other wording that expresses the facts.
    (d) The statement of the place of business shall include the street 
address, city, state, and ZIP Code; however, the street address may be 
omitted if it is shown in a current city directory or telephone 
directory. The requirement for inclusion of the ZIP Code shall apply 
only to consumer commodity labels developed or revised after the 
effective date of this section. In the case of nonconsumer packages, the 
ZIP Code shall appear either on the label or the labeling (including 
invoice).
    (e) If a person manufactures, packs, or distributes a food at a 
place other than his principal place of business, the label may state 
the principal place of business in lieu of the actual place where such 
food was manufactured or packed or is to be distributed, unless such 
statement would be misleading.



Sec. 501.8  Labeling of animal food with number of servings.

    (a) The label of any package of a food which bears a representation 
as to the number of servings contained in such package shall bear in 
immediate conjunction with such statement, and in the same size type as 
is used for such statement, a statement of the net quantity (in terms of 
weight, measure, or numerical count) of each such serving; however, such 
statement may be expressed in terms that differ from the terms used in 
the required statement of net quantity of contents (for example, 
cupfuls, tablespoonfuls, etc.) when such differing term is common to 
cookery and describes a constant quantity.

[[Page 20]]

Such statement may not be misleading in any particular. A statement of 
the number of units in a package is not in itself a statement of the 
number of servings.
    (b) If there exists a voluntary product standard promulgated 
pursuant to the procedures found in 15 CFR part 10 by the Department of 
Commerce, quantitatively defining the meaning of the term serving with 
respect to a particular food, then any label representation as to the 
number of servings in such packaged food shall correspond with such 
quantitative definition. (Copies of published standards are available 
upon request from the National Bureau of Standards, Department of 
Commerce, Washington, DC 20234.)



Sec. 501.15  Animal food; prominence of required statements.

    (a) A word, statement, or other information required by or under 
authority of the act to appear on the label may lack that prominence and 
conspicuousness required by section 403(f) of the act by reason (among 
other reasons) of:
    (1) The failure of such word, statement, or information to appear on 
the part or panel of the label which is presented or displayed under 
customary conditions of purchase;
    (2) The failure of such word, statement, or information to appear on 
two or more parts or panels of the label, each of which has sufficient 
space therefor, and each of which is so designed as to render it likely 
to be, under customary conditions of purchase, the part or panel 
displayed;
    (3) The failure of the label to extend over the area of the 
container or package available for such extension, so as to provide 
sufficient label space for the prominent placing of such word, 
statement, or information;
    (4) Insufficiency of label space (for the prominent placing of such 
word, statement, or information) resulting from the use of label space 
for any word, statement, design, or device which is not required by or 
under authority of the act to appear on the label;
    (5) Insufficiency of label space (for the prominent placing of such 
word, statement, or information) resulting from the use of label space 
to give materially greater conspicuousness to any other word, statement, 
or information, or to any design or device; or
    (6) Smallness or style of type in which such word, statement, or 
information appears, insufficient background contrast, obscuring designs 
or vignettes, or crowding with other written, printed, or graphic 
matter.
    (b) No exemption depending on insufficiency of label space, as 
prescribed in regulations promulgated under section 403(e) or (i) of the 
act, shall apply if such insufficiency is caused by:
    (1) The use of label space for any word, statement, design, or 
device which is not required by or under authority of the act to appear 
on the label;
    (2) The use of label space to give greater conspicuousness to any 
word, statement, or other information that is required by section 403(f) 
of the act; or
    (3) The use of label space for any representation in a foreign 
language.
    (c)(1) All words, statements, and other information required by or 
under authority of the act to appear on the label or labeling shall 
appear thereon in the English language: Provided, however, That in the 
case of articles distributed solely in the Commonwealth of Puerto Rico 
or in a territory where the predominant language is one other than 
English, the predominant language may be substituted for English.
    (2) If the label contains any representation in a foreign language, 
all words, statements, and other information required by or under 
authority of the act to appear on the label shall appear thereon in the 
foreign language.
    (3) If any article of labeling (other than a label) contains any 
representation in a foreign language, all words, statements, and other 
information required by or under authority of the act to appear on the 
label or labeling shall appear on such article of labeling.



Sec. 501.17  Animal food labeling warning statements.

    (a) Self-pressurized containers. (1) The label of a food packaged in 
a self-pressurized container and intended to be expelled from the 
package under pressure shall bear the following warning:

[[Page 21]]

    Warning Avoid spraying in eyes. Contents under pressure. Do not 
puncture or incinerate. Do not store at temperature above 120 [deg]F. 
Keep out of reach of children.
    (2) In the case of products intended for use by children, the phrase 
``except under adult supervision'' may be added at the end of the last 
sentence in the warning required by paragraph (a)(1) of this section.
    (3) In the case of products packaged in glass containers, the word 
``break'' may be substituted for the word ``puncture'' in the warning 
required by paragraph (a)(1) of this section.
    (4) The words ``Avoid spraying in eyes'' may be deleted from the 
warning required by paragraph (a)(1) of this section in the case of a 
product not expelled as a spray.
    (b) Self-pressurized containers with halocarbon or hydrocarbon 
propellants. (1) In addition to the warning required by paragraph (a) of 
this section, the label of a food packaged in a self-pressurized 
container in which the propellant consists in whole or in part of a 
halocarbon or a hydrocarbon shall bear the following warning:
    Warning Use only as directed. Intentional misuse by deliberately 
concentrating and inhaling the contents can be harmful or fatal.
    (2) The warning required by paragraph (b)(1) of this section is not 
required for the following products:
    (i) Products expelled in the form of a foam or cream, which contain 
less than 10 percent propellant in the container.
    (ii) Products in a container with a physical barrier that prevents 
escape of the propellant at the time of use.
    (iii) Products of a net quantity of contents of less than 2 ozs that 
are designed to release a measured amount of product with each valve 
actuation.
    (iv) Products of a net quantity of contents of less than \1/2\ oz.
    (c) Animal food containing or manufactured with a chlorofluorocarbon 
or other ozone-depleting substance. Labeling requirements for animal 
foods that contain or are manufactured with a chlorofluorocarbon or 
other ozone-depleting substance designated by the Environmental 
Protection Agency (EPA) are set forth in 40 CFR part 82.

[41 FR 38619, Sept. 10, 1976, as amended at 42 FR 22033, Apr. 29, 1977; 
61 FR 20101, May 3, 1996]



Sec. 501.18  Misbranding of animal food.

    (a) Among representations in the labeling of a food which render 
such food misbranded is a false or misleading representation with 
respect to another food or a drug, device, or cosmetic.
    (b) The labeling of a food which contains two or more ingredients 
may be misleading by reason (among other reasons) of the designation of 
such food in such labeling by a name which includes or suggests the name 
of one or more but not all such ingredients, even though the names of 
all such ingredients are stated elsewhere in the labeling.
    (c) Among representations in the labeling of a food which render 
such food misbranded is any representation that expresses or implies a 
geographical origin of the food or any ingredient of the food except 
when such representation is either:
    (1) A truthful representation of geographical origin.
    (2) A trademark or trade name provided that as applied to the 
article in question its use is not deceptively misdescriptive. A 
trademark or trade name comprised in whole or in part of geographical 
words shall not be considered deceptively misdescriptive if it:
    (i) Has been so long and exclusively used by a manufacturer or 
distributor that it is generally understood by the consumer to mean the 
product of a particular manufacturer or distributor; or
    (ii) Is so arbitrary or fanciful that it is not generally understood 
by the consumer to suggest geographic origin.
    (3) A part of the name required by applicable Federal law or 
regulation.
    (4) A name whose market significance is generally understood by the 
consumer to connote a particular class, kind, type, or style of food 
rather than to indicate geographical origin.

[[Page 22]]



          Subpart B_Specific Animal Food Labeling Requirements



Sec. 501.22  Animal foods; labeling of spices, flavorings, colorings, and 

chemical preservatives.

    (a)(1) The term artificial flavor or artificial flavoring means any 
substance, the function of which is to impart flavor, which is not 
derived from a spice, fruit or fruit juice, vegetable or vegetable 
juice, edible yeast, herb, bark, bud, root, leaf or similar plant 
material, meat, fish, poultry, eggs, dairy products, or fermentation 
products thereof. Artificial flavor includes the substances listed in 
Sec. Sec. 172.515(b) and 582.60 of this chapter except where these are 
derived from natural sources.
    (2) The term spice means any aromatic vegetable substance in the 
whole, broken, or ground form, except for those substances which have 
been traditionally regarded as foods, such as onions, garlic and celery; 
whose significant function in food is seasoning rather than nutritional; 
that is true to name; and from which no portion of any volatile oil or 
other flavoring principle has been removed. Spices include the spices 
listed in subpart A of part 582 of this chapter, such as the following:

Allspice, Anise, Basil, Bay leaves, Caraway seed, Cardamon, Celery seed, 
Chervil, Cinnamon, Cloves, Coriander, Cumin seed, Dill seed, Fennel 
seed, Fenugreek, Ginger, Horseradish, Mace, Marjoram, Mustard flour, 
Nutmeg, Oregano, Paprika, Parsley, Pepper, black; Pepper, white; Pepper, 
red; Rosemary, Saffron, Sage, Savory, Star aniseed, Tarragon, Thyme, 
Turmeric.


Paprika, turmeric, and saffron or other spices which are also colors, 
shall be declared as spice and coloring unless declared by their common 
or usual name.
    (3) The term natural flavor or natural flavoring means the essential 
oil, oleoresin, essence or extractive, protein hydrolysate, distillate, 
or any product of roasting, heating or enzymolysis, which contains the 
flavoring constituents derived from a spice, fruit or fruit juice, 
vegetable or vegetable juice, edible yeast, herb, bark, bud, root, leaf 
or similar plant material, meat, seafood, poultry, eggs, dairy products, 
or fermentation products thereof, whose significant function in food is 
flavoring rather than nutritional. Natural flavors, include the natural 
essence or extractives obtained from plants listed in subpart A of part 
582 of this chapter, and the substances listed in Sec. 172.510 of this 
chapter.
    (4) The term artificial color or artificial coloring means any color 
additive as defined in Sec. 70.3(f) of this chapter.
    (5) The term chemical preservative means any chemical that, when 
added to food, tends to prevent or retard deterioration thereof, but 
does not include common salt, sugars, vinegars, spices, or oils 
extracted from spices, substances added to food by direct exposure 
thereof to wood smoke, or chemicals applied for their insecticidal or 
herbicidal properties.
    (b) A food which is subject to the requirements of section 403(k) of 
the act shall bear labeling, even though such food is not in package 
form.
    (c) A statement of artificial flavoring, artificial coloring, or 
chemical preservative shall be placed on the food, or on its container 
or wrapper, or on any two or all of these, as may be necessary to render 
such statement likely to be read by the ordinary individual under 
customary conditions of purchase and use of such food.
    (d) A food shall be exempt from compliance with the requirements of 
section 403(k) of the act if it is not in package form and the units 
thereof are so small that a statement of artificial flavoring, 
artificial coloring, or chemical preservative, as the case may be, 
cannot be placed on such units with such conspicuousness as to render it 
likely to be read by the ordinary individual under customary conditions 
of purchase and use.
    (e) A food shall be exempt while held for sale from the requirements 
of section 403(k) of the act (requiring label statement of any 
artificial flavoring, artificial coloring, or chemical preservatives) if 
said food, having been received in bulk containers at a retail 
establishment, is displayed to the purchaser with either (1) the 
labeling of the bulk container plainly in view or (2) a counter card, 
sign, or other appropriate device bearing prominently and conspicuously 
the information required to be stated on the label pursuant to section 
403(k) of the act.

[[Page 23]]

    (f) A fruit or vegetable shall be exempt from compliance with the 
requirements of section 403(k) of the act with respect to a chemical 
preservative applied to the fruit or vegetable as a pesticide chemical 
prior to harvest.
    (g) A flavor shall be labeled in the following way when shipped to a 
food manufacturer or processor (but not a consumer) for use in the 
manufacture of a fabricated food, unless it is a flavor for which a 
standard of identity has been promulgated, in which case it shall be 
labeled as provided in the standard:
    (1) If the flavor consists of one ingredient, it shall be declared 
by its common or usual name.
    (2) If the flavor consists of two or more ingredients, the label 
either may declare each ingredient by its common or usual name or may 
state ``All flavor ingredients contained in this product are approved 
for use in a regulation of the Food and Drug Administration.'' Any 
flavor ingredient not contained in one of these regulations, and any 
nonflavor ingredient, shall be separately listed on the label.
    (3) In cases where the flavor contains a solely natural flavor(s), 
the flavor shall be so labeled, e.g., strawberry flavor, banana flavor, 
or natural strawberry flavor. In cases where the flavor contains both a 
natural flavor and an artificial flavor, the flavor shall be so labeled, 
e.g., natural and artificial strawberry flavor. In cases where the 
flavor contains a solely artificial flavor(s), the flavor shall be so 
labeled, e.g., artificial strawberry flavor.
    (h) The label of a food to which flavor is added shall declare the 
flavor in the statement of ingredients in the following way:
    (1) Spice, natural flavor, and artificial flavor may be declared as 
spice, natural flavor, or artificial flavor, or any combination thereof, 
as the case may be.
    (2) An incidental additive in a food, originating in a spice or 
flavor used in the manufacture of the food, need not be declared in the 
statement of ingredients if it meets the requirements of Sec. 
501.100(a)(3).
    (3) Substances obtained by cutting, grinding, drying, pulping, or 
similar processing of tissues derived from fruit, vegetable, meat, fish, 
or poultry, e.g., powdered or granulated onions, garlic powder, and 
celery powder, are commonly understood by consumers to be food rather 
than flavor and shall be declared by their common or usual name.
    (4) Any salt (sodium chloride) used as an ingredient in food shall 
be declared by its common or usual name salt.
    (5) Any monosodium glutamate used as an ingredient in food shall be 
declared by its common or usual name monosodium glutamate.
    (6) Any pyroligneous acid or other artificial smoke flavors used as 
an ingredient in a food may be declared as artificial flavor or 
artificial smoke flavor. No representation may be made, either directly 
or implied, that a food flavored with pyroligneous acid or other 
artificial smoke flavor has been smoked or has a true smoked flavor, or 
that a seasoning sauce or similar product containing pyroligneous acid 
or other artificial smoke flavor and used to season or flavor other 
foods will result in a smoked product or one having a true smoked 
flavor.
    (i) If the label, labeling, or advertising of a food makes any 
direct or indirect representations with respect to the primary 
recognizable flavor(s), by word, vignette, e.g., depiction of a fruit, 
or other means, or if for any other reason the manufacturer or 
distributor of a food wishes to designate the type of flavor in the food 
other than through the statement of ingredients, such flavor shall be 
considered the characterizing flavor and shall be declared in the 
following way:
    (1) If the food contains no artificial flavor which simulates, 
resembles or reinforces the characterizing flavor, the name of the food 
on the principal display panel or panels of the label shall be 
accompanied by the common or usual name of the characterizing flavor in 
letters not less than one-half the height of the letters used in the 
name of the food, except that:
    (i) If the food is one that is commonly expected to contain a 
characterizing food ingredient, and the food contains natural flavor 
derived from such ingredient and an amount of characterizing ingredient 
insufficient to independently characterize the food, or the food 
contains no such ingredient, the

[[Page 24]]

name of the characterizing flavor may be immediately preceded by the 
word natural and shall be immediately followed by the word flavored in 
letters not less than one-half the height of the letters in the name of 
the characterizing flavor.
    (ii) If none of the natural flavor used in the food is derived from 
the product whose flavor is simulated, the food in which the flavor is 
used shall be labeled either with the flavor of the product from which 
the flavor is derived or as artificially flavored.
    (iii) If the food contains both a characterizing flavor from the 
product whose flavor is simulated and other natural flavor which 
simulates, resembles or reinforces the characterizing flavor, the food 
shall be labeled in accordance with the introductory text and paragraph 
(i)(1)(i) of this section and the name of the food shall be immediately 
followed by the words with other natural flavor in letters not less than 
one-half the height of the letters used in the name of the 
characterizing flavor.
    (2) If the food contains any artificial flavor which simulates, 
resembles or reinforces the characterizing flavor, the name of the food 
on the principal display panel or panels of the label shall be 
accompanied by the common or usual name(s) of the characterizing flavor, 
in letters not less than one-half the height of the letters used in the 
name of the food and the name of the characterizing flavor shall be 
accompanied by the word(s) artificial or artificially flavored, in 
letters not less than one-half the height of the letters in the name of 
the characterizing flavor.
    (3) Wherever the name of the characterizing flavor appears on the 
label (other than in the statement of ingredients) so conspicuously as 
to be easily seen under customary conditions of purchase, the words 
prescribed by this paragraph shall immediately and conspicuously precede 
or follow such name, without any intervening written, printed, or 
graphic matter, except:
    (i) Where the characterizing flavor and a trademark or brand are 
presented together, other written, printed, or graphic matter that is a 
part of or is associated with the trademark or brand may intervene if 
the required words are in such relationship with the trademark or brand 
as to be clearly related to the characterizing flavor; and
    (ii) If the finished product contains more than one flavor subject 
to the requirements of this paragraph, the statements required by this 
paragraph need appear only once in each statement of characterizing 
flavors present in such food.
    (iii) If the finished product contains three or more distinguishable 
characterizing flavors, or a blend of flavors with no primary 
recognizable flavor, the flavor may be declared by an appropriately 
descriptive generic term in lieu of naming each flavor.
    (4) A flavor supplier shall certify, in writing, that any flavor he 
supplies which is designated as containing no artificial flavor does 
not, to the best of his knowledge and belief, contain any artificial 
flavor, and that he has added no artificial flavor to it. The 
requirement for such certification may be satisfied by a guarantee under 
section 303(c)(2) of the act which contains such a specific statement. A 
flavor used shall be required to make such a written certification only 
where he adds to or combines another flavor with a flavor which has been 
certified by a flavor supplier as containing no artificial flavor, but 
otherwise such user may rely upon the supplier's certification and need 
make no separate certification. All such certifications shall be 
retained by the certifying party throughout the period in which the 
flavor is supplied and for a minimum of 3 years thereafter, and shall be 
subject to the following conditions:
    (i) The certifying party shall make such certifications available 
upon request at all reasonable hours to any duly authorized officer, or 
employee of the Food and Drug Administration or any other employee 
acting on behalf of the Secretary of Health and Human Services. Such 
certifications are regarded by the Food and Drug Administration as 
reports to the government and as guarantees or other undertakings within 
the meaning of section 301(h) of the act and subject the certifying 
party to the penalties for making any false report to the government 
under 18 U.S.C. 1001 and any false guarantee or undertaking under 
section

[[Page 25]]

303(a) of the act. The defenses provided under section 303(c)(2) of the 
act shall be applicable to the certifications provided for in this 
section.
    (ii) Wherever possible, the Food and Drug Administration shall 
verify the accuracy of a reasonable number of certifications made 
pursuant to this section, constituting a representative sample of such 
certifications, and shall not request all such certifications.
    (iii) Where no person authorized to provide such information is 
reasonably available at the time of inspection, the certifying party 
shall arrange to have such person and the relevant materials and records 
ready for verification as soon as practicable; provided that, whenever 
the Food and Drug Administration has reason to believe that the supplier 
or user may utilize this period to alter inventories or records, such 
additional time shall not be permitted. Where such additional time is 
provided, the Food and Drug Administration may require the certifying 
party to certify that relevant inventories have not been materially 
disturbed and relevant records have not been altered or concealed during 
such period.
    (iv) The certifying party shall provide, to an officer or 
representative duly designated by the Secretary, such qualitative 
statement of the composition of the flavor or product covered by the 
certification as may be reasonably expected to enable the Secretary's 
representatives to determine which relevant raw and finished materials 
and flavor ingredient records are reasonably necessary to verify the 
certifications. The examination conducted by the Secretary's 
representative shall be limited to inspection and review of inventories 
and ingredient records for those certifications which are to be 
verified.
    (v) Review of flavor ingredient records shall be limited to the 
qualitative formula and shall not include the quantitative formula. The 
person verifying the certifications may make only such notes as are 
necessary to enable him to verify such certification. Only such notes or 
such flavor ingredient records as are necessary to verify such 
certification or to show a potential or actual violation may be removed 
or transmitted from the certifying party's place of business: Provided, 
That, where such removal or transmittal is necessary for such purposes 
the relevant records and notes shall be retained as separate documents 
in Food and Drug Administration files, shall not be copied in other 
reports, and shall not be disclosed publicly other than in a judicial 
proceeding brought pursuant to the act or 18 U.S.C. 1001.
    (j) A food to which a chemical preservative(s) is added shall, 
except when exempt pursuant to Sec. 501.100, bear a label declaration 
stating both the common or usual name of the ingredient(s) and a 
separate description of its function, e.g., preservative, to retard 
spoilage, a mold inhibitor, to help protect flavor or to promote color 
retention.

[41 FR 38619, Sept. 10, 1976, as amended at 42 FR 14091, Mar. 15, 1977; 
42 FR 15675, Mar. 22, 1977]

Subparts C-E [Reserved]



       Subpart F_Exemptions From Animal Food Labeling Requirements



Sec. 501.100  Animal food; exemptions from labeling.

    (a) The following foods are exempt from compliance with the 
requirements of section 403(i)(2) of the act (requiring a declaration on 
the label of the common or usual name of each ingredient when the food 
is fabricated from two or more ingredients).
    (1) An assortment of different items of food, when variations in the 
items that make up different packages packed from such assortment 
normally occur in good packing practice and when such variations result 
in variations in the ingredients in different packages, with respect to 
any ingredient that is not common to all packages. Such exemption, 
however, shall be on the condition that the label shall bear, in 
conjunction with the names of such ingredients as are common to all 
packages, a statement (in terms that are as informative as practicable 
and that are not misleading) indicating by name other ingredients which 
may be present.

[[Page 26]]

    (2) A food having been received in bulk containers at a retail 
establishment, if displayed to the purchaser with either (i) the 
labeling of the bulk container plainly in view or (ii) a counter card, 
sign, or other appropriate device bearing prominently and conspicuously 
the information required to be stated on the label pursuant to section 
403(i)(2) of the act.
    (3) Incidental additives that are present in a food at insignificant 
levels and do not have any technical or functional effect in that food. 
For the purposes of this paragraph (a)(3), incidental additives are:
    (i) Substances that have no technical or functional effect but are 
present in a food by reason of having been incorporated into the food as 
an ingredient of another food, in which the substance did have a 
functional or technical effect.
    (ii) Processing aids, which are as follows:
    (a) Substances that are added to a food during the processing of 
such food but are removed in some manner from the food before it is 
packaged in its finished form.
    (b) Substances that are added to a food during processing, are 
converted into constituents normally present in the food, and do not 
significantly increase the amount of the constituents naturally found in 
the food.
    (c) Substances that are added to a food for their technical or 
functional effect in the processing but are present in the finished food 
at insignificant levels and do not have any technical or functional 
effect in that food.
    (iii) Substances migrating to food from equipment or packaging or 
otherwise affecting food that are not food additives as defined in 
section 201(s) of the act; or if they are food additives as so defined, 
they are used in conformity with regulations established pursuant to 
section 409 of the act.
    (b) A food repackaged in a retail establishment is exempt from the 
following provisions of the act if the conditions specified are met.
    (1) Section 403(e)(1) of the act (requiring a statement on the label 
of the name and place of business of the manufacturer, packer, or 
distributor).
    (2) Section 403(g)(2) of the act (requiring the label of a food 
which purports to be or is represented as one for which a definition and 
standard of identity has been prescribed to bear the name of the food 
specified in the definition and standard and, insofar as may be required 
by the regulation establishing the standard the common names of the 
optional ingredients present in the food), if the food is displayed to 
the purchaser with its interstate labeling clearly in view, or with a 
counter card, sign, or other appropriate device bearing prominently and 
conspicuously the information required by these provisions.
    (3) Section 403(i)(1) of the act (requiring the label to bear the 
common or usual name of the food), if the food is displayed to the 
purchaser with its interstate labeling clearly in view, or with a 
counter card, sign, or other appropriate device bearing prominently and 
conspicuously the common or usual name of the food, or if the common or 
usual name of the food is clearly revealed by its appearance.
    (c) [Reserved]
    (d) Except as provided by paragraphs (e) and (f) of this section, a 
shipment or other delivery of a food which is, in accordance with the 
practice of the trade, to be processed, labeled, or repacked in 
substantial quantity at an establishment other than that where 
originally processed or packed, shall be exempt, during the time of 
introduction into and movement in interstate commerce and the time of 
holding in such establishment, from compliance with the labeling 
requirements of section 403 (c), (e), (g), (h), (i), (j) and (k) of the 
act if:
    (1) The person who introduced such shipment or delivery into 
interstate commerce is the operator of the establishment where such food 
is to be processed, labeled, or repacked; or
    (2) In case such person is not such operator, such shipment or 
delivery is made to such establishment under a written agreement, signed 
by and containing the post office addresses of such person and such 
operator, and containing such specifications for the processing, 
labeling, or repacking, as the case may be, of such food in such 
establishment as will ensure, if such specifications are followed, that 
such

[[Page 27]]

food will not be adulterated or misbranded within the meaning of the act 
upon completion of such processing, labeling, or repacking. Such person 
and such operator shall each keep a copy of such agreement until 2 years 
after the final shipment or delivery of such food from such 
establishment, and shall make such copies available for inspection at 
any reasonable hour to any officer or employee of the Department who 
requests them.
    (e) Conditions affecting expiration of exemptions.
    (1) An exemption of a shipment or other delivery of a food under 
paragraph (d)(1) of this section shall, at the beginning of the act of 
removing such shipment or delivery, or any part thereof, from such 
establishment become void ab initio if the food comprising such 
shipment, delivery, or part is adulterated or misbranded within the 
meaning of the act when so removed.
    (2) An exemption of a shipment or other delivery of a food under 
paragraph (d)(2) of this section shall become void ab initio with 
respect to the person who introduced such shipment or delivery into 
interstate commerce upon refusal by such person to make available for 
inspection a copy of the agreement, as required by paragraph (d)(2) of 
this section.
    (3) An exemption of a shipment or other delivery of a food under 
paragraph (d)(2) of this section shall expire:
    (i) At the beginning of the act of removing such shipment or 
delivery, or any part thereof, from such establishment if the food 
comprising such shipment, delivery, or part is adulterated or misbranded 
within the meaning of the act when so removed; or
    (ii) Upon refusal by the operator of the establishment where such 
food is to be processed, labeled, or repacked, to make available for 
inspection a copy of the agreement as required by such paragraph.
    (f) [Reserved]
    (g) The label declaration of a harmless marker used to identify a 
particular manufacturer's product may result in unfair competition 
through revealing a trade secret. Exemption from the label declaration 
of such a marker is granted, therefore, provided that the following 
conditions are met:
    (1) The person desiring to use the marker without label declaration 
of its presence has submitted to the Commissioner of Food and Drugs full 
information concerning the proposed usage and the reasons why he 
believes label declaration of the marker should be subject to this 
exemption; and
    (2) The person requesting the exemption has received from the 
Commissioner of Food and Drugs a finding that the marker is harmless and 
that the exemption has been granted.



Sec. 501.103  Petitions requesting exemptions from or special requirements for 

label declaration of ingredients.

    The Commissioner of Food and Drugs, either on his own initiative or 
on behalf of any interested person who has submitted a petition pursuant 
to part 10 of this chapter may issue a proposal to amend Sec. 501.4 to 
specify the manner in which an ingredient(s) shall be declared, i.e., by 
specific or class name, or Sec. 501.100 to exempt an ingredient(s) from 
the requirements for label declaration.

[41 FR 38619, Sept. 10, 1976, as amended at 42 FR 15675, Mar. 22, 1977]



Sec. 501.105  Declaration of net quantity of contents when exempt.

    (a) The principal display panel of a food in package form shall bear 
a declaration of the net quantity of contents. This shall be expressed 
in the terms of weight, measure, numerical count, or a combination of 
numerical count and weight or measure. The statement shall be in terms 
of fluid measure if the food is liquid, or in terms of weight if the 
food is solid, semisolid, or viscous, or a mixture of solid and liquid; 
except that such statement may be in terms of dry measure if the food is 
a fresh fruit, fresh vegetable, or other dry commodity that is 
customarily sold by dry measure. If there is a firmly established 
general consumer usage and trade custom of declaring the contents of a 
liquid by weight, or a solid, semisolid, or viscous product by fluid 
measure, it may be used. Whenever the Commissioner determines that an 
existing practice of declaring net quantity of contents by

[[Page 28]]

weight, measure, numerical count, or a combination in the case of a 
specific packaged food does not facilitate value comparisons by 
consumers and offers opportunity for consumer confusion, he will by 
regulation designate the appropriate term or terms to be used for such 
commodity.
    (b)(1) Statements of weight shall be in terms of avoirdupois pound 
and ounce.
    (2) Statements of fluid measure shall be in terms of the U.S. gallon 
of 231 cubic inches and quart, pint, and fluid ounce subdivisions 
thereof, and shall:
    (i) In the case of frozen food that is sold and consumed in a frozen 
state, express the volume at the frozen temperature.
    (ii) In the case of refrigerated food that is sold in the 
refrigerated state, express the volume at 40 [deg]F (4 [deg]C).
    (iii) In the case of other foods, express the volume at 68 [deg]F 
(20 [deg]C).
    (3) Statements of dry measure shall be in terms of the U.S. bushel 
of 2,150.42 cubic inches and peck, dry quart, and dry pint subdivisions 
thereof.
    (c) When the declaration of quantity of contents by numerical count 
does not give adequate information as to the quantity of food in the 
package, it shall be combined with such statement of weight, measure, or 
size of the individual units of the foods as will provide such 
information.
    (d) The declaration may contain common or decimal fractions. A 
common fraction shall be in terms of halves, quarters, eighths, 
sixteenths, or thirty-seconds; except that if there exists a firmly 
established general consumer usage and trade custom of employing 
different common fractions in the net quantity declaration of a 
particular commodity, they may be employed. A common fraction shall be 
reduced to its lowest terms; a decimal fraction shall not be carried out 
to more than two places. A statement that includes small fractions of an 
ounce shall be deemed to permit smaller variations than one which does 
not include such fractions.
    (e) The declaration shall be located on the principal display panel 
of the label, and with respect to packages bearing alternate principal 
panels it shall be duplicated on each principal display panel.
    (f) The declaration shall appear as a distinct item on the principal 
display panel, shall be separated (by at least a space equal to the 
height of the lettering used in the declaration) from other printed 
label information appearing above or below the declaration and (by at 
least a space equal to twice the width of the letter ``N'' of the style 
of type used in the quantity of contents statement) from other printed 
label information appearing to the left or right of the declaration. It 
shall not include any term qualifying a unit of weight, measure, or 
count (such as jumbo quart and full gallon) that tends to exaggerate the 
amount of the food in the container. It shall be placed on the principal 
display panel within the bottom 30 percent of the area of the label 
panel in lines generally parallel to the base on which the package rests 
as it is designed to be displayed: Provided, That on packages having a 
principal display panel of 5 square inches or less, the requirement for 
placement within the bottom 30 percent of the area of the label panel 
shall not apply when the declaration of net quantity of contents meets 
the other requirements of this part.
    (g) The declaration shall accurately reveal the quantity of food in 
the package exclusive of wrappers and other material packed therewith; 
provided that in the case of foods packed in containers designed to 
deliver the food under pressure, the declaration shall state the net 
quantity of the contents that will be expelled when the instructions for 
use as shown on the container are followed. The propellant is included 
in the net quantity declaration.
    (h) The declaration shall appear in conspicuous and easily legible 
boldface print or type in distinct contrast (by typography, layout, 
color, embossing, or molding) to other matter on the package; except 
that a declaration of net quantity blown, embossed, or molded on a glass 
or plastic surface is permissible when all label information is so 
formed on the surface. Requirements of conspicuousness and legibility 
shall include the specifications that:

[[Page 29]]

    (1) The ratio of height to width (of the letter) shall not exceed a 
differential of 3 units to 1 unit (no more than 3 times as high as it is 
wide).
    (2) Letter heights pertain to upper case or capital letters. When 
upper and lower case or all lower case letters are used, it is the lower 
case letter ``o'' or its equivalent that shall meet the minimum 
standards.
    (3) When fractions are used, each component numeral shall meet one-
half the minimum height standards.
    (i) The declaration shall be in letters and numerals in a type size 
established in relationship to the area of the principal display panel 
of the package and shall be uniform for all packages of substantially 
the same size by complying with the following type specifications:
    (1) Not less than \1/16\ inch in height on packages the principal 
display panel of which has an area of 5 square inches or less.
    (2) Not less than \1/8\ inch in height on packages the principal 
display panel of which has an area of more than 5 but not more than 25 
square inches.
    (3) Not less than \3/16\ inch in height on packages the principal 
display panel of which has an area of more than 25 but not more than 100 
square inches.
    (4) Not less than \1/4\ inch in height on packages the principal 
display panel of which has an area of more than 100 square inches, 
except not less than \1/2\ inch in height if the area is more than 400 
square inches.


Where the declaration is blown, embossed, or molded on a glass or 
plastic surface rather than by printing, typing, or coloring, the 
lettering sizes specified in paragraphs (i) (1) through (4) of this 
section shall be increased by \1/16\ of an inch.
    (j) On packages containing less than 4 pounds or 1 gallon and 
labeled in terms of weight or fluid measure:
    (1) The declaration shall be expressed both in ounces, with 
identification by weight or by liquid measure and, if applicable (1 
pound or 1 pint or more) followed in parentheses by a declaration in 
pounds for weight units, with any remainder in terms of ounces or common 
or decimal fractions of the pound (see examples set forth in paragraphs 
(m) (1) and (2) of this section), or in the case of liquid measure, in 
the largest whole units (quarts, quarts and pints, or pints, as 
appropriate) with any remainder in terms of fluid ounces or common or 
decimal fractions of the pint or quart (see examples in paragraphs (m) 
(3) and (4) of this section).
    (2) If the net quantity of contents declaration appears on a random 
package, that is a package which is one of a lot, shipment, or delivery 
of packages of the same consumer commodity with varying weights and with 
no fixed weight pattern, it may, when the net weight exceeds 1 pound, be 
expressed in terms of pounds and decimal fractions of the pound carried 
out to not more than two decimal places. When the net weight does not 
exceed 1 pound, the declaration on the random package may be in decimal 
fractions of the pound in lieu of ounces (see example in paragraph 
(m)(5) of this section).
    (3) The declaration may appear in more than one line. The term net 
weight shall be used when stating the net quantity of contents in terms 
of weight. Use of the terms net or net contents in terms of fluid 
measure or numerical count is optional. It is sufficient to distinguish 
avoirdupois ounce from fluid ounce through association of terms; for 
example, Net wt. 6 oz. or 6 oz. net wt. and 6 fl. oz. or net contents 6 
fl. oz.
    (k) On packages containing 4 pounds or 1 gallon or more and labeled 
in terms of weight or fluid measure, the declaration shall be expressed 
in pounds for weight units with any remainder in terms of ounces or 
common or decimal fraction of the pound, or in the case of fluid 
measure, it shall be expressed in the largest whole unit (gallons 
followed by common or decimal fraction of a gallon or by the next 
smaller whole unit or units (quarts, or quarts and pints)) with any 
remainder in terms of fluid ounces or common or decimal fractions of the 
pint or quart (see paragraph (m)(6) of this section).
    (l) [Reserved]
    (m) Examples: (1) A declaration of 1\1/2\ pounds weight shall be 
expressed as Net Wt. 24 oz. (1 lb. 8 oz.), Net Wt. 24 oz. (1\1/2\ lb.), 
or Net Wt. 24 oz. (1.5 lb.).
    (2) A declaration of \3/4\ pound avoirdupois weight shall be 
expressed as Net Wt. 12 oz.

[[Page 30]]

    (3) A declaration of 1 quart liquid measure shall be expressed as 
Net 32 fl. oz. (1 qt.).
    (4) A declaration of 1\3/4\ quarts liquid measure shall be expressed 
as Net contents 56 fluid ounces (1 quart 1\1/2\ pints) or as Net 56 
fluid oz. (1 qt. 1 pt. 8 oz.), but not in terms of quart and ounce such 
as Net 56 fluid oz. (1 quart 24 ounces).
    (5) On a random package, declaration of \3/4\ pound avoirdupois may 
be expressed as Net Wt. .75 lb.
    (6) A declaration of 2\1/2\ gallons liquid measure shall be 
expressed as Net contents 2\1/2\ gallons, Net contents 2.5 gallons, or 
Net contents 2 gallons 2 quarts and not as 2 gallons 4 pints.
    (n) For quantities, the following abbreviations and none other may 
be employed (periods and plural forms are optional):

weight wt.
ounce oz.
pound lb.
gallon gal.
pint pt.
quart qt.
fluid fl.

    (o) Nothing in this section shall prohibit supplemental statements 
at locations other than the principal display panel(s) describing in 
nondeceptive terms the net quantity of contents; provided, that such 
supplemental statements of net quantity of contents shall not include 
any term qualifying a unit of weight, measure, or count that tends to 
exaggerate the amount of the food contained in the package; for example, 
jumbo quart and full gallon. Dual or combination declarations of net 
quantity of contents as provided for in paragraphs (a), (c), and (j) of 
this section (for example, a combination of net weight plus numerical 
count, net contents plus dilution directions of a concentrate, etc.) are 
not regarded as supplemental net quantity statements and may be located 
on the principal display panel.
    (p) A separate statement of the net quantity of contents in terms of 
the metric system is not regarded as a supplemental statement and an 
accurate statement of the net quantity of contents in terms of the 
metric system of weight or measure may also appear on the principal 
display panel or on other panels.
    (q) The declaration of net quantity of contents shall express an 
accurate statement of the quantity of contents of the package. 
Reasonable variations caused by loss or gain of moisture during the 
course of good distribution practice or by unavoidable deviations in 
good manufacturing practice will be recognized. Variations from stated 
quantity of contents shall not be unreasonably large.
    (r) [Reserved]
    (s) On a multiunit retail package, a statement of the quantity of 
contents shall appear on the outside of the package and shall include 
the number of individual units, the quantity of each individual unit, 
and, in parentheses, the total quantity of contents of the multiunit 
package in terms of avoirdupois or fluid ounces, except that such 
declaration of total quantity need not be followed by an additional 
parenthetical declaration in terms of the largest whole units and 
subdivisions thereof, as required by paragraph (j)(1) of this section. A 
multiunit retail package may thus be properly labeled: 6-16 oz. 
bottles--(96 fl. oz.) or 3-16 oz. cans--(net wt. 48 oz). For the 
purposes of this section, multiunit retail package means a package 
containing two or more individually packaged units of the identical 
commodity and in the same quantity, intended to be sold as part of the 
multiunit retail package but capable of being individually sold in full 
compliance with all requirements of the regulations in this part. Open 
multiunit retail packages that do not obscure the number of units nor 
prevent examination of the labeling on each of the individual units are 
not subject to this paragraph if the labeling of each individual unit 
complies with the requirements of paragraphs (f) and (i) of this 
section.
    (t) Where the declaration of net quantity of contents is in terms of 
net weight and/or drained weight or volume and does not accurately 
reflect the actual quantity of the contents or the product falls below 
the applicable standard of fill of container because of equipment 
malfunction or otherwise unintentional product variation, and the label 
conforms in all other respects to the requirements of this chapter 
(except the requirement that food falling below the applicable standard 
of fill of container shall bear the general statement of substandard 
fill specified in

[[Page 31]]

Sec. 564.14(b) of this chapter), the mislabeled food product, including 
any food product that fails to bear the general statement of substandard 
fill specified in Sec. 564.14(b) of this chapter, may be sold by the 
manufacturer or processor directly to institutions operated by Federal, 
State or local governments: Provided, That:
    (1) The purchaser shall sign a statement at the time of sale stating 
that he is aware that the product is mislabeled to include 
acknowledgement of the nature and extent of the mislabeling, e.g., 
``Actual net weight may be as low as ----% below labeled quantity'' and 
that any subsequent distribution by him of said product except for his 
own institutional use is unlawful. This statement shall be kept on file 
at the principal place of business of the manufacturer or processor for 
2 years subsequent to the date of shipment of the product and shall be 
available to the Food and Drug Administration upon request.
    (2) The product shall be labeled on the outside of its shipping 
container with the statement(s):
    (i) When the variation concerns net weight and/or drained weight of 
volume--``Product Mislabeled. Actual net weight (drained weight or 
volume where appropriate) may be as low as ----% below labeled quantity. 
This Product Not for Retail Distribution,'' the blank to be filled in 
with the maximum percentage variance between the labeled and actual 
weight or volume of contents of the individual packages in the shipping 
container, and
    (ii) When the variation is in regard to a fill of container 
standard--``Product Mislabeled. Actual fill may be as low as ----% below 
standard of fill. This Product Not for Retail Distribution.''
    (3) The statements required by paragraphs (t)(2) (i) and (ii) of 
this section, which may be consolidated where appropriate, shall appear 
prominently and conspicuously as compared to other printed matter on the 
shipping container and in boldface print or type on a clear, contrasting 
background in order to render them likely to be read and understood by 
the purchaser under ordinary conditions of purchase.

[41 FR 38619, Sept. 10, 1976, as amended at 54 FR 18279, Apr. 28, 1989]



Sec. 501.110  Animal feed labeling; collective names for feed ingredients.

    (a) An animal feed shall be exempt from the requirements of section 
403(i)(2) of the act with respect to its label bearing the common or 
usual names of the animal feed ingredients listed in paragraph (b) of 
this section under the following prescribed conditions:
    (1) The animal feed is intended solely for livestock and poultry.
    (2) The label of the animal feed bears the collective name(s) 
prescribed in paragraph (b) of this section in lieu of the corresponding 
common or usual names of the individual feed ingredients contained 
therein.
    (3) The label of the animal feed otherwise conforms to the 
requirements of section 403(i)(2) of the act.
    (4) The ingredients of any feed listed in paragraph (b) of this 
section neither contain nor are food additives as defined in section 
201(s) of the act unless provided for by and in conformity with 
applicable regulations established pursuant to section 409 of the act.
    (b) Each collective name referred to in this paragraph may be used 
for the purpose of labeling where one or more of the ingredients listed 
for that collective name are present. The animal feed ingredients listed 
under each of the collective names are the products defined by the 
Association of American Feed Control Officials. The collective names are 
as follows:
    (1) Animal protein products include one or more of the following: 
Animal products, marine products, and milk products.
    (2) Forage products include one or more of the following: Alfalfa 
meals, entire plant meals, hays, and stem meals.
    (3) Grain products include one or more of the following: Barley, 
grain sorghums, maize (corn), oats, rice, rye, and wheat.
    (4) Plant protein products include one or more of the following: 
Algae meals, coconut meals (copra), cottonseed meals, guar meal, linseed 
meals, peanut meals, safflower meals, soybean meals, sunflower meals, 
and yeasts.
    (5) Processed grain byproducts include one or more of the following: 
Brans, brewers dried grains, distillers grains,

[[Page 32]]

distillers solubles, flours, germ meals, gluten feeds, gluten meals, 
grits, groats, hominy feeds, malt sprouts, middlings, pearled, 
polishings, shorts, and wheat mill run.
    (6) Roughage products include one or more of the following: Cobs, 
hulls, husks, pulps, and straws.



PART 502_COMMON OR USUAL NAMES FOR NONSTANDARDIZED ANIMAL FOODS--Table of 

Contents




Sec.
502.5 General principles.
502.19 Petitions.

    Authority: 21 U.S.C. 321, 343, 371.



Sec. 502.5  General principles.

    (a) The common or usual name of a food, which may be a coined term, 
shall accurately identify or describe, in as simple and direct terms as 
possible, the basic nature of the food or its characterizing properties 
or ingredients. The name shall be uniform among all identical or similar 
products and may not be confusingly similar to the name of any other 
food that is not reasonably encompassed within the same name. Each class 
or subclass of food shall be given its own common or usual name that 
states, in clear terms, what it is in a way that distinguishes it from 
different foods.
    (b) The common or usual name of a food shall include the 
percentage(s) of any characterizing ingredient(s) or component(s) when 
the proportion of such ingredient(s) or component(s) in the food has a 
material bearing on price or consumer acceptance or when the labeling or 
the appearance of the food may otherwise create an erroneous impression 
that such ingredient(s) or component(s) is present in an amount greater 
than is actually the case. The following requirements shall apply unless 
modified by a specific regulation in this part.
    (1) The percentage of a characterizing ingredient or component shall 
be declared on the basis of its quantity in the finished product (i.e., 
weight/weight in the case of solids, or volume/volume in the case of 
liquids).
    (2) The percentage of a characterizing ingredient or component shall 
be declared by the words ``containing (or contains) ---- percent (or %) 
----'' or ``---- percent (or %) ----'' with the first blank filled in 
with the percentage expressed as a whole number not greater than the 
actual percentage of the ingredient or component named and the second 
blank filled in with the common or usual name of the ingredient or 
component. The word ``containing'' (or ``contains''), when used, shall 
appear on a line immediately below the part of the common or usual name 
of the food required by paragraph (a) of this section. For each 
characterizing ingredient or component, the words ``---- percent (or %) 
----''shall appear following or directly below the word ``containing'' 
(or ``contains''), or directly below the part of the common or usual 
name of the food required by paragraph (a) of this section when the word 
``containing'' (or ``contains'') is not used, in easily legible boldface 
print or type in distinct contrast to other printed or graphic matter, 
and in a height not less than the larger of the following alternatives:
    (i) Not less than one-sixteenth inch in height on packages having a 
principal display panel with an area of 5 square inches or less and not 
less than one-eighth inch in height if the area of the principal display 
panel is greater than 5 square inches; or
    (ii) Not less than one-half the height of the largest type appearing 
in the part of the common or usual name of the food required by 
paragraph (a) of this section.
    (c) The common or usual name of a food shall include a statement of 
the presence or absence of any characterizing ingredient(s) or 
component(s) and/or the need for the user to add any characterizing 
ingredient(s) or component(s) when the presence or absence of such 
ingredient(s) or component(s) in the food has a material bearing on 
price or consumer acceptance or when the labeling or the appearance of 
the food may otherwise create an erroneous impression that such 
ingredient(s) or component(s) is present when it is not, and consumers 
may otherwise be misled about the presence or absence of the 
ingredient(s) or component(s) in the food. The following requirements 
shall apply unless modified by a specific regulation in this part.

[[Page 33]]

    (1) The presence or absence of a characterizing ingredient or 
component shall be declared by the words ``containing (or contains) ----
----'' or ``containing (or contains) ----------'' or ``no ----------'' 
or ``does not contain ----------'', with the blank being filled in with 
the common or usual name of the ingredient or component.
    (2) The need for the user of a food to add any characterizing 
ingredient(s) or component(s) shall be declared by an appropriate 
informative statement.
    (3) The statement(s) required under paragraph (c) (1) and/or (2) of 
this section shall appear following or directly below the part of the 
common or usual name of the food required by paragraphs (a) and (b) of 
this section, in easily legible boldface print or type in distinct 
contrast to other printed or graphic matter, and in a height not less 
than the larger of the alternatives established under paragraph (b)(2) 
(i) and (ii) of this section.
    (d) A common or usual name of a food may be established by common 
usage or by establishment of a regulation in this part, in a standard of 
identity, or in other regulations in this chapter.

[41 FR 38627, Sept. 10, 1976. Redesignated at 42 FR 14091, Mar. 15, 
1977]



Sec. 502.19  Petitions.

    (a) The Commissioner of Food and Drugs, either on his own initiative 
or on behalf of any interested person who has submitted a petition, may 
publish a proposal to issue, amend, or revoke, under this part, a 
regulation prescribing a common or usual name for a food, pursuant to 
part 10 of this chapter.
    (b) If the principal display panel of a food for which a common or 
usual name regulation is established is too small to accommodate all 
mandatory requirements, the Commissioner may establish by regulation an 
acceptable alternative, e.g., a smaller type size. A petition requesting 
such a regulation, which would amend the applicable regulation, shall be 
submitted pursuant to part 10 of this chapter.

[42 FR 4716, Jan. 25, 1977; 42 FR 10980, Feb. 25, 1977. Redesignated at 
42 FR 14091, Mar. 15, 1977, and amended at 42 FR 15675, Mar. 22, 1977; 
42 FR 24254, May 13, 1977]



PART 509_UNAVOIDABLE CONTAMINANTS IN ANIMAL FOOD AND FOOD-PACKAGING MATERIAL--

Table of Contents




                      Subpart A_General Provisions

Sec.
509.3 Definitions and interpretations.
509.4 Establishment of tolerances, regulatory limits, and action levels.
509.5 Petitions.
509.6 Added poisonous or deleterious substances.
509.7 Unavoidability.
509.15 Use of polychlorinated biphenyls (PCB's) in establishments 
          manufacturing food-packaging materials.

Subpart B_Tolerances for Unavoidable Poisonous or Deleterious Substances

509.30 Temporary tolerances for polychlorinated biphenyls (PCB's).

Subpart C--Regulatory Limits for Added Poisonous or Deleterious Substances 
[Reserved]

Subpart D--Naturally Occurring Poisonous or Deleterious Substances 
[Reserved]

    Authority: 21 U.S.C. 336, 342, 346, 346a, 348, 371.

    Source: 42 FR 52821, Sept. 30, 1977, unless otherwise noted.



                      Subpart A_General Provisions



Sec. 509.3  Definitions and interpretations.

    (a) Act means the Federal Food, Drug, and Cosmetic Act.
    (b) The definitions of terms contained in section 201 of the act are 
applicable to such terms when used in this part unless modified in this 
section.
    (c) A naturally occurring poisonous or deleterious substance is a 
poisonous or deleterious substance that is an inherent natural 
constituent of a food and is not the result of environmental, 
agricultural, industrial, or other contamination.
    (d) An added poisonous or deleterious substance is a poisonous or 
deleterious substance that is not a naturally occurring poisonous or 
deleterious substance. When a naturally occurring poisonous or 
deleterious substance is increased to abnormal levels through

[[Page 34]]

mishandling or other intervening acts, it is an added poisonous or 
deleterious substance to the extent of such increase.
    (e) Food includes pet food, animal feed, and substances migrating to 
food from food-contact articles.



Sec. 509.4  Establishment of tolerances, regulatory limits, and action levels.

    (a) When appropriate under the criteria of Sec. 509.6, a tolerance 
for an added poisonous or deleterious substance, which may be a food 
additive, may be established by regulation in subpart B of this part 
under the provisions of section 406 of the act. A tolerance may prohibit 
any detectable amount of the substance in food.
    (b) When appropriate under the criteria of Sec. 509.6, and under 
section 402(a)(1) of the act, a regulatory limit for an added poisonous 
or deleterious substance, which may be a food additive, may be 
established by regulation in subpart C of this part under the provisions 
of sections 402(a)(1) and 701(a) of the act. A regulatory limit may 
prohibit any detectable amount of the substance in food. The regulatory 
limit established represents the level at which food is adulterated 
within the meaning of section 402(a)(1) of the act.
    (c)(1) When appropriate under the criteria of Sec. 509.6, an action 
level for an added poisonous or deleterious substance, which may be a 
food additive, may be established to define a level of contamination at 
which a food may be regarded as adulterated.
    (2) Whenever an action level is established or changed, a notice 
shall be published in the Federal Register as soon as practicable 
thereafter. The notice shall call attention to the material supporting 
the action level which shall be on file with the Division of Dockets 
Management before the notice is published. The notice shall invite 
public comment on the action level.
    (d) A regulation may be established in subpart D of this part to 
identify a food containing a naturally occurring poisonous or 
deleterious substance which will be deemed to be adulterated under 
section 402(a)(1) of the act. These regulations do not constitute a 
complete list of such foods.

[42 FR 52821, Sept. 30, 1977, as amended at 55 FR 20786, May 21, 1990]



Sec. 509.5  Petitions.

    The Commissioner of Food and Drugs, either on his own initiative or 
on behalf of any interested person who has submitted a petition, may 
issue a proposal to establish, revoke, or amend a regulation under this 
part. Any such petition shall include an adequate factual basis to 
support the petition, shall be in the form set forth in Sec. 10.30 of 
this chapter, and will be published in the Federal Register for comment 
if it contains reasonable grounds for the proposed regulation.

[42 FR 52821, Sept. 30, 1977, as amended at 54 FR 18280, Apr. 28, 1989]



Sec. 509.6  Added poisonous or deleterious substances.

    (a) Use of an added poisonous or deleterious substance, other than a 
pesticide chemical, that is also a food additive will be controlled by a 
regulation issued under section 409 of the act when possible. When such 
a use cannot be approved under the criteria of section 409 of the act, 
or when the added poisonous or deleterious substance is not a food 
additive, a tolerance, regulatory limit, or action level may be 
established pursuant to the criteria in paragraphs (b), (c), or (d) of 
this section. Residues resulting from the use of an added poisonous or 
deleterious substance that is also a pesticide chemical will ordinarily 
be controlled by a tolerance established in a regulation issued under 
sections 406, 408, or 409 of the act by the U.S. Environmental 
Protection Agency (EPA). When such a regulation has not been issued, an 
action level for an added poisonous or deleterious substance that is 
also a pesticide chemical may be established by the Food and Drug 
Administration. The Food and Drug Administration will request EPA to 
recommend such an action level pursuant to the criteria established in 
paragraph (d) of this section.
    (b) A tolerance for an added poisonous or deleterious substance in 
any food may be established when the following criteria are met:

[[Page 35]]

    (1) The substance cannot be avoided by good manufacturing practice.
    (2) The tolerance established is sufficient for the protection of 
the public health, taking into account the extent of which the presence 
of the substance cannot be avoided and the other ways in which the 
consumer may be affected by the same or related poisonous or deleterious 
substances.
    (3) No technological or other changes are foreseeable in the near 
future that might affect the appropriateness of the tolerance 
established. Examples of changes that might affect the appropriateness 
of the tolerance include anticipated improvements in good manufacturing 
practice that would change the extent to which use of the substance is 
unavoidable and anticipated studies expected to provide significant new 
toxicological or use data.
    (c) A regulatory limit for an added poisonous or deleterious 
substance in any food may be established when each of the following 
criteria is met:
    (1) The substance cannot be avoided by current good manufacturing 
practices.
    (2) There is no tolerance established for the substance in the 
particular food under sections 406, 408, or 409 of the act.
    (3) There is insufficient information by which a tolerance may be 
established for the substance under section 406 of the act or 
technological changes appear reasonably possible that may affect the 
appropriateness of a tolerance. The regulatory limit established 
represents the level at which food is adulterated within the meaning of 
section 402(a)(1) of the act.
    (d) An action level for an added poisonous or deleterious substance 
in any food may be established when the criteria in paragraph (b) of 
this section are met, except that technological or other changes that 
might affect the appropriateness of the tolerance are foreseeable in the 
near future. An action level for an added poisonous or deleterious 
substance in any food may be established at a level at which the Food 
and Drug Administration may regard the food as adulterated within the 
meaning of section 402(a)(1) of the act, without regard to the criteria 
in paragraph (b) of this section or in section 406 of the act. An action 
level will be withdrawn when a tolerance or regulatory limit for the 
same substance and use has been established.
    (e) Tolerances will be established under authority appropriate for 
action levels (sections 306, 402(a), and 701(a) of the act, together 
with section 408 or 409 of the act, if appropriate) as well as under 
authority appropriate for tolerances (sections 406 and 701 of the act). 
In the event the effectiveness of a tolerance is stayed pursuant to 
section 701(e)(2) of the act by the filing of an objection, the order 
establishing the tolerance shall be deemed to be an order establishing 
an action level until final action is taken upon such objection.

[42 FR 52821, Sept. 30, 1977, as amended at 55 FR 20786, May 21, 1990]



Sec. 509.7  Unavoidability.

    (a) Tolerances and action levels in this part are established at 
levels based on the unavoidability of the poisonous or deleterious 
substance concerned and do not establish a permissible level of 
contamination where it is avoidable.
    (b) Compliance with tolerances, regulatory limits, and action levels 
does not excuse failure to observe either the requirement in section 
402(a)(4) of the act that food may not be prepared, packed, or held 
under insanitary conditions or the other requirements in this chapter 
that food manufacturers must observe current good manufacturing 
practices. Evidence obtained through factory inspection or otherwise 
indicating such a violation renders the food unlawful, even though the 
amounts of poisonous or deleterious substances are lower than the 
currently established tolerances, regulatory limits, or action levels. 
The manufacturer of food must at all times utilize quality control 
procedures which will reduce contamination to the lowest level currently 
feasible.

[42 FR 52821, Sept. 30, 1977, as amended at 55 FR 20786, May 21, 1990]



Sec. 509.15  Use of polychlorinated biphenyls (PCB's) in establishments 

manufacturing food-packaging materials.

    (a) Polychlorinated biphenyls (PCB's) represent a class of toxic 
industrial chemicals manufactured and sold under

[[Page 36]]

a variety of trade names, including: Aroclor (United States); Phenoclor 
(France); Colphen (Germany); and Kanaclor (Japan). PCB's are highly 
stable, heat resistant, and nonflammable chemicals. Industrial uses of 
PCB's include, or did include in the past, their use as electrical 
transformer and capacitor fluids, heat transfer fluids, hydraulic 
fluids, and plasticizers, and in formulations of lubricants, coatings, 
and inks. Their unique physical and chemical properties and widespread, 
uncontrolled industrial applications have caused PCB's to be a 
persistent and ubiquitous contaminant in the environment, causing the 
contamination of certain foods. In addition, incidents have occurred in 
which PCB's have directly contaminated animal feeds as a result of 
industrial accidents (leakage or spillage of PCB fluids from plant 
equipment). These accidents in turn caused the contamination of food 
products intended for human consumption (meat, milk and eggs). 
Investigations by the Food and Drug Administration have revealed that a 
significant percentage of paper food-packaging material contains PCB's 
which can migrate to the packaged food. The origin of PCB's in such 
material is not fully understood. Reclaimed fibers containing carbonless 
copy paper (contains 3 to 5 percent PCB's) have been identified as a 
primary source of PCB's in paper products. Some virgin paper products 
have also been found to contain PCB's, the source of which is generally 
attributed to direct contamination from industrial accidents from the 
use of PCB-containing equipment and machinery in food-packaging 
manufacturing establishments. Since PCB's are toxic chemicals, the PCB 
contamination of food-packaging materials as a result of industrial 
accidents, which can cause the PCB contamination of food, represents a 
hazard to public health. It is therefore necessary to place certain 
restrictions on the industrial uses of PCB's in establishments 
manufacturing food-packaging materials.
    (b) The following special provisions are necessary to preclude the 
accidental PCB contamination of food-packaging materials:
    (1) New equipment or machinery for manufacturing food-packaging 
materials shall not contain or use PCB's.
    (2) On or before September 4, 1973, the management of establishments 
manufacturing food-packaging materials shall:
    (i) Have the heat exchange fluid used in existing equipment for 
manufacturing food-packaging materials sampled and tested to determine 
whether it contains PCB's or verify the absence of PCB's in such 
formulations by other appropriate means. On or before Sept. 4, 1973, any 
such fluid formulated with PCB's must to the fullest extent possible 
commensurate with current good manufacturing practices be replaced with 
a heat exchange fluid that does not contain PCB's.
    (ii) Eliminate to the fullest extent possible commensurate with 
current good manufacturing practices from the establishment any other 
PCB-containing equipment, machinery and materials wherever there is a 
reasonable expectation that such articles could cause food-packaging 
materials to become contaminated with PCB's either as a result of normal 
use or as a result of accident, breakage, or other mishap.
    (iii) The toxicity and other characteristics of fluids selected as 
PCB replacements must be adequately determined so that the least 
potentially hazardous replacement is used. In making this determination 
with respect to a given fluid, consideration should be given to (a) its 
toxicity; (b) the maximum quantity that could be spilled onto a given 
quantity of food before it would be noticed, taking into account its 
color and odor; (c) possible signaling devices in the equipment to 
indicate a loss of fluid, etc.; and (d) its environmental stability and 
tendency to survive and be concentrated through the food chain. The 
judgment as to whether a replacement fluid is sufficiently non-hazardous 
is to be made on an individual installation and operation basis.
    (c) The provisions of this section do not apply to electrical 
transformers and condensers containing PCB's in sealed containers.

[[Page 37]]



Subpart B_Tolerances for Unavoidable Poisonous or Deleterious Substances



Sec. 509.30  Temporary tolerances for polychlorinated biphenyls (PCB's).

    (a) Polychlorinated biphenyls (PCB's) are toxic, industrial 
chemicals. Because of their widespread, uncontrolled industrial 
applications, PCB's have become a persistent and ubiquitous contaminant 
in the environment. As a result, certain foods and animal feeds, 
principally those of animal and marine origin, contain PCB's as 
unavoidable, environmental contaminants. PCB's are transmitted to the 
food portion (meat, milk, and eggs) of food producing animals ingesting 
PCB contaminated animal feed. In addition, a significant percentage of 
paper food-packaging materials contain PCB's which may migrate to the 
packaged food. The source of PCB's in paper food-packaging materials is 
primarily of certain types of carbonless copy paper (containing 3 to 5 
percent PCB's) in waste paper stocks used for manufacturing recycled 
paper. Therefore, temporary tolerances for residues of PCB's as 
unavoidable environmental or industrial contaminants are established for 
a sufficient period of time following the effective date of this 
paragraph to permit the elimination of such contaminants at the earliest 
practicable time. For the purposes of this paragraph, the term 
polychlorinated biphenyls (PCB's) is applicable to mixtures of 
chlorinated biphenyl compounds, irrespective of which mixture of PCB's 
is present as the residue. The temporary tolerances for residues of 
PCB's are as follows:
    (1) 0.2 part per million in finished animal feed for food-producing 
animals (except the following finished animal feeds: feed concentrates, 
feed supplements, and feed premixes).
    (2) 2 parts per million in animal feed components of animal origin, 
including fishmeal and other by-products of marine origin and in 
finished animal feed concentrates, supplements, and premixes intended 
for food-producing animals.
    (3) 10 parts per million in paper food-packaging material intended 
for or used with finished animal feed and any components intended for 
animal feeds. The tolerance shall not apply to paper food-packaging 
material separated from the food therein by a functional barrier which 
is impermeable to migration of PCB's.
    (b) A compilation entitled ``Analytical Methodology for 
Polychlorinated Biphenyls, February 1973'' for determining compliance 
with the tolerances established in this section is available from the 
Division of Dockets Management, Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852.

[42 FR 52821, Sept. 30, 1977, as amended at 46 FR 8460, Jan. 27, 1981; 
59 FR 14365, Mar. 28, 1994; 68 FR 24879, May 9, 2003]

Subpart C--Regulatory Limits for Added Poisonous or Deleterious Substances 
[Reserved]

Subpart D--Naturally Occurring Poisonous or Deleterious Substances 
[Reserved]



PART 510_NEW ANIMAL DRUGS--Table of Contents




                      Subpart A_General Provisions

Sec.
510.3 Definitions and interpretations.
510.4 Biologics; products subject to license control.
510.7 Consignees of new animal drugs for use in the manufacture of 
          animal feed.
510.95 [Reserved]

         Subpart B_Specific Administrative Rulings and Decisions

510.105 Labeling of drugs for use in milk-producing animals.
510.106 Labeling of antibiotic and antibiotic-containing drugs intended 
          for use in milk-producing animals.
510.110 Antibiotics used in food-producing animals.
510.112 Antibiotics used in veterinary medicine and for nonmedical 
          purposes; required data.

Subpart C [Reserved]

                      Subpart D_Records and Reports

510.301 Records and reports concerning experience with animal feeds 
          bearing or containing new animal drugs for which an approved 
          medicated feed mill license application is in effect.

[[Page 38]]

510.305 Maintenance of copies of approved medicated feed mill licenses 
          to manufacture animal feed bearing or containing new animal 
          drugs.

          Subpart E_Requirements for Specific New Animal Drugs

510.410 Corticosteroids for oral, injectable, and ophthalmic use in 
          animals; warnings and labeling requirements.
510.440 Injectable iron preparations.
510.455 Requirements for free-choice medicated feeds.

Subpart F [Reserved]

               Subpart G_Sponsors of Approved Applications

510.600 Names, addresses, and drug labeler codes of sponsors of approved 
          applications.

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

    Source: 40 FR 13807, Mar. 27, 1975, unless otherwise noted.



                      Subpart A_General Provisions



Sec. 510.3  Definitions and interpretations.

    As used in this part:
    (a) The term act means the Federal Food, Drug, and Cosmetic Act, as 
amended (secs. 201-902, 52 Stat. 1040 et seq., as amended; 21 U.S.C. 
321-392).
    (b) Department means the Department of Health and Human Services.
    (c) Secretary means the Secretary of Health and Human Services.
    (d) Commissioner means the Commissioner of Food and Drugs.
    (e) Person means individuals, partnerships, corporations, and 
associations.
    (f) The definitions and interpretations of terms contained in 
section 201 of the act shall be applicable to such terms when used in 
the regulations in this part.
    (g) The term new animal drug means any drug intended for use for 
animals other than man, including any drug intended for use in animal 
feed but not including such animal feed:
    (1) The composition of which is such that such drug is not generally 
recognized, among experts qualified by scientific training and 
experience to evaluate the safety and effectiveness of animal drugs, as 
safe and effective for use under the conditions prescribed, recommended, 
or suggested in the labeling thereof; except that such a drug not so 
recognized shall not be deemed to be a new animal drug if at any time 
prior to June 25, 1938, it was subject to the Food and Drug Act of June 
30, 1906, as amended, and if at such time its labeling contained the 
same representations concerning the conditions of its use; or
    (2) The composition of which is such that such drug, as a result of 
investigations to determine its safety and effectiveness for use under 
such conditions, has become so recognized but which has not, otherwise 
than in such investigations, been used to a material extent or for a 
material time under such conditions.
    (h) The term animal feed means an article which is intended for use 
for food for animals other than man and which is intended for use as a 
substantial source of nutrients in the diet of the animal, and is not 
limited to a mixture intended to be the sole ration of the animal.
    (i) The newness of an animal drug, including a new animal drug 
intended for use in or on animal feed, may arise by reason of: (1) The 
newness for its intended drug use of any substance of which the drug is 
comprised, in whole or in part, whether it be an active substance or a 
menstruum, excipient, carrier, coating, or other component; (2) the 
newness for its intended drug use of a combination of two or more 
substances, none of which is itself a new animal drug; (3) the newness 
for its intended drug use of the proportion of a substance in a 
combination, even though such combination containing such substance in 
other proportion is not a new animal drug; (4) the newness for its 
intended drug use in a different species of animal; (5) the newness of 
its intended drug use in diagnosing, curing, mitigating, treating, or 
preventing a disease, or to affect a structure or function of the animal 
body, even though such drug is not a new animal drug when used in 
another disease or to affect another structure or function of the body; 
or (6) the newness of a dosage, or method or duration of administration 
or application, or any other condition of use prescribed, recommended, 
or suggested in the labeling

[[Page 39]]

of such drug, even though such drug or animal feed containing such drug 
when used in another dosage, or another method or duration of 
administration or application, or different condition, is not a new 
animal drug.
    (j) Animals used only for laboratory research and laboratory 
research animals mean individual animals or groups of animals intended 
for use and used solely for laboratory research purposes, regardless of 
species, and does not include animals intended to be used for any food 
purposes or animals intended to be kept as livestock.
    (k) Sponsor means the person requesting designation for a minor-use 
or minor-species drug as defined in part 516 of this chapter, who must 
be the real party in interest of the development and the intended or 
actual production and sales of such drug (in this context, the sponsor 
may be an individual, partnership, organization, or association). 
Sponsor also means the person responsible for an investigation of a new 
animal drug. In this context, the sponsor may be an individual, 
partnership, corporation, or Government agency or may be a manufacturer, 
scientific institution, or an investigator regularly and lawfully 
engaged in the investigation of new animal drugs. Sponsor also means the 
person submitting or receiving approval for a new animal drug 
application (in this context, the sponsor may be an individual, 
partnership, organization, or association). In all contexts, the sponsor 
is responsible for compliance with applicable provisions of the act and 
regulations.

[40 FR 13807, Mar. 27, 1975, as amended at 50 FR 7517, Feb. 22, 1985; 54 
FR 22741, May 26, 1989; 64 FR 69190, Dec. 10, 1999; 72 FR 41017, July 
26, 2007]



Sec. 510.4  Biologics; products subject to license control.

    An animal drug produced and distributed in full conformance with the 
animal virus, serum, and toxin law of March 4, 1913 (37 Stat. 832; 21 
U.S.C. 151 et seq. ) and any regulations issued thereunder shall not be 
deemed to be subject to section 512 of the Federal Food, Drug, and 
Cosmetic Act.



Sec. 510.7  Consignees of new animal drugs for use in the manufacture of animal feed.

    (a) A new animal drug intended for use in the manufacture of animal 
feed shall be deemed to be unsafe unless at the time of its removal from 
the establishment of a manufacturer, packer, or distributor of such 
drug, such manufacturer, packer, or distributor has an unrevoked written 
statement from the consignee of such drug, or a notice from the 
Secretary, to the effect that with respect to the use of such drug in 
animal feed the consignee:
    (1) Holds a license issued under Sec. 515.20 of this chapter; or
    (2) Will, if the consignee is not the user of the drug, ship such 
drug only to a holder of an approved application under Sec. 515.10 of 
this chapter.
    (b) The requirements of paragraph (a) of this section do not apply:
    (1) Where such drugs are intended for export and/or
    (2) When the use of such drug in the manufacture of a finished feed 
has been exempted from the requirements of section 512(m) of the act 
under the conditions specified by regulations published in part 558 of 
this chapter.

[40 FR 13807, Mar. 27, 1975, as amended at 64 FR 63203, Nov. 19, 1999]



Sec. 510.95  [Reserved]



         Subpart B_Specific Administrative Rulings and Decisions



Sec. 510.105  Labeling of drugs for use in milk-producing animals.

    (a) Part 526 of this chapter provides for new animal drugs intended 
for intramammary use in animals and includes conditions of use intended 
to prevent the contamination of milk from the use of such drugs.
    (b) Preparations containing antibiotics and other potent drugs 
labeled with directions for use in milk-producing animals will be 
misbranded under section 502(f)(2) of the act unless their labeling 
bears appropriate warnings and directions for use to avoid adulteration 
of milk under section 402(a)(2)(c)(ii) of the act.
    (c) It is the position of the Food and Drug Administration that the 
labeling

[[Page 40]]

for such preparations should bear a clear warning that either:
    (1) The article should not be administered to animals producing 
milk, since to do so would result in contamination of the milk; or
    (2) The label should bear the following statement: ``Warning: Milk 
that has been taken from animals during treatment and for ---- hours 
after the latest treatment must not be used for food'', the blank being 
filled in with the figure that the manufacturer has determined by 
appropriate investigation is needed to insure that the milk will not 
carry violative residues resulting from use of the preparation. If the 
use of the preparation as recommended does not result in contamination 
of the milk, neither of the above warning statements is required.

[40 FR 13807, Mar. 27, 1975, as amended at 63 FR 32980, June 17, 1998; 
64 FR 51241, Sept. 22, 1999]



Sec. 510.106  Labeling of antibiotic and antibiotic-containing drugs intended 

for use in milk-producing animals.

    Whenever the labeling of an antibiotic drug included in the 
regulations in this chapter suggests or recommends its use in milk-
producing animals, the label of such drugs shall bear either the 
statement ``Warning: Not for use in animals producing milk, since this 
use will result in contamination of the milk'' or the statement 
``Warning: Milk that has been taken from animals during treatment and 
for ----hours after the latest treatment must not be used for food'', 
the blank being filled in with the figure that the Commissioner has 
authorized the manufacturer of the drug to use. The Commissioner shall 
determine what such figures shall be from information submitted by the 
manufacturer and which the Commissioner considers is adequate to prove 
that period of time after the latest treatment that the milk from 
treated animals will contain no violative residues from use of the 
preparation. If the Commissioner determines from the information 
submitted that the use of the antibiotic drug as recommended does not 
result in its appearance in the milk, the Commissioner may exempt the 
drug from bearing either of the above warning statements.

[63 FR 32980, June 17, 1998]



Sec. 510.110  Antibiotics used in food-producing animals.

    (a) The Food and Drug Administration in the interest of fulfilling 
its responsibilities with regard to protection of the public health has 
requested an evaluation of the public health aspects of the use of 
antibiotics in veterinary medical and nonmedical uses. There is 
particular concern with regard to the potential hazards associated with 
the extensive use of antibiotics administered to food-producing animals. 
Accordingly, an ad hoc committee on the Veterinary Medical and 
Nonmedical Uses of Antibiotics was established by the Food and Drug 
Administration to study and advise the Commissioner of Food and Drugs on 
the uses of antibiotics in veterinary medicine and for various 
nonmedical purposes as such uses may affect the enforcement of the 
Federal Food, Drug, and Cosmetic Act with respect to their safety and 
effectiveness.
    (b) Based upon an evaluation of the conclusions of said Committee 
and other relevant material, Sec. 510.112 was published in the Federal 
Register of August 23, 1966 (31 FR 11141), asking sponsors of drugs 
containing any antibiotic intended for use in food-producing animals to 
submit data to establish whether such antibiotic and its metabolites are 
present as residues in edible tissues, milk, and eggs from treated 
animals. The data on the residues of antibiotics in milk from 
intramammary infusion preparations were requested within 60 days and the 
data on all other products were requested within 180 days following the 
date of publication of Sec. 510.112 in the Federal Register.
    (c) An evaluation of the data now available shows that use of many 
antibiotic preparations cause residues in edible products of treated 
animals for varying and, in some cases, for long periods of time 
following the last administration. Because of the accumulation of new 
information with regard to the development of resistance of bacteria to 
antibiotics, the ability of bacteria to

[[Page 41]]

transfer this resistance, and the development of sensitivity to 
antibiotics in humans, unauthorized and unsafe residues of antibiotics 
cannot be permitted in food obtained from treated animals.
    (d) Based on evaluation of information available, including the 
conclusions of the aforementioned ad hoc Committee, the Commissioner 
concludes that antibiotic preparations intended for use in food-
producing animals, other than topical and ophthalmic preparations, are 
not generally recognized among qualified experts as having been shown to 
be safe for their intended use(s) within the meaning of section 201(s) 
of the Federal Food, Drug, and Cosmetic Act.
    (e) Therefore, all exemptions from the provisions of section 409 of 
the act for use of antibiotics in food-producing animals based on 
sanctions or approvals granted prior to enactment of the Food Additives 
Amendment of 1958 (Pub. L. 85-929; 72 Stat. 1784) will be revoked and 
the uses which are concluded to be safe will be covered by food additive 
regulations. On those products for which there are inadequate residue 
data, actions will be initiated to withdraw approval of new-drug 
applications under the provisions of section 505 of the act. Antibiotic 
preparations, other than those for topical and ophthalmic application in 
food-producing animals, which are not covered by food additive 
regulations will be subject to regulatory action within 180 days after 
publication of the forthcoming revocation order.
    (f) Because of the variation in the period of time that antibiotic 
residues may remain in edible products from treated animals, all 
injectable, intramammary infusion, intrauterine, and oral preparations, 
including medicated premixes intended for use in food-producing animals, 
are deemed to be new drugs as well as food additives.

[40 FR 13807, Mar. 27, 1975, as amended at 54 FR 18280, Apr. 28, 1989; 
64 FR 403, Jan. 5, 1999]



Sec. 510.112  Antibiotics used in veterinary medicine and for nonmedical 

purposes; required data.

    (a) An ad hoc committee, Committee on the Veterinary Medical and 
Nonmedical Uses of Antibiotics, was formed by the Food and Drug 
Administration to study, and advise the Commissioner on, the use of 
antibiotics in veterinary medicine and for various nonmedical purposes 
as such uses may affect the enforcement of the Federal Food, Drug, and 
Cosmetic Act with respect to the safety and effectiveness of such 
substances. A copy of the report may be obtained from the Food and Drug 
Administration, Office of Public Affairs, Room 15-05, Parklawn Building, 
5600 Fishers Lane, Rockville, MD 20857.
    (b) On the basis of the report of the Committee and other 
information, sponsors of drugs containing any antibiotic intended for 
use in food-producing animals shall submit data for determining whether 
or not such antibiotics and their metabolites are present as residues in 
edible tissues, milk, and eggs from treated animals; however, in the 
case of a drug for which such data have already been submitted and for 
which a regulation has been promulgated under section 409 of the act, 
only such data as has been accumulated since the issuance of the 
regulation need be submitted.
    (c) The required data shall be submitted within 180 days of the date 
of publication of this section in the Federal Register; except that in 
the case of data on intramammary infusion preparations the data shall be 
submitted within 60 days of such publication. Data demonstrating the 
absence in milk of residues of intramammary infusion preparations when 
used as directed in their labeling are needed within the 60-day period 
because of the importance of milk in the human diet.
    (d) Regulatory proceedings including revocation of prior sanctions, 
or actions to suspend or amend new drug or antibiotic approvals granted 
prior to passage of the Food Additives Amendment of 1958 (72 Stat. 
1784), may be initiated with regard to the continued marketing of any 
antibiotic preparation on which the required information is not 
submitted within the period of time prescribed by paragraph (c) of this 
section.
    (e) Questions relating to the acceptability of proposed research 
protocols and assay methods for determining the amount of antibiotic 
residues in food

[[Page 42]]

should be directed to the Director, Center for Veterinary Medicine, Food 
and Drug Administration, 7500 Standish Pl., Rockville, MD 20855.

[40 FR 13807, Mar. 27, 1975, as amended at 46 FR 8460, Jan. 27, 1981; 54 
FR 18280, Apr. 28, 1989; 57 FR 6475, Feb. 25, 1992]

Subpart C [Reserved]



                      Subpart D_Records and Reports



Sec. 510.301  Records and reports concerning experience with animal feeds 

bearing or containing new animal drugs for which an approved medicated feed 

mill license application is in effect.

    Records and reports of clinical and other experience with the new 
animal drug will be maintained and reported, appropriately identified 
with the new animal drug application(s) or index listing(s) to which 
they relate, to the Center for Veterinary Medicine in duplicate in 
accordance with the following:
    (a) Immediately upon receipt by the applicant, complete records or 
reports covering information of the following kinds:
    (1) Information concerning any mixup in the new animal drug or its 
labeling with another article.
    (2) Information concerning any bacteriological or any significant 
chemical, physical, or other change or deterioration in the drug, or any 
failure of one or more distributed batches of the drug to meet the 
specifications established for it in the new animal drug application or 
request for determination of eligibility for indexing.
    (b) As soon as possible, and in any event within 15 working days of 
its receipt by the applicant, complete records or reports concerning any 
information of the following kinds:
    (1) Information concerning any unexpected side effect, injury, 
toxicity, or sensitivity reaction or any unexpected incidence or 
severity thereof associated with clinical uses, studies, investigations, 
or tests, whether or not determined to be attributable to the new animal 
drug, except that this requirement shall not apply to the submission of 
information described in a written communication to the applicant from 
the Food and Drug Administration as types of information that may be 
submitted at other designated intervals. Unexpected as used in this 
paragraph refers to conditions or developments not previously submitted 
as part of the new animal drug application or in support of the index 
listing or not encountered during clinical trials of the drug, or 
conditions or developments occurring at a rate higher than shown by 
information previously submitted as part of the new animal drug 
application or in support of the index listing or at a rate higher than 
encountered during such clinical trials.
    (2) Information concerning any unusual failure of the new animal 
drug to exhibit its expected pharmacological activity.

[40 FR 13807, Mar. 27, 1975, as amended at 54 FR 18280, Apr. 28, 1989; 
72 FR 69121, Dec. 6, 2007]



Sec. 510.305  Maintenance of copies of approved medicated feed mill licenses 

to manufacture animal feed bearing or containing new animal drugs.

    Each applicant shall maintain in a single accessible location:
    (a) A copy of the approved medicated feed mill license (Form FDA 
3448) on the premises of the manufacturing establishment; and
    (b) Approved or index listed labeling for each Type B and/or Type C 
feed being manufactured on the premises of the manufacturing 
establishment or the facility where the feed labels are generated.

[64 FR 63203, Nov. 19, 1999, as amended at 72 FR 69121, Dec. 6, 2007]



          Subpart E_Requirements for Specific New Animal Drugs



Sec. 510.410  Corticosteroids for oral, injectable, and ophthalmic use in 

animals; warnings and labeling requirements.

    (a) The Food and Drug Administration has received reports of side 
effects associated with the oral, injectable, and ophthalmic use of 
corticosteroid animal drugs. The use of these drugs administered orally 
or by injection has resulted in premature parturition when administered 
during the last trimester of pregnancy. Premature parturition

[[Page 43]]

may be followed by dystocia, fetal death, retained placenta, and 
metritis. Additionally, corticosteroids used in dogs, rabbits, and 
rodents during pregnancy have produced cleft palate in offspring. Use in 
dogs has resulted in other congenital anomalies, including deformed 
forelegs, phocomelia, and anasarca. Drugs subject to this section are 
required to carry the veterinary prescription legend and are subject to 
the labeling requirements of Sec. 201.105 of this chapter.
    (b) In view of these potentially serious side effects, the Food and 
Drug Administration has concluded that the labeling on or within 
packaged corticosteroid-containing preparations intended for animal use 
shall bear conspicuously the following warning statement:

    Warning: Clinical and experimental data have demonstrated that 
corticosteroids administered orally or by injection to animals may 
induce the first stage of parturition if used during the last trimester 
of pregnancy and may precipitate premature parturition followed by 
dystocia, fetal death, retained placenta, and metritis.
    Additionally, corticosteroids administered to dogs, rabbits, and 
rodents during pregnancy have resulted in cleft palate in offspring. 
Corticosteroids administered to dogs during pregnancy have also resulted 
in other congenital anomalies, including deformed forelegs, phocomelia, 
and anasarca.

[49 FR 48535, Dec. 13, 1984]



Sec. 510.440  Injectable iron preparations.

    There has been an increasing interest in the use of injectable iron 
compounds for the prevention or treatment of iron-deficiency anemia in 
animals. Although some such preparations have been shown to be safe, 
such articles are regarded as new animal drugs within the meaning of the 
Federal Food, Drug, and Cosmetic Act. Accordingly, an approved new 
animal drug application is required prior to the marketing of such 
preparations within the jurisdiction of the act. In addition to the need 
for demonstrating the safety of such articles, the labeling of such 
preparations should not only recommend appropriate dosages of iron but 
also declare the amount (in milligrams) of available iron (Fe) per 
milliliter of the subject product.



Sec. 510.455  Requirements for free-choice medicated feeds.

    (a) What is free-choice medicated feed? For the purpose of this 
part, free-choice medicated feed is medicated feed that is placed in 
feeding or grazing areas and is not intended to be consumed fully at a 
single feeding or to constitute the entire diet of the animal. Free-
choice feeds include, but are not limited to, medicated blocks 
(agglomerated feed compressed or rendered into a solid mass and cohesive 
enough to hold its form), mineral mixes, and liquid feed tank 
supplements (``lick tank'' supplements) containing one or more new 
animal drugs. The manufacture of medicated free-choice feeds is subject 
to the current good manufacturing practice regulations in part 225 of 
this chapter for medicated feeds.
    (b) What is required for new animal drugs intended for use in free-
choice feed? Any new animal drug intended for use in free-choice feed 
must be approved for such use under section 512 of the Federal Food, 
Drug, and Cosmetic Act (the act) (21 U.S.C. 360(b)) or listed in the 
index under section 572 of the act (21 U.S.C. 360ccc-1). Such approvals 
under section 512 of the act must be:
    (1) An original new animal drug application (NADA),
    (2) A supplemental NADA, or
    (3) An abbreviated NADA.
    (c) What are the approval requirements under section 512 of the act 
for new animal drugs intended for use in free-choice feed? An approval 
under section 512 of the act for a Type A medicated article intended for 
use in free-choice feed must contain the following information:
    (1) Data, or reference to data in a master file (MF), showing that 
the target animal consumes the new animal drug in the Type C free-choice 
feed in an amount that is safe and effective (consumption/effectiveness 
data); and
    (2) Data, or reference to data in an MF, showing the relevant ranges 
of conditions under which the drug will be chemically and physically 
stable in the Type C free-choice feed under field conditions.
    (d) How are consumption/effectiveness and/or stability data to be 
submitted? The data must be submitted as follows:

[[Page 44]]

    (1) Directly in the NADA, by a sponsor; and/or
    (2) To an MF that a sponsor may then reference in its NADA with 
written consent of the MF holder.
    (e) What will be stated in the published approval for a new animal 
drug intended for use in free-choice feed? The approval of a new animal 
drug intended for use in free-choice feed, as published in this 
subchapter, will include:
    (1) The formula and/or specifications of the free-choice medicated 
feed, where the owner of this information requests such publication, or
    (2) A statement that the approval has been granted for a proprietary 
formula and/or specifications.
    (f) When is a medicated feed mill license required for the 
manufacture of a free-choice medicated feed? An approved medicated feed 
mill license is required for the manufacture of the following types of 
feeds:
    (1) All free-choice medicated feeds that contain a Category II drug, 
and
    (2) Free-choice medicated feeds that contain a Category I drug and 
use a proprietary formula and/or specifications.

[69 FR 30197, May 27, 2004, as amended at 72 FR 69121, Dec. 6, 2007]

Subpart F [Reserved]



               Subpart G_Sponsors of Approved Applications



Sec. 510.600  Names, addresses, and drug labeler codes of sponsors of approved 

applications.

    (a) Section 512(i) of the act requires publication of names and 
addresses of sponsors of approved applications for new animal drugs.
    (b) In this section each name and address is identified by a 
numerical drug labeler code. The labeler codes identify the sponsors of 
the new animal drug applications associated with the regulations 
published pursuant to section 512(i) of the act. The codes appear in the 
appropriate regulations and serve as a reference to the names and 
addresses listed in this section. The drug labeler code is established 
pursuant to section 510 of the act.
    (c) The names, addresses, and drug labeler codes of sponsors of 
approved new animal drug applications are as follows:

                  (1) Alphabetical Listing of Sponsors
------------------------------------------------------------------------
                                                           Drug labeler
                  Firm name and address                        code
------------------------------------------------------------------------
Abbott Laboratories, North Chicago, IL 60064............          000074
Abraxis Pharmaceutical Products, a Div. of Abraxis                063323
 Bioscience, 6133 River Rd., suite 500, Rosemont, IL
 60018..................................................
ADM Alliance Nutrition, Inc., 1000 North 30th St.,                021930
 Quincy, IL 62305-3115..................................
A & G Pharmaceuticals, Inc., 1030 West Commodore Blvd.,           057699
 Jackson, NJ 08527......................................
Ag-Mark, Inc., P.O. Box 127, Teachey, NC 28464..........          024174
Agri Laboratories, Ltd., P.O. Box 3103, St. Joseph, MO            057561
 64503..................................................
Agri-Tech, Inc., 4722 Broadway, Kansas City, MO 64112...          017762
Alaco, Inc., 1500 North Wilmot Rd., suite 290-C, Tucson,          064146
 AZ 85712...............................................
Alpharma Inc., 440 Rte. 22, Bridgewater, NJ 08807.......          046573
Alstoe, Ltd., Animal Health, Pera Innovation Park,                062408
 Nottingham Rd., Melton Mowbray, Leicestershire, England
 LE13 0PB...............................................
American Pharmaceuticals Partners, Inc., 2045 North               063323
 Cornell Ave., Melrose Park, IL 60160...................
Anika Therapeutics Inc., 236 West Cummings Park, Woburn,          060865
 MA 01801...............................................
Animal Health Pharmaceuticals, LLC, 1805 Oak Ridge                068718
 Circle, suite 101, St. Joseph, MO 64506................
Argent Laboratories, 8702 152d Ave. NE., Redmond, WA              051212
 98052..................................................
Ausa International, Inc., Rt. 8, P.O. Box 324-12, Tyler,          059521
 TX 75703...............................................
B.L. Mitchell, Inc., 103 Hwy. 82 E., Leland, MS 38756...          067188
Baxter Healthcare Corp., 95 Spring St., New Providence,           010019
 NJ 07974...............................................
Bayer HealthCare LLC, Animal Health Division, P.O. Box            000859
 390, Shawnee Mission, KS 66201.........................
Belcher Pharmaceuticals, Inc., 12393 Belcher Rd., suite           062250
 420, Largo, FL 33773...................................
Bioniche Animal Health USA, Inc., 119 Rowe Rd., Athens,           064847
 GA 30601...............................................
Bioproducts, Inc., 320 Springside Dr., Suite 300,                 051359
 Fairlawn, OH 44333-2435................................
Biopure Corp., 11 Hurley St., Cambridge, MA 02141.......          063075
BioScience Division of Milk Specialties Co., 1902                 032761
 Tennyson Lane, Madison, WI 53704.......................
Boehringer Ingelheim Vetmedica, Inc., 2621 North Belt             000010
 Highway, St. Joseph, MO 64506-2002.....................
Chanelle Pharmaceuticals Manufacturing Ltd., Loughrea,            061651
 County Galway, Ireland.................................
Church & Dwight Co., Inc., 469 North Harrison St.,                010237
 Princeton, NJ 08543-5297...............................
ConAgra Pet Products Co., 3902 Leavenworth St., Omaha,            021091
 NE 68105...............................................
Contemporary Products, Inc., 3788 Elm Springs Rd.,                055462
 Springdale, AR 72764-6067..............................

[[Page 45]]

 
Cooperative Research Farms, Box 69, Charlotteville, NY            051267
 12036..................................................
Cross Vetpharm Group Ltd., Broomhill Rd., Tallaght,               061623
 Dublin 24, Ireland.....................................
Custom Feed Blenders Corp., 540 Hawkeye Ave., Fort                046987
 Dodge, IA 50501........................................
ECO LLC, 8209 Hollister Ave., Las Vegas, NV 89131.......          066916
Eka Chemicals, Inc., 1775 West Oak Commons Ct.,                   061088
 Marietta, GA 30062-2254................................
Elanco Animal Health, A Division of Eli Lilly & Co.,              000986
 Lilly Corporate Center, Indianapolis, IN 46285.........
Endo Pharmaceuticals, Inc., 100 Painters Dr., Chadds              060951
 Ford, PA 19317.........................................
Eon Labs Manufacturing, Inc. 227-15 North Conduit Ave.,           000185
 Laurelton, NY 11413....................................
Evsco Pharmaceuticals, An Affiliate of IGI, Inc., Box             017030
 209, Harding Hwy., Buena, NJ 08310.....................
Farmland Industries, Inc., Kansas City, MO 64116........          021676
Pharmacosmos, Inc., 776 Mountain Blvd., Watchung, NJ              042552
 07069..................................................
Farnam Companies, Inc., 301 West Osborn, Phoenix, AZ              017135
 85013-3928.............................................
Feed Service Co., Inc., 303 Lundin Blvd., P.O. Box 698,           030841
 Mankato, MN 56001......................................
John J. Ferrante, 11 Fairway Lane, Trumbull, CT 06611...          058034
First Priority, Inc., 1585 Todd Farm Dr., Elgin, IL               058829
 60123..................................................
Fleming Laboratories, Inc., P.O. Box 34384, Charlotte,            015565
 NC 28234...............................................
Fort Dodge Animal Health, A Division of Wyeth Holdings            053501
 Corp., P.O. Box 1339, Fort Dodge, IA 50501.............
Fort Dodge Animal Health, Division of Wyeth, 800 Fifth            000856
 St. NW., Fort Dodge, IA 50501..........................
Furst-McNess Co., Freeport, IL 61032....................          010439
Gossett Nutrition, Inc., 1676 Cascade Dr., Marion, OH             050972
 43302..................................................
G. C. Hanford Manufacturing Co., P.O. Box 1017,                   010515
 Syracuse, NY 13201.....................................
Halocarbon Laboratories, Division of Halocarbon Products          012164
 Corp., 887 Kinderkamack Rd., P.O. Box 661, River Ridge,
 NJ 07661...............................................
Happy Jack, Inc., Snow Hill, NC 28580...................          023851
Heska Corp., 1825 Sharp Point Dr., Fort Collins, CO               063604
 80525..................................................
Hess & Clark, Inc., 944 Nandino Blvd., Lexington, KY              050749
 40511..................................................
Huvepharma AD, 33 James Boucher Blvd., Sophia 1407,               016592
 Bulgaria...............................................
IDEXX Pharmaceuticals, Inc., 7009 Albert Pick Rd.,                065274
 Greensboro, NC 27409...................................
I.M.S. Inc., 13619 Industrial Rd., Omaha, NE 68137......          050639
International Nutrition, Inc., 7706 `I' Plaza, Omaha, NE          043733
 68127..................................................
Intervet Inc., P.O. Box 318, 29160 Intervet Lane,                 057926
 Millsboro, DE 19966....................................
IVX Animal Health, Inc., 3915 South 48th Street Ter.,             059130
 St. Joseph, MO 64503...................................
Ivy Laboratories, Div. of Ivy Animal Health, Inc., 8857           021641
 Bond Street, Overland Park, KS 66214...................
J. C. Feed Mills, 1050 Sheffield, P.O. Box 224,                   039741
 Waterloo, IA 50704.....................................
Jazz Pharmaceuticals, Inc., 3180 Porter Dr., Palo Alto,           068727
 CA 94304...............................................
K. C. Pharmacal, Inc., 8345 Melrose Dr., Lenexa, KS               038782
 66214..................................................
Lloyd, Inc., 604 W. Thomas Ave., Shenandoah, IA 51601...          061690
Luitpold Pharmaceuticals, Inc., Animal Health Division,           010797
 Shirley, NY 11967......................................
Macleod Pharmaceuticals, Inc., 2600 Canton Ct., Fort              058711
 Collins, CO 80525......................................
Marsam Pharmaceuticals, LLC, Bldg. 31, 24 Olney Ave.,             000209
 Cherry Hill, NJ 08034..................................
Medicis Dermatologics, Inc., 8125 North Hayden Rd.,               099207
 Scottsdale, AZ 85258...................................
Med-Pharmex, Inc., 2727 Thompson Creek Rd., Pomona, CA            054925
 91767-1861.............................................
Merial Ltd., 3239 Satellite Blvd., Bldg. 500, Duluth, GA          050604
 30096-4640.............................................
Micro Beef Technologies LTD, P.O. Box 9262, Amarillo, TX          047126
 79105..................................................
Mid-Continent Agrimarketing, Inc., 8833 Quivira Rd.,              059620
 Overland Park, KS 66214................................
Minrad, Inc., 836 Main St., 2d floor, Buffalo, NY 14202.          060307
Modern Veterinary Therapeutics, LLC, 1550 Madruga Ave.,           015914
 suite 329, Coral Gables, FL 33146......................
Monsanto Co., 800 North Lindbergh Blvd., St. Louis, MO            000911
 63167..................................................
Natchez Animal Supply Co., 201 John R. Junkin Dr.,                049968
 Natchez, MS 39120......................................
Nicholas Piramal India Ltd. UK, 1st Floor, Alpine House,          066112
 Unit II, Honeypot Lane, London, NW99RX, England, UK....
Norbrook Laboratories, Ltd., Station Works, Newry BT35            055529
 6JP, Northern Ireland..................................
Norco Mills of Norfolk, Inc., P.O. Box 56, Norfolk, NE            027190
 68701..................................................
North American Nutrition Companies, Inc., C.S. 5002,              017790
 6531 St., Rt. 503, Lewisburg, OH 45338.................
Novartis Animal Health US, Inc., 3200 Northline Ave.,             058198
 suite 300, Greensboro, NC 27408........................
Novopharm Ltd., 30 Novopharm Ct., Toronto, Ontario,               043806
 Canada M1B 2K9.........................................
NutriBasics Co., North Highway 71, P.O. Box 1014,                 053740
 WIllmar, MN 56201......................................
Nycomed US, Inc., 60 Baylis Rd., Melville, NY 11747.....          025463
Orion Corp., Orionintie 1, 02200 Espoo, Finland.........          052483
OXIS International, Inc., 6040 N. Cutter Circle, Suite            024991
 317, Portland, OR 97217-3935...........................
Parnell Laboratories (Aust) Pty. Ltd., Century Estate,            068504
 unit 6, 476 Gardeners Rd., Alexandria, New South Wales
 2015, Australia........................................
Peavey Co., 730 Second Ave. South, Minneapolis, MN 55402          028459
Pegasus Laboratories, Inc., 8809 Ely Rd., Pensacola, FL           055246
 32514..................................................
Pennfield Oil Co., 14040 Industrial Rd., Omaha, NE 68144          048164
Peptech Animal Health Pty, Ltd., 19-25 Khartoum Rd.,              064288
 Macquarie Park, New South Wales 2113, Australia........
Pfizer, Inc., 235 East 42d St., New York, NY 10017......          000069
Pharmaceutical Ventures, Ltd., P.O. Box D1400, Pomona,            050057
 NY 10970...............................................
Pharmacia & Upjohn Co., a Division of Pfizer, Inc., 235           000009
 East 42d St., New York, NY 10017.......................
Pharmaq AS, Skogmo Industriomrade, N-7863 Overhalla,              015331
 Norway.................................................
Phibro Animal Health, 65 Challenger Rd., 3d floor,                066104
 Ridgefield Park, NJ 07660..............................

[[Page 46]]

 
Planalquimica Industrial Ltda., Rua das Magnolias nr.             060728
 2405, Jardim das Bandeiras, CEP 13053-120, Campinas,
 Sao Paulo, Brazil......................................
Purina Mills, Inc., P.O. Box 66812, St. Louis, MO 63166-          017800
 6812...................................................
Putney, Inc., 400 Congress St., suite 200, Portland, ME           026637
 04101..................................................
Quali-Tech Products, Inc., 318 Lake Hazeltine Drive,              016968
 Chaska, MN 55318.......................................
Ridley Block Operations Inc., 424 North Riverfront Dr.,           068287
 P.O. Box 8500, Mankato, MN 56002-8500..................
Ridley U.S. Holdings, Inc., 424 North Riverfront Dr.,             067949
 P.O. Box 8500, Mankato, MN 56002-8500..................
RMS Laboratories, Inc., 1903 East First St., Vidalia, GA          067292
 30474..................................................
Roche Vitamins, Inc., 45 Waterview Blvd., Parsippany, NJ          063238
 07054-1298.............................................
RSR Laboratories, Inc., 501 Fifth St., Bristol, TN 37620          058670
R. P. Scherer North America, P.O. Box 5600, Clearwater,           011014
 FL 33518...............................................
Schering-Plough Animal Health Corp., 556 Morris Ave.,             000061
 Summit, NJ 07901.......................................
G. D. Searle LLC, Pharmacia Corp., 4901 Searle Pkwy.,             000014
 Skokie, IL 60077.......................................
Seeco Inc., Box 1014, North Highway 71, Willmar, MN               011749
 56201..................................................
Sioux Biochemical, Inc., 204 Third St. NW., Sioux                 063112
 Center, IA 51250.......................................
Southern Micro-Blenders, Inc., 3801 North Hawthorne St.,          049685
 Chattanooga, TN 37406..................................
Sparhawk Laboratories, Inc., 12340 Santa Fe Trail Dr.,            058005
 Lenexa, KS 66215.......................................
Springfield Milling Corp., Vigorena Feeds, Springfield,           035955
 MN 56087...............................................
Squire Laboratories, Inc., 100 Mill St., Revere, MA               017153
 02151..................................................
Summit Hill Laboratories, P.O. Box 535, Navesink, NJ              037990
 07752..................................................
Superior Equine Pharmaceuticals, Inc., Pleasant Grove,            027053
 UT 84062...............................................
Technology Transfer, Inc., 33 East Broadway, suite 190,           067647
 Columbia, MO 65203.....................................
Texas Vitamin Co., P.O. Box 18417, 10695 Aledo St.,               000842
 Dallas, TX 57218.......................................
Triple ``F'', Inc., 10104 Douglas Ave., Des Moines, IA            011490
 50322..................................................
UDL Laboratories, Inc., 12720 Dairy Ashford, Sugar Land,          051079
 TX 77478...............................................
United Vaccines, A Harlan Sprague Dawley, Inc., Co.,              058639
 P.O. Box 4220, Madison, WI 53711.......................
Vetem, S.p.A., Viale E. Bezzi 24, 20146 Milano, Italy...          055882
Veterinary Service, Inc., 416 North Jefferson St., P.O.           033008
 Box 2467, Modesto, CA 95354............................
V[eacute]toquinol N.-A., Inc., 2000 chemin Georges,               059320
 Lavaltrie (PQ), Canada, J5T 3S5........................
Virbac AH, Inc., 3200 Meacham Blvd., Ft. Worth, TX 76137          051311
Walco International, Inc., 15 West Putnam, Porterville,           049185
 CA 93257
Waterloo Mills Co., 2050 Mitchell Ave., Waterloo, IA              017139
 50704..................................................
Watson Laboratories, Inc., 311 Bonnie Circle, Corona, CA          000402
 92880..................................................
Wayne Feed Division, Continental Grain Co., P.O. Box              034936
 459, Libertyville, IL 60048............................
Webel Feeds, Inc., R.R. 3, Pittsfield, IL 62363.........          035098
Wellmark International, 1501 East Woodfield Rd., suite            011536
 200 West, Schaumburg, IL 60173.........................
Wendt Laboratories , Inc., 100 Nancy Dr., Belle Plaine,           015579
 MN 56011...............................................
West Agro, Inc., 11100 N. Congress Ave., Kansas City, MO          033392
 64153..................................................
Western Chemical, Inc., 1269 Lattimore Rd., Ferndale, WA          050378
 98248..................................................
West-Ward Pharmaceutical Corp., 465 Industrial Way West,          000143
 Eatontown, NJ 07724....................................
Wildlife Laboratories, Inc., 1401 Duff Dr., Suite 600,            053923
 Fort Collins, CO 80524.................................
Wyeth Laboratories, Division American Home Products               000008
 Corp., P.O. Box 8299, Philadelphia, PA 19101...........
Yoder Feed, Division of Yoder, Inc., Kalona, IA 52247...          035369
------------------------------------------------------------------------


                    (2) Numerical Listing of Sponsors
------------------------------------------------------------------------
 Drug labeler
     code                         Firm name and address
------------------------------------------------------------------------
        000008  Wyeth Laboratories, Division American Home Products
                 Corp., P.O. Box 8299, Philadelphia, PA 19101.
        000009  Pharmacia & Upjohn Co., a Division of Pfizer, Inc., 235
                 East 42d St., New York, NY 10017.
        000010  Boehringer Ingelheim Vetmedica, Inc., 2621 North Belt
                 Highway, St. Joseph, MO 64506-2002.
        000014  G. D. Searle LLC, Pharmacia Corp., 4901 Searle Pkwy.,
                 Skokie, IL 60077.
        000061  Schering-Plough Animal Health Corp., 556 Morris Ave.,
                 Summit, NJ 07901.
        000069  Pfizer, Inc., 235 East 42d St., New York, NY 10017.
        000074  Abbott Laboratories, North Chicago, IL 60064.
        000143  West-Ward Pharmaceutical Corp., 465 Industrial Way West,
                 Eatontown, NJ 07724
        000185  Eon Labs Manufacturing, Inc., 227-15 North Conduit Ave.,
                 Laurelton, NY 11413.
        000209  Marsam Pharmaceuticals, LLC, Bldg. 31, 24 Olney Ave.,
                 Cherry Hill, NJ 08034.
        000402  Watson Laboratories, Inc., 311 Bonnie Circle, Corona, CA
                 92880.
        000842  Texas Vitamin Co., P.O. Box 18417, 10695 Aledo St.,
                 Dallas, TX 57218.
        000856  Fort Dodge Animal Health, Division of Wyeth, 800 Fifth
                 St. NW., Fort Dodge, IA 50501.
        000859  Bayer HealthCare LLC, Animal Health Division, P.O. Box
                 390, Shawnee Mission, KS 66201
        000911  Monsanto Co., 800 North Lindbergh Blvd., St. Louis, MO
                 63167.
        000986  Elanco Animal Health, A Division of Eli Lilly & Co.,
                 Lilly Corporate Center, Indianapolis, IN 46285.
        010019  Baxter Healthcare Corp., 95 Spring St., New Providence,
                 NJ 07974.
        010237  Church & Dwight Co., Inc., 469 North Harrison St.,
                 Princeton, NJ 08543-5297.
        010439  Furst-McNess Co., Freeport, IL 61032.
        010515  G. C. Hanford Manufacturing Co., P.O. Box 1017,
                 Syracuse, NY 13201.
        010797  Luitpold Pharmaceuticals, Inc., Animal Health Division,
                 Shirley, NY 11967.
        011014  R. P. Scherer North America, P.O. Box 5600, Clearwater,
                 FL 33518.

[[Page 47]]

 
        011490  Triple ``F'', Inc., 10104 Douglas Ave., Des Moines, IA
                 50322.
        011536  Wellmark International, 1501 East Woodfield Rd., suite
                 200 West, Schaumburg, IL 60173
        011749  Seeco Inc., Box 1014, North Highway 71, Willmar, MN
                 56201.
        012164  Halocarbon Laboratories, Division of Halocarbon Products
                 Corp., 887 Kinderkamack Rd., P.O. Box 661, River Ridge,
                 NJ 07661.
        015331  Pharmaq AS, Skogmo Industriomrade, N-7863 Overhalla,
                 Norway.
        015565  Fleming Laboratories, Inc., P.O. Box 34384, Charlotte,
                 NC 28234.
        015579  Wendt Laboratories, Inc., 100 Nancy Dr., Belle Plaine,
                 MN 56011.
        015914  Modern Veterinary Therapeutics, LLC, 1550 Madruga Ave.,
                 suite 329, Coral Gables, FL 33146
        016592  Huvepharma AD, 33 James Boucher Blvd., Sophia 1407,
                 Bulgaria
        016968  Quali-Tech Products, Inc., 318 Lake Hazeltine Dr.,
                 Chaska, MN 55318.
        017030  Evsco Pharmaceuticals, An Affiliate of IGI, Inc., Box
                 209, Harding Hwy., Buena, NJ 08310.
        017135  Farnam Companies, Inc., 301 West Osborn, Phoenix, AZ
                 85013-3928.
        017139  Waterloo Mills Co., 2050 Mitchell Ave., Waterloo, IA
                 50704.
        017153  Squire Laboratories, Inc., 100 Mill St., Revere, MA
                 02151.
        017762  Agri-Tech, Inc., 4722 Broadway, Kansas City, MO 64112.
        017790  North American Nutrition Companies, Inc., C.S. 5002,
                 6531 St., Rt. 503, Lewisburg, OH 45338.
        017800  Purina Mills, Inc., P.O. Box 66812, St. Louis, MO 63166-
                 6812.
        021091  ConAgra Pet Products Co., 3902 Leavenworth St., Omaha,
                 NE 68105.
        021641  Ivy Laboratories, Div. of Ivy Animal Health, Inc., 8857
                 Bond Street, Overland Park, KS 66214.
        021676  Farmland Industries, Inc., Kansas City, MO 64116.
        021930  ADM Alliance Nutrition, Inc., 1000 North 30th St.,
                 Quincy, IL 62305-3115
        023851  Happy Jack, Inc., Snow Hill, NC 28580.
        024174  Ag-Mark, Inc., P.O. Box 127, Teachey, NC 28464.
        024991  OXIS International, Inc., 6040 N. Cutter Circle, Suite
                 317 Portland, OR 97217-3935.
        025463  Nycomed US, Inc., 60 Baylis Rd., Melville, NY 11747
        026637  Putney, Inc., 400 Congress St., suite 200, Portland, ME
                 04101
        027053  Superior Equine Pharmaceuticals, Inc., Pleasant Grove,
                 UT 84062.
        027190  Norco Mills of Norfolk, Inc., P.O. Box 56, Norfolk, NE
                 68701.
        028459  Peavey Co., 730 Second Ave. South, Minneapolis, MN
                 55402.
        030841  Feed Service Co., Inc., 303 Lundin Blvd., P.O. Box 698,
                 Mankato, MN 56001.
        032761  BioScience Division of Milk Specialties Co., 1902
                 Tennyson Lane, Madison, WI 53704
        033008  Veterinary Service, Inc., 416 North Jefferson St., P.O.
                 Box 2467, Modesto, CA 95354.
        033392  West Agro, Inc., 11100 N. Congress Ave., Kansas City, MO
                 64153.
        034936  Wayne Feed Division, Continental Grain Co., P.O. Box
                 459, Libertyville, IL 60048.
        035098  Webel Feeds, Inc., R.R. 3, Pittsfield, IL 62363.
        035369  Yoder Feed, Division of Yoder, Inc., Kalona, IA 52247.
        035955  Springfield Milling Corp., Vigorena Feeds, Springfield,
                 MN 56087.
        037990  Summit Hill Laboratories, P.O. Box 535, Navesink, NJ
                 07752.
        038782  K. C. Pharmacal, Inc., 8345 Melrose Dr., Lenexa, KS
                 66214.
        039741  J. C. Feed Mills, 1050 Sheffield, P.O. Box 224,
                 Waterloo, IA 50704.
        042552  Pharmacosmos, Inc., 776 Mountain Blvd., Watchung, NJ
                 07069
        043733  International Nutrition, Inc., 7706 `I' Plaza, Omaha, NE
                 68127.
        043806  Novopharm Ltd., 30 Novopharm Ct., Toronto, Ontario,
                 Canada M1B 2K9
        046573  Alpharma Inc., 440 Rte. 22, Bridgewater, NJ 08807.
        046987  Custom Feed Blenders Corp., 540 Hawkeye Ave., Fort
                 Dodge, IA 50501.
        047126  Micro Beef Technologies LTD, P.O. Box 9262, Amarillo, TX
                 79105.
        048164  Pennfield Oil Co., 14040 Industrial Rd., Omaha, NE
                 68144.
        049185  Walco International, Inc., 15 West Putnam, Porterville,
                 CA 93257.
        049685  Southern Micro-Blenders, Inc., 3801 North Hawthorne St.,
                 Chattanooga, TN 37406.
        049968  Natchez Animal Supply Co., 201 John R. Junkin Dr.,
                 Natchez, MS 39120.
        050057  Pharmaceutical Ventures, Ltd., P.O. Box D1400, Pomona,
                 NY 10970.
        050378  Western Chemical, Inc., 1269 Lattimore Rd., Ferndale, WA
                 98248.
        050604  Merial Ltd., 3239 Satellite Blvd., Bldg. 500, Duluth, GA
                 30096-4640.
        050639  I.M.S. Inc., 13619 Industrial Rd., Omaha, NE 68137.
        050749  Hess & Clark, Inc., 944 Nandino Blvd., Lexington, KY
                 40511.
        050972  Gossett Nutrition, Inc., 1676 Cascade Dr., Marion, OH
                 43302.
        051079  UDL Laboratories, Inc., 12720 Dairy Ashford, Sugar Land,
                 TX 77478.
        051212  Argent Laboratories, 8702 152d Ave. NE., Redmond, WA
                 98052.
        051267  Cooperative Research Farms, Box 69, Charlotteville, NY
                 12036.
        051311  Virbac AH, Inc., 3200 Meacham Blvd., Ft. Worth, TX
                 76137.
        051359  Bioproducts, Inc., 320 Springside Dr., Suite 300,
                 Fairlawn, OH 44141.
        052483  Orion Corp., Orionintie 1, 02200 Espoo, Finland.
        053501  Fort Dodge Animal Health, A Division of Wyeth Holdings
                 Corp., P.O. Box 1339, Fort Dodge, IA 50501.
        053740  NutriBasics Co., North Highway 71, P.O. Box 1014,
                 WIllmar, MN 56201.
        053923  Wildlife Laboratories, Inc., 1401 Duff Dr., Suite 600,
                 Fort Collins, CO 80524.
        054925  Med-Pharmex, Inc., 2727 Thompson Creek Rd., Pomona, CA
                 91767-1861.
        055246  Pegasus Laboratories, Inc., 8809 Ely Rd., Pensacola, FL
                 32514.
        055462  Contemporary Products, Inc., 3788 Elm Springs Rd.,
                 Springdale, AR 72764-6067.
        055529  Norbrook Laboratories, Ltd., Station Works, Newry BT35
                 6JP, Northern Ireland.
        055882  Vetem, S.p.A., Viale E. Bezzi 24, 20146 Milano, Italy.

[[Page 48]]

 
        057561  Agri Laboratories, Ltd., P.O. Box 3103, St. Joseph, MO
                 64503.
        057699  A & G Pharmaceuticals, Inc., 1030 West Commodore Blvd.,
                 Jackson, NJ 08527.
        057926  Intervet, Inc., P.O. Box 318, 29160 Intervet Lane,
                 Millsboro, DE 19966.
        058005  Sparhawk Laboratories, Inc., 12340 Santa Fe Trail Dr.,
                 Lenexa, KS 66215.
        058034  John J. Ferrante, 11 Fairway Lane, Trumbull, CT 06611.
        058198  Novartis Animal Health US, Inc., 3200 Northline Ave.,
                 suite 300, Greensboro, NC 27408.
        058639  United Vaccines, A Harlan Sprague Dawley, Inc., Co.,
                 P.O. Box 4220, Madison, WI 53711.
        058670  RSR Laboratories, Inc., 501 Fifth St., Bristol, TN
                 37620.
        058711  Macleod Pharmaceuticals, Inc., 2600 Canton Ct., Fort
                 Collins, CO 80525.
        058829  First Priority, Inc., 1585 Todd Farm Dr., Elgin, IL
                 60123.
        059130  IVX Animal Health, Inc., 3915 South 48th Street Ter.,
                 St. Joseph, MO 64503
        059320  V[eacute]toquinol N.-A., Inc., 2000 chemin Georges,
                 Lavaltrie (PQ), Canada, J5T 3S5.
        059521  Ausa International, Inc., Rt. 8, P.O. Box 324-12, Tyler,
                 TX 75703.
        059620  Mid-Continent Agrimarketing, Inc., 8833 Quivira Rd.,
                 Overland Park, KS 66214.Blvd., St. Louis, MO 63167.
        060307  Minrad, Inc., 836 Main St., 2d floor, Buffalo, NY 14202.
        060728  Planalquimica Industrial Ltda., Rua das Magnolias nr.
                 Jardim das Bandeiras, CEP 13053-120, Campinas, Sao
                 Alto, Brazil.
        060865  Anika Therapeutics Inc., 236 West Cummings Park, Woburn,
                 MA 01801.
        060951  Endo Pharmaceuticals, Inc., 100 Painters Dr., Chadds
                 Ford, PA 19317.
        061088  Eka Chemicals, Inc., 1775 West Oak Commons Ct.,
                 Marietta, GA 30062-2254
        061623  Cross Vetpharm Group Ltd., Broomhill Rd., Tallaght,
                 Dublin 24, Ireland.
        061651  Chanelle Pharmaceuticals Manufacturing Ltd., Loughrea,
                 County Galway, Ireland.
        061690  Lloyd, Inc., 604 W. Thomas Ave., Shenandoah, IA 51601.
        062250  Belcher Pharmaceuticals, Inc., 12393 Belcher Rd., suite
                 420, Largo, FL 33773
        062408  Alstoe, Ltd., Animal Health, Pera Innovation Park,
                 Nottingham Rd., Melton Mowbray, Leicestershire, England
                 LE13 0PB.
        062794  Mylan Bertek Pharmaceuticals, Inc., 12720 Dairy Ashford,
                 Sugar Land, TX 77478
        063075  Biopure Corp., 11 Hurley St., Cambridge, MA 02141.
        063112  Sioux Biochemical, Inc., 204 Third St. NW., Sioux
                 Center, IA 51250.
        063238  Roche Vitamins, Inc., 45 Waterview Blvd., Parsippany, NJ
                 07054-1298.
        063323  Abraxis Pharmaceutical Products, a Div. of Abraxis
                 Bioscience, 6133 River Rd., suite 500, Rosemont, IL
                 60018.
        063604  Heska Corp., 1825 Sharp Point Dr., Fort Collins, CO
                 80525.
        064146  Alaco, Inc., 1500 North Wilmot Rd., suite 290-C, Tucson,
                 AZ 85712.
        064288  Peptech Animal Health Pty, Ltd., 19-25 Khartoum Rd.,
                 Macquarie Park, New South Wales 2113, Australia
        064847  Bioniche Animal Health USA, Inc., 119 Rowe Rd., Athens,
                 GA 30601
        065274  IDEXX Pharmaceuticals, Inc., 7009 Albert Pick Rd.,
                 Greensboro, NC 27409
        066104  Phibro Animal Health, 65 Challenger Rd., 3d floor,
                 Ridgefield Park, NJ 07660
        066112  Nicholas Piramal India Ltd. UK, 1st Floor, Alpine House,
                 Unit II, Honeypot Lane, London, NW99RX, England, UK
        066916  ECO LLC, 8209 Hollister Ave., Las Vegas, NV 89131
        067188  B.L. Mitchell, Inc., 103 Hwy. 82 E., Leland, MS 38756
        067292  RMS Laboratories, Inc., 1903 East First St., Vidalia, GA
                 30474
        067647  Technology Transfer, Inc., 33 East Broadway, suite 190,
                 Columbia, MO 65203
        067949  Ridley U.S. Holdings, Inc., 424 N. Riverfront Dr., P.O.
                 Box 8500, Mankato, MN 56002-8500
        068287  Ridley Block Operations Inc., 424 North Riverfront Dr.,
                 P.O. Box 8500, Mankato, MN 56002-8500
        068504  Parnell Laboratories (Aust) Pty. Ltd., Century Estate,
                 unit 6, 476 Gardeners Rd., Alexandria, New South Wales
                 2015, Australia
        068718  Animal Health Pharmaceuticals, LLC, 1805 Oak Ridge
                 Circle, suite 101, St. Joseph, MO 64506
        068727  Jazz Pharmaceuticals, Inc., 3180 Porter Dr., Palo Alto,
                 CA 94304
        099207  Medicis Dermatologics, Inc., 8125 North Hayden Rd.,
                 Scottsdale, AZ 85258
------------------------------------------------------------------------


[40 FR 13807, Mar. 27, 1975]

    Editorial Note: For Federal Register citations affecting Sec. 
510.600, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and on GPO Access.

    Editorial Note: At 72 FR 36595, July 5, 2007, Sec. 510.600, in the 
table in paragraph (c)(2), was amended by removing the entry for 
``062749''; however, the amendment could not be incorporated because the 
entry does not exist.

[[Page 49]]



PART 511_NEW ANIMAL DRUGS FOR INVESTIGATIONAL USE--Table of Contents




    Authority: 21 U.S.C. 321, 351, 352, 353, 360b, 371.



Sec. 511.1  New animal drugs for investigational use exempt from section 

512(a) of the act.

    (a) New animal drugs for tests in vitro and in laboratory research 
animals. (1) A shipment or other delivery of a new animal drug or animal 
feed bearing or containing a new animal drug intended solely for tests 
in vitro or in animals used only for laboratory research purposes shall 
be exempt from section 512 (a) and (m) of the act if it is labeled as 
follows:

    Caution. Contains a new animal drug for investigational use only in 
laboratory research animals or for tests in vitro. Not for use in 
humans.

    (2) The person distributing or causing the distribution of new 
animal drugs for tests in vitro or in animals used only for laboratory 
research purposes under this exemption shall use due diligence to assure 
that the consignee is regularly engaged in conducting such tests and 
that the shipment of the new animal drug will actually be used for tests 
in vitro or in animals used only for laboratory research.
    (3) The person who introduced such shipment or who delivered the new 
animal drug for introduction into interstate commerce shall maintain 
adequate records showing the name and post office address of the expert 
or expert organization to whom the new animal drug is shipped and the 
date, quantity, and batch or code mark of each shipment and delivery for 
a period of 2 years after such shipment and delivery. Upon the request 
of a properly authorized employee of the Department at reasonable times, 
he shall make such records available for inspection and copying.
    (4) The exemption allowed in this paragraph shall not apply to any 
new animal drug intended for in vitro use in the regular course of 
diagnosing or treating disease, including antibacterial sensitivity 
discs impregnated with any new animal drug or drugs, which discs are 
intended for use in determining susceptibility of microorganisms to the 
new animal drug or drugs.
    (b) New animal drugs for clinical investigation in animals. A 
shipment or other delivery of a new animal drug or an animal feed 
containing a new animal drug intended for clinical investigational use 
in animals shall be exempt from section 512(a) and (m) of the act if all 
the following conditions are met:
    (1) The label shall bear the statements:

    Caution. Contains a new animal drug for use only in investigational 
animals in clinical trials. Not for use in humans. Edible products of 
investigational animals are not to be used for food unless authorization 
has been granted by the U.S. Food and Drug Administration or by the U.S. 
Department of Agriculture.

    In the case of containers too small or otherwise unable to 
accommodate a label with sufficient space to bear the caution statements 
required by paragraph (a) or (b) of this section, the statements may be 
included on the carton label and other labeling on or within the package 
from which the new animal drug is to be dispensed.
    (2) The person or firm distributing or causing the distribution of 
the new animal drug or animal feed containing a new animal drug shall 
use due diligence to assure that the new animal drug or animal feed 
containing a new animal drug will actually be used for tests in animals 
and is not used in humans.
    (3) The person who introduced such shipment or who delivered the new 
animal drug or animal feed containing a new animal drug for introduction 
into interstate commerce shall maintain adequate records showing the 
name and post office address of the investigator to whom the new animal 
drug or animal feed containing a new animal drug is shipped and the 
date, quantity, and batch or code mark of each shipment and delivery for 
a period of 2 years after such shipment and delivery. Upon the request 
of a properly authorized employee of the Department at reasonable times, 
such records shall be made available for inspection and copying.
    (4) Prior to shipment of the new animal drug for clinical tests in 
animals, the sponsor of the investigation shall

[[Page 50]]

submit in triplicate to the Food and Drug Administration a ``Notice of 
Claimed Investigational Exemption for a New Animal Drug'' including a 
signed statement containing the following information:
    (i) The identity of the new animal drug.
    (ii) All labeling and other pertinent information to be supplied to 
the investigators. When such pertinent information includes nonclinical 
laboratory studies, the information shall include, with respect to each 
nonclinical study, either a statement that the study was conducted in 
compliance with the requirements set forth in part 58 of this chapter, 
or, if the study was not conducted in compliance with such regulations, 
a brief statement of the reason for the noncompliance.
    (iii) The name and address of each clinical investigator.
    (iv) The approximate number of animals to be treated (or if not 
available, the amount of new animal drug to be shipped).
    (v) If the new animal drug is given to food-producing animals, the 
statement shall contain the following additional information:
    (a) A commitment that the edible products from such animals shall 
not be used for food without prior authorization in accordance with the 
provisions prescribed in this section.
    (b) Approximate dates of the beginning and end of the experiment or 
series of experiments.
    (c) The maximum daily dose(s) to be administered to a given species, 
the size of animal, maximum duration of administration, method(s) of 
administration, and proposed withdrawal time, if any.
    (vi) If a sponsor has transferred any obligations for the conduct of 
any clinical study to a contract research organization, a statement 
containing the name and address of the contract research organization, 
identification of the clinical study, and a listing of the obligations 
transferred. If all obligations governing the conduct of the study have 
been transferred, a general statement of this transfer--in lieu of a 
listing of the specific obligations transferred--may be submitted.
    (5) Authorization for use of edible products derived from a treated 
food-producing animal may be granted under the provisions of this 
section and when the following specified conditions are met, except that 
in the case of an animal administered any unlicensed experimental 
veterinary biological product regulated under the viruses, serums, 
toxins statute (21 U.S.C., chapter V, sec. 151 et seq. ) the product 
shall be exempt from the requirements of this section when U.S. 
Department of Agriculture approval has been obtained as provided in 9 
CFR 103.2. Conditional authorization may be granted in advance of 
identification of the name(s) and address(es) of the clinical 
investigator(s) as required by paragraph (b)(4)(iii) of this section. 
Information required for authorization shall include, in addition to all 
other requirements of this section, the following:
    (i) Data to show that consumption of food derived from animals 
treated at the maximum levels with the minimum withdrawal periods, if 
any, specified in accordance with paragraph (b)(4)(v)(c) of this 
section, will not be inconsistent with the public health; or
    (ii) Data to show that food derived from animals treated at the 
maximum levels and with the minimum withdrawal periods, if any, 
specified in accordance with paragraph (b)(4)(v)(c) of this section, 
does not contain drug residues or metabolites.
    (iii) The name and location of the packing plant where the animals 
will be processed, except that this requirement may be waived, on 
request, by the terms of the authorization.

Authorizations granted under this paragraph do not exempt 
investigational animals and their products from compliance with other 
applicable inspection requirements. Any person who contests a refusal to 
grant such authorization shall have an opportunity for a regulatory 
hearing before the Food and Drug Administration pursuant to part 16 of 
this chapter.
    (6) On written request of the Food and Drug Administration, the 
sponsor shall submit any additional information reported to or otherwise 
received by him with respect to the investigation deemed necessary to 
facilitate a determination whether there are

[[Page 51]]

grounds in the interest of public health for terminating the exemption.
    (7) The sponsor shall assure himself that the new animal drug is 
shipped only to investigators who:
    (i) Are qualified by scientific training and/experience to evaluate 
the safety and/or effectiveness of the new animal drug.
    (ii) Shall maintain complete records of the investigations, 
including complete records of the receipt and disposition of each 
shipment or delivery of the new animal drug under investigation. Copies 
of all records of the investigation shall be retained by the 
investigator for 2 years after the termination of the investigation or 
approval of a new animal drug application.
    (iii) Shall furnish adequate and timely reports of the investigation 
to the sponsor.
    (8) The sponsor:
    (i) Shall retain all reports received from investigators for 2 years 
after the termination of the investigation or approval of a new animal 
drug application and make such reports available to a duly authorized 
employee of the Department for inspection at all reasonable times.
    (ii) Shall provide for current monitoring of the investigation by a 
person qualified by scientific training and experience to evaluate 
information obtained from the investigation, and shall promptly 
investigate and report to the Food and Drug Administration and to all 
investigators any findings associated with use of the new animal drug 
that may suggest significant hazards pertinent to the safety of the new 
animal drug.
    (iii) Shall not unduly prolong distribution of the new animal drug 
for investigational use.
    (iv) Shall not, nor shall any person acting for or on behalf of the 
sponsor, represent that the new animal drug is safe or effective for the 
purposes for which it is under investigation. This requirement is not 
intended to restrict the full exchange of scientific information.
    (v) Shall not commercially distribute nor test-market the new animal 
drug until a new animal drug application is approved pursuant to section 
512(c) of the act.
    (9) If the shipment or other delivery of the new animal drug is 
imported or offered for importation into the United States for clinical 
investigational use in animals, it shall also meet the following 
conditions:
    (i) The importer of all such shipments or deliveries is an agent of 
the foreign exporter residing in the United States or the ultimate 
consignee, which person has, prior to such shipments and deliveries, 
informed the Food and Drug Administration of his intention to import the 
new animal drug as sponsor in compliance with the conditions prescribed 
in this subdivision; or
    (ii) The new animal drug is shipped directly to a scientific 
institution with adequate facilities and qualified personnel to conduct 
laboratory or clinical investigations and is intended solely for use in 
such institutions and which institution has submitted a statement as 
sponsor of the investigation.
    (10) The sponsor shall submit either a claim for categorical 
exclusion under Sec. 25.30 or Sec. 25.33 of this chapter or an 
environmental assessment under Sec. 25.40 of this chapter.
    (c) Withdrawal of eligibility to receive investigational-use new 
animal drugs. (1) Whenever the Food and Drug Administration has 
information indicating that an investigator has repeatedly or 
deliberately failed to comply with the conditions of these exempting 
regulations or has submitted false information either to the sponsor of 
the investigation or in any required report, the Center for Veterinary 
Medicine will furnish the investigator written notice of the matter 
complained of in general terms and offer him an opportunity to explain 
the matter in an informal conference and/or in writing. If an 
explanation is offered but not accepted by the Center for Veterinary 
Medicine, the investigator shall have an opportunity for a regulatory 
hearing before the Food and Drug Administration pursuant to part 16 of 
this chapter on the question of whether the investigator is entitled to 
receive investigational new animal drugs.
    (2) If, after evaluating all available information, including any 
explanation presented by the investigator, the

[[Page 52]]

Commissioner determines that the investigator has repeatedly or 
deliberately failed to comply with the conditions of the exempting 
regulations in this section or has repeatedly or deliberately submitted 
false information to the sponsor of an investigation, the Commissioner 
will notify the investigator and the sponsor of any investigation in 
which he has been named as a participant that the investigator is not 
entitled to receive investigational use new animal drugs with a 
statement of the basis for such determination.
    (3) Each ``Notice of Claimed Investigational Exemption for a New 
Animal Drug'' and each approved new animal drug application containing 
data reported by an investigator who has been determined to be 
ineligible to receive investigational-use new animal drugs will be 
examined to determine whether he has submitted unreliable data that are 
essential to the continuation of the investigation or essential to the 
approval of any new animal drug application.
    (4) If the Commissioner determines, after the unreliable data 
submitted by the investigator are eliminated from consideration, that 
the data remaining are inadequate to support a conclusion that it is 
reasonably safe to continue the investigation, he shall first notify the 
sponsor, who shall have an opportunity for a regulatory hearing before 
the Food and Drug Administration pursuant to part 16 of this chapter on 
whether the exemption should be terminated. If a danger to the public 
health exists, however, he shall terminate the exemption forthwith and 
notify the sponsor of the termination. In such event the sponsor shall 
have an opportunity for a regulatory hearing before the Food and Drug 
Administration pursuant to part 16 (see 42 FR 15675, March 22, 1977) of 
this chapter on the question of whether the exemption should be 
reinstated.
    (5) If the Commissioner determines, after the unreliable data 
submitted by the investigator are eliminated from consideration, that 
the data remaining are such that a new animal drug application would not 
have been approved, he will proceed to withdraw approval of the 
application in accordance with section 512(e) of the act.
    (6) An investigator who has been determined to be ineligible may be 
reinstated as eligible to receive investigational-use new animal drugs 
when the Commissioner determines that he has presented adequate 
assurance that he will employ such new animal drugs solely in compliance 
with the exempting regulations in this section for investigational-use 
new animal drugs.
    (d) Termination of exemption. If the Commissioner finds that:
    (1) The sponsor of the investigation has failed to comply with any 
of the conditions for the exemption established under this section, or
    (2) The continuance of the investigation is unsafe or otherwise 
contrary to the public interest or the drug is being or has been used 
for purposes other than bona fide scientific investigation, he shall 
first notify the sponsor and invite his immediate correction. If the 
conditions of the exemption are not immediately met, the sponsor shall 
have an opportunity for a regulatory hearing before the Food and Drug 
Administration pursuant of part 16 of this chapter on whether the 
exemption should be terminated. If the exemption is terminated the 
sponsor shall recall or have destroyed the unused supplies of the new 
animal drug.
    (e) Statements and requests. ``Notice(s) of Claimed Investigational 
Exemption for a New Animal Drug'' and requests for authorization to use 
investigational animals and their products for food should be addressed 
to the Department of Health and Human Services, Food and Drug 
Administration, Center for Veterinary Medicine, 7500 Standish Pl., 
Rockville, MD 20855.
    (f) Contract research organizations. (1) For purposes of this part 
and part 514, contract research organization means a person that 
assumes, as an independent contractor with the sponsor, one or more of 
the obligations of a sponsor, e.g., design of a protocol, selection or 
monitoring of investigations, evaluation of reports, and preparation of 
materials to be submitted to the Food and Drug Administration.
    (2) A sponsor may transfer responsibility for any or all of the 
obligations set forth in this part to a contract research organization. 
Any such transfer

[[Page 53]]

shall be in writing and, if not all obligations are transferred, shall 
describe each of the obligations being assumed by the contract research 
organization. If all obligations are transferred, a general statement 
that all obligations have been transferred is acceptable. Any obligation 
not covered by the written description shall be deemed not to have been 
transferred.
    (3) A contract research organization that assumes any obligation of 
a sponsor shall comply with the specific regulations in this chapter 
applicable to this obligation and shall be subject to the same 
regulatory action as a sponsor for failure to comply with any obligation 
assumed under these regulations. Thus, all references to sponsor in this 
part apply to a contract research organization to the extent that it 
assumes one or more obligations of the sponsor.
    (g) Index of legally marketed unapproved new animal drugs for minor 
species. All provisions of part 511 apply to new animal drugs for 
investigational use in support of indexing, as described in section 572 
of the act, subject to the provisions of Sec. 516.125 of this chapter.

[40 FR 13823, Mar. 27, 1975, as amended at 41 FR 48268, Nov. 2, 1976; 42 
FR 15675, Mar. 22, 1977; 50 FR 7517, Feb. 22, 1985; 50 FR 16668, Apr. 
26, 1985; 52 FR 8847, Mar. 19, 1987; 54 FR 18280, Apr. 28, 1989; 57 FR 
6475, Feb. 25, 1992; 62 FR 40599, July 29, 1997; 72 FR 69121, Dec. 6, 
2007]



PART 514_NEW ANIMAL DRUG APPLICATIONS--Table of Contents




                      Subpart A_General Provisions

Sec.
514.1 Applications.
514.3 Definitions.
514.4 Substantial evidence.
514.5 Presubmission conferences.
514.6 Amended applications.
514.7 Withdrawal of applications without prejudice.
514.8 Supplements and other changes to an approved application.
514.11 Confidentiality of data and information in a new animal drug 
          application file.
514.12 Confidentiality of data and information in an investigational new 
          animal drug notice.
514.15 Untrue statements in applications.

            Subpart B_Administrative Actions on Applications

514.80 Records and reports concerning experience with approved new 
          animal drugs.
514.100 Evaluation and comment on applications.
514.105 Approval of applications.
514.106 Approval of supplemental applications.
514.110 Reasons for refusing to file applications.
514.111 Refusal to approve an application.
514.115 Withdrawal of approval of applications.
514.116 Notice of withdrawal of approval of application.
514.117 Adequate and well-controlled studies.
514.120 Revocation of order refusing to approve an application or 
          suspending or withdrawing approval of an application.
514.121 Service of notices and orders.

                      Subpart C_Hearing Procedures

514.200 Contents of notice of opportunity for a hearing.
514.201 Procedures for hearings.

Subparts D-E [Reserved]

                        Subpart F_Judicial Review

514.235 Judicial review.

    Authority: 21 U.S.C. 321, 331, 351, 352, 356a, 360b, 371, 379e, 381.

    Source: 40 FR 13825, Mar. 27, 1975, unless otherwise noted.



                      Subpart A_General Provisions



Sec. 514.1  Applications.

    (a) Applications to be filed under section 512(b) of the act shall 
be submitted in the form described in paragraph (b) of this section. If 
any part of the application is in a foreign language, an accurate and 
complete English translation shall be appended to such part. 
Translations of literature printed in a foreign language shall be 
accompanied by copies of the original publication. The application must 
be signed by the applicant or by an authorized attorney, agent, or 
official. If the applicant or such authorized representative does not 
reside or have a place of business within the United States, the 
application must also furnish the name and post office address of, and 
must be

[[Page 54]]

countersigned by, an authorized attorney, agent, or official residing or 
maintaining a place of business within the United States. Pertinent 
information may be incorporated in, and will be considered as part of, 
an application on the basis of specific reference to such information, 
including information submitted under the provisions of Sec. 511.1 of 
this chapter, in the files of the Food and Drug Administration; however, 
the reference must be specific in identifying the information. Any 
reference to information furnished by a person other than the applicant 
may not be considered unless its use is authorized in a written 
statement signed by the person who submitted it.
    (b) Applications for new animal drugs shall be submitted in 
triplicate and assembled in the manner prescribed by paragraph (b)(15) 
of this section, and shall include the following information:
    (1) Identification. Whether the submission is an original or 
supplemental application; the name and the address of the applicant; the 
date of the application; the trade name(s) (if one has been proposed) 
and chemical name(s) of the new animal drug. Upon receipt, the 
application will be assigned a number NADA ----, which shall be used for 
all correspondence with respect to the application.
    (2) Table of contents and summary. The application shall be 
organized in a cohesive fashion, shall contain a table of contents which 
identifies the data and other material submitted, and shall contain a 
well-organized summary and evaluation of the data in the following form:
    (i) Chemistry:
    (a) Chemical structural formula or description for any new animal 
drug substance.
    (b) Relationship to other chemically or pharmacologically related 
drugs.
    (c) Description of dosage form and quantitative composition.
    (ii) Scientific rationale and purpose the new animal drug is to 
serve:
    (a) Clinical purpose.
    (b) Highlights of laboratory studies: The reasons why certain types 
of studies were done or omitted as related to the proposed conditions of 
use and to information already known about this class of compounds. 
Emphasize any unusual or particularly significant pharmacological 
effects or toxicological findings.
    (c) Highlights of clinical studies: The rationale of the clinical 
study plan showing why types of studies were done, amended, or omitted 
as related to laboratory studies and prior clinical experience.
    (d) Conclusions: A short statement of conclusions combining the 
major points of effectiveness and safety as they relate to the use of 
the new animal drug.
    (3) Labeling. Three copies of each piece of all labeling to be used 
for the article (total of 9).
    (i) All labeling should be identified to show its position on, or 
the manner in which it is to accompany the market package.
    (ii) Labeling for nonprescription new animal drugs should include 
adequate directions for use by the layman under all conditions of use 
for which the new animal drug is intended, recommended, or suggested in 
any of the labeling or advertising sponsored by the applicant.
    (iii) Labeling for prescription veterinary drugs should bear 
adequate information for use under which veterinarians can use the new 
animal drug safely and for the purposes for which it is intended, 
including those purposes for which it is to be advertised or 
represented, in accord with Sec. 201.105 of this chapter.
    (iv) All labeling for prescription or nonprescription new animal 
drugs shall be submitted with any necessary use restrictions prominently 
and conspicuously displayed.
    (v) Labeling for new animal drugs intended for use in the 
manufacture of medicated feeds shall include:
    (a) Specimens of labeling to be used for such new animal drug with 
adequate directions for the manufacture and use of finished feeds for 
all conditions for which the new animal drug is intended, recommended, 
or suggested in any of the labeling, including advertising, sponsored by 
the applicant. Ingredient labeling may utilize collective names as 
provided in Sec. 501.110 of this chapter.

[[Page 55]]

    (b) Representative labeling proposed to be used for Type B and Type 
C medicated feeds containing the new animal drug.
    (vi) Draft labeling may be submitted for preliminary consideration 
of an application. Final printed labeling will ordinarily be required 
prior to approval of an application. Proposed advertising for veterinary 
prescription drugs may be submitted for comment or approval.
    (4) Components and composition. A complete list of all articles used 
for production of the new animal drug including a full list of the 
composition of each article:
    (i) A full list of the articles used as components of the new animal 
drug. This list should include all substances used in the synthesis, 
extraction, or other method of preparation of any new animal drug and in 
the preparation of the finished dosage form, regardless of whether they 
undergo chemical change or are removed in the process. Each component 
should be identified by its established name, if any, or complete 
chemical name, using structural formulas when necessary for specific 
identification. If any proprietary name is used, it should be followed 
by a complete quantitative statement of composition. Reasonable 
alternatives for any listed component may be specified.
    (ii) A full statement of the composition of the new animal drug. The 
statement shall set forth the name and amount of each ingredient, 
whether active or not, contained in a stated quantity of the new animal 
drug in the form in which it is to be distributed (for example, amount 
per tablet or milliliter) and a batch formula representative of that to 
be employed for the manufacture of the finished dosage form. All 
components should be included in the batch formula regardless of whether 
they appear in the finished product. Any calculated excess of an 
ingredient over the label declaration should be designated as such and 
percent excess shown. Reasonable variation may be specified.
    (iii) If it is a new animal drug produced by fermentation:
    (a) Source and type of microorganism used to produce the new animal 
drug.
    (b) Composition of media used to produce the new animal drug.
    (c) Type of precursor used, if any, to guide or enhance production 
of the antibiotic during fermentation.
    (d) Name and composition of preservative, if any, used in the broth.
    (e) A complete description of the extraction and purification 
processes including the names and compositions of the solvents, 
precipitants, ion exchange resins, emulsifiers, and all other agents 
used.
    (f) If the new animal drug is produced by a catalytic hydrogenation 
process (such as tetracycline from chlortetracycline), a complete 
description of each chemical reaction with graphic formulas used to 
produce the new animal drug, including the names of the catalyst used, 
how it is removed, and how the new animal drug is extracted and 
purified.
    (5) Manufacturing methods, facilities, and controls. A full 
description of the methods used in, and the facilities and controls used 
for, the manufacture, processing, and packing of the new animal drug. 
This description should include full information with respect to any new 
animal drug in sufficient detail to permit evaluation of the adequacy of 
the described methods of manufacture, processing, and packing, and the 
described facilities and controls to determine and preserve the 
identity, strength, quality, and purity of the new animal drug, and the 
following:
    (i) If the applicant does not himself perform all the manufacturing, 
processing, packaging, labeling, and control operations for any new 
animal drug, he shall: Identify each person who will perform any part of 
such operations and designate the part; and provide a signed statement 
from each such person fully describing, directly or by reference, the 
methods, facilities, and controls he will use in his part of the 
operation. The statement shall include a commitment that no changes will 
be made without prior approval by the Food and Drug Administration, 
unless permitted under Sec. 514.8.
    (ii) A description of the qualifications, including educational 
background and experience, of the technical

[[Page 56]]

and professional personnel who are responsible for assuring that the new 
animal drug has the identity, strength, quality, and purity it purports 
or is represented to possess, and a statement of their responsibilities.
    (iii) A description of the physical facilities including building 
and equipment used in manufacturing, processing, packaging, labeling, 
storage, and control operations.
    (iv) The methods used in the synthesis, extraction, isolation, or 
purification of any new animal drug. When the specifications and 
controls applied to such new animal drugs are inadequate in themselves 
to determine its identity, strength, quality, and purity, the methods 
should be described in sufficient detail, including quantities used, 
times, temperature, pH, solvents, etc., to determine these 
characteristics. Alternative methods or variations in methods within 
reasonable limits that do not affect such characteristics of the new 
animal drug may be specified. A flow sheet and indicated equations 
should be submitted when needed to explain the process.
    (v) Precautions to insure proper identity, strength, quality, and 
purity of the raw materials, whether active or not, including:
    (a) The specifications for acceptance and methods of testing for 
each lot of raw material.
    (b) A statement as to whether or not each lot of raw materials is 
given a serial number to identify it, and the use made of such numbers 
in subsequent plant operations.
    (vi) The instructions used in the manufacturing, processing, 
packaging, and labeling of each dosage form of the new animal drug, 
including:
    (a) The method of preparation of the master formula records and 
individual batch records and the manner in which these records are used.
    (b) The number of individuals checking weight or volume of each 
individual ingredient entering into each batch of the new animal drug.
    (c) A statement as to whether or not the total weight or volume of 
each batch is determined at any stage of the manufacturing process 
subsequent to making up a batch according to the formula card and, if 
so, at what stage and by whom it is done.
    (d) The precautions used in checking the actual package yield 
produced from a batch of the new animal drug with the theoretical yield. 
This should include a description of the accounting for such items as 
discards, breakage, etc., and the criteria used in accepting or 
rejecting batches of drugs in the event of an unexplained discrepancy.
    (e) The precautions used to assure that each lot of the new animal 
drug is packaged with the proper label and labeling, including 
provisions for labeling storage and inventory control.
    (f) Any special precautions used in the operations.
    (vii) The analytical controls used during the various stages of the 
manufacturing, processing, packaging, and labeling of the new animal 
drug, including a detailed description of the collection of samples and 
the analytical procedures to which they are subjected. The analytical 
procedures should be capable of determining the active components within 
a reasonable degree of accuracy and of assuring the identity of such 
components.
    (a) A description of practicable methods of analysis of adequate 
sensitivity to determine the amount of the new animal drug in the final 
dosage form should be included. The dosage form may be a finished 
pharmaceutical product, a Type A medicated article, a Type B or a Type C 
medicated feed, or a product for use in animal drinking water. Where two 
or more active ingredients are included, methods should be quantitative 
and specific for each active ingredient.
    (b) If the article is one that is represented to be sterile, the 
same information with regard to the manufacturing, processing, 
packaging, and the collection of samples of the drug should be given for 
sterility controls. Include the standards used for acceptance of each 
lot of the finished drug.
    (viii) An explanation of the exact significance of any batch control 
numbers used in the manufacturing, processing, packaging, and labeling 
of the new animal drug, including such control numbers that may appear 
on the label of the finished article. State whether these numbers enable 
determination of

[[Page 57]]

the complete manufacturing history of the product. Describe any methods 
used to permit determination of the distribution of any batch if its 
recall is required.
    (ix) Adequate information with respect to the characteristics of and 
the test methods employed for the container, closure, or other component 
parts of the drug package to assure their suitability for the intended 
use.
    (x) A complete description of, and data derived from, studies of the 
stability of the new animal drug in the final dosage form, including 
information showing the suitability of the analytical methods used. A 
description of any additional stability studies underway or planned. 
Stability data for the finished dosage form of the new animal drug in 
the container in which it is to be marketed, including any proposed 
multiple dose container, and, if it is to be put into solution at the 
time of dispensing, for the solution prepared as directed. If the new 
animal drug is intended for use in the manufacture of Type C medicated 
feed as defined in Sec. 558.3 of this chapter, stability data derived 
from studies in which representative formulations of the medicated feed 
articles are used. Similar data may be required for Type B medicated 
feeds as determined by the Food and Drug Administration on a case-by-
case basis. Expiration dates shall be proposed for finished 
pharmaceutical dosage forms and Type A medicated articles. If the data 
indicate that an expiration date is needed for Type B or Type C 
medicated feeds, the applicant shall propose such expiration date. If no 
expiration date is proposed for Type B or Type C medicated feeds, the 
applicant shall justify its absence with data.
    (xi) Additional procedures employed which are designed to prevent 
contamination and otherwise assure proper control of the product. An 
application may be refused unless it includes adequate information 
showing that the methods used in, and the facilities and controls used 
for, the manufacturing, processing, and packaging of the new animal drug 
are adequate to preserve its identity, strength, quality, and purity in 
conformity with good manufacturing practice and identifies each 
establishment, showing the location of the plant conducting these 
operations.
    (6) Samples. Samples of the new animal drug and articles used as 
components and information concerning them may be requested by the 
Center for Veterinary Medicine as follows:
    (i) Each sample shall consist of four identical, separately packaged 
subdivisions, each containing at least three times the amount required 
to perform the laboratory test procedures described in the application 
to determine compliance with its control specifications for identity and 
assays. Each of the samples submitted shall be appropriately packaged 
and labeled to preserve its characteristics, to identify the material 
and the quantity in each subdivision of the sample, and to identify each 
subdivision with the name of the applicant and the new animal drug 
application to which it relates. Included are:
    (a) A sample or samples of any reference standard and blank used in 
the procedures described in the application for assaying each new animal 
drug and other assayed components of the finished new animal drug.
    (b) A representative sample or samples of each strength of the 
finished dosage form proposed in the application and employed in the 
clinical investigations and a representative sample or samples of each 
new animal drug from the batch(es) employed in the production of such 
dosage form.
    (c) A representative sample or samples of finished market packages 
of each strength of the dosage form of the new animal drug prepared for 
initial marketing and, if any such sample is not from a representative 
commercial-scale production batch, such a sample from a representative 
commercial-scale production batch, and a representative sample or 
samples of each new animal drug from the batch(es) employed in the 
production of such dosage form, provided that in the case of new animal 
drugs marketed in large packages the sample should contain only three 
times a sufficient quantity of the new animal drug to allow for 
performing the control tests for drug identity and assays.

[[Page 58]]

    (ii) The following information shall be included for the samples 
when requested:
    (a) For each sample submitted, full information regarding its 
identity and the origin of any new animal drug contained therein 
(including a statement whether it was produced on a laboratory, pilot-
plant, or full-production scale) and detailed results of all laboratory 
tests made to determine the identity, strength, quality, and purity of 
the batch represented by the sample, including assays.
    (b) For any reference standard submitted, a complete description of 
its preparation and the results of all laboratory tests on it. If the 
test methods used differed from those described in the application, full 
details of the methods employed in obtaining the reporting results.
    (7) Analytical methods for residues. Applications shall include a 
description of practicable methods for determining the quantity, if any, 
of the new animal drug in or on food, and any substance formed in or on 
food because of its use, and the proposed tolerance or withdrawal period 
or other use restrictions to ensure that the proposed use of this drug 
will be safe. When data or other adequate information establish that it 
is not reasonable to expect the new animal drug to become a component of 
food at concentrations considered unsafe, a regulatory method is not 
required.
    (i) The kind of information required by this subdivision may 
include: Complete experimental protocols for determining drug residue 
levels in the edible products, and the length of time required for 
residues to be eliminated from such products following the drug's use; 
residue studies conducted under appropriate (consistent with the 
proposed usage) conditions of dosage, time, and route of administration 
to show levels, if any, of the drug and/or its metabolites in test 
animals during and upon cessation of treatment and at intervals 
thereafter in order to establish a disappearance curve; if the drug is 
to be used in combination with other drugs, possible effects of 
interaction demonstrated by the appropriate disappearance curve or 
depletion patterns after drug withdrawal under appropriate (consistent 
with the proposed usage) conditions of dosage, time, and route of 
administration; if the drug is given in the feed or water, appropriate 
consumption records of the medicated feed or water and appropriate 
performance data in the treated animal; if the drug is to be used in 
more than one species, drug residue studies or appropriate metabolic 
studies conducted for each species that is food-producing. To provide 
these data, a sufficient number of birds or animals should be used at 
each sample interval. Appropriate use of labeled compounds (e.g. 
radioactive tracers), may be utilized to establish metabolism and 
depletion curves. Drug residue levels ordinarily should be determined in 
muscle, liver, kidney, and fat and where applicable, in skin, milk, and 
eggs (yolk and egg white). As a part of the metabolic studies, levels of 
the drug or metabolite should be determined in blood where feasible. 
Samples may be combined where necessary. Where residues are suspected or 
known to be present in litter from treated animals, it may be necessary 
to include data with respect to such residues becoming components of 
other agricultural commodities because of use of litter from treated 
animals.
    (ii) A new animal drug that has the potential to contaminate human 
food with residues whose consumption could present a risk of cancer to 
people must satisfy the requirements of subpart E of part 500 of this 
chapter.
    (8) Evidence to establish safety and effectiveness. (i) An 
application may be refused unless it contains full reports of adequate 
tests by all methods reasonably applicable to show whether or not the 
new animal drug is safe and effective for use as suggested in the 
proposed labeling.
    (ii) An application may be refused unless it includes substantial 
evidence of the effectiveness of the new animal drug as defined in Sec. 
514.4.
    (iii) An application may be refused unless it contains detailed 
reports of the investigations, including studies made on laboratory 
animals, in which the purpose, methods, and results obtained are clearly 
set forth of acute, subacute, and chronic toxicity, and unless it 
contains appropriate clinical laboratory results related to safety and

[[Page 59]]

efficacy. Such information should include identification of the person 
who conducted each investigation, a statement of where the 
investigations were conducted, and where the raw data are available in 
the application.
    (iv) All information pertinent to an evaluation of the safety and 
effectiveness of the new animal drug received or otherwise obtained by 
the applicant from any source, including information derived from other 
investigations or commercial marketing (for example, outside the United 
States), or reports in the scientific literature, both favorable and 
unfavorable, involving the new animal drug that is the subject of the 
application and related new animal drugs shall be submitted. An adequate 
summary may be acceptable in lieu of a reprint of a published report 
that only supports other data submitted. Include any evaluation of the 
safety or effectiveness of the new animal drug that has been made by the 
applicant's veterinary or medical department, expert committee, or 
consultants.
    (v) If the new animal drug is a combination of active ingredients or 
animal drugs, an application may be refused unless it includes 
substantial evidence of the effectiveness of the combination new animal 
drug as required in Sec. 514.4.
    (vi) An application shall include a complete list of the names and 
post office addresses of all investigators who received the new animal 
drug. This may be incorporated in whole or in part by reference to 
information submitted under the provisions of Sec. 511.1 of this 
chapter.
    (vii) Explain any omission of reports from any investigator to whom 
the investigational new animal drug has been made available. The 
unexplained omission of any reports of investigations made with the new 
animal drug by the applicant or submitted to him by an investigator or 
the unexplained omission of any pertinent reports of investigations or 
clinical experience received or otherwise obtained by the applicant from 
published literature or other sources that would bias an evaluation of 
the safety of the new animal drug or its effectiveness in use, 
constitutes grounds for the refusal or withdrawal of the approval of an 
application.
    (viii) If a sponsor has transferred any obligations for the conduct 
of any clinical study to a contract research organization, the 
application is required to include a statement containing the name and 
address of the contract research organization, identifying the clinical 
study, and listing the obligations transferred. If all obligations 
governing the conduct of the study have been transferred, a general 
statement of this transfer--in lieu of a listing of the specific 
obligations transferred--may be submitted.
    (ix) If original subject records were audited or reviewed by the 
sponsor in the course of monitoring any clinical study to verify the 
accuracy of the case reports submitted to the sponsor, a list 
identifying each clinical study so audited or reviewed.
    (9) Veterinary feed directive. Three copies of a veterinary feed 
directive (VFD) must be submitted in the format described under Sec. 
558.6(a)(4) of this chapter.
    (10) Supplemental applications. If it is a supplemental application, 
full information shall be submitted on each proposed change concerning 
any statement made in the approved application.
    (11) Applicant's commitment. It is understood that the labeling and 
advertising for the new animal drug will prescribe, recommend, or 
suggest its use only under the conditions stated in the labeling which 
is part of this application and if the article is a prescription new 
animal drug, it is understood that any labeling which furnishes or 
purports to furnish information for use or which prescribes, recommends, 
or suggests a dosage for use of the new animal drug will also contain, 
in the same language and emphasis, information for its use including 
indications, effects, dosages, routes, methods, and frequency and 
duration of administration, any relevant hazards, contraindications, 
side effects, and precautions contained in the labeling which is part of 
this application. It is understood that all representations in this 
application apply to the drug produced until changes are made in 
conformity with Sec. 514.8.
    (12) Additional commitments. (i) New animal drugs as defined in 
Sec. 510.3 of this

[[Page 60]]

chapter, intended for use in the manufacture of animal feeds in any 
State will be shipped only to persons who may receive such drugs in 
accordance with Sec. 510.7 of this chapter.
    (ii) The methods, facilities, and controls described under item 5 of 
this application conform to the current good manufacturing practice 
regulations in subchapter C of this chapter.
    (iii) With respect to each nonclinical laboratory study contained in 
the application, either a statement that the study was conducted in 
compliance with the good laboratory practice regulations set forth in 
part 58 of this chapter, or, if the study was not conducted in 
compliance with such regulations, a brief statement of the reason for 
the noncompliance.
    (13) [Reserved]
    (14) Environmental assessment. The applicant is required to submit 
either a claim for categorical exclusion under Sec. 25.30 or Sec. 
25.33 of this chapter or an environmental assessment under Sec. 25.40 
of this chapter.
    (15) Assembling and binding the application. Assemble and bind an 
original and two copies of the application as follows:
    (i) Bind the original or ribbon copy of the application as copy No. 
1.
    (ii) Bind two identical copies as copy No. 2 and copy No. 3.
    (iii) Identify each front cover with the name of the applicant, new 
animal drug, and the copy number.
    (iv) Number each page of the application sequentially in the upper 
right hand corner or in another location so that the page numbers remain 
legible after the application has been bound, and organize the 
application consistent with paragraphs (b) (1) through (14) of this 
section. Each copy should bear the same page numbering, whether 
sequential in each volume or continuous and sequential throughout the 
application.
    (v) Include complete labeling in each of the copies. It is suggested 
that labeling be identified by date of printing or date of preparation.
    (vi) Submit separate applications for each different dosage form of 
the drug proposed. Repeating basic information pertinent to all dosage 
forms in each application is unnecessary if reference is made to the 
application containing such information. Include in each application 
information applicable to the specific dosage form, such as labeling, 
composition, stability data, and method of manufacture.
    (vii) Submit in folders amendments, supplements, and other 
correspondence sent after submission of an original application. The 
front cover of these submissions should be identified with the name of 
the applicant, new animal drug, copy number, and the new animal drug 
application number, if known.
    (c) When a new animal drug application is submitted for a new animal 
drug which has a stimulant, depressant, or hallucinogenic effect on the 
central nervous system, if it appears that the drug has a potential for 
abuse, the Commissioner shall forward that information to the Attorney 
General of the United States.

[40 FR 13825, Mar. 27, 1975]

    Editorial Note: For Federal Register citations affecting Sec. 
514.1, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and on GPO Access.



Sec. 514.3  Definitions.

    The definition and interpretation of terms contained in this section 
apply to those terms as used throughout subchapter E.
    Adverse drug experience is any adverse event associated with the use 
of a new animal drug, whether or not considered to be drug related, and 
whether or not the new animal drug was used in accordance with the 
approved labeling (i.e., used according to label directions or used in 
an extralabel manner, including but not limited to different route of 
administration, different species, different indications, or other than 
labeled dosage). Adverse drug experience includes, but is not limited 
to:
    (1) An adverse event occurring in animals in the course of the use 
of an animal drug product by a veterinarian or by a livestock producer 
or other animal owner or caretaker.
    (2) Failure of a new animal drug to produce its expected 
pharmacological or clinical effect (lack of expected effectiveness).

[[Page 61]]

    (3) An adverse event occurring in humans from exposure during 
manufacture, testing, handling, or use of a new animal drug.
    ANADA is an abbreviated new animal drug application including all 
amendments and supplements.
    Applicant is a person or entity who owns or holds on behalf of the 
owner the approval for an NADA or an ANADA, and is responsible for 
compliance with applicable provisions of the act and regulations.
    Increased frequency of adverse drug experience is an increased rate 
of occurrence of a particular serious adverse drug event, expected or 
unexpected, after appropriate adjustment for drug exposure.
    NADA is a new animal drug application including all amendments and 
supplements.
    Nonapplicant is any person other than the applicant whose name 
appears on the label and who is engaged in manufacturing, packing, 
distribution, or labeling of the product.
    Potential applicant means any person:
    (1) Intending to investigate a new animal drug under section 512(j) 
of the Federal Food, Drug, and Cosmetic Act (the act),
    (2) Investigating a new animal drug under section 512(j) of the act,
    (3) Intending to file a new animal drug application (NADA) or 
supplemental NADA under section 512(b)(1) of the act, or
    (4) Intending to file an abbreviated new animal drug application 
(ANADA) under section 512(b)(2) of the act.
    Presubmission conference means one or more conferences between a 
potential applicant and FDA to reach a binding agreement establishing a 
submission or investigational requirement.
    Presubmission conference agreement means that section of the 
memorandum of conference headed ``Presubmission Conference Agreement'' 
that records any agreement on the submission or investigational 
requirement reached by a potential applicant and FDA during the 
presubmission conference.
    Product defect/manufacturing defect is the deviation of a 
distributed product from the standards specified in the approved 
application, or any significant chemical, physical, or other change, or 
deterioration in the distributed drug product, including any microbial 
or chemical contamination. A manufacturing defect is a product defect 
caused or aggravated by a manufacturing or related process. A 
manufacturing defect may occur from a single event or from deficiencies 
inherent to the manufacturing process. These defects are generally 
associated with product contamination, product deterioration, 
manufacturing error, defective packaging, damage from disaster, or 
labeling error. For example, a labeling error may include any incident 
that causes a distributed product to be mistaken for, or its labeling 
applied to, another product.
    Serious adverse drug experience is an adverse event that is fatal, 
or life-threatening, or requires professional intervention, or causes an 
abortion, or stillbirth, or infertility, or congenital anomaly, or 
prolonged or permanent disability, or disfigurement.
    Unexpected adverse drug experience is an adverse event that is not 
listed in the current labeling for the new animal drug and includes any 
event that may be symptomatically and pathophysiologically related to an 
event listed on the labeling, but differs from the event because of 
greater severity or specificity. For example, under this definition 
hepatic necrosis would be unexpected if the labeling referred only to 
elevated hepatic enzymes or hepatitis.

[68 FR 15365, Mar. 31, 2003, as amended at 69 FR 51170, Aug. 18, 2004]



Sec. 514.4  Substantial evidence.

    (a) Definition of substantial evidence. Substantial evidence means 
evidence consisting of one or more adequate and well-controlled studies, 
such as a study in a target species, study in laboratory animals, field 
study, bioequivalence study, or an in vitro study, on the basis of which 
it could fairly and reasonably be concluded by experts qualified by 
scientific training and experience to evaluate the effectiveness of the 
new animal drug involved that the new animal drug will have the effect 
it purports or is represented to have under the conditions of use 
prescribed, recommended, or suggested in the labeling

[[Page 62]]

or proposed labeling thereof. Substantial evidence shall include such 
adequate and well-controlled studies that are, as a matter of sound 
scientific judgment, necessary to establish that a new animal drug will 
have its intended effect.
    (b) Characteristics of substantial evidence--(1) Qualifications of 
experts. Any study that is intended to be part of substantial evidence 
of the effectiveness of a new animal drug shall be conducted by experts 
qualified by scientific training and experience.
    (2) Intended uses and conditions of use. Substantial evidence of 
effectiveness of a new animal drug shall demonstrate that the new animal 
drug is effective for each intended use and associated conditions of use 
for and under which approval is sought.
    (i) Dose range labeling. Sponsors should, to the extent possible, 
provide for a dose range because it increases the utility of the new 
animal drug by providing the user flexibility in the selection of a safe 
and effective dose. In general, substantial evidence to support dose 
range labeling for a new animal drug intended for use in the diagnosis, 
cure, mitigation, treatment, or prevention of disease must consist of at 
least one adequate and well-controlled study on the basis of which 
qualified experts could fairly and reasonably conclude that the new 
animal drug will be effective for the intended use at the lowest dose of 
the dose range suggested in the proposed labeling for that intended use. 
Substantial evidence to support dose range labeling for a new animal 
drug intended to affect the structure or function of the body of an 
animal generally must consist of at least one adequate and well-
controlled study on the basis of which qualified experts could fairly 
and reasonably conclude that the new animal drug will be effective for 
the intended use at all doses within the range suggested in the proposed 
labeling for the intended use.
    (ii) [Reserved]
    (3) Studies--(i) Number. Substantial evidence of the effectiveness 
of a new animal drug for each intended use and associated conditions of 
use shall consist of a sufficient number of current adequate and well-
controlled studies of sufficient quality and persuasiveness to permit 
qualified experts:
    (A) To determine that the parameters selected for measurement and 
the measured responses reliably reflect the effectiveness of the new 
animal drug;
    (B) To determine that the results obtained are likely to be 
repeatable, and that valid inferences can be drawn to the target animal 
population; and
    (C) To conclude that the new animal drug is effective for the 
intended use at the dose or dose range and associated conditions of use 
prescribed, recommended, or suggested in the proposed labeling.
    (ii) Types. Adequate and well-controlled studies that are intended 
to provide substantial evidence of the effectiveness of a new animal 
drug may include, but are not limited to, published studies, foreign 
studies, studies using models, and studies conducted by or on behalf of 
the sponsor. Studies using models shall be validated to establish an 
adequate relationship of parameters measured and effects observed in the 
model with one or more significant effects of treatment.
    (c) Substantial evidence for combination new animal drugs--(1) 
Definitions. The following definitions of terms apply to this section:
    (i) Combination new animal drug means a new animal drug that 
contains more than one active ingredient or animal drug that is applied 
or administered simultaneously in a single dosage form or simultaneously 
in or on animal feed or drinking water.
    (ii) Dosage form combination new animal drug means a combination new 
animal drug intended for use other than in animal feed or drinking 
water.
    (iii) Antibacterial with respect to a particular target animal 
species means an active ingredient or animal drug: That is approved in 
that species for the diagnosis, cure, mitigation, treatment, or 
prevention of bacterial disease; or that is approved for use in that 
species for any other use that is attributable to its antibacterial 
properties. But, antibacterial does not include ionophores or arsenicals 
intended for use in combination in animal feed or drinking water.
    (iv) Appropriate concurrent use exists when there is credible 
evidence that

[[Page 63]]

the conditions for which the combination new animal drug is intended can 
occur simultaneously.
    (2) Combination new animal drugs that contain only active 
ingredients or animal drugs that have previously been separately 
approved. (i) For dosage form combination new animal drugs, except for 
those that contain a nontopical antibacterial, that contain only active 
ingredients or animal drugs that have previously been separately 
approved for the particular uses and conditions of use for which they 
are intended in combination, a sponsor shall demonstrate:
    (A) By substantial evidence, as defined in this section, that any 
active ingredient or animal drug intended only for the same use as 
another active ingredient or animal drug in the combination makes a 
contribution to the effectiveness of the combination new animal drug;
    (B) That each active ingredient or animal drug intended for at least 
one use that is different from all the other active ingredients or 
animal drugs used in the combination provides appropriate concurrent use 
for the intended target animal population; and
    (C) That the active ingredients or animal drugs are physically 
compatible and do not have disparate dosing regimens if FDA, based on 
scientific information, has reason to believe the active ingredients or 
animal drugs are physically incompatible or have disparate dosing 
regimens.
    (ii) For combination new animal drugs intended for use in animal 
feed or drinking water that contain only active ingredients or animal 
drugs that have previously been separately approved for the particular 
uses and conditions of use for which they are intended in combination, 
the sponsor shall demonstrate:
    (A) By substantial evidence, as defined in this section, that any 
active ingredient or animal drug intended only for the same use as 
another active ingredient or animal drug in the combination makes a 
contribution to the effectiveness of the combination new animal drug;
    (B) For such combination new animal drugs that contain more than one 
antibacterial ingredient or animal drug, by substantial evidence, as 
defined in this section, that each antibacterial makes a contribution to 
labeled effectiveness;
    (C) That each active ingredient or animal drug intended for at least 
one use that is different from all other active ingredients or animal 
drugs used in the combination provides appropriate concurrent use for 
the intended target animal population; and
    (D) That the active ingredients or animal drugs intended for use in 
drinking water are physically compatible if FDA, based on scientific 
information, has reason to believe the active ingredients or animal 
drugs are physically incompatible.
    (3) Other combination new animal drugs. For all other combination 
new animal drugs, the sponsor shall demonstrate by substantial evidence, 
as defined in this section, that the combination new animal drug will 
have the effect it purports or is represented to have under the 
conditions of use prescribed, recommended, or suggested in the proposed 
labeling and that each active ingredient or animal drug contributes to 
the effectiveness of the combination new animal drug.

[64 FR 40756, July 28, 1999]



Sec. 514.5  Presubmission conferences.

    (a) General principle underlying the conduct of a presubmission 
conference. The general principle underlying the conduct of any 
presubmission conference is that there should be candid, full, and open 
communication.
    (b) Requesting a presubmission conference. A potential applicant is 
entitled to one or more conferences prior to the submission of an NADA, 
supplemental NADA, or an ANADA to reach an agreement establishing part 
or all of a submission or investigational requirement. A potential 
applicant's request for a presubmission conference must be submitted to 
FDA in a signed letter. The letter must include a proposed agenda that 
clearly outlines the scope, purpose, and objectives of the presubmission 
conference and must list the names and positions of the representatives 
who are expected to attend the presubmission conference on behalf of the 
applicant.

[[Page 64]]

    (c) Timing. A potential applicant may request one or more 
presubmission conferences at any time prior to the filing of a NADA, 
supplemental NADA, or an ANADA. A request for a presubmission conference 
must be received by FDA at least 30 calendar days in advance of the 
requested conference date. FDA will schedule the presubmission 
conference at a time agreeable to both FDA and the potential applicant.
    (d) Advance information. The potential applicant must provide to 
FDA, at least 30 calendar days before a scheduled presubmission 
conference, a detailed agenda, a copy of any materials to be presented 
at the conference, a list of proposed indications and, if available, a 
copy of the proposed labeling for the product under consideration, and 
copies of materials evaluated or referenced relative to issues listed in 
the agenda for the conference. If the materials are not provided or are 
not sufficient to provide the basis for meaningful discussion, FDA may 
elect to postpone part or all of the meeting until sufficient materials 
are provided to FDA.
    (e) Conduct of a presubmission conference. The potential applicant 
and FDA may each bring consultants to the presubmission conference. The 
presubmission conference(s) will be directed primarily at establishing 
agreement between FDA and the potential applicant regarding a submission 
or investigational requirement. The submission or investigational 
requirement may include, among other things, the number, types, and 
general design of studies that are necessary to demonstrate the safety 
and effectiveness of a new animal drug for the intended uses and 
conditions of use prescribed, recommended, or suggested in the proposed 
labeling for the new animal drug.
    (f) Documentation of a presubmission conference--(1) Memorandum of 
conference--(i) Preparation. FDA will prepare a memorandum for each 
presubmission conference that will include, among other things, any 
background pertinent to the request for meeting; a summary of the key 
points of discussion; agreements; and action items and assignments of 
responsibility. That portion of the memorandum of conference that 
documents any agreements reached regarding all or part of a submission 
or investigational requirement will be included under the heading 
``Presubmission Conference Agreement.'' If the presubmission conference 
agreement section of the memorandum is silent on an issue, including one 
that was discussed in the conference or addressed by materials provided 
for the conference, such silence does not constitute agreement between 
FDA and the potential applicant on the issue.
    (ii) Sending a copy to the potential applicant. FDA will send a copy 
of the memorandum to the potential applicant for review no later than 45 
calendar days after the date of the conference
    (iii) Requests for changes or clarification. If a potential 
applicant requests changes to, or clarification of, the substance of the 
memorandum, the request must be sent to FDA within 30 calendar days from 
the date a copy of the memorandum is sent to the applicant. If the 
potential applicant requests changes or clarification, FDA will send the 
potential applicant a response to their request no later than 45 
calendar days after the date of receipt of the request.
    (iv) Administrative record. A copy of FDA's original memorandum of 
conference and, as appropriate, a copy of an amended memorandum to 
correct or clarify the content of the original memorandum will be made 
part of the administrative file.
    (2) Field studies. If FDA requires more than one field study to 
establish by substantial evidence that the new animal drug is effective 
for its intended uses under the conditions of use prescribed, 
recommended, or suggested in the proposed labeling, FDA will provide 
written scientific justification for requiring more than one field 
study. Such justification must be provided no later than 25 calendar 
days after the date of the conference at which the requirement for more 
than one field study is established. If FDA does not believe more than 
one field study is required but the potential applicant voluntarily 
proposes to conduct more than one field study, FDA will not provide such 
written justification. If FDA

[[Page 65]]

requires one field study to be conducted at multiple locations, FDA will 
provide justification for requiring multiple locations verbally during 
the presubmission conference and in writing as part of the memorandum of 
conference.
    (g) Modification of presubmission conference agreements. An 
agreement made under a presubmission conference requested under section 
512(b)(3) of the act and documented in a memorandum of conference is 
binding on the potential applicant and FDA and may only be modified if:
    (1) FDA and the potential applicant mutually agree to modify, in 
part or in whole, the agreement and such modification is documented and 
provided to the potential applicant as described in paragraph (f)(1) of 
this section; or
    (2) FDA by written order determines that a substantiated scientific 
requirement essential to the determination of safety or effectiveness of 
the new animal drug appeared after the conference.
    (h) When the terms of a presubmission conference agreement are not 
valid--(1) A presubmission conference agreement will no longer be valid 
if:
    (i) The potential applicant makes to FDA, before, during, or after 
the presubmission conference, any untrue statement of material fact; or
    (ii) The potential applicant fails to follow any material term of 
the agreement; and
    (2) A presubmission conference may no longer be valid if the 
potential applicant submits false or misleading data relating to a new 
animal drug to FDA.
    (i) Dispute resolution. FDA is committed to resolving differences 
between a potential applicant and FDA reviewing divisions with respect 
to requirements for the investigation of new animal drugs and for NADAs, 
supplemental NADAs, and ANADAs as quickly and amicably as possible 
through a cooperative exchange of information and views. When 
administrative or procedural disputes arise, a potential applicant 
should first attempt to resolve the matter within the appropriate review 
division beginning with the individual(s) most directly assigned to the 
review of the application or investigational exemption. If the dispute 
cannot be resolved after such attempts, the dispute shall be evaluated 
and administered in accordance with applicable regulations (21 CFR 
10.75). Dispute resolution procedures may be further explained by 
guidance available from the Center for Veterinary Medicine.

[69 FR 51170, Aug. 18, 2004]



Sec. 514.6  Amended applications.

    The applicant may submit an amendment to an application that is 
pending, including changes that may alter the conditions of use, the 
labeling, safety, effectiveness, identity, strength, quality, or purity 
of the drug or the adequacy of the manufacturing methods, facilities, 
and controls to preserve them, in which case the unamended application 
may be considered as withdrawn and the amended application may be 
considered resubmitted on the date on which the amendment is received by 
the Food and Drug Administration. The applicant will be notified of such 
date.



Sec. 514.7  Withdrawal of applications without prejudice.

    The sponsor may withdraw his pending application from consideration 
as a new animal drug application upon written notification to the Food 
and Drug Administration. Such withdrawal may be made without prejudice 
to a future filing. Upon resubmission, the time limitation will begin to 
run from the date the resubmission is received by the Food and Drug 
Administration. The original application will be retained by the Food 
and Drug Administration although it is considered withdrawn. The 
applicant shall be furnished a copy at cost on request.



Sec. 514.8  Supplements and other changes to an approved application.

    (a) Definitions. (1) The definitions and interpretations contained 
in section 201 of the Federal Food, Drug, and Cosmetic Act (the act) 
apply to those terms when used in this part.
    (2) The following definitions of terms apply to this part:
    (i) Assess the effects of the change means to evaluate the effects 
of a manufacturing change on the identity, strength, quality, purity, 
and potency

[[Page 66]]

of a drug as these factors may relate to the safety or effectiveness of 
the drug.
    (ii) Drug substance means an active ingredient as defined under 
Sec. 210.3(b)(7) of this chapter.
    (iii) Minor changes and stability report (MCSR) means an annual 
report that is submitted to the application once each year within 60 
days before or after the anniversary date of the application's original 
approval or on a mutually agreed upon date. The report must include 
minor manufacturing and control changes made according to Sec. 
514.8(b)(4) or state that no changes were made; and stability data 
generated on commercial or production batches according to an approved 
stability protocol or commitment.
    (iv) Specification means the quality standard (i.e., tests, 
analytical procedures, and acceptance criteria) provided in an approved 
application to confirm the quality of drugs including, for example, drug 
substances, Type A medicated articles, drug products, intermediates, raw 
materials, reagents, components, in-process materials, container closure 
systems, and other materials used in the production of a drug. For the 
purpose of this definition, the term ``acceptance criteria'' means 
numerical limits, ranges, or other criteria for the tests described.
    (b) Manufacturing changes to an approved application--(1) General 
provisions. (i) The applicant must notify FDA about each change in each 
condition established in an approved application beyond the variations 
already provided for in the application. The notice is required to 
describe the change fully. Depending on the type of change, the 
applicant must notify FDA about it in a supplement under paragraph 
(b)(2) or (b)(3) of this section or by inclusion of the information in 
the annual report to the application under paragraph (b)(4) of this 
section.
    (ii) The holder of an approved application under section 512 of the 
act must assess the effects of the change before distributing a drug 
made with a manufacturing change.
    (iii) Notwithstanding the requirements of paragraphs (b)(2) and 
(b)(3) of this section, an applicant must make a change provided for in 
those paragraphs in accordance with a regulation or guidance that 
provides for a less burdensome notification of the change (for example, 
by submission of a supplement that does not require approval prior to 
distribution of the drug, or by notification in the next annual report 
described in paragraph (b)(4) of this section).
    (iv) In each supplement and amendment to a supplement providing for 
a change under paragraph (b)(2) or (b)(3) of this section, the applicant 
must include a statement certifying that a field copy has been provided 
to the appropriate FDA district office. No field copy is required for a 
supplement providing for a change made to a drug manufactured outside of 
the United States.
    (v) A supplement or annual report described in paragraph (b)(4) of 
this section must include a list of all changes contained in the 
supplement or annual report. For supplements, this list must be provided 
in the cover letter.
    (2) Changes requiring submission and approval of a supplement prior 
to distribution of the drug made using the change (major changes). (i) A 
supplement must be submitted for any change in the drug, production 
process, quality controls, equipment, or facilities that has a 
substantial potential to have an adverse effect on the identity, 
strength, quality, purity, or potency of the drug as these factors may 
relate to the safety or effectiveness of the drug.
    (ii) These changes include, but are not limited to:
    (A) Except those described in paragraphs (b)(3) and (b)(4) of this 
section, changes in the qualitative or quantitative formulation of the 
drug, including inactive ingredients, or in the specifications provided 
in the approved application;
    (B) Changes requiring completion of appropriate clinical studies to 
demonstrate the equivalence of the drug to the drug as manufactured 
without the change;
    (C) Changes that may affect drug substance or drug product sterility 
assurance, such as changes in drug substance, drug product or component 
sterilization method(s) or an addition, deletion, or substitution of 
steps in an aseptic processing operation;

[[Page 67]]

    (D) Changes in the synthesis or manufacture of the drug substance 
that may affect the impurity profile and/or the physical, chemical, or 
biological properties of the drug substance;
    (E) Changes in a drug product container closure system that controls 
the drug delivered to the animal or changes in the type or composition 
of a packaging component that may affect the impurity profile of the 
drug product;
    (F) Changes solely affecting a natural product, a recombinant DNA-
derived protein/polypeptide, or a complex or conjugate of a drug 
substance with a monoclonal antibody for the following:
    (1) Changes in the virus or adventitious agent removal or 
inactivation method(s),
    (2) Changes in the source material or cell line, and
    (3) Establishment of a new master cell bank or seed;
    (G) Changes to a drug under an application that is subject to a 
validity assessment because of significant questions regarding the 
integrity of the data supporting that application.
    (iii) The applicant must obtain approval of a supplement from FDA 
prior to distribution of a drug made using a change under paragraph 
(b)(2) of this section. The supplement must be labeled ``Prior Approval 
Supplement.'' Except for submissions under paragraph (b)(2)(v) of this 
section, the following information must be contained in the supplement:
    (A) A completed Form FDA 356V;
    (B) A detailed description of the proposed change;
    (C) The drug(s) involved;
    (D) The manufacturing site(s) or area(s) affected;
    (E) A description of the methods used and studies performed to 
assess the effects of the change;
    (F) The data derived from such studies;
    (G) Appropriate documentation (for example, updated master batch 
records, specification sheets) including previously approved 
documentation (with the changes highlighted) or references to previously 
approved documentation;
    (H) For a natural product, a recombinant DNA-derived protein/
polypeptide, or a complex or conjugate of a drug substance with a 
monoclonal antibody, relevant validation protocols and standard 
operating procedures must be provided in addition to the requirements in 
paragraphs (b)(2)(iii)(E) and (b)(2)(iii)(F) of this section;
    (I) For sterilization process and test methodologies related to 
sterilization process validation, relevant validation protocols and a 
list of relevant standard operating procedures must be provided in 
addition to the requirements in paragraphs (b)(2)(iii)(E) and 
(b)(2)(iii)(F) of this section; and
    (J) Any other information as directed by FDA.
    (iv) An applicant may ask FDA to expedite its review of a supplement 
for public health reasons or if a delay in making the change described 
in it would impose an extraordinary hardship on the applicant. Such a 
supplement and its mailing cover must be plainly marked: ``Prior 
Approval Supplement-Expedited Review Requested.''
    (v) Comparability Protocols. An applicant may submit one or more 
protocols describing the specific tests and studies and acceptance 
criteria to be achieved to demonstrate the lack of adverse effect for 
specified types of manufacturing changes on the identity, strength, 
quality, purity, and potency of the drug as these factors may relate to 
the safety or effectiveness of the drug. Any such protocols, if not 
included in the approved application, or changes to an approved 
protocol, must be submitted as a supplement requiring approval from FDA 
prior to distribution of the drug produced with the manufacturing 
change. The supplement, if approved, may subsequently justify a reduced 
reporting category for the particular change because the use of the 
protocol for that type of change reduces the potential risk of an 
adverse effect. A comparability protocol supplement must be labeled 
``Prior Approval Supplement--Comparability Protocol.''
    (3) Changes requiring submission of a supplement at least 30 days 
prior to distribution of the drug made using the change (moderate 
changes). (i) A supplement must be submitted for any change in the drug, 
production process,

[[Page 68]]

quality controls, equipment, or facilities that has a moderate potential 
to have an adverse effect on the identity, strength, quality, purity, or 
potency of the drug as these factors may relate to the safety or 
effectiveness of the drug.
    (ii) These changes include, but are not limited to:
    (A) A change in the container closure system that does not affect 
the quality of the drug except as otherwise described in paragraphs 
(b)(2) and (b)(4) of this section;
    (B) Changes solely affecting a natural protein, a recombinant DNA-
derived protein/polypeptide or a complex or conjugate of a drug 
substance with a monoclonal antibody, including:
    (1) An increase or decrease in production scale during finishing 
steps that involves different equipment, and
    (2) Replacement of equipment with that of a different design that 
does not affect the process methodology or process operating parameters.
    (C) Relaxation of an acceptance criterion or deletion of a test to 
comply with an official compendium that is consistent with FDA statutory 
and regulatory requirements.
    (iii) A supplement submitted under paragraph (b)(3)(i) or (b)(3)(vi) 
of this section is required to give a full explanation of the basis for 
the change and identify the date on which the change is made. The 
supplement submitted under paragraph (b)(3)(i) must be labeled 
``Supplement-Changes Being Effected in 30 Days.''
    (iv) Pending approval of the supplement by FDA and except as 
provided in paragraph (b)(3)(vi) of this section, distribution of the 
drug made using the change may begin not less than 30 days after receipt 
of the supplement by FDA. The information listed in paragraphs 
(b)(2)(iii)(A) through (b)(2)(iii)(J) of this section must be contained 
in the supplement.
    (v) The applicant must not distribute the drug made using the change 
if within 30 days following FDA's receipt of the supplement, FDA informs 
the applicant that either:
    (A) The change requires approval prior to distribution of the drug 
in accordance with paragraph (b)(2) of this section; or
    (B) Any of the information required under paragraph (b)(3)(iv) of 
this section is missing. In this case, the applicant must not distribute 
the drug made using the change until the supplement has been amended to 
provide the missing information.
    (vi) The agency may designate a category of changes for the purpose 
of providing that, in the case of a change in such category, the holder 
of an approved application may commence distribution of the drug 
involved upon receipt by the agency of a supplement for the change. The 
information listed in paragraphs (b)(2)(iii)(A) through (b)(2)(iii)(J) 
of this section must be contained in the supplement. The supplement must 
be labeled ``Supplement-Changes Being Effected.'' These changes include, 
but are not limited to:
    (A) Addition to a specification or changes in the methods or 
controls to provide increased assurance that the drug will have the 
characteristics of identity, strength, quality, purity, or potency that 
it purports or is represented to possess; and
    (B) A change in the size and/or shape of a container for a 
nonsterile drug product, except for solid dosage forms, without a change 
in the labeled amount of drug product or from one container closure 
system to another.
    (vii) If the agency disapproves the supplemental application, it may 
order the manufacturer to cease distribution of the drug(s) made with 
the manufacturing change.
    (4) Changes and updated stability data to be described and submitted 
in an annual report (minor changes). (i) Changes in the drug, production 
process, quality controls, equipment, or facilities that have a minimal 
potential to have an adverse effect on the identity, strength, quality, 
purity, or potency of the drug as these factors may relate to the safety 
or effectiveness of the drug must be documented by the applicant in an 
annual report to the application as described under paragraph 
(a)(2)(iii) of this section. The report must be labeled ``Minor Changes 
and Stability Report.''
    (ii) These changes include but are not limited to:
    (A) Any change made to comply with a change to an official 
compendium,

[[Page 69]]

except a change in paragraph (b)(3)(ii)(C) of this section, that is 
consistent with FDA statutory and regulatory requirements;
    (B) The deletion or reduction of an ingredient intended to affect 
only the color of the drug product;
    (C) Replacement of equipment with that of the same design and 
operating principles except for those equipment changes described in 
paragraph (b)(3)(ii)(B)(2) of this section;
    (D) A change in the size and/or shape of a container containing the 
same number of dosage units for a nonsterile solid dosage form drug 
product, without a change from one container closure system to another;
    (E) A change within the container closure system for a nonsterile 
drug product, based upon a showing of equivalency to the approved system 
under a protocol approved in the application or published in an official 
compendium;
    (F) An extension of an expiration dating period based upon full 
shelf-life data on production batches obtained from a protocol approved 
in the application;
    (G) The addition or revision of an alternative analytical procedure 
that provides the same or increased assurance of the identity, strength, 
quality, purity, or potency of the drug being tested as the analytical 
procedure described in the approved application, or deletion of an 
alternative analytical procedure; and
    (H) The addition by embossing, debossing, or engraving of a code 
imprint to a solid oral dosage form drug product other than a modified 
release dosage form, or a minor change in an existing code imprint.
    (iii) For changes under this category, the applicant is required to 
submit in the annual report:
    (A) A completed Form FDA 356V;
    (B) A statement by the holder of the approved application that the 
effects of the change have been assessed;
    (C) A detailed description of the change(s);
    (D) The manufacturing site(s) or area(s) involved;
    (E) The date each change was implemented;
    (F) Data from studies and tests performed to assess the effects of 
the change;
    (G) For a natural product, recombinant DNA-derived protein/
polypeptide, complex or conjugate of a drug substance with a monoclonal 
antibody, sterilization process or test methodology related to 
sterilization process validation, relevant validation protocols and/or 
standard operating procedures;
    (H) Appropriate documentation (for example, updated master batch 
records, specification sheets, etc.) including previously approved 
documentation (with the changes highlighted) or references to previously 
approved documentation;
    (I) Updated stability data generated on commercial or production 
batches according to an approved stability protocol or commitment; and
    (J) Any other information as directed by FDA.
    (c) Labeling and other changes to an approved application--(1) 
General provisions. The applicant must notify FDA about each change in 
each condition established in an approved application beyond the 
variations already provided for in the application. The notice is 
required to describe the change fully.
    (2) Labeling changes requiring the submission and approval of a 
supplement prior to distribution of the drug made using the change 
(major changes). (i) Addition of intended uses and changes to package 
labeling require a supplement. These changes include, but are not 
limited to:
    (A) Revision in labeling, such as updating information pertaining to 
effects, dosages, adverse reactions, contraindications, which includes 
information headed ``adverse reactions,'' ``warnings,'' ``precautions,'' 
and ``contraindications,'' except ones described in (c)(3) of this 
section;
    (B) Addition of an intended use;
    (C) If it is a prescription drug, any mailing or promotional piece 
used after the drug is placed on the market is labeling requiring a 
supplemental application, unless:
    (1) The parts of the labeling furnishing directions, warnings, and 
information for use of the drug are the same

[[Page 70]]

in language and emphasis as labeling approved or permitted; and
    (2) Any other parts of the labeling are consistent with and not 
contrary to such approved or permitted labeling.
    (3) Prescription drug labeling not requiring an approved 
supplemental application is submitted in accordance with Sec. 
514.80(b)(5)(ii).
    (D) Any other changes in labeling, except ones described in 
paragraph (c)(3) of this section.
    (ii) The applicant must obtain approval of the supplement from FDA 
prior to distribution of the drug. The supplement must contain the 
following:
    (A) A completed Form FDA 356V;
    (B) A detailed description of the proposed change;
    (C) The drug(s) involved;
    (D) The data derived from studies in support of the change; and
    (E) Any other information as directed by FDA.
    (3) Labeling changes to be placed into effect prior to receipt of a 
written notice of approval of a supplemental application. (i) Labeling 
changes of the following kinds that increase the assurance of drug 
safety proposed in supplemental applications must be placed into effect 
immediately:
    (A) The addition to package labeling, promotional labeling, or 
prescription drug advertising of additional warning, contraindication, 
adverse reaction, and precaution information;
    (B) The deletion from package labeling, promotional labeling, or 
drug advertising of false, misleading, or unsupported intended uses or 
claims for effectiveness; and
    (C) Any other changes as directed by FDA.
    (ii) Labeling changes (for example, design and style) that do not 
decrease safety of drug use proposed in supplemental applications may be 
placed into effect prior to written notice of approval from FDA of a 
supplemental application.
    (iii) A supplement submitted under paragraph (c)(3) of this section 
must include the following information:
    (A) A full explanation of the basis for the changes, the date on 
which such changes are being effected, and plainly marked on the mailing 
cover and on the supplement, ``Supplement--Labeling Changes Being 
Effected'';
    (B) Two sets of printed copies of any revised labeling to be placed 
in use, identified with the new animal drug application number; and
    (C) A statement by the applicant that all promotional labeling and 
all drug advertising will promptly be revised consistent with the 
changes made in the labeling on or within the new animal drug package no 
later than upon approval of the supplemental application.
    (iv) If the supplemental application is not approved and the drug is 
being distributed with the proposed labeling, FDA may initiate an 
enforcement action because the drug is misbranded under section 502 of 
the act and/or adulterated under section 501 of the act. In addition, 
under section 512(e) of the act, FDA may, after due notice and 
opportunity for a hearing, issue an order withdrawing approval of the 
application.
    (4) Changes providing for additional distributors to be reported 
under Records and reports concerning experience with approved new animal 
drugs (Sec. 514.80). Supplemental applications as described under 
paragraph (c)(2) of this section will not be required for an additional 
distributor to distribute a drug that is the subject of an approved new 
animal drug application or abbreviated new animal drug application if 
the conditions described under Sec. 514.80(b)(5)(iii) are met.
    (d) Patent information. The applicant must comply with the patent 
information requirements under section 512(c)(3) of the act.
    (e) Claimed exclusivity. If an applicant claims exclusivity under 
section 512(c)(2)(F) of the act upon approval of a supplemental 
application for a change in its previously approved drug, the applicant 
must include such a statement.
    (f) Good laboratory practice for nonclinical laboratory studies. A 
supplemental application that contains nonclinical laboratory studies 
must include, with respect to each nonclinical study, either a statement 
that the study was conducted in compliance with the requirements set 
forth in part 58 of this

[[Page 71]]

chapter, or, if the study was not conducted in compliance with such 
regulations, a brief statement of the reason for the noncompliance.

[71 FR 74782, Dec. 13, 2006]



Sec. 514.11  Confidentiality of data and information in a new animal drug 

application file.

    (a) For purposes of this section the NADA file includes all data and 
information submitted with or incorporated by reference in the NADA, 
INAD's incorporated into the NADA, supplemental NADA's, reports under 
Sec. Sec. 514.80 and 510.301 of this chapter, master files, and other 
related submissions. The availability for public disclosure of any 
record in the NADA file shall be handled in accordance with the 
provisions of this section.
    (b) The existence of an NADA file will not be disclosed by the Food 
and Drug Administration before an approval has been published in the 
Federal Register, unless it has previously been publicly disclosed or 
acknowledged.
    (c) If the existence of an NADA file has not been publicly disclosed 
or acknowledged, no data or information in the NADA file is available 
for public disclosure.
    (d) If the existence of an NADA file has been publicly disclosed or 
acknowledged before an approval has been published in the Federal 
Register, no data or information contained in the file is available for 
public disclosure before such approval is published, but the 
Commissioner may, in his discretion, disclose a summary of such selected 
portions of the safety and effectiveness data as are appropriate for 
public consideration of a specific pending issue, e.g., at an open 
session of a Food and Drug Administration advisory committee or pursuant 
to an exchange of important regulatory information with a foreign 
government.
    (e) After an approval has been published in the Federal Register, 
the following data and information in the NADA file are immediately 
available for public disclosure unless extraordinary circumstances are 
shown:
    (1) All safety and effectiveness data and information previously 
disclosed to the public, as defined in Sec. 20.81 of this chapter.
    (2) A summary or summaries of the safety and effectiveness data and 
information submitted with or incorporated by reference in the NADA 
file. Such summaries do not constitute the full reports of 
investigations under section 512(b)(1) of the act (21 U.S.C. 360b(b)(1)) 
on which the safety or effectiveness of the drug may be approved. Such 
summaries shall consist of the following:
    (i) For an NADA approved prior to July 1, 1975, internal agency 
records that describe such data and information, e.g., a summary of 
basis for approval or internal reviews of the data and information, 
after deletion of:
    (a) Names and any information that would identify the investigators.
    (b) Any inappropriate gratuitous comments unnecessary to an 
objective analysis of the data and information.
    (ii) For an NADA approved on or after July 1, 1975, a summary of 
such data and information prepared in one of the following two 
alternative ways shall be publicly released when the approval is 
published in the Federal Register.
    (a) The Center for Veterinary Medicine may at an appropriate time 
prior to approval of the NADA require the applicant to prepare a summary 
of such data and information, which will be reviewed and, where 
appropriate, revised by the Center.
    (b) The Center for Veterinary Medicine may prepare its own summary 
of such data and information.
    (3) A protocol for a test or study, unless it is shown to fall 
within the exemption established for trade secrets and confidential 
commercial information in Sec. 20.61 of this chapter.
    (4) Adverse reaction reports, product experience reports, consumer 
complaints, and other similar data and information, after deletion of:
    (i) Names and any information that would identify the person using 
the product.
    (ii) Names and any information that would identify any third party 
involved with the report, such as a physician, hospital, or other 
institution.
    (5) A list of all active ingredients and any inactive ingredients 
previously

[[Page 72]]

disclosed to the public as defined in Sec. 20.81 of this chapter.
    (6) An assay method or other analytical method, unless it serves no 
regulatory or compliance purpose and is shown to fall within the 
exemption established in Sec. 20.61 of this chapter.
    (7) All correspondence and written summaries of oral discussions 
relating to the NADA, in accordance with the provisions of part 20 of 
this chapter.
    (f) All safety and effectiveness data and information not previously 
disclosed to the public are available for public disclosure at the time 
any one of the following events occurs unless extraordinary 
circumstances are known:
    (1) The NADA has been abandoned and no further work is being 
undertaken with respect to it.
    (2) A final determination is made that the NADA is not approvable, 
and all legal appeals have been exhausted.
    (3) Approval of the NADA is withdrawn, and all legal appeals have 
been exhausted.
    (4) A final determination has been made that the animal drug is not 
a new animal drug.
    (5) A final determination has been made that the animal drug may be 
marketed without submission of such safety and/or effectiveness data and 
information.
    (g) The following data and information in an NADA file are not 
available for public disclosure unless they have been previously 
disclosed to the public as defined in Sec. 20.81 of this chapter or 
they relate to a product or ingredient that has been abandoned and they 
no longer represent a trade secret or confidential commercial or 
financial information as defined in Sec. 20.61 of this chapter:
    (1) Manufacturing methods or processes, including quality control 
procedures.
    (2) Production, sales, distribution, and similar data and 
information, except that any compilation of such data and information 
aggregated and prepared in a way that does not reveal data or 
information which is not available for public disclosure under this 
provision is available for public disclosure.
    (3) Quantitative or semiquantitative formulas.
    (h) For purposes of this regulation, safety and effectiveness data 
include all studies and tests of an animal drug on animals and all 
studies and tests on the animal drug for identity, stability, purity, 
potency, and bioavailability.

[40 FR 13825, Mar. 27, 1975, as amended at 42 FR 3109, Jan. 14, 1977; 42 
FR 15675, Mar. 22, 1977; 54 FR 18280, Apr. 28, 1989; 68 FR 15365, Mar. 
31, 2003]



Sec. 514.12  Confidentiality of data and information in an investigational new 

animal drug notice.

    (a) The existence of an INAD notice will not be disclosed by the 
Food and Drug Administration unless it has previously been publicly 
disclosed or acknowledged.
    (b) The availability for public disclosure of all data and 
information in an INAD file shall be handled in accordance with 
provisions established in Sec. 514.11.



Sec. 514.15  Untrue statements in applications.

    Among the reasons why an application for a new animal drug or animal 
feed bearing or containing a new animal drug may contain an untrue 
statement of a material fact are:
    (a) Differences in:
    (1) Conditions of use prescribed, recommended, or suggested by the 
applicant for the product from the conditions of such use stated in the 
application;
    (2) Articles used as components of the product from those listed in 
the application;
    (3) Composition of the product from that stated in the application;
    (4) Methods used in or the facilities and controls used for the 
manufacture, processing, or packing of the product from such methods, 
facilities, and controls described in the application;
    (5) Labeling from the specimens contained in the application; or
    (b) The unexplained omission in whole or in part from an application 
or from an amendment or supplement to an application or from any record 
or report required under the provisions of section 512 of the act and 
Sec. 514.80 or Sec. 510.301 of this chapter of any information 
obtained from:

[[Page 73]]

    (1) Investigations as to the safety, effectiveness, identity, 
strength, quality, or purity of the drug, made by the applicant on the 
drug, or
    (2) Investigations or experience with the product that is the 
subject of the application, or any related product, available to the 
applicant from any source if such information is pertinent to an 
evaluation of the safety, effectiveness, identity, strength, quality, or 
purity of the drug, when such omission would bias an evaluation of the 
safety or effectiveness of the product.
    (c) Any nonclinical laboratory study contained in the application 
was not conducted in compliance with the good laboratory practice 
regulations as set forth in part 58 of this chapter, and the application 
fails to include a brief statement of the reason for the noncompliance.

[40 FR 13825, Mar. 27, 1975, as amended at 49 FR 7226, Feb. 28, 1984; 50 
FR 7517, Feb. 22, 1985; 68 FR 15365, Mar. 31, 2003]



            Subpart B_Administrative Actions on Applications


Sec. 514.80  Records and reports concerning experience with approved 
          new animal drugs.

    The following table outlines the purpose for each paragraph of this 
section:

------------------------------------------------------------------------
                 Purpose                    21 CFR Paragraph and Title
------------------------------------------------------------------------
What information must be reported         514.80(a) Applicability.
 concerning approved NADAs or ANADAs?
------------------------------------------------------------------------
What authority does FDA have for          514.80(a)(1).
 requesting records and reports?
Who is required to establish, maintain,
 and report required information
 relating to experiences with a new
 animal drug?
Is information from foreign sources
 required?
------------------------------------------------------------------------
What records must be established and      514.80(a)(2).
 maintained and what reports filed with
 FDA?
------------------------------------------------------------------------
What is FDA's purpose for requiring       514.80(a)(3).
 reports?
------------------------------------------------------------------------
Do applicants of Type A medicated         514.80(a)(4).
 articles have to establish, maintain,
 and report information required under
 Sec.  514.80?
------------------------------------------------------------------------
How do the requirements under Sec.       514.80(a)(5).
 514.80 relate to current good
 manufacturing practices?
------------------------------------------------------------------------
                                          514.80(b) Reporting
                                           requirements.
------------------------------------------------------------------------
What are the requirements for reporting   514.80(b)(1) Three-day NADA/
 product/manufacturing defects?            ANADA field alert report.
------------------------------------------------------------------------
                                          514.80(b)(2) Fifteen-day NADA/
                                           ANADA alert report.
------------------------------------------------------------------------
What are the requirements for reporting   514.80(b)(2)(i) Initial
 serious and unexpected adverse drug       report.
 experiences?
------------------------------------------------------------------------
What are the requirements for followup    514.80(b)(2)(ii) Followup
 reporting of serious and unexpected       report.
 adverse drug experiences?
------------------------------------------------------------------------
What are the requirements for             514.80(b)(3) Nonapplicant
 nonapplicants for reporting adverse       report.
 drug experiences?
------------------------------------------------------------------------
What are the general requirements for     514.80(b)(4) Periodic drug
 submission of periodic drug experience    experience report.
 reports, e.g., forms to be submitted,
 submission date and frequency, when is
 it to be submitted, how many copies?
How do I petition to change the date of
 submission or frequency of submissions?
------------------------------------------------------------------------
What must be submitted in the periodic    514.80(b)(4)(i) through
 drug experience reports?                  (b)(4)(iv).
------------------------------------------------------------------------
What distribution data must be            514.80(b)(4)(i) Distribution
 submitted?                                data.
How should the distribution data be
 submitted?
------------------------------------------------------------------------

[[Page 74]]

 
What labeling materials should be         514.80(b)(4)(ii) Labeling.
 submitted?
How do I report changes to the labeling
 materials since the last report?
------------------------------------------------------------------------
                                          514.80(b)(4)(iii) Nonclinical
                                           laboratory studies and
                                           clinical data not previously
                                           reported.
------------------------------------------------------------------------
What are the requirements for submission  514.80(b)(4)(iii)(A).
 of nonclinical laboratory studies?
------------------------------------------------------------------------
What are the requirements for submission  514.80(b)(4)(iii)(B).
 of clinical laboratory data?
------------------------------------------------------------------------
When must results of clinical trials      514.80(b)(4)(iii)(C).
 conducted by or for the applicant be
 reported?
------------------------------------------------------------------------
                                          514.80(b)(4)(iv) Adverse drug
                                           experiences.
------------------------------------------------------------------------
How do I report product/manufacturing     514.80(b)(4)(iv)(A).
 defects and adverse drug experiences
 not previously reported to FDA?
------------------------------------------------------------------------
What are the requirements for submitting  514.80(b)(4)(iv)(B).
 adverse drug experiences cited in
 literature?
------------------------------------------------------------------------
What are the requirements for submitting  514.80(b)(4)(iv)(C).
 adverse drug experiences in
 postapproval studies and clinical
 trials?
------------------------------------------------------------------------
What are the requirements for reporting   514.80(b)(4)(v) Summary report
 increases in the frequency of serious,    of increased frequency of
 expected, and unexpected adverse drug     adverse drug experience.
 experiences?
------------------------------------------------------------------------
                                          514.80(b)(5) Other reporting.
------------------------------------------------------------------------
Can FDA request that an applicant submit  514.80(b)(5)(i) Special drug
 information at different times than       experience report.
 stated specifically in this regulation?
------------------------------------------------------------------------
What are the requirements for submission  514.80(b)(5)(ii)
 of advertisement and promotional          Advertisements and
 labeling to FDA?                          promotional labeling.
------------------------------------------------------------------------
What are the requirements for adding a    514.80(b)(5)(iii)
 new distributor to the approved           Distributor's statement.
 application?
------------------------------------------------------------------------
What labels and how many labels need to   514.80(b)(5)(iii)(A).
 be submitted for review?
------------------------------------------------------------------------
What changes are required and allowed to  514.80(b)(5)(iii)(A)(1).
 distributor labeling?
------------------------------------------------------------------------
What are the requirements for making      514.80(b)(5)(iii)(A)(2).
 other changes to the distributor
 labeling?
------------------------------------------------------------------------
What information should be included in    514.80(b)(5)(iii)(B)(1)
 each new distributor's signed             through (b)(5)(iii)(B)(5).
 statement?
------------------------------------------------------------------------
What are the conditions for submitting    514.80(c) Multiple
 information that is common to more than   applications.
 one application? (i.e., can I submit
 common information to one application?)
------------------------------------------------------------------------
What information has to be submitted to   514.80(c)(1) through (c)(4).
 the common application and related
 application?
------------------------------------------------------------------------
What forms do I need?                     514.80(d) Reporting forms.
What are Forms FDA 1932 and 2301?
How can I get them?
Can I use computer-generated
 equivalents?
------------------------------------------------------------------------
How long must I maintain Form FDA 1932    514.80(e) Records to be
 and records and reports of other          maintained.
 required information, i.e., how long do
 I need to maintain this information?
------------------------------------------------------------------------
What are the requirements for allowing    514.80(f) Access to records
 access to these records and reports,      and reports.
 and copying by authorized FDA officer
 or employee?
------------------------------------------------------------------------
How do I obtain Forms FDA 1932 and 2301?  514.80(g) Mailing addresses.
Where do I mail FDA's required forms,
 records, and reports?
------------------------------------------------------------------------

[[Page 75]]

 
What happens if the applicant fails to    514.80(h) Withdrawal of
 establish, maintain, or make the          approval.
 required reports?
What happens if the applicant refuses to
 allow FDA access to, and/or copying and/
 or verify records and reports?
------------------------------------------------------------------------
Does an adverse drug experience reflect   514.80(i) Disclaimer.
 a conclusion that the report or
 information constitutes an admission
 that the drug caused an adverse effect?
------------------------------------------------------------------------

    (a) Applicability. (1) Each applicant must establish and maintain 
indexed and complete files containing full records of all information 
pertinent to safety or effectiveness of a new animal drug that has not 
been previously submitted as part of the NADA or ANADA. Such records 
must include information from domestic as well as foreign sources. Each 
nonapplicant must establish and maintain indexed and complete files 
containing full records of all information pertinent to safety or 
effectiveness of a new animal drug that is received or otherwise 
obtained by the nonapplicant. Such records must include information from 
domestic as well as foreign sources.
    (2) Each applicant must submit reports of data, studies, and other 
information concerning experience with new animal drugs to the Food and 
Drug Administration (FDA) for each approved NADA and ANADA, as required 
in this section. A nonapplicant must submit data, studies, and other 
information concerning experience with new animal drugs to the 
appropriate applicant, as required in this section. The applicant, in 
turn, must report the nonapplicant's data, studies, and other 
information to FDA. Applicants and nonapplicants must submit data, 
studies, and other information described in this section from domestic, 
as well as foreign sources.
    (3) FDA reviews the records and reports required in this section to 
facilitate a determination under section 512(e) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360b(e)) as to whether there may be 
grounds for suspending or withdrawing approval of the NADA or ANADA.
    (4) The requirements of this section also apply to any approved Type 
A medicated article. In addition, the requirements contained in Sec. 
514.80(b)(1), (b)(2), (b)(4)(iv), and (b)(4)(v) apply to any approved 
Type A medicated article incorporated in animal feeds.
    (5) The records and reports referred to in this section are in 
addition to those required by the current good manufacturing practice 
regulations in parts 211, 225, and 226 of this chapter.
    (b) Reporting requirements--(1) Three-day NADA/ANADA field alert 
report. This report provides information pertaining to product and 
manufacturing defects that may result in serious adverse drug events. 
The applicant (or nonapplicant through the applicant) must submit the 
report to the appropriate FDA District Office or local FDA resident post 
within 3 working days of first becoming aware that a defect may exist. 
The information initially may be provided by telephone or other 
telecommunication means, with prompt written followup using Form FDA 
1932 ``Veterinary Adverse Drug Reaction, Lack of Effectiveness, Product 
Defect Report.'' The mailing cover for these reports must be plainly 
marked ``3-Day NADA/ANADA Field Alert Report.''
    (2) Fifteen-day NADA/ANADA alert report--(i) Initial report. This 
report provides information on each serious, unexpected adverse drug 
event, regardless of the source of the information. The applicant (or 
nonapplicant through the applicant) must submit the report to FDA within 
15 working days of first receiving the information. The report must be 
submitted on Form FDA 1932, and its mailing cover must be plainly marked 
``15-Day NADA/ANADA Alert Report.''
    (ii) Followup report. The applicant must promptly investigate all 
adverse drug events that are the subject of 15-day NADA/ANADA alert 
reports. If this investigation reveals significant new information, a 
followup report must be submitted within 15 working days of receiving 
such information. A followup

[[Page 76]]

report must be submitted on Form FDA 1932, and its mailing cover must be 
plainly marked ``15-Day NADA/ANADA Alert Report Followup.'' The followup 
report must state the date of the initial report and provide the 
additional information. If additional information is sought but not 
obtained within 3 months of the initial report, a followup report is 
required describing the steps taken and why additional information was 
not obtained.
    (3) Nonapplicant report. Nonapplicants must forward reports of 
adverse drug experiences to the applicant within 3 working days of first 
receiving the information. The applicant must then submit the report(s) 
to FDA as required in this section. The nonapplicant must maintain 
records of all nonapplicant reports, including the date the nonapplicant 
received the information concerning adverse drug experiences, the name 
and address of the applicant, and a copy of the adverse drug experience 
report including the date such report was submitted to the applicant. If 
the nonapplicant elects to also report directly to FDA, the nonapplicant 
should submit the report on Form FDA 1932 within 15 working days of 
first receiving the information.
    (4) Periodic drug experience report. This report must be accompanied 
by a completed Form FDA 2301 ``Transmittal of Periodic Reports and 
Promotional Materials for New Animal Drugs.'' It must be submitted every 
6 months for the first 2 years following approval of an NADA or ANADA 
and yearly thereafter. Reports required by this section must contain 
data and information for the full reporting period. The 6-month periodic 
drug experience reports must be submitted within 30 days following the 
end of the 6-month reporting period. The yearly periodic drug experience 
reports must be submitted within 60 days of the anniversary date of the 
approval of the NADA or ANADA. Any previously submitted information 
contained in the report must be identified as such. For yearly (annual) 
periodic drug experience reports, the applicant may petition FDA to 
change the date of submission or frequency of reporting, and after 
approval of such petition, file such reports on the new filing date or 
at the new reporting frequency. Also, FDA may require a report at 
different times or more frequently. The periodic drug experience report 
must contain the following:
    (i) Distribution data. Information about the distribution of each 
new animal drug product, including information on any distributor-
labeled product. This information must include the total number of 
distributed units of each size, strength, or potency (e.g., 100,000 
bottles of 100 5-milligram tablets; 50,000 10-milliliter vials of 5-
percent solution). This information must be presented in two categories: 
Quantities distributed domestically and quantities exported.
    (ii) Labeling. Applicant and distributor current package labeling, 
including package inserts (if any). For large-size package labeling or 
large shipping cartons, a representative copy must be submitted (e.g., a 
photocopy of pertinent areas of large feed bags). A summary of any 
changes in labeling made since the last report (listed by date of 
implementation) must be included with the labeling or if there have been 
no changes, a statement of such fact must be included with the labeling.
    (iii) Nonclinical laboratory studies and clinical data not 
previously reported.
    (A) Copies of in vitro studies (e.g., mutagenicity) and other 
nonclinical laboratory studies conducted by or otherwise obtained by the 
applicant.
    (B) Copies of published clinical trials of the new animal drug (or 
abstracts of them) including clinical trials on safety and 
effectiveness, clinical trials on new uses, and reports of clinical 
experience pertinent to safety conducted by or otherwise obtained by the 
applicant. Review articles, papers, and abstracts in which the drug is 
used as a research tool, promotional articles, press clippings, and 
papers that do not contain tabulations or summaries of original data are 
not required to be reported.
    (C) Descriptions of completed clinical trials conducted by or for 
the applicant must be submitted no later than 1 year after completion of 
research. Supporting information is not to be reported.

[[Page 77]]

    (iv) Adverse drug experiences. (A) Product/manufacturing defects and 
adverse drug experiences not previously reported under Sec. 
514.80(b)(1) and (b)(2) must be reported individually on Form FDA 1932.
    (B) Reports of adverse drug experiences in the literature must be 
noted in the periodic drug experience report. A bibliography of 
pertinent references must be included with the report. Upon FDA's 
request, the applicant must provide a full text copy of these 
publications.
    (C) Reports of previously not reported adverse drug experiences that 
occur in postapproval studies must be reported separately from other 
experiences in the periodic drug experience report and clearly marked or 
highlighted.
    (v) Summary report of increased frequency of adverse drug 
experience. The applicant must periodically review the incidence of 
reports of adverse drug experiences to determine if there has been an 
increased frequency of serious (expected and unexpected) adverse drug 
events. The applicant must evaluate the increased frequency of serious 
(expected or unexpected) adverse drug events at least as often as 
reporting of periodic drug experience reports. The applicant must report 
the increased frequency of serious (expected and unexpected) adverse 
drug events in the periodic drug experience report. Summaries of reports 
of increased frequency of adverse drug events must be submitted in 
narrative form. The summaries must state the time period on which the 
increased frequency is based, time period comparisons in determining 
increased frequency, references to any previously submitted Form FDA 
1932, the method of analysis, and the interpretation of the results. The 
summaries must be submitted in a separate section within the periodic 
drug experience report.
    (5) Other reporting--(i) Special drug experience report. Upon 
written request, FDA may require that the applicant submit a report 
required under Sec. 514.80 at different times or more frequently than 
the timeframes stated in Sec. 514.80.
    (ii) Advertisements and promotional labeling. The applicant must 
submit at the time of initial dissemination one set of specimens of 
mailing pieces and other labeling for prescription and over-the-counter 
new animal drugs. For prescription new animal drugs, the applicant must 
also submit one set of specimens of any advertisement at the time of 
initial publication or broadcast. Mailing pieces and labeling designed 
to contain product samples must be complete except that product samples 
may be omitted. Each submission of promotional labeling or 
advertisements must be accompanied by a completed Form FDA 2301.
    (iii) Distributor's statement. At the time of initial distribution 
of a new animal drug product by a distributor, the applicant must submit 
a special drug experience report accompanied by a completed Form FDA 
2301 containing the following:
    (A) The distributor's current product labeling.
    (1) The distributor's labeling must be identical to that in the 
approved NADA/ANADA except for a different and suitable proprietary name 
(if used) and the name and address of the distributor. The name and 
address of the distributor must be preceded by an appropriate qualifying 
phrase as permitted by the regulations such as ``manufactured for'' or 
``distributed by.''
    (2) Other labeling changes must be the subject of a supplemental 
NADA or ANADA as described under Sec. 514.8.
    (B) A signed statement by the distributor stating:
    (1) The category of the distributor's operations (e.g., wholesale or 
retail),
    (2) That the distributor will distribute the new animal drug only 
under the approved labeling,
    (3) That the distributor will promote the product only for use under 
the conditions stated in the approved labeling,
    (4) That the distributor will adhere to the records and reports 
requirements of this section, and
    (5) That the distributor is regularly and lawfully engaged in the 
distribution or dispensing of prescription products if the product is a 
prescription new animal drug.
    (c) Multiple applications. Whenever an applicant is required to 
submit a periodic drug experience report under the provisions of Sec. 
514.80(b)(4) with respect

[[Page 78]]

to more than one approved NADA or ANADA for preparations containing the 
same new animal drug so that the same information is required to be 
reported for more than one application, the applicant may elect to 
submit as a part of the report for one such application (the primary 
application) all the information common to such applications in lieu of 
reporting separately and repetitively on each. If the applicant elects 
to do this, the applicant must do the following:
    (1) State when a report applies to multiple applications and 
identify all related applications for which the report is submitted by 
NADA or ANADA number.
    (2) Ensure that the primary application contains a list of the NADA 
or ANADA numbers of all related applications.
    (3) Submit a completed Form FDA 2301 to the primary application and 
each related application with reference to the primary application by 
NADA/ANADA number and submission date for the complete report of the 
common information.
    (4) All other information specific to a particular NADA/ANADA must 
be included in the report for that particular NADA/ANADA.
    (d) Reporting forms. Applicant must report adverse drug experiences 
and product/manufacturing defects on Form FDA 1932, ``Veterinary Adverse 
Drug Reaction, Lack of Effectiveness, Product Defect Report.'' Periodic 
drug experience reports and special drug experience reports must be 
accompanied by a completed Form FDA 2301 ``Transmittal of Periodic 
Reports and Promotional Material for New Animal Drugs,'' in accordance 
with directions provided on the forms. Computer-generated equivalents of 
Form FDA 1932 or Form FDA 2301, approved by FDA before use, may be used. 
Form FDA 1932 and Form FDA 2301 may be obtained on the Internet at 
http://www.fda.gov/cvm/forms/forms.html, by telephoning the Division of 
Surveillance (HFV-210), or by submitting a written request to the 
following address: Food and Drug Administration, Center for Veterinary 
Medicine, Division of Surveillance (HFV-210), 7500 Standish Pl., 
Rockville, MD 20855-2764.
    (e) Records to be maintained. The applicants and nonapplicants must 
maintain records and reports of all information required by this section 
for a period of 5 years after the date of submission.
    (f) Access to records and reports. The applicant and nonapplicant 
must, upon request from any authorized FDA officer or employee, at all 
reasonable times, permit such officer or employee to have access to copy 
and to verify all such required records and reports.
    (g) Mailing addresses. Completed 15-day alert reports, periodic drug 
experience reports, and special drug experience reports must be 
submitted to the following address: Food and Drug Administration, Center 
for Veterinary Medicine, Document Control Unit (HFV-199), 7500 Standish 
Pl., Rockville, MD 20855-2764. Three-day alert reports must be submitted 
to the appropriate FDA district office or local FDA resident post. 
Addresses for district offices and resident posts may be obtained from 
the Internet at http://www.fda.gov (click on ``Contact FDA,'' then ``FDA 
Field Offices'').
    (h) Withdrawal of approval. If FDA finds that the applicant has 
failed to establish the required records, or has failed to maintain 
those records, or failed to make the required reports, or has refused 
access to an authorized FDA officer or employee to copy or to verify 
such records or reports, FDA may withdraw approval of the application to 
which such records or reports relate. If FDA determines that withdrawal 
of the approval is necessary, the agency shall give the applicant notice 
and opportunity for hearing, as provided in Sec. 514.200, on the 
question of whether to withdraw approval of the application.
    (i) Disclaimer. Any report or information submitted under this 
section and any release of that report or information by FDA will be 
without prejudice and does not necessarily reflect a conclusion that the 
report or information constitutes an admission that the drug caused or 
contributed to an adverse event. A person need not admit, and may deny, 
that the report or information constitutes an admission that a

[[Page 79]]

drug caused or contributed to an adverse event.

[68 FR 15365, Mar. 31, 2003]



Sec. 514.100  Evaluation and comment on applications.

    (a) After the filed application has been evaluated, the applicant 
will be furnished written comment on any apparent deficiencies in the 
application.
    (b) When the description of the methods used in, and the facilities 
and controls used for, the manufacture, processing, and packing of such 
new animal drug appears adequate on its face, but it is not feasible to 
reach a conclusion as to the safety and effectiveness of the new animal 
drug solely from consideration of this description, the applicant may be 
notified that an establishment inspection is required to verify their 
adequacy.
    (c) A request for samples of a new animal drug or any edible tissues 
and byproducts of animals treated with such a drug, shall specify the 
quantity deemed adequate to permit tests of analytical methods to 
determine their adequacy for regulatory purposes. The request should be 
made as early in the 180-day period as possible to assure timely 
completion. The date used for computing the 180-day limit for the 
purposes of section 512(c) of the act shall be moved forward 1 day for 
each day after the mailing date of the request until all of the 
requested samples are received. If the samples are not received within 
90 days after the request, the application will be considered withdrawn 
without prejudice.
    (d) The information contained in an application may be insufficient 
to determine whether a new animal drug is safe or effective in use if it 
fails to include (among other things) a statement showing whether such 
drug is to be limited to prescription sale and exempt under section 
502(f) of the act from the requirement that its labeling bear adequate 
directions for lay use. If such drug is to be exempt, the information 
may also be insufficient if:
    (1) The specimen labeling proposed fails to bear adequate 
information for professional use including indications, effects, 
dosages, routes, methods, and frequency and duration of administration 
and any relevant hazards, contraindications, side effects, and 
precautions under which practitioners licensed by law to administer such 
drug can use the drug for the purposes for which it is intended, 
including all purposes for which it is to be advertised, or represented, 
in accordance with Sec. 201.105 of this chapter, and information 
concerning hazards, contraindications, side effects, and precautions 
relevant with respect to any uses for which such drug is to be 
prescribed.
    (2) The application fails to show that the labeling and advertising 
of such drug will offer the drug for use only under those conditions for 
which it is offered in the labeling that is part of the application.
    (3) The application fails to show that all labeling that furnishes 
or purports to furnish information for professional use of such drug 
will contain, in the same language and emphasis, the information for use 
including indications, effects, dosages, routes, methods, and frequency 
and duration of administration and any relevant warnings, hazards, 
contraindications, side effects, and precautions, which is contained in 
the labeling that is part of the application in accordance with Sec. 
201.105 of this chapter.
    (e) The information contained in an application will be considered 
insufficient to determine whether a new animal drug is safe and 
effective for use when there is a refusal or failure upon written notice 
to furnish inspectors authorized by the Food and Drug Administration an 
adequate opportunity to inspect the facilities, controls, and records 
pertinent to the application.
    (f) On the basis of preliminary consideration of an application or 
supplemental application containing typewritten or other draft labeling 
in lieu of final printed labeling, an applicant may be informed that 
such application is approvable when satisfactory final printed labeling 
identical in content to such draft copy is submitted.
    (g) When an application has been found incomplete on the basis of a 
need for the kind of information described in Sec. 514.6, such 
application shall be considered withdrawn without prejudice to future 
filing on the date of issuance of the letter citing the inadequacies 
contained in the application, unless within

[[Page 80]]

30 days the sponsor chooses to avail himself of the opportunity for 
hearing as prescribed by Sec. 514.111.



Sec. 514.105  Approval of applications.

    (a) The Commissioner shall forward for publication in the Federal 
Register a regulation prescribing the conditions under which the new 
animal drug may be used, including the name and address of the 
applicant; the conditions and indications for use covered by the 
application; any tolerance, withdrawal period, or other use 
restrictions; any tolerance required for the new animal drug substance 
or its metabolites in edible products of food-producing animals; and, if 
such new animal drug is intended for use in animal feed, appropriate 
purposes and conditions of use (including special labeling requirements) 
applicable to any animal feed; and such other information the 
Commissioner deems necessary to assure safe and effective use.
    (b) He shall notify the applicant by sending him a copy of the 
proposed publication as described in paragraph (a)(1) of this section.

[40 FR 13825, Mar. 27, 1975, as amended at 51 FR 7392, Mar. 3, 1986; 64 
FR 63203, Nov. 19, 1999]



Sec. 514.106  Approval of supplemental applications.

    (a) Within 180 days after a supplement to an approved application is 
filed pursuant to Sec. 514.8, the Commissioner shall approve the 
supplemental application in accordance with procedures set forth in 
Sec. 514.105(a)(1) and (2) if he/she determines that the application 
satisfies the requirements of applicable statutory provisions and 
regulations.
    (b) The Commissioner will assign a supplemental application to its 
proper category to ensure processing of the application.
    (1) Category I. Supplements that ordinarily do not require a 
reevaluation of any of the safety or effectiveness data in the parent 
application. Category I supplements include the following:
    (i) A corporate change that alters the identity or address of the 
sponsor of the new animal drug application (NADA).
    (ii) The sale, purchase, or construction of manufacturing 
facilities.
    (iii) The sale or purchase of an NADA.
    (iv) A change in container, container style, shape, size, or 
components.
    (v) A change in approved labeling (color, style, format, addition, 
deletion, or revision of certain statements, e.g., trade name, storage, 
expiration dates, etc).
    (vi) A change in promotional material for a prescription new animal 
drug not exempted by Sec. 514.8(c)(2)(i)(C)(1) through (c)(2)(i)(C)(3).
    (vii) Changes in manufacturing processes that do not alter the 
method of manufacture or change the final dosage form.
    (viii) A change in bulk drug shipments.
    (ix) A change in an analytical method or control procedures that do 
not alter the approved standards.
    (x) A change in an expiration date.
    (xi) Addition of an alternate manufacturer, repackager, or relabeler 
of the drug product.
    (xii) Addition of an alternate supplier of the new drug substance.
    (xiii) A change permitted in advance of approval as described under 
Sec. 514.8(b)(3).
    (2) Category II. Supplements that may require a reevaluation of 
certain safety or effectiveness data in the parent application. Category 
II supplements include the following:
    (i) A change in the active ingredient concentration or composition 
of the final product.
    (ii) A change in quality, purity, strength, and identity 
specifications of the active or inactive ingredients.
    (iii) A change in dose (amount of drug administered per dose).
    (iv) A change in the treatment regimen (schedule of dosing).
    (v) Addition of a new therapeutic claim to the approved uses of the 
product.
    (vi) Addition of a new or revised animal production claim.
    (vii) Addition of a new species.
    (viii) A change in the prescription or over-the-counter status of a 
drug product.
    (ix) A change in statements regarding side effects, warnings, 
precautions,

[[Page 81]]

and contraindications, except the addition of approved statements to 
container, package, and promotional labeling, and prescription drug 
advertising.
    (x) A change in the drug withdrawal period prior to slaughter or in 
the milk discard time.
    (xi) A change in the tolerance for drug residues.
    (xii) A change in analytical methods for drug residues.
    (xiii) A revised method of synthesis or fermentation of the new drug 
substance.
    (xiv) Updating or changes in the manufacturing process of the new 
drug substance and/or final dosage form (other than a change in 
equipment that does not alter the method of manufacture of a new animal 
drug, or a change from one commercial batch size to another without any 
change in manufacturing procedure), or changes in the methods, 
facilities, or controls used for the manufacture, processing, packaging, 
or holding of the new animal drug (other than use of an establishment 
not covered by the approval that is in effect) that give increased 
assurance that the drug will have the characteristics of identity, 
strength, quality, and purity which it purports or is represented to 
possess.

[55 FR 46052, Nov. 1, 1990; 55 FR 49973, Dec. 3, 1990; 56 FR 12422, Mar. 
25, 1991; 71 FR 74785, Dec. 13, 2006]



Sec. 514.110  Reasons for refusing to file applications.

    (a) The date of receipt of an application for a new animal drug 
shall be the date on which the application shall be deemed to be filed.
    (b) An application for a new animal drug shall not be considered 
acceptable for filing for any of the following reasons:
    (1) It does not contain complete and accurate English translations 
of any pertinent part in a foreign language.
    (2) Fewer than three copies are submitted.
    (3) It is incomplete on its face in that it is not properly 
organized and indexed.
    (4) On its face the information concerning required matter is so 
inadequate that the application is clearly not approvable.
    (5) The new animal drug is to be manufactured, prepared, propagated, 
compounded, or processed in whole or in part in any State in an 
establishment that has not been registered or exempted from registration 
under the provisions of section 510 of the act.
    (6) The sponsor does not reside or maintain a place of business 
within the United States and the application has not been countersigned 
by an attorney, agent, or other representative of the applicant, which 
representative resides in the United States and has been duly authorized 
to act on behalf of the applicant and to receive communications on all 
matters pertaining to the application.
    (7) The new animal drug is a drug subject to licensing under the 
animal virus, serum, and toxin law of March 4, 1913 (37 Stat. 832; 21 
U.S.C. 151 et seq. ). Such applications will be referred to the U.S. 
Department of Agriculture for action.
    (8) It fails to include, with respect to each nonclinical laboratory 
study contained in the application, either a statement that the study 
was conducted in compliance with the good laboratory practice 
regulations set forth in part 58 of this chapter, or, if the study was 
not conducted in compliance with such regulations, a brief statement of 
the reasons for the noncompliance.
    (9) [Reserved]
    (10) The applicant fails to submit a complete environmental 
assessment under Sec. 25.40 of this chapter or fails to provide 
sufficient information to establish that the requested action is subject 
to categorical exclusion under Sec. 25.30 or Sec. 25.33 of this 
chapter.
    (c) If an application is determined not to be acceptable for filing, 
the applicant shall be notified within 30 days of receipt of the 
application and shall be given the reasons therefore.
    (d) If the applicant disputes the findings that his application is 
not acceptable for filing, he may make written request that the 
application be filed over protest, in which case it will be filed as of 
the day originally received.

[40 FR 13825, Mar. 27, 1975, as amended at 50 FR 7517, Feb. 22, 1985; 50 
FR 16668, Apr. 26, 1985; 62 FR 40600, July 29, 1997]

[[Page 82]]



Sec. 514.111  Refusal to approve an application.

    (a) The Commissioner shall, within 180 days after the filing of the 
application, inform the applicant in writing of his intention to issue a 
notice of opportunity for a hearing on a proposal to refuse to approve 
the application, if the Commissioner determines upon the basis of the 
application, or upon the basis of other information before him with 
respect to a new animal drug, that:
    (1) The reports of investigations required to be submitted pursuant 
to section 512(b) of the act do not include adequate tests by all 
methods reasonably applicable to show whether or not such drug is safe 
for use under the conditions prescribed, recommended, or suggested in 
the proposed labeling thereof; or
    (2) The results of such tests show that such drug is unsafe for use 
under such conditions or do not show that such drug is safe for use 
under such conditions; or
    (3) The methods used in and the facilities and controls used for the 
manufacture, processing, and packing of such drug are inadequate to 
preserve its identity, strength, quality, and purity; or
    (4) Upon the basis of the information submitted to the Food and Drug 
Administration as part of the application, or upon the basis of any 
other information before it with respect to such drug, it has 
insufficient information to determine whether such drug is safe for use 
under such conditions. In making this determination the Commissioner 
shall consider, among other relevant factors:
    (i) The probable consumption of such drug and of any substance 
formed in or on food because of the use of such drug;
    (ii) The cumulative effect on man or animal of such drug, taking 
into account any chemically or pharmacologically related substances;
    (iii) Safety factors which, in the opinion of experts qualified by 
scientific training and experience to evaluate the safety of such drugs, 
are appropriate for the use of animal experimentation data; and
    (iv) Whether the conditions of use prescribed, recommended, or 
suggested in the proposed labeling are reasonably certain to be followed 
in practice; or
    (5) Evaluated on the basis of information submitted as part of the 
application and any other information before the Food and Drug 
Administration with respect to such drug, there is lack of substantial 
evidence as defined in Sec. 514.4.
    (6) Failure to include an appropriate proposed tolerance for 
residues in edible products derived from animals or a withdrawal period 
or other restrictions for use of such drug if any tolerance or 
withdrawal period or other restrictions for use are required in order to 
assure that the edible products derived from animals treated with such 
drug will be safe.
    (7) Based on a fair evaluation of all material facts, the labeling 
is false or misleading in any particular; or
    (8) Such drug induces cancer when ingested by man or animal or, 
after appropriate tests for evaluation of the safety of such drug, 
induces cancer in man or animal, except that this subparagraph shall not 
apply with respect to such drug if the Commissioner finds that, under 
the conditions of use specified in proposed labeling and reasonably 
certain to be followed in practice:
    (i) Such drug will not adversely affect the animal for which it is 
intended; and
    (ii) No residue of such drug will be found (by methods of 
examination prescribed or approved by the Commissioner by regulations) 
in any edible portion of such animal after slaughter or in any food 
yielded by, or derived from the living animals.
    (9) The applicant fails to submit an adequate environmental 
assessment under Sec. 25.40 of this chapter or fails to provide 
sufficient information to establish that the requested action is subject 
to categorical exclusion under Sec. 25.30 or Sec. 25.33 of this 
chapter.
    (10) The drug fails to satisfy the requirements of subpart E of part 
500 of this chapter.
    (11) Any nonclinical laboratory study that is described in the 
application and that is essential to show that the drug is safe for use 
under the conditions prescribed, recommended, or suggested in its 
proposed labeling, was not conducted in compliance with the good

[[Page 83]]

laboratory practice regulations as set forth in part 58 of this chapter 
and no reason for the noncompliance is provided or, if it is, the 
differences between the practices used in conducting the study and the 
good laboratory practice regulations do not support the validity of the 
study.
    (b) The Commissioner, as provided in Sec. 514.200 of this chapter, 
shall expeditiously notify the applicant of an opportunity for a hearing 
on the question of whether such application is approvable, unless by the 
30th day following the date of issuance of the letter informing the 
applicant of the intention to issue a notice of opportunity for a 
hearing the applicant:
    (1) Withdraws the application; or
    (2) Waives the opportunity for a hearing; or
    (3) Agrees with the Commissioner on an additional period to precede 
issuance of such notice of hearing.

[40 FR 13825, Mar. 27, 1975, as amended at 43 FR 22675, May 26, 1978; 44 
FR 16007, Mar. 16, 1979; 50 FR 7517, Feb. 22, 1985; 50 FR 16668, Apr. 
26, 1985; 52 FR 49588, Dec. 31, 1987; 54 FR 18280, Apr. 28, 1989; 62 FR 
40600, July 29, 1997; 63 FR 10770, Mar. 5, 1998; 64 FR 40757, July 28, 
1999; 64 FR 63204, Nov. 19, 1999]



Sec. 514.115  Withdrawal of approval of applications.

    (a) The Secretary may suspend approval of an application approved 
pursuant to section 512(c) of the act and give the applicant prompt 
notice of his action and afford the applicant the opportunity for an 
expedited hearing on a finding that there is an imminent hazard to the 
health of man or of the animals for which such new animal drug or animal 
feed is intended.
    (b) The Commissioner shall notify in writing the person holding an 
application approved pursuant to section 512(c) of the act and afford an 
opportunity for a hearing on a proposal to withdraw approval of such 
application if he finds:
    (1) That the application contains any untrue statement of a material 
fact; or
    (2) That the applicant has made any changes from the standpoint of 
safety or effectiveness beyond the variations provided for in the 
application unless he has supplemented the application by filing with 
the Secretary adequate information respecting all such changes and 
unless there is in effect an approval of the supplemental application, 
or such changes are those for which written authorization or approval is 
not required as provided for in Sec. 514.8. The supplemental 
application shall be treated in the same manner as the original 
application.
    (3) That in the case of an application for use of a new animal drug 
approved or deemed approved pursuant to section 512(c) of the act:
    (i) Experience or scientific data show that such drug is unsafe for 
use under the conditions of use upon the basis of which the application 
was approved; or
    (ii) New evidence not contained in such application or not available 
to the Secretary until after such application was approved, or tests by 
new methods, or tests by methods not deemed reasonably applicable when 
such application was approved, evaluated together with the evidence 
available to the Secretary when the application was approved, shows that 
such drug is not shown to be safe for use under the conditions of use 
upon the basis of which the application was approved or that section 512 
(d)(1)(H) of the act applies to such drug; or
    (iii) On the basis of new information before him with respect to 
such drug, evaluated together with the evidence available to him when 
the application was approved, there is a lack of substantial evidence 
that such drug will have the effect it purports or is represented to 
have under the conditions of use prescribed, recommended, or suggested 
in the labeling thereof.
    (4) That any nonclinical laboratory study that is described in the 
application and that is essential to show that the drug is safe for use 
under the conditions prescribed, recommended, or suggested in its 
proposed labeling, was not conducted in compliance with the good 
laboratory practice regulations as set forth in part 58 of this chapter 
and no reason for the noncompliance is provided or, if it is, the 
differences between the practices used in conducting the study and the 
good laboratory practice regulations do not support the validity of the 
study.

[[Page 84]]

    (c) The Commissioner may notify in writing the person holding an 
application approved pursuant to section 512(c) of the act and afford an 
opportunity for a hearing on a proposal to withdraw approval of such 
application if he finds:
    (1) That the applicant has failed to establish a system for 
maintaining required records, or has repeatedly or deliberately failed 
to maintain such records or to make required reports in accordance with 
a regulation or order under section 512(l)(1) of the act, or the 
applicant has refused to permit access to, or copying, or verification 
of, such records as required by section 512(l)(2) of the act; or
    (2) That on the basis of new information before him evaluated 
together with the evidence before him when the application was approved, 
the methods used in, or the facilities and controls used for, the 
manufacture, processing, and packing of such drug or animal feed are 
inadequate to assure and preserve its identity, strength, quality, and 
purity and were not made adequate within a reasonable time after receipt 
of written notice from the Secretary specifying the matter complained 
of; or
    (3) That on the basis of new information before him, evaluated 
together with the evidence before him when the application was approved, 
the labeling of such drug, based on a fair evaluation of all material 
facts, is false or misleading in any particular and was not corrected 
within a reasonable time after receipt of written notice from the 
Secretary specifying the matter complained of.
    (d) Approval of an application pursuant to section 512(c) of the act 
will be withdrawn on the basis of a request for its withdrawal submitted 
in writing by a person holding an approved new animal drug application 
on the grounds that the drug subject to such application is no longer 
being marketed and information is included in support of this finding, 
provided none of the conditions cited in paragraphs (a), (b), and (c) of 
this section pertain to the subject drug. A written request for such 
withdrawal shall be construed as a waiver of the opportunity for a 
hearing as otherwise provided for in this section. Withdrawal of 
approval of an application under the provisions of this paragraph shall 
be without prejudice.
    (e) On the basis of the withdrawal of approval of an application for 
a new animal drug approved pursuant to section 512(c) of the act, the 
regulation published pursuant to section 512(i) of the act covering the 
conditions of use of such drug as provided for in the application shall 
be revoked.

[40 FR 13825, Mar. 27, 1975, as amended at 50 FR 7517, Feb. 22, 1985; 64 
FR 63204, Nov. 19, 1999]



Sec. 514.116  Notice of withdrawal of approval of application.

    When an approval of an application submitted pursuant to section 512 
of the act is withdrawn by the Commissioner, he will give appropriate 
public notice of such action by publication in the Federal Register.



Sec. 514.117  Adequate and well-controlled studies.

    (a) Purpose. The primary purpose of conducting adequate and well-
controlled studies of a new animal drug is to distinguish the effect of 
the new animal drug from other influences, such as spontaneous change in 
the course of the disease, normal animal production performance, or 
biased observation. One or more adequate and well-controlled studies are 
required to establish, by substantial evidence, that a new animal drug 
is effective. The characteristics described in paragraph (b) of this 
section have been developed over a period of years and are generally 
recognized as the essentials of an adequate and well-controlled study. 
Well controlled, as used in the phrase adequate and well controlled, 
emphasizes an important aspect of adequacy. The Food and Drug 
Administration (FDA) considers these characteristics in determining 
whether a study is adequate and well controlled for purposes of section 
512 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 
360b). Adequate and well-controlled studies, in addition to providing a 
basis for determining whether a new animal drug is effective, may also 
be relied upon to support target animal safety. The report of an 
adequate and well-controlled study should provide sufficient details of 
study design, conduct, and analysis

[[Page 85]]

to allow critical evaluation and a determination of whether the 
characteristics of an adequate and well-controlled study are present.
    (b) Characteristics. An adequate and well-controlled study has the 
following characteristics:
    (1) The protocol for the study (protocol) and the report of the 
study results (study report) must include a clear statement of the study 
objective(s).
    (2) The study is conducted in accordance with an appropriate 
standard of conduct that addresses, among other issues, study conduct, 
study personnel, study facilities, and study documentation. The protocol 
contains a statement acknowledging the applicability of, and intention 
to follow, a standard of conduct acceptable to FDA. The study report 
contains a statement describing adherence to the standard.
    (3) The study is conducted with a new animal drug that is produced 
in accordance with appropriate manufacturing practices, which include, 
but are not necessarily limited to, the manufacture, processing, 
packaging, holding, and labeling of the new animal drug such that the 
critical characteristics of identity, strength, quality, purity, and 
physical form of the new animal drug are known, recorded, and 
reproducible, to permit meaningful evaluations of and comparisons with 
other studies conducted with the new animal drug. The physical form of a 
new animal drug includes the formulation and physical characterization 
(including delivery systems thereof, if any) of the new animal drug as 
presented to the animal. The protocol and study report must include an 
identification number which can be correlated with the specific 
formulation and production process used to manufacture the new animal 
drug used in the study.
    (4) The study uses a design that permits a valid comparison with one 
or more controls to provide a quantitative evaluation of drug effects. 
The protocol and the study report must describe the precise nature of 
the study design, e.g., duration of treatment periods, whether 
treatments are parallel, sequential, or crossover, and the determination 
of sample size. Within the broad range of studies conducted to support a 
determination of the effectiveness of a new animal drug, certain of the 
controls listed below would be appropriate and preferred depending on 
the study conducted:
    (i) Placebo concurrent control. The new animal drug is compared with 
an inactive preparation designed to resemble the new animal drug as far 
as possible.
    (ii) Untreated concurrent control. The new animal drug is compared 
with the absence of any treatment. The use of this control may be 
appropriate when objective measurements of effectiveness, not subject to 
observer bias, are available.
    (iii) Active treatment concurrent control. The new animal drug is 
compared with known effective therapy. The use of this control is 
appropriate when the use of a placebo control or of an untreated 
concurrent control would unreasonably compromise the welfare of the 
animals. Similarity of the new animal drug and the active control drug 
can mean either that both drugs were effective or that neither was 
effective. The study report should assess the ability of the study to 
have detected a difference between treatments. The evaluation of the 
study should explain why the new animal drugs should be considered 
effective in the study, for example, by reference to results in previous 
placebo-controlled studies of the active control.
    (iv) Historical control. The results of treatment with the new 
animal drug are quantitatively compared with experience historically 
derived from the adequately documented natural history of the disease or 
condition, or with a regimen (therapeutic, diagnostic, prophylactic) 
whose effectiveness is established, in comparable animals. Because 
historical control populations usually cannot be as well assessed with 
respect to pertinent variables as can concurrent control populations, 
historical control designs are usually reserved for special 
circumstances. Examples include studies in which the effect of the new 
animal drug is self-evident or studies of diseases with high and 
predictable mortality, or signs and symptoms of predictable duration or 
severity, or, in the case of prophylaxis, predictable morbidity.

[[Page 86]]

    (5) The study uses a method of selecting animals that provides 
adequate assurances that the animals are suitable for the purposes of 
the study. For example, the animals can reasonably be expected to have 
animal production characteristics typical of the class(es) of animals 
for which the new animal drug is intended, there is adequate assurance 
that the animals have the disease or condition being studied, or, in the 
case of prophylactic agents, evidence of susceptibility and exposure to 
the condition against which prophylaxis is desired has been provided. 
The protocol and the study report describe the method of selecting 
animals for the study.
    (6) The study uses a method to assign a treatment or a control to 
each experimental unit of animals that is random and minimizes bias. 
Experimental units of animals are groups of animals that are comparable 
with respect to pertinent variables such as age, sex, class of animal, 
severity of disease, duration of disease, dietary regimen, level of 
animal production, and use of drugs or therapy other than the new animal 
drug. The protocol and the study report describe the method of 
assignment of animals to an experimental unit to account for pertinent 
variables and method of assignment of a treatment or a control to the 
experimental units. When the effect of such variables is accounted for 
by an appropriate design, and when, within the same animal, effects due 
to the test drug can be obtained free of the effects of such variables, 
the same animal may be used for both the test drug and the control using 
the controls set forth in paragraph (b)(4) of this section.
    (7) The study uses methods to minimize bias on the part of observers 
and analysts of the data that are adequate to prevent undue influences 
on the results and interpretation of the study data. The protocol and 
study report explain the methods of observation and recording of the 
animal response variables and document the methods, such as ``blinding'' 
or ``masking,'' used in the study for excluding or minimizing bias in 
the observations.
    (8) The study uses methods to assess animal response that are well 
defined and reliable. The protocol and study report describe the methods 
for conducting the study, including any appropriate analytical and 
statistical methods, used to collect and analyze the data resulting from 
the conduct of the study, describe the criteria used to assess response, 
and, when appropriate, justify the selection of the methods to assess 
animal response.
    (9) There is an analysis and evaluation of the results of the study 
in accord with the protocol adequate to assess the effects of the new 
animal drug. The study report evaluates the methods used to conduct, and 
presents and evaluates the results of, the study as to their adequacy to 
assess the effects of the new animal drug. This evaluation of the 
results of the study assesses, among other items, the comparability of 
treatment and control groups with respect to pertinent variables and the 
effects of any interim analyses performed.
    (c) Field studies. (1) Field conditions as used in this section 
refers to conditions which closely approximate the conditions under 
which the new animal drug, if approved, is intended to be applied or 
administered.
    (2) Studies of a new animal drug conducted under field conditions 
shall, consistent with generally recognized scientific principles and 
procedures, use an appropriate control that permits comparison, employ 
procedures to minimize bias, and have the characteristics generally 
described in paragraph (b) of this section. However, because field 
studies are conducted under field conditions, it is recognized that the 
level of control over some study conditions need not or should not be 
the same as the level of control in laboratory studies. While not all 
conditions relating to a field study need to be or should be controlled, 
observations of the conditions under which the new animal drug is tested 
shall be recorded in sufficient detail to permit evaluation of the 
study. Adequate and well-controlled field studies shall balance the need 
to control study conditions with the need to observe the true effect of 
the new animal drug under closely approximated actual use conditions.
    (d) Waiver. The Director of the Center for Veterinary Medicine (the 
Director) may, on the Director's own initiative

[[Page 87]]

or on the petition of an interested person, waive in whole or in part 
any of the criteria in paragraph (b) of this section with respect to a 
specific study. A petition for a waiver is required to set forth clearly 
and concisely the specific criteria from which waiver is sought, why the 
criteria are not reasonably applicable to the particular study, what 
alternative procedures, if any, are to be, or have been employed, and 
what results have been obtained. The petition is also required to state 
why the studies so conducted will yield, or have yielded, substantial 
evidence of effectiveness, notwithstanding nonconformance with the 
criteria for which waiver is requested.
    (e) Uncontrolled studies. Uncontrolled studies or partially 
controlled studies are not acceptable as the sole basis for the approval 
of claims of effectiveness or target animal safety. Such studies, 
carefully conducted and documented, may provide corroborative support of 
adequate and well-controlled studies regarding effectiveness and may 
yield valuable data regarding safety of the new animal drug. Such 
studies will be considered on their merits in light of the 
characteristics listed here. Isolated case reports, random experience, 
and reports lacking the details which permit scientific evaluation will 
not be considered.

[63 FR 10770, Mar. 5, 1998]



Sec. 514.120  Revocation of order refusing to approve an application or 

suspending or withdrawing approval of an application.

    The Commissioner, upon his own initiative or upon request of an 
applicant stating reasonable grounds therefor and if he finds that the 
facts so require, may issue an order approving an application that 
previously has had its approval refused, suspended, or withdrawn.



Sec. 514.121  Service of notices and orders.

    All notices and orders under this subchapter E and section 512 of 
the act pertaining to new animal drug applications shall be served:
    (a) In person by any officer or employee of the Department 
designated by the Commissioner; or
    (b) By mailing the order by certified mail addressed to the 
applicant or respondent at his last known address in the records of the 
Food and Drug Administration.



                      Subpart C_Hearing Procedures



Sec. 514.200  Contents of notice of opportunity for a hearing.

    (a) The notice to the applicant of opportunity for a hearing on a 
proposal by the Commissioner to refuse to approve an application or to 
withdraw the approval of an application will specify the grounds upon 
which he proposes to issue his order. On request of the applicant, the 
Commissioner will explain the reasons for his action. The notice of 
opportunity for a hearing will be published in the Federal Register and 
will specify that the applicant has 30 days after issuance of the notice 
within which he is required to file a written appearance electing 
whether:
    (1) To avail himself of the opportunity for a hearing; or
    (2) Not to avail himself of the opportunity for a hearing.
    (b) If the applicant fails to file a written appearance in answer to 
the notice of opportunity for hearing, his failure will be construed as 
an election not to avail himself of the opportunity for the hearing, and 
the Commissioner without further notice may enter a final order.
    (c) If the applicant elects to avail himself of the opportunity for 
a hearing, he is required to file a written appearance requesting the 
hearing within 30 days after the publication of the notice, giving the 
reason why the application should not be refused or should not be 
withdrawn, together with a well-organized and full-factual analysis of 
the clinical and other investigational data he is prepared to prove in 
support of his opposition to the Commissioner's proposal. A request for 
a hearing may not rest upon mere allegations or denials, but must set 
forth specific facts showing there is a genuine and substantial issue of 
fact that requires a hearing. When it clearly appears from the data in 
the application and from the reasons and a factual analysis in the 
request for the hearing that no genuine and substantial issue

[[Page 88]]

of fact precludes the refusal to approve the application or the 
withdrawal of approval of the application (for example, no adequate and 
well-controlled clinical investigations to support the claims of 
effectiveness have been identified), the Commissioner will enter an 
order on this data, stating his findings and conclusions. If a hearing 
is requested and is justified by the applicant's response to the notice 
of opportunity for a hearing, the issues will be defined, an 
Administrative Law Judge will be named, and he shall issue a written 
notice of the time and place at which the hearing will commence. In the 
case of denial of approval, such time shall be not more than 90 days 
after the expiration of such 30 days unless the Administrative Law Judge 
and the applicant otherwise agree; and, in the case of withdrawal of 
approval, such time shall be as soon as practicable.
    (d) The hearing will be open to the public; however, if the 
Commissioner finds that portions of the application which serve as a 
basis for the hearing contain information concerning a method or process 
entitled to protection as a trade secret, the part of the hearing 
involving such portions will not be public, unless the respondent so 
specifies in his appearance.

[40 FR 13825, Mar. 27, 1975, as amended at 43 FR 1941, Jan. 13, 1978]



Sec. 514.201  Procedures for hearings.

    Hearings relating to new animal drugs under section 512(d) and (e) 
of the act shall be governed by part 12 of this chapter.

[64 FR 63204, Nov. 19, 1999]

Subparts D-E [Reserved]



                        Subpart F_Judicial Review



Sec. 514.235  Judicial review.

    (a) The transcript and record shall be certified by the 
Commissioner. In any case in which the Commissioner enters an order 
without a hearing pursuant to Sec. 314.200(g) of this chapter, the 
request(s) for hearing together with the data and information submitted 
and the Commissioner's findings and conclusions shall be included in the 
record certified by the Commissioner.
    (b) Judicial review of an order withdrawing approval of a new drug 
application, whether or not a hearing has been held, may be sought by a 
manufacturer or distributor of an identical, related, or similar drug 
product, as defined in Sec. 310.6 of this chapter, in a United States 
court of appeals pursuant to section 505(h) of the act.

[42 FR 4717, Jan. 25, 1977]



PART 515_MEDICATED FEED MILL LICENSE--Table of Contents




                         Subpart A_Applications

Sec.
515.10 Medicated feed mill license applications.
515.11 Supplemental medicated feed mill license applications.

              Subpart B_Administrative Actions on Licenses

515.20 Approval of medicated feed mill license applications.
515.21 Refusal to approve a medicated feed mill license application.
515.22 Suspension and/or revocation of approval of a medicated feed mill 
          license.
515.23 Voluntary revocation of medicated feed mill license.
515.24 Notice of revocation of a medicated feed mill license.
515.25 Revocation of order refusing to approve a medicated feed mill 
          license application or suspending or revoking a license.
515.26 Services of notices and orders.

                      Subpart C_Hearing Procedures

515.30 Contents of notice of opportunity for a hearing.
515.31 Procedures for hearings.

                        Subpart D_Judicial Review

515.40 Judicial review.

    Authority: 21 U.S.C. 360b, 371.

    Source: 64 FR 63204, Nov. 19, 1999 unless otherwise noted.

[[Page 89]]



                         Subpart A_Applications



Sec. 515.10  Medicated feed mill license applications.

    (a) Medicated feed mill license applications (Forms FDA 3448) may be 
obtained from the Public Health Service, Consolidated Forms and 
Publications Distribution Center, Washington Commerce Center, 3222 
Hubbard Rd., Landover, MD 20785, or electronically from the Center for 
Veterinary Medicine home page at http://www.fda.gov/cvm.
    (b) A completed medicated feed mill license must contain the 
following information:
    (1) The full business name and address of the facility at which the 
manufacturing is to take place.
    (2) The facility's FDA registration number as required by section 
510 of the Federal Food, Drug, and Cosmetic Act (the act).
    (3) The name, title, and signature of the responsible individual or 
individuals for that facility.
    (4) A certification that the animal feeds bearing or containing new 
animal drugs are manufactured and labeled in accordance with the 
applicable regulations published under section 512(i) of the act or in 
accordance with the index listing published under section 572(e)(2) of 
the act.
    (5) A certification that the methods used in, and the facilities and 
controls used for, manufacturing, processing, packaging, and holding 
such animal feeds conform to current good manufacturing practice as 
described in section 501(a)(2)(B) of the act and in part 225 of this 
chapter.
    (6) A certification that the facility will establish and maintain 
all records required by regulation or order issued under sections 
512(m)(5)(A) or 504(a)(3)(A) of the act, and will permit access to, or 
copying or verification of such records.
    (7) A commitment that current approved or index listed Type B and/or 
Type C medicated feed labeling for each Type B and/or Type C medicated 
feed to be manufactured will be in the possession of the feed 
manufacturing facility prior to receiving the Type A medicated article 
containing such drug.
    (8) A commitment to renew registration every year with FDA as 
required in Sec. Sec. 207.20 and 207.21 of this chapter.
    (c) Applications must be completed, signed, and submitted to the 
Division of Animal Feeds (HFV-220), Center for Veterinary Medicine, Food 
and Drug Administration, 7500 Standish Pl., Rockville, MD 20855.
    (d) Applications that are facially deficient will be returned to the 
applicant. All reasons for the return of the application will be made 
known to the applicant.
    (e) Upon approval, the original copy of the application will be 
signed by an authorized employee of FDA designated by the Commissioner 
of Food and Drugs, and a copy will be returned to the applicant.

[64 FR 63204, Nov. 19, 1999, as amended at 72 FR 69121, Dec. 6, 2007]



Sec. 515.11  Supplemental medicated feed mill license applications.

    (a) After approval of a medicated feed mill license application to 
manufacture animal feed, a supplemental application shall be submitted 
for a change in ownership and/or a change in mailing address of the 
facility site.
    (b) Each supplemental application should be accompanied by a fully 
completed Form FDA 3448 and include an explanation of the change.
    (c) Within 30 working days after a supplemental application has been 
filed, if the Commissioner of Food and Drugs determines that the 
application provides adequate information respecting the change in 
ownership and/or postal address of the facility site, then an authorized 
employee of the Food and Drug Administration designated by the 
Commissioner shall notify the applicant that it is approved by signing 
and mailing to the applicant a copy of the Form FDA 3448. Supplemental 
applications that do not provide adequate information shall be returned 
to the applicant and all reasons for the return of the application shall 
be made known to the applicant.

[[Page 90]]



              Subpart B_Administrative Actions on Licenses



Sec. 515.20  Approval of medicated feed mill license applications.

    Within 90 days after an application has been filed under Sec. 
515.10, if the Commissioner of Food and Drugs (the Commissioner) 
determines that none of the grounds for denying approval specified in 
section 512(m)(3) of the Federal Food, Drug, and Cosmetic Act (the act) 
applies, an authorized employee of the Food and Drug Administration 
designated by the Commissioner shall notify the applicant that it is 
approved by signing and mailing to the applicant a copy of the Form FDA 
3448.



Sec. 515.21  Refusal to approve a medicated feed mill license application.

    (a) The Commissioner of Food and Drugs (the Commissioner) shall 
within 90 days, or such additional period as may be agreed upon by the 
Commissioner and the applicant, after the filing of an application under 
Sec. 515.10, inform the applicant in writing of his/her intention to 
issue a notice of opportunity for a hearing on a proposal to refuse to 
approve the application, if the Commissioner determines upon the basis 
of the application, on the basis of a preapproval inspection, or upon 
the basis of any other information before him that:
    (1) The application is incomplete, false, or misleading in any 
particular; or
    (2) The methods used in and the facilities and controls used for the 
manufacturing, processing, and packaging of such animal feed are not 
adequate to preserve the identity, strength, quality, and purity of the 
new animal drug therein; or
    (3) The facility manufactures animal feeds bearing or containing new 
animal drugs in a manner that does not accord with the specifications 
for manufacture or labels animal feeds bearing or containing new animal 
drugs in a manner that does not accord with the conditions or 
indications of use that are published under section 512(i) or 572(e)(2) 
of the act.
    (b) The Commissioner, as provided in Sec. 515.30, shall 
expeditiously notify the applicant of an opportunity for a hearing on 
the question of whether such application is approvable, unless by the 
30th day following the date of issuance of the letter informing the 
applicant of the intention to issue a notice of opportunity for a 
hearing the applicant:
    (1) Withdraws the application; or
    (2) Waives the opportunity for a hearing; or
    (3) Agrees with the Commissioner on an additional period to preceed 
issuance of such notice of hearing.

[64 FR 63204, Nov. 19, 1999, as amended at 72 FR 69121, Dec. 6, 2007]



Sec. 515.22  Suspension and/or revocation of approval of a medicated feed mill 

license.

    (a) The Secretary of Health and Human Services may suspend a 
medicated feed mill license approved under section 512(m)(2) of the 
Federal Food, Drug, and Cosmetic Act (the act) and give the person 
holding the medicated feed mill license application prompt notice of 
this action and afford the applicant the opportunity for an expedited 
hearing on a finding that there is an imminent hazard to the health of 
man or of the animals for which such animal feed is intended.
    (b) The Commissioner of Food and Drugs (the Commissioner) shall 
notify in writing the person holding an application approved under 
section 512(m)(2) of the act and afford an opportunity for a hearing on 
a proposal to revoke approval of such application if the Commissioner 
finds:
    (1) That the application contains any untrue statement of a material 
fact; or
    (2) That the applicant has made any changes that would cause the 
application to contain any untrue statements of material fact or that 
would affect the safety or effectiveness of the animal feeds 
manufactured at the facility unless the applicant has supplemented the 
application by filing a supplemental application under Sec. 515.11.
    (c) The Commissioner may notify in writing the person holding an 
application approved under section 512(m)(2) of the act and afford an 
opportunity for a hearing on a proposal to revoke approval of such 
application if the Commissioner finds:

[[Page 91]]

    (1) That the applicant has failed to establish a system for 
maintaining required records, or has repeatedly or deliberately failed 
to maintain such records or to make required reports in accordance with 
a regulation or order under sections 512(m)(5)(A) or 504(a)(3)(A) of the 
act, or the applicant has refused to permit access to, or copying, or 
verification of, such records as required by sections 512(m)(5)(B) or 
504(a)(3)(B) of the act; or
    (2) That on the basis of new information before him, evaluated 
together with the evidence before him when such license was issued, the 
methods used in, or the facilities and controls used for, the 
manufacture, processing, packing, and holding of such animal feed are 
inadequate to assure and preserve the identity, strength, quality, and 
purity of the new animal drug therein, and were not made adequate within 
a reasonable time after receipt of written notice from the Commissioner 
specifying the matter complained of; or
    (3) That on the basis of new information before him, evaluated 
together with the evidence before him when such license was issued, the 
labeling of any animal feeds, based on a fair evaluation of all material 
facts, is false or misleading in any particular and was not corrected 
within a reasonable time after receipt of written notice from the 
Commissioner specifying the matter complained of; or
    (4) That on the basis of new information before him, evaluated 
together with the evidence before him when such license was issued, the 
facility has manufactured, processed, packed, or held animal feed 
bearing or containing a new animal drug adulterated under section 
501(a)(6) of the act, and the facility did not discontinue the 
manufacture, processing, packing, or holding of such animal feed within 
a reasonable time after receipt of written notice from the Commissioner 
specifying the matter complained of.



Sec. 515.23  Voluntary revocation of medicated feed mill license.

    A license issued under section 512(m)(2) of the Federal Food, Drug, 
and Cosmetic Act (the act) will be revoked on the basis of a request for 
its revocation submitted in writing by a responsible individual holding 
such license on the grounds that the facility no longer manufactures any 
animal feed covered under Sec. 558.4(b) of this chapter. A written 
request for such revocation shall be construed as a waiver of the 
opportunity for a hearing as otherwise provided for in this section. 
Revocation of approval of a medicated feed mill license under the 
provisions of this paragraph shall be without prejudice.



Sec. 515.24  Notice of revocation of a medicated feed mill license.

    When a license approved under section 512 of the Federal Food, Drug, 
and Cosmetic Act (the act) is revoked by the Commissioner of Food and 
Drugs (the Commissioner), the Commissioner will give appropriate public 
notice of such action by publication in the Federal Register.



Sec. 515.25  Revocation of order refusing to approve a medicated feed mill 

license application or suspending or revoking a license.

    The Commissioner of Food and Drugs (the Commissioner), upon his/her 
own initiative or upon request of an applicant stating reasonable 
grounds therefor and if the Commissioner finds that the facts so 
require, may issue an order approving a medicated feed mill license 
application that previously has had its approval refused, suspended, or 
revoked.



Sec. 515.26  Services of notices and orders.

    All notices and orders under this part 515 and section 512 of the 
Federal Food, Drug, and Cosmetic Act (the act) pertaining to medicated 
feed mill licenses shall be served:
    (a) In person by any officer or employee of the Department of Health 
and Human Services designated by the Commissioner of Food and Drugs; or
    (b) By mailing the order by certified mail addressed to the 
applicant or respondent at the applicant or respondent's last known 
address in the records of the Food and Drug Administration.

[[Page 92]]



                      Subpart C_Hearing Procedures



Sec. 515.30  Contents of notice of opportunity for a hearing.

    (a) The notice to the applicant of opportunity for a hearing on a 
proposal by the Commissioner of Food and Drugs (the Commissioner) to 
refuse to approve a medicated feed mill license application or to revoke 
the approval of a medicated feed mill license will specify the grounds 
upon which the Commissioner proposes to issue this order. On request of 
the applicant, the Commissioner will explain the reasons for the action. 
The notice of opportunity for a hearing will be published in the Federal 
Register and will specify that the applicant has 30 days after issuance 
of the notice within which the Commissioner is required to file a 
written appearance electing whether:
    (1) To avail himself of the opportunity for a hearing; or
    (2) Not to avail himself of the opportunity for a hearing.
    (b) If the applicant fails to file a written appearance in answer to 
the notice of opportunity for hearing, this failure will be construed as 
an election not to avail himself of the opportunity for the hearing, and 
the Commissioner without further notice may enter a final order.
    (c) If the applicant elects to avail himself of the opportunity for 
a hearing, the applicant is required to file a written appearance 
requesting the hearing within 30 days after the publication of the 
notice, giving the reason why the application should not be refused or 
the medicated feed mill license should not be revoked, together with a 
well-organized and full-factual analysis of the information the 
applicant is prepared to prove in support of his opposition to the 
Commissioner's proposal. A request for a hearing may not rest upon mere 
allegations or denials, but must set forth specific facts showing there 
is a genuine and substantial issue of fact that requires a hearing. When 
it clearly appears from the information in the application and from the 
reasons and factual analysis in the request for the hearing that no 
genuine and substantial issue of fact precludes the refusal to approve 
the application or the revocation of approval of the application, the 
Commissioner will enter an order on this information, stating his/her 
findings and conclusions. If a hearing is requested and is justified by 
the applicant's response to the notice of opportunity for a hearing, the 
issues will be defined, an Administrative Law Judge will be named, and 
the Judge shall issue a written notice of the time and place at which 
the hearing will commence. In the case of denial of approval, such time 
shall be not more than 90 days after the expiration of such 30 days 
unless the Administrative Law Judge and the applicant otherwise agree; 
and, in the case of withdrawal of approval, such time shall be as soon 
as practicable.
    (d) The hearing will be open to the public; however, if the 
Commissioner finds that portions of the application which serve as a 
basis for the hearing contain information concerning a method or process 
entitled to protection as a trade secret, the part of the hearing 
involving such portions will not be public, unless the respondent so 
specifies in the appearance.



Sec. 515.31  Procedures for hearings.

    Hearings relating to new animal drugs under section 512(m)(3) and 
(m)(4) of the Federal Food, Drug, and Cosmetic Act (the act) shall be 
governed by part 12 of this chapter.



                        Subpart D_Judicial Review



Sec. 515.40  Judicial review.

    The transcript and record shall be certified by the Commissioner of 
Food and Drugs (the Commissioner). In any case in which the Commissioner 
enters an order without a hearing under Sec. 314.200(g) of this 
chapter, the request(s) for hearing together with the data and 
information submitted and the Commissioner's findings and conclusions 
shall be included in the record certified by the Commissioner.

[[Page 93]]



PART 516_NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES--Table of Contents




                      Subpart A_General Provisions

Sec.
516.1 Scope.
516.2 Purpose.
516.3 Definitions.

  Subpart B_Designation of a Minor Use or Minor Species New Animal Drug

516.11 Scope of this subpart.
516.12 Purpose.
516.13 Definitions.
516.14 Submission of requests for designation.
516.16 Eligibility to request designation.
516.20 Content and format of a request for MUMS-drug designation.
516.21 Documentation of minor use status.
516.22 Permanent-resident U.S. agent for foreign sponsor.
516.23 Timing of requests for MUMS-drug designation.
516.24 Granting MUMS-drug designation.
516.25 Refusal to grant MUMS-drug designation.
516.26 Amendment to MUMS-drug designation.
516.27 Change in sponsorship.
516.28 Publication of MUMS-drug designations.
516.29 Termination of MUMS-drug designation.
516.30 Annual reports for a MUMS-designated drug.
516.31 Scope of MUMS-drug exclusive marketing rights.
516.34 FDA recognition of exclusive marketing rights.
516.36 Insufficient quantities of MUMS-designated drugs.
516.52 Availability for public disclosure of data and information in 
          requests.

  Subpart C_Index of Legally Marketed Unapproved New Animal Drugs for 
                              Minor Species

516.111 Scope of this subpart.
516.115 Definitions.
516.117 Submission of correspondence under this subpart.
516.119 Permanent-resident U.S. agent for foreign requestors and 
          holders.
516.121 Meetings.
516.123 Informal conferences regarding agency administrative actions.
516.125 Investigational use of minor species new animal drugs to support 
          indexing.
516.129 Content and format of a request for determination of eligibility 
          for indexing.
516.131 Refuse to file a request for determination of eligibility for 
          indexing.
516.133 Denying a request for determination of eligibility for indexing.
516.135 Granting a request for determination of eligibility for 
          indexing.
516.137 Notification of decision regarding eligibility for indexing.
516.141 Qualified expert panels.
516.143 Written report.
516.145 Content and format of a request for addition to the index.
516.147 Refuse to file a request for addition to the index.
516.149 Denying a request for addition to the index.
516.151 Granting a request for addition to the index.
516.153 Notification of decision regarding index listing.
516.155 Labeling of indexed drugs.
516.157 Publication of the index and content of an index listing.
516.161 Modifications to indexed drugs.
516.163 Change in ownership of an index file.
516.165 Records and reports.
516.167 Removal from the index.
516.171 Confidentiality of data and information in an index file.

Subpart D [Reserved]

  Subpart E_Conditionally Approved New Animal Drugs For Minor Use and 
                              Minor Species

516.1215 Florfenicol.

    Authority: 21 U.S.C. 360ccc-1, 360ccc-2, 371.

    Source: 72 FR 41017, July 26, 2007, unless otherwise noted.



                      Subpart A_General Provisions



Sec. 516.1  Scope.

    (a) This part implements section 573 of the Federal Food, Drug, and 
Cosmetic Act (the act) (21 U.S.C. 360ccc-2) and contains the following 
subparts:
    (1) Subpart A--General Provisions.
    (2) Subpart B--Designation of a Minor Use or Minor Species New 
Animal Drug.
    (3) Subpart C [Reserved]
    (4) Subpart D [Reserved]
    (b) References in this part to regulatory sections of the Code of 
Federal Regulations are to Chapter I of Title 21, unless otherwise 
noted.

[[Page 94]]



Sec. 516.2  Purpose.

    This part establishes standards and procedures for implementing 
section 573 of the act, including designation of minor use or minor 
species new animal drugs and associated exclusive marketing rights.



Sec. 516.3  Definitions.

    (a) The definitions and interpretations contained in section 201 of 
the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 321) apply 
to those terms when used in this part.
    (b) The following definitions of terms apply to all subparts of part 
516:
    Active moiety means the molecule or ion, excluding those appended 
portions of the molecule that cause the drug to be an ester, salt 
(including a salt with hydrogen or coordination bonds), or other 
noncovalent derivative (such as a complex, chelate, or clathrate) of the 
molecule, responsible for the pharmacological action of the drug 
substance.
    Functionally superior means that a drug has been shown to provide a 
significant therapeutic or physiologic advantage over that provided by a 
conditionally-approved or approved MUMS drug, that is otherwise the same 
drug, in one or more of the following ways:
    (i) The drug has been shown to be more effective, as assessed by 
effect on a clinically meaningful endpoint in adequate and well-
controlled clinical trials, than a conditionally approved or approved 
MUMS drug, that is otherwise the same drug. Generally, this would 
represent the same kind of evidence needed to support a comparative 
effectiveness claim for two different drugs; in most cases, direct 
comparative clinical trials will be necessary; or
    (ii) The drug has been shown to be safer than a conditionally-
approved or approved MUMS drug, that is otherwise the same drug, in a 
substantial portion of the target population, for example, by the 
elimination of an ingredient or contaminant that is associated with 
relatively frequent adverse effects. In some cases, direct comparative 
clinical trials will be necessary.
    Infrequently, as used in the minor use definition, means a disease 
or condition that is uncommon or that occurs only sporadically on an 
annualized basis.
    Limited geographical areas, as used in the minor use definition, 
means regions of the United States distinguished by physical, chemical, 
or biological factors that limit the distribution of a disease or 
condition.
    Major species means cattle, horses, swine, chickens, turkeys, dogs, 
and cats.
    Minor species means animals, other than humans, that are not major 
species.
    Minor use means the intended use of a drug in a major species for an 
indication that occurs infrequently and in only a small number of 
animals or in limited geographical areas and in only a small number of 
animals annually.
    MUMS drug means a new animal drug, as defined in section 201 of the 
act, intended for a minor use or for use in a minor species.
    Same dosage form means the same as one of the dosage forms specified 
in the following parts of this chapter:
    (i) Part 520: Oral dosage form new animal drugs (excluding use in 
animal feeds as specified in part 558 of this chapter).
    (ii) Part 522: Implantation or injectable dosage form new animal 
drugs.
    (iii) Part 524: Ophthalmic and topical dosage form new animal drugs.
    (iv) Part 526: Intramammary dosage forms.
    (v) Part 529: Certain other dosage form new animal drugs.
    (vi) Part 558: New animal drugs for use in animal feeds.
    Same drug means a MUMS drug for which designation, indexing, or 
conditional approval is sought that meets the following criteria:
    (i) If it is a MUMS drug composed of small molecules and contains 
the same active moiety as a prior designated, conditionally-approved, or 
approved MUMS drug, even if the particular ester or salt (including a 
salt with hydrogen or coordination bonds) or other noncovalent 
derivative such as a complex, chelate or clathrate is not the same, it 
is considered the same drug; except that, if the prior MUMS drug is 
conditionally approved or approved and the second MUMS drug is shown to 
be functionally superior to the conditionally approved or approved MUMS

[[Page 95]]

drug for the same intended use, it is not considered the same drug.
    (ii) If it is a MUMS drug composed of large molecules 
(macromolecules) and contains the same principal molecular structural 
features (but not necessarily all of the same structural features) as a 
prior designated, conditionally approved, or approved MUMS drug, it is 
considered the same drug; except that, if the prior MUMS drug is 
conditionally approved or approved and the second MUMS drug is shown to 
be functionally superior to the conditionally approved or approved MUMS 
drug for the same intended use, it is not considered the same drug. This 
criterion will be applied as follows to different kinds of 
macromolecules:
    (A) Two protein drugs would be considered the same if the only 
differences in structure between them were due to post-translational 
events or infidelity of translation or transcription or were minor 
differences in amino acid sequence; other potentially important 
differences, such as different glycosylation patterns or different 
tertiary structures, would not cause the drugs to be considered 
different unless the subsequent drug is shown to be functionally 
superior.
    (B) Two polysaccharide drugs would be considered the same if they 
had identical saccharide repeating units, even if the number of units 
were to vary and even if there were postpolymerization modifications, 
unless the subsequent drug is shown to be functionally superior.
    (C) Two polynucleotide drugs consisting of two or more distinct 
nucleotides would be considered the same if they had an identical 
sequence of purine and pyrimidine bases (or their derivatives) bound to 
an identical sugar backbone (ribose, deoxyribose, or modifications of 
these sugars), unless the subsequent drug is shown to be functionally 
superior.
    (D) Closely related, complex partly definable drugs with similar 
pharmacologic intent would be considered the same unless the subsequent 
drug is shown to be functionally superior.
    Same intended use means an intended use of a MUMS drug, for which 
designation, indexing, or conditional approval is sought, that is 
determined to be the same as (or not different from) a previously 
designated, conditionally approved, or approved intended use of a MUMS 
drug. Same intended use is established by comparing two intended uses 
and not by simply comparing the specific language by means of which the 
intent is established in labeling in accordance with the following 
criteria:
    (i) Two intended uses are considered the same if one of the intended 
uses falls completely within the scope of the other.
    (ii) For intended uses associated with diseases or conditions with 
multiple causative organisms, two intended uses are not considered the 
same when they involve different causative organisms or different 
subsets of causative organisms of that disease or condition when the 
causative organisms involved can reliably be shown to be clinically 
significant causes of the disease or condition.
    (iii) Two intended uses of a drug are not considered the same if 
they involve different intended species or different definable 
subpopulations (including ``production classes'') of a species.
    Sponsor means the person requesting designation for a MUMS drug who 
must be the real party in interest of the development and the intended 
or actual production and sales of such drug (in this context, the 
sponsor may be an individual, partnership, organization, or 
association). Sponsor also means the person responsible for an 
investigation of a new animal drug (in this context, the sponsor may be 
an individual, partnership, corporation, or Government agency or may be 
a manufacturer, scientific institution, or an investigator regularly and 
lawfully engaged in the investigation of new animal drugs). Sponsor also 
means the person submitting or receiving approval for a new animal drug 
application (in this context, the sponsor may be an individual, 
partnership, organization, or association). In all contexts, the sponsor 
is responsible for compliance with applicable provisions of the act and 
regulations.

[[Page 96]]



  Subpart B_Designation of a Minor Use or Minor Species New Animal Drug



Sec. 516.11  Scope of this subpart.

    This subpart implements section 573 of the act. Specifically, this 
subpart sets forth the procedures and requirements for submissions to 
FDA of requests for designation of a new animal drug for a minor use or 
a minor species.



Sec. 516.12  Purpose.

    This subpart establishes standards and procedures for determining 
eligibility for designation and the associated incentives and benefits 
described in section 573 of the act, including a 7-year period of 
exclusive marketing rights.



Sec. 516.13  Definitions.

    The following definitions of terms apply only in the context of 
subpart B of this part:
    Director means the Director of the Office of Minor Use and Minor 
Species Animal Drug Development of the FDA Center for Veterinary 
Medicine.
    Intended use means the intended treatment, control or prevention of 
a disease or condition, or the intention to affect the structure or 
function of the body of animals within an identified species, 
subpopulation of a species, or collection of species.
    MUMS-designated drug means a new animal drug, as defined in section 
201 of the act, intended for a minor use or for use in a minor species 
that has been designated under section 573 of the act.
    MUMS-drug exclusive marketing rights or exclusive marketing rights 
means that, effective on the date of FDA conditional approval or 
approval as stated in the approval letter of an application for a MUMS-
designated drug, no conditional approval or approval will be given to a 
subsequent application for the same drug, in the same dosage form, for 
the same intended use for 7 years, except as otherwise provided by law 
or in this subpart.



Sec. 516.14  Submission of requests for designation.

    All correspondence relating to a request for designation of a MUMS 
drug must be addressed to the Director of the Office of Minor Use and 
Minor Species Animal Drug Development. Submissions not including all 
elements specified in Sec. 516.20 will be returned to the sponsor 
without review.



Sec. 516.16  Eligibility to request designation.

    The person requesting designation must be the sponsor and the real 
party in interest of the development and the intended or actual 
production and sales of the drug or the permanent-resident U.S. agent 
for such a sponsor.



Sec. 516.20  Content and format of a request for MUMS-drug designation.

    (a) A sponsor that submits a request for designation of a new animal 
drug intended for a minor use or minor species must submit each request 
in the form and containing the information required in paragraph (b) of 
this section. While a request for designation may involve multiple 
intended uses, each request for designation must constitute a separate 
submission. A sponsor may request MUMS-drug designation of a previously 
unapproved drug, or a new intended use or dosage form for an already 
conditionally approved or approved drug. Only one sponsor may receive 
MUMS-drug designation of the same drug, in the same dosage form, for the 
same intended use.
    (b) A sponsor must submit two copies of a completed, dated, and 
signed request for designation that contains the following information:
    (1) A request for designation of a new animal drug for a minor use 
or use in a minor species, which must be specific.
    (2) The name and address of the sponsor; the name of the sponsor's 
primary contact person and/or permanent-resident U.S. agent including 
title, address, and telephone number; the generic and trade name, if 
any, of the drug; and the name and address of the source of the drug.
    (3) A description of the proposed intended use for which the drug is 
being or will be investigated.

[[Page 97]]

    (4) A description of the drug and dosage form.
    (5) A discussion of the scientific rationale for the intended use of 
the drug; specific reference, including date(s) of submission, to all 
data from nonclinical laboratory studies, clinical investigations, 
copies of pertinent unpublished and published papers, and other relevant 
data that are available to the sponsor, whether positive, negative, or 
inconclusive.
    (6) A specific description of the product development plan for the 
drug, its dosage form, and its intended use.
    (7) If the drug is intended for a minor use in a major species, 
documentation in accordance with Sec. 516.21, with appended 
authoritative references, to demonstrate that such use is a minor use.
    (8) A statement that the sponsor submitting the request is the real 
party in interest of the development and the intended or actual 
production and sales of the product.
    (9) A statement that the sponsor acknowledges that, upon granting a 
request for MUMS designation, FDA will make information regarding the 
designation publicly available as specified in Sec. 516.28.



Sec. 516.21  Documentation of minor use status.

    So that FDA can determine whether a drug qualifies for MUMS-drug 
designation as a minor use in a major species under section 573 of the 
act, the sponsor shall include in its request to FDA for MUMS-drug 
designation under Sec. 516.20 documentation demonstrating that the use 
is limited to a small number of animals (annualized). This documentation 
must include the following information:
    (a) The estimated total number of animals to which the drug could 
potentially be administered on an annual basis for the treatment, 
control, or prevention of the disease or condition for which the drug is 
being developed, including animals administered the drug as part of herd 
or flock treatment, together with a list of the sources (including dates 
of information provided and literature citations) for the estimate.
    (b) The estimated total number of animals referred to in paragraph 
(a) of this section may be further reduced to only a subset of the 
estimated total number of animals if administration of the drug is only 
medically justified for this subset. To establish this, requestors must 
demonstrate that administration of the drug to animals subject to the 
disease or condition for which the drug is being developed other than 
the subset is not medically justified. The sponsor must also include a 
list of the sources (including dates of information provided and 
literature citations) for the justification that administration of the 
drug to animals other than the targeted subset is medically 
inappropriate.
    (c) An estimate of the potential market associated with the total 
number of animals established in paragraph (a) of this section compared 
to an estimate of the development costs of the proposed drug, in the 
proposed dosage form, for the proposed intended use.



Sec. 516.22  Permanent-resident U.S. agent for foreign sponsor.

    Every foreign sponsor that seeks MUMS-drug designation shall name a 
permanent resident of the United States as the sponsor's agent upon whom 
service of all processes, notices, orders, decisions, requirements, and 
other communications may be made on behalf of the sponsor. Notifications 
of changes in such agents or changes of address of agents should 
preferably be provided in advance, but not later than 60 days after the 
effective date of such changes. The permanent-resident U.S. agent may be 
an individual, firm, or domestic corporation and may represent any 
number of sponsors. The name and address of the permanent-resident U.S. 
agent shall be provided to the Director of the Office of Minor Use and 
Minor Species Animal Drug Development.



Sec. 516.23  Timing of requests for MUMS-drug designation.

    A sponsor may request MUMS-drug designation at any time in the drug 
development process prior to the submission of an application for either 
conditional approval or approval of the

[[Page 98]]

MUMS drug for which designation is being requested.



Sec. 516.24  Granting MUMS-drug designation.

    (a) FDA may grant the request for MUMS-drug designation if none of 
the reasons described in Sec. 516.25 for refusal to grant such a 
request apply.
    (b) When a request for MUMS-drug designation is granted, FDA will 
notify the sponsor in writing and will give public notice of the MUMS-
drug designation in accordance with Sec. 516.28.



Sec. 516.25  Refusal to grant MUMS-drug designation.

    (a) FDA will refuse to grant a request for MUMS-drug designation if 
any of the following reasons apply:
    (1) The drug is not intended for use in a minor species or FDA 
determines that there is insufficient evidence to demonstrate that the 
drug is intended for a minor use in a major species.
    (2) The drug is the same drug in the same dosage form for the same 
intended use as one that already has a MUMS-drug designation but has not 
yet been conditionally approved or approved.
    (3) The drug is the same drug in the same dosage form for the same 
intended use as one that is already conditionally approved or approved. 
A drug that FDA has found to be functionally superior is not considered 
the same drug as an already conditionally approved or approved drug even 
if it is otherwise the same drug in the same dosage form for the same 
intended use.
    (4) The sponsor has failed to provide:
    (i) A credible scientific rationale in support of the intended use,
    (ii) Sufficient information about the product development plan for 
the drug, its dosage form, and its intended use to establish that 
adherence to the plan can lead to successful drug development in a 
timely manner, and
    (iii) Any other information required under Sec. 516.20.
    (b) FDA may refuse to grant a request for MUMS-drug designation if 
the request for designation contains an untrue statement of material 
fact or omits material information.



Sec. 516.26  Amendment to MUMS-drug designation.

    (a) At any time prior to conditional approval or approval of an 
application for a MUMS-designated drug, the sponsor may apply for an 
amendment to the designated intended use if the proposed change is due 
to new and unexpected findings in research on the drug, information 
arising from FDA recommendations, or other unforeseen developments.
    (b) FDA will grant the amendment if it finds:
    (1) That the initial designation request was made in good faith;
    (2) That the amendment is intended to make the MUMS-drug designated 
intended use conform to the results of new and unexpected findings in 
research on the drug, information arising from FDA recommendations, or 
other unforeseen developments; and
    (3) In the case of a minor use, that as of the date of the 
submission of the amendment request, the amendment would not result in 
the intended use of the drug no longer being considered a minor use.



Sec. 516.27  Change in sponsorship.

    (a) A sponsor may transfer sponsorship of a MUMS-designated drug to 
another person. A change of sponsorship will also transfer the 
designation status of the drug which will remain in effect for the new 
sponsor subject to the same conditions applicable to the former sponsor 
provided that at the time of a potential transfer, the new and former 
sponsors submit the following information in writing and obtain 
permission from FDA:
    (1) The former sponsor shall submit a letter to FDA that documents 
the transfer of sponsorship of the MUMS-designated drug. This letter 
shall specify the date of the transfer. The former sponsor shall also 
certify in writing to FDA that a complete copy of the request for MUMS-
drug designation, including any amendments to the request, and 
correspondence relevant to the MUMS-drug designation, has been provided 
to the new sponsor.
    (2) The new sponsor shall submit a letter or other document 
containing the following information:

[[Page 99]]

    (i) A statement accepting the MUMS-drug designated file or 
application;
    (ii) The date that the change in sponsorship is intended to be 
effective;
    (iii) A statement that the new sponsor has a complete copy of the 
request for MUMS-drug designation, including any amendments to the 
request and any correspondence relevant to the MUMS-drug designation;
    (iv) A statement that the new sponsor understands and accepts the 
responsibilities of a sponsor of a MUMS-designated drug established 
elsewhere in this subpart;
    (v) The name and address of a new primary contact person or 
permanent resident U.S. agent; and
    (vi) Evidence that the new sponsor is capable of actively pursuing 
approval with due diligence.
    (b) No sponsor may relieve itself of responsibilities under the act 
or under this subpart by assigning rights to another person without:
    (1) Assuring that the new sponsor will carry out such 
responsibilities; and
    (2) Obtaining prior permission from FDA.



Sec. 516.28  Publication of MUMS-drug designations.

    FDA will periodically update a publicly available list of MUMS-
designated drugs. This list will be placed on file at the FDA Division 
of Dockets Management, and will contain the following information for 
each MUMS-designated drug:
    (a) The name and address of the sponsor;
    (b) The established name and trade name, if any, of the drug;
    (c) The dosage form of the drug;
    (d) The species and the proposed intended use for which MUMS-drug 
designation was granted; and
    (e) The date designation was granted.



Sec. 516.29  Termination of MUMS-drug designation.

    (a) The sponsor of a MUMS-designated drug must notify FDA of any 
decision to discontinue active pursuit of conditional approval or 
approval of such MUMS drug. FDA must terminate the designation upon such 
notification.
    (b) A conditionally-approved or approved MUMS-designated drug 
sponsor must notify FDA at least 1 year before it intends to discontinue 
the manufacture of such MUMS drug. FDA must terminate designation upon 
such notification.
    (c) MUMS designation shall terminate upon the expiration of any 
applicable period of exclusive marketing rights under this subpart.
    (d) FDA may terminate designation if it independently determines 
that the sponsor is not actively pursuing conditional approval or 
approval with due diligence. At a minimum, due diligence must be 
demonstrated by:
    (1) Submission of annual progress reports in a timely manner in 
accordance with Sec. 516.30 that demonstrate that the sponsor is 
progressing in accordance with the drug development plan submitted to 
the agency under Sec. 516.20 and
    (2) Compliance with all applicable requirements of part 511 of this 
chapter.
    (e) Designation of a conditionally approved or approved MUMS-
designated drug and the associated exclusive marketing rights may be 
terminated if the sponsor is unable to provide sufficient quantities of 
the drug to meet the needs for which it is designated.
    (f) FDA may also terminate MUMS-drug designation for any drug if the 
agency finds that:
    (1) The request for designation contained an untrue statement of 
material fact; or
    (2) The request for designation omitted material information 
required by this subpart; or
    (3) FDA subsequently finds that the drug in fact had not been 
eligible for MUMS-drug designation at the time of submission of the 
request;
    (4) The same drug, in the same dosage form, for the same intended 
use becomes conditionally approved or approved for another sponsor; or
    (5) FDA withdraws the conditional approval or approval of the 
application for the new animal drug.
    (g) For a conditionally approved or approved drug, termination of 
MUMS-drug designation also terminates the sponsor's exclusive marketing 
rights for the drug but does not withdraw the conditional approval or 
approval of the drug's application.

[[Page 100]]

    (h) Where a drug has been MUMS-designated for a minor use in a major 
species, its designation will not be terminated on the grounds that the 
number of animals to which the drug could potentially be administered on 
an annual basis for the treatment, control, or prevention of the disease 
or condition for which the drug is being developed, including animals 
administered the drug as part of herd or flock treatment, subsequently 
increases.
    (i) When a MUMS-drug designation is terminated, FDA will notify the 
sponsor in writing and will give public notice of the termination of the 
MUMS-drug designation.



Sec. 516.30  Annual reports for a MUMS-designated drug.

    Within 14 months after the date on which a MUMS drug is granted 
designation and annually thereafter until approval, the sponsor of a 
MUMS-designated drug shall submit a brief progress report on the drug to 
the investigational new animal drug file addressed to the Director of 
the Office of Minor Use and Minor Species Animal Drug Development that 
includes the following information:
    (a) A short account of the progress of drug development including a 
description of studies initiated, ongoing, and completed, and a short 
summary of the status or results of such studies;
    (b) A description of the investigational plan for the coming year, 
as well as any anticipated difficulties in development, testing, and 
marketing; and
    (c) A brief discussion of any changes that may affect the MUMS-
designated drug status of the product. For example, situations in which 
testing data demonstrate that the proposed intended use is inappropriate 
due to unexpected issues of safety or effectiveness.



Sec. 516.31  Scope of MUMS-drug exclusive marketing rights.

    (a) After conditional approval or approval of an application for a 
MUMS-designated drug in the dosage form and for the intended use for 
which MUMS-drug designation has been granted, FDA will not conditionally 
approve or approve another application or abbreviated application for 
the same drug in the same dosage form for the same intended use before 
the expiration of 7 years after the date of conditional approval or 
approval as stated in the approval letter from FDA, except that such an 
application can be conditionally approved or approved sooner if, and at 
such time as, any of the following occurs:
    (1) FDA terminates the MUMS-drug designation and associated 
exclusive marketing rights under Sec. 516.29; or
    (2) FDA withdraws the conditional approval or approval of the 
application for the drug for any reason; or
    (3) The sponsor with exclusive marketing rights provides written 
consent to FDA to conditionally approve or approve another application 
before the expiration of 7 years; or
    (4) The sponsor fails to assure a sufficient quantity of the drug in 
accordance with section 573 of the act and Sec. 516.36.
    (b) If an application for a MUMS drug cannot be approved until the 
expiration of the period of exclusive marketing of a MUMS-designated 
drug, FDA will so notify the sponsor in writing.



Sec. 516.34  FDA recognition of exclusive marketing rights.

    (a) FDA will send the sponsor (or the permanent-resident U.S. agent, 
if applicable) timely written notice recognizing exclusive marketing 
rights when an application for a MUMS-designated drug has been 
conditionally approved or approved. The written notice will inform the 
sponsor of the requirements for maintaining MUMS-designated drug 
exclusive marketing rights for the full 7-year term. This notice will 
generally be contained in the letter conditionally approving or 
approving the application.
    (b) When an application is conditionally approved or approved for a 
MUMS-designated drug that qualifies for exclusive marketing rights, FDA 
will publish this information in the Federal Register at the time of the 
conditional approval or approval. This notice will generally be 
contained in the notice of conditional approval or approval of the 
application.

[[Page 101]]



Sec. 516.36  Insufficient quantities of MUMS-designated drugs.

    (a) Under section 573 of the act, whenever FDA has reason to believe 
that sufficient quantities of a conditionally-approved or approved, 
MUMS-designated drug to meet the needs for which the drug was designated 
cannot be assured by the sponsor, FDA will so notify the sponsor of this 
possible insufficiency and will offer the sponsor the following options, 
one of which must be exercised by a time that FDA specifies:
    (1) Provide FDA information and data regarding how the sponsor can 
assure the availability of sufficient quantities of the MUMS-designated 
drug within a reasonable time to meet the needs for which the drug was 
designated; or
    (2) Provide FDA in writing the sponsor's consent for the conditional 
approval or approval of other applications for the same drug before the 
expiration of the 7-year period of exclusive marketing rights.
    (b) If, within the time that FDA specifies, the sponsor fails to 
consent to the conditional approval or approval of other applications 
and if FDA finds that the sponsor has not shown that it can assure the 
availability of sufficient quantities of the MUMS-designated drug to 
meet the needs for which the drug was designated, FDA will issue a 
written order terminating designation of the MUMS drug and the 
associated exclusive marketing rights. This order will state FDA's 
findings and conclusions and will constitute final agency action. An 
order terminating designation and associated exclusive marketing rights 
may issue whether or not there are other sponsors that can assure the 
availability of alternative sources of supply. Such an order will not 
withdraw the conditional approval or approval of an application. Once 
terminated under this section, neither designation, nor exclusive 
marketing rights may be reinstated.



Sec. 516.52  Availability for public disclosure of data and information in 

requests.

    (a) FDA will not publicly disclose the existence of a request for 
MUMS-drug designation under section 573 of the act prior to final FDA 
action on the request unless the existence of the request has been 
previously publicly disclosed or acknowledged.
    (b) Whether or not the existence of a pending request for 
designation has been publicly disclosed or acknowledged, no data or 
information in the request are available for public disclosure prior to 
final FDA action on the request.
    (c) Except as provided in paragraph (d) of this section, upon final 
FDA action on a request for designation, the public availability of data 
and information in the request will be determined in accordance with 
part 20 of this chapter and other applicable statutes and regulations.
    (d) In accordance with Sec. 516.28, FDA will make a cumulative list 
of all MUMS-drug designations available to the public and update such 
list periodically. In accordance with Sec. 516.29, FDA will give public 
notice of the termination of all MUMS-drug designations.



  Subpart C_Index of Legally Marketed Unapproved New Animal Drugs for 
                              Minor Species

    Source: 72 FR 69121, Dec. 6, 2007, unless otherwise noted.



Sec. 516.111  Scope of this subpart.

    This subpart implements section 572 of the act and provides 
standards and procedures to establish an index of legally marketed 
unapproved new animal drugs. This subpart applies only to minor species 
and not to minor use in major species. This index is only available for 
new animal drugs intended for use in a minor species for which there is 
a reasonable certainty that the animal or edible products from the 
animal will not be consumed by humans or food-producing animals and for 
new animal drugs intended for use only in a hatchery, tank, pond, or 
other similar contained man-made structure in an early, nonfood life 
stage of a food-producing minor species, where safety for humans is 
demonstrated in accordance with the standard of section 512(d) of the 
act (including, for an antimicrobial new animal drug, with respect to 
antimicrobial resistance). The index shall not include a new animal drug 
that is

[[Page 102]]

contained in, or a product of, a transgenic animal. Among its topics, 
this subpart sets forth the standards and procedures for:
    (a) Investigational exemptions for indexing purposes;
    (b) Submissions to FDA of requests for determination of eligibility 
of a new animal drug for indexing;
    (c) Establishment and operation of expert panels;
    (d) Submissions to FDA of requests for addition of a new animal drug 
to the index;
    (e) Modifications to index listings;
    (f) Publication of the index; and
    (g) Records and reports.



Sec. 516.115  Definitions.

    (a) The following definitions of terms apply only in the context of 
subpart C of this part:
    Director OMUMS means the Director of the Office of Minor Use and 
Minor Species Animal Drug Development of the FDA Center for Veterinary 
Medicine.
    Holder means the requestor of an index listing after the request is 
granted and the new animal drug is added to the index.
    Index means FDA's list of legally marketed unapproved new animal 
drugs for minor species.
    Intended use has the same meaning as that given in Sec. 516.13 of 
this chapter.
    Qualified expert panel means a panel that is composed of experts 
qualified by scientific training and experience to evaluate the target 
animal safety and effectiveness of a new animal drug under consideration 
for indexing.
    Requestor means the person making a request for determination of 
eligibility for indexing or a request for addition to the index.
    Transgenic animal means an animal whose genome contains a nucleotide 
sequence that has been intentionally modified in vitro, and the progeny 
of such an animal, provided that the term `transgenic animal' does not 
include an animal of which the nucleotide sequence of the genome has 
been modified solely by selective breeding.
    (b) The definitions of the following terms are given in Sec. 514.3 
of this chapter:
    Adverse drug experience.
    Product defect/manufacturing defect.
    Serious adverse drug experience.
    Unexpected adverse drug experience.
    (c) The definitions of the following terms are given in Sec. 516.3 
of this chapter:
    Same dosage form.
    Same drug.
    Same intended use.



Sec. 516.117  Submission of correspondence under this subpart.

    Unless directed otherwise by FDA, all correspondence relating to any 
aspect of the new animal drug indexing process described in this subpart 
must be addressed to the Director, OMUMS. The initial correspondence for 
a particular index listing should include the name and address of the 
authorized contact person. Notifications of changes in such person or 
changes of address of such person should be provided in a timely manner.



Sec. 516.119  Permanent-resident U.S. agent for foreign requestors and 

holders.

    Every foreign requestor and holder shall name a permanent resident 
of the United States as their agent upon whom service of all processes, 
notices, orders, decisions, requirements, and other communications may 
be made on behalf of the requestor or holder. Notifications of changes 
in such agents or changes of address of agents should preferably be 
provided in advance, but not later than 60 days after the effective date 
of such changes. The permanent resident U.S. agent may be an individual, 
firm, or domestic corporation and may represent any number of requestors 
or holders. The name and address of the permanent-resident U.S. agent 
shall be submitted to the Director, OMUMS, and included in the index 
file.



Sec. 516.121  Meetings.

    (a) A requestor or potential requestor is entitled to one or more 
meetings to discuss the requirements for indexing a new animal drug.
    (b) Requests for such meetings should be in writing, be addressed to 
the Director, OMUMS, specify the participants attending on behalf of the 
requestor or potential requestor, and

[[Page 103]]

contain a proposed agenda for the meeting.
    (c) Within 30 days of receiving a request for a meeting, FDA will 
attempt to schedule the meeting at a time agreeable to both FDA and the 
person making the request.



Sec. 516.123  Informal conferences regarding agency administrative actions.

    (a) Should FDA make an initial decision denying a request for 
determination of eligibility for indexing, terminating an 
investigational exemption, determining that a qualified expert panel 
does not meet the selection criteria, denying a request for addition to 
the index, or removing a new animal drug from the index, FDA will give 
written notice that specifies the grounds for the initial decision and 
provides an opportunity for an informal conference for review of the 
decision.
    (b) The written notice will include information for scheduling the 
informal conference and state that a written request for a conference 
must be made within 60 days of the date FDA sends its notice.
    (c) Within 45 days of receiving a request for an informal 
conference, FDA will schedule and hold the informal conference at a time 
agreeable to both FDA and the person making the request.
    (d) Such an informal conference will be conducted by a presiding 
officer who will be the Director of the Center for Veterinary Medicine 
or his or her designee, excluding the Director of the Office of Minor 
Use and Minor Species Animal Drug Development and other persons 
significantly involved in the initial decision.
    (e) The person requesting an informal conference must provide a 
written response to FDA's initial decision at least 2 weeks prior to the 
date of the scheduled meeting. Generally, this written response would be 
attached to the request for an informal conference. At the option of the 
person requesting an informal conference, such written response to FDA's 
initial decision may act in lieu of a face-to-face meeting. In this 
case, the informal conference will consist of a review by the presiding 
officer of the submitted written response.
    (f) The purpose of an informal conference is to discuss scientific 
and factual issues. It will involve a discussion of FDA's initial 
decision and any written response to that decision.
    (g) Internal agency review of a decision must be based on the 
information in the administrative file. If the person requesting an 
informal conference presents new information not in the file, the matter 
will be returned to the appropriate lower level in the agency for 
reevaluation based on the new information.
    (h) Informal conferences under this part are not subject to the 
separation of functions rules in Sec. 10.55 of this chapter.
    (i) The rules of evidence do not apply to informal conferences. No 
motions or objections relating to the admissibility of information and 
views will be made or considered, but any party to the conference may 
comment upon or rebut all such data, information and views.
    (j) [Reserved]
    (k) The presiding officer will prepare a written report regarding 
the subject of the informal conference that states and describes the 
basis for his or her findings. Whenever time permits, the parties to the 
informal conference will have 30 days to review and comment on the 
report.
    (l) The administrative record of the informal conference will 
consist of:
    (1) The notice providing an opportunity for an informal conference 
and the written response to the notice.
    (2) All written information and views submitted to the presiding 
officer at the conference or, at the discretion of the presiding 
officer, thereafter.
    (3) The presiding officer's written report.
    (4) All correspondence and memoranda of any and all meetings between 
the participants and the presiding officer.
    (m) The administrative record of the informal conference is closed 
to the submission of information at the close of the conference, unless 
the presiding officer specifically permits additional time for further 
submission.
    (n) The administrative record of the informal conference specified 
herein

[[Page 104]]

constitutes the exclusive record for decision.



Sec. 516.125  Investigational use of minor species new animal drugs to support 

indexing.

    (a) The investigational use of a new animal drug or animal feed 
bearing or containing a new animal drug intended solely for 
investigational use in minor species shall meet the requirements of part 
511 of this chapter if the investigational use is for the purpose of:
    (1) Demonstrating human food safety under section 572(a)(1)(B) of 
the act;
    (2) Demonstrating safety with respect to individuals exposed to the 
new animal drug through its manufacture and use under section 
572(c)(1)(F) of the act;
    (3) Conducting an environmental assessment under section 
572(c)(1)(E) of the act; or
    (4) Obtaining approval of a new animal drug application or 
abbreviated new animal drug application under section 512(b) of the act.
    (b) Correspondence and information associated with investigations 
described in paragraph (a) of this section shall not be sent to the 
Director, OMUMS, but shall be submitted to FDA in accordance with the 
provisions of part 511 of this chapter.
    (c) The investigational use of a new animal drug or animal feed 
bearing or containing a new animal drug intended solely for 
investigational use in minor species, other than for an investigational 
use described in paragraph (a) of this section, shall meet the 
requirements of this section. For such investigations, all provisions of 
part 511 of this chapter apply with the following modifications:
    (1) Under Sec. 511.1(a)(1) of this chapter, the label statement is 
as follows:
    ``Caution. Contains a new animal drug for investigational use only 
in laboratory animals or for tests in vitro in support of index listing. 
Not for use in humans.''
    (2) Under Sec. 511.1(b)(1) of this chapter, the label statement is 
as follows:
    ``Caution. Contains a new animal drug for use only in 
investigational animals in clinical trials in support of index listing. 
Not for use in humans. Edible products of investigational animals are 
not to be used for food for humans or other animals unless authorization 
has been granted by the U.S. Food and Drug Administration or by the U.S. 
Department of Agriculture.''
    (3) Under Sec. 511.1(b)(4) of this chapter, the notice is titled 
``Notice of Claimed Investigational Exemption for a New Animal Drug for 
Index Listing'' and is submitted in duplicate to the Director, OMUMS.
    (4) Under Sec. 511.1(c)(3) of this chapter, if an investigator is 
determined to be ineligible to receive new animal drugs, each ``Notice 
of Claimed Investigational Exemption for a New Animal Drug for Index 
Listing'' and each request for indexing shall be examined with respect 
to the reliability of information submitted by the investigator.
    (5) Under Sec. 511.1(c)(4) and (d)(2) of this chapter, with respect 
to termination of exemptions, the sponsor of an investigation shall not 
be granted an opportunity for a regulatory hearing before FDA pursuant 
to part 16 of this chapter. Instead, the sponsor shall have an 
opportunity for an informal conference as described in Sec. 516.123.
    (6) Under Sec. 511.1(c)(5) of this chapter, if the Commissioner of 
Food and Drugs determines, after the unreliable data submitted by the 
investigator are eliminated from consideration, that the data remaining 
are such that a request for addition to the index would have been 
denied, FDA will remove the new animal drug from the index in accordance 
with Sec. 516.167.
    (d) The investigational use of a new animal drug or animal feed 
bearing or containing a new animal drug subject to paragraph (c) of this 
section shall not be subject to the good laboratory practice 
requirements in part 58 of this chapter.
    (e) Correspondence and information associated with investigations 
described in paragraph (c) of this section shall be sent to the 
Director, OMUMS, in accordance with the provisions of this section.



Sec. 516.129  Content and format of a request for determination of eligibility 

for indexing.

    (a) Each request for determination of eligibility:

[[Page 105]]

    (1) May involve only one drug (or one combination of drugs) in one 
dosage form;
    (2) May not involve a new animal drug that is contained in or a 
product of a transgenic animal;
    (3) May not involve the same drug in the same dosage form for the 
same intended use as a drug that is already approved or conditionally 
approved; and
    (4) Must be submitted separately.
    (b) A request for determination of eligibility for indexing may 
involve multiple intended uses and/or multiple minor species. However, 
if a request for determination of eligibility for indexing that contains 
multiple intended uses and/or multiple minor species cannot be granted 
in any part, the entire request will be denied.
    (c) A requestor must submit two copies of a dated request signed by 
the authorized contact person for determination of eligibility for 
indexing that contains the following:
    (1) Identification of the minor species or groups of minor species 
for which the new animal drug is intended;
    (2) Information regarding drug components and composition;
    (3) A statement of the intended use(s) of the new animal drug in the 
identified minor species or groups of minor species;
    (4) A statement of the proposed conditions of use associated with 
the stated intended use(s) of the new animal drug, including the 
proposed dosage, route of administration, contraindications, warnings, 
and any other significant limitations associated with the intended 
use(s) of the new animal drug;
    (5) A brief discussion of the need for the new animal drug for the 
intended use(s);
    (6) An estimate of the anticipated annual distribution of the new 
animal drug, in terms of the total quantity of active ingredient, after 
indexing;
    (7) Information to establish that the new animal drug is intended 
for use:
    (i) In a minor species for which there is a reasonable certainty 
that the animal or edible products from the animal will not be consumed 
by humans or food-producing animals; or
    (ii) In a hatchery, tank, pond, or other similar contained man-made 
structure in (which includes on) an early, non-food life stage of a 
food-producing minor species, and information to demonstrate food safety 
in accordance with the standards of section 512(d) of the act and Sec. 
514.111 of this chapter (including, for an antimicrobial new animal 
drug, with respect to antimicrobial resistance);
    (8) A description of the methods used in, and the facilities and 
controls used for, the manufacture, processing and packing of the new 
animal drug sufficient to demonstrate that the requestor has established 
appropriate specifications for the manufacture and control of the new 
animal drug and that the requestor has an understanding of current good 
manufacturing practices;
    (9) Either a claim for categorical exclusion under Sec. 25.30 or 
Sec. 25.33 of this chapter or an environmental assessment under Sec. 
25.40 of this chapter;
    (10) Information sufficient to support the conclusion that the new 
animal drug is safe under section 512(d) of the act with respect to 
individuals exposed to the new animal drug through its manufacture and 
use; and
    (11) The name and address of the contact person or permanent-
resident U.S. agent.



Sec. 516.131  Refuse to file a request for determination of eligibility for 

indexing.

    (a) If a request for determination of eligibility for indexing 
contains all of the information required by Sec. 516.129, FDA shall 
file it, and the filing date shall be the date FDA receives the request.
    (b) If a request for a determination of eligibility lacks any of the 
information required by Sec. 516.129, FDA will not file it, but will 
inform the requestor in writing within 30 days of receiving the request 
as to what information is lacking.



Sec. 516.133  Denying a request for determination of eligibility for indexing.

    (a) FDA will deny a request for determination of eligibility for 
indexing if it determines upon the basis of the request evaluated 
together with any other information before it with respect to the new 
animal drug that:

[[Page 106]]

    (1) The same drug in the same dosage form for the same intended use 
is already approved or conditionally approved;
    (2) There is insufficient information to demonstrate that the new 
animal drug is intended for use:
    (i) In a minor species for which there is a reasonable certainty 
that the animal or edible products from the animal will not be consumed 
by humans or food-producing animals, or
    (ii) In a hatchery, tank, pond, or other similar contained man-made 
structure in (which includes on) an early, non-food life stage of a 
food-producing minor species, and there is insufficient evidence to 
demonstrate safety for humans in accordance with the standard of section 
512(d) of the act and Sec. 514.111 of this chapter (including, for an 
antimicrobial new animal drug, with respect to antimicrobial 
resistance);
    (3) The new animal drug is contained in or is a product of a 
transgenic animal;
    (4) There is insufficient information to demonstrate that the 
requestor has established appropriate specifications for the manufacture 
and control of the new animal drug and that the requestor has an 
understanding of current good manufacturing practices;
    (5) The requester fails to submit an adequate environmental 
assessment under Sec. 25.40 of this chapter or fails to provide 
sufficient information to establish that the requested action is subject 
to categorical exclusion under Sec. 25.30 or Sec. 25.33 of this 
chapter;
    (6) There is insufficient information to determine that the new 
animal drug is safe with respect to individuals exposed to the new 
animal drug through its manufacture or use; or
    (7) The request for determination of eligibility for indexing fails 
to contain any other information required under the provisions of Sec. 
516.129.
    (b) FDA may deny a request for determination of eligibility for 
indexing if it contains any untrue statement of a material fact or omits 
material information.
    (c) When a request for determination of eligibility for indexing is 
denied, FDA will notify the requestor in accordance with Sec. 516.137.



Sec. 516.135  Granting a request for determination of eligibility for 

indexing.

    (a) FDA will grant the request for determination of eligibility for 
indexing if none of the reasons described in Sec. 516.133 for denying 
such a request applies.
    (b) When a request for determination of eligibility for indexing is 
granted, FDA will notify the requestor in accordance with Sec. 516.137.



Sec. 516.137  Notification of decision regarding eligibility for indexing.

    (a) Within 90 days after the filing of a request for a determination 
of eligibility for indexing based on Sec. 516.129(c)(7)(i), or 180 days 
for a request based on Sec. 516.129(c)(7)(ii), FDA shall grant or deny 
the request, and notify the requestor of FDA's decision in writing.
    (b) If FDA denies the request, FDA shall provide due notice and an 
opportunity for an informal conference as described in Sec. 516.123 
regarding its decision. A decision of FDA to deny a request for 
determination of eligibility for indexing following an informal 
conference shall constitute final agency action subject to judicial 
review.



Sec. 516.141  Qualified expert panels.

    (a) Establishment of a qualified expert panel. Establishing a 
qualified expert panel is the first step in the process of requesting 
the addition of a new animal drug to the index. A qualified expert panel 
may not be established until FDA has determined that the new animal drug 
is eligible for indexing. The requestor must choose members for the 
qualified expert panel in accordance with selection criteria listed in 
paragraph (b) of this section and submit information about these 
proposed members to FDA. FDA must determine whether the proposed 
qualified expert panel meets the selection criteria prior to the panel 
beginning its work. Qualified expert panels operate external to FDA and 
are not subject to the Federal Advisory Committee Act, as amended, 5 
U.S.C. App.
    (b) Criteria for the selection of a qualified expert panel. (1) A 
qualified expert panel member must be an expert qualified by training 
and experience to evaluate a significant aspect of target

[[Page 107]]

animal safety or effectiveness of the new animal drug under 
consideration.
    (2) A qualified expert panel member must certify that he or she has 
a working knowledge of section 572 of the act (the indexing provisions 
of the statute) and this subpart, and that he or she has also read and 
understood a clear written statement provided by the requestor stating 
his or her duties and responsibilities with respect to reviewing the new 
animal drug proposed for addition to the index.
    (3) A qualified expert panel member may not be an FDA employee.
    (4) A qualified expert panel must have at least three members.
    (5) A qualified expert panel must have members with a range of 
expertise such that the panel, as a whole, is qualified by training and 
experience to evaluate the target animal safety and effectiveness of the 
new animal drug under consideration.
    (6) Unless FDA makes a determination to allow participation 
notwithstanding an otherwise disqualifying financial interest, a 
qualified expert panel member must not have a conflict of interest or 
the appearance of a conflict of interest, as described in paragraph (g) 
of this section.
    (c) Requestor responsibilities. (1) The requestor must:
    (i) Choose members for the qualified expert panel in accordance with 
selection criteria listed in paragraph (b) of this section.
    (ii) Provide each potential expert panel member a copy of section 
572 of the act (the indexing provisions of the statute) and this subpart 
and obtain certification that he or she has a working knowledge of the 
information.
    (iii) Provide each potential expert panel member a written statement 
describing the purpose and scope of his or her participation on the 
qualified expert panel and obtain certification that he or she has read 
and understood the information. The written statement should describe 
the duties and responsibilities of qualified expert panels and their 
members established by paragraphs (e) and (f) of this section, including 
the need to prepare a written report under Sec. 516.143.
    (iv) Obtain information from each potential expert panel member 
demonstrating that he or she is qualified by training and experience to 
evaluate the target animal safety and effectiveness of the new animal 
drug under consideration. This information can be obtained from a 
comprehensive curriculum vitae or similar document.
    (v) Notify each potential expert panel member that he or she must 
submit information relating to potential conflict of interest directly 
to FDA in a timely manner, as required in paragraph (e)(6) of this 
section.
    (2) The requestor must submit, in writing, the names and addresses 
of the proposed qualified expert panel members and sufficient 
information about each proposed member for FDA to determine whether the 
panel meets the selection criteria listed in paragraphs (b)(1) through 
(b)(5) of this section.
    (3) After FDA has determined that the qualified expert panel meets 
the selection criteria, the requestor must provide to the panel all 
information known by the requestor that is relevant to a determination 
of the target animal safety and the effectiveness of the new animal drug 
at issue. In addition, the requestor must notify FDA of the name of the 
qualified expert panel leader.
    (4) The requestor must immediately notify FDA if it believes a 
qualified expert panel member no longer meets the selection criteria 
listed in paragraph (b) of this section or is otherwise not in 
compliance with the requirements of this section.
    (5) If a qualified expert panel member cannot complete the review 
for which he or she was selected, the requestor must either choose a 
replacement or justify the continued work of the panel in the absence of 
the lost panelist. In either case, the requestor must submit sufficient 
information for FDA to determine whether the proposed revised qualified 
expert panel meets the selection criteria listed in paragraphs (b)(1) 
through (b)(5) of this section.
    (6) The requestor must keep copies of all information provided to, 
or received from, qualified expert panel members, including the written 
report, for 2 years after the completion of the report, or the product 
is added to the index, whichever occurs later, and

[[Page 108]]

make them available to a duly authorized employee of the agency at all 
reasonable times.
    (d) FDA responsibilities. (1) FDA will determine whether the 
requestor's proposed qualified expert panel meets the selection criteria 
listed in paragraph (b) of this section. FDA will expeditiously inform 
the requestor, in writing, of its determination. If FDA determines that 
the qualified expert panel does not meet the selection criteria, FDA 
will provide due notice and an opportunity for an informal conference as 
described in Sec. 516.123. A determination by FDA that a proposed 
qualified expert panel does not meet the selection criteria following an 
informal conference shall constitute final agency action subject to 
judicial review.
    (2) If FDA determines that a qualified expert panel no longer meets 
the selection criteria listed in paragraph (b) of this section or that 
the panel or its members are not in compliance with the requirements of 
this section, the agency will expeditiously inform the requestor, in 
writing, of this determination and provide due notice and an opportunity 
for an informal conference as described in Sec. 516.123. A 
determination by FDA, following an informal conference, that a qualified 
expert panel no longer meets the selection criteria listed in paragraph 
(b) of this section or that the panel or its members are not in 
compliance with the requirements of this section shall constitute final 
agency action subject to judicial review.
    (e) Responsibilities of a qualified expert panel member. A qualified 
expert panel member must do the following:
    (1) Continue to meet all selection criteria described in paragraph 
(b) of this section.
    (2) Act in accordance with generally accepted professional and 
ethical business practices.
    (3) Review all information relevant to a determination of the target 
animal safety and effectiveness of the new animal drug provided by the 
requestor. The panel should also consider all relevant information 
otherwise known by the panel members, including anecdotal information.
    (4) Participate in the preparation of the written report of the 
findings of the qualified expert panel, described in Sec. 516.143.
    (5) Sign, or otherwise approve in writing, the written report. Such 
signature or other written approval will serve as certification that the 
written report meets the requirements of the written report in Sec. 
516.143.
    (6) Provide the information relating to potential conflict of 
interest described in paragraph (g) of this section to FDA for its 
consideration. Such information should be submitted directly to the 
Director, OMUMS, when notified by the requestor.
    (7) Immediately notify the requestor and FDA of any change in 
conflict of interest status.
    (8) Certify at the time of submission of the written report that 
there has been no change in conflict of interest status, or identify and 
document to FDA any such change.
    (f) Additional responsibilities of a qualified expert panel leader. 
(1) The qualified expert panel leader must ensure that the activities of 
the panel are performed efficiently and in accordance with generally 
accepted professional and ethical business practices.
    (2) The qualified expert panel leader serves as the principal point 
of contact between representatives of the agency and the panel.
    (3) The qualified expert panel leader is responsible for submitting 
the written report and all notes or minutes relating to panel 
deliberations to the requestor.
    (4) The qualified expert panel leader must maintain a copy of the 
written report and all notes or minutes relating to panel deliberations 
that are submitted to the requestor for 2 years after the report is 
submitted. Such records must be made available to a duly authorized 
employee of the agency for inspection at all reasonable times.
    (g) Prevention of conflicts of interest. (1) For the purposes of 
this subpart, FDA will consider a conflict of interest to be any 
financial or other interest that could impair a person's objectivity in 
serving on the qualified expert panel or could create an unfair 
competitive advantage for a person or organization.

[[Page 109]]

    (2) Factors relevant to whether there is a conflict of interest or 
the appearance of a conflict of interest include whether the qualified 
expert panel member, their spouse, their minor children, their general 
partners, or any organizations in which they serve as an officer, 
director, trustee, general partner or employee:
    (i) Is currently receiving or seeking funding from the requestor 
through a contract or research grant (either directly or indirectly 
through another entity, such as a university).
    (ii) Has any employment, contractual, or other financial arrangement 
with the requestor other than receiving a reasonable fee for serving as 
a member of the qualified expert panel.
    (iii) Has any ownership or financial interest in any drug, drug 
manufacturer, or drug distributor which will benefit from either a 
favorable or unfavorable evaluation or opinion.
    (iv) Has any ownership or financial interest in the new animal drug 
being reviewed by the qualified expert panel.
    (v) Has participated in the design, manufacture, or distribution of 
any drug that will benefit from either a favorable or unfavorable 
opinion of the qualified expert panel.
    (vi) Has provided within 1 year any consultative services regarding 
the new animal drug being reviewed by the qualified expert panel.
    (vii) Has entered into an agreement in which fees charged or 
accepted are contingent upon the panel member making a favorable 
evaluation or opinion.
    (viii) Receives payment for services related to preparing 
information the requestor presents to the qualified expert panel, other 
than for services related to the written report described in Sec. 
516.143.
    (3) To permit FDA to make a decision regarding potential conflict of 
interest, a potential qualified expert panel member must submit to the 
Director, OMUMS, the following information relating to themselves, their 
spouse, their minor children, their general partners, or any 
organizations in which they serve as an officer, director, trustee, 
general partner or employee, regarding the following issues to the 
extent that they are, in any way, relevant to the subject of the review 
of the qualified expert panel:
    (i) Investments (for example, stocks, bonds, retirement plans, 
trusts, partnerships, sector funds, etc.), including for each the 
following: Name of the firm, type of investment, owner (self, spouse, 
etc.), number of shares / current value.
    (ii) Employment (full or part time, current or under negotiation), 
including for each the following: Name of the firm, relationship (self, 
spouse, etc.), position in firm, date employment or negotiation began.
    (iii) Consultant/advisor (current or under negotiation), including 
for each the following: Name of the firm, topic/issue, amount received, 
date initiated.
    (iv) Contracts, grants, Cooperation Research and Development 
Agreement (CRADAs) (current or under negotiation), including for each 
the following: Type of agreement, product under study and indications, 
amount of remuneration (institution/self), time period, sponsor 
(government, firm, institution, individual), role of the person (site 
investigator, principal investigator, co-investigator, partner, no 
involvement, other), awardee.
    (v) Patents/royalties/trademarks, including for each the following: 
Description, name of firm involved, income received.
    (vi) Expert witness (last 12 months or under negotiation), including 
for each the following: For or against, name of firm, issue, amount 
received.
    (vii) Speaking/writing (last 12 months or under negotiation), 
including for each the following: Firm, topic/issue, amount received 
(honorarium/travel), date.
    (viii) Whether the potential qualified expert panel member, their 
spouse, their minor children, their general partners or any 
organizations in which they serve as an officer, director, trustee, 
general partner or employee, have had, at any time in the past, 
involvement of the kind noted in paragraph (g)(3)(i) through (g)(3)(vii) 
of this section with respect to the animal drug that is the subject of 
the qualified expert panel review.
    (ix) Whether there are any other involvements (other kinds of 
relationships) that would give the appearance

[[Page 110]]

of a conflict of interest which have not been described in paragraph 
(g)(3)(i) through (g)(3)(viii) of this section.
    (x) In all cases, a response of ``no,'' ``none,'' or ``not 
applicable'' is satisfactory when there is no relevant information to 
submit.
    (xi) A certification statement signed by the potential qualified 
expert panel member to the effect that all information submitted is true 
and complete to the best of their knowledge, that they have read and 
understood their obligations as an expert panel member, and that they 
will notify FDA and the requestor of any change in their conflict of 
interest status.
    (4) The fact that a qualified expert panel member receives a 
reasonable fee for services as a member of the qualified expert panel, 
provided that the fee is no more than commensurate with the value of the 
time that the member devotes to the review process, does not constitute 
a conflict of interest or the appearance of a conflict of interest.



Sec. 516.143  Written report.

    The written report required in Sec. 516.145(b)(3) shall:
    (a) Be written in English by a qualified expert panel meeting the 
requirements of Sec. 516.141;
    (b) Describe the panel's evaluation of all available target animal 
safety and effectiveness information relevant to the proposed use of the 
new animal drug, including anecdotal information;
    (c) For all information considered, including anecdotal information, 
include either a citation to published literature or a summary of the 
information;
    (d) State the panel's opinion regarding whether the benefits of 
using the new animal drug for the proposed use in a minor species 
outweigh its risks to the target animal, taking into account the harm 
being caused by the absence of an approved or conditionally-approved new 
animal drug for the minor species in question;
    (e) Be signed, or otherwise approved in writing, by all panel 
members, in accordance with Sec. 516.141; and
    (f) If the panel unanimously concludes that the benefits of using 
the new animal drug for the proposed use in a minor species outweigh its 
risks to the target animal, taking into account the harm being caused by 
the absence of an approved or conditionally-approved new animal drug for 
the minor species in question, the written report shall:
    (1) Provide draft labeling that includes all conditions of use and 
limitations of use of the new animal drug deemed necessary by the panel 
to assure that the benefits of use of the new animal drug outweigh the 
risks, or provide narrative information from which such labeling can be 
written by the requestor; and
    (2) Include a recommendation regarding whether the new animal drug 
should be limited to use under the professional supervision of a 
licensed veterinarian.



Sec. 516.145  Content and format of a request for addition to the index.

    (a) A requestor may request addition of a new animal drug to the 
index only after the new animal drug has been granted eligibility for 
indexing.
    (b) A requestor shall submit two copies of a dated request signed by 
the authorized contact for addition of a new animal drug to the index 
that contains the following:
    (1) A copy of FDA's determination of eligibility issued under Sec. 
516.137;
    (2) A copy of FDA's written determination that the proposed 
qualified expert panel meets the selection criteria provided for in 
Sec. 516.141(b);
    (3) A written report that meets the requirements of Sec. 516.143;
    (4) A proposed index entry that contains the information described 
in Sec. 516.157;
    (5) Proposed labeling, including representative labeling proposed to 
be used for Type B and Type C medicated feeds if the drug is intended 
for use in the manufacture of medicated feeds;
    (6) Anticipated annual distribution of the new animal drug, in terms 
of the total quantity of active ingredient, after indexing;
    (7) A written commitment to manufacture the new animal drug and 
animal feeds bearing or containing such new animal drug according to 
current good manufacturing practices;

[[Page 111]]

    (8) A written commitment to label, distribute, and promote the new 
animal drug only in accordance with the index entry;
    (9) The name and address of the contact person or permanent-resident 
U.S. agent; and
    (10) A draft Freedom of Information summary which includes the 
following information:
    (i) A general information section that contains the name and address 
of the requestor and a description of the drug, route of administration, 
indications, and recommended dosage.
    (ii) A list of the names and affiliations of the members of the 
qualified expert panel, not including their addresses or other contact 
information.
    (iii) A summary of the findings of the qualified expert panel 
concerning the target animal safety and effectiveness of the drug.
    (iv) Citations of all publicly-available literature considered by 
the qualified expert panel.
    (v) For an early life stage of a food-producing minor species 
animal, a human food safety summary.
    (c) Upon specific request by FDA, the requestor shall submit the 
information described in Sec. 516.141 that it submitted to the 
qualified expert panel. Any such information not in English should be 
accompanied by an English translation.



Sec. 516.147  Refuse to file a request for addition to the index.

    (a) If a request for addition to the index contains all of the 
information required by Sec. 516.145(b), FDA shall file it, and the 
filing date shall be the date FDA receives the request.
    (b) If a request for addition to the index lacks any of the 
information required by Sec. 516.145, FDA will not file it, but will 
inform the requestor in writing within 30 days of receiving the request 
as to what information is lacking.



Sec. 516.149  Denying a request for addition to the index.

    (a) FDA will deny a request for addition to the index if it finds 
the following:
    (1) The same drug in the same dosage form for the same intended use 
is already approved or conditionally approved;
    (2) On the basis of new information, the new animal drug no longer 
meets the conditions for eligibility for indexing;
    (3) The request for indexing fails to contain information required 
under the provisions of Sec. 516.145;
    (4) The qualified expert panel fails to meet any of the selection 
criteria listed in Sec. 516.141(b);
    (5) The written report of the qualified expert panel and other 
information available to FDA is insufficient to permit FDA to determine 
that the benefits of using the new animal drug for the proposed use in a 
minor species outweigh its risks to the target animal, taking into 
account the harm caused by the absence of an approved or conditionally-
approved new animal drug for the minor species in question;
    (6) On the basis of the report of the qualified expert panel and 
other information available to FDA, the benefits of using the new animal 
drug for the proposed use in a minor species do not outweigh its risks 
to the target animal, taking into account the harm caused by the absence 
of an approved or conditionally-approved new animal drug for the minor 
species in question; or
    (7) The request contains any untrue statement of a material fact or 
omits material information.
    (b) When a request for addition to the index is denied, FDA will 
notify the requestor in accordance with Sec. 516.153.



Sec. 516.151  Granting a request for addition to the index.

    (a) FDA will grant the request for addition of a new animal drug to 
the index if none of the reasons described in Sec. 516.149 for denying 
such a request applies.
    (b) When a request for addition of a new animal drug to the index is 
granted, FDA will notify the requestor in accordance with Sec. 516.153.



Sec. 516.153  Notification of decision regarding index listing.

    (a) Within 180 days after the filing of a request for addition of a 
new animal drug to the index, FDA shall grant or

[[Page 112]]

deny the request and notify the requestor of FDA's decision in writing.
    (b) If FDA denies the request for addition of a new animal drug to 
the index, FDA shall provide due notice and an opportunity for an 
informal conference as described in Sec. 516.123. A decision of FDA to 
deny a request to index a new animal drug following an informal 
conference shall constitute final agency action subject to judicial 
review.



Sec. 516.155  Labeling of indexed drugs.

    (a) The labeling of an indexed drug that is found to be eligible for 
indexing under Sec. 516.129(c)(7)(i) shall state, prominently and 
conspicuously: ``NOT APPROVED BY FDA.--Legally marketed as an FDA 
indexed product. Extra-label use is prohibited.'' ``This product is not 
to be used in animals intended for use as food for humans or other 
animals.''
    (b) The labeling of an indexed drug that was found to be eligible 
for indexing for use in an early, non-food life stage of a food-
producing minor species animal, under Sec. 516.129(c)(7)(ii), shall 
state, prominently and conspicuously: ``NOT APPROVED BY FDA.--Legally 
marketed as an FDA indexed product. Extra-label use is prohibited.''
    (c) The labeling of an indexed drug shall contain such other 
information as may be prescribed in the index listing.



Sec. 516.157  Publication of the index and content of an index listing.

    (a) FDA will make the list of indexed drugs available through the 
FDA Web site. A printed copy can be obtained by writing to the FDA 
Freedom of Information Staff or by visiting the FDA Freedom of 
Information Public Reading Room.
    (b) The list will contain the following information for each indexed 
drug:
    (1) The name and address of the person who holds the index listing;
    (2) The name of the drug and the intended use and conditions of use 
for which it is indexed;
    (3) Product labeling; and
    (4) Conditions and any limitations that FDA deems necessary 
regarding use of the drug.



Sec. 516.161  Modifications to indexed drugs.

    (a) After a drug is listed in the index, certain modifications to 
the index listing may be requested. Any modification of an index listing 
may not cause an indexed drug to be a different drug (or different 
combination of drugs) or a different dosage form. If such modification 
is requested, FDA will notify the holder that a new index listing is 
required for the new drug or dosage form.
    (b) Modifications to the indexed drug will fall under one of three 
categories and must be submitted as follows:
    (1) Urgent changes. (i) The following modifications to an indexed 
drug or its labeling should be made as soon as possible, and a request 
to modify the indexed drug should be concurrently submitted:
    (A) The addition to package labeling, promotional labeling, or 
prescription drug advertising of additional warning, contraindication, 
side effect, or cautionary information.
    (B) The deletion from package labeling, promotional labeling, and 
drug advertising of false, misleading, or unsupported indications for 
use or claims for effectiveness.
    (C) Changes in manufacturing methods or controls required to correct 
product or manufacturing defects that may result in serious adverse drug 
events.
    (ii) The modifications described in paragraph (b)(1)(i) of this 
section must be submitted to the Director, OMUMS, in the form of a 
request for modification of an indexed drug, and must contain sufficient 
information to permit FDA to determine the need for the modification and 
whether the modification appropriately addresses the need.
    (iii) FDA will take no action against an indexed drug or index 
holder solely because modifications of the kinds described in paragraph 
(b)(1)(i) of this section are placed into effect by the holder prior to 
receipt of a written notice granting the request if all the following 
conditions are met:
    (A) A request to modify the indexed drug providing a full 
explanation of the basis for the modifications has been submitted, 
plainly marked on the mailing cover and on the request as follows:

[[Page 113]]

``Special indexing request-- modifications being effected;''
    (B) The holder specifically informs FDA of the date on which such 
modifications are to be effected and submits two printed copies of any 
revised labeling to be placed in use, and
    (C) All promotional labeling and all drug advertising are promptly 
revised consistent with modifications made in the labeling on or within 
the indexed drug package.
    (2) Significant changes. (i) The following modifications to an 
indexed drug or its labeling may be made only after a request has been 
submitted to and subsequently granted by FDA:
    (A) Addition of an intended use.
    (B) Addition of a species.
    (C) Addition or alteration of an active ingredient.
    (D) Alteration of the concentration of an active ingredient.
    (E) Alteration of dose or dosage regimen.
    (F) Alteration of prescription or over-the-counter status.
    (ii) Each modification described in paragraph (b)(2)(i) of this 
section must go through the same review process as an original index 
listing and is subject to the same standards for review.
    (iii) Each submission of a request for a modification described in 
paragraph (b)(2)(i) of this section should contain only one type of 
modification unless one modification is actually necessitated by 
another, such as a modification of dose necessitated by a modification 
of the concentration of an active ingredient. Submissions relating to 
addition of an intended use for an existing species or addition of a 
species should be submitted separately, but each such submission may 
include multiple additional intended uses and/or multiple additional 
species.
    (3) Minor changes. All modifications other than those described in 
paragraphs (b)(1) and (b)(2) of this section including, but not limited 
to, formulation, labeling, and manufacturing methods and controls (at 
the same level of detail that these were described in the request for 
determination of eligibility for indexing) must be submitted as part of 
the annual indexed drug experience report or as otherwise required by 
Sec. 516.165.
    (c) When changes affect the index listing, it will be updated 
accordingly.



Sec. 516.163  Change in ownership of an index file.

    (a) A holder may transfer ownership of a drug's index file to 
another person.
    (1) The former owner shall submit in writing to FDA a statement that 
all rights in the index file have been transferred, giving the name and 
address of the new owner and the date of the transfer. The former owner 
shall also certify that a complete copy of the following, to the extent 
that they exist at the time of the transfer of ownership, has been 
provided to the new owner:
    (i) The request for determination of eligibility;
    (ii) The request for addition to the index;
    (iii) Any modifications to the index listing;
    (iv) Any records and reports under Sec. 516.165; and
    (v) All correspondence with FDA relevant to the indexed drug and its 
index listing.
    (2) The new owner shall submit the following information in writing 
to FDA:
    (i) The date that the change in ownership is effective;
    (ii) A statement that the new owner has a complete copy of all 
documents listed in paragraph (a)(1) of this section to the extent that 
they exist at the time of the transfer of ownership;
    (iii) A statement that the new owner understands and accepts the 
responsibilities of a holder of an indexed drug;
    (iv) The name and address of a new primary contact person or 
permanent-resident U.S. agent; and
    (v) A list of labeling changes associated with the change of 
ownership (e.g., a new trade name) as draft labeling, with complete 
final printed labeling to be submitted in the indexed drug annual report 
in accordance with Sec. Sec. 516.161 and 516.165.
    (b) Upon receiving the necessary information to support a change of 
ownership of a drug's index file, FDA will update its publicly-available 
listing in accordance with Sec. 516.157.

[[Page 114]]



Sec. 516.165  Records and reports.

    (a) Scope and purpose. (1) The recordkeeping and reporting 
requirements of this section apply to all holders of indexed drugs, 
including indexed drugs intended for use in medicated feeds.
    (2) A holder is not required to report information under this 
section if the holder has reported the same information under Sec. 
514.80 of this chapter.
    (3) The records and reports referred to in this section are in 
addition to those required by the current good manufacturing practice 
regulations in parts 211, 225, and 226 of this chapter.
    (4) FDA will review the records and reports required in this section 
to determine, or facilitate a determination, whether there may be 
grounds for removing a drug from the index under section 572(f) of the 
act.
    (b) Recordkeeping requirements. (1) Each holder of an indexed drug 
must establish and maintain complete files containing full records of 
all information pertinent to the safety or effectiveness of the indexed 
drug. Such records must include information from foreign and domestic 
sources.
    (2) The holder must, upon request from any authorized FDA officer or 
employee, at all reasonable times, permit such officer or employee to 
have access to copy and to verify all such records.
    (c) Reporting requirements. (1) Three-day indexed drug field alert 
report. The holder must inform the appropriate FDA District Office or 
local FDA resident post of any product or manufacturing defects that may 
result in serious adverse drug events within 3 working days of first 
becoming aware that such a defect may exist. The holder may initially 
provide this information by telephone or other electronic communication 
means, with prompt written followup. The mailing cover must be plainly 
marked ``3-Day Indexed Drug Field Alert Report.''
    (2) Fifteen-day indexed drug alert report. The holder must submit a 
report on each serious, unexpected adverse drug event, regardless of the 
source of the information. The holder must submit the report within 15 
working days of first receiving the information. The mailing cover must 
be plainly marked ``15-Day Indexed Drug Alert Report.''
    (3) Annual indexed drug experience report. The holder must submit 
this report every year on the anniversary date of the letter granting 
the request for addition of the new animal drug to the index, or within 
60 days thereafter. The report must contain data and information for the 
full reporting period. Any previously submitted information contained in 
the report must be identified as such. The holder may ask FDA to change 
the date of submission and, after approval of such request, file such 
reports by the new filing date. The report must contain the following:
    (i) The number of distributed units of each size, strength, or 
potency (e.g., 100,000 bottles of 100 5-milligram tablets; 50,000 10-
milliliter vials of 5- percent solution) distributed during the 
reporting period. This information must be presented in two categories: 
Quantities distributed domestically and quantities exported. This 
information must include any distributor-labeled product.
    (ii) If the labeling has changed since the last report, include a 
summary of those changes and the holder's and distributor's current 
package labeling, including any package inserts. For large-size package 
labeling or large shipping cartons, submit a representative copy (e.g., 
a photocopy of pertinent areas of large feed bags). If the labeling has 
not changed since the last report, include a statement of such fact.
    (iii) A summary of any changes made during the reporting period in 
the methods used in, and facilities and controls used for, manufacture, 
processing, and packing. This information must be presented in the same 
level of detail that it was presented in the request for determination 
of eligibility for indexing. Do not include changes that have already 
been submitted under Sec. 516.161.
    (iv) Nonclinical laboratory studies and clinical data not previously 
reported under this section.
    (v) Adverse drug experiences not previously reported under this 
section.
    (vi) Any other information pertinent to safety or effectiveness of 
the indexed drug not previously reported under this section.
    (4) Distributor's statement. At the time of initial distribution of 
an indexed drug by a distributor, the holder must

[[Page 115]]

submit a report containing the following:
    (i) The distributor's current product labeling. This must be 
identical to that in the index listing except for a different and 
suitable proprietary name (if used) and the name and address of the 
distributor. The name and address of the distributor must be preceded by 
an appropriate qualifying phrase such as ``manufactured for'' or 
``distributed by.''
    (ii) A signed statement by the distributor stating:
    (A) The category of the distributor's operations (e.g., wholesale or 
retail);
    (B) That the distributor will distribute the drug only under the 
indexed drug labeling;
    (C) That the distributor will promote the indexed drug only for use 
under the conditions stated in the index listing; and
    (D) If the indexed drug is a prescription new animal drug, that the 
distributor is regularly and lawfully engaged in the distribution or 
dispensing of prescription products.
    (5) Other reporting. FDA may by order require that a holder submit 
information in addition to that required by this section or that the 
holder submit the same information but at different times or reporting 
periods.



Sec. 516.167  Removal from the index.

    (a) After due notice to the holder of the index listing and an 
opportunity for an informal conference as described in Sec. 516.123, 
FDA shall remove a new animal drug from the index if FDA finds that:
    (1) The same drug in the same dosage form for the same intended use 
has been approved or conditionally approved;
    (2) The expert panel failed to meet the requirements in Sec. 
516.141;
    (3) On the basis of new information before FDA, evaluated together 
with the evidence available to FDA when the new animal drug was listed 
in the index, the benefits of using the new animal drug for the indexed 
use do not outweigh its risks to the target animal, taking into account 
the harm caused by the absence of an approved or conditionally-approved 
new animal drug for the minor species in question;
    (4) Any of the conditions in Sec. 516.133(a)(2), (5), or (6) are 
present;
    (5) The manufacture of the new animal drug is not in accordance with 
current good manufacturing practices;
    (6) The labeling, distribution, or promotion of the new animal drug 
is not in accordance with the index listing;
    (7) The conditions and limitations of use associated with the index 
listing have not been followed; or
    (8) Any information used to support the request for addition to the 
index contains any untrue statement of material fact.
    (b) The agency may partially remove an indexing listing if, in the 
opinion of the agency, such partial removal would satisfactorily resolve 
a safety or effectiveness issue otherwise warranting removal of the 
listing under section 572(f)(1)(B) of the act.
    (c) FDA may immediately suspend a new animal drug from the index if 
FDA determines that there is a reasonable probability that the use of 
the drug would present a risk to the health of humans or other animals. 
The agency will subsequently provide due notice and an opportunity for 
an informal conference as described in Sec. 516.123.
    (d) A decision of FDA to remove a new animal drug from the index 
following an informal conference, if any, shall constitute final agency 
action subject to judicial review.



Sec. 516.171  Confidentiality of data and information in an index file.

    (a) For purposes of this section, the index file includes all data 
and information submitted to or incorporated by reference into the index 
file, such as data and information related to investigational use 
exemptions under Sec. 516.125, requests for determination of 
eligibility for indexing, requests for addition to the index, 
modifications to indexed drugs, changes in ownership, reports submitted 
under Sec. 516.165, and master files. The availability for public 
disclosure of any record in the index file shall be handled in 
accordance with the provisions of this section.
    (b) The existence of an index file will not be disclosed by FDA 
before an index listing has been made public by

[[Page 116]]

FDA, unless it has previously been publicly disclosed or acknowledged by 
the requestor.
    (c) If the existence of an index file has not been publicly 
disclosed or acknowledged, no data or information in the index file are 
available for public disclosure.
    (d) If the existence of an index file has been publicly disclosed or 
acknowledged before an index listing has been made public by FDA, no 
data or information contained in the file will be available for public 
disclosure before such index listing is made public, but the agency may, 
at its discretion, disclose a brief summary of such selected portions of 
the safety and effectiveness data as are appropriate for public 
consideration of a specific pending issue, e.g., at an open session of a 
Food and Drug Administration advisory committee or pursuant to an 
exchange of important regulatory information with a foreign government.
    (e) After FDA sends a written notice to the requestor granting a 
request for addition to the index, the following data and information in 
the index file are available for public disclosure unless extraordinary 
circumstances are shown:
    (1) All safety and effectiveness data and information previously 
disclosed to the public, as defined in Sec. 20.81 of this chapter.
    (2) A summary or summaries of the safety and effectiveness data and 
information submitted with or incorporated by reference in the index 
file. Such summaries do not constitute the full information described 
under section 572(c) and (d) of the act on which the safety or 
effectiveness of the drug may be determined. Such summaries will be 
based on the draft Freedom of Information summary submitted under Sec. 
516.145, which will be reviewed and, where appropriate, revised by FDA.
    (3) A protocol for a test or study, unless it is shown to fall 
within the exemption established for trade secrets and confidential 
commercial information in Sec. 20.61 of this chapter.
    (4) Adverse reaction reports, product experience reports, consumer 
complaints, and other similar data and information, after deletion of 
the following:
    (i) Names and any information that would identify the person using 
the product.
    (ii) Names and any information that would identify any third party 
involved with the report, such as a veterinarian.
    (5) A list of all active ingredients and any inactive ingredients 
previously disclosed to the public as defined in Sec. 20.81 of this 
chapter.
    (6) An assay method or other analytical method, unless it serves no 
regulatory or compliance purpose and is shown to fall within the 
exemption established in Sec. 20.61 of this chapter.
    (7) All correspondence and written summaries of oral discussions 
relating to the index file, in accordance with the provisions of part 20 
of this chapter.
    (f) The following data and information in an index file are not 
available for public disclosure unless they have been previously 
disclosed to the public as defined in Sec. 20.81 of this chapter, or 
they relate to a product or ingredient that has been abandoned and they 
no longer represent a trade secret or confidential commercial or 
financial information as defined in Sec. 20.61 of this chapter:
    (1) Manufacturing methods or processes, including quality control 
procedures.
    (2) Production, sales, distribution, and similar data and 
information, except that any compilation of such data and information 
aggregated and prepared in a way that does not reveal data or 
information which is not available for public disclosure under this 
provision is available for public disclosure.
    (3) Quantitative or semiquantitative formulas.
    (g) Subject to the disclosure provisions of this section, the agency 
shall regard the contents of an index file as confidential information 
unless specifically notified in writing by the holder of the right to 
disclose, to reference, or otherwise utilize such information on behalf 
of another named person.
    (h) For purposes of this regulation, safety and effectiveness data 
include all studies and tests of an animal drug on animals and all 
studies and tests on the animal drug for identity, stability, purity, 
potency, and bioavailability.

[[Page 117]]

    (i) Safety and effectiveness data and information that have not been 
previously disclosed to the public are available for public disclosure 
at the time any of the following events occurs unless extraordinary 
circumstances are shown:
    (1) No work is being or will be undertaken to have the drug indexed 
in accordance with the request.
    (2) A final determination is made that the drug cannot be indexed 
and all legal appeals have been exhausted.
    (3) The drug has been removed from the index and all legal appeals 
have been exhausted.
    (4) A final determination has been made that the animal drug is not 
a new animal drug.

Subpart D [Reserved]



 Subpart E_Conditionally Appr. New Animal Drugs For Minor Use and Minor 
                                 Species

    Source: 72 FR 57200, Oct. 9, 2007, unless otherwise noted.



Sec. 516.1215  Florfenicol.

    (a) Specifications. Type A medicated article containing 500 grams 
(g) florfenicol per kilogram.
    (b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
    (c) Special considerations. Labeling shall bear the following: 
``Conditionally approved by FDA pending a full demonstration of 
effectiveness under application number 141-259. Extra-label use of this 
drug in or on animal feed is strictly prohibited.''
    (d) Related tolerances. See Sec. 556.283 of this chapter.
    (e) Conditions of use--(1) Catfish--(i) Amount. Feed 182 to 1816 g 
florfenicol per ton of feed as a sole ration for 10 consecutive days to 
deliver 10 milligrams florfenicol per kilogram of fish.
    (ii) Indications for use. For the control of mortality due to 
columnaris disease associated with Flavobacterium columnare.
    (iii) Limitations. Feed containing florfenicol shall not be fed to 
catfish for more than 10 days. Following administration, fish should be 
reevaluated by a licensed veterinarian before initiating a further 
course of therapy. A dose-related decrease in hematopoietic/
lymphopoietic tissue may occur. The time required for hematopoietic/
lymphopoietic tissues to regenerate was not evaluated. The effects of 
florfenicol on reproductive performance have not been determined. Feeds 
containing florfenicol must be withdrawn 12 days prior to slaughter. 
Federal law limits this drug to use under the professional supervision 
of a licensed veterinarian. The expiration date of veterinary feed 
directives (VFDs) for florfenicol must not exceed 15 days from the date 
of prescribing. VFDs for florfenicol shall not be refilled. See Sec. 
558.6 of this chapter for additional requirements.
    (2) [Reserved]



PART 520_ORAL DOSAGE FORM NEW ANIMAL DRUGS--Table of Contents




Sec.
520.23 Acepromazine maleate tablets.
520.44 Acetazolamide sodium soluble powder.
520.45 Albendazole oral dosage forms.
520.45a Albendazole suspension.
520.45b Albendazole paste.
520.48 Altrenogest.
520.62 Aminopentamide hydrogen sulphate tablets.
520.82 Aminopropazine fumarate oral dosage forms.
520.82a Aminopropazine fumarate tablets.
520.82b Aminopropazine fumarate, neomycin sulfate tablets.
520.88 Amoxicillin oral dosage forms.
520.88a Amoxicillin trihydrate film-coated tablets.
520.88b Amoxicillin trihydrate for oral suspension.
520.88c Amoxicillin trihydrate oral suspension.
520.88d Amoxicillin trihydrate soluble powder.
520.88e Amoxicillin trihydrate boluses.
520.88f Amoxicillin trihydrate tablets.
520.88g Amoxicillin trihydrate and clavulanate potassium film-coated 
          tablets.
520.88h Amoxicillin trihydrate and clavulanate potassium for oral 
          suspension.
520.90 Ampicillin oral dosage forms.
520.90a Ampicillin capsules.
520.90b Ampicillin trihydrate tablets.
520.90c Ampicillin trihydrate capsules.

[[Page 118]]

520.90d Ampicillin trihydrate for oral suspension.
520.90e Ampicillin trihydrate soluble powder.
520.90f Ampicillin trihydrate boluses.
520.100 Amprolium.
520.110 Apramycin sulfate soluble powder.
520.154 Bacitracin oral dosage forms.
520.154a Soluble bacitracin methylene disalicylate.
520.154b Bacitracin methylene disalicylate and streptomycin sulfate 
          powder.
520.154c Bacitracin zinc soluble powder.
520.182 Bicyclohexylammonium fumagillin.
520.222 Bunamidine hydrochloride.
520.246 Butorphanol tartrate tablets.
520.260 n-Butyl chloride capsules.
520.300 Cambendazole oral dosage forms.
520.300a Cambendazole suspension.
520.300b Cambendazole pellets.
520.300c Cambendazole paste.
520.309 Carprofen.
520.310 Caramiphen ethanedisulfonate and ammonium chloride tablets.
520.312 Carnidazole tablets.
520.314 Cefadroxil tablets.
520.315 Cefadroxil powder for oral suspension.
520.370 Cefpodoxime tablets.
520.390 Chloramphenicol oral dosage forms.
520.390a Chloramphenicol tablets.
520.390b Chloramphenicol capsules.
520.390c Chloramphenicol palmitate oral suspension.
520.420 Chlorothiazide tablets and boluses.
520.434 Chlorphenesin carbamate tablets.
520.445 Chlortetracycline oral dosage forms.
520.445a Chlortetracycline bisulfate/sulfamethazine bisulfate soluble 
          powder.
520.445b Chlortetracycline powder.
520.445c Chlortetracycline tablets and boluses.
520.446 Clindamycin capsules and tablets.
520.447 Clindamycin solution.
520.452 Clenbuterol syrup.
520.455 Clomipramine tablets.
520.462 Clorsulon drench.
520.522 Cyclosporine.
520.530 Cythioate oral liquid.
520.531 Cythioate tablets.
520.534 Decoquinate.
520.538 Deracoxib.
520.540 Dexamethasone oral dosage forms.
520.540a Dexamethasone powder.
520.540b Dexamethasone tablets and boluses.
520.540c Dexamethasone chewable tablets.
520.550 Dextrose/glycine/electrolyte.
520.563 Diatrizoate meglumine and diatrizoate sodium oral solution.
520.580 Dichlorophene and toluene capsules.
520.581 Dichlorophene tablets.
520.600 Dichlorvos.
520.606 Diclazuril.
520.608 Dicloxacillin sodium monohydrate capsules.
520.620 Diethylcarbamazine oral dosage forms.
520.622 Diethylcarbamazine citrate oral dosage forms.
520.622a Diethylcarbamazine citrate tablets.
520.622b Diethylcarbamazine citrate syrup.
520.622c Diethylcarbamazine citrate chew- able tablets.
520.622d Diethylcarbamazine citrate capsules.
520.623 Diethylcarbamazine citrate, oxibendazole chewable tablets.
520.645 Difloxacin.
520.666 Dirlotapide.
520.763 Dithiazanine iodide oral dosage forms.
520.763a Dithiazanine iodide tablets.
520.763b Dithiazanine iodide powder.
520.763c Dithiazanine iodide and piperazine citrate suspension.
520.784 Doxylamine succinate tablets.
520.804 Enalapril tablets.
520.812 Enrofloxacin.
520.816 Epsiprantel tablets.
520.823 Erythromycin phosphate.
520.863 Ethylisobutrazine hydrochloride tablets.
520.870 Etodolac.
520.903 Febantel oral dosage forms.
520.903a Febantel paste.
520.903b Febantel suspension.
520.903c [Reserved]
520.903d Febantel-praziquantel paste.
520.903e Febantel tablets.
520.905 Fenbendazole oral dosage forms.
520.905a Fenbendazole suspension.
520.905b Fenbendazole granules.
520.905c Fenbendazole paste.
520.905d Fenbendazole powder.
520.905e Fenbendazole blocks.
520.928 Firocoxib tablets.
520.930 Firocoxib paste.
520.955 Florfenicol.
520.960 Flumethasone tablets.
520.970 Flunixin oral dosage forms.
520.970a Flunixin meglumine granules.
520.970b Flunixin meglumine paste.
520.980 Fluoxetine.
520.1010 Furosemide.
520.1044 Gentamicin sulfate oral dosage forms.
520.1044a Gentamicin sulfate oral solution.
520.1044b Gentamicin sulfate pig pump oral solution.
520.1044c Gentamicin sulfate soluble powder.
520.1100 Griseofulvin.
520.1120 Haloxon oral dosage forms.
520.1120a Haloxon drench.
520.1120b Haloxon boluses.
520.1130 Hetacillin oral dosage forms.
520.1130a Hetacillin potassium capsules.
520.1130b Hetacillin potassium oral suspension.
520.1130c Hetacillin potassium tablets.
520.1157 Iodinated casein tablets.
520.1158 Iodochlorhydroxyquin boluses.

[[Page 119]]

520.1182 Iron dextran suspension.
520.1192 Ivermectin paste.
520.1193 Ivermectin tablets and chewables.
520.1194 Ivermectin meal.
520.1195 Ivermectin liquid.
520.1196 Ivermectin and pyrantel pamoate chewable tablets.
520.1197 Ivermectin sustained-release bolus.
520.1198 Ivermectin and praziquantel paste.
520.1199 Ivermectin, pyrantel, and praziquantel tablets.
520.1204 Kanamycin, bismuth subcarbonate, activated attapulgite.
520.1242 Levamisole hydrochloride oral dosage forms.
520.1242a Levamisole powder for oral solution.
520.1242b Levamisole hydrochloride tablet or oblet (bolus).
520.1242c Levamisole hydrochloride and piperazine dihydrochloride.
520.1242d Levamisole resinate.
520.1242e Levamisole hydrochloride effervescent tablets.
520.1242f Levamisole hydrochloride gel.
520.1242g Levamisole resinate and famphur paste.
520.1263 Lincomycin hydrochloride monohydrate oral dosage forms.
520.1263a Lincomycin hydrochloride monohydrate tablets and sirup.
520.1263b [Reserved]
520.1263c Lincomycin hydrochloride soluble powder.
520.1265 Lincomycin and spectinomycin powder.
520.1284 Sodium liothyronine tablets.
520.1288 Lufenuron tablets.
520.1289 Lufenuron suspension.
520.1310 Marbofloxacin tablets.
520.1315 Maropitant.
520.1320 Mebendazole oral.
520.1326 Mebendazole and trichlorfon oral dosage forms.
520.1326a Mebendazole and trichlorfon powder.
520.1326b Mebendazole and trichlorfon paste.
520.1330 Meclofenamic acid granules.
520.1331 Meclofenamic acid tablets.
520.1341 Megestrol acetate tablets.
520.1350 Meloxicam.
520.1380 Methocarbamol tablets.
520.1390 (S)-methoprene.
520.1408 Methylprednisolone tablets.
520.1409 Methylprednisolone, aspirin tablets.
520.1422 Metoserpate hydrochloride.
520.1430 Mibolerone.
520.1445 Milbemycin oxime tablets.
520.1446 Milbemcyin oxime and lufenuron tablets.
520.1448 Monensin oral dosage forms.
520.1448a Monensin blocks.
520.1450 Morantel tartrate oral dosage forms.
520.1450a Morantel tartrate bolus.
520.1450b Morantel tartrate cartridge.
520.1450c Morantel tartrate sustained-release trilaminate cylinder/
          sheet.
520.1451 Moxidectin tablets.
520.1452 Moxidectin gel.
520.1453 Moxidectin and praziquantel gel.
520.1454 Moxidectin solution.
520.1468 Naproxen granules.
520.1484 Neomycin.
520.1498 Nitazoxanide paste.
520.1510 Nitenpyram tablets.
520.1615 Omeprazole.
520.1616 Orbifloxacin.
520.1628 Oxfendazole powder and pellets.
520.1629 Oxfendazole paste.
520.1630 Oxfendazole suspension.
520.1631 Oxfendazole and trichlorfon paste.
520.1638 Oxibendazole paste.
520.1640 Oxibendazole suspension.
520.1660 Oxytetracycline.
520.1660a Oxytetracycline and carbomycin in combination.
520.1660b Oxytetracycline hydrochloride capsules.
520.1660c Oxytetracycline hydrochloride tablets/boluses.
520.1660d Oxytetracycline powder.
520.1696 Penicillin oral dosage forms.
520.1696a Buffered penicillin powder, penicillin powder with buffered 
          aqueous diluent.
520.1696b Penicillin G potassium in drinking water.
520.1696c Penicillin V potassium for oral solution.
520.1696d Penicillin V potassium tablets.
520.1720 Phenylbutazone oral dosage forms.
520.1720a Phenylbutazone tablets and boluses.
520.1720b Phenylbutazone granules.
520.1720c Phenylbutazone paste.
520.1720d Phenylbutazone gel.
520.1720e Phenylbutazone powder.
520.1780 Pimobendan.
520.1802 Piperazine-carbon disulfide complex oral dosage forms.
520.1802a Piperazine-carbon disulfide complex suspension.
520.1802b Piperazine-carbon disulfide complex boluses.
520.1802c Piperazine-carbon disulfide complex with phenothiazine 
          suspension.
520.1803 Piperazine citrate capsules.
520.1804 Piperazine phosphate capsules.
520.1805 Piperazine phosphate with thenium closylate tablets.
520.1806 Piperazine suspension.
520.1807 Piperazine.
520.1840 Poloxalene.
520.1846 Polyoxyethylene (23) lauryl ether blocks.
520.1855 Ponazuril.
520.1870 Praziquantel tablets.
520.1871 Praziquantel and pyrantel.
520.1872 Praziquantel, pyrantel pamoate, and febantel tablets.
520.1880 Prednisolone tablets.
520.1900 Primidone tablets.

[[Page 120]]

520.1920 Prochlorperazine, isopropamide sustained release capsules.
520.1921 Prochlorperazine, isopropamide, with neomycin sustained-release 
          capsules.
520.1962 Promazine hydrochloride.
520.2002 Propiopromazine hydrochloride.
520.2041 Pyrantel pamoate chewable tablets.
520.2042 Pyrantel pamoate tablets.
520.2043 Pyrantel pamoate suspension.
520.2044 Pyrantel pamoate paste.
520.2045 Pyrantel tartrate powder; pyrantel tartrate pellets.
520.2087 Roxarsone soluble powder.
520.2088 Roxarsone tablets.
520.2089 Roxarsone liquid.
520.2098 Selegiline hydrochloride tablets.
520.2100 Selenium, vitamin E capsules.
520.2123 Spectinomycin oral dosage forms.
520.2123a Spectinomycin tablets.
520.2123b Spectinomycin powder.
520.2123c Spectinomycin solution.
520.2130 Spinosad.
520.2150 Stanozolol oral dosage forms.
520.2150a Stanozolol tablets.
520.2150b Stanozolol chewable tablets.
520.2158 Streptomycin/dihydrostreptomycin oral dosage forms.
520.2158a Streptomycin sulfate oral solution.
520.2158b Dihydrostreptomycin tablets.
520.2158c Dihydrostreptomycin oral suspension.
520.2160 Styrylpyridinium, diethylcarbamazine oral dosage forms.
520.2170 Sulfabromomethazine sodium boluses.
520.2184 Sodium sulfachloropyrazine monohydrate.
520.2200 Sulfachlorpyridazine oral dosage forms.
520.2200a Sulfachlorpyridazine bolus.
520.2200b Sulfachlorpyridazine medicated milk and drinking water.
520.2200c Sulfachlorpyridazine tablets.
520.2215 Sulfadiazine/pyrimethamine suspension.
520.2218 Sulfamerazine, sulfamethazine, and sulfaquinoxaline powder.
520.2220 Sulfadimethoxine oral dosage forms.
520.2220a Sulfadimethoxine oral solution and soluble powder.
520.2220b Sulfadimethoxine tablets and boluses.
520.2220c Sulfadimethoxine oral suspension.
520.2220d Sulfadimethoxine-ormetoprim tablets.
520.2240 Sulfaethoxypyridazine.
520.2240a Sulfaethoxypyridazine drinking water.
520.2240b Sulfaethoxypyridazine tablets.
520.2260 Sulfamethazine oral dosage forms.
520.2260a Sulfamethazine oblet, tablet, and bolus.
520.2260b Sulfamethazine sustained-release boluses.
520.2260c Sulfamethazine sustained-release tablets.
520.2261 Sulfamethazine sodium oral dosage forms.
520.2261a Sulfamethazine sodium drinking water solution.
520.2261b Sulfamethazine powder.
520.2280 Sulfamethizole and methenamine mandelate tablets.
520.2320 Sulfanitran and aklomide in combination.
520.2325 Sulfaquinoxaline oral dosage forms.
520.2325a Sulfaquinoxaline drinking water.
520.2325b Sulfaquinoxaline drench.
520.2330 Sulfisoxazole tablets.
520.2340 Tepoxalin.
520.2345 Tetracycline oral dosage forms.
520.2345a Tetracycline hydrochloride capsules.
520.2345b Tetracycline tablets.
520.2345c Tetracycline boluses.
520.2345d Tetracycline powder.
520.2345e Tetracycline oral liquid.
520.2345f Tetracycline phosphate complex and sodium novobiocin capsules.
520.2345g Tetracycline hydrochloride and sodium novobiocin tablets.
520.2345h Tetracycline hydrochloride, sodium novobiocin, and 
          prednisolone tablets.
520.2362 Thenium closylate tablets.
520.2380 Thiabendazole oral dosage forms.
520.2380a Thiabendazole top dressing and mineral protein block.
520.2380b Thiabendazole drench or oral paste.
520.2380c Thiabendazole bolus.
520.2380d Thiabendazole, piperazine citrate suspension.
520.2380e Thiabendazole with trichlorfon.
520.2380f Thiabendazole, piperazine phosphate powder.
520.2455 Tiamulin.
520.2473 Tioxidazole oral dosage forms.
520.2473a Tioxidazole granules.
520.2473b Tioxidazole paste.
520.2481 Triamcinolone acetonide tablets.
520.2482 Triamcinolone acetonide oral powder.
520.2520 Trichlorfon oral dosage forms.
520.2520b Trichlorfon and atropine.
520.2520e Trichlorofon boluses.
520.2520f Trichlorofon granules.
520.2520g Trichlorfon, phenothiazine, and piperazine dihydrochloride 
          powder.
520.2582 Triflupromazine hydrochloride tablets.
520.2604 Trimeprazine tartrate and prednisolone tablets.
520.2605 Trimeprazine tartrate and prednisolone capsules.
520.2610 Trimethoprim and sulfadiazine tablets.
520.2611 Trimethoprim and sulfadiazine paste.
520.2612 Trimethoprim and sulfadiazine oral suspension.

[[Page 121]]

520.2613 Trimethoprim and sulfadiazine powder.
520.2640 Tylosin.

    Authority: 21 U.S.C. 360b.

    Source: 40 FR 13838, Mar. 27, 1975, unless otherwise noted.



Sec. 520.23  Acepromazine maleate tablets.

    (a) Sponsors. See drug labeler codes in Sec. 510.600(c) of this 
chapter for identification of sponsors as follows:
    (1) For No. 000856, use of 5-, 10-, or 25-milligram tablets as in 
paragraph (b) of this section.
    (2) For No. 000010, use of 10- or 25-milligram tablets as in 
paragraph (c) of this section.
    (b) Conditions of use. It is used in dogs and cats as follows:
    (1) Indications for use. It is used in dogs and cats as a 
tranquilizer.
    (2) Amount. Dogs: 0.25 to 1.0 milligram per pound of body weight; 
Cats: 0.5 to 1.0 milligram per pound of body weight.
    (3) Limitations. The drug is administered orally. Dosage may be 
repeated as required. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (c) Conditions of use. It is used in dogs as follows:
    (1) Indications for use. It is used in dogs as an aid in 
tranquilization and as a preanesthetic agent.
    (2) Amount. Dogs: 0.25 to 1.0 milligram per pound of body weight.
    (3) Limitations. The drug is administered orally. Dosage may be 
repeated as required. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

[46 FR 44443, Sept. 4, 1981, as amended at 49 FR 49091, Dec. 18, 1984; 
52 FR 666, Jan. 8, 1987; 53 FR 40727, Oct. 18, 1988; 56 FR 37473, Aug. 
7, 1991; 62 FR 35075, June 30, 1997]



Sec. 520.44  Acetazolamide sodium soluble powder.

    (a) Specifications. The drug is in a powder form containing 
acetazolamide sodium, USP equivalent to 25 percent acetazolamide 
activity.
    (b) Sponsor. See No. 053501 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use. (1) It is used in dogs as an aid in the 
treatment of mild congestive heart failure and for rapid reduction of 
intraocular pressure.\1\
---------------------------------------------------------------------------

    \1\ These conditions are NAS/NRC reviewed and deemed effective. 
Applications for these uses need not include effectiveness data as 
specified by Sec. 514.111 of this chapter, but may require 
bioequivalency and safety information.
---------------------------------------------------------------------------

    (2) It is administered orally at a dosage level of 5 to 15 
milligrams per pound of body weight daily.\1\
    (3) For use only by or on the order of a licensed veterinarian.\1\

[40 FR 13838, Mar. 27, 1975, as amended at 67 FR 78355, Dec. 24, 2002]



Sec. 520.45  Albendazole oral dosage forms.



Sec. 520.45a  Albendazole suspension.

    (a) Specifications. Each milliliter of suspension contains 45.5 
milligrams (mg) (4.55 percent) or 113.6 mg (11.36 percent) albendazole.
    (b) Sponsor. See No. 000069 in Sec. 510.600 of this chapter.
    (c) Related tolerances. See Sec. 556.34 of this chapter.
    (d) Special considerations. See Sec. 500.25 of this chapter.
    (e) Conditions of use--(1) Cattle. Administer 11.36 percent 
suspension:
    (i) Amount. 4.54 mg/pound (lb) body weight (10 mg/kilogram (kg)) as 
a single oral dose using dosing gun or dosing syringe.
    (ii) Indications for use. For removal and control of adult liver 
flukes (Fasciola hepatica); heads and segments of tapeworms (Moniezia 
benedeni and M. expansa); adult and 4th stage larvae of stomach worms 
(brown stomach worms including 4th stage inhibited larvae (Ostertagia 
ostertagi), barberpole worm (Haemonchus contortus and H. placei), small 
stomach worm (Trichostrongylus axei)); adult and 4th stage larvae of 
intestinal worms (thread-necked intestinal worm (Nematodirus spathiger 
and N. helvetianus), small intestinal worm (Cooperia punctata and C. 
oncophora)); adult stages of intestinal worms (hookworm (Bunostomum 
phlebotomum), bankrupt worm (Trichostrongylus colubriformis), nodular 
worm (Oesophagostomum radiatum)); adult and 4th stage larvae of 
lungworms (Dictyocaulus viviparus).

[[Page 122]]

    (iii) Limitations. Do not slaughter within 27 days of last 
treatment. Do not use in female dairy cattle of breeding age: Do not 
administer to female cattle during first 45 days of pregnancy or for 45 
days after removal of bulls.
    (2) Sheep. Administer 4.45 or 11.36 percent suspension:
    (i) Amount. 3.4 mg/lb body weight (7.5 mg/kg) as a single oral dose 
using dosing gun or dosing syringe.
    (ii) Indications for use. For removal and control of adult liver 
flukes (Fasciola hepatica and Fascioloides magna); heads and segments of 
common tapeworms (Moniezia expansa) and fringed tapeworm (Thysanosoma 
actinioides); adult and fourth stage larvae of stomach worms (brown 
stomach worm (Ostertagia circumcinta and Marshallagia marshalli), 
barberpole worm (Haemonchus contortus), small stomach worm 
(Trichostrongylus axei)); adult and fourth stage larvae of intestinal 
worms (thread-necked intestinal worm (Nematodirus spathiger and N. 
filicollis), Cooper's worm (Cooperia oncophora), bankrupt worm 
(Trichostrongylus colubriformis), nodular worm (Oesophagostomum 
columbianum), and large-mouth bowel worm (Chabertia ovina)); adult and 
larval stages of lungworms (Dictyocaulus filaria).
    (iii) Limitations. Do not slaughter within 7 days of last treatment. 
Do not administer to ewes during first 30 days of pregnancy or for 30 
days after removal of rams.
    (3) Goats. Administer 11.36 percent suspension:
    (i) Amount. 4.54 mg/lb body weight (10 mg/kg) as a single oral dose 
using dosing gun or dosing syringe.
    (ii) Indications for use. For the treatment of adult liver flukes 
(Fasciola hepatica) in nonlactating goats.
    (iii) Limitations. Do not slaughter within 7 days of last treatment. 
Do not administer to does during the first 30 days of pregnancy or for 
30 days after removal of bucks.

[73 FR 11027, Feb. 29, 2008]



Sec. 520.45b  Albendazole paste.

    (a) Specifications. The product contains 30 percent albendazole.
    (b) Sponsor. See No. 000069 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.34 of this chapter.
    (d) Conditions of use in cattle--(1) Amount. Equivalent to 4.54 
milligrams per 1 pound of body weight (10 milligrams per kilogram).
    (2) Indications for use. For removal and control of the following 
internal parasites of cattle: adult liver flukes (Fasciola hepatica); 
heads and segments of tapeworms (Moniezia benedeni, M. expansa); adult 
and 4th stage larvae of stomach worms (brown stomach worms including 4th 
stage inhibited larvae (Ostertagia ostertagi); barberpole worm 
(Haemonchus contortus, H. placei); small stomach worm (Trichostrongylus 
axei)); adult and 4th stages larvae of intestinal worms (thread-necked 
intestinal worm (Nematodirus spathiger, N. helvetianus); small 
intestinal worm (Cooperia punctata and C. oncophora)); adult stages of 
intestinal worms (hookworm (Bunostomum phlebotmum); bankrupt worm 
(Trichostrongylus colubriformis), nodular worm (Oesophagostomum 
radiatum)); adult and 4th stage larvae of lungworms (Dictyocaulus 
viviparus).
    (3) Limitations. Administer as a single oral dose. Do not slaughter 
within 27 days of last treatment. Do not use in female dairy cattle of 
breeding age. Do not administer to female cattle during first 45 days of 
pregnancy or for 45 days after removal of bulls. Consult your 
veterinarian for assistance in the diagnosis, treatment, and control of 
parasitism.

[54 FR 51385, Dec. 15, 1989, as amended at 56 FR 50653, Oct. 8, 1991; 60 
FR 55658, Nov. 2, 1995]



Sec. 520.48  Altrenogest.

    (a) Specifications. Each milliliter (mL) of solution contains 2.2 
milligrams (mg) altrenogest.
    (b) Sponsor. See No. 057926 in Sec. 510.600(c) of this chapter.
    (c) Tolerances. See Sec. 556.36 of this chapter.
    (d) Conditions of use--(1)Horses--(i) Amount. 1.0 mL per 110 pounds 
body weight (0.044 mg/kg) daily for 15 consecutive days.
    (ii) Indications for use. For suppression of estrus in mares.

[[Page 123]]

    (iii) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.
    (2) Swine--(i) Amount. Administer 6.8 mL (15 mg altrenogest) per 
gilt once daily for 14 consecutive days by top-dressing on a portion of 
each gilt's daily feed.
    (ii) Indications for use. For synchronization of estrus in sexually 
mature gilts that have had at least one estrous cycle.
    (iii) Limitations. Do not use in gilts having a previous or current 
history of uterine inflammation (i.e., acute, subacute or chronic 
endometritis). Gilts must not be slaughtered for human consumption for 
21 days after the last treatment.

[66 FR 47960, Sept. 17, 2001, as amended at 68 FR 62006, Oct. 31, 2003; 
72 FR 9455, Feb. 21, 2008]



Sec. 520.62  Aminopentamide hydrogen sulphate tablets.

    (a) Chemical name. 4-(Dimethylamino)-2,2-diphenylvaleramide hydrogen 
sulfate.
    (b) Specifications. Each tablet contains 0.2 milligram of the drug.
    (c) Sponsor. See No. 000856 in Sec. 510.600(c) of this chapter.
    (d) Conditions of use. (1) It is intended for use in dogs and cats 
only for the treatment of vomiting and/or diarrhea, nausea, acute 
abdominal visceral spasm, pylorospasm, or hypertrophic gastritis.

    Note: Not for use in animals with glaucoma because of the occurrence 
of mydriasis.

    (2) Dosage is administered by oral tablet every 8 to 12 hours, as 
follows:

------------------------------------------------------------------------
                                                               Dosage in
                 Weight of animal in pounds                   milligrams
------------------------------------------------------------------------
Up to 10....................................................         0.1
11 to 20....................................................         0.2
21 to 50....................................................         0.3
51 to 100...................................................         0.4
Over 100....................................................         0.5
------------------------------------------------------------------------


Dosage may be gradually increased up to a maximum of five times the 
suggested dosage. Oral administration of tablets may be preceded by 
subcutaneous or intramuscular use of the injectable form of the drug.
    (3) For use only by or on the order of a licensed veterinarian.

[40 FR 13838, Mar. 27, 1975, as amended at 53 FR 27851, July 25, 1988]



Sec. 520.82  Aminopropazine fumarate oral dosage forms.



Sec. 520.82a  Aminopropazine fumarate tablets.

    (a) Specifications. The drug is in tablet form. Each tablet contains 
aminopropazine fumarate equivalent to 25 milligrams of aminopropazine 
base.
    (b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use. (1) The drug is used in dogs and cats for 
reducing excessive smooth muscle contractions, such as occur in urethral 
spasms associated with urolithiasis.\1\
    (2) It is administered at a dosage level of 1 to 2 milligrams per 
pound of body weight. The dosage can be repeated every 12 hours, as 
indicated.\1\
    (3) Not for use in animals intended for food purposes.
    (4) For use only by or on the order of a licensed veterinarian.\1\

[40 FR 13838, Mar. 27, 1975, as amended at 46 FR 48642, Oct. 2, 1981; 61 
FR 8873, Mar. 6, 1996; 62 FR 61624, Nov. 19, 1997]



Sec. 520.82b  Aminopropazine fumarate, neomycin sulfate tablets.

    (a) Specifications. The drug is in tablet form. Each tablet contains 
both aminopropazine fumarate equivalent to 25 milligrams of 
aminopropazine base and neomycin sulfate equivalent to 50 milligrams of 
neomycin base.
    (b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use. (1) The drug is used in dogs to control 
bacterial diarrhea caused by organisms susceptible to neomycin and to 
reduce smooth muscle contractions.\1\
---------------------------------------------------------------------------

    \1\ These conditions are NAS/NRC reviewed and deemed effective. 
Applications for these uses need not include effectiveness data as 
specified by Sec. 514.111 of this chapter, but may require 
bioequivalency and safety information.
---------------------------------------------------------------------------

    (2) It is administered at a dosage level of one to two tablets per 
10 pounds of body weight twice daily for 3 days.\1\

[[Page 124]]

    (3) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.\1\

[40 FR 13838, Mar. 27, 1975, as amended at 46 FR 48642, Oct. 2, 1981; 61 
FR 8873, Mar. 6, 1996; 62 FR 61624, Nov. 19, 1997]



Sec. 520.88  Amoxicillin oral dosage forms.



Sec. 520.88a  Amoxicillin trihydrate film-coated tablets.

    (a) Specifications. Each tablet contains amoxicillin trihydrate 
equivalent to 50, 100, 150, 200, or 400 milligrams of amoxicillin.
    (b) Sponsor. See No. 000069 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Dogs--(i) Amount. 5 milligrams per pound 
of body weight, twice a day.
    (ii) Indications for use. Treatment of infections of the respiratory 
tract (tonsillitis, tracheobronchitis), genitourinary tract (cystitis), 
gastrointestinal tract (bacterial gastroenteritis), and soft tissues 
(abscesses, lacerations, wounds), caused by susceptible strains of 
Staphylococcus aureus, Streptococcus spp., Escherichia coli, Proteus 
mirabilis, and bacterial dermatitis caused by S. aureus, Streptococcus 
spp., and P. mirabilis.
    (iii) Limitations. Administer for 5 to 7 days or 48 hours after all 
symptoms have subsided. If no improvement is seen in 5 days, review 
diagnosis and change therapy. Federal law restricts this drug to use by 
or on the order of a licensed veterinarian.
    (2) Cats--(i) Amount. 50 milligrams (5 to 10 milligrams per pound of 
body weight) once a day.
    (ii) Indications for use. Treatment of infections caused by 
susceptible organisms as follows: upper respiratory tract due to S. 
aureus, Streptococcus spp., and E. coli; genitourinary tract (cystitis) 
due to S. aureus, Streptococcus spp., E. coli, and P. mirabilis; 
gastrointestinal tract due to E. coli; and skin and soft tissue 
(abscesses, lacerations, and wounds) due to S. aureus, Streptococcus 
spp., E. coli, and Pasteurella multocida.
    (iii) Limitations. Administer for 5 to 7 days or 48 hours after all 
symptoms have subsided. If no improvement is seen in 5 days, review 
diagnosis and change therapy. Federal law restricts this drug to use by 
or on the order of a licensed veterinarian.

[57 FR 37319, Aug. 18, 1992, as amended at 60 FR 55658, Nov. 2, 1995]



Sec. 520.88b  Amoxicillin trihydrate for oral suspension.

    (a) Specifications. When reconstituted, each milliliter contains 
amoxicillin trihydrate equivalent to 50 milligrams of amoxicillin.
    (b) Sponsor. See No. 000069 in Sec. 510.600(c) of this chapter.
    (1) Conditions of use--(i) Dogs--(A) Amount. 5 milligrams per pound 
of body weight twice daily.
    (B) Indications for use. Treatment of infections caused by 
susceptible strains of organisms as follows: respiratory tract 
(tonsillitis, tracheobronchitis) caused by Staphylococcus aureus, 
Streptococcus spp., Escherichia coli, and Proteus mirabilis; 
genitourinary tract (cystitis) caused by S. aureus, Streptococcus spp., 
E. coli, and P. mirabilis; gastrointestinal tract (bacterial 
gastroenteritis) caused by S. aureus, Streptococcus spp., E. coli, and 
P. mirabilis; bacterial dermatitis caused by S. aureus, Streptococcus 
spp., and P. mirabilis; and soft tissues (abscesses, lacerations, and 
wounds) caused by S. aureus, Streptococcus spp., E. coli, and P. 
mirabilis.
    (C) Limitations. Use for 5 to 7 days or 48 hours after all symptoms 
have subsided. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.
    (ii) Cats--(A) Amount. 50 milligrams (5 to 10 milligrams per pound) 
once daily.
    (B) Indications for use. Treatment of infections caused by 
susceptible strains of organisms as follows: upper respiratory tract due 
to Staphylococcus spp., Streptococcus spp., Hemophilus spp., E. coli, 
Pasteurella spp., and P. mirabilis; genitourinary tract (cystitis) due 
to S. aureus, Streptococcus spp., E. coli, P. mirabilis, and 
Corynebacterium spp.; gastrointestinal tract due to E. coli, Proteus 
spp., Staphylococcus spp., and Streptococcus spp.; skin and soft tissue 
(abscesses, lacerations, and wounds) due to Staphylococcus spp., 
Streptococcus spp., E. coli, and Pasteurella multocida.

[[Page 125]]

    (C) Limitations. Use for 5 to 7 days or 48 hours after all symptoms 
have subsided. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.
    (2) [Reserved]
    (c) Sponsors. See Nos. 000856 and 051311 in Sec. 510.600(c) of this 
chapter.
    (1) Conditions of use. Dogs--(i) Amount. 5 milligrams per pound of 
body weight twice daily.
    (ii) Indications for use. Treatment of bacterial dermatitis due to 
S. aureus, Streptococcus spp., Staphylococcus spp., and E. coli, and 
soft tissue infections (abscesses, wounds, lacerations) due to S. 
aureus, Streptococcus spp., E. coli, P. mirabilis and Staphylococcus 
spp.
    (iii) Limitations. Use for 5 to 7 days. Continue for 48 hours after 
all symptoms have subsided. If no improvement is seen in 5 days, review 
diagnosis and change therapy. Federal law restricts this drug to use by 
or on the order of a licensed veterinarian.
    (2) [Reserved]

[57 FR 37319, Aug. 18, 1992; 57 FR 42623, Sept. 15, 1992, as amended at 
60 FR 55658, Nov. 2, 1995; 62 FR 13302, Mar. 20, 1997; 67 FR 67521, Nov. 
6, 2002; 68 FR 54658, Sept. 18, 2003; 68 FR 55824, Sept. 29, 2003]



Sec. 520.88c  Amoxicillin trihydrate oral suspension.

    (a) Specifications. Each 0.8-milliliter dose contains amoxicillin 
trihydrate equivalent to 40 milligrams of amoxicillin.
    (b) Sponsor. See No. 000069 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.510 of this chapter.
    (d) Conditions of use. Swine--(1) Amount. 40 milligrams orally, 
twice a day using a dosing pump.
    (2) Indications for use. Treatment of baby pigs under 10 pounds for 
porcine colibacillosis caused by Escherichia coli susceptible to 
amoxicillin.
    (3) Limitations. Treat animals for 48 hours after all symptoms have 
subsided but not beyond 5 days. Do not slaughter during treatment or for 
15 days after latest treatment. Federal law restricts this drug to use 
by or on the order of a licensed veterinarian.

[57 FR 37319, Aug. 18, 1992, as amended at 60 FR 55658, Nov. 2, 1995]



Sec. 520.88d  Amoxicillin trihydrate soluble powder.

    (a) Specifications. Each gram contains amoxicillin trihydrate 
equivalent to 115.4 milligrams of amoxicillin.
    (b) Sponsor. See No. 000069 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.38 of this chapter.
    (d) Conditions of use. Preruminating calves including veal calves--
(1) Amount. 400 milligrams per 100 pounds of body weight twice daily.
    (2) Indications for use. Treatment of bacterial enteritis when due 
to susceptible Escherichia coli in preruminating calves including veal 
calves.
    (3) Limitations. Administer by drench or by mixing in milk. 
Treatment should be continued for 48 hours after all symptoms have 
subsided but not to exceed 5 days. For use in preruminating calves 
including veal calves only, not for use in other animals which are 
raised for food production. Do not slaughter animals during treatment or 
for 20 days after the latest treatment. Federal law restricts this drug 
to use by or on the order of a licensed veterinarian.

[57 FR 37319, Aug. 18, 1992; 57 FR 42623, Sept. 15, 1992; 58 FR 18304, 
Apr. 8, 1993, as amended at 60 FR 55658, Nov. 2, 1995; 62 FR 5525, Feb. 
6, 1997]



Sec. 520.88e  Amoxicillin trihydrate boluses.

    (a) Specifications. Each bolus contains the equivalent of 400 
milligrams of amoxicillin.
    (b) Sponsor. See No. 000069 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.38 of this chapter.
    (d) Conditions of use. Preruminating calves including veal calves--
(1) Amount. 400 milligrams per 100 pounds of body weight twice daily.
    (2) Indications for use. Treatment of bacterial enteritis when due 
to susceptible Escherichia coli in preruminating calves including veal 
calves.
    (3) Limitations. For oral use in preruminating calves including veal 
calves only, not for use in other animals which are raised for food 
production. Treatment should be continued for 48 hours after all 
symptoms have subsided but not to exceed 5 days. Do

[[Page 126]]

not slaughter animals during treatment or for 20 days after the latest 
treatment. Federal law restricts this drug to use by or on the order of 
a licensed veterinarian.

[57 FR 37320, Aug. 18, 1992, as amended at 60 FR 55659, Nov. 2, 1995; 62 
FR 5526, Feb. 6, 1997]



Sec. 520.88f  Amoxicillin trihydrate tablets.

    (a) Specifications. Each tablet contains amoxicillin trihydrate 
equivalent to 50, 100, 200, or 400 milligrams of amoxicillin.
    (b) Sponsors. See Nos. 000856 and 051311 in Sec. 510.600(c) of this 
chapter.
    (c) Conditions of use--(1) Dogs--(i) Amount. 5 milligrams per pound 
of body weight twice a day.
    (ii) Indications for use. Treatment of bacterial dermatitis due to 
Staphylococcus aureus, Streptococcus spp., Staphylococcus spp., and 
Escherichia coli; and soft tissue infections (abscesses, wounds, 
lacerations) due to S. aureus, Streptococcus spp., E. coli, Proteus 
mirabilis, and Staphylococcus spp.
    (iii) Limitations. Use for 5 to 7 days or 48 hours after all 
symptoms have subsided. If no improvement is seen in 5 days, review 
diagnosis and change therapy. Federal law restricts this drug to use by 
or on the order of a licensed veterinarian.
    (2) [Reserved]

[57 FR 37320, Aug. 18, 1992, as amended at 62 FR 13302, Mar. 20, 1997; 
67 FR 67521, Nov. 6, 2002; 68 FR 54658, Sept. 18, 2003; 68 FR 55824, 
Sept. 29, 2003]



Sec. 520.88g  Amoxicillin trihydrate and clavulanate potassium film-coated 

tablets.

    (a) Specifications. Each tablet contains amoxicillin trihydrate and 
clavulanate potassium, equivalent to either 50 milligrams of amoxicillin 
and 12.5 milligrams clavulanic acid, or 100 milligrams of amoxicillin 
and 25 milligrams clavulanic acid, or 200 milligrams amoxicillin and 50 
milligrams clavulanic acid or 300 milligrams amoxicillin and 75 
milligrams clavulanic acid.
    (b) Sponsor. See No. 000069 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Dogs--(i) Amount. 6.25 milligrams 
(equivalent to 5 milligrams amoxicillin and 1.25 milligrams clavulanic 
acid) per pound of body weight twice daily.
    (ii) Indications for use. Treatment of skin and soft tissue 
infections such as wounds, abscesses, cellulitis, superficial/juvenile 
and deep pyoderma due to susceptible strains of beta-lactamase 
(penicillinase) Staphylococcus aureus, nonbeta-lactamase S. aureus, 
Staphylococcus spp., Streptococcus spp., and Escherichia coli. Treatment 
of periodontal infections due to susceptible strains of aerobic and 
anaerobic bacteria.
    (iii) Limitations. Wounds, abscesses, cellulitis, and superficial/
juvenile pyoderma: Treat for 5 to 7 days or for 48 hours after all signs 
have subsided. If no improvement is seen after 5 days of treatment, 
discontinue therapy and reevaluate diagnosis. Deep pyoderma may require 
treatment for 21 days; do not treat for more than 30 days. Not for use 
in dogs maintained for breeding. Federal law restricts this drug to use 
by or on the order of a licensed veterinarian.
    (2) Cats--(i) Amount. 62.5 milligrams (1 milliliter) (50 milligrams 
amoxicillin and 12.5 milligrams clavulanic acid) twice daily.
    (ii) Indications for use. Treatment of skin and soft tissue 
infections, such as wounds, abscesses and cellulitis/dermatitis due to 
susceptible strains of beta-lactamase (penicillinase) producing S. 
aureus, nonbeta-lactamase producing S. aureus, Staphylococcus spp., 
Streptococcus spp., E. coli, and Pasteurella spp. Also, treatment of 
urinary tract infections (cystitis) due to susceptible strains of E. 
coli.
    (iii) Limitations. Skin and soft tissue infections: abscesses, 
cellulitis/dermatitis should be treated for 5 to 7 days or for 48 hours 
after all signs have subsided. If no response is seen after 3 days of 
treatment, therapy should be discontinued and diagnosis reevaluated. 
Urinary tract infections may require treatment for 10 to 14 days or 
longer. The maximum duration of treatment should not exceed 30 days. 
Safety of use in pregnant or breeding animals has

[[Page 127]]

not been established. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

[57 FR 37320, Aug. 18, 1992, as amended at 60 FR 55659, Nov. 2, 1995; 63 
FR 13121, Mar. 18, 1998]



Sec. 520.88h  Amoxicillin trihydrate and clavulanate potassium for oral 

suspension.

    (a) Specifications. When reconstituted, each milliliter contains 
amoxicillin trihydrate equivalent to 50 milligrams of amoxicillin with 
clavulanate potassium equivalent to 12.5 milligrams of clavulanic acid.
    (b) Sponsor. See No. 000069 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Dogs--(i) Amount. 6.25 milligrams 
(equivalent to 5 milligrams amoxicillin and 1.25 milligrams clavulanic 
acid) per pound of body weight twice daily.
    (ii) Indications for use. Treatment of skin and soft tissue 
infections such as wounds, abscesses, cellulitis, superficial/juvenile 
and deep pyoderma due to susceptible strains of beta-lactamase 
(penicillinase) producing Staphylococcus aureus, nonbeta-lactamase 
Staphylococcus aureus, Staphylococcus spp., Streptococcus spp., and 
Escherichia coli. Treatment of periodontal infections due to susceptible 
strains of aerobic and anaerobic bacteria.
    (iii) Limitations. Administer for 5 to 7 days or 48 hours after all 
symptoms subsided. Deep pyoderma may require 21 days, not to exceed 30 
days. If no improvement is seen in 5 days, discontinue therapy and 
reevaluate the case. Not for use in dogs maintained for breeding. 
Federal law restricts this drug to use by or on the order of a licensed 
veterinarian.
    (2) Cats--(i) Amount. 62.5 milligrams (1 milliliter) (50 milligrams 
of amoxicillin and 12.5 milligrams clavulanic acid) twice daily.
    (ii) Indications for use. Treatment of feline skin and soft tissue 
infections, such as wounds, abscesses and cellulitis/dermatitis due to 
susceptible strains of beta-lactamase (penicillinase) producing S. 
aureus, nonbeta-lactamase S. aureus, Staphylococcus spp., Streptococcus 
spp., E. coli, Pasteurella multocida, and Pasteurella spp.
    (iii) Limitations. Administer 48 hours after all symptoms have 
subsided. If no improvement is seen after 3 days of treatment, 
discontinue therapy and reevaluate diagnosis. Maximum duration of 
treatment should not exceed 30 days. Not for use in cats maintained for 
breeding. Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.

[57 FR 37320, Aug. 18, 1992, as amended at 60 FR 55659, Nov. 2, 1995; 63 
FR 13121, Mar. 18, 1998]



Sec. 520.90  Ampicillin oral dosage forms.



Sec. 520.90a  Ampicillin capsules.

    (a) Specifications. Each capsule contains 125 milligrams or 250 
milligrams of ampicillin.
    (b) Sponsor. See No. 000008 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Dogs--(i) Amount. 5 to 10 milligrams per 
pound of body weight, e.g., one 125 mg capsule per 14 to 25 pounds, 
given 2 to 4 times daily; for animals weighing 6 to 14 pounds, one 
capsule twice daily.
    (ii) Indications for use. Treatment of urinary tract infections 
(cystitis) due to Proteus spp., hemolytic and nonhemolytic streptococci, 
beta hemolytic streptococci, and Escherichia coli. In upper respiratory 
tract infections tracheobronchitis (kennel cough), tonsillitis due to 
alpha and beta hemolytic streptococci, hemolytic positive staphylococci, 
E. coli, and Proteus spp. In infections associated with abscesses, 
lacerations, and wounds due to Staphylococcus spp. and Streptococcus 
spp.
    (iii) Limitations. Bacteriologic studies to determine the causative 
organisms and their susceptibility to ampicillin should be performed. 
Use of the drug is contraindicated in animals with a history of an 
allergic reaction to any of the penicillins. Ampicillin is 
contraindicated in infections caused by penicillinase-producing 
organisms. Not for use in animals which are raised for food production. 
Federal law restricts this drug to use by or on the order of a licensed 
veterinarian.
    (2) Cats--(i) Amount. 125 milligrams twice daily; in more acute 
conditions three times daily.

[[Page 128]]

    (ii) Indications for use. Treatment of respiratory tract infections 
(bacterial pneumonia) due to alpha and beta hemolytic streptococci, 
hemolytic positive staphylococci, E. coli, and Proteus spp. In 
infections associated with abscesses, lacerations, and wounds due to 
Staphylococcus spp. and Streptococcus spp.
    (iii) Limitations. Bacteriologic studies to determine the causative 
organisms and their susceptibility to ampicillin should be performed. 
Use of the drug is contraindicated in animals with a history of an 
allergic reaction to any of the penicillins. Ampicillin is 
contraindicated in infections caused by penicillinase-producing 
organisms. Not for use in animals which are raised for food production. 
Federal law restricts this drug to use by or on the order of a licensed 
veterinarian.

[57 FR 37321, Aug. 18, 1992]



Sec. 520.90b  Ampicillin trihydrate tablets.

    (a) Specifications. Each tablet contains ampicillin trihydrate 
equivalent to 50 or 100 milligrams of ampicillin.
    (b) Sponsor. See No. 000069 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use. Dogs--(1) Amount. 5 milligrams per pound of 
body weight, at 8-hour intervals, 1 to 2 hours prior to feeding, to be 
continued 36 to 48 hours after all symptoms have subsided. If no 
improvement is seen within 5 days, stop treatment, reevaluate diagnosis, 
and change therapy.
    (2) Indications for use. Oral treatment of infections caused by 
susceptible organisms as follows: Upper respiratory infections, 
tonsillitis, and bronchitis due to Streptococcus spp., Staphylococcus 
spp., Escherichia coli, Proteus mirabilis, and Pasteurella spp., urinary 
tract infections (cystitis) due to Streptococcus spp., Staphylococcus 
spp., E., coli, P. mirabilis, and Enterococcus spp.; gastrointestinal 
infections due to Staphylococcus spp., Streptococcus spp., Enterococcus 
spp., and E. coli. ; infections associated with abscesses, lacerations, 
and wounds caused by Staphylococcus spp., and Streptococcus spp.
    (3) Limitations. Not for use in animals which have shown 
hypersensitivity to penicillin or for infections caused by 
penicillinase-producing organisms. Not for use in animals which are 
raised for food production. Federal law restricts this drug to use by or 
on the order of a licensed veterinarian.

[57 FR 37321, Aug. 18, 1992, as amended at 60 FR 55659, Nov. 2, 1995]



Sec. 520.90c  Ampicillin trihydrate capsules.

    (a) Specifications. Each capsule contains ampicillin trihydrate 
equivalent to 125, 250, or 500 milligrams of ampicillin.
    (b) Sponsor. See No. 055529 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Dogs--(i) Amount. 5 to 10 milligrams per 
pound of body weight two or three times daily. In severe or acute 
conditions, 10 milligrams per pound of body weight, three times daily. 
Administer 1 to 2 hours prior to feeding.
    (ii) Indications for use. Treatment against strains of gram-negative 
and gram-positive organisms sensitive to ampicillin and associated with 
respiratory tract infections (tracheobronchitis and tonsillitis); 
urinary tract infections (cystitis); bacterial gastroenteritis; 
generalized infections (septicemia) associated with abscesses, 
lacerations, and wounds; and bacterial dermatitis.
    (iii) Limitations. The drug may be given as an emergency measure; 
however, in vitro sensitivity tests on samples collected prior to 
treatment should be made. Ampicillin is contraindicated for use in 
infections caused by penicillinase-producing organisms and for use in 
animals known to be allergic to any of the penicillins. Not for use in 
animals raised for food production. Federal law restricts this drug to 
use by or on the order of a licensed veterinarian.
    (2) Cats--(i) Amount. 10 to 30 milligrams per pound of body weight 
or three times daily. Administer 1 to 2 hours prior to feeding.
    (ii) Indications for use. Treatment against strains of gram-negative 
and gram-positive organisms sensitive to ampicillin and associated with 
respiratory tract infections (bacterial pneumonia); urinary tract 
infections (cystitis); and generalized infections (septicemia) 
associated with abscesses, lacerations, and wounds.

[[Page 129]]

    (iii) Limitations. The drug may be given as an emergency measure; 
however, in vitro sensitivity tests on samples collected prior to 
treatment should be made. Ampicillin is contraindicated for use in 
infections caused by penicillinase-producing organisms and for use in 
animals known to be allergic to any of the penicillins. Not for use in 
animals raised for food production. Federal law restricts this drug to 
use by or on the order of a licensed veterinarian.

[57 FR 37321, Aug. 18, 1992, as amended at 58 FR 61016, Nov. 19, 1993]



Sec. 520.90d  Ampicillin trihydrate for oral suspension.

    (a) Specifications. When reconstituted as directed, each milliliter 
contains ampicillin trihydrate equivalent to 25 milligrams of 
ampicillin.
    (b) Sponsor. See No. 055529 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Dogs--(i) Amount. 5 to 10 milligrams per 
pound of body weight orally, 2 or 3 times daily, 1 to 2 hours prior to 
feeding. In severe or acute conditions, 10 milligrams per pound of body 
weight 3 times daily.
    (ii) Indications for use. Treatment of respiratory tract infections 
(tracheobronchitis and tonsillitis) due to Escherichia coli, Pseudomonas 
spp., Proteus spp., Staphylococcus spp., and Streptococcus spp., urinary 
tract infections (cystitis) due to E. coli, Staphylococcus spp., 
Streptococcus spp., and Proteus spp.; bacterial gastroenteritis due to 
E. coli; generalized infections (septicemia) associated with abscesses, 
lacerations, and wounds, due to Staphylococcus spp. and Streptococcus 
spp.; bacterial dermatitis due to Staphylococcus spp., Streptococcus 
spp., Proteus spp., and Pseudomonas spp.
    (iii) Limitations. Duration of treatment is usually 3 to 5 days. 
Continue treatment 48 hours after the animal's temperature has returned 
to normal and all other signs of infection have subsided. If no response 
is obtained within 3 to 5 days, reevaluate diagnosis and treatment. 
Appropriate laboratory tests should be conducted, including in vitro 
culturing and susceptibility tests on samples collected prior to 
treatment. Federal law restricts this drug to use by or on the order of 
a licensed veterinarian.
    (2) Cats--(i) Amount. 10 to 30 milligrams per pound of body weight 
orally, 2 or 3 times daily, 1 to 2 hours prior to feeding.
    (ii) Indications for use. Treatment of respiratory tract infections 
(bacterial pneumonia) due to Staphylococcus spp., Streptococcus spp., E. 
coli, and Proteus spp.; urinary tract infections (cystitis) due to E. 
coli, Staphylococcus spp., Streptococcus spp., Proteus spp., and 
Corynebacterium spp.; generalized infections (septicemia) associated 
with abscesses, lacerations, and wounds, due to Staphylococcus spp., 
Streptococcus spp., Bacillus spp., and Pasteurella spp.
    (iii) Limitations. Duration of treatment is usually 3 to 5 days. 
Continue treatment 48 hours after the animal's temperature has returned 
to normal and all other signs of infection have subsided. If no response 
is obtained within 3 to 5 days, reevaluate diagnosis and treatment. 
Appropriate laboratory tests should be conducted, including in vitro 
culturing and susceptibility tests on samples collected prior to 
treatment. Federal law restricts this drug to use by or on the order of 
a licensed veterinarian.

[57 FR 37321, Aug. 18, 1992, as amended at 58 FR 61016, Nov. 19, 1993]



Sec. 520.90e  Ampicillin trihydrate soluble powder.

    (a) Specifications. Each gram contains ampicillin trihydrate 
equivalent to 88.2 milligrams of ampicillin.
    (b) Sponsor. See No. 055529 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.40 of this chapter.
    (d) Conditions of use. Swine--(1) Amount. 5 milligrams of ampicillin 
per pound of body weight twice daily, orally by gavage or in drinking 
water for up to 5 days.
    (2) Indications for use. Oral treatment of porcine colibacillosis 
(Escherichia coli) and salmonellosis (Salmonella spp.) infections in 
swine up to 75 pounds of body weight, and bacterial pneumonia caused by 
Pasteurella multocida, Staphylococcus spp., Streptococcus spp., and 
Salmonella spp.
    (3) Limitations. For use in swine only. Not for use in other animals 
which are

[[Page 130]]

raised for food production. Treated swine must not be slaughtered for 
food during treatment and for 24 hours following the last treatment. 
Federal law restricts this drug to use by or on the order of a licensed 
veterinarian.

[57 FR 37322, Aug. 18, 1992, as amended at 58 FR 61016, Nov. 19, 1993]



Sec. 520.90f  Ampicillin trihydrate boluses.

    (a) Specifications. Each bolus contains ampicillin trihydrate 
equivalent to 400 milligrams of ampicillin.
    (b) Sponsor. See No. 055529 in Sec. 510.600(c) of this chapter for 
use as in paragraph (d)(1), 000069 for use as in paragraph (d)(2).
    (c) Related tolerances. See Sec. 556.40 of this chapter.
    (d) Conditions of use. Nonruminating calves--(1) Amount. 5 
milligrams per pound of body weight twice daily for up to 5 days.
    (i) Indications for use. Oral treatment of colibacillosis caused by 
Escherichia coli, bacterial enteritis caused by Salmonella spp., and 
bacterial pneumonia caused by Pasteurella spp.
    (ii) Limitations. Treated calves must not be slaughtered for food 
during treatment and for 15 days after the last treatment. Not for use 
in other animals raised for food production. Federal law restricts this 
drug to use by or on the order of a licensed veterinarian.
    (2) Amount. 5 milligrams per pound of body weight twice daily not to 
exceed 4 days.
    (i) Indications for use. Oral treatment of bacterial enteritis 
(colibacillosis) caused by E. coli.
    (ii) Limitations. Treated calves must not be slaughtered for food 
during treatment and for 7 days after the last treatment. Not for use in 
other animals raised for food production. Federal law restricts this 
drug to use by or on the order of a licensed veterinarian.

[57 FR 37322, Aug. 18, 1992, as amended at 58 FR 61016, Nov. 19, 1993; 
60 FR 55659, Nov. 2, 1995]



Sec. 520.100  Amprolium.

    (a) Specifications--(1) Each milliliter of solution contains 96 
milligrams (mg) amprolium (9.6 percent solution).
    (2) Each gram of powder contains 200 mg amprolium (20 percent).
    (3) Each ounce (28.4 grams) of crumbles contains 355 mg amprolium 
(1.25 percent).
    (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter.
    (1) No. 016592 for use of products described in paragraph (a) of 
this section as in paragraph (e) of this section.
    (2) No. 051311 for use of product described in paragraph (a)(1) of 
this section as in paragraph (e)(1) of this section.
    (3) No. 059130 for use of product described in paragraph (a)(1) of 
this section as in paragraph (e)(2) of this section.
    (c) Related tolerances. See Sec. 556.50 of this chapter.
    (d) Special considerations. See Sec. 500.25 of this chapter.
    (e) Conditions of use--(1) Chickens and turkeys. It is used in 
drinking water as follows:
    (i) Amount. Administer at the 0.012 percent level in drinking water 
as soon as coccidiosis is diagnosed and continue for 3 to 5 days (in 
severe outbreaks, give amprolium at the 0.024 percent level); continue 
with 0.006 percent amprolium-medicated water for an additional 1 to 2 
weeks.
    (ii)Indications for use. For the treatment of coccidiosis.
    (iii) Limitations. Use as the sole source of amprolium.
    (2) Calves. Administer crumbles top-dressed on or thoroughly mixed 
in the daily feed ration; administer concentrate solution or soluble 
powder as a drench or in drinking water as follows:
    (i) Indications for use and amounts--(A) As an aid in the prevention 
of coccidiosis caused by Eimeria bovis and E. zuernii, administer 5 mg 
per kilogram (mg/kg) body weight in drinking water for 21 days during 
periods of exposure or when experience indicates that coccidiosis is 
likely to be a hazard.
    (B) As an aid in the treatment of coccidiosis caused by E. bovis and 
E. zuernii, administer 10 mg/kg body weight in drinking water for 5 
days.
    (ii) Limitations. Withdraw 24 hours before slaughter. A withdrawal 
period has not been established for this product in preruminating 
calves. Do not use in

[[Page 131]]

calves to be processed for veal. Use as the sole source of amprolium.

[71 FR 56346, Sept. 27, 2006, as amended at 72 FR 60551, Oct. 25, 2007]



Sec. 520.110  Apramycin sulfate soluble powder.

    (a) Specifications. A water soluble powder used to make a medicated 
drinking water containing apramycin sulfate equivalent to 0.375 gram of 
apramycin activity per gallon of drinking water.
    (b) Sponsor. See No. 000986 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.52 of this chapter.
    (d) Conditions of use. (1) In swine for control of porcine 
colibacillosis (weanling pig scours) caused by strains of E. coli 
sensitive to apramycin.
    (2) It is administered for 7 days in drinking water at the rate of 
12.5 milligrams of apramycin per kilogram (5.7 milligrams per pound) of 
body weight per day. Swine will normally consume 1 gallon per day of 
medicated water containing 375 milligrams of apramycin for each 66 
pounds of body weight. Water consumption should be monitored to 
determine that the required amount of apramycin is being consumed. The 
drug concentration should be adjusted according to water consumption 
which varies depending on ambient temperature, humidity, and other 
factors.
    (3) Prepare fresh medicated water daily.
    (4) Do not slaughter treated swine for 28 days following treatment

[47 FR 15771, Apr. 13, 1982, as amended at 49 FR 19642, May 9, 1984; 53 
FR 37753, Sept. 28, 1988]



Sec. 520.154  Bacitracin oral dosage forms.



Sec. 520.154a  Soluble bacitracin methylene disalicylate.

    (a) Specifications. Each pound of soluble powder contains the 
equivalent of 50 grams of bacitracin activity for use as in paragraph 
(d)(1) or (d)(2) of this section, or the equivalent of 200 grams of 
bacitracin activity for use as in paragraph (d) of this section.
    (b) Sponsor. See No. 046573 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.70 of this chapter.
    (d) Conditions of use--(1) Growing turkeys--(i) Amount. 400 
milligrams per gallon in drinking water.
    (ii) Indications for use. Aid in the control of transmissible 
enteritis complicated by organisms susceptible to bacitracin methylene 
disalicylate.
    (iii) Limitations. Prepare a fresh solution daily.
    (2) Broiler and replacement chickens--(i) Amount. 100 milligrams per 
gallon in drinking water.
    (A) Indications for use. Aid in the prevention of necrotic enteritis 
caused by Clostridium perfringens susceptible to bacitracin methylene 
disalicylate.
    (B) Limitations. Prepare a fresh solution daily.
    (ii) Amount. 200 to 400 milligrams per gallon in drinking water.
    (A) Indications for use. Aid in the control of necrotic enteritis 
caused by C. perfringens susceptible to bacitracin methylene 
disalicylate.
    (B) Limitations. Prepare a fresh solution daily.
    (3) Swine--(i) Amount. 1 gram per gallon in drinking water.
    (ii) Indications for use. Treatment of swine dysentery associated 
with Treponema hyodysenteriae. Administer continuously for 7 days or 
until signs of dysentery disappear.
    (iii) Limitations. Prepare a fresh solution daily. Treatment not to 
exceed 14 days. If symptoms persist after 4 to 5 days consult a 
veterinarian. Not to be given to swine that weigh more than 250 pounds.
    (4) Growing quail--(i) Amount. 400 milligrams per gallon in drinking 
water.
    (ii) Indications for use. For prevention of ulcerative enteritis due 
to Clostridium colinum susceptible to bacitracin methylene disalicylate.
    (iii) Limitations. Prepare fresh solution daily. Use as sole source 
of drinking water.

[57 FR 37322, Aug. 18, 1992; 57 FR 42623, Sept. 15, 1992, as amended at 
63 FR 38474, July 17, 1998; 64 FR 13068, Mar. 17, 1999]

[[Page 132]]



Sec. 520.154b  Bacitracin methylene disalicylate and streptomycin sulfate 

powder.

    (a) Specifications. Each gram of powder contains 200 units 
bacitracin methylene disalicylate and streptomycin sulfate equivalent to 
20 milligrams of streptomycin.
    (b) Sponsor. See No. 046573 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer 1 level 
teaspoonful per 10 pounds of body weight three times daily, mixed in a 
small quantity of liquid or feed.
    (2) Indications for use. For the treatment of bacterial enteritis 
caused by pathogens susceptible to bacitracin and streptomycin such as 
Escherichia coli, Proteus spp., Staphylococcus spp., and Streptococcus 
spp., and for the symptomatic treatment of associated diarrhea.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[71 FR 17702, Apr. 7, 2006]



Sec. 520.154c  Bacitracin zinc soluble powder.

    (a) Specifications. Each pound contains the equivalent of not less 
than 5 grams of bacitracin.
    (b) Sponsor. See No. 053501 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.70 of this chapter.
    (d) Conditions of use--(1) Broiler chickens--(i) Amount. 100 
milligrams per gallon in drinking water.
    (A) Indications for use. Prevention of necrotic enteritis caused by 
Clostridium perfringens susceptible to bacitracin zinc.
    (B) Limitations. Prepare a fresh solution daily.
    (ii) Amount. 200 to 400 milligrams per gallon in drinking water.
    (A) Indications for use. Control of necrotic enteritis caused by 
Clostridium perfringens susceptible to bacitracin zinc.
    (B) Limitations. Prepare a fresh solution daily.
    (2) Growing quail--(i) Amount. 500 milligrams per gallon in drinking 
water for 5 days followed by 165 milligrams per gallon in drinking water 
for 10 days.
    (ii) Indications for use. Control of ulcerative enteritis caused by 
Clostridium spp. susceptible to bacitracin zinc.
    (iii) Limitations. Prepare a fresh solution daily.

[57 FR 37322, Aug. 18, 1992, as amended at 67 FR 78355, Dec. 24, 2002]



Sec. 520.182  Bicyclohexylammonium fumagillin.

    (a) Specifications. The drug is a sol- uble powder containing 
bicyclohexylammonium fumagillin and appropriate phosphate buffers.
    (b) Sponsor. See No. 059620 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use. (1) The drug is used for the prevention of 
nosema in honey bees.\1\
---------------------------------------------------------------------------

    \1\ These conditions are NAS/NRC reviewed and deemed effective. 
Applications for these uses need not include effectiveness data as 
specified by Sec. 514.111 of this chapter, but may require 
bioequivalency and safety information.
---------------------------------------------------------------------------

    (2) It is administered usually in a 2:1 sugar sirup containing a 
concentration of from 75 to 100 milligrams of fumagillin activity per 
gallon of sugar sirup.\1\
    (3) Colonies used for package production should be fed medicated 
sirup as a principal food supply for a month prior to stocking nuclei or 
shaking packages for market.\1\
    (4) The medicated sirup should not be fed immediately before or 
during the honey flow.

[40 FR 13838, Mar. 27, 1975, as amended at 42 FR 65151, Dec. 30, 1977; 
56 FR 43699, Sept. 4, 1991; 58 FR 5608, Jan. 22, 1993]



Sec. 520.222  Bunamidine hydrochloride.

    (a) Chemical name. N,N-Dibutyl-4-(hexyloxy)-1-naphthamidine 
hydrochloride.
    (b) Specifications. The drug is an oral tablet containing 100, 200, 
or 400 milligrams of bunamidine hydrochloride.
    (c) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
    (d) Conditions of use. (1) The drug is intended for oral 
administration to dogs for the treatment of the tapeworms Dipylidium 
caninum, Taenia pisiformis, and Echinococcus granulosus, and to cats for 
the treatment of the

[[Page 133]]

tapeworms Dipylidium caninum and Taenia taeniaeformis.
    (2) It is administered to cats and dogs at the rate of 25 to 50 
milligrams per kilogram of body weight. The drug should be given on an 
empty stomach and food should not be given for 3 hours following 
treatment.
    (3) Tablets should not be crushed, mixed with food, or dissolved in 
liquid. Repeat treatments should not be given within 14 days. The drug 
should not be given to male dogs within 28 days prior to their use for 
breeding. Do not administer to dogs or cats having known heart 
conditions.
    (4) For use only by or on the order of a licensed veterinarian.

[40 FR 13838, Mar. 27, 1975, as amended at 42 FR 13018, Mar. 8, 1977; 46 
FR 48642, Oct. 2, 1981; 61 FR 8873, Mar. 6, 1996; 62 FR 61624, Nov. 19, 
1997]



Sec. 520.246  Butorphanol tartrate tablets.

    (a) Specifications. Each tablet contains 1, 5, or 10 milligrams of 
butorphanol base activity as butorphanol tartrate.
    (b) Sponsor. See No. 000856 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use. The drug is used for the treatment of dogs as 
follows:
    (1) Amount. 0.25 milligram of butorphanol base activity per pound of 
body weight.
    (2) Indications for use. For the relief of chronic nonproductive 
cough associated with tracheo-bronchitis, tracheitis, tonsillitis, 
laryngitis, and pharyngitis associated with inflammatory conditions of 
the upper respiratory tract.
    (3) Limitations. For oral use in dogs only. Repeat at intervals of 6 
to 12 hours as required. If necessary, increase dose to a maximum of 0.5 
milligram per pound of body weight. Treatment should not normally be 
required for longer than 7 days. Federal law restricts this drug to use 
by or on the order of a licensed veterinarian.

[47 FR l4702, Apr. 6, 1982, as amended at 53 FR 27851, July 25, 1988]



Sec. 520.260  n-Butyl chloride capsules.

    (a)(1) Specifications. n-Butyl chloride capsules, veterinary contain 
272 milligrams or 816 milligrams of n-butyl chloride in each capsule.
    (2) Sponsor. See No. 021091 in Sec. 510.600(c) of this chapter.
    (3) Conditions of use. (i) It is used for the removal of ascarids 
(Toxocara canis and Toxascaris leonina) and hookworms (Ancylostoma 
caninum, Ancylostoma braziliense, and Uncinaria stenocephala) from dogs 
and of the ascarid (Toxocara cati) and hookworm (Ancylostoma tubaeforme) 
from cats.
    (ii)(a) Animals should not be fed for 18 to 24 hours before being 
given the drug. Puppies and kittens should be wormed at 6 weeks of age. 
However, if heavily infested, they may be wormed at 4 or 5 weeks of age. 
Administration of the drug should be followed in \1/2\ to 1 hour with a 
teaspoonful to a tablespoonful of milk of magnesia or 1 or 2 milk of 
magnesia tablets. Normal rations may be resumed 4 to 8 hours after 
treatment. Puppies and kittens should be given a repeat treatment in a 
week or 10 days. After that they should be treated every 2 months (or as 
symptoms reappear) until a year old. When the puppy or kitten is a year 
old, one treatment every 3 to 6 months is sufficient.
    (b) For dogs or cats that have been wormed regularly, treatment 
every 3 to 6 months will be sufficient. If a dog or cat has not been 
wormed previously and has the symptoms of large roundworms a dose should 
be given and repeated in 10 days. Removal of hookworms may require 3 or 
4 doses at 10-day intervals.
    (c) Puppies, dogs, cats, or kittens weighing 1 to 3 pounds should be 
given 2 capsules per dose which contain 272 milligrams of n-butyl 
chloride each. Such animals weighing 4 to 5 pounds should be given 3 
such capsules. Animals weighing 6 to 7 pounds should be given 4 such 
capsules and animals weighing 8 to 9 pounds should be given 5 such 
capsules. Animals weighing 10 to 20 pounds should be given 3 capsules 
which contain 816 milligrams of n-butyl chloride each, animals weighing 
20 to 40 pounds should be given 4 such capsules and animals weighing 
over 40 pounds should be given 5 such capsules with the maximum dosage 
being 5 capsules, each of which contains 816 milligrams of n-butyl 
chloride.

[[Page 134]]

    (iii) A veterinarian should be consulted before using in severely 
debilitated dogs or cats and also prior to repeated use in cases which 
present signs of persistent parasitism.
    (b)(1) Specifications. n-Butyl chloride capsules contain 221, 442, 
884, or 1,768 milligrams or 4.42 grams of n-butyl chloride in each 
capsule. \1\
---------------------------------------------------------------------------

    \1\ These conditions are NAS/NRC reviewed and deemed effective. 
Applications for these uses need not include effectiveness data as 
specified by Sec. 514.111 of this chapter.
---------------------------------------------------------------------------

    (2) Sponsors. See No. 023851 in Sec. 510.600(c) of this chapter for 
221, 442, 884, or 1,768 milligram or 4.42 gram capsules; No. 038782 for 
884 or 1,768 milligram or 4.42 gram capsules; and No. 000069 for 221 
milligram capsules.
    (3) Conditions of use. (i) It is used for the removal of ascarids 
(Toxocara canis and Toxascaris leonina) and hookworms (Ancylostoma 
caninum, Ancylostoma braziliense, and Uncinaria stenocephala) from dogs. 
\1\
    (ii)(a) Dogs should not be fed for 18 to 24 hours before being given 
the drug. Administration of the drug should be followed in \1/2\ to 1 
hour with a mild cathartic. Normal feeding may be resumed 4 to 8 hours 
after treatment. Animals subject to reinfection may be retreated in 2 
weeks. \1\
    (b) The drug is administered orally to dogs. Capsules containing 221 
milligrams of n-butyl chloride are administered to dogs weighing under 5 
pounds at a dosage level of 1 capsule per 1\1/4\ pound of body weight. 
Capsules containing 442 milligrams of n-butyl chloride are administered 
to dogs weighing under 5 pounds at a dosage level of 1 capsule per 2\1/
2\ pounds body weight. Capsules containing 884 milligrams of n-butyl 
chloride are administered to dogs as follows: Weighing under 5 pounds, 1 
capsule; weighing 5 to 10 pounds, 2 capsules; weighing 10 to 20 pounds, 
3 capsules; weighing 20 to 40 pounds, 4 capsules; over 40 pounds, 5 
capsules. Capsules containing 1,768 milligrams of n-butyl chloride are 
administered at a dosage level of 1 capsule per dog weighing 5 to 10 
pounds. Capsules containing 4.42 grams of n-butyl chloride are 
administered at a dosage level of 1 capsule per dog weighing 40 pounds 
or over. \1\
    (iii) A veterinarian should be consulted before using in severely 
debilitated dogs. \1\

[40 FR 13838, Mar. 27, 1975, as amended at 40 FR 39858, Aug. 29, 1975; 
44 FR 10059, Feb. 16, 1979; 54 FR 38515, Sept. 19, 1989; 55 FR 24556, 
June 18, 1990; 64 FR 15684, Apr. 1, 1999; 70 FR 50182, Aug. 26, 2005]



Sec. 520.300  Cambendazole oral dosage forms.



Sec. 520.300a  Cambendazole suspension.

    (a) Specifications. Each fluid ounce contains 0.9 gram of 
cambendazole.
    (b) Sponsor. No. 050604 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use. (1) It is used in horses for the control of 
large strongyles (Strongylus vulgaris, S. edentatus, S. equinus); small 
strongyles (Trichonema, Poteriostomum, Cylicobrachytus, Craterostomum, 
Oesophagodontus); roundworms (Parascaris); pinworms. (Oxyuris); and 
threadworms (Strongyloides).
    (2) It is administered by stomach tube or as a drench at a dose of 
0.9 gram of cambendazole per 100 pounds of body weight (20 milligrams 
per kilogram).
    (3) For animals maintained on premises where reinfection is likely 
to occur, re-treatments may be necessary. For most effective results, 
re-treat in 6 to 8 weeks.
    (4) Not for use in horses intended for food.
    (5) Caution: Do not administer to pregnant mares during first 3 
months of pregnancy.
    (6) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.

[40 FR 13838, Mar. 27, 1975. Redesignated at 41 FR 1276, Jan. 7, 1976, 
and amended at 42 FR 3838, Jan. 21, 1977; 62 FR 63270, Nov. 28, 1997]



Sec. 520.300b  Cambendazole pellets.

    (a) Specifications. The drug is in feed pellets containing 5.3 
percent cambendazole.
    (b) Sponsor. No. 050604 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use. (1) It is used in horses for the control of 
large strongyles (Strongylus vulgaris, S. edentatus, S. equinus); small 
strongyles (Trichonema, Poteriostomum,

[[Page 135]]

Cylicobrachytus, Craterostomum, Oesophagodontus); roundworms 
(Parascaris); pinworms (Oxyuris); and threadworms (Strongyloides).
    (2) Administer 20 milligrams cambendazole per kilogram body weight 
(6 ounces per 1,000 pounds) by mixing with normal grain ration given at 
one feeding. Doses for individual horses should be mixed and fed 
separately to assure that each horse will consume the correct amount.
    (3) For animals maintained on premises where reinfection is likely 
to occur, re-treatments may be necessary. For most effective results, 
re-treat in 6 to 8 weeks.
    (4) Not for use in horses intended for food.
    (5) Caution: Do not administer to pregnant mares during first 3 
months of pregnancy.
    (6) Consult your veterinarian for assistance in the diagnosis, 
treatment, and control of parasitism.

[41 FR 1276, Jan. 7, 1976, as amended at 42 FR 3838, Jan. 21, 1977; 62 
FR 63270, Nov. 28, 1997]



Sec. 520.300c  Cambendazole paste.

    (a) Specifications. The drug is a paste containing 45 percent 
cambendazole.
    (b) Sponsor. No. 050604 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use. (1) It is used in horses for the control of 
large strongyles (Strongylus vulgaris, S. edentatus, S. equinus); small 
strongyles (Trichonema, Poteriostomum, Cylicobrachytus, Craterostomum, 
Oesophagodontus); roundworms (Parascaris); pinworms (Oxyuris); and 
threadworms (Strongyloides).
    (2) Administer 20 milligrams cambendazole per kilogram body weight 
(5 grams per 550 pounds (250 kilograms)) by depositing the paste on the 
back of the tongue using a dosing gun.
    (3) For animals maintained on premises where reinfection is likely 
to occur, re-treatments may be necessary. For most effective results, 
re-treat in 6 to 8 weeks.
    (4) Not for use in horses intended for food.
    (5) Caution: Do not administer to pregnant mares during first 3 
months of pregnancy.
    (6) Consult your veterinarian for assistance in the diagnosis, 
treatment, and control of parasitism.

[41 FR 1276, Jan. 7, 1976, as amended at 42 FR 3838, Jan. 21, 1977; 62 
FR 63270, Nov. 28, 1997]



Sec. 520.309  Carprofen.

    (a) Specifications. (1) Each caplet contains 25, 75, or 100 
milligrams (mg) carprofen.
    (2) Each chewable tablet contains 25, 75, or 100 mg carprofen.
    (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for 
uses as in paragraph (d) of this section.
    (1) No. 000069 for use of products described in paragraph (a) of 
this section as in paragraph (d) of this section.
    (2) Nos. 000115 and 062250 for use of product described in paragraph 
(a)(1) as in paragraph (d) of this section.
    (c) [Reserved]
    (d) Conditions of use in dogs--(1) Amount. 2 mg per pound (/lb) of 
body weight once daily or 1 mg/lb twice daily. For the control of 
postoperative pain, administer approximately 2 hours before the 
procedure.
    (2) Indications for use. For the relief of pain and inflammation 
associated with osteoarthritis and for the control of postoperative pain 
associated with soft tissue and orthopedic surgeries.
    (3) Limitations. Federal Law restricts this drug to use by or on the 
order of a licensed veterinarian.

[61 FR 66581, Dec. 18, 1996, as amended at 64 FR 32181, June 16, 1999; 
66 FR 63165, Dec. 5, 2001; 67 FR 6866, Feb. 14, 2002; 67 FR 65038, Oct. 
23, 2002; 67 FR 65697, Oct. 28, 2002; 70 FR 30626, May 27, 2005; 71 FR 
51995, Sept. 1, 2006; 72 FR 68478, Dec. 5, 2007]



Sec. 520.310  Caramiphen ethanedisulfonate and ammonium chloride tablets.

    (a) Specifications. Each tablet contains 10 milligrams of 5st 
caramiphen ethanedisulfonate and 80 milligrams of ammonium chloride.\1\
---------------------------------------------------------------------------

    \1\ These conditions are NAS/NRC reviewed and deemed effective. 
Applications for these uses need not include effectiveness data as 
specified by Sec. 514.111 of this chapter, but may require 
bioequivalency and safety information.
---------------------------------------------------------------------------

    (b) Sponsor. See No. 000856 in Sec. 510.600(c) of this chapter.

[[Page 136]]

    (c) Conditions of use in dogs--(1) Amount. One tablet per 15 to 30 
pounds of body weight every 4 to 6 hours.\1\
    (2) Indications for use. For relief of cough.\1\

[43 FR 55385, Nov. 28, 1978]



Sec. 520.312  Carnidazole tablets.

    (a) Specifications. Each tablet contains 10 milligrams of 
carnidazole.
    (b) Sponsor. See 053923 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. Adult pigeons: 1 tablet (10 
milligrams); newly weaned pigeons: \1/2\ tablet (5 milligrams).
    (2) Indications for use. For treating trichomoniasis (canker) in 
ornamental and homing pigeons.
    (3) Limitations. Not for use in pigeons intended for human food. 
Consult your veterinarian for assistance in the diagnosis, treatment, 
and control of parasitism or when severely ill birds do not respond to 
treatment.

[54 FR 32336, Aug. 7, 1989]



Sec. 520.314  Cefadroxil tablets.

    (a) Specifications. 50-, 100-, and 200-milligram tablets for dogs 
and cats; 1 gram tablet for dogs.
    (b) Sponsor. See No. 000856 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use. (1) For use in dogs as follows:
    (i) Indications for use. For the treatment of skin and soft tissue 
infections including cellulitis, pyoderma, dermatitis, wound infections, 
and abscesses due to susceptible strains of Staphylococcus aureus. For 
the treatment of genitourinary tract infections (cystitis) due to 
susceptible strains of Escherichia coli, Proteus mirabilis, and 
Staphylococcus aureus.
    (ii) Amount. Ten milligrams per pound of body weight twice daily.
    (iii) Limitations. The drug is administered orally. For skin and 
soft tissue infections, treatment should be continued for a minimum of 3 
days. For genitourinary tract infections, treatment should be continued 
for a minimum of 7 days. Continue treatment at least 48 hours after the 
dog has become afebrile or asymptomatic. If no response is seen after 3 
days of treatment, therapy should be discontinued and the case 
reevaluated. Do not treat for more than 30 days. Safety for use in 
pregnant bitches and stud dogs has not been determined. Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.
    (2) For use in cats as follows:
    (i) Indications for use. For the treatment of skin and soft tissue 
infections including abscesses, wound infections, cellulitis, and 
dermatitis caused by susceptible strains of Pasteurella multocida, 
Staphylococcus aureus, Staphylococcus epidermidis, and Streptococcus 
spp.
    (ii) Amount. Ten milligrams per pound of body weight once daily.
    (iii) Limitations. The drug is administered orally. Continue 
treatment at least 48 hours after the cat has become afebrile or 
asymptomatic. If no response is seen after 3 days of treatment, therapy 
should be discontinued and the case reevaluated. Do not treat for more 
than 21 days. Safety for use in pregnant cats and breeding male cats has 
not been determined. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[47 FR 41105, Sept. 17, 1982, as amended at 49 FR 43052, Oct. 26, 1984; 
51 FR 4165, Feb. 3, 1986; 52 FR 11989, Apr. 14, 1987; 53 FR 27851, July 
25, 1988]



Sec. 520.315  Cefadroxil powder for oral suspension.

    (a) Specifications. Cefadroxil powder is reconstituted to form a 50 
milligram-per-milliliter aqueous suspension.
    (b) Sponsor. See No. 000856 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use. (1) For use in dogs as follows:
    (i) Indications for use. For treating genitourinary tract infections 
(cystitis) caused by susceptible strains of Escherichia coli, Proteus 
mirabilis, and Staphylococcus aureus; and skin and soft tissue 
infections including cellulitis, pyoderma, dermatitis, wound infections, 
and abscesses caused by susceptible strains of Staphylococcus aureus.
    (ii) Amount. 10 milligrams per pound of body weight, twice daily.
    (2) For use in cats as follows:
    (i) Indications for use. For treating skin and soft tissue 
infections including abscesses, wound infections,

[[Page 137]]

cellulitis, and dermatitis caused by susceptible strains of Pasteurella 
multocida, Staphylococcus aureus, Staphylococcus epidermidis, and 
Streptococcus spp.
    (ii) Amount. 10 milligrams per pound of body weight, once daily.
    (3) Limitations. Discard unused portion of reconstituted product 
after 14 days. Treatment should continue for 48 hours after animal is 
afebrile or asymptomatic. If no response after 3 days, discontinue 
treatment and reevaluate therapy. Not for use in animals raised for food 
production. Safe use in pregnant or breeding animals has not been 
established. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

[53 FR 27344, July 20, 1988]



Sec. 520.370  Cefpodoxime tablets.

    (a) Specifications. Each tablet contains cefpodoxime proxetil 
equivalent to 100 or 200 milligrams (mg) cefpodoxime.
    (b) Sponsors. See No. 000009 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. 5 to 10 mg per kilogram 
(2.3 to 4.5 mg per pound) body weight daily for 5 to 7 days, or for 2 to 
3 days beyond the cessation of clinical signs, up to a maximum of 28 
days.
    (2) Indications for use. For the treatment of skin infections 
(wounds and abscesses) caused by susceptible strains of Staphylococcus 
intermedius, S. aureus, Streptococcus canis (group G, -hemolytic), 
Escherichia coli, Pasteurella multocida, and Proteus mirabilis.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[69 FR 52815, Aug. 30, 2004]



Sec. 520.390  Chloramphenicol oral dosage forms.



Sec. 520.390a  Chloramphenicol tablets.

    (a)(1) Specifications. Each tablet contains 100, 250, or 500 
milligrams, 1 or 2.5 grams of chloramphenicol.
    (2) Sponsor. In Sec. 510.600(c) of this chapter: No. 000010 for 
100-, 250-, and 500-milligram and 1-gram tablets; No. 000856 for 100-, 
250-. and 500-milligram tablets; No. 017030 for 100-milligram tablets; 
No. 000010 for 100-, 250-, and 500-milligram and 1- and 2.5-gram 
tablets; No. 000069 for 250-milligram tablets.
    (3) Conditions of use. Dogs--(i) Amount. 25 milligrams per pound of 
body weight every 6 hours.
    (ii) Indications for use. Oral treatment of bacterial pulmonary 
infections, bacterial infections of the urinary tract, bacterial 
enteritis, and bacterial infections associated with canine distemper 
caused by susceptible organisms.
    (iii) Limitations. Laboratory tests should be conducted, including 
in vitro culturing and susceptibility tests on samples collected prior 
to treatment. If no response to chloramphenicol therapy is obtained in 3 
to 5 days, discontinue its use and review diagnosis. Not for animals 
which are raised for food production. Chloramphenicol products must not 
be used in meat-, egg-, or milk-producing animals. The length of time 
that residues persist in milk or tissues has not been determined. 
Because of potential antagonism, chloramphenicol should not be 
administered simultaneously with penicillin or streptomycin. Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.
    (b)(1) Specifications. Each tablet contains 50, 100, 250, or 500 
milligrams, or 1 gram of chloramphenicol.
    (2) Sponsor. See No. 061623 in Sec. 510.600(c) of this chapter.
    (3) Conditions of use. Dogs--(i) Amount. 25 milligrams per pound of 
body weight every 6 hours.
    (ii) Indications for use. Oral treatment of bacterial 
gastroenteritis associated with bacterial diarrhea, bacterial pulmonary 
infections, and bacterial infections of the urinary tract caused by 
susceptible organisms.
    (iii) Limitations. Laboratory tests should be conducted, including 
in vitro culturing and susceptibility tests on samples collected prior 
to treatment. If no response is obtained in 3 to 5 days, discontinue use 
and reevaluate diagnosis. Not for animals that are raised for food 
production. Chloramphenicol products should not be administered in 
conjunction with or 2 hours prior to the induction of general anesthesia 
with pentobarbital because of prolonged recovery. Chloramphenicol should 
not be administered to dogs

[[Page 138]]

maintained for breeding purposes. Because of potential antagonism, 
chloramphenicol should not be administered simultaneously with 
penicillin or streptomycin. Federal law restricts this drug to use by or 
on the order of a licensed veterinarian.

[57 FR 37323, Aug. 18, 1992, as amended at 62 FR 35076, June 30, 1997; 
66 FR 14073, Mar. 9, 2001; 68 FR 4914, Jan. 31, 2003]



Sec. 520.390b  Chloramphenicol capsules.

    (a) Specifications. Each capsule contains 50, 100, 250, or 500 
milligrams (mg) chloramphenicol.
    (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for 
use as in paragraph (d) of this section.
    (1) Nos. 000069, 000185, and 050057 for capsules containing 50, 100, 
250, or 500 mg chloramphenicol.
    (2) No. 058034 for capsules containing 100 or 250 mg 
chloramphenicol.
    (c) Special considerations. Federal law prohibits the extralabel use 
of this product in food-producing animals.
    (d) Conditions of use in dogs--(1) Amount. 25 mg per pound of body 
weight every 6 hours.
    (2) Indications for use. For treatment of bacterial pulmonary 
infections, bacterial infections of the urinary tract, bacterial 
enteritis, and bacterial infections associated with canine distemper 
caused by susceptible organisms.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[70 FR 75398, Dec. 20, 2005]



Sec. 520.390c  Chloramphenicol palmitate oral suspension.

    (a) Specifications. Each milliliter contains chloramphenicol 
palmitate equivalent to 30 milligrams of chloramphenicol.
    (b) Sponsor. See No. 000856 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use. Dogs--(1) Amount. 25 milligrams per pound of 
body weight every 6 hours. If no response is obtained in 3 to 5 days, 
discontinue use and reevaluate diagnosis.
    (2) Indications for use. Treatment of bacterial pulmonary 
infections, infections of the urinary tract, enteritis, and infections 
associated with canine distemper that are caused by organisms 
susceptible to chloramphenicol.
    (3) Limitations. Not for use in animals that are raised for food 
production. Must not be used in meat-, egg-, or milk-producing animals. 
The length of time that residues persist in milk or tissues has not been 
determined. Federal law restricts this drug to use by or on the order of 
a licensed veterinarian.

[57 FR 37323, Aug. 18, 1992; 57 FR 42623, Sept. 15, 1992]



Sec. 520.420  Chlorothiazide tablets and boluses.

    (a)(1) Specifications. Each tablet contains 0.25 gram of 
chlorothiazide.
    (2) Sponsor. See No. 050604 in Sec. 510.600(c) of this chapter.
    (3) Conditions of use--(i) Amount. Usual dosage is 5 to 10 
milligrams per pound of body weight two or three times daily. \1\
---------------------------------------------------------------------------

    \1\ These conditions are NAS/NRC reviewed and deemed effective. 
Applications for these uses need not include effectiveness data as 
specified by Sec. 514.111 of this chapter, but may require 
bioequivalency and safety information.
---------------------------------------------------------------------------

    (ii) Indications for use. For use in dogs for treatment of 
congestive heart failure and renal edema. \1\
    (iii) Limitations. (a) Dosage must be adjusted to meet the changing 
needs of the individual animal. In mild and responsive cases, it is 
suggested that a dose of 5 milligrams per pound of body weight be 
administered two or three times daily. In moderately edematous and 
moderately responsive animals, a dose of 7.5 to 10 milligrams per pound 
of body weight may be administered three times daily. Severe conditions 
may require higher doses. Certain animals may respond adequately to 
intermittent therapy; in these cases, the drug may be administered 
either every other day or for 3 to 5 days each week.
    (b) Animals should be regularly and carefully observed for early 
signs of fluid and electrolyte imbalance. Take appropriate 
countermeasures if this should occur. In some dogs, hypochloremic 
alkalosis may occur (that is, excretion of chloride in relation to 
sodium is excessive; the plasma bicarbonate level increases and 
alkalosis results). Federal law restricts this drug to use by or on the 
order of a licensed veterinarian. \1\

[[Page 139]]

    (b)(1) Specifications. Each bolus contains 2 grams of 
chlorothiazide.
    (2) Sponsor. See No. 000006 in Sec. 510.600(c) of this chapter.
    (3) Conditions of use--(i) Amount. 2 grams once or twice daily for 3 
or 4 days. \1\
    (ii) Indications for use. For use in cattle as an aid in reduction 
of postparturient udder edema. \1\
    (iii) Limitations. Animals should be regularly and carefully 
observed for early signs of fluid and electrolyte imbalance. Take 
appropriate countermeasures if this should occur. Milk taken from dairy 
animals during treatment and for 72 hours (six milkings) after latest 
treatment must not be used for food. Federal law restricts this drug to 
use by or on the order of a licensed veterinarian. \1\

[43 FR 39085, Sept. 1, 1978, as amended at 62 FR 63270, Nov. 28, 1997]



Sec. 520.434  Chlorphenesin carbamate tablets.

    (a) Specifications. Each tablet contains 400 milligrams of 
chlorphenesin carbamate.
    (b) Sponsor. See No. 000009 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. 50 milligrams per pound 
of body weight on first day; 25 milligrams per pound of body weight each 
following day. Divide total daily dose into 2 or 3 equal doses--
administer at 12- or 8-hour intervals.
    (2) Indications for use. For use as an adjunct to therapy of acute 
inflammatory and traumatic conditions of skeletal muscles. The drug 
provides relief of the signs of discomfort associated with myositis, 
muscle sprains, traumatic injuries, stifle injuries--especially when 
administered before or after surgery--and invertebral disc syndrome (can 
be used concurrently with adrenal corticosteroids).
    (3) Limitations. Not recommended for pregnant animals or those with 
a known hepatic dysfunction. Periodic liver function studies are 
recommended for animals on prolonged treatment. If no response is 
evident within 5 days of the beginning of treatment, the diagnosis 
should be redetermined and appropriate therapy instituted. Not 
recommended for use with general anesthetics other than the 
barbiturates. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

[44 FR 16009, Mar. 16, 1979]



Sec. 520.445  Chlortetracycline oral dosage forms.



Sec. 520.445a  Chlortetracycline bisulfate/sulfamethazine bisulfate soluble 

powder.

    (a) Specifications. Each pound contains chlortetracycline bisulfate 
equivalent to 102.4 grams of chlortetracycline hydrochloride with 
sulfamethazine bisulfate equivalent to 102.4 grams of sulfamethazine.
    (b) Sponsor. See No. 053501 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. Sec. 556.150 and 556.670 of this 
chapter.
    (d) Conditions of use. Swine--Used in drinking water as follows:
    (1) Amount. 250 milligrams of chlortetracycline with 250 milligrams 
of sulfamethazine per gallon.
    (2) Indications for use. Prevention and treatment of bacterial 
enteritis; aid in the reduction of the incidence of cervical abscesses; 
aid in the maintenance of weight gains in the presence of bacterial 
enteritis and atrophic rhinitis.
    (3) Limitations. Not to be used for more than 28 consecutive days; 
withdraw 15 days before slaughter; as sole source of chlortetracycline 
and sulfonamide.

[57 FR 37323, Aug. 18, 1992, as amended at 67 FR 78355, Dec. 24, 2002]



Sec. 520.445b  Chlortetracycline powder.

    (a) Specifications. Chlortetracycline powder contains not less than 
15 milligrams per gram chlortetracycline hydrochloride, or 
chlortetracycline bisulfate equivalent to 25.6, 64 or 102.4 grams per 
pound (56.4, 141 or 225.6 milligrams per gram) chlortetracycline 
hydrochloride.
    (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for 
use as in paragraph (d) of this section.
    (1) No. 048164 for use as in paragraph (d) of this section.
    (2) No. 053501 for use as in paragraph (d)(5) of this section.

[[Page 140]]

    (3) No. 000010 for use as in paragraphs (d)(4)(i)(A), (d)(4)(i)(B), 
and (d)(4)(ii) through (iv) of this section.
    (4) Nos. 021930 and 059130 for use as in paragraphs (d)(4)(i)(A), 
(d)(4)(i)(B), (d)(4)(ii), and (d)(4)(iii) of this section.
    (c) Related tolerances. See Sec. 556.150 of this chapter.
    (d) Conditions of use. (1) Use as chlortetracycline hydrochloride in 
drinking water as follows:
    (i) Swine--(A) Amount. Ten milligrams per pound of body weight daily 
in divided doses.
    (1) Indications for use. Control and treatment of bacterial 
enteritis (scours) caused by Escherichia coli and bacterial pneumonia 
associated with Pasteurella spp., Actinobacillus pleuropneumoniae 
(Hemophilus spp.), and Klebsiella spp.
    (2) Limitations. Prepare a fresh solution twice daily; as sole 
source of chlortetracycline; administer for not more than 5 days.
    (B) [Reserved]
    (ii) [Reserved]
    (2) Use as chlortetracycline hydrochloride in a drench or drinking 
water as follows:
    (i) Calves--(A) Amount. Ten milligrams per pound of body weight 
daily in divided doses.
    (1) Control and treatment of bacterial enteritis (scours) caused by 
E. coli and bacterial pneumonia (shipping fever) associated with 
Pasteurella spp., A. pleuropneumoniae (Hemophilus spp.), and Klebsiella 
spp.
    (2) Limitations. Prepare fresh solution daily; as sole source of 
chlortetracycline; administer for not more than 5 days; do not slaughter 
animals for food within 24 hours of treatment; do not administer this 
product with milk or milk replacers; administer 1 hour before or 2 hours 
after feeding milk or milk replacers; a withdrawal period has not been 
established in preruminating calves; do not use in calves to be 
processed for veal.
    (B) [Reserved]
    (ii) [Reserved]
    (3) [Reserved]
    (4) The following uses of chlortetracycline hydrochloride or 
chlortetracycline bisulfate in drinking water or drench were reviewed by 
the National Academy of Sciences/National Research Council (NAS/NRC) and 
found effective:
    (i) Chickens--(A) Amount. 200 to 400 milligrams per gallon.
    (1) Indications for use. Control of infectious synovitis caused by 
Mycoplasma synoviae.
    (2) Limitations. Prepare fresh solution daily; as sole source of 
chlortetracycline; do not use for more than 14 days; do not slaughter 
animals for food within 24 hours of treatment; do not use in laying 
chickens.
    (B) Amount. 400 to 800 milligrams per gallon.
    (1) Indications for use. Control of chronic respiratory disease and 
air-sac infections caused by M. gallisepticum and E. coli.
    (2) Limitations. Prepare fresh solution daily; as sole source of 
chlortetracycline; do not use for more than 14 days; do not slaughter 
animals for food within 24 hours of treatment; do not use in laying 
chickens.
    (C) Amount. One thousand milligrams per gallon.
    (1) Indications for use. Control of mortality due to fowl cholera 
caused by Pasteurella multocida susceptible to chlortetracycline.
    $(2) Limitations. See paragraph (d)(4)(i)(A)(2) of this section.
    (ii) Growing turkeys--(A) Amount. 400 milligrams per gallon.
    (1) Indications for use. Control of infectious synovitis caused by 
M. synoviae.
    (2) Limitations. Prepare fresh solution daily; as sole source of 
chlortetracycline; do not use for more than 14 days; do not slaughter 
animals for food within 24 hours of treatment.
    (B) Amount. 25 milligrams per pound of body weight daily.
    (1) Indications for use. Control of complicating bacterial organisms 
associated with bluecomb (transmissible enteritis, coronaviral 
enteritis).
    (2) Limitations. Prepare fresh solution daily; as sole source of 
chlortetracycline; do not use for more than 14 days; do not slaughter 
animals for food within 24 hours of treatment.
    (iii) Swine--(A) Amount. 10 milligrams per pound body weight daily 
in divided doses.
    (B) Indications for use. Control and treatment of bacterial 
enteritis

[[Page 141]]

(scours) caused by E. coli and Salmonella spp. and bacterial pneumonia 
associated with Pasteurella spp., Actinobacillus pleuropneumoniae 
(Hemophilus spp.), and Klebsiella spp.
    (C) Limitations. Prepare fresh solution daily; as sole source of 
chlortetracycline; do not use for more than 5 days. For Nos. 000010 and 
021930, do not slaughter animals for food within 5 days of treatment; 
for No. 053501, do not slaughter animals for food within 24 hours of 
treatment.
    (iv) Calves, beef cattle, and nonlactating dairy cattle--(A) Amount. 
10 milligrams per pound daily in divided doses.
    (B) Indications for use. Control and treatment of bacterial 
enteritis (scours) caused by E. coli and Salmonella spp. and bacterial 
pneumonia (shipping fever complex) associated with Pasteurella spp., A. 
pleuropneumoniae (Hemophilus spp.), and Klebsiella spp.
    (C) Limitations. Prepare fresh solution daily; use as a drench; as 
sole source of chlortetracycline; do not use for more than 5 days; do 
not slaughter animals for food within 24 hours of treatment; do not use 
in lactating cattle; do not administer this product with milk or milk 
replacers; administer 1 hour before or 2 hours after feeding milk or 
milk replacers; a withdrawal period has not been established in 
preruminating calves; do not use in calves to be processed for veal.
    (5) Use in a drench or drinking water as follows:
    (i) Chickens--(A) Amount. 200 to 400 mg/gal, for 7 to 14 days.
    (1) Indications for use. Control of infectious synovitis caused by 
M. synoviae susceptible to chlortetracycline.
    (2) Limitations. Prepare fresh solution daily; use as the sole 
source of chlortetracycline; do not use for more than 14 consecutive 
days; do not use in laying chickens; do not administer to chickens 
within 24 hours of slaughter.
    (B) Amount. 400 to 800 mg/gal, for 7 to 14 days.
    (1) Indications for use. Control of chronic respiratory disease 
(CRD) and air-sac infections caused by M. gallisepticum and E. coli 
susceptible to chlortetracycline.
    (2) Limitations. As in paragraph (d)(5)(i)(A)(2) of this section.
    (C) Amount. One thousand mg/gal, for 7 to 14 days.
    (1) Indications for use. Control of mortality due to fowl cholera 
caused by Pasteurella multocida susceptible to chlortetracycline.
    (2) Limitations. As in paragraph (d)(5)(i)(A)(2) of this section.
    (ii) Growing Turkeys--(A) Amount. 400 mg/gal, for 7 to 14 days.
    (1) Indications for use. Control of infectious synovitis caused by 
Mycoplasma synoviae susceptible to chlortetracycline.
    (2) Limitations. Prepare fresh solution daily; use as the sole 
source of chlortetracycline; do not use for more than 14 consecutive 
days; do not administer to growing turkeys within 24 hours of slaughter.
    (B) Amount. 25 mg/lb body weight daily, for 7 to 14 days.
    (1) Indications for use. Control of complicating bacterial organisms 
associated with bluecomb (transmissible enteritis, coronaviral 
enteritis) susceptible to chlortetracycline.
    (2) Limitations. As in paragraph (d)(5)(ii)(A)(2) of this section.
    (iii) Swine--(A) Amount. 10 mg/lb body weight daily, for 3 to 5 
days.
    (B) Indications for use. Control and treatment of bacterial 
enteritis (scours) caused by E. coli and Salmonella spp., and bacterial 
pneumonia associated with Pasteurella spp., A. pleuropneumoniae, and 
Klebsiella spp. susceptible to chlortetracycline.
    (C) Limitations. Prepare fresh solution daily; use as the sole 
source of chlortetracycline; do not use for more than 5 days; do not 
administer to swine within 24 hours of slaughter.
    (iv) Calves, beef cattle, and nonlactating dairy cattle--(A) Amount. 
10 mg/lb body weight daily in divided doses, for 3 to 5 days.
    (B) Indications for use. Control and treatment of bacterial 
enteritis (scours) caused by Escherichia coli and Salmonella spp., and 
bacterial pneumonia associated with Pasteurella spp., Histophilus spp., 
and Klebsiella spp. susceptible to chlortetracycline.
    (C) Limitations. Prepare fresh solution daily; use as a drench; use 
as the sole source of chlortetracycline; do not use

[[Page 142]]

for more than 5 days; do not administer to cattle within 24 hours of 
slaughter; do not use in lactating dairy cattle; do not administer this 
product with milk or milk replacers; administer 1 hour before or 2 hours 
after feeding milk or milk replacers; a withdrawal period has not been 
established in preruminating calves; do not use in calves to be 
processed for veal.

[57 FR 37324, Aug. 18, 1992; 57 FR 42623, Sept. 15, 1992; 58 FR 61015, 
Nov. 19, 1993; 59 FR 39439, Aug. 3, 1994; 60 FR 26827, May 19, 1995; 60 
FR 47052, Sept. 11, 1995; 62 FR 27691, May 21, 1997; 62 FR 35076, June 
30, 1997; 62 FR 60656, Nov. 12, 1997; 64 FR 37673, July 13, 1999; 65 FR 
10706, Feb. 29, 2000; 66 FR 35898, July 10, 2001; 67 FR 78355, Dec. 24, 
2002; 69 FR 62406, Oct. 26, 2004; 72 FR 1174, Jan. 10, 2007; 72 FR 
63987, Nov. 14, 2007]



Sec. 520.445c  Chlortetracycline tablets and boluses.

    (a) Specifications. Each tablet/bolus contains 25, 250, or 500 
milligrams of chlortetracycline hydrochloride.
    (b) Sponsors. See No. 000010 in Sec. 510.600(c) of this chapter for 
the 250-milligram chlortetracycline hydrochloride bolus; see No. 053501 
for the 25-milligram tablet and the 500 milligram bolus.
    (c) Related tolerances. See Sec. 556.150 of this chapter.
    (d) National Academy of Sciences/National Research Council NAS/NRC) 
status. The conditions of use specified in this section were NAS/NRC 
reviewed and found effective. Applications for these uses need not 
include effectiveness data as specified in Sec. 514.111 of this chapter 
but may require bioequivalency and safety information.
    (e) Conditions of use. Calves--(1) Amount. One 250 milligram bolus 
per 50 pounds of body weight twice a day for 3 to 5 days.
    (i) Indications for use. Treatment of bacterial enteritis (scours) 
caused by Escherichia coli and bacterial pneumonia associated with 
Pasteurella spp., Klesbsiella spp., and Hemophilus spp.
    (ii) Limitations. Administer bolus directly by mouth or crush and 
dissolve in milk or water for drenching or bucket feeding; if no 
improvement is noted after 3 days of treatment, consult a veterinarian; 
do not use for more than 5 days; do not administer within 24 hours of 
slaughter.
    (2) Amount. One 25 milligram tablet for each 5 pounds of body weight 
every 12 hours daily for 3 to 5 days.
    (i) Indications for use. Control and treatment of bacterial 
enteritis (scours) caused by E. coli and Salmonella spp. and bacterial 
pneumonia associated with Pasteurella spp., Hemophilus spp., and 
Klebsiella spp., susceptible to chlortetracycline.
    (ii) Limitations. Administer tablet directly by mouth or crush and 
dissolve in water for drenching; if no improvement is noted after 3 days 
of treatment, consult a veterinarian; do not use for more than 5 days; 
when feeding milk or milk replacer, administration 1 hour before or 2 
hours after feeding; do not administer within 24 hours of slaughter.
    (3) Amount. One 500 milligram bolus per 100 pounds of body weight 
twice a day for 3 to 5 days.
    (i) Indications for use. Treatment of bacterial enteritis (scours) 
caused by E. coli and Salmonella spp., and bacterial pneumonia 
associated with Pasteurella spp., Hemophilus spp., and Klebsiella spp., 
susceptible to chlortetracycline.
    (ii) Limitations. Administer directly by mouth or crush and dissolve 
in water for drenching; if no improvement is noted after 3 days of 
treatment, consult a veterinarian; do not use for more than 5 days; do 
not administer within 24 hours of slaughter.

[57 FR 37325, Aug. 18, 1992, as amended at 67 FR 78355, Dec. 24, 2002]



Sec. 520.446  Clindamycin capsules and tablets.

    (a) Specifications--(1) Each capsule contains the equivalent of 25, 
75, 150, or 300 milligrams (mg) clindamycin as the hydrochloride salt.
    (2) Each tablet contains the equivalent of 25, 75, or 150 mg 
clindamycin as the hydrochloride salt.
    (3) Each capsule contains the equivalent of 25, 75, or 150 mg 
clindamycin as the hydrochloride salt.
    (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter as 
follows:
    (1) Nos. 000009 and 059130 for use of capsules described in 
paragraph (a)(1) of this section.
    (2) No. 051311 for use of tablets described in paragraph (a)(2) of 
this section.

[[Page 143]]

    (3) No. 043806 for use of tablets described in paragraph (a)(3) of 
this section.
    (c) Conditions of use in dogs--(1) Amount. Wounds, abscesses, and 
dental infections: 2.5 to 15 mg per pound (/lb) body weight every 12 
hours for a maximum of 28 days. Osteomyelitis: 5.0 to 15 mg/lb body 
weight every 12 hours for a minimum of 28 days.
    (2) Indications for use. For the treatment of skin infections 
(wounds and abscesses) due to susceptible strains of coagulase-positive 
staphylococci (Staphylococcus aureus or S. intermedius), deep wounds and 
abscesses due to susceptible strains of Bacteroides fragilis, Prevotella 
melaninogenicus, Fusobacterium necrophorum, and Clostridium perfringens, 
dental infections due to susceptible strains of S. aureus, B. fragilis, 
P. melaninogenicus, F. necrophorum, and C. perfringens, and 
osteomyelitis due to susceptible strains of S. aureus, B. fragilis, P. 
melaninogenicus, F. necrophorum, and C. perfringens.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[67 FR 54954, Aug. 27, 2002, as amended at 68 FR 55824, Sept. 29, 2003; 
69 FR 32273, June 9, 2004; 71 FR 39204, July 12, 2006; 73 FR 4077, Jan. 
24, 2008]



Sec. 520.447  Clindamycin solution.

    (a) Specifications. Each milliliter of solution contains the 
equivalent of 25 milligrams (mg) clindamycin as the hydrochloride salt.
    (b) Sponsors. See Nos. 000009, 051311, 058829, and 059130 in Sec. 
510.600(c) of this chapter.
    (c) Special considerations. Federal law restricts this drug to use 
by  or on the order of a licensed veterinarian.
    (d) Conditions of use--(1) Dogs--(i) Amount. Wounds, abscesses, and 
dental infections: 2.5 to 15 mg per pound (/lb) body weight every 12 
hours for a maximum of 28 days. Osteomyelitis: 5.0 to 15 mg/lb body 
weight every 12 hours for a minimum of 28 days.
    (ii) Indications for use. For the treatment of skin infections 
(wounds and abscesses) due to susceptible strains of coagulase-positive 
staphylococci (Staphylococcus aureus or S. intermedius), deep wounds and 
abscesses due to susceptible strains of Bacteroides fragilis, Prevotella 
melaninogenicus, Fusobacterium necrophorum, and Clostridium perfringens; 
dental infections due to susceptible strains of S. aureus, B. fragilis, 
P. melaninogenicus, F. necrophorum, and C. perfringens; and 
osteomyelitis due to susceptible strains of S. aureus, B. fragilis, P. 
melaninogenicus, F. necrophorum, and C. perfringens.
    (2) Cats--(i) Amount. 5.0 to 15.0 mg/lb body weight every 24 hours 
for a maximum of 14 days.
    (ii) Indications for use. For the treatment of skin infections 
(wounds and abscesses) due to susceptible strains of Staphylococcus 
aureus, S. intermedius, Streptococcus spp.; deep wounds and abscesses 
due to susceptible strains of Clostridium perfringens and Bacteroides 
fragilis; and dental infections due to susceptible strains of S. aureus, 
S. intermedius, Streptococcus spp., C. perfringens, and B. fragilis.

[67 FR 54954, Aug. 27, 2002, as amended at 67 FR 78684, Dec. 26, 2002; 
68 FR 55824, Sept. 29, 2003; 69 FR 31734, June 7, 2004; 71 FR 39543, 
July 13, 2006; 72 FR 19796, Apr. 20, 2007]



Sec. 520.452  Clenbuterol syrup.

    (a) Specifications. Each milliliter contains 72.5 micrograms of 
clenbuterol hydrochloride.
    (b) Sponsor. See 000010 in Sec. 510.600(c) of this chapter.
    (c) [Reserved]
    (d) Conditions of use--(1) Horses--(i) Amount. Administer orally 
twice a day (b.i.d.). Initial dose is 0.5 milliliter per 100 pounds body 
weight (0.8 micrograms per kilogram) for 3 days (6 treatments). If no 
improvement, administer 1 milliliter per 100 pounds (1.6 micrograms per 
kilogram) for 3 days (6 treatments). If no improvement, administer 1.5 
milliliters per 100 pounds (2.4 micrograms per kilogram) for 3 days (6 
treatments). If no improvement, administer 2.0 milliliters per 100 
pounds (3.2 micrograms per kilogram) for 3 days (6 treatments). If no 
improvement, horse is nonresponder to clenbuterol and treatment should 
be discontinued.
    (ii) Indications for use. Indicated for the management of horses 
affected with airway obstruction, such as occurs in chronic obstructive 
pulmonary disease (COPD).

[[Page 144]]

    (iii) Limitations. Treat at effective dose for 30 days. At the end 
of the 30-day treatment period, drug should be withdrawn. If signs 
return, the 30-day treatment period may be repeated. If repeating 
treatment, the step-wise dosage schedule should be repeated. The effect 
of this drug on breeding stallions and brood mares has not been 
determined. Treatment starting with dosages higher than the initial dose 
is not recommended. Federal law prohibits the extralabel use of this 
drug in food animals. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) [Reserved]

[63 FR 41419, Aug. 4, 1998]



Sec. 520.455  Clomipramine tablets.

    (a) Specifications. Each tablet contains 5, 20, 40, or 80 milligrams 
(mg) clomipramine hydrochloride.
    (b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. 2 to 4 milligrams of clomipramine 
hydrochloride per kilogram (0.9 to 1.8 milligrams per pound) of body 
weight per day, administered as a single daily dose or divided twice 
daily.
    (2) Indications for use. For use as part of a comprehensive 
behavioral management program to treat separation anxiety in dogs 
greater than 6 months of age.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[64 FR 1762, Jan. 12, 1999, as amended at 72 FR 262, Jan. 4, 2007]



Sec. 520.462  Clorsulon drench.

    (a) Specifications. The drug is a suspension containing 8.5 percent 
clorsulon (85 milligrams per milliliter).
    (b) Sponsor. See No. 050604 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use. Cattle--(1) Amount. One-quarter fluid ounce 
per 200 pounds of body weight (7 milligrams per kilogram or 3.2 
milligrams per pound of body weight).
    (2) Indications for use. For the treatment of immature and adult 
liver fluke (Fasciola hepatica) infestations in cattle.
    (3) Limitations. Using dose syringe, deposit drench over back of 
tongue. Do not treat cattle within 8 days of slaughter. Because a 
withdrawal time in milk has not been established, do not use in female 
dairy cattle of breeding age. Consult your veterinarian for assistance 
in the diagnosis, treatment, and control of parasitism.

[50 FR 10221, Mar. 14, 1985, as amended at 62 FR 63270, Nov. 28, 1997]



Sec. 520.522  Cyclosporine.

    (a) Specifications. Each capsule contains 10, 25, 50, or 100 
milligrams (mg) cyclosporine.
    (b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
    (c) [Reserved]
    (d) Conditions of use in dogs--(1) Amount. 5 mg per kilogram of body 
weight given orally as a single daily dose for 30 days. Following this 
initial daily treatment period, the dosage may be tapered by decreasing 
the frequency of administration to every other day or two times a week, 
until a minimum frequency is reached which will maintain the desired 
therapeutic effect.
    (2) Indications for use. For the control of atopic dermatitis in 
dogs weighing at least 4 pounds body weight.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[68 FR 54804, Sept. 19, 2003]



Sec. 520.530  Cythioate oral liquid.

    (a) Specifications. Each milliliter contains 15 milligrams of 
cythioate.
    (b) Sponsor. See Nos. 000859 and 053501 in Sec. 510.600 of this 
chapter.
    (c) Special considerations. Cythioate is a cholinesterase inhibitor. 
Do not use this product in animals simultaneously with or within a few 
days before or after treatment with or exposure to cholinesterase-
inhibiting drugs, insecticides, pesticides, or chemicals.
    (d) Conditions of use--(1) Amount. 15 milligrams cythioate per 10 
pounds of body weight every third day or twice a week.
    (2) Indications for use. Dogs, for control of fleas.
    (3) Limitations. For oral use in dogs only. Do not use in greyhounds 
or in animals that are pregnant, sick, under

[[Page 145]]

stress, or recovering from surgery. Federal law restricts this drug to 
use by or on the order of a licensed veterinarian.

[49 FR 5614, Feb. 14, 1984, as amended at 67 FR 78355, Dec. 24, 2002]



Sec. 520.531  Cythioate tablets.

    (a) [Reserved]
    (b) Sponsors. See No. 000859 in Sec. 510.600(c) of this chapter for 
use of 30- and 90-milligram (mg) tablets and see No. 053501 in Sec. 
510.600(c) of this chapter for use of 30-mg tablet.
    (c) Special considerations. Cythioate is a cholinesterase inhibitor. 
Do not use this product in animals simultaneously with or within a few 
days before or after treatment with or exposure to cholinesterase-
inhibiting drugs, insecticides, pesticides, or chemicals.
    (d) Conditions of use--(1) Amount. 30 milligrams cythioate per 20 
pounds of body weight every third day or twice a week.
    (2) Indications for use. Dogs, for control of fleas.
    (3) Limitations. For oral use in dogs only. Do not use in greyhounds 
or in animals that are pregnant, sick, under stress, or recovering from 
surgery. Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.

[49 FR 5615, Feb. 14, 1984, as amended at 59 FR 26942, May 25, 1994; 67 
FR 78355, Dec. 24, 2002]



Sec. 520.534  Decoquinate.

    (a) Specifications. The drug is a powder containing 0.8 percent 
decoquinate.
    (b) Sponsor. See No. 046573 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.170 of this chapter.
    (d) Conditions of use. Calves--(1) Amount. Feed 22.7 milligrams per 
100 pounds of body weight (0.5 milligram per kilogram) per day.
    (2) Indications for use. For the prevention of coccidiosis in 
ruminating and nonruminating calves, including veal calves, caused by 
Eimeria bovis and E. zuernii.
    (3) Limitations. Feed in whole milk at the rate of 22.7 milligrams 
per 100 pounds body weight daily (0.5 milligram per kilogram) for at 
least 28 days.

[64 FR 10103, Mar. 2, 1999, as amended at 64 FR 30386, June 8, 1999]



Sec. 520.538  Deracoxib.

    (a) Specifications. Each chewable tablet contains 25, 75, or 100 
milligrams (mg) deracoxib.
    (b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
    (c) [Reserved]
    (d) Conditions of use in dogs--(1) Amount. Administer orally as 
needed, as a single daily dose based on body weight.
    (i) 1 to 2 mg/kilograms (kg) (0.45 to 0.91 mg/pound (lb), for use as 
in paragraph (d)(2)(i) of this section.
    (ii) 3 to 4 mg/kg (1.4 to 1.8 mg/lb) for up to 7 days, for use as in 
paragraph (d)(2)(ii) of this section.
    (2) Indications for use. (i) For the control of pain and 
inflammation associated with osteoarthritis.
    (ii) For the control of postoperative pain and inflammation 
associated with orthopedic surgery in dogs weighing 4 or more pounds 
(1.8 kg).
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[67 FR 68760, Nov. 13, 2002, as amended at 68 FR 18882, Apr. 17, 2003; 
72 FR 37437, July 10, 2007]



Sec. 520.540  Dexamethasone oral dosage forms.



Sec. 520.540a  Dexamethasone powder.

    (a) Specifications. Dexamethasone powder is packaged in packets 
containing 10 milligrams of dexamethasone.
    (b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use. (1) Dexamethasone powder is indicated in 
cases where cattle and horses require additional steroid therapy 
following its parenteral administration. The drug is used as supportive 
therapy for management or inflammatory conditions such as acute 
arthritic lameness, and for various stress conditions where 
corticosteroids are required while the animal is being treated for a 
specific condition.
    (2) The drug is administered at a dosage level of 5 to 10 milligrams 
per animal the first day then 5 milligrams per day as required by drench 
or by sprinkling on a small amount of feed.
    (3) Clinical and experimental data have demonstrated that 
corticosteroids

[[Page 146]]

administered orally or parenterally to animals may induce the first 
stage of parturition when administered during the last trimester of 
pregnancy and may precipitate premature parturition followed by 
dystocia, fetal death, retained placenta, and metritis.
    (4) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian. A withdrawal period has not been established for 
this product in preruminating calves. Do not use in calves to be 
processed for veal.

[40 FR 13838, Mar. 27, 1975; 41 FR 9149, Mar. 3, 1976; 52 FR 7832, Mar. 
13, 1987; 70 FR 16934, Apr. 4, 2005]



Sec. 520.540b  Dexamethasone tablets and boluses.

    (a)(1) Specifications. Each bolus is half-scored and contains 10 
milligrams of dexamethasone.
    (2) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
    (3) Conditions of use. (i) Dexamethasone bolus is indicated in cases 
where cattle and horses require additional steroid therapy following its 
parenteral administration. The drug may be used as supportive therapy 
for management of inflammatory conditions such as acute arthritic 
lamenesses, and for various stress conditions where corticosteroids are 
required while the animal is being treated for a specific condition.
    (ii) Administered orally, 5 to 10 milligrams for the first day, then 
5 milligrams per day as required.
    (iii) Do not use in viral infections during the viremic stage. With 
bacterial infections, appropriate antibacterial therapy should be used.
    (iv) Do not use in animals with chronic nephritis and 
hypercorticalism (cushingoid syndrome), except for emergency therapy.
    (v) Clinical and experimental data have demonstrated that 
corticosteroids administered orally or by injection to animals may 
induce the first stage of parturition when administered during the last 
trimester of pregnancy and may precipitate premature parturition 
followed by dystocia, fetal death, retained placenta, and metritis.
    (vi) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian. A withdrawal period has not been established for 
this product in preruminating calves. Do not use in calves to be 
processed for veal.
    (b)(1) Specifications. Each tablet contains 0.25 milligram of 
dexamethasone.\1\
    (2) Sponsors. See Nos. 000061 and 061623 in Sec. 510.600(c) of this 
chapter.
    (3) Conditions of use--(i) Amount. Dogs: Administer orally at 0.25 
to 1.25 milligrams per day for up to 7 days. Cats: 0.125 to 0.5 
milligram per day for up to 7 days.\1\
    (ii) Indications for use. In treatment of dogs and cats as an anti-
inflammatory agent.\1\
---------------------------------------------------------------------------

    \1\ These conditions are NAS/NRC reviewed and deemed effective. 
Applications for these uses need not include effectiveness data as 
specified by Sec. 514.111 of this chapter.
---------------------------------------------------------------------------

    (iii) Limitations. (a) Clinical and experimental data have 
demonstrated that corticosteriods administered orally or by injection to 
animals may induce the first stage of parturition when administered 
during the last trimester of pregnancy; and they may precipitate 
premature parturition followed by dystocia, fetal death, retained 
placenta, and metritis.
    (b) Do not use in viral infections. Anti-inflammatory action of 
corticosteroids may mask signs of infections. Do not use in animals with 
tuberculosis, chronic nephritis, cushingoid syndrome, or peptic ulcers, 
except for emergency therapy.\1\
    (c) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.\1\

[40 FR 26273, June 23, 1975, as amended at 44 FR 7130, Feb. 6, 1979; 50 
FR 49372, Dec. 2, 1985; 52 FR 7832, Mar. 13, 1987; 55 FR 8461, Mar. 8, 
1990; 66 FR 14073, Mar. 9, 2001; 68 FR 4914, Jan. 31, 2003; 70 FR 16934, 
Apr. 4, 2005]



Sec. 520.540c  Dexamethasone chewable tablets.

    (a) Specifications. Each half-scored tablet contains 0.25 milligram 
of dexamethasone.\1\
    (b) Sponsor. See No. 000069 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. 0.25 to 1.25 milligrams per 
day.\1\
    (2) Indications for use. Supportive therapy in nonspecific 
dermatosis and inflammatory conditions in dogs.\1\

[[Page 147]]

    (3) Limitations. (i) Administer by free-choice feeding or crumble 
over food. Administer 0.25 to 1.25 milligrams daily in single or two 
divided doses until response is noted or 7 days have elapsed. When 
response is attained, dosage should be gradually reduced by 0.125 
milligram per day until maintenance level is achieved.
    (ii) Clinical and experimental data have demonstrated that 
corticosteriods administered orally or parenterally to animals may 
induce the first stage of parturition when administered during the last 
trimester of pregnancy; and they may precipitate premature parturition 
followed by dystocia, fetal death, retained placenta, and metritis.
    (iii) Do not use in viral infections. Anti-inflammatory action of 
corticosteriods may mask signs of infection. Do not use in animals with 
tuberculosis, chronic nephritis, cushingoid syndrome, or peptic ulcers, 
except for emergency therapy.\1\
    (iv) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.

[44 FR 7130, Feb. 6, 1979, as amended at 56 FR 50653, Oct. 8, 1991; 60 
FR 55659, Nov. 2, 1995]



Sec. 520.550  Dextrose/glycine/electrolyte.

    (a) Specifications. The product is distributed in packets each of 
which contains the following ingredients: sodium chloride 8.82 grams, 
potassium phosphate 4.20 grams, citric acid anhydrous 0.5 gram, 
potassium citrate 0.12 gram, aminoacetic acid (glycine) 6.36 grams, and 
dextrose 44.0 grams.
    (b) Sponsor. See No. 000069 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use. (1) Dextrose/glycine/electrolyte is indicated 
for use in the control of dehydration associated with diarrhea (scours) 
in calves. It is used as an early treatment at the first signs of 
scouring. It may also be used as followup treatment following 
intravenous fluid therapy.
    (2) Dissolve each packet in two quarts of warm water and administer 
to each calf as follows:
    (i) Scouring and/or dehydrated calves. Feed 2 quarts of solution, 
twice daily for 2 days (four feedings). No milk or milk replacer should 
be fed during this period. For the next four feedings (days 3 and 4), 
use 1 quart of solution together with 1 quart of milk replacer. 
Thereafter, feed as normal.
    (ii) Newly purchased calves. Feed 2 quarts of solution instead of 
milk as the first feed upon arrival. For the next scheduled feeding, use 
1 quart of solution mixed together with 1 quart of milk or milk 
replacer. Thereafter, feed as normal.
    (3) The product should not be used in animals with severe 
dehydration (down, comatose, or in a state of shock). Such animals need 
intravenous therapy. Oral therapy in these cases is too slow. Animals 
which cannot drink after initial intravenous therapy may need to be 
dosed with a stomach tube or esophageal tube. Adequate colostrum intake 
during the first 12 hours is essential for healthy, vigorous calves. 
Antibacterial therapy is often indicated in bacterial scours due to E. 
coli and/or Salmonella. The product does not contain antibacterial 
agents. A veterinarian should be consulted in severely scouring calves 
or cases requiring antibacterial therapy. The product is not 
nutritionally complete if administered by itself for long periods of 
time. It should not be administered beyond the recommended treatment 
period without the addition of milk or milk replacer.

[48 FR 38606, Aug. 25, 1983, as amended at 56 FR 50653, Oct. 8, 1991; 60 
FR 55659, Nov. 2, 1995]



Sec. 520.563  Diatrizoate meglumine and diatrizoate sodium oral solution.

    (a) Specifications. Diatrizoate meglumine oral solution is a water 
soluble radiopaque medium containing 66 percent diatrizoate meglumine 
and 10 percent diatrizoate sodium.
    (b) Sponsor. See No. 053501 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use. (1) It is indicated for radiography of the 
gastrointestinal tract in dogs and cats.
    (2) It is administered orally at a dosage level of 0.5 to 1.0 
milliliter per pound of body weight by gavage or stomach tube. It is 
administered rectally at a dosage level of 0.5 to 1.0 milliliter per 
pound of body weight diluted with 1 part of the drug to 5 parts of 
water.

[[Page 148]]

    (3) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.

[44 FR 12993, Mar. 9, 1979, as amended at 50 FR 41489, Oct. 11, 1985]



Sec. 520.580  Dichlorophene and toluene capsules.

    (a) Specifications. Each soft gelatin capsule contains 50 milligrams 
of dichlorophene and 60 milligrams of toluene or multiples thereof.
    (b) Sponsor. (1) For single dose only, see 000010, 000061, 000842, 
010237, 017135, 023851, 051311, and 058670 in Sec. 510.600(c) of this 
chapter.
    (2) For single and multiple dose, see 000010, 000061, and 038782 in 
Sec. 510.600(c) of this chapter.
    (c) Required statement. Consult your veterinarian for assistance in 
the diagnosis, treatment, and control of parasitism, and before 
administering to weak or debilitated animals.
    (d) Conditions of use--(1) Amount. (i) Single dose of 100 milligrams 
of dicholorophene and 120 milligrams of toluene per pound of body 
weight.
    (ii) Divided dose of 100 milligrams of dichlorophene and 120 
milligrams of toluene per 5 pounds of body weight (20 and 24 milligrams 
per pound) daily for 6 days.
    (2) Indications for use. It is used for the removal of ascarids 
(Toxocara canis and Toxascaris leonina) and hookworms (Ancylostoma 
caninum and Uncinaria stenocephala) and as an aid in removing tapeworms 
(Taenia pisiformis, Dipylidium caninum, and Echinococcus granulosus) 
from dogs and cats.
    (3) Limitations. Withhold solid foods and milk for at least 12 hours 
prior to medication and for 4 hours afterward. Repeat treatment in 2 to 
4 weeks in animals subject to reinfection.

[45 FR 10332, Feb. 15, 1980]

    Editorial Note: For Federal Register citations affecting Sec. 
520.580, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and on GPO Access.



Sec. 520.581  Dichlorophene tablets.

    (a) Specifications. Each tablet contains 1 gram of dichlorophene.
    (b) Sponsor. See 023851 in Sec. 510.600(c) of this chapter.
    (c) Required statement. Consult your veterinarian for assistance in 
the diagnosis, treatment, and control of parasitism, and before 
administering to weak or debilitated animals.
    (d) Conditions of use. Dogs--(1) Amount. Single dose of 1 tablet (1 
gram of dichlorophene) for each 10 pounds of body weight.
    (2) Indications for use. It is used as an aid in the removal of 
tapeworms (Taenia pisiformis and Dipylidium caninum).
    (3) Limitations. Withhold solid foods and milk for at least 12 hours 
prior to medication and for 4 hours afterward.

[45 FR 10333, Feb. 15, 1980]



Sec. 520.600  Dichlorvos.

    (a) Chemical name. 2,2-Dichlorvinyl dimethyl phosphate.
    (b) [Reserved]
    (c) Sponsor. See No. 000010 in Sec. 510.600(c) of this chapter.
    (d) Related tolerances. See Sec. 556.180 of this chapter.
    (e) Conditions of use in swine. (1) It is recommended for the 
removal and control of sexually mature (adult), sexually immature and/or 
4th stage larvae of the whipworm (Trichuris suis), nodular worms 
(Oesophagostomum spp.), large round-worm (Ascaris suum), and the mature 
thick stomach worm (Ascarops strongylina) occurring in the lumen of the 
gastrointestinal tract of pigs, boars, and open or bred gilts and sows.
    (2) The preparation should be added to the indicated amount of feed 
as set forth in paragraph (e)(2) of this section and administered 
shortly after mixing, as follows:

------------------------------------------------------------------------
                                                  Pounds of
                                     Pounds of   mixed feed    Number of
                                    feed to be      to be     pigs to be
    Weight of animal in pounds      mixed with  administered    treated
                                     each 0.08   to each pig   per 0.08
                                     ounce of    as a single   ounce of
                                    dichlorvos    treatment   dichlorvos
------------------------------------------------------------------------
20-30.............................           4         0.33           12
31-40.............................           5         0.56            9
41-60.............................           6         1.00            6
61-80.............................           5         1.00            5
81-100............................           4         1.00            4
Adult Gilts, Sows, and Boars......          16         4.00            4
------------------------------------------------------------------------

    (3) Do not use this product on animals either simultaneously or 
within a

[[Page 149]]

few days before or after treatment with or exposure to cholinesterase 
inhibiting drugs, pesticides, or chemicals. The preparation should be 
mixed thoroughly with the feed on a clean, impervious surface. Do not 
allow swine access to feed other than that containing the preparation 
until treatment is complete. Do not treat pigs with signs of scours 
until these signs subside or are alleviated by proper medication. Resume 
normal feeding schedule afterwards. Swine may be retreated in 4 to 5 
weeks.
    (f) Conditions of use in dogs. (1) For removal of Toxocara canis and 
Toxascaris leonina (roundworms), Ancylostoma caninum and Uncinaria 
stenocephala (hookworms), and Trichuris vulpis (whipworm) residing in 
the lumen of the gastrointestinal tract.
    (2) The drug is in capsule form for direct administration and in 
pellet form for administration in about one-third of the regular canned 
dog food ration or in ground meat. Dogs may be treated with any 
combination of capsules and/or pellets so that the animal receives a 
single dose equaling 12 to 15 milligrams of the active ingredient per 
pound of body weight. One-half of the single recommended dosage may be 
given, and the other half may be administered 8 to 24 hours later. This 
split dosage schedule should be used in animals which are very old, 
heavily parasitized, anemic, or otherwise debilitated. The drug should 
not be used in dogs weighing less than 2 pounds.
    (3) In some dogs, efficacy against Trichurias vulpis (whipworm) may 
be erratic. Dogs that do not develop a negative stool for Trichuris 
vulpis ova 10 to 14 days following initial treatment should be re-
treated. If a negative stool is not obtained in 10 to 14 days following 
re-treatment, alternate means of therapy should be considered.
    (4) Do not use in dogs infected with Dirofilaria immitis.
    (5) Do not use with other anthelmintics, taeniacides, antifilarial 
agents, muscle relaxants, or tranquilizers.
    (6) The drug is a cholinesterase inhibitor. Not for use 
simultaneously or within a few days before or after treatment with or 
exposure to cholinesterase-inhibiting drugs, pesticides, or chemicals.
    (7) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.
    (g) Conditions of use in horses when administered in grain. (1) It 
is recommended for the removal and control of bots (Gastrophilus 
intestinalis, G. nasalis), large strongyles (Strongylus vulgaris, S. 
equinus, S. edentatus), small strongyles (of the genera Cyathostomum, 
Cylicocercus, Cylicocyclus, Cylicodontophorus, Triodontophorus, 
Poteriostomum, Gyalocephalus), pinworms (Oxyuris equi), and large 
roundworm (Parascaris equorum) in horses including ponies and mules. Not 
for use in foals (sucklings and young weanlings).
    (2) For a satisfactory diagnosis, a microscopic fecal examination 
should be performed by a veterinarian or a diagnostic laboratory prior 
to worming.
    (3) It is administered in the grain portion of the ration at a 
dosage of 14.2 milligrams to 18.5 milligrams per pound of body weight as 
a single dose. It may be administered at one-half of the single 
recommended dosage and repeated 8 to 12 hours later in the treatment of 
very aged, emaciated or debilitated subjects or those reluctant to 
consume medicated feed. In suspected cases of severe ascarid infection 
sufficient to cause concern over mechanical blockage of the intestinal 
tract, the split dosage should be utilized.
    (4) Do not use in horses which are severely debilitated, suffering 
from diarrhea or severe constipation, infectious disease, toxemia or 
colic. Do not administer in conjunction with or within 1 week of 
administration of muscle relaxant drugs, phenothiazine derived 
tranquilizers or central nervous system depressant drugs. Horses should 
not be subjected to insecticide treatment for 5 days prior to or after 
treating with the drug. Do not administer to horses afflicted with 
chronic alveolar emphysema (heaves) or related respiratory conditions. 
The product is a cholinesterase inhibitor and should not be used 
simultaneously or within a few days before or after treatment with or 
exposure to cholinesterase inhibiting drugs, pesticides or chemicals.

[[Page 150]]

    (5) Do not use in animals other than horses, ponies, and mules. Do 
not use in horses, ponies, and mules intended for food purposes. Do not 
allow fowl access to feed containing this preparation or to fecal 
excrement from treated animals.
    (h) Conditions of use in horses when administered orally by syringe. 
(1) It is recommended for the removal and control of first, second, and 
third instar bots (Gastrophilus intestinalis and G. nasalis), sexually 
mature and sexually immature (4th stage) ascarids (Parascaris equorum) 
in horses and foals.
    (2) The product is in the form of a gel which is administered 
directly from a syringe onto the horse's tongue. The product is 
administered at a dosage level of 20 milligrams of dichlorvos per 
kilogram of body weight for the removal of bots and ascarids. The same 
dosage level is repeated every 21 to 28 days for the control of bots and 
ascarids. For the control of bots only, the repeat dosage is 10 
milligrams per kilogram of body weight every 21 to 28 days during bot 
fly season.
    (3) Do not use this product in animals simultaneously or within a 
few days before or after treatment with or exposure to cholinesterase-
inhibiting drugs, pesticides or chemicals. Do not administer in 
conjunction with or within 1 week of administration of muscle-relaxant 
drugs, phenothiazine derived tranquilizers, or central nervous system 
depressants.
    (4) Do not use in horses which are severly debilitated or suffering 
from diarrhea or severe constipation, infectious disease, toxemia, or 
colic. Do not administer to horses affected with chronic alveolar 
emphysema (heaves) or other respiratory conditions.
    (5) Do not use in horses intended for food purposes.
    (6) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.
    (i) Conditions of use in dogs, cats, puppies, and kittens. (1) Each 
tablet contains 2, 5, 10, or 20 milligrams of dichlorvos.
    (2) It is administered orally at 5 milligrams of dichlorvos per 
pound of body weight.
    (3) Dogs and puppies: Removal and control of intestinal roundworms 
(Toxocara canis and Toxascaris leonina) and hookworms (Ancylostoma 
caninum and Uncinaria stenocephala).
    (4) Cats and kittens: Removal and control of intestinal roundworms 
(Toxocara cati and Toxascaris leonina) and hookworms (Ancylostoma 
tubaeforme and Uncinaria stenocephala).
    (5) Dichlorvos is a cholinesterase inhibitor. Do not use 
simultaneously with or within a few days before or after treatment with 
or exposure to cholinesterase-inhibiting drugs, pesticides, or 
chemicals.
    (6) Do not use in animals under 10 days of age or 1 pound of body 
weight.
    (7) Do not administer to animals showing signs of constipation, 
mechanical blockage of the intestinal tract, impaired liver function, or 
recently exposed to or showing signs of infectious disease.
    (8) Do not use in dogs or puppies infected with Dirofilaria immitis.
    (9) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.

[40 FR 13838, Mar. 27, 1975, as amended at 48 FR 40704, Sept. 9, 1983; 
51 FR 28546, Aug. 8, 1986; 62 FR 35076, June 30, 1997; 64 FR 18571, Apr. 
15, 1999]



Sec. 520.606  Diclazuril.

    (a) Specifications. Each 100 grams (g) of pellets contain 1.56 g 
diclazuril.
    (b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in horses--(1) Amount. Administer 1 milligram 
(mg) per kilogram (0.45 mg per pound) of body weight in the daily grain 
ration for 28 days.
    (2) Indications for use. For the treatment of equine protozoal 
myeloencephalitis (EPM) caused by Sarcocystis neurona.
    (3) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

[72 FR 20943, Apr. 27, 2007]



Sec. 520.608  Dicloxacillin sodium monohydrate capsules.

    (a) Specifications. Each capsule contains dicloxacillin sodium 
monohydrate equivalent to 50, 100, 200, or 500 milligrams of 
dicloxacillin.

[[Page 151]]

    (b) Sponsor. See No. 000856 in Sec. 510.600 (c) of this chapter.
    (c) Conditions of use. Dogs--(1) Amount. 5 to 10 milligrams per 
pound of body weight, three times daily. In severe cases, up to 25 
milligrams per pound of body weight three times daily.
    (2) Indications for use. Treatment of pyoderma (pyogenic dermatitis) 
due to penicillinase-producing staphylococci sensitive to the drug.
    (3) Limitations. For the treatment of dogs only. Continue treatment 
for 24 to 48 hours after the animal has become afebrile or asymptomatic, 
Administer 1 to 2 hours before feeding to ensure maximum absorption. Not 
for use in animals which are raised for food production. Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.

[57 FR 37325, Aug. 18, 1992]



Sec. 520.620  Diethylcarbamazine oral dosage forms.



Sec. 520.622  Diethylcarbamazine citrate oral dosage forms.



Sec. 520.622a  Diethylcarbamazine citrate tablets.

    (a) Sponsors. (1) See 015579 in Sec. 510.600(c) of this chapter for 
use of 50, 200, and 400 milligram tablets for prevention of heartworm 
disease in dogs and as an aid in the treatment of ascarid infections in 
dogs and cats.
    (2) See 053501 in Sec. 510.600(c) of this chapter for use of 100, 
200, and 300 milligram tablets for prevention of heartworm disease in 
dogs and as an aid in the treatment of ascarid infections in dogs.
    (3) See 061623 in Sec. 510.600(c) of this chapter for use of 50, 
100, 200, 300, or 400 milligram tablets for prevention of heartworm 
disease in dogs, as an aid in the control of ascarid infections in dogs, 
and as an aid in the treatment of ascarid infections in dogs and cats.
    (4) See 017030 in Sec. 510.600(c) of this chapter for use of 50, 
100, 200, 300, and 400 milligram tablets for prevention of heartworm 
disease in dogs and as an aid in the treatment of ascarid infections in 
dogs and cats.
    (5) See 000081 in Sec. 510.600(c) of this chapter for use of 60, 
120, or 180 milligram tablets for prevention of heartworm disease in 
dogs, as an aid in the control of ascarid infections in dogs, and as an 
aid in the treatment of ascarid infections in dogs and cats.
    (6) See No. 000010 in Sec. 510.600(c) of this chapter for use of 
50, 100, 200, 300, or 400 milligram tablets for prevention of heartworm 
disease in dogs, as an aid in the control of ascarid infections in dogs, 
and as an aid in the treatment of ascarid infections in dogs and cats.
    (b) Conditions of use--(1) Dosage/indications for use. (i) Three 
milligrams per pound of body weight daily for prevention of heartworm 
disease (Dirofilaria immitis) in dogs.
    (ii) Three milligrams per pound of body weight daily as an aid in 
the control of ascarid infections (Toxocara canis) in dogs.
    (iii) Twenty-five to 50 milligrams per pound of body weight as an 
aid in the treatment of ascarid infections in dogs (Toxocara canis) and 
cats (Toxocara canis and Toxascaris leonina).
    (2) Limitations. Administer orally either pulverized and given in 
feed or water or directly by mouth. For the treatment of ascarid 
infections, repeat in 10 to 20 days to remove immature worms that may 
enter the intestine from the lungs after the first dose. Do not treat 
dogs with established heartworm infections until they have been 
converted to a negative status by the use of adulticidal and 
microfilaricidal drugs. Inadvertent administration to heartworm-infected 
dogs may cause adverse reactions because of pulmonary occlusion. 
Overdosage may cause emesis. For prevention of heartworm disease in 
heartworm-endemic areas, administration of the drug should start at the 
beginning of mosquito activity and be continued daily throughout the 
mosquito season and for approximately a month thereafter. Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.

[46 FR 23230, Apr. 24, 1981, as amended at 46 FR 41038, Aug. 14, 1981; 
46 FR 46315, Sept. 18, 1981; 46 FR 61653, Dec. 18, 1981; 47 FR 10805, 
Mar. 12, 1982; 47 FR 14150, Apr. 2, 1982; 50 FR 41489, Oct. 11, 1985; 50 
FR 49372, Dec. 2, 1985; 53 FR 40056, Oct. 13, 1988; 53 FR 40727, Oct. 
18, 1988; 55 FR 8461, Mar. 8, 1990; 61 FR 34728, July 3, 1996; 62 FR 
35076, June 30, 1997; 66 FR 14073, Mar. 9, 2001; 68 FR 4914, Jan. 31, 
2003]

[[Page 152]]



Sec. 520.622b  Diethylcarbamazine citrate syrup.

    (a)(1) Specifications. Each milliliter of syrup contains 60 
milligrams of diethylcarbamazine citrate.
    (2) Sponsor. See No. 053501 in Sec. 510.600(c) of this chapter.
    (3) Conditions of use. (i) The drug is indicated for use in dogs for 
the prevention of infection with Dirofilaria immitis and T. canis and T. 
leonina. It is also indicated for treatment of ascarid infections of T. 
canis and T. leonina in dogs and T. cati in cats.
    (ii) For prevention of heartworm and ascarid infections in dogs, the 
drug may be added to the daily diet at a dosage rate of 3.0 milligrams 
per pound of body weight per day or given directly by mouth at the same 
dosage rate. For treatment of ascarid infections in dogs and cats, the 
drug is administered at a dosage level of 25 to 50 milligrams per pound 
of body weight preferably administered immediately after feeding.
    (iii) Older dogs should be proven negative for the presence of 
Dirofilaria immitis infection before administration of the drug. Those 
with proven infection of Dirofilaria immitis should be rendered negative 
using adulticidal and microfilaricidal drugs before administration of 
this drug.
    (iv) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.
    (b)(1) Specifications. Each milliliter of syrup contains 60 
milligrams of diethylcarbamazine citrate.
    (2) Sponsors. (i) See No. 017030 for use as in paragraphs 
(b)(3)(ii)(a) and (b)(3)(ii)(c) of this section.
    (ii) See No. 017030 for use as in paragraphs (b)(3)(ii) (a) and (c) 
of this section.
    (3) Conditions of use--(i) Amount. 3 milligrams per pound of body 
weight per day for prevention of heartworm disease and as an aid in 
control of large roundworms; 25 to 50 milligrams per pound of body 
weight as an aid in treatment of ascarid infections.
    (ii) Indications for use. (a) For prevention of heartworm disease 
(Dirofilaria immitis) in dogs.
    (b) As an aid in control of large roundworms (T. canis) in dogs.
    (c) As an aid in treatment of ascarid infections in dogs (T. canis) 
and cats (T. canis and T. leonina).
    (iii) Limitations. The drug may be placed on the daily ration or 
given directly by mouth. For treatment of ascarid infections, a repeat 
dose should be given in 10 to 20 days to remove immature worms which may 
enter the intestine from the lungs after the first dose. Older dogs 
should be proven negative for presence of Dirofilaria immitis infections 
before administering the drug. Dogs with established heartworm 
infections should not receive the drug until they have been converted to 
a negative status by the use of adulticidal and microfilaricidal drugs. 
Inadvertent administration to heartworm-infected dogs may cause adverse 
reactions due to pulmonary occlusion. Overdosage may cause emesis. For 
prevention of heartworm disease in heartworm-endemic areas, 
administration of the drug should start 1 month before the mosquito 
season and be continued daily throughout the mosquito season and for 2 
months thereafter. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.
    (c)(1) Specifications. Each milliliter of syrup contains 60 
milligrams of diethylcarbamazine citrate.
    (2) Sponsor. See No. 000010 in Sec. 510.600(c) of this chapter.
    (3) Conditions of use. (i) The drug is used in dogs between 4 weeks 
and 8 months of age for the removal of ascarids (Toxacara canis) and in 
animals over 4 weeks of age for the prevention of heartworm disease 
(Dirofilaria immitis).
    (ii) The drug is administered (a) for removal of ascarids at a 
dosage of 50 milligrams per pound of body weight divided into two equal 
doses and administered 8 to 12 hours apart (morning and night), orally 
or mixed with either dry or wet food, and (b) for prevention of 
heartworm disease at a dosage of 3 milligrams per pound of body weight 
daily, orally or in food, in heartworm endemic areas, from the beginning 
of mosquito activity, during the mosquito season, and for 2 months 
following the end thereof.
    (iii) Dogs older than 8 months of age may be infected with 
Dirofilaria immitis.

[[Page 153]]

Use of the drug is contraindicated in dogs with active D. immitis 
infections.
    (iv) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.

[40 FR 13838, Mar. 27, 1975, as amended at 41 FR 28265, July 9, 1976; 44 
FR 3967, Jan. 19, 1979; 47 FR 14150, Apr. 2, 1982; 47 FR 35186, Aug. 13, 
1982; 49 FR 33997, Aug. 28, 1984; 50 FR 41489, Oct. 11, 1985; 53 FR 
47027, Oct. 18, 1988; 61 FR 34728, July 3, 1996; 62 FR 35076, June 30, 
1997; 62 FR 38906, July 21, 1997]



Sec. 520.622c  Diethylcarbamazine citrate chewable tablets.

    (a) Specifications. Each chewable tablet contains 30, 45, 60, 120, 
150, or 180 milligrams of diethylcarbamazine citrate.
    (b) Sponsors. See drug listing nos. in Sec. 510.600(c) of this 
chapter for identification of sponsors as follows:
    (1) For 015579, use of 30 or 120 milligram tablets as in paragraph 
(c)(2)(i) of this section.
    (2) For 000069, use of 60, 120, or 180 milligram tablets as in 
paragraph (c)(2)(ii) of this section.
    (3) For 061690, use of 45 or 150 milligram tablets as in paragraph 
(c)(2)(iii) of this section.
    (4) For 061133, use of 60-, 120-, or 180-milligram tablets as in 
paragraph (c)(2)(i) of this section.
    (5) For 000061, use of 60-milligram tablets as in paragraph 
(c)(2)(i) of this section.
    (6) For 000010, use of 30, 60, 120, or 180 milligram tablets as in 
paragraph (c)(2)(i) of this section.
    (7) [Reserved]
    (c) Conditions of use--(1) Amount. 3 milligrams per pound of body 
weight per day for prevention of heartworm disease and control of 
ascarids; 25 to 50 milligrams per pound of body weight as an aid in 
treatment of ascarid infections.
    (2) Indications for use. (i) For prevention of heartworm disease 
(Dirofilaria immitis) in dogs; as an aid in control of ascarids 
(Toxocara canis) in dogs; as an aid in treatment of ascarid (Toxocara 
canis and Toxascaris leonina) infections in dogs and cats.
    (ii) For prevention of infection with Dirofilaria immitis (heartworm 
disease) in dogs; as an aid in treatment of ascarid (Toxocara canis and 
Toxascaris leonina) infections in dogs.
    (iii) For prevention of heartworm disease (Dirofilaria immitis) in 
dogs.
    (3) Limitations. Tablets are administered orally or pulverized and 
given in the feed. For treatment of ascarid infections, a repeat dose 
should be given in 10 to 20 days to remove immature worms which may 
enter the intestine from the lungs after the first dose. Dogs with 
established heartworm infections should not receive the drug until they 
have been converted to a negative status by the use of adulticidal and 
microfilaricidal drugs. Inadvertent administration to heartworm-infected 
dogs may cause adverse reactions due to pulmonary occlusion. Overdosage 
may cause emesis. For prevention of heartworm disease in heartworm-
endemic areas, administration of the drug should start at the beginning 
of mosquito activity and be continued daily throughout the mosquito 
season and for approximately a month thereafter. Federal law restricts 
this drug to use by or on the order of a licensed veterinarian.

[43 FR 6941, Feb. 17, 1978]

    Editorial Note: For Federal Register citations affecting Sec. 
520.622c, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and on GPO Access.



Sec. 520.622d  Diethylcarbamazine citrate capsules.

    (a) Specifications. Each capsule contains 12.5, 50, 200, or 400 
milligrams (mg) diethylcarbamazine citrate.
    (b) Sponsor. See No. 011014 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount/indications for use. 3 mg 
per pound (/lb) body weight daily for prevention of heartworm disease 
(Dirofilaria immitis); 25 to 50 mg/lb body weight in a single dose as an 
aid in the treatment of ascarid infections (Toxocara canis and 
Toxascaris leonina).
    (2) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[70 FR 50182, Aug. 26, 2005]



Sec. 520.623  Diethylcarbamazine citrate, oxibendazole chewable tablets.

    (a) Specifications. Each tablet contains either 60, 120, or 180 
milligrams of

[[Page 154]]

diethylcarbamazine citrate with 45, 91, or 136 milligrams of 
oxibendazole, respectively.
    (b) Sponsor. See 000069 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer orally to dogs 
at a dosage level of 6.6 milligrams of diethylcarbamazine citrate per 
kilogram of body weight (3 milligrams per pound of body weight) and 5.0 
milligrams of oxibendazole per kilogram of body weight (2.27 milligrams 
per pound of body weight).
    (2) Indications for use. For prevention of infection with 
Dirofilaria immitis (heartworm disease) and Ancylostoma caninum 
(hookworm infection) and for removal and control of Trichuris vulpis 
(whipworm infection) and mature and immature stages of intestinal 
Toxocara canis (ascarid infection).
    (3) Limitations. Orally administer daily during heartworm season. 
For free-choice feeding or broken and placed on or mixed with feed. Do 
not use in dogs that may harbor adult heartworms. Federal law restricts 
this drug to use by or on the order of a licensed veterinarian.

[50 FR 28768, July 16, 1985, as amended at 53 FR 45759, Nov. 14, 1988; 
54 FR 3776, Jan. 26, 1989; 54 FR 6804, Feb. 14, 1989; 56 FR 50653, Oct. 
8, 1991; 60 FR 55659, Nov. 2, 1995]



Sec. 520.645  Difloxacin.

    (a) Specifications. Each tablet contains 11.4, 45.4, or 136 
milligrams (mg) of difloxacin hydrochloride.
    (b) Sponsor. See No. 000856 in Sec. 510.600(c) of this chapter.
    (c) [Reserved]
    (d) Conditions of use--(1) Dogs--(i) Amount. 5 to 10 mg per kilogram 
(2.3 to 4.6 mg/pound) of body weight.
    (ii) Indications for use. For management of diseases in dogs 
associated with bacteria susceptible to difloxacin.
    (iii) Limitations. Use once a day for 2 to 3 days beyond cessation 
of clinical signs of disease up to a maximum of 30 days. Federal law 
prohibits the extra-label use of this drug in food-producing animals. 
Federal law restricts this drug to use by or on the order of a licensed 
veterinarian.
    (2) [Reserved]

[63 FR 8123, Feb. 18, 1998]



Sec. 520.666  Dirlotapide.

    (a) Specifications. Each milliliter (mL) of solution contains 5 
milligrams (mg) dirlotapide.
    (b) Sponsor. See No. 000069 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. The initial dosage is 
0.01 mL/kg (0.0045 mL/lb) body weight for the first 14 days. After the 
first 14 days of treatment, the dose volume is doubled to 0.02 mL/kg 
(0.009 mL/lb) body weight for the next 14 days (days 15 to 28 of 
treatment). Dogs should be weighed monthly and the dose volume adjusted 
every month, as necessary, to maintain a target percent weight loss 
until the desired weight is achieved.
    (2) Indications for use. For the management of obesity.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[72 FR 263, Jan. 4, 2007]



Sec. 520.763  Dithiazanine iodide oral dosage forms.



Sec. 520.763a  Dithiazanine iodide tablets.

    (a) Chemical name. 3-Ethyl-2-[5-(3-ethyl - 2 - 
benzothiazolinylidene) - 1,3 - pentadienyl]-benzothiazolium iodide.
    (b) Specifications. Dithiazanine iodide tablets contain 10 
milligrams, 50 milligrams, 100 milligrams, or 200 milligrams of 
dithiazanine iodide in each tablet.
    (c) Sponsor. See No. 000010 in Sec. 510.600(c) of this chapter.
    (d) Conditions of use. (1) The tablets are administered orally to 
dogs immediately after feeding using the following dosage schedule for 
various parasite infestations:

------------------------------------------------------------------------
                                             Milligrams
                                              per pound     Length of
                                               of body   treatment--days
                                               weight
------------------------------------------------------------------------
Large roundworms (Toxocara canis,                    10            3-5
 Toxascaris leonina).......................
Hookworms (Ancylostoma caninum, Uncinaria            10              7
 stenocephala).............................
Whipworms (Trichuris vulpis)...............          10
Strongyloides (Strongyloides canis,                  10          10-12
 Strongyloides stercoralis)................

[[Page 155]]

 
Heartworm microfilariae (Dirofilaria                3-5           7-10
 immitus)..................................
------------------------------------------------------------------------
Note: Treatment with dithiazanine iodide for heartworm microfilariae
  should follow 6 weeks after therapy for adult worms.

    (2) The drug is contraindicated in animals sensitive to dithiazanine 
iodide and should be used cautiously, if at all, in dogs with reduced 
renal function.
    (3) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.
    (e) Use for treating dogs for large roundworms, hookworms, 
whipworms, and strongyloides as provided for in this section has been 
NAS/NRC reviewed and deemed effective. Applications for these uses need 
not include effectiveness data as specified by Sec. 514.111 of this 
chapter, but may require bioequivalency and safety information.

[40 FR 13838, Mar. 27, 1975, as amended at 47 FR 51564, Nov. 16, 1982; 
48 FR 32342, July 15, 1983; 53 FR 40727, Oct. 18, 1988; 62 FR 35076, 
June 30, 1997]



Sec. 520.763b  Dithiazanine iodide powder.

    (a) Chemical name. 3-Ethyl-2-[5-(3-ethyl-2-benzothiazolinylidene)-
1,3-pentadienyl]-benzothiazoliumiodide.
    (b) Specifications. Dithiazanine iodide powder contains 200 
milligrams of dithiazanine iodide per level standard tablespoon.
    (c) Sponsor. See No. 000010 in Sec. 510.600(c) of this chapter.
    (d) Conditions of use. (1) Dithiazanine iodide powder is 
administered to dogs by mixing the proper dosage in the dog's food, 
using the following dosage schedule for various parasite infestations:

------------------------------------------------------------------------
                                             Milligrams
                                              per pound     Length of
                                               of body   treatment--days
                                               weight
------------------------------------------------------------------------
Large roundworms (Toxocara canis,                    10            3-5
 Toxascaris leonina).......................
Hookworms (Ancylostoma caninum, Uncinaria            10              7
 stenocephala).............................
Whipworms (Trichuris vulpis)...............          10              7
Strongyloides (Strongyloides canis,                  10          10-12
 Strongyloides stercoralis)................
Heartworm microfilariae (Dirofilaria                3-5           7-10
 immitus)..................................
------------------------------------------------------------------------
Note: Treatment with dithiazanine iodide for heartworm microfilariae
  should follow 6 weeks after therapy for adult worms.

    (2) The drug is contraindicated in animals sensitive to dithiazanine 
iodide and should be used cautiously, if at all, in dogs with reduced 
renal function.
    (3) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.
    (e) Use for treating dogs for large roundworms, hookworms, 
whipworms, and strongyloides as provided for in this section has been 
NAS/NRC reviewed and deemed effective. Applications for these uses need 
not include effectiveness data as specified by Sec. 514.111 of this 
chapter, but may require bioequivalency and safety information.

[40 FR 13838, Mar. 27, 1975, as amended at 47 FR 51564, Nov. 16, 1982; 
48 FR 32342, July 15, 1983; 53 FR 40727, Oct. 18, 1988; 62 FR 35076, 
June 30, 1997]



Sec. 520.763c  Dithiazanine iodide and piperazine citrate suspension.

    (a) Specifications. Each milliliter of the drug contains 69 
milligrams of dithiazanine iodide and 83 milligrams of piperazine base 
(as piperazine citrate).
    (b) Sponsor. See 000010 in Sec. 510.600(c) of this chapter.
    (c) NAS/NRC status. The conditions of use are NAS/NRC reviewed and 
found effective. Applications for these uses need not include 
effectiveness data as specified by Sec. 514.111 of this chapter, but 
may require bioequivalency and safety information.
    (d) Conditions of use--(1) Amount. 1 ounce (30 milliliters) per 100 
pounds of body weight for the first 500 pounds; \3/4\ ounce for each 100 
pounds thereafter, up to 1,200 pounds; 10\1/4\ ounces to animals over 
1,200 pounds.
    (2) Indications for use. For control of large roundworms, Parascaris 
equorum; small strongyles; large strongyles, Strongylus vulgaris; and 
pinworms, Oxyuris equi.

[[Page 156]]

    (3) Limitations. Administer by drench or mixed with the daily ration 
as a single dose. Treatment is recommended in spring and fall. In a 
heavily infested environment, treatment may be repeated every 30 days. 
Not for use in horses intended for food purposes. Severely debilitated 
animals should not be wormed except on the advice of a veterinarian. If 
the drug is for administration by stomach tube, it shall be labeled: 
``Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.''

[47 FR 52696, Nov. 23, 1982, as amended at 48 FR 32342, July 15, 1983; 
53 FR 40727, Oct. 18, 1988; 62 FR 35076, June 30, 1997]



Sec. 520.784  Doxylamine succinate tablets.

    (a) Specifications. The drug is in tablet form and contains 
doxylamine succinate as the active drug ingredient.
    (b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use. (1) The drug is used in conditions in which 
antihistaminic therapy may be expected to alleviate some signs of 
disease in horses, dogs, and cats. \1\
---------------------------------------------------------------------------

    \1\ These conditions are NAS/NRC reviewed and deemed effective. 
Applications for these uses need not include effectiveness data as 
specified by Sec. 514.111 of this chapter.
---------------------------------------------------------------------------

    (2) It is administered orally to horses at a dosage level of 1 to 2 
milligrams per pound of body weight per day divided into 3 or 4 equal 
doses. It is administered orally to dogs and cats at a dosage level of 2 
to 3 milligrams per pound of body weight per day divided into 3 or 4 
equal doses. \1\
    (3) Not for use in horses intended for food. \1\
    (4) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian. \1\

[40 FR 13838, Mar. 27, 1975, as amended at 42 FR 60140, Nov. 25, 1977; 
46 FR 48642, Oct. 2, 1981; 61 FR 8873, Mar. 6, 1996; 62 FR 61624, Nov. 
19, 1997]



Sec. 520.804  Enalapril tablets.

    (a) Specifications. Each tablet contains either 1.0, 2.5, 5.0, 10.0, 
or 20.0 milligrams of enalapril maleate.
    (b) Sponsor. See 050604 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Dogs--(i) Amount. 0.5 to 1.0 milligram of 
enalapril maleate per kilogram of body weight per day.
    (ii) Indications for use. Treatment of mild, moderate, and severe 
(modified New York Heart Association Class II, III, IV) heart failure in 
dogs.
    (iii) Limitations. Use 0.5 milligram per kilogram once daily. In the 
absence of adequate clinical response within a 2-week period, use may be 
increased to twice daily (a total of 1.0 milligram per kilogram). 
Enalapril maleate is administered as conjunctive therapy with furosemide 
and digoxin in the treatment of dilated cardiomyopathy and furosemide 
with or without digoxin in the treatment of chronic valvular disease. 
The safety of enalapril for use in breeding dogs has not been 
established. Use in pregnant bitches is not recommended. Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.
    (2) [Reserved]

[59 FR 17694, Apr. 14, 1994, as amended at 62 FR 63270, Nov. 28, 1997]



Sec. 520.812  Enrofloxacin tablets.

    (a) Specifications. Each tablet contains either 22.7, 68.0, or 136.0 
milligrams of enrofloxacin.
    (b) Sponsor. See No. 000859 in Sec. 510.600(c) of this chapter.
    (c) [Reserved]
    (d) Conditions of use--(1) Amount. 5 to 20 milligrams per kilogram 
(2.27 to 9.07 milligrams per pound) of body weight.
    (2) Indications for use. Dogs and cats for management of diseases 
associated with bacteria susceptible to enrofloxacin.
    (3) Limitations. Administer orally as a single dose or divided into 
2 equal doses at 12 hour intervals, daily. Administer for at least 2 to 
3 days beyond cessation of clinical symptoms, for a maximum of 30 days. 
Safety in breeding or pregnant cats has not been established. Federal 
law restricts this drug to use by or on the order of a licensed 
veterinarian.

[54 FR 3444, Jan. 24, 1989, as amended at 55 FR 43327, Oct. 29, 1990; 62 
FR 38906, July 21, 1997; 64 FR 48295, Sept. 3, 1999]

[[Page 157]]



Sec. 520.816  Epsiprantel tablets.

    (a) Specifications. Each tablet contains either 12.5, 25, 50, or 100 
milligrams of epsiprantel.
    (b) Sponsor. See No. 000069 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Dogs--(i) Amount. 2.5 milligrams per 
pound of body weight.
    (ii) Indications for use. Removal of canine cestodes Dipylidium 
caninum and Taenia pisiformis.
    (2) Cats--(i) Amount. 1.25 milligrams per pound of body weight.
    (ii) Indications for use. Removal of feline cestodes D. caninum and 
T. taeniaeformis.
    (3) Limitations. For oral use only as a single dose. Do not use in 
animals less than 7 weeks of age. Safety of use in pregnant or breeding 
animals has not been established. Federal law restricts this drug to use 
by or on the order of a licensed veterinarian.

[54 FR 50615, Dec. 8, 1989, as amended at 56 FR 50653, Oct. 8, 1991; 60 
FR 55659, Nov. 2, 1995]



Sec. 520.823  Erythromycin phosphate.

    (a) Specifications. Erythromycin phosphate is the phosphate salt of 
the antibiotic substance produced by the growth of Streptomyces 
erythreus or the same antibiotic substance produced by any other means. 
One gram of erythromycin phosphate is equivalent to 0.89 gram of 
erythromycin master standard.
    (b) Sponsor. See No. 061623 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.230 of this chapter.
    (d) Conditions of use. It is used in drinking water as follows:
    (1) Broiler and replacement chickens--(i) Amount. 0.500 gram per 
gallon.
    (ii) Indications for use. As an aid in the control of chronic 
respiratory disease due to Mycoplasma gallisepticum susceptible to 
erythromycin.
    (iii) Limitations. Administer for 5 days; do not use in replacement 
pullets over 16 weeks of age; do not use in chickens producing eggs for 
human consumption; to assure effectiveness, treated birds must consume 
enough medicated water to provide a therapeutic dosage; solutions older 
than 3 days should not be used; withdraw 1 day before slaughter.
    (2) Replacement chickens and chicken breeders--(i) Amount. 0.500 
gram per gallon.
    (ii) Indications for use. As an aid in the control of infectious 
coryza due to Hemophilus gallinarum susceptible to erythromycin.
    (iii) Limitations. Administer for 7 days; do not use in replacement 
pullets over 16 weeks of age; do not use in chickens producing eggs for 
human consumption; to assure effectiveness, treated birds must consume 
enough medicated water to provide a therapeutic dosage; solutions older 
than 3 days should not be used; withdraw 1 day before slaughter.
    (3) Growing turkeys--(i) Amount. 0.500 gram per gallon.
    (ii) Indications for use. As an aid in the control of blue comb 
(nonspecific infectious enteritis) caused by organisms susceptible to 
erythromycin.
    (iii) Limitations. Administer for 7 days; do not use in turkeys 
producing eggs for human consumption; to assure effectiveness, treated 
birds must consume enough medicated water to provide a therapeutic 
dosage; solutions older than 3 days should not be used; withdraw 1 day 
before slaughter.

[40 FR 13838, Mar. 27, 1975, as amended at 45 FR 56798, Aug. 26, 1980; 
66 FR 14073, Mar. 9, 2001; 68 FR 4914, Jan. 31, 2003]



Sec. 520.863  Ethylisobutrazine hydrochloride tablets.

    (a) Specifications. Each tablet contains either 10 milligrams or 50 
milligrams of ethylisobutrazine hydrochloride.
    (b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use. (1) It is administered orally to dogs as a 
tranquilizer.\1\
---------------------------------------------------------------------------

    \1\ These conditions are NAS/NRC reviewed and deemed effective. 
Applications for these uses need not include effectiveness data as 
specified by Sec. 514.111 of this chapter, but may require 
bioequivalency and safety information.
---------------------------------------------------------------------------

    (2) It is administered once daily at a dosage level of 2 to 5 
milligrams of ethylisobutrazine hydrochloride per pound of body 
weight.\1\
    (3) It is not to be used in conjunction with organophosphates and/or 
procaine

[[Page 158]]

hydrochloride because phenothiazine may potentiate the toxicity of 
organophosphates and the activity of procaine hydrochloride.\1\
    (4) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.\1\

[40 FR 13838, Mar. 27, 1975, as amended at 46 FR 48642, Oct. 2, 1981; 61 
FR 8873, Mar. 6, 1996; 62 FR 61624, Nov. 19, 1997]



Sec. 520.870  Etodolac.

    (a) Specifications. Each tablet contains 150, 300, or 500 milligrams 
(mg) of etodolac.
    (b) Sponsor. See 053501 in Sec. 510.600(c) of this chapter.
    (c) [Reserved]
    (d) Conditions of use--(1) Dogs--(i) Amount. 10 to 15 mg per 
kilogram (4.5 to 6.8 mg/pound) of body weight per day.
    (ii) Indications for use. For the management of pain and 
inflammation associated with osteoarthritis in dogs.
    (iii) Limitations. Use once-a-day. Federal law restricts this drug 
to use by or on the order of a licensed veterinarian.
    (2) [Reserved]

[63 FR 51300, Sept. 25, 1998, as amended at 68 FR 51705, Aug. 28, 2003]



Sec. 520.903  Febantel oral dosage forms.



Sec. 520.903a  Febantel paste.

    (a) Chemical name. Dimethyl [[2-[(methoxyacetyl)amino]-4-(phenyl-
thio)phenyl] carbonimidoyl]bis [carbamate].
    (b) Specifications. The drug is a paste containing 45.5 percent 
febantel.
    (c) Sponsor. See No. 000859 in Sec. 510.600(c) of this chapter.
    (d) Conditions of use--(1) Amount. Six milligrams per kilogram (2.73 
milligrams per pound) of body weight in horses.
    (2) Indications for use. For removal of large strongyles (Strongylus 
vulgaris, S. edentatus, S. equinus); ascarids (Parascaris equorum-- 
sexually mature and immature); pinworms (Oxyuris equi-- adult and 4th 
stage larva); and the various small strongyles in horses, foals, and 
ponies.
    (3) Limitations. (i) The paste may be administered on the base of 
the tongue or well mixed into a portion of the normal grain ration.
    (ii) [Reserved]
    (iii) For animals maintained on premises where reinfection is likely 
to occur, retreatment may be necessary. For most effective results, 
retreat in 6 to 8 weeks.
    (iv) Not for use in horses intended for food.
    (v) Consult your veterinarian for assistance in the diagnosis, 
treatment, and control of parasitism.

[43 FR 8797, Mar. 3, 1978; 43 FR 12311, Mar. 24, 1978, as amended at 43 
FR 60882, Dec. 29, 1978. Redesignated at 45 FR 8587, Feb. 8, 1980]



Sec. 520.903b  Febantel suspension.

    (a) Specifications. The suspension contains 9.3 percent (2.75 grams 
per ounce) febantel.
    (b) Sponsor. See 000859 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. 3 milliliters per 100 pounds body 
weight or 1 fluid ounce per 1000 pounds (6 milligrams per kilogram body 
weight).
    (2) Indications for use. For removal of ascarids (Parascaris 
equorum--adult and sexually immature), pinworms (Oxyuris equi--adult and 
4th stage larvae), large strongyles (Strongylus vulgaris, S. edentatus, 
S. equinus), and the various small strongyles in horses, breeding 
stallions and mares, pregnant mares, foals, and ponies.
    (3) Limitations. Administer by stomach tube or drench, or by mixing 
well into a portion of the normal grain ration. For animals maintained 
on premises where reinfection is likely to occur, retreatment may be 
necessary. For most effective results, retreat in 6 to 8 weeks. Not for 
use in horses intended for food. Federal law restricts this drug to use 
by or on the order of a licensed veterinarian.
    (d) Special considerations. Febantel suspension may be used in 
combination with trichlorfon oral liquid in accordance with the 
provisions of Sec. 520.2520c, this section, and the following 
conditions:
    (1) Combine 1 part febantel suspension with 5 parts trichlorfon 
liquid.
    (2) Allow animal to consume a portion of daily grain ration; 
administer mixture by stomach tube at rate of 18 milliliters per 100 
pounds of body weight.

[45 FR 8587, Feb. 8, 1980]

[[Page 159]]



Sec. 520.903c  [Reserved]



Sec. 520.903d  Febantel-praziquantel paste.

    (a) Specifications. Each gram of paste contains 34 milligrams of 
febantel and 3.4 milligrams of praziquantel.
    (b) Sponsor. See No. 000859 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount--(i) Dogs and cats (over 6 months 
of age): 10 milligrams of febantel and 1 milligram of praziquantel per 
kilogram of body weight (1 gram of paste per 7.5 pounds body weight) 
administered by mouth or in the food once daily for 3 days.
    (ii) Puppies and kittens (less than 6 months of age): 15 milligrams 
of febantel and 1.5 milligrams of praziquantel per kilogram of body 
weight (1 gram of paste per 5 pounds body weight) administered by mouth 
on a full stomach once daily for 3 days.
    (2) Indications for use. (i) Dogs and puppies: For removal of 
hookworms (Ancylostoma caninum and Uncinaria stenocephala), whipworms 
(Trichuris vulpis), ascarids (Toxocara canis and Toxascaris leonina), 
and tapeworms (Dipylidium caninum and Taenia pisiformis).
    (ii) Cats and kittens: For removal of hookworms (Ancylostoma 
tubaeforme), ascarids (Toxocara cati) and tapeworms (Dipylidium caninum 
and Taenia taeniaeformis).
    (3) Limitations. Do not use in pregnant animals. Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.
    (4) Special considerations. Consider alternative therapy or use with 
caution in animals with pre-existing liver or kidney dysfunction.

[50 FR 19167, May 7, 1985, as amended at 53 FR 48533, Dec. 1, 1988; 56 
FR 50813, Oct. 9, 1991]



Sec. 520.903e  Febantel tablets.

    (a) Specifications. Each scored tablet contains 27.2 milligrams of 
febantel for use in dogs, puppies, cats, and kittens or 163.3 milligrams 
of febantel for use in dogs, puppies, and cats.
    (b) Sponsor. See 000859 in Sec. 510.600(c)(2) of this chapter.
    (c) Conditions of use--(1) Amount--(i) Dogs and cats. Ten milligrams 
per kilogram body weight. Administer once daily for 3 consecutive days.
    (ii) Puppies and kittens fewer than 6 months of age. Fifteen 
milligrams per kilogram body weight. Administer once daily for 3 
consecutive days.
    (2) Indications for use. (i) For removal of hookworms (Ancylostoma 
caninum and Uncinaria stenocephala), ascarids (Toxocara canis and 
Toxascaris leonina) and whipworms (Trichuris vulpis) in dogs and 
puppies.
    (ii) For removal of hookworms (Ancylostoma tubaeforme) and ascarids 
(Toxocara cati) in cats and kittens.
    (3) Limitations. Do not use in pregnant animals. Consider 
alternative therapy or use with caution in animals with preexisting 
liver or kidney dysfunction. Administer to puppies and kittens on a full 
stomach. Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.

[56 FR 50655, Oct. 8, 1991]



Sec. 520.905  Fenbendazole oral dosage forms.



Sec. 520.905a  Fenbendazole suspension.

    (a) Specifications. The drug is a suspension containing 10 percent 
(100 milligrams per milliliter) fenbendazole.
    (b) Sponsor. See No. 057926 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.275 of this chapter.
    (d) Conditions of use--(1) Horses--(i) Amount. 5 milligrams per 
kilogram (2.3 milligrams per pound) for the control of large strongyles, 
small strongyles, and pinworms; 10 milligrams per kilogram for the 
control of ascarids.
    (ii) Indications for use. For the control of large strongyles 
(Strongylus edentatus, S. equinus, S. vulgaris), small strongyles 
(Cyanthostomum spp., Cylicocyclus spp., Cylicostephanus spp., 
Triodontophorus spp.), pinworms (Oxyuris equi), and ascarids (Parascaris 
equorum) in horses.
    (iii) Limitations. Administer orally by dose syringe or suitable 
plastic syringe. Do not use in horses intended for food. Consult a 
veterinarian for assistance in the diagnosis, treatment, and control of 
parasitism.
    (2) Cattle including dairy cows of breeding age--(i) Amount. 
Administer orally 5

[[Page 160]]

milligrams per kilogram of body weight (2.3 milligrams per pound).
    (ii) Indications for use. For the removal and control of lungworm 
(Dictyocaulus viviparus); stomach worm (adults)--brown stomach worm 
(Ostertagia ostertagi); stomach worms (adults and 4th-stage larvae)--
barberpole worm (Haemonchus contortus and H. placei) and small stomach 
worm (Trichostongylus axei); intestinal worms (adults and 4th-stage 
larvae)--hookworm (Bunostonmum phlebotomum), threadnecked intestinal 
worm (Nematodirus helvetianus), small intestinal worm (Cooperia punctata 
and C. oncophora), bankrupt worm (Trichostrongylus colubriformis), and 
nodular worm (Oesophagostomum radiatum).
    (iii) Limitations. Retreatment may be needed after 4 to 6 weeks. 
Cattle must not be slaughtered within 8 days following last treatment. 
Consult a veterinarian for assistance in the diagnosis, treatment, and 
control of parasitism.
    (3) Beef cattle--(i) Amount. Administer orally 10 milligrams per 
kilogram of body weight.
    (ii) For the removal and control of stomach worm (4th-stage 
inhibited larvae/type II ostertagiasis), Ostertagia ostertagi, and 
tapeworm, Moniezia benedeni.
    (iii) Limitations. Retreatment may be needed after 4 to 6 weeks. 
Cattle must not be slaughtered within 8 days following last treatment. 
Federal law restricts this drug to use by or on the order of a licensed 
veterinarian.
    (4) Goats--(i) Amount. Administer orally 5 milligrams per kilogram 
of body weight (2.3 milligrams per pound).
    (ii) Indications for use. For the removal and control of stomach 
worms (adults) Haemonchus contortus and Teladorsagia circumcincta.
    (iii) Limitations. Retreatment may be needed after 4 to 6 weeks. 
Goats must not be slaughtered for food within 6 days following last 
treatment. Do not use in lactating goats.
    (e) Special considerations. Fenbendazole suspension 10 percent and 
approved forms of trichlorfon, when used concomitantly for treating the 
indications provided in paragraph (d) of this section and for treating 
infections of stomach bot as provided in Sec. 520.2520, have been shown 
to be compatible and not to interfere with one another.

[42 FR 59069, Nov. 15, 1977; 43 FR 12311, Mar. 24, 1978. Redesignated at 
44 FR 1375, Jan. 5, 1979, and amended at 46 FR 29464, June 2, 1981; 47 
FR 15327, Apr. 9, 1982; 48 FR 42809, Sept. 20, 1983; 49 FR 1983, Jan. 
17, 1984; 53 FR 40058, Oct. 13, 1988; 59 FR 26943, May 25, 1994; 61 FR 
29478, June 11, 1996; 63 FR 63983, Nov. 18, 1998; 66 FR 47960, Sept. 17, 
2001; 68 FR 26205, May 15, 2003]



Sec. 520.905b  Fenbendazole granules.

    (a) Specifications. Each gram of granules contains 222 milligrams 
(mg) fenbendazole.
    (b) Sponsor. See No. 057926 in Sec. 510.600(c) of this chapter.
    (c) Special considerations. See Sec. 500.25 of this chapter.
    (d) Conditions of use--(1) Horses--(i) Amount. 5 mg/kilogram (kg) 
for large strongyles, small strongyles, and pinworms; 10 mg/kg for 
ascarids.
    (ii) Indications for use. For the control of infections of large 
strongyles (Strongylus edentatus, S. equinus, S. vulgaris), small 
strongyles, pinworms (Oxyuris equi), and ascarids (Parascaris equorum).
    (iii) Limitations. Sprinkle the appropriate amount of drug on a 
small amount of the usual grain ration. Prepare for each horse 
individually. Withholding feed or water is not necessary. Retreat in 6 
to 8 weeks if required. Do not use in horses intended for food.
    (2) Dogs--(i) Amount. 50 mg/kg daily for 3 consecutive days.
    (ii) Indications for use. For the treatment and control of ascarids 
(Toxocara canis, Toxascaris leonina), hookworms (Ancylostoma caninum, 
Uncinaria stenocephala), whipworms (Trichuris vulpis), and tapeworms 
(Taenia pisiformis).
    (iii) Limitations. Mix the appropriate amount of drug with a small 
amount of the usual food; dry dog food may require slight moistening to 
facilitate mixing. Medicated food must be fully consumed.
    (3) Zoo and wildlife animals--(i) Amount. 10 mg/kg per day for 3 
days.
    (ii) Indications for use. For control of internal parasites of 
Felidae and Ursidae as follows:

[[Page 161]]

    (A) Lion (Panthera leo) and Tiger (Panthera tigris): Ascarid 
(Toxocara cati, Toxascaris leonina), Hookworm (Ancylostoma spp.).
    (B) Cheetah (Acinonyx jubatus): Ascarid (Toxocara cati, Toxascaris 
leonina).
    (C) Puma (Felis concolor), Panther (Panthera spp.), Leopard 
(Panthera pardus), Jaguar (Panthera onca): Ascarid (Toxocara cati, 
Toxascaris leonina), Hookworm (Ancylostoma spp.), Tapeworm (Taenia 
hydatigena, T. krabbei, T. taeniaeformis).
    (D) Black Bear (Ursus americanus): Ascarid (Baylisascaris transfuga, 
Toxascaris leonina), Hookworm (Ancylostoma caninum), Tapeworm (Taenia 
hydatigena, T. krabbei).
    (E) Polar Bear (Ursus maritimus) and Grizzly Bear (Ursus 
horribilis): Ascarid (Baylisascaris transfuga, Toxascaris leonina).
    (iii) Limitations. Top dress or mix with a small portion of food. 
Must be fully consumed prior to feeding. Federal law restricts this drug 
to use by or on the order of a licensed veterinarian. Do not use 14 days 
before or during the hunting season.

[44 FR 1375, Jan. 5, 1979, as amended at 47 FR 15327, Apr. 9, 1982; 48 
FR 50528, Nov. 2, 1983; 59 FR 35252, July 11, 1994; 66 FR 47960, Sept. 
17, 2001; 67 FR 47450, July 19, 2002; 71 FR 19429, Apr. 14, 2006]



Sec. 520.905c  Fenbendazole paste.

    (a) Specifications. Each gram of paste contains 100 milligrams (mg) 
fenbendazole (10 percent).
    (b) Sponsor. See No. 057926 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.275 of this chapter.
    (d) Special considerations. See Sec. 500.25 of this chapter.
    (e) Conditions of use--(1) Horses--(i) Indications for use and 
amounts--(A) For control of large strongyles (Strongylus edentatus, S. 
equinus, S. vulgaris), small strongyles, pinworms (Oxyuris equi), and 
ascarids (Parascaris equorum): 2.3 mg per pound (/lb) of body weight, or 
for foals and weanlings (less than 18 months of age), 4.6 mg/lb of body 
weight. Retreatment at intervals of 6 to 8 weeks may be required.
    (B) For control of arteritis caused by the fourth-stage larvae of S. 
vulgaris: 4.6 mg/lb of body weight daily for 5 days. Treatment should be 
initiated in the spring and repeated in 6 months.
    (C) For treatment of encysted mucosal cyathostome (small strongyle) 
larvae including early third-stage (hypobiotic), late third-stage, and 
fourth-stage larvae: 4.6 mg/lb of body weight daily for 5 consecutive 
days.
    (D) Fenbendazole paste 10 percent may be used concomitantly with 
approved forms of trichlorfon for the indications provided in paragraph 
(e)(1)(i)(A) of this section and for treating infections of stomach bots 
as provided in Sec. 520.2520.
    (ii) Limitations. Do not use in horses intended for human 
consumption.
    (2) Cattle--(i) Amount. 2.3 mg/lb of body weight. Retreatment may be 
needed after 4 to 6 weeks.
    (ii) Indications for use. For the removal and control of lungworms 
(Dictyocaulus viviparus), stomach worms (Haemonchus contortus, 
Ostertagia ostertagi, Trichostrongylus axei), and intestinal worms 
(Bunostomum phlebotomum, Nematodirus helvetianus, Cooperia punctata, C. 
oncophora, Trichostrongylus colubriformis, and Oesophagostomum 
radiatum).
    (iii) Limitations. Cattle must not be slaughtered within 8 days 
following last treatment.

[72 FR 24185, May 2, 2007]



Sec. 520.905d  Fenbendazole powder.

    (a) Specifications. (1) Each 2-ounce packet contains 2.27 grams (4 
percent) of fenbendazole plus other inert ingredients.
    (2) Each 4-ounce packet contains 1.7 grams (1.5 percent) of 
fenbendazole plus other inert ingredients.
    (b) Sponsors. (1) See No. 057926 in Sec. 510.600(c) of this chapter 
for use of the 4-percent product.
    (2) See No. 051311 in Sec. 510.600(c) of this chapter for use of 
the 1.5-percent product.
    (c) Related tolerances. See Sec. 556.275 of this chapter.
    (d) Conditions of use. It is administered to swine as follows:
    (1) Amount. 3 milligrams fenbendazole per kilogram body weight per 
day (1.36 milligrams per pound per day).
    (2) Indications for use. For removal and control of large roundworms

[[Page 162]]

(Ascaris suum); lungworms (Metastrongylus apri); nodular worms 
(Oesophagostomum dentatum, O. quadrispinulatum); small stomach worms 
(Hyostrongylus rubidus); whipworms (Trichuris suis); and kidneyworms 
(Stephanurus dentatus-- mature and immature).
    (3) Limitations. Thoroughly mix the contents of the packet(s) with 
swine ration and administer according to label directions. Feed as sole 
ration for 3 consecutive days. Can be fed to pregnant sows. No prior 
withdrawal of feed or water is necessary. Consult your veterinarian for 
assistance in the diagnosis, treatment, and control of parasitism.

[49 FR 18090, Apr. 27, 1984, as amended at 49 FR 20485, May 15, 1984; 66 
FR 47960, Sept. 17, 2001; 70 FR 32489, June 3, 2005]



Sec. 520.905e  Fenbendazole blocks.

    (a) Specifications. (1) Each pound of molasses block contains 750 
milligrams of fenbendazole.
    (2) Each pound of protein block contains 750 milligrams of 
fenbendazole.
    (b) Sponsor. See 057926 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.275 of this chapter.
    (d) Conditions of use--(1) Amount. 0.1 pound of block per 100 pounds 
of body weight per day for 3 days. Total dose for the 3-day period is 
2.27 milligrams of fenbendazole per pound of body weight for mature 
cattle.
    (2) Indications for use. For removal and control of infections of 
lungworms (Dictyocaulus viviparus) and gastrointestinal roundworms 
(Haemonchus contortus, Ostertagia ostertagi, Trichostrongylus axei, 
Bunostomum phlebotomum, Nematodirus helvetianus, Cooperia oncophora and 
C. punctata, Trichostrongylus colubriformis, and Oesophagostomum 
radiatum) in beef cattle.
    (3) Limitations. Administer free choice of beef cattle on pasture 
that have become accustomed to nonmedicated block feeding during an 
adaptation period of 12 to 19 days. Molasses block: Cattle must not be 
slaughtered within 11 days following last treatment. Protein block: 
Cattle must not be slaughtered within 16 days following last treatment; 
do not use in dairy cattle of breeding age. Animals maintained under 
conditions of constant worm exposure may require retreatment within 6 to 
8 weeks. Consult your veterinarian for assistance in the diagnosis, 
treatment, and control of parasitism.

[51 FR 41783, Nov. 19, 1986, as amended at 54 FR 20787, May 15, 1989; 66 
FR 47960, Sept. 17, 2001]



Sec. 520.928  Firocoxib tablets.

    (a) Specifications. Each chewable tablet contains 57 or 227 
milligrams (mg) firocoxib.
    (b) Sponsor. See No. 050604 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. 5 mg/kg (2.27 mg/lb) body 
weight. Administer once daily for osteoarthritis. Administer 
approximately 2 hours before soft-tissue surgery.
    (2) Indications for use. For the control of pain and inflammation 
associated with osteoarthritis and for the control of postoperative pain 
and inflammation associated with soft-tissue surgery.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[69 FR 51171, Aug. 18, 2004, as amended at 73 FR 2808, Jan. 16, 2008]



Sec. 520.930  Firocoxib paste.

    (a) Specifications. Each milligram (mg) of paste contains 0.82 mg 
firocoxib.
    (b) Sponsors. See No. 050604 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in horses--(1) Amount. 0.1 mg per kilogram 
(0.045 mg per pound) body weight daily for up to 14 days.
    (2) Indications for use. For the control of pain and inflammation 
associated with osteoarthritis.
    (3) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

[71 FR 5788, Feb. 3, 2006]



Sec. 520.955  Florfenicol.

    (a) Specifications. Each milliliter (mL) contains 23 milligrams (mg) 
florfenicol.
    (b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.

[[Page 163]]

    (c) Related tolerances. See Sec. 556.283 of this chapter.
    (d) Conditions of use in swine--(1) Amount. Administer in drinking 
water ad libitum at 400 mg per gallon (100 parts per million (ppm)) for 
5 consecutive days.
    (2) Indications for use. For the treatment of swine respiratory 
disease (SRD) associated with Actinobacillus pleuropneumoniae, 
Pasteurella multocida, Salmonella choleraesuis and Streptococcus suis.
    (3) Limitations. Do not slaughter within 16 days of last treatment. 
Federal law restricts this drug to use by or on the order of a licensed 
veterinarian.

[67 FR 78357, Dec. 24, 2002, as amended at 72 FR 262, Jan. 4, 2007]



Sec. 520.960  Flumethasone tablets.

    (a) Specifications. Each tablet contains 0.0625 milligram of 
flumethasone.
    (b) Sponsor. See No. 000856 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. (i) Dogs: Administer orally from 
0.0625 to 0.25 milligram daily in divided doses.
    (ii) Cats: Administer orally from 0.03125 to 0.125 milligram daily 
in divided doses.
    (2) Indications for use. (i) Dogs: It is used for musculoskeletal 
conditions due to inflammation of muscles or joints and accessory 
structures, where permanent structural changes do not exist, such as 
arthritis, the disc syndrome, and myositis.
    (ii) Dogs and cats: It is used in certain acute and chronic 
dermatoses of varying etiology to help control the pruritus, irritation, 
and inflammation associated with these conditions.
    (3) Limitations. Do not use in viral infections. Anti-inflammatory 
action of corticosteroids may mask signs of infection. Do not use in 
animals with tuberculosis, chronic nephritis, cushingoid syndrome, or 
where peptic ulcers occur, except for emergency therapy. Clinical and 
experimental data have demonstrated that corticosteroids administered 
orally or parenterally to animals may induce the first stage of 
parturition when administered during last trimester of pregnancy and may 
precipitate premature parturition followed by dystocia, fetal death, 
retained placenta, and metritis. Federal law restricts this drug to use 
by or on the order of a licensed veterinarian.

[44 FR 7131, Feb. 6, 1979, as amended at 61 FR 5506, Feb. 13, 1996]



Sec. 520.970  Flunixin oral dosage forms.



Sec. 520.970a  Flunixin meglumine granules.

    (a) Specifications. Each 10-gram packet contains flunixin meglumine 
equivalent to 250 milligrams of flunixin.
    (b) Sponsor. No. 000061 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. 0.5 milligram of flunixin per 
pound of body weight (one packet per 500 pounds) per day.
    (2) Indications for use. For alleviation of inflammation and pain 
associated with musculoskeletal disorders in the horse.
    (3) Limitations. Administer daily dose for up to 5 days by 
sprinkling on small amount of feed. The effect of this drug on pregnancy 
has not been determined. Not for use in horses intended for food. 
Federal law restricts this drug to use by or on the order of a licensed 
veterinarian.

[44 FR 36381, June 22, 1979. Redesignated at 50 FR 38114, Sept. 20, 
1985, and amended at 52 FR 7832, Mar. 13, 1987]



Sec. 520.970b  Flunixin meglumine paste.

    (a) Specifications. Each 30-gram syringe contains flunixin meglumine 
equivalent to 1,500 milligrams of flunixin.
    (b) Sponsor. No. 000061 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use. Horses--(1) Amount. 0.5 milligram of flunixin 
per pound of body weight daily.
    (2) Indications for use. For alleviation of inflammation and pain 
associated with musculoskeletal disorders.
    (3) Limitations. For oral use only. Treatment should not exceed 5 
consecutive days. The effect of this drug on pregnancy has not been 
determined. Not for use in horses intended for food. Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.

[50 FR 38114, Sept. 20, 1985, as amended at 52 FR 7832, Mar. 13, 1987]

[[Page 164]]



Sec. 520.980  Fluoxetine.

    (a) Specifications. Each chewable tablet contains 8, 16, 32, or 64 
milligrams (mg) fluoxetine hydrochloride.
    (b) Sponsor. See No. 000986 in Sec. 510.600 of this chapter.
    (c) Conditions of use in dogs--(1) Amount. 1 to 2 mg per kilogram 
body weight once daily.
    (2) Indications for use. For the treatment of canine separation 
anxiety in conjunction with a behavior modification plan.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[72 FR 6463, Feb. 12, 2007]



Sec. 520.1010  Furosemide.

    (a) Specifications. (1) Each tablet contains 12.5 or 50 milligrams 
(mg) furosemide.
    (2) Each bolus contains 2 grams (g) furosemide.
    (3) Each packet of powder contains 2 g furosemide.
    (4) Each milliliter of syrup contains 10 mg furosemide.
    (b) Sponsors. See sponsor numbers in Sec. 510.600(c) of this 
chapter for use of dosage forms and strengths listed in paragraph (a) of 
this section for uses as in paragraph (d) of this section.
    (1) No. 000010 for tablets in paragraph (a)(1) of this section for 
conditions of use in paragraphs (d)(2)(i), (d)(2)(ii)(A), and (d)(3) of 
this section.
    (2) No. 057926 for tablets in paragraph (a)(1) of this section for 
conditions of use in paragraphs (d)(2)(i), (d)(2)(ii)(A), and (d)(3) of 
this section; for boluses in paragraph (a)(2) of this section and powder 
in paragraph (a)(3) of this section for conditions of use in paragraph 
(d)(1) of this section; and for syrup in paragraph (a)(4) of this 
section for conditions of use in paragraphs (d)(2)(i) and (d)(2)(ii)(A).
    (3) Nos. 058829 and 059130 for use of syrup in paragraph (a)(4) of 
this section for conditions of use in paragraph (d)(2)(i) and 
(d)(2)(ii)(A) of this section.
    (c) Special considerations. Federal law restricts this drug to use 
by or on the order of a licensed veterinarian.
    (d) Conditions of use. It is used as follows:
    (1) Cattle--(i) Amount. 1 to 2 mg per pound (/lb) body weight using 
powder, or one 2-g bolus per animal, per day.
    (ii) Indications for use. For treatment of physiological parturient 
edema of the mammary gland and associated structures.
    (iii) Limitations. Treatment not to exceed 48 hours post-
parturition. Milk taken during treatment and for 48 hours after the last 
treatment must not be used for food. Cattle must not be slaughtered for 
food within 48 hours following last treatment.
    (2) Dogs--(i) Amount. 1 to 2 mg/lb body weight, once or twice daily.
    (ii) Indications for use--(A) For treatment of edema (pulmonary 
congestion, ascites) associated with cardiac insufficiency and acute 
noninflammatory tissue edema.
    (B) For treatment of edema (pulmonary congestion, ascites) 
associated with cardiac insufficiency.
    (3) Cats--(i) Amount. 1 to 2 mg/lb body weight, once or twice daily.
    (ii) Indications for use. For treatment of edema (pulmonary 
congestion, ascites) associated with cardiac insufficiency and acute 
noninflammatory tissue edema.

[66 FR 47960, Sept. 17, 2001, as amended at 69 FR 74419, Dec. 14, 2004; 
70 FR 50182, Aug. 26, 2005; 70 FR 76396, Dec. 27, 2005]



Sec. 520.1044  Gentamicin sulfate oral dosage forms.



Sec. 520.1044a  Gentamicin sulfate oral solution.

    (a) Specifications. Each milliliter of aqueous solution contains 
gentamicin sulfate equivalent to 50 milligrams of gentamicin.
    (b) Sponsor. See Nos. 000061 and 054925 in Sec. 510.600(c) of this 
chapter.
    (c) Related tolerances. See Sec. 556.300 of this chapter.
    (d) Conditions of use--(1) Amount. Colibacillosis: 1 milliliter per 
2 gallons of drinking water for 3 consecutive days, to provide 0.5 
milligram/pound/day; swine dysentery: 1 milliliter per 1 gallon of 
drinking water for 3 consecutive days, to provide 1.0 milligram/pound/
day.
    (2) Indications for use. In weanling swine for control and treatment 
of colibacillosis caused by strains of E.

[[Page 165]]

coli sensitive to gentamicin, and in swine for control and treatment of 
swine dysentery associated with Treponema hyodysenteriae.
    (3) Limitations. For use in swine drinking water only. Do not store 
or offer medicated drinking water in rusty containers since the drug is 
quickly destroyed in such containers. Medicated drinking water should be 
prepared daily and be the sole source of drinking water for 3 
consecutive days. Treatment may be repeated if dysentery recurs. Do not 
slaughter treated swine for food for at least 3 days following 
treatment.

[48 FR 10302, Mar. 11, 1983. Redesignated at 49 FR 572, Jan. 5, 1984, 
and amended at 49 FR 14332, Apr. 11, 1984; 52 FR 7832, Mar. 13, 1987; 62 
FR 34169, June 25, 1997; 71 FR 13542, Mar. 16, 2006]



Sec. 520.1044b  Gentamicin sulfate pig pump oral solution.

    (a) Specifications. Each milliliter of pig pump oral solution 
contains gentamicin sulfate equivalent to 4.35 milligrams of gentamicin.
    (b) Sponsor. See Nos. 000061 and 059130 in Sec. 510.600(c) of this 
chapter.
    (c) Related tolerances. See Sec. 556.300 of this chapter.
    (d) Conditions of use--(1) Amount. Administer 1.15 milliliters of 
pig pump oral solution (5 milligrams of gentamicin) orally per pig one 
time.
    (2) Indications for use. In neonatal swine 1 to 3 days of age for 
control and treatment of colibacillosis caused by strains of E. coli 
sensitive to gentamicin.
    (3) Limitations. For use in neonatal swine only. Do not slaughter 
treated swine for food for at least 14 days following treatment.

[49 FR 572, Jan. 5, 1984, as amended at 52 FR 7832, Mar. 13, 1987; 62 FR 
29011, May 29, 1997]



Sec. 520.1044c  Gentamicin sulfate soluble powder.

    (a) Specifications. Each gram of gentamicin sulfate soluble powder 
contains gentamicin sulfate equivalent to 16.7, 66.7, or 333.3 
milligrams of gentamicin.
    (b) Sponsor. See Nos. 000061 and 057561 in Sec. 510.600(c) of this 
chapter.
    (c) Related tolerances. See Sec. 556.300 of this chapter.
    (d) Conditions of use--(1) Amount. Colibacillosis: gentamicin 
sulfate equivalent to 25 milligrams of gentamicin per gallon of drinking 
water for 3 consecutive days, to provide 0.5 milligram per pound of body 
weight per day; swine dysentery: gentamicin sulfate equivalent to 50 
milligrams of gentamicin per gallon of drinking water for 3 consecutive 
days, to provide 1 milligram per pound of body weight per day.
    (2) Indications for use. In weanling swine for control and treatment 
of colibacillosis caused by strains of E. coli sensitive to gentamicin, 
and in swine for control and treatment of swine dysentery associated 
with Treponema hyodysenteriae.
    (3) Limitations. For use in swine drinking water only. Do not store 
or offer medicated drinking water in rusty containers since the drug is 
quickly destroyed in such containers. Medicated drinking water should be 
prepared daily and be the sole source of drinking water for 3 
consecutive days. Treatment may be repeated if dysentery recurs. Do not 
slaughter treated swine for food for at least 10 days following 
treatment.

[49 FR 29778, July 24, 1984, as amended at 52 FR 7832, Mar. 13, 1987; 52 
FR 48675, Dec. 24, 1987; 62 FR 29013, May 29, 1997]



Sec. 520.1100  Griseofulvin.

    (a) Specifications--(1) The powder complies with U.S.P. for 
griseofulvin, microsize.
    (2) Each bolus contains 2.5 grams griseofulvin.
    (3) Each tablet contains 125 or 500 milligrams griseofulvin.
    (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter.
    (1) No. 000061 for use of products described in paragraph (a) for 
use as in paragraph (d) of this section.
    (2) No. 059130 for use of the powder described in paragraph (a)(1) 
for use as in paragraphs (d)(1)(i)(A) and (d)(1)(ii) of this section.
    (c) Special considerations. Federal law restricts this drug to use 
by or on the order of a licensed veterinarian.
    (d) Conditions of use--(1) Horses--(i) Amount and indications for 
use--(A) For equine ringworm infection caused by Trichophyton equinum or 
Microsporum

[[Page 166]]

gypseum, administer soluble powder described in paragraph (a)(1) of this 
section daily as a drench or as a top dressing on feed for not less than 
10 days as follows: adults, 2.5 grams; yearlings, 1.25 to 2.5 grams; and 
foals, 1.25 grams.
    (B) For treating ringworm infection caused by T. equinum, administer 
boluses described in paragraph (a)(2) of this section daily for not less 
than 10 days as follows: adults, 1 bolus; yearlings, one-half to 1 
bolus; and foals, one-half bolus.
    (ii) Limitations. Not for use in horses intended for food.
    (2) Dogs and cats: (i) Amount. 125- and 500-milligram tablets 
administered orally as follows:
    (A) Daily (single or divided) dose:

------------------------------------------------------------------------
                                                               Dosage
                   Body weight (pounds)                     (milligrams)
------------------------------------------------------------------------
Up to 6...................................................         62.5
6 to 18...................................................          125
18 to 36..................................................          250
36 to 48..................................................          375
48 to 75..................................................          500
------------------------------------------------------------------------

    (B) Weekly (single) dose: If experience indicates that treatment is 
more effective for the drug given in large doses, administer at 
intervals of 7 to 10 days, a dose equal to 10 milligrams/pound of body 
weight x body weight x number of days between treatments. Dosage should 
be adjusted according to response. Administer additional dose after the 
animal is free of infection.
    (ii) Indications for use. For treatment of fungal infections of the 
skin, hair, and claws caused by Trichophyton mentagrophytes, T. rubrum, 
T. schoenleini, T. sulphurem, T. verrucosum, T. interdigitale, 
Epidermophyton floccosum, Microsporum gypseum, M. canis, M. audouini.

[40 FR 13838, Mar. 27, 1975, as amended at 41 FR 42948, Sept. 29, 1976; 
43 FR 28458, June 30, 1978; 52 FR 7832, Mar. 13, 1987; 54 FR 30205, July 
19, 1989; 71 FR 38073, July 5, 2006]



Sec. 520.1120  Haloxon oral dosage forms.



Sec. 520.1120a  Haloxon drench.

    (a) Chemical name. 3-Choloro-7-hydoxy-4-methylcoumarin bis (2-
chloroethyl) phosphate.
    (b) Specifications. Haloxon assay of not less than 96 percent by 
infrared spectrum at 8.62 microns.
    (c) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
    (d) Special considerations. Do not use any drug, insecticide, 
pesticide, or other chemical having cholinesterase-inhibiting activity 
either simultaneously or within a few days before or after treatment 
with haloxon.
    (e) Related tolerances. See Sec. 556.310 of this chapter.
    (f) Conditions of use. It is used as a drench as follows:
    (1) Cattle--(i) Amount. 141.5 grams per packet.
    (ii) Indications for use. Control of gastrointestinal roundworms of 
the genera Haemonchus, Ostertagia, Trichostrongylus, and Cooperia.
    (iii) Limitations. (a) Dissolve each packet in 32 fluid ounces of 
water and administer as follows:

------------------------------------------------------------------------
                                                                 Dose
                  Weight of animal (pounds)                     (fluid
                                                                ounces)
------------------------------------------------------------------------
Up to 100...................................................       \1/2\
100 to 150..................................................       \3/4\
150 to 200..................................................           1
200 to 300..................................................      1\1/2\
300 to 450..................................................           2
450 to 700..................................................           3
700 to 1,000................................................           4
1,000 to 1,200..............................................           5
Over 1,200..................................................           6
------------------------------------------------------------------------

    (b) Do not treat within 1 week of slaughter; do not treat dairy 
animals of breeding age; animals should be retreated in 3 to 4 weeks.

[40 FR 13838, Mar. 27, 1975, as amended at 45 FR 10333, Feb. 15, 1980; 
46 FR 48642, Oct. 2, 1981; 61 FR 8873, Mar. 6, 1996; 62 FR 61624, Nov. 
19, 1997]



Sec. 520.1120b  Haloxon boluses.

    (a) Chemical name. 3-Chloro-7-hydroxy-4-methylcoumarin bis (2-
chloroethyl) phosphate.
    (b) Specifications. Each bolus contains 10.1 grams of haloxon.
    (c) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
    (d) Related tolerances. See Sec. 556.310 of this chapter.
    (e) Conditions of use. (1) Haloxon bolus is an anthelmintic used in 
cattle for the control of gastrointestinal roundworms of the genera 
Haemonchus, Ostertagia, Trichostrongylus and Cooperia.
    (2) It is administered by giving one bolus per approximately 500 
pounds

[[Page 167]]

body weight (35 to 50 milligrams per kilogram of body weight).
    (3) For most effective results, re-treat animals in 3 to 4 weeks. If 
reinfection is likely to occur, additional re-treatments may be 
necessary.
    (4) Do not use any drug, pesticide or other chemical having 
cholinesterase inhibiting activity either simultaneously or within a few 
days before or after treatment with haloxon.
    (5) Do not treat animals within one week of slaughter.
    (6) Do not treat dairy animals of breeding age or older.

[40 FR 13838, Mar. 27, 1975, as amended at 44 FR 61591, Oct. 29, 1979; 
46 FR 48642, Oct. 2, 1981; 61 FR 8873, Mar. 6, 1996; 62 FR 61625, Nov. 
19, 1997]



Sec. 520.1130  Hetacillin oral dosage forms.



Sec. 520.1130a  Hetacillin potassium capsules.

    (a) Specifications. Each capsule contains hetacillin potassium 
equivalent to 50, 100, or 200 milligrams of ampicillin.
    (b) Sponsor. See No. 000856 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Dogs--(i) Amount. 5 milligrams per pound 
of body weight, twice daily. In severe infections, up to three times 
daily, or up to 10 milligrams per pound of body weight twice daily. For 
stubborn urinary tract infections, up to 20 milligrams per pound of body 
weight twice daily.
    (ii) Indications for use. Treatment against strains of organisms 
sensitive to hetacillin potassium and associated with respiratory tract 
infections, urinary tract infections, gastrointestinal infections, skin 
infections, soft tissue infections, and postsurgical infections.
    (iii) Limitations. For use in dogs and cats only. Continue treatment 
for 48 to 72 hours after the animal has become afebrile or asymptomatic. 
Administer 1 to 2 hours prior to feeding to ensure maximum absorption. 
In stubborn infections, therapy may be required for several weeks. Not 
for use in animals raised for food production. Federal law restricts 
this drug to use only by or on the order of a licensed veterinarian.
    (2) Cats--(i) Amount. Administer 50 milligrams twice daily.
    (ii) Indications for use. Treatment against strains of organisms 
sensitive to hetacillin potassium and associated with respiratory tract 
infections, urinary tract infections, gastrointestinal infections, skin 
infections, soft tissue infections, and postsurgical infections.
    (3) Limitations. For use in dogs and cats only. Continue treatment 
for 48 to 72 hours after the animal has become afebrile or asymptomatic. 
Administer in a fasting state to ensure maximum absorption. In stubborn 
infections, therapy may be required for several weeks. Not for use in 
animals raised for food production. Federal law restricts this drug to 
use only by or on the order of a licensed veterinarian.

[57 FR 37325, Aug. 18, 1992]



Sec. 520.1130b  Hetacillin potassium oral suspension.

    (a) Specifications. Each milliliter contains hetacillin potassium 
equivalent to 50 milligrams of ampicillin.
    (b) Sponsor. See No. 000856 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Dogs--(i) Amount. 5 milligrams per pound 
of body weight twice daily. In severe infections, up to three times 
daily, or up to 10 milligrams per pound of body weight twice daily. For 
stubborn urinary tract infections, up to 20 milligrams per pound of body 
weight twice daily.
    (ii) Indications for use. Treatment against strains of organisms 
susceptible to hetacillin potassium and associated with respiratory 
tract infections, urinary tract infections, gastrointestinal infections, 
skin infections, soft-tissue infections, and postsurgical infections.
    (iii) Limitations. For use in dogs only. Not for use in animals 
raised for food production. Continue treatment 48 to 72 hours after the 
animal has become afebrile or asymptomatic. Administer 1 to 2 hours 
prior to feeding to ensure maximum absorption. In stubborn infections, 
therapy may be required for several weeks. Federal law restricts this 
drug to use by or on the order of a licensed veterinarian.
    (2) Cats--(i) Amount. 50 milligrams twice daily.

[[Page 168]]

    (ii) Indications for use. Treatment against strains of organisms 
susceptible to hetacillin potassium and associated with respiratory 
tract infections, urinary tract infections, gastrointestinal infections, 
skin infections, soft-tissue infections, and postsurgical infections.
    (iii) Limitations. For use in cats only. Not for use in animals 
raised for food production. Continue treatment 48 to 72 hours after the 
animal has become afebrile or asymptomatic. Administer 1 to 2 hours 
prior to feeding to ensure maximum absorption. In stubborn infections, 
therapy may be required for several weeks. Federal law restricts this 
drug to use by or on the order of a licensed veterinarian.

[57 FR 37326, Aug. 18, 1992]



Sec. 520.1130c  Hetacillin potassium tablets.

    (a) Specifications. Each tablet contains hetacillin potassium 
equivalent to 50, 100, or 200 milligrams of ampicillin.
    (b) Sponsor. See No. 000856 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Dogs--(i) Amount. 5 milligrams per pound 
of body weight twice daily. In severe infections, up to three times 
daily, or up to 10 milligrams per pound of body weight twice daily. For 
stubborn urinary tract infections, up to 20 milligrams per pound of body 
weight twice daily.
    (ii) Indications for use. Oral treatment against strains of 
organisms sensitive to hetacillin potassium and associated with 
respiratory tract infections, urinary tract infections, gastrointestinal 
infections, skin infections, soft tissue infections, and postsurgical 
infections.
    (iii) Limitations. For use in dogs and cats only. Continue treatment 
for 48 to 72 hours after the animal has become afebrile or asymptomatic. 
Administer 1 to 2 hours prior to feeding to ensure maximum absorption. 
In stubborn infections, therapy may be required for several weeks. Not 
for use in animals which are raised for food production. Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.
    (2) Cats--(i) Amount. 50 milligrams twice daily.
    (ii) Indications for use. Treatment against strains of organisms 
sensitive to hetacillin potassium and associated with respiratory tract 
infections, urinary tract infections, gastrointestinal infections, skin 
infections, soft tissue infections, and postsurgical infections.
    (iii) Limitations. For use in dogs and cats only. Continue treatment 
for 48 to 72 hours after the animal has become afebrile or asymptomatic. 
Administer 1 to 2 hours prior to feeding to ensure maximum absorption. 
In stubborn infections, therapy may be required for several weeks. Not 
for use in animals which are raised for food production. Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.

[57 FR 37326, Aug. 18, 1992]



Sec. 520.1157  Iodinated casein tablets.

    (a) Specifications. Each 1-gram tablet contains 25 milligrams of 
iodinated casein.
    (b) Sponsor. See No. 017762 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. \1/5\ to 1 tablet per 10 pounds 
of body weight (equivalent to 0.5 to 2.5 milligrams of iodinated casein 
per pound of body weight).
    (2) Indications for use. For dogs for apparent decreased thyroid 
activity where the signs are alopecia, scaliness of the skin surface, 
loss of hair, seborrhea, thickening of the skin, hyperpigmentation, and 
lethargy.
    (3) Limitations. If no response is observed in 30 to 45 days, the 
drug should be withdrawn and the diagnosis reconsidered. Do not use in 
the presence of cardiac disease, ischemia, adrenal insufficiency, or 
nephrosis. Federal law restricts this drug to use by or on the order of 
a licensed veterinarian.

[49 FR 22469, May 30, 1984]



Sec. 520.1158  Iodochlorhydroxyquin boluses.

    (a) Specifications. Each bolus contains 10 grams of 
iodochlorhydroxyquin.
    (b) Sponsor. See No. 053501 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. 1 bolus (10 grams) daily for a 
1,000-pound horse.

[[Page 169]]

    (2) Indications for use. For treatment of equine diarrhea.
    (3) Limitations. For horses only; not to be administered to food-
producing animals. Do not administer to horses intended for use as food. 
Federal law restricts this drug to use by or on the order of a licensed 
veterinarian.

[48 FR 8054, Feb. 25, 1983, as amended at 50 FR 41489, Oct. 11, 1985]



Sec. 520.1182  Iron dextran suspension.

    (a) Specifications. Each milliliter (mL) of suspension contains 
55.56 milligrams (mg) iron as ferric hydroxide in complex with a low 
molecular weight dextran.
    (b) Sponsor. See No. 051311 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in swine--(1) Amount. Administer 100 mg (1.8 
mL) orally by automatic dose dispenser.
    (2) Indications for use. For the prevention of iron deficiency 
anemia in baby pigs.
    (3) Limitations. Treat each pig within 24 hours of farrowing.

[70 FR 32489, June 3, 2005]



Sec. 520.1192  Ivermectin paste.

    (a) Specifications. Each milligram (mg) of paste contains 0.0187 mg 
(1.87 percent) or 0.00153 mg (0.153 percent) of ivermectin.
    (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for 
use as in paragraph (e) of this section:
    (1) No. 050604 for use of a 1.87-percent paste as in (e)(1)(i), 
(e)(1)(ii)(A), and (e)(1)(iii) of this section and a 0.153-percent paste 
for use as in paragraph (e)(2) of this section.
    (2) No. 059130 for use of a 1.87-percent paste for use as in 
paragraph (e)(1)(i), (e)(1)(ii)(B), and (e)(1)(iii) of this section.
    (3) No. 061623 for use of a 1.87 percent paste for use as in 
paragraph (e)(1)(i), (e)(1)(ii)(C), and (e)(1)(iii) of this section.
    (4) Nos. 051311 and 054925 for use of a 1.87 percent paste as in 
paragraphs (e)(1)(i), (e)(1)(ii)(A), and (e)(1)(iii) of this section.
    (c) Related tolerances. See Sec. 556.344 of this chapter.
    (d) Special considerations. See Sec. 500.25 of this chapter.
    (e) Conditions of use--(1) Horses--(i) Amount. 200 micrograms per 
kilogram (91 micrograms per pound) of body weight.
    (ii) Indications for use. For treatment and control of:
    (A) Large Strongyles (adults): Strongylus vulgaris (also early forms 
in blood vessels), S. edentatus (also tissue stages), S. equinus, 
Triodontophorus spp. including T. brevicauda and T. serratus, and 
Craterostomum acuticaudatum; Small Strongyles (adults, including those 
resistant to some benzimidazole class compounds): Coronocyclus spp. 
including C. coronatus, C. labiatus, and C. labratus, Cyathostomum spp. 
including C. catinatum and C. pateratum, Cylicocyclus spp. including C. 
insigne, C. leptostomum, C. nassatus, and C. brevicapsulatus, 
Cylicodontophorus spp., Cylicostephanus spp., including C. calicatus, C. 
goldi, C. longibursatus, and C. minutus, and Petrovinema poculatum; 
Small Strongyles (fourth-stage larvae); Pinworms (adults and fourth 
stage larvae): Oxyuris equi; Ascarids (adults and third- and fourth-
stage larvae): Parascaris equorum; Hairworms (adults): Trichostrongylus 
axei; Large mouth Stomach Worms (adults), Habronema muscae; Bots (oral 
and gastric stages): Gasterophilus spp. including G. intestinalis and G. 
nasalis; Lungworms (adults and fourth-stage larvae): Dictyocaulus 
arnfieldi; Intestinal Threadworms (adults): Strongyloides westeri; 
Summer Sores caused by Habronema and Draschia spp. cutaneous third-stage 
larvae; Dermatitis caused by neck threadworm microfilariae, Onchocerca 
sp.
    (B) Large Strongyles (adult) (Strongylus equinus), (adult and 
arterial larval stages) (Strongylus vulgaris), (adult and migrating 
tissue stages) (Strongylus edentatus), (adult) (Triodontophorus spp.); 
Small Strongyles, including those resistant to some benzimidazole class 
compounds (adult and fourth-stage larvae) (Cyathostomum spp., 
Cylicocyclus spp., Cylicodontophorus spp., Cylicostephanus spp.); 
Pinworms (adult and fourth-stage larvae) (Oxyuris equi); Ascarids 
(third- and fourth-stage larvae and adults) (Parascaris equorum); 
hairworms (adult) (Trichostrongylus axei); Large mouth Stomach Worms 
(adult)

[[Page 170]]

(Habronema muscae); Stomach Bots (oral and gastric stages) (Gastrophilus 
spp.); Lungworms (adults and fourth-stage larvae) (Dictyocaulus 
arnfieldi); Intestinal Threadworms (adults) (Strongyloides westeri); 
Summer Sores caused by Habronema and Draschia spp. cutaneous third-stage 
larvae; and Dermatitis caused by neck threadworm microfilariae 
(Onchocerca sp.).
    (C) Large strongyles (adults)--Strongylus vulgaris (also early forms 
in blood vessels), S. edentatus (also tissue stages), S. equinus, and 
Triodontophorus spp. including T. brevicauda and T. serratus; Small 
Strongyles (adults, including those resistant to some benzimidazole 
class compounds)--Cyathostomum spp. including C. catinatum and C. 
pateratum, Cylicocyclus spp. including C. insigne, C. leptostomum, C. 
nassatus, and C. brevicapsulatus, Cylicodontophorus spp., and 
Cylicostephanus spp. including C. calicatus, C. goldi, C. longibursatus, 
and C. minutus; Small Strongyles--fourth-stage larvae; Pinworms (adults 
and fourth-stage larvae)--Oxyuris equi; Ascarids (adults and third- and 
fourth-stage larvae)--Parascaris equorum; Hairworms (adults)--
Trichostrongylus axei; Large-mouth Stomach Worms (adults)--Habronema 
muscae; Bots (oral and gastric stages)--Gasterophilus spp. including G. 
intestinalis and G. nasalis; Lungworms (adults and fourth-stage 
larvae)--Dictyocaulus arnfieldi; Intestinal Threadworms (adults)--
Strongyloides westeri; Summer Sores caused by Habronema and Draschia 
spp. cutaneous third-stage larvae; Dermatitis caused by neck threadworm 
microfilariae, Onchocerca sp.
    (iii) Limitations. For oral use only. Do not use in horses intended 
for human consumption.
    (2) Cattle--(i) Amount. 23 milligrams per 250 pounds of body weight.
    (ii) Indications for use. It is used in cattle for the treatment and 
control of gastrointestinal roundworms (adults and fourth-stage larvae) 
(Ostertagia ostertagi (including inhibited forms), O. lyrata, Haemonchus 
placei, Trichostrongylus axei, T. colubriformis, Cooperia oncophora, C. 
punctata, Nematodirus helvetianus, Bunostomum phlebotomum, Strongyloides 
papillosus (adults only), Oesophagostomum radiatum, Trichuris ovis 
(adults only)); lungworms (adults and fourth-stage larvae) (Dictyocaulus 
viviparus); grubs (first, second, and third instars) (Hypoderma bovis, 
H. lineatum); and sucking lice (Linognathus vituli, Haematopinus 
eurysternus).
    (iii) Limitations. For oral use only. Do not treat cattle within 24 
days of slaughter. Because withdrawal time in milk has not been 
established, do not use in female dairy cattle of breeding age.

[49 FR 22275, May 29, 1984, as amended at 50 FR 27819, July 8, 1985; 51 
FR 44449, Dec. 10, 1986; 53 FR 51273, Dec. 21, 1988; 62 FR 63270, Nov. 
28, 1997; 65 FR 70661, Nov. 27, 2000; 67 FR 71820, Dec. 3, 2002; 68 FR 
43294, July 22, 2003; 69 FR 59131, Oct. 4, 2004; 70 FR 8514, Feb. 22, 
2005; 71 FR 40010, July 14, 2006; 71 FR 67298, Nov. 21, 2006]



Sec. 520.1193  Ivermectin tablets and chewables.

    (a) Specifications. (1) Each tablet or chewable contains 68, 136, or 
272 micrograms (mcg) ivermectin.
    (2) Each chewable contains 55 or 165 mcg ivermectin.
    (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for 
use as in paragraph (d) of this section.
    (1) No. 050604 for use of tablets or chewables described in 
paragraph (a)(1) as in paragraph (d)(1) and chewables described in 
paragraph (a)(2) as in paragraph (d)(2) of this section.
    (2) Nos. 051311 and 059130 for use of tablets described in paragraph 
(a)(1) as in paragraph (d)(1) of this section.
    (c) Special considerations. Federal law restricts this drug to use 
by or on the order of a licensed veterinarian.
    (d) Conditions of use--(1) Dogs. For use in dogs 6 weeks of age and 
older as follows:
    (i) Amount. 6.0 mcg per kilogram (kg) of body weight (2.72 mcg per 
pound (lb)), minimum. Up to 25 lb, 68 mcg; 26 to 50 lb, 136 mcg; 51 to 
100 lb, 272 mcg; over 100 lb, a combination of the appropriate tablets. 
Administer at monthly dosing intervals.
    (ii) Indications for use. To prevent canine heartworm disease by 
eliminating the tissue stage of heartworm larvae (Dirofilaria immitis) 
for 1 month (30 days) after infection.
    (2) Cats. For use in cats 6 weeks of age and older as follows:

[[Page 171]]

    (i) Amount. Up to 2.3 kilograms (up to 5 lb), 55 mcg; 2.3 to 6.8 
kilograms (5 to 15 lb), 165 mcg; over 6.8 kilograms (15 lb), a 
combination of the appropriate chewables (recommended minimum dose of 24 
mcg/kg of body weight (10.9 mcg/lb)). Administer once a month.
    (ii) Indications for use. To prevent feline heartworm disease by 
eliminating the tissue stage of heartworm larvae Dirofilaria immitis for 
a month (30 days) after infection, and for removal and control of adult 
and immature (L4) hookworms Ancylostoma tubaeforme and A. braziliense.

[67 FR 11230, Mar. 13, 2002, as amended at 67 FR 21996, May 2, 2002; 69 
FR 43735, July 22, 2004]



Sec. 520.1194  Ivermectin meal.

    (a) Specifications. Each gram of meal contains 6 milligrams 
ivermectin (0.6 percent).
    (b) Sponsor. See No. 017135 in Sec. 510.600(c) of this chapter.
    (c) Special considerations. See Sec. 500.25 of this chapter.
    (d) Conditions of use in horses--(1) Amount. Administer 136 
micrograms (mcg) ivermectin per pound (/lb) body weight (300 mcg/
kilogram) as a single dose on approximately 2 lb grain or sweet feed.
    (2) Indications for use. For treatment and control of Large 
Strongyles (adults): Strongylus vulgaris (also early forms in blood 
vessels), S. edentatus (also tissue stages), S. equinus, Triodontophorus 
spp. including T. brevicauda and T. serratus, and Craterostomum 
acuticaudatum; Small Strongyles (adults, including those resistant to 
some benzimidazole class compounds): Coronocyclus spp. including C. 
coronatus, C. labiatus, and C. labratus, Cyathostomum spp. including C. 
catinatum and C. pateratum, Cylicocyclus spp. including C. insigne, C. 
leptostomum, C. nassatus, and C. brevicapsulatus, Cylicodontophorus 
spp., Cylicostephanus spp. including C. calicatus, C. goldi, C. 
longibursatus, and C. minutus, and Petrovinema poculatum; Small 
Strongyles (fourth-stage larvae); Pinworms (adults and fourth stage 
larvae): Oxyuris equi; Ascarids (adults and third- and fourth-stage 
larvae): Parascaris equorum; Hairworms (adults): Trichostrongylus axei; 
Large Mouth Stomach Worms (adults): Habronema muscae; Bots (oral and 
gastric stages): Gasterophilus spp. including G. intestinalis and G. 
nasalis; Lungworms (adults and fourth-stage larvae): Dictyocaulus 
arnfieldi; Intestinal Threadworms (adults): Strongyloides westeri; 
Summer Sores caused by Habronema and Draschia spp. cutaneous third-stage 
larvae; Dermatitis caused by neck threadworm microfilariae, Onchocerca 
sp.
    Limitations. Do not use in horses intended for human consumption.

[70 FR 1817, Jan. 11, 2005, as amended at 70 FR 19262, Apr. 13, 2005]



Sec. 520.1195  Ivermectin liquid.

    (a) Specifications--(1) Each milliliter (mL) contains 10 milligrams 
(mg) ivermectin.
    (2) Each mL of micellar solution contains 0.8 mg ivermectin.
    (b) Sponsors. See sponsor numbers in Sec. 510.600(c) of this 
chapter.
    (1) Nos. 050604, 054925, and 059130 for use of product described in 
paragraph (a)(1) of this section as in paragraphs (e)(1)(i), 
(e)(1)(ii)(A), and (e)(1)(iii) of this section.
    (2) Nos. 058005 and 058829 for use of product described in paragraph 
(a)(1) of this section as in paragraphs (e)(1)(i), (e)(1)(ii)(B), and 
(e)(1)(iii) of this section.
    (3) Nos. 050604 and 058829 for use of product described in paragraph 
(a)(2) of this section as in paragraph (e)(2) of this section.
    (c) Related tolerances. See Sec. 556.344 of this chapter.
    (d) Special considerations. See Sec. 500.25 of this chapter.
    (e) Conditions of use--(1) Horses--(i) Amount. 200 micrograms (mcg) 
per kilogram (/kg) of body weight as a single dose by stomach tube or as 
an oral drench.
    (ii) Indications for use. For treatment and control of:
    (A) Large Strongyles (adults): Strongylus vulgaris (also early forms 
in blood vessels), S. edentatus (also tissue stages), S. equinus, 
Triodontophorus spp. including T. brevicauda and T. serratus, and 
Craterostomum acuticaudatum; Small Strongyles (adults, including those 
resistant to some benzimidazole

[[Page 172]]

class compounds): Coronocyclus spp. including C. coronatus, C. labiatus, 
and C. labratus, Cyathostomum spp. including C. catinatum and C. 
pateratum, Cylicocyclus spp. including C. insigne, C. leptostomum, C. 
nassatus, and C. brevicapsulatus, Cylicodontophorus spp., 
Cylicostephanus spp. including C. calicatus, C. goldi, C. longibursatus, 
and C. minutus, and Petrovinema poculatum; Small Strongyles (fourth-
stage larvae); Pinworms (adults and fourth stage larvae): Oxyuris equi; 
Ascarids (adults and third- and fourth-stage larvae): Parascaris 
equorum; Hairworms (adults): Trichostrongylus axei; Large mouth Stomach 
Worms (adults): Habronema muscae; Bots (oral and gastric stages): 
Gasterophilus spp. including G. intestinalis and G. nasalis; Lungworms 
(adults and fourth-stage larvae): Dictyocaulus arnfieldi; Intestinal 
Threadworms (adults), Strongyloides westeri; Summer Sores caused by 
Habronema and Draschia spp. cutaneous third-stage larvae; Dermatitis 
caused by neck threadworm microfilariae, Onchocerca sp.
    (B) Large Strongyles (Strongylus equinus (adult), S. vulgaris (adult 
and arterial larval stages), S. endentatus (adult and migrating tissue 
stages), Triodontophorus spp. (adult)); Small Strongyles including those 
resistant to some benzimidazole class compounds (Cyathostomum spp. 
(adult and fourth-stage larvae), Cylicocyclus spp., Cylicodontophorus 
spp., Cylicostephanus spp.); Pinworms (Oxyuris equi (adult and fourth-
stage larvae)); Ascarids (Parascaris equorum (adult and third- and 
fourth-stage larvae)); Hairworms (Trichostongylus axei(adult)); Large 
mouth Stomach Worms (Habronema muscae (adult)); Stomach Bots 
(Gastrophilus spp. (oral and gastric stages)); Lungworms (Dictyocaulus 
arnfieldi (adult and fourth-stage larvae)); intestinal threadworms 
(Strongyloides westeri (adult)); Summer Sores caused by Habronema and 
Draschia spp. cutaneous third-stage larvae; and Dermatitis caused by 
neck threadworm microfilariae (Onchocerca spp.).
    (iii) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.
    (2) Sheep--(i) Amount. 200 mcg/kg (3 mL/26 pounds) of body weight as 
a single dose oral drench.
    (ii) Indications for use. For treatment and control of the adult and 
fourth-stage larvae of gastrointestinal roundworms (Haemonchus 
contortus, H. placei (adults only), Ostertagia circumcincta, 
Trichostrongylus axei, T. colubriformis, Cooperia oncophora (adults 
only), C. curticei, Oesophagostomum columbianum, O. venulosum(adults 
only), Nematodirus battus, N. spathiger, S. papillosus (adults only), 
Chabertia ovina (adult only), Trichuris ovis (adults only)); lungworms 
(D. filaria); and all larval stages of the nasal bot Oestrus ovis.
    (iii) Limitations. For use in sheep only. Do not use in other animal 
species as severe adverse reactions, including fatalities in dogs, may 
result. Do not treat sheep within 11 days of slaughter.

[67 FR 50597, Aug. 5, 2002, as amended at 69 FR 57173, Sept. 24, 2004; 
71 FR 13542, Mar. 16, 2006; 71 FR 38072, July 5, 2006; 72 FR 9456, Feb. 
21, 2008]



Sec. 520.1196  Ivermectin and pyrantel pamoate chewable tablets.

    (a) Specifications. Each chewable tablet contains either 68 
micrograms ([micro]g) of ivermectin and 57 milligrams (mg) of pyrantel 
(as pamoate salt), or 136 [micro]g and 114 mg, or 272 [micro]g and 227 
mg, respectively.
    (b) Sponsors. See Nos. 050604, 051311, and 063604 in Sec. 
510.600(c) of this chapter.
    (c) Conditions of use--(1) Dogs--(i) Amount. A minimum of 6 [micro]g 
of ivermectin and 5 mg of pyrantel (as pamoate salt) per kilogram (2.72 
[micro]g and 2.27 mg per pound) of body weight.
    (ii) Indications for use. To prevent canine heartworm disease by 
eliminating the tissue larval stages of Dirofilaria immitis for up to a 
month (30 days) after infection and treatment and control of adult 
ascarids Toxocara canis and Toxascaris leonina, and adult hookworms 
Ancylostoma caninum, A. braziliense, and Uncinaria stenocephala.
    (iii) Limitations. Use monthly. Recommended for dogs 6 weeks of age 
and older. Federal law restricts this drug to use by or on the order of 
a licensed veterinarian.

[[Page 173]]

    (2) [Reserved]

[58 FR 8542, Feb. 16, 1993, as amended at 61 FR 15186, Apr. 5, 1996; 61 
FR 59004, Nov. 20, 1996; 62 FR 63270, Nov. 28, 1997; 66 FR 35756, July 
9, 2001; 67 FR 21996, May 2, 2002; 68 FR 55823, Sept. 29, 2003]



Sec. 520.1197  Ivermectin sustained-release bolus.

    (a) Specifications. Each sustained-release bolus contains 1.72 grams 
of ivermectin.
    (b) Sponsor. See No. 050604 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.344 of this chapter.
    (d) Conditions of use in ruminating calves--(1) Amount. Administer 
one bolus per calf weighing at least 275 pounds (lb) (125 kilograms 
(kg)) and not more than 660 lb (300 kg) on the day of administration.
    (2) Indications. For treatment and control, throughout the grazing 
season (approximately 130 days), of gastrointestinal roundworms 
Haemonchus placei, Ostertagia ostertagi (including inhibited fourth-
stage larvae), Trichostrongylus axei, T. colubriformis, Cooperia spp., 
Nematodirus helvetianus, Bunostomum phlebotomum, Oesophagostomum 
radiatum; lungworms Dictyocaulus viviparus; grubs Hypoderma spp.; 
sucking lice Linognathus vituli, Solenopotes capillatus; mange mites 
Psoroptes ovis, Sarcoptes scabiei, and ticks Amblyomma americanum.
    (3) Limitations. The bolus was specifically designed for use in 
cattle; do not use in other animal species. Calves must be ruminating 
and older than 12 weeks of age. Do not administer to calves weighing 
less than 275 lb (125 kg). Do not administer a damaged bolus. Because a 
milk withdrawal time has not been established, do not use in female 
dairy cattle of breeding age. Do not slaughter cattle within 180 days of 
treatment. Consult your veterinarian for assistance in the diagnosis, 
treatment, and control of parasitism.

[61 FR 67452, Dec. 23, 1996, as amended at 62 FR 63270, Nov. 28, 1997; 
65 FR 45876, July 26, 2000]



Sec. 520.1198  Ivermectin and praziquantel paste.

    (a) Specifications. Each milligram (mg) of paste contains:
    (1) 0.0155 mg (1.55 percent) ivermectin and 0.0775 mg (7.75 percent) 
praziquantel.
    (2) 0.0187 mg (1.87 percent) ivermectin and 0.1403 mg (14.03 
percent) praziquantel.
    (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for 
uses as in paragraph (d) of this section.--
    (1) No. 050604 for use of product described in paragraph (a)(1) of 
this section as in paragraphs (d)(1)(i), (d)(2)(i) and (d)(3) of this 
section.
    (2) No. 051311 for use of product described in paragraph (a)(2) of 
this section as in paragraphs (d)(1)(ii), (d)(2)(ii), and (d)(3) of this 
section.
    (c) Special considerations. See Sec. 500.25 of this chapter.
    (d) Conditions of use in horses--(1) Amount--(i) 200 micrograms 
(mcg) per kilogram (/kg) ivermectin (91 mcg per pound (/lb)) and 1 mg/kg 
praziquantel (454 mcg/lb) body weight.
    (ii) 200 mcg/kg ivermectin (91 mcg/lb) and 1.5 mg/kg praziquantel 
(681 mcg/lb) body weight.
    (2) Indications for use. For treatment and control of:
    (i) Tapeworms--Anoplocephala perfoliata; Large strongyles (adults)--
Strongylus vulgaris (also early forms in blood vessels), S. edentatus 
(also tissue stages), S. equinus, Triodontophorus spp. including T. 
brevicauda and T. serratus, and Craterostomum acuticaudatum; Small 
Strongyles (adults, including those resistant to some benzimidazole 
class compounds)--Coronocyclus spp. including C. coronatus, C. labiatus, 
and C. labratus, Cyathostomum spp. including C. catinatum and C. 
pateratum, Cylicocyclus spp. including C. insigne, C. leptostomum, C. 
nassatus, and C. brevicapsulatus, Cylicodontophorus spp., 
Cylicostephanus spp. including C. calicatus, C. goldi, C. longibursatus, 
and C. minutus, and Petrovinema poculatum; Small Strongyles--fourth-
stage larvae; Pinworms (adults and fourth-stage larvae)--Oxyuris equi; 
Ascarids (adults and third- and fourth-stage larvae)--Parascaris 
equorum; Hairworms (adults)--Trichostrongylus axei; Large-mouth Stomach 
Worms (adults)--Habronema muscae; Bots (oral and gastric stages)--
Gasterophilus spp. including G. intestinalis and G. nasalis; Lungworms 
(adults and fourth-stage

[[Page 174]]

larvae)--Dictyocaulus arnfieldi; Intestinal Threadworms (adults)--
Strongyloides westeri; Summer Sores caused by Habronema and Draschia 
spp. cutaneous third-stage larvae; Dermatitis caused by neck threadworm 
microfilariae, Onchocerca sp.
    (ii) Tapeworms--Anoplocephala perfoliata; Large Strongyles 
(adults)--Strongylus vulgaris (also early forms in blood vessels), 
S.edentatus (also tissue stages), S. equinus, Triodontophorus spp.; 
Small Strongyles (adults, including those resistant to some 
benzimidazole class compounds)--Cyathostomum spp., Cylicocyclus spp., 
Cylicostephanus spp., Cylicodontophorus spp.; Small Strongyles--fourth-
stage larvae; Pinworms (adults and fourth-stage larvae)--Oxyuris equi; 
Ascarids (adults and third- and fourth-stage larvae)--Parascaris 
equorum; Hairworms (adults)--Trichostrongylus axei; Large-mouth Stomach 
Worms (adults)--Habronema muscae; Bots (oral and gastric stages)--
Gasterophilus spp.; Lungworms (adults and fourth-stage larvae)--
Dictyocaulus arnfieldi; Intestinal Threadworms (adults)--Strongyloides 
westeri; Summer Sores caused by Habronema and Draschia spp. cutaneous 
third-stage larvae; Dermatitis caused by neck threadworm microfilariae, 
Onchocerca sp.
    (3) Limitations. For oral use only. Do not use in horses intended 
for human consumption.

[68 FR 55309, Sept. 25, 2003, as amended at 69 FR 49808, Aug. 12, 2004; 
70 FR 65835, Nov. 1, 2005]



Sec. 520.1199  Ivermectin, pyrantel, and praziquantel tablets.

    (a) Specifications. Each chewable tablet contains:
    (1) 34 micrograms (mcg) ivermectin, 28.5 milligrams (mg) pyrantel 
pamoate, and 28.5 mg praziquantel;
    (2) 68 mcg ivermectin, 57 mg pyrantel pamoate, and 57 mg 
praziquantel;
    (3) 136 mcg ivermectin, 114 mg pyrantel pamoate, and 114 mg 
praziquantel; or
    (4) 272 mcg ivermectin, 228 mg pyrantel pamoate, and 228 mg 
praziquantel.
    (b) Sponsors. See No. 051311 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer monthly 
according to body weight as follows:
    (i) 6 to 12 lb: one tablet as described in paragraph (a)(1) of this 
section.
    (ii) 12.1 to 25 lb: one tablet as described in paragraph (a)(2) of 
this section.
    (iii) 25.1 to 50 lb: one tablet as described in paragraph (a)(3) of 
this section.
    (iv) 50.1 to 100 lb: one tablet as described in paragraph (a)(4) of 
this section.
    (v) Greater than 100 lb: use the appropriate combination of tablets.
    (2) Indications for use. Prevents canine heartworm disease by 
eliminating the tissue stage of heartworm larvae (Dirofilaria immitis) 
for 1 month (30 days) after infection and for the treatment and control 
of roundworm (Toxocara canis, Toxascaris leonina), hookworm (Ancylostoma 
caninum, Uncinaria stenocephala, Ancylostoma braziliense) and tapeworm 
(Dipylidium caninum, Taenia pisiformis) infections.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[71 FR 65052, Nov. 7, 2006]



Sec. 520.1204  Kanamycin, bismuth subcarbonate, activated attapulgite.

    (a) Specifications--(1) Each 5 milliliters (mL) of suspension 
contains 100 milligrams (mg) kanamycin (as the sulfate), 250 mg bismuth 
subcarbonate, and 500 mg activated attapulgite (aluminum magnesium 
silicate).
    (2) Each tablet contains 100 mg kanamycin (as the sulfate), 250 mg 
bismuth subcarbonate, and 500 mg activated attapulgite.
    (b) Sponsor. See No. 000856 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. 5 mL of suspension or 1 
tablet per 20 pounds body weight every 8 hours. Maximum dose: 5 mL of 
suspension or 3 tablets every 8 hours. Dogs under 10 pounds: 2.5 mL of 
suspension or 1/2 tablet every 8 hours. A recommended initial loading 
dose should be twice the amount of a single dose.
    (2) Indications for use. For the treatment of bacterial enteritis 
caused by organisms susceptible to kanamycin

[[Page 175]]

and the symptomatic relief of the associated diarrhea.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[40 FR 13838, Mar. 27, 1975, as amended at 53 FR 27851, July 25, 1988; 
56 FR 8710, Mar. 1, 1991; 64 FR 403, Jan. 5, 1999; 71 FR 43968, Aug. 3, 
2006]



Sec. 520.1242  Levamisole hydrochloride oral dosage forms.



Sec. 520.1242a  Levamisole powder for oral solution.

    (a) Specifications. Each package of powder contains 9.075, 11.7, 
18.15, 46.8, 362.7, or 544.5 grams (g) levamisole hydrochloride.
    (b) Sponsors. See sponsors in Sec. 510.600(c) for use as follows:
    (1) No. 000061 for use of 46.8- and 544.5-g packages as in paragraph 
(e)(1)(i), (e)(1)(ii)(B), and (e)(1)(iii) of this section; for 11.7-, 
46.8-, and 544.5-g packages as in paragraph (e)(2)(i), (e)(2)(ii)(B), 
and (e)(2)(iii) of this section; and for an 18.15-g package as in 
paragraph (e)(3) of this section.
    (2) No. 053501 for use of a 46.8-g package as in paragraph 
(e)(1)(i), (e)(1)(ii)(A), and (e)(1)(iii) of this section; for 11.7- and 
46.8-g packages as in paragraph (e)(2)(i), (e)(2)(ii)(A), and 
(e)(2)(iii) of this section; and for 9.075- and 18.15-g packages as in 
paragraph (e)(3) of this section.
    (3) No. 057561 for use of 46.8- and 544.5-g packages as in 
paragraphs (e)(1)(i), (e)(1)(ii)(A), and (e)(1)(iii) and (e)(2)(i), 
(e)(2)(ii)(A), and (e)(2)(iii) of this section.
    (4) No. 059130 for use of 46.8-, 362.7-, and 544.5-g packages as in 
paragraphs (e)(1)(i), (e)(1)(ii)(B), (e)(1)(iii), (e)(2)(i), 
(e)(2)(ii)(B), and (e)(2)(iii) of this section; and for use of an 18.15-
g package as in paragraph (e)(3) of this section.
    (c) Related tolerances. See Sec. 556.350 of this chapter.
    (d) Special considerations. See Sec. 500.25 of this chapter.
    (e) Conditions of use. It is used as an anthelmintic as follows:
    (1) Cattle--(i) Amount. 8 milligrams per kilogram (mg/kg) body 
weight as a drench.
    (ii) Indications for use--(A) Effective against the following 
nematode infections: Stomach worms (Haemonchus, Trichostrongylus, 
Ostertagia); intestinal worms (Trichostrongylus, Cooperia, Nematodirus, 
Bunostomum, Oesophagostomum); and lungworms (Dictyocaulus).
    (B) Effective against the following adult nematode infections: 
Stomach worms (Haemonchus placei, Ostertagia ostertagi, Trichostrongylus 
axei); intestinal worms (T. longispicularis, Cooperia oncophora, C. 
punctata, Nematodirus spathiger, Bunostomum phlebotomum, Oesophagostomum 
radiatum); and lungworms (Dictyocaulus viviparus).
    (iii) Limitations. Do not slaughter for food within 48 hours of 
treatment. Not for use in dairy animals of breeding age. Conditions of 
constant helminth exposure may require retreatment 2 to 4 weeks after 
the first treatment. Consult your veterinarian before using in severely 
debilitated animals.
    (2) Sheep--(i) Amount. 8 mg/kg body weight as a drench.
    (ii) Indications for use--(A) Effective against the following 
nematode infections: Stomach worms (Haemonchus, Trichostrongylus, 
Ostertagia); intestinal worms (Trichostrongylus, Cooperia, Nematodirus, 
Bunostomum, Oesophagostomum, Chabertia); and lungworms (Dictyocaulus).
    (B) Effective against the following adult nematode infections: 
Stomach worms (Haemonchus contortus, Trichostrongylus axei, Teladorsagia 
circumcincta); intestinal worms (Trichostrongylus colubriformis, 
Cooperia curticei, Nematodirus spathiger, Bunostomum trigonocephalum, 
Oesophagostomum columbianum, Chabertia ovina), and lungworms 
(Dictyocaulus filaria).
    (iii) Limitations. Do not slaughter for food within 72 hours of 
treatment. Conditions of constant helminth exposure may require 
retreatment 2 to 4 weeks after the first treatment. Consult veterinarian 
before using in severely debilitated animals.
    (3) Swine--(i) Amount. 8 mg/kg body weight in drinking water.
    (ii) Indications for use. Effective against the following nematode 
infections: Large roundworms (Ascaris suum), nodular worms 
(Oesophagostomum spp.), intestinal thread worms (Strongyloides ransomi) 
and lungworms (Metastrongylus spp. ).

[[Page 176]]

    (iii) Limitations. Do not administer within 72 hours of slaughter 
for food. Pigs maintained under conditions of constant exposure to worms 
may require retreatment within 4 to 5 weeks after the first treatment. 
Consult your veterinarian before administering to sick swine.

[69 FR 9753, Mar. 2, 2004, as amended at 69 FR 33839, June 17, 2004; 70 
FR 2353, Jan. 13, 2005]



Sec. 520.1242b  Levamisole hydrochloride tablet or oblet (bolus).

    (a) Chemical name. (-)-2,3,5,6-Tetrahydro-6-phenylimidazo [2,1-b] 
thiazole monohydrochloride.
    (b) Specifications. Assay of not less than 98 percent by nonaqueous 
titration with 0.1 N potassium isopropoxide; 1 isomer minimum 95 percent 
pure by optical rotation.
    (c) Sponsor. See Nos. 000061 and 053501 in Sec. 510.600(c) of this 
chapter.
    (d) Required labeling. Consult your veterinarian for assistance in 
the diagnosis, treatment, and control of parasitism.
    (e) Related tolerances. See Sec. 556.350 of this chapter.
    (f) Conditions of use. (1) It is used in an oblet for cattle as 
follows:
    (i) Amount. 2.19 grams per oblet.
    (ii) Indications for use. Anthelmintic effective against the 
following nematode infections: Stomach worms (Haemonchus, 
Trichostrongylus, Ostertagia), intestinal worms (Trichostrongylus, 
Cooperia, Nematodirus, Bunostomum, Oesophagostomum), and lungworms 
(Dictyocaulus).
    (iii) Limitations. Administer as a single dose as follows: 250 to 
450 pounds, \1/2\ oblet; 450 to 750 pounds, 1 oblet; and 750 to 1,050 
pounds, 1\1/2\ oblets; conditions of constant helminth exposure may 
require re-treatment within 2 to 4 weeks after the first treatment; do 
not slaughter for food within 48 hours of treatment; not for use in 
dairy animals of breeding age; consult veterinarian before using in 
severely debilitated animals.
    (2) It is used in a tablet for sheep as follows:
    (i) Amount. 0.184 gram per tablet.
    (ii) Indications for use. Anthelmintic effective against the 
following nematode infections: Stomach worms (Haemonchus, 
Trichostrongylus, Ostertagia), intestinal worms (Trichostrongylus, 
Cooperia, Nematodirus, Bunostomum, Oesophagostomum, Chabertia), and 
lungworms (Dictyocaulus).
    (iii) Limitations. Administer one tablet for each 50 pounds of body 
weight; conditions of constant helminth exposure may require re-
treatment within 2 to 4 weeks after the first treatment; do not 
slaughter for food within 72 hours of treatment; consult a veterinarian 
before using in severely debilitated animals.

[40 FR 13838, Mar. 27, 1975, as amended at 44 FR 59507, Oct. 16, 1979; 
62 FR 61625, Nov. 19, 1997; 67 FR 63055, Oct. 10, 2002]



Sec. 520.1242c  Levamisole hydrochloride and piperazine dihydrochloride.

    (a) Specifications. (1) The drug is an aqueous solution which 
contains in each fluid ounce 0.36 gram of levamisole hydrochloride and 
piperazine dihydrochloride equivalent to 3.98 grams of piperazine base.
    (2) The drug is a soluble powder which when reconstituted with water 
contains in each fluid ounce 0.45 gram of levamisole hydrochloride and 
piperazine dihydrochloride equivalent to 5.0 grams of piperazine base.
    (b) Sponsor. See No. 053501 in Sec. 510.600(c) of this chapter.
    (c) [Reserved]
    (d) Conditions of use. It is used as a drench for horses as follows:
    (1) Indications for use. An anthelmintic effective against 
infections of large strongyles (Strongylus vulgaris, S. edentatus), 
small strongyles (Cylicocercus spp., Cylicocylclus spp., 
Cylicodontophorus spp., Cylicostephanus spp., Cylicotetrapedon spp. ), 
ascarids (Parascaris equorum), and pinworms (Oxyuris equii).
    (2) Limitations. Aqueous solution: administer by stomach tube or 
drench 1 fluid ounce per 100 pounds of body weight. Reconstituted 
soluble powder: administer by stomach tube 1 fluid ounce per 125 pounds 
of body weight. If reinfection occurs, re-treat animals at

[[Page 177]]

6- to 8-week intervals. Do not treat animals intended for food. Federal 
law restricts this drug to use by or on the order of a licensed 
veterinarian.

[40 FR 32831, Aug. 5, 1975, as amended at 41 FR 48731, Nov. 5, 1976; 43 
FR 11176 Mar. 17, 1978; 67 FR 63055, Oct. 10, 2002]



Sec. 520.1242d  Levamisole resinate.

    (a) Specifications. The drug is levamisole adsorbed on a resin, in a 
concentration equivalent to 10 percent levamisole hydrochloride. Each 
2.05-ounce (58.1 gram) packet contains levamisole equivalent to 5.806 
grams of levamisole hydrochloride.
    (b) Sponsor. See No. 043781 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.350 of this chapter.
    (d) Conditions of use. In swine it is used as follows:
    (1) Amount. The equivalent of 8 milligrams per kilogram of body 
weight, as a single dose, mixed in the animal's ration.
    (2) Indications for use. For the removal of and control of the 
following nematode infections: large roundworms (Ascaris suum), nodular 
worms (Oesophagostomum spp.), lungworms (Metastrongylus spp.), 
intestinal threadworms (Strongyloides ransomi), and swine kidney worms 
(Stephanurus dentatum).
    (3) Limitations. For pigs from weaning to market weight, mix one 
58.1-gram packet of levamisole resinate containing the equivalent of 10-
percent levamisole hydrochloride in 40 pounds of feed and administer 1 
pound of medicated feed per 40 pounds of body weight as sole ration. For 
breeding swine, mix 1 packet of the 10-percent resinate in 16 pounds of 
feed and administer 1 pound of medicated feed per 100 pounds of body 
weight as sole ration. Administer as single doses. Withhold regular feed 
overnight and administer medicated feed the following morning. Do not 
withhold water during fasting. Do not treat within 72 hours of 
slaughter. Salivation or muzzle foam may be observed. The reaction will 
disappear a short time after feeding. If pigs are infected with mature 
lungworms, coughing and vomiting may be observed. Consult your 
veterinarian for assistance in the diagnosis, treatment, and control of 
parasitism.

[43 FR 18171, Apr. 28, 1978, as amended at 45 FR 3574, Jan. 18, 1980]



Sec. 520.1242e  Levamisole hydrochloride effervescent tablets.

    (a) Specifications. Each tablet contains 907 milligrams of 
levamisole hydrochloride.
    (b) Sponsor. See No. 053501 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.350 of this chapter.
    (d) Conditions of use. It is used for swine as follows:
    (1) Amount. The equivalent of 8 milligrams of levamisole 
hydrochloride per kilogram of body weight, as a single dose.
    (2) Indications for use. See Sec. 520.1242a(f)(3)(ii).
    (3) Limitations. Withholding water from pigs before treatment is not 
necessary. Add one tablet for each 2\1/2\ gallons of water; mix 
thoroughly. Allow 1 gallon of medicated water for each 100 pounds body 
weight of pigs to be treated. No other source of water should be 
offered. After pigs have consumed medicated water, resume use of regular 
water. Pigs maintained under conditions of constant worm exposure may 
require re-treatment within 4 to 5 weeks. Consult your veterinarian 
before administering to sick swine. Consult your veterinarian for 
assistance in the diagnosis, treatment, and control of parasitism. Do 
not administer within 72 hours of slaughter for food.

[45 FR 6087, Jan. 25, 1980, as amended at 67 FR 63055, Oct. 10, 2002]



Sec. 520.1242f  Levamisole hydrochloride gel.

    (a) Specifications. The drug is a gel containing 11.5 percent 
levamisole hydrochloride.
    (b) Sponsor. See No. 053501 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.350 of this chapter.
    (d) Conditions of use--(1) Cattle--(i) Amount. Eight milligrams of 
levamisole hydrochloride per kilogram of body weight, as a single oral 
dose.
    (ii) Indications for use. Anthelmintic effective against the 
following nematode infections: Stomach worms

[[Page 178]]

(Haemonchus, Trichostrongylus, Ostertagia), intestinal worms 
(Trichostrongylus, Cooperia, Nematodirus, Bunostomum, Oesophagostomum), 
and lungworms (Dictyocaulus).
    (iii) Limitations. Conditions of constant helminth exposure may 
require re-treatment within 2 to 4 weeks after the first treatment; do 
not administer to cattle within 6 days of slaughter for food; do not 
administer to dairy animals of breeding age; consult veterinarian before 
using in severely debilitated animals.
    (2) Breeding swine--(i) Amount. Eight milligrams per kilogram of 
body weight (3.6 milligrams per pound) as a single oral dose.
    (ii) Conditions of use. For treating breeding swine infected with 
the following nematodes: Large roundworms (Ascaris suum), nodular worms 
(Oesophagostomum spp.), lungworms (Metastrongylus spp.), intestinal 
threadworms (Strongyloides ransomi), and kidney worms (Stephanurus 
dentatus).
    (iii) Limitations. May require retreatment in 4 to 5 weeks. Do not 
use within 11 days of slaughter for food. Consult your veterinarian for 
assistance before using in severely debilitated animals and in the 
diagnosis, treatment, and control of parasitism.

[47 FR 22517, May 25, 1982; 47 FR 30242, July 13, 1982, as amended at 48 
FR 11429, Mar. 18, 1983; 51 FR 29215, Aug. 15, 1986; 67 FR 63055, Oct. 
10, 2002]



Sec. 520.1242g  Levamisole resinate and famphur paste.

    (a) Chemical name of famphur. O, O-Dimethyl O-[p-(dimethylsulfamoyl) 
phenyl] phosphorothioate.
    (b) Specifications. The drug is a paste containing 11.6 percent 
levamisole resinate (50 percent potency) and 23.6 percent famphur.
    (c) Sponsor. See 000061 in Sec. 510.600(c) of this chapter.
    (d) Special considerations. Do not use any cholinesterase-inhibiting 
drugs, pesticides, insecticides, or chemicals on cattle simultaneously 
or within a few days before or after treatment with this product.
    (e) Related tolerances. See Sec. 556.350 of this chapter for 
levamisole and Sec. 556.273 of this chapter for famphur.
    (f) Conditions of use in cattle--(1) Amount. 8 milligrams of 
levamisole hydrochloride (equivalent) and 30 milligrams of famphur 
activity per kilogram of body weight.
    (2) Indications for use. For treatment of cattle infected with the 
following parasites: Stomach worms (Haemonchus, Trichostrongylus, 
Ostertagia), intestinal worms (Trichostrongylus, Cooperia, Nematodirus, 
Bunostomum, Oesophagostomum), lungworms (Dictyocaulus), cattle grubs 
(Hypoderma), biting lice (Bovicola), and sucking lice (Linognathus, 
Solenoptes).
    (3) Limitations. Drug is not effective against lice eggs. Conditions 
of constant helminth and ectoparasitic exposure may require retreatment 
within 2 to 4 weeks after first treatment. Do not administer to cattle 
within 19 days of slaughter. Do not administer to dairy animals of 
breeding age. Do not use in calves less than 3 months old, or in 
debilitated animals. Do not treat Brahman bulls. Consult your 
veterinarian for assistance in the diagnosis, treatment, and control of 
parasitism.

[53 FR 23757, June 24, 1988, as amended at 54 FR 1353, Jan. 13, 1989; 57 
FR 7652, Mar. 4, 1992; 62 FR 55160, Oct. 23, 1997; 62 FR 61625, Nov. 19, 
1997]



Sec. 520.1263  Lincomycin hydrochloride monohydrate oral dosage forms.



Sec. 520.1263a  Lincomycin hydrochloride monohydrate tablets and sirup.

    (a) Specifications. The sirup contains lincomycin hydrochloride 
equivalent to either 25 milligrams or 50 milligrams of lincomycin.
    (b) Sponsor. See No. 000009 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use. (1) The drug is indicated in infections 
caused by gram-positive organisms which are sensitive to its action, 
particularly streptococci and staphylococci.
    (2) It is administered orally to dogs and cats at a dosage level of 
10 mgs per pound of body weight every 12 hours, or 7 mgs per pound of 
body weight every 8 hours. Treatment may be continued for

[[Page 179]]

periods as long as 12 days if clinical judgment indicates.
    (3) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.

[40 FR 13838, Mar. 27, 1975, as amended at 44 FR 7130, Feb. 6, 1979; 64 
FR 403, Jan. 5, 1999]



Sec. 520.1263b  [Reserved]



Sec. 520.1263c  Lincomycin hydrochloride soluble powder.

    (a) Specifications. Each gram of soluble powder contains lincomycin 
hydrochloride equivalent to 0.4 grams of lincomycin.
    (b) Sponsors. See Nos. 000009, 046573, 054925, 059130, and 061623 in 
Sec. 510.600(c) of this chapter for use as in paragraph (d) of this 
section.
    (c) Tolerances. See Sec. 556.360 of this chapter.
    (d) Conditions of use--(1) Swine--(i) Amount. 250 milligrams per 
gallon of drinking water to provide 3.8 milligrams per pound of body 
weight per day.
    (ii) Indications for use. For the treatment of swine dysentery 
(bloody scours).
    (iii) Limitations. Discard medicated drinking water if not used 
within 2 days. Prepare fresh stock solution daily. Do not use for more 
than 10 days. If clinical signs of disease have not improved within 6 
days, discontinue treatment and reevaluate diagnosis. The safety of 
lincomycin has not been demonstrated in pregnant swine or swine intended 
for breeding. For No. 051259: Do not slaughter swine for 6 days 
following last treatment.
    (2) Chickens--(i) Amount. 64 milligrams per gallon of drinking 
water.
    (ii) Indications for use. For the control of necrotic enteritis 
caused by Clostridium perfringens susceptible to lincomycin in broiler 
chickens.
    (iii) Limitations. Discard medicated drinking water if not used 
within 2 days. Prepare fresh stock solution daily. Administer for 7 
consecutive days. Do not allow rabbits, hamsters, guinea pigs, horses, 
or ruminants access to water containing lincomycin. Not for use in layer 
and breeder chickens.

[48 FR 3966, Jan. 28, 1983, as amended at 55 FR 3209, Jan. 31, 1990; 60 
FR 14217, Mar. 16, 1995; 62 FR 65020, Dec. 10, 1997; 64 FR 13341, Mar. 
18, 1999; 64 FR 13508, Mar. 19, 1999; 64 FR 66382, Nov. 26, 1999; 65 FR 
10705, Feb. 29, 2000; 67 FR 17284, Apr. 10, 2002; 67 FR 71819, Dec. 3, 
2002; 67 FR 78356, Dec. 24, 2002; 68 FR 3817, Jan. 27, 2003; 70 FR 1818, 
Jan. 11, 2005]



Sec. 520.1265  Lincomycin and spectinomycin powder.

    (a) Specifications. The following salts of lincomycin and 
spectinomycin are present in a soluble powder in the ratio of 1 to 2 on 
the basis of equivalency of lincomycin base to equivalency of 
spectinomycin base:
    (1) Lincomycin hydrochloride monohydrate and spectinomycin sulfate 
tetrahydrate.
    (2) Lincomycin hydrochloride monohydrate and spectinomycin 
dihydrochloride pentahydrate.
    (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for 
use as in paragraph (d) of this section.
    (1) No. 000009 for use of product described in paragraph (a)(1) of 
this section.
    (2) Nos. 057561, 059130, and 061623 for use of product described in 
paragraph (a)(2) of this section.
    (c) Tolerances. See Sec. Sec. 556.360 and 556.600 of this chapter.
    (d) Conditions of use in chickens--(1) Amount. 2 grams of antibiotic 
activity per gallon of drinking water; administer as the sole source of 
water for the first 5 to 7 days of life.
    (2) Indications for use. As an aid in the control of airsacculitis 
caused by either Mycoplasma synoviae or M. gallisepticum susceptible to 
lincomycin-spectinomycin and complicated chronic respiratory disease 
(air sac infection) caused by Escherichia coli and M. gallisepticum 
susceptible to lincomycin-spectinomycin.

[69 FR 13220, Mar. 22, 2004, as amended at 70 FR 40881, July 15, 2005; 
71 FR 71038, Dec. 8, 2006]



Sec. 520.1284  Sodium liothyronine tablets.

    (a) Specifications. Sodium liothyronine tablets consist of tablets 
intended for oral administration which contain liothyronine at 60 or 120

[[Page 180]]

micrograms per tablet, as the sodium salt.
    (b) Sponsor. See No. 000069 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use. (1) It is indicated in cases of 
hypothyroidism in dogs.
    (2) It is administered orally to dogs at levels up to 12.8 
micrograms per kilogram of body weight per day. Dosage should be 
adjusted according to the severity of the condition and the response of 
the patient. Dosage at the total replacement level (12.8[micro]g per 
kilogram of body weight) should be considered for initiating therapy and 
then titrated downward for optimum maintenance effect. Twice daily 
administration is recommended.
    (3) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.

[40 FR 13838, Mar. 27, 1975, as amended at 56 FR 50653, Oct. 8, 1991; 60 
FR 55659, Nov. 2, 1995]



Sec. 520.1288  Lufenuron tablets.

    (a) Specifications--(1) Tablets containing 45, 90, 204.9, or 409.8 
milligrams (mg) lufenuron for use as in paragraphs (c)(1)(i), 
(c)(1)(ii)(A), (c)(1)(iii), (c)(2)(i), (c)(2)(ii)(A), and (c)(2)(iii) of 
this section.
    (2) Flavored tablets containing 45, 90, 204.9, or 409.8 milligrams 
(mg) lufenuron for use as in paragraphs (c)(1)(i), (c)(1)(ii)(A) or 
(c)(1)(ii)(B), and (c)(1)(iii) of this section.
    (3) Flavored tablets containing 90 or 204.9 mg lufenuron for use as 
in paragraphs (c)(2)(i), (c)(2)(ii)(A) or (c)(2)(ii)(B), and (c)(2)(iii) 
of this section.
    (4) Flavored tablets containing 135 or 270 mg lufenuron for use as 
in paragraphs (c)(2)(i), (c)(2)(ii)(A), and (c)(2)(iii) of this section.
    (b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Dogs--(i) Amount. Minimum of 10 mg 
lufenuron per kilogram (4.5 mg per pound (lb)) of body weight, once a 
month.
    (ii) Indications for use--(A) For the prevention and control of flea 
populations.
    (B) The concurrent use of flavored lufenuron tablets described in 
paragraph (a)(2) of this section as in paragraph (c)(1)(ii)(A) of this 
section with nitenpyram tablets as in Sec. 520.1510(d)(1) of this 
chapter is indicated to kill adult fleas and prevent flea eggs from 
hatching.
    (iii) Limitations. For use in dogs and puppies 4 weeks of age and 
older.
    (2) Cats--(i) Amount. Minimum of 30 mg lufenuron per kilogram (13.6 
mg/lb) of body weight, once a month.
    (ii) Indications for use--(A) For the control of flea populations.
    (B) The concurrent use of flavored lufenuron tablets described in 
paragraph (a)(3) of this section as in paragraph (c)(2)(ii)(A) of this 
section with nitenpyram tablets as in Sec. 520.1510(d)(2) of this 
chapter is indicated to kill adult fleas and prevent flea eggs from 
hatching.
    (iii) Limitations. For use in cats and kittens 4 weeks of age and 
older.

[68 FR 51905, Aug. 29, 2003]



Sec. 520.1289  Lufenuron suspension.

    (a) Specifications. Each individual dose pack contains either 135 or 
270 milligrams of lufenuron.
    (b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in cats--(1) Amount. Minimum of 13.6 
milligrams per pound of body weight (30 milligrams per kilogram). 
Recommended dose of 135 milligrams for up to 10 pounds of body weight or 
270 milligrams for 11 to 20 pounds. Cats over 20 pounds are provided the 
appropriate combination of packs.
    (2) Indications for use. For control of flea populations.
    (3) Limitations. For oral use in cats 6 weeks of age or older, once 
a month, mixed with food. Administer in conjunction with a full meal to 
ensure adequate absorption. Treat all cats in the household to ensure 
maximum benefits. Because the drug has no affect on adult fleas, the 
concurrent use of insecticides that kill adults may be necessary 
depending on the severity of the infestation.

[60 FR 20402, Apr. 26, 1995, as amended at 62 FR 8371, Feb. 25, 1997]



Sec. 520.1310  Marbofloxacin tablets.

    (a) Specifications. Each tablet contains 25, 50, 100, or 200 
milligrams (mg) marbofloxacin.

[[Page 181]]

    (b) Sponsor. See No. 000069 in Sec. 510.600(c) of this chapter.
    (c) [Reserved]
    (d) Conditions of use--(1) Amount. 1.25 mg per pound (/lb) of body 
weight once daily, but may be increased to 2.5 mg/lb of body weight once 
daily.
    (2) Indications for use. For the treatment of infections in dogs and 
cats associated with bacteria susceptible to marbofloxacin.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian. Federal law prohibits the extralabel 
use of this drug in food-producing animals.

[64 FR 39919, July 23, 1999, as amended at 66 FR 46369, Sept. 5, 2001]



Sec. 520.1315  Maropitant.

    (a) Specifications. Each tablet contains 16, 24, 60, or 160 
milligrams (mg) maropitant as maropitant citrate.
    (b) Sponsor. See No. 000069 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Indications for use and amount. 
For the prevention of acute vomiting, administer a minimum of 2.0 mg per 
kilogram (/kg) body weight once daily for up to 5 consecutive days. For 
the prevention of vomiting due to motion sickness, administer a minimum 
of 8.0 mg/kg body weight once daily for up to 2 consecutive days.
    (2) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[72 FR 9243, Mar. 1, 2007]



Sec. 520.1320  Mebendazole oral.

    (a) Chemical name. Methyl 5-benzoyl-benzimindazole-2-carbamate.
    (b) Specifications. As oral powder: Each gram contains either 40 or 
166.7 milligrams of mebendazole. As oral paste: Each gram contains 200 
milligrams of mebendazole. As oral suspension: Each milliliter contains 
33.3 milligrams of mebendazole.
    (c) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
    (d) Conditions of use--(1) Horses--(i) Amount. 1 gram of mebendazole 
per 250 pounds of body weight per dose, as an oral powder, paste or 
suspension.
    (ii) Indications for use. It is used in horses for treatment of 
infections caused by large roundworms (Parascaris equorum); large 
strongyles (Strongylus edentatus, S. equinus, S. vulgaris); small 
strongyles; and mature and immature (4th larval stage pinworms (Oxyuris 
equi)).
    (iii) Limitations--(a) Oral powder. The drug is given by sprinkling 
directly on the grain portion of the ration or dissolving in 2 to 4 
pints of water and administering by stomach tube. The drug is compatible 
with carbon disulfide, which can be used concurrently for both control 
(Gastrophilus spp. ). Routine cautions regarding the use of carbon 
disulfide must be observed. Do not administer to horses intended for use 
as food. Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.
    (b) Oral paste. The drug is given by dosing gun (syringe), inserting 
the tip of the gun at the interdental space in the horse's mouth and 
depositing the paste on the animal's tongue. The hand is placed under 
the animal's jaw, and the head is raised to assure that the paste is 
deposited on the roof of the mouth. Not for use in horses intended for 
food. Consult your veterinarian for assistance in the diagnosis, 
treatment, and control of parasitism.
    (c) Oral suspension. The drug is administered by stomach tube. Not 
for horses intended for food use. Federal law restricts this drug to use 
by or on the order of a licensed veterinarian.
    (2) Dogs--(i) Amount. One hundred milligrams of mebendazole per 10 
pounds of body weight, once daily for 3 days, as an oral powder.
    (ii) Indications for use. The drug is used for treatment of 
infections of roundworms (Toxocara canis), hookworms (Ancylostoma 
caninum, Uncinaria stenocephala), whipworms (Trichuris vulpis), and 
tapeworms (Taenia pisiformis).
    (iii) Limitations. Administer as an oral powder by mixing with a 
small quantity of food, preferably before the regular meal. Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.

[42 FR 61255, Dec. 2, 1977, as amended at 43 FR 35686, Aug. 11, 1978; 45 
FR 3574, Jan. 18, 1980; 46 FR 47218, Sept. 25, 1981; 46 FR 53658, Oct. 
30, 1981; 62 FR 61625, Nov. 19, 1997]

[[Page 182]]



Sec. 520.1326  Mebendazole and trichlorfon oral dosage forms.



Sec. 520.1326a  Mebendazole and trichlorfon powder.

    (a) Specifications. Each gram of powder contains 83.3 milligrams of 
mebendazole and 375.0 milligrams of trichlorofon.
    (b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use. Horses--(1) Amount. 8.8 milligrams of 
mebendazole and 40 milligrams of trichlorofon per kilogram of body 
weight.
    (2) Indications for use. It is used in horses for the treatment of 
infections of bots (Gastrophilus intestinalis and G. nasalis), large 
roundworms (Parascaris equorum), large strongyles (Strongylus edentatus, 
S. equinus, S. vulgaris), small strongyles, and pinworms (Oxyuris equi.)
    (3) Limitations. Administer orally as an individual dose by stomach 
tube or throughly mixed in the ground grain portion of the ration to be 
consumed in one feeding. Discard treated feed not consumed. Do not 
administer more than once every 30 days. Do not treat sick or 
debilitated animals, foals under 4 months of age, or mares in the last 
month of pregnancy. Trichlorofon is a cholinesterase inhibitor. Do not 
administer simultaneously or within a few days before or after treatment 
with, or exposure to, cholinesterase-inhibiting drugs, pesticides or 
chemicals. Do not administer intravenous anesthetics, especially muscle 
relaxants, concurrently. Not for horses intended for food use. Federal 
law restricts this drug to use by or on the order of a licensed 
veterinarian.

[45 FR 10759, Feb. 19, 1980, as amended at 46 FR 52330, Oct. 27, 1981. 
Redesignated at 51 FR 13212, Apr. 18, 1986, as amended at 62 FR 61625, 
Nov. 19, 1997]



Sec. 520.1326b  Mebendazole and trichlorfon paste.

    (a) Specifications. Each gram of paste contains 100 milligrams of 
mebendazole and 454 milligrams of trichlorfon.
    (b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. 8.8 milligrams of mebendazole and 
40 milligrams of trichlorfon per kilogram of body weight.
    (2) Indications for use. It is used in horses for treatment of 
infections of bots (Gastrophilus intestinalis and G. nasalis), large 
roundworms (Parascaris equorum), large strongyles (Strongylus edentatus, 
S. equinus, S. vulgaris), small strongyles, and pinworms (Oxyuris equi).
    (3) Limitations. Do not administer more than once every 30 days. Do 
not treat sick or debilitated animals, foals under 4 months of age, or 
mares in the last month of pregnancy. Trichlorfon is a cholinesterase 
inhibitor. Do not administer simultaneously or within a few days before 
or after treatment with, or exposure to, cholinesterase-inhibiting 
drugs, pesticides, or chemicals. Do not administer intravenous 
anesthetics, especially muscle relaxants, concurrently. Not for use in 
horses intended for food. Consult your veterinarian for assistance in 
the diagnosis, treatment, and control of parasitism.

[51 FR 13212, Apr. 18, 1986, as amended at 62 FR 61625, Nov. 19, 1997]



Sec. 520.1330  Meclofenamic acid granules.

    (a) Chemical name. N-(2,6-Dichlorom-tolyl) anthranilic acid.
    (b) Specifications. The drug is in granular form containing 5 
percent meclofenamic acid.
    (c) Sponsor. See No. 000856 in Sec. 510.600(c) of this chapter.
    (d) Conditions of use. (1) The drug is used in horses for the 
treatment of acute or chronic inflammatory diseases involving the 
musculoskeletal system.
    (2) It is administered orally at a dosage of 1 milligram per pound 
of body weight (1 gram per 1,000 pounds) once daily for 5 to 7 days by 
addition to the daily grain ration.
    (3) Treatment beyond the initial 5- to 7-day period may be 
indicated. A maintenance dosage level should be individualized for each 
animal.
    (4) This drug should not be administered to horses with active 
gastrointestinal, hepatic, or renal disease.
    (5) Not for use in horses intended for food.

[[Page 183]]

    (6) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.

[41 FR 5632, Feb. 9, 1976, as amended at 53 FR 23390, June 22, 1988]



Sec. 520.1331  Meclofenamic acid tablets.

    (a) Specifications. Each tablet contains either 10 or 20 milligrams 
of meclofenamic acid.
    (b) Sponsor. See No. 000856 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. 1.1 milligrams per 
kilogram (0.5 milligram per pound) daily for 5 to 7 days.
    (2) Indications for use. For the relief of signs and symptoms of 
chronic inflammatory disease involving the musculoskeletal system.
    (3) Limitations. For oral use only. Should not be administered to 
animals with congestive heart failure or active gastrointestinal, 
hepatic, or renal disease. Federal law restricts this drug to use by or 
on the order of a licensed veterinarian.

[50 FR 43385, Oct. 25, 1985, as amended at 53 FR 23390, June 22, 1988]



Sec. 520.1341  Megestrol acetate tablets.

    (a) Specifications. Each tablet contains 5 or 20 milligrams of 
megestrol acetate.
    (b) Sponsor. No. 000061 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use. (1) The drug is used in female dogs for the 
postponement of estrus and the alleviation of false pregnancy.
    (2) It is administered orally, intact, or crushed and mixed with 
food as follows:
    (i) For the postponement of estrus by proestrus treatment, 1 
milligram per pound of body weight per day for 8 days.
    (ii) For the postponement of estrus by anestrus treatment, 0.25 
milligram per pound of body weight per day for 32 days.
    (iii) For alleviation of false pregnancy, 1 milligram per pound of 
body weight per day for 8 days.
    (3) Full dosage regimen must be completed to produce the desired 
effect.
    (4) Examination of vaginal smears is recommended to confirm 
detection of proestrus.
    (5) Do not administer for more than two consecutive treatments.
    (6) Once therapy is started, the animal should be confined for 3 to 
8 days or until cessation of bleeding, since dogs in proestrus accept a 
male.
    (7) Do not use prior to or during first estrus cycle.
    (8) Do not use in pregnant animals.
    (9) Do not use in the presence of a disease of the reproductive 
system or with mammary tumors.
    (10) Should estrus occur within 30 days after cessation of 
treatment, mating should be prevented.
    (11) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.

[40 FR 13838, Mar. 27, 1975, as amended at 52 FR 7832, Mar. 13, 1987]



Sec. 520.1350  Meloxicam.

    (a) Specifications. Each milliliter of suspension contains 0.5 or 
1.5 milligrams (mg) meloxicam.
    (b) Sponsor. See No. 000010 in Sec. 510.600(c) of this chapter for 
uses as in paragraph (c) of this section.
    (c) Conditions of use in dogs--(1) Amount. Administer orally as a 
single dose at 0.09 mg per pound (mg/lb) body weight (0.2 mg per 
kilogram (mg/kg)) on the first day of treatment. For all treatment after 
day 1, administer 0.045 mg/lb (0.1 mg/kg) body weight once daily.
    (2) Indications for use. For the control of pain and inflammation 
associated with osteoarthritis.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[68 FR 42968, July 21, 2003, as amended at 69 FR 69523, Nov. 30, 2004]



Sec. 520.1380  Methocarbamol tablets.

    (a) Chemical name. 3-(O-Methoxyphenoxy)-1,2-propanediol 1-carbamate.
    (b) Specifications. Each tablet contains 500 milligrams of 
methocarbamol.
    (c) Sponsor. See No. 000856 in Sec. 510.600(c) of this chapter.

[[Page 184]]

    (d) Conditions of use. (1) The drug is administered to dogs and cats 
as an adjunct to therapy for acute inflammatory and traumatic conditions 
of the skeletal muscles in order to reduce muscular spasms.
    (2) Dosage is based upon severity of symptoms and response noted. 
The usual initial dose in 60 milligrams per pound of body weight in two 
or three equally divided doses followed by 30 to 60 milligrams per pound 
of body weight each following day, usually not to exceed 14 to 21 days.
    (3) For use only by or on the order of a licensed veterinarian.

[40 FR 13838, Mar. 27, 1975, as amended at 67 FR 67521, Nov. 6, 2002]



Sec. 520.1390  (S)-methoprene.

    (a) Specifications. Each capsule contains 154, 308, or 462 
milligrams (mg) of (S)-methoprene.
    (b) Sponsor. See No. 011536 in Sec. 510.600(c) of this chapter.
    (c) [Reserved]
    (d) Conditions of use--(1) Amount. Capsules are given orally, once 
per week at the recommended minimum dosage of 10 mg of (S)-methoprene 
per pound of body weight (22 mg/kilograms).
    (2) Indications for use. For oral use in dogs, 9 weeks of age and 
older and 4 pounds body weight or greater, for the prevention and 
control of flea populations. (S)-methoprene prevents and controls flea 
populations by preventing the development of flea eggs but does not kill 
adult fleas. Concurrent use of insecticides may be necessary for 
adequate control of adult fleas.

[65 FR 20730, Apr. 18, 2000]



Sec. 520.1408  Methylprednisolone tablets.

    (a) Specifications. Each table contains 1, 2, or 4 milligrams of 
methylprednisolone.
    (b) Sponsor. See No. 000009 in Sec. 510.600(c) of this chapter for 
use of 1- and 4-milligram tablets; see No. 000010 for use of 1- and 2-
milligram tablets.
    (c) NAS/NRC status. The conditions of use have been NAS/NRC reviewed 
and found effective. NADA's for approval of drugs for these conditions 
of use need not include effectiveness data specified by Sec. 514.111 of 
this chapter, but may require bioequivalency and safety information.
    (d) Special consideration. (1) Clinical and experimental data have 
demonstrated that corticosteroids administered orally or parenterally to 
animals may induce the first stage of parturition when administered 
during the last trimester of pregnancy and may precipitate premature 
parturition followed by dystocia, fetal death, retained placenta, and 
metritis.
    (2) Systemic therapy with methylprednisolone is contraindicated in 
animals with arrested tuberculosis, peptic ulcer, acute psychoses, or 
cushingoid syndrome. The presence of active tuberculosis, diabetes, 
osteoporosis, chronic psychotic reactions, predisposition to 
thrombophlebitis, hypertension, congestive heart failure, or renal 
insufficiency necessitates carefully controlled use of corticosteroids. 
Some of these conditions occur only rarely in dogs and cats but should 
be kept in mind.
    (3) Anti-inflammatory action of corticosteroids may mask signs of 
infection.
    (e) Conditions of use--(1) Amount. Dogs and cats: 5 to 15 pounds, 2 
milligrams; 15 to 40 pounds, 2 to 4 milligrams; 40 to 80 pounds, 4 to 8 
milligrams.
    (2) Indications for use. For use in dogs and cats as an anti-
inflammatory agent.
    (3) Limitations. Administer total daily dose orally in equally 
divided doses 6 to 10 hours apart until response is noted or 7 days have 
elapsed. When response is attained, dosage should be gradually reduced 
until maintenance level is achieved. Hazardous for human use. Federal 
law restricts this drug to use by or on the order of a licensed 
veterinarian.

[47 FR 52697, Nov. 23, 1982, as amended at 49 FR 20810, May 17, 1984; 50 
FR 32844, Aug. 15, 1985; 53 FR 40727, Oct. 18, 1988; 62 FR 35076, June 
30, 1997]



Sec. 520.1409  Methylprednisolone, aspirin tablets.

    (a) Specifications. Each tablet contains 0.5 milligram of 
methylprednisolone and 300 milligrams of aspirin.

[[Page 185]]

    (b) Sponsor. See No. 000009 in Sec. 510.600(c) of this chapter.
    (c) NAS/NRC status. The conditions of use have been NAS/NRC reviewed 
and found effective. New animal drug applications for approval of drugs 
for these conditions of use need not include effectiveness data 
specified by Sec. 514.111 of this chapter, but may require 
bioequivalency and safety information.
    (d) Special considerations. (1) Clinical and experimental data have 
demonstrated that corticosteroids administered orally or parenterally to 
animals may induce the first stage of parturition when administered 
during the last trimester of pregnancy and may precipitate premature 
parturition followed by dystocia, fetal death, retained placenta, and 
metritis.
    (2) Systemic therapy with methylprednisolone is contraindicated in 
animals with tuberculosis, chronic nephritis, peptic ulcer, or 
Cushingoid syndrome. The presence of diabetes mellitus, osteoporosis, 
predisposition to thrombophlebitis, hypertension, congestive heart 
failure, or renal insufficiency necessitates carefully controlled use of 
corticosteroids.
    (3) Anti-inflammatory action of corticosteroids may mask signs of 
infection.
    (e) Conditions of use--(1) Amount. Dogs under 15 pounds, \1/4\ to 1 
tablet daily; 15 to 60 pounds, 1 to 2 tablets daily; 60 pounds and over, 
2 tablets daily.
    (2) Indications for use. As an anti-inflammatory and analgesic agent 
in dogs.
    (3) Limitations. Administer total daily dose in divided doses 6 to 
10 hours apart, with a light feeding. When response is attained, dosage 
should be gradually reduced until maintenance level is achieved. Do not 
administer to cats. Do not overdose. Federal law restricts this drug to 
use by or on the order of a licensed veterinarian.

[48 FR 21566, May 13, 1983]



Sec. 520.1422  Metoserpate hydrochloride.

    (a) Chemical name. Methyl-o-methyl-18-epireserpate hydrochloride.
    (b) Sponsor. See No. 000003 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.410 of this chapter.
    (d) Conditions of use. It is used in drinking water for replacement 
chickens as follows:
    (1) Amount. 568.5 milligrams per gallon (0.015 percent).
    (i) Indications for use. As a tranquilizer for flock treatment of 
chickens prior to handling.
    (ii) Limitations. To be used one time as a treatment for replacement 
chickens up to 16 weeks of age; usual drinking water should be withheld 
prior to treatment to provide adequate consumption of medicated drinking 
water; not for use in laying chickens; chickens slaughtered within 72 
hours following treatment must not be used for food.
    (2) Amount. 2 to 4 milligrams per 2.2 pounds of body weight.
    (i) Indications for use. As an aid in control of hysteria.
    (ii) Limitations. To be used as a treatment for replacement chickens 
up to 16 weeks of age; usual drinking water should be withheld prior to 
treatment to provide adequate consumption of medicated drinking water; 
the drug should be administered at a dosage level of 4 milligrams per 
2.2 pounds of body weight followed by 2 treatments at 4-day intervals of 
2 milligrams per 2.2 pounds of body weight; not for use in laying 
chickens; chickens slaughtered within 72 hours following treatment must 
not be used for food.



Sec. 520.1430  Mibolerone.

    (a) Specifications. Each milliliter contains 100 micrograms of 
mibolerone.
    (b) Sponsor. See No. 000009 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. 30 micrograms for animals 
weighing 1 to 25 pounds; 60 micrograms for animals weighing 26 to 50 
pounds; 120 micrograms for animals weighing 51 to 100 pounds; 180 
micrograms for animals weighing over 100 pounds, German Shepherds, or 
German Shepherd mix.
    (2) Indications for use. For the prevention of estrus (heat) in 
adult female dogs not intended primarily for breeding purposes.
    (3) Limitations. Administer daily, orally or in a small amount of 
food, at least 30 days before expected initiation of heat, and continue 
daily as long as desired, but not for more than 24

[[Page 186]]

months. Mibolerone should not be used in bitches before the first 
estrous period. It is not intended for animals being used primarily for 
breeding purposes. Use orally in adult female dogs only. Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.

[43 FR 15625, Apr. 14, 1978]



Sec. 520.1445  Milbemycin oxime tablets.

    (a) Specifications--(1) Dogs. Each tablet contains 2.3, 5.75, 11.5, 
or 23.0 milligrams of milbemycin oxime.
    (2) Cats. Each tablet contains 5.75, 11.5, or 23.0 milligrams of 
milbemycin oxime.
    (b) Sponsor. See 058198 in Sec. 510.600(c) of this chapter.
    (c) [Reserved]
    (d) Conditions of use--(1) Dogs and puppies--(i) Amount. For 
hookworm, roundworm, and whipworm, use 0.23 milligram per pound of body 
weight (0.5 milligram per kilogram). For heartworm, use 0.05 milligram 
per pound of body weight (0.1 milligram per kilogram).
    (ii) Indications for use. For prevention of heartworm disease caused 
by Dirofilaria immitis, control of hookworm infections caused by 
Ancylostoma caninum, and removal and control of adult roundworm 
infections caused by Toxocara canis and Toxascaris leonina and whipworm 
infections caused by Trichuris vulpis in dogs and in puppies 4 weeks of 
age or greater and 2 pounds of body weight or greater.
    (iii) Limitations. Do not use in puppies less than 4 weeks of age 
and less than 2 pounds of body weight. Administer once a month. First 
dose given within 1 month after first exposure to mosquitoes and 
continue regular use until at least 1 month after end of mosquito 
season. Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.
    (2) Cats and kittens--(i) Amount. 0.91 milligram per pound of body 
weight (2.0 milligrams per kilogram).
    (ii) Indications for use. For prevention of heartworm disease caused 
by Dirofilaria immitis and the removal of adult Toxocara cati 
(roundworm) and Ancylostoma tubaeforme (hookworm) infections in cats 6 
weeks of age or greater and 1.5 pounds body weight or greater.
    (iii) Limitations. Do not use in kittens less than 6 weeks of age or 
1.5 pounds body weight. Administer once a month. Federal law restricts 
this drug to use by or on the order of a licensed veterinarian.

[55 FR 25301, June 21, 1990, as amended at 55 FR 49888, Dec. 3, 1990; 58 
FR 5608, Jan. 22, 1993; 60 FR 50097, Sept. 28, 1995; 61 FR 43654, Aug. 
26, 1996; 63 FR 29352, May 29, 1998; 63 FR 41189, Aug. 3, 1998]



Sec. 520.1446  Milbemcyin oxime and lufenuron tablets.

    (a) Specifications--(1) Tablets containing: 2.3 milligrams (mg) 
milbemycin oxime and 46 mg lufenuron, 5.75 mg milbemycin oxime and 115 
mg lufenuron, 11.5 mg milbemycin oxime and 230 mg lufenuron, or 23 mg 
milbemycin oxime and 460 mg lufenuron.
    (2) Flavored tablets containing: 2.3 mg milbemycin oxime and 46 mg 
lufenuron, 5.75 mg milbemycin oxime and 115 mg lufenuron, 11.5 mg 
milbemycin oxime and 230 mg lufenuron, or 23 mg milbemycin oxime and 460 
mg lufenuron.
    (b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
    (c) [Reserved]
    (d) Conditions of use--(1) Dogs--(i) Amount. 0.5 mg milbemycin oxime 
and 10 mg lufenuron per kilogram of body weight, once a month.
    (ii) Indications for use--(A) For use in dogs and puppies for the 
prevention of heartworm disease caused by Dirofilaria immitis, for 
prevention and control of flea populations, for control of adult 
Ancylostoma caninum (hookworm), and for removal and control of adult 
Toxocara canis, Toxascaris leonina (roundworm), and Trichuris vulpis 
(whipworm) infections.
    (B) The concurrent use of flavored milbemycin oxime and lufenuron 
tablets described in paragraph (a)(2) of this section as in paragraph 
(d)(1)(ii)(A) of this section with nitenpyram tablets as in Sec. 
520.1510(d)(1) of this chapter is indicated to kill adult fleas and 
prevent flea eggs from hatching.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

[[Page 187]]

    (2) [Reserved]

[62 FR 28629, May 27, 1997, as amended at 63 FR 41190, Aug. 3, 1998; 68 
FR 51905, Aug. 29, 2003]



Sec. 520.1448  Monensin oral dosage forms.

    Monensin, as the base or the sodium salt, contains a minimum of 90 
percent monensin activity derived from monensin A and a minimum of 95 
percent derived from monensin A plus B. Using thin layer chromatography, 
the Rf value must be comparable to a reference standard (the Rf value is 
the distance the spots travel from the starting line divided by the 
distance the solvent front travels from the starting line). The loss on 
drying is not more than 10 percent when dried in vacuum at 60 [deg]C for 
2 hours.

[55 FR 3586, Feb. 2, 1990]



Sec. 520.1448a  Monensin blocks.

    (a)(1) Specifications. Each pound of protein-mineral block contains 
400 milligrams of monensin (0.088 percent) as monensin sodium.
    (2) Sponsor. See 067949 in Sec. 510.600(c) of this chapter.
    (3) Related tolerances. See Sec. 556.420 of this chapter.
    (4) Conditions of use--(i) Amount. 80 to 200 milligrams of monensin 
(0.2 to 0.5 pound of block) per head per day.
    (ii) Indications for use. Increased rate of weight gain.
    (iii) Limitations. Block to be fed free choice to pasture cattle 
(slaughter, stocker, feeder, and dairy and beef replacement heifers). 
Provide at least 1 block per 5 head of cattle. Feed blocks continuously. 
Do not feed salt or minerals containing salt. Do not allow horses or 
other equines access to formulations containing monensin (ingestion of 
monensin by equines has been fatal). The effectiveness of this block in 
cull cows and bulls has not been established.
    (b) [Reserved]
    (c)(1) Specifications. Each pound of protein block contains 175 
milligrams of monensin (0.038 percent) as monensin sodium.
    (2) Sponsor. See 021676 in Sec. 510.600(c) of this chapter.
    (3) Related tolerances. See Sec. 556.420 of this chapter.
    (4) Conditions of use--(i) Amount. 40 to 200 milligrams of monensin 
(0.25 to 1.13 pounds or 4 to 18 ounces of block) per head per day.
    (ii) Indications for use. Increased rate of weight gain.
    (iii) Limitations. Blocks to be fed free choice to pasture cattle 
(slaughter, stocker, and feeder). Provide at least 1 block per 4 head of 
cattle. Do not allow cattle access to salt or mineral while being fed 
this product. Ingestion by cattle of monensin at levels of 600 
milligrams per head per day and higher has been fatal. Do not allow 
horses or other equines access to formulations containing monensin 
(ingestion of monensin by equines has been fatal). Block's effectiveness 
in cull cows and bulls has not been established.
    (d)(1) Specifications. Each pound of block contains 400 milligrams 
of monensin (0.088 percent) as monensin sodium.
    (2) Sponsor. See 051267 in Sec. 510.600(c) of this chapter.
    (3) Related tolerances. See Sec. 556.420 of this chapter.
    (4) Conditions of use--(i) Amount. 50 to 200 milligrams of monensin 
(2 to 8 ounces of block) per head per day.
    (ii) Indications for use. Pasture cattle: Increased rate of weight 
gain.
    (iii) Limitations. Blocks to be fed free choice to pasture cattle 
(slaughter, stocker, feeder, and dairy and beef replacement heifers). 
Provide at least one block per five head of cattle. Feed blocks 
continously. Do not feed salt or mineral supplements in addition to the 
blocks. Ingestion by cattle of monensin at levels of 600 milligrams per 
head per day and higher has been fatal. Do not allow horses or other 
equines access to formulations containing monensin (ingestion of 
monensin by equines has been fatal). The effectiveness of this block in 
cull cows and bulls has not been established.

[46 FR 19466, Mar. 31, 1981]

    Editorial Note: For Federal Register citations affecting Sec. 
520.1448a, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and on GPO Access.

[[Page 188]]



Sec. 520.1450  Morantel tartrate oral dosage forms.



Sec. 520.1450a  Morantel tartrate bolus.

    (a) Specifications. Each bolus contains 2.2 grams morantel tartrate 
equivalent to 1.3 grams of morantel base.
    (b) Sponsor. See No. 000069 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.425 of this chapter.
    (d) Conditions of use--(1) Amount. One bolus per 500 pounds of body 
weight (4.4 milligrams per pound of body weight) as a single oral dose. 
Boluses may be divided in half for more accurate dosing as follows: up 
to 325 pounds, \1/2\ bolus; 326 to 600 pounds, 1 bolus; 601 to 900 
pounds, 1\1/2\ boluses; and 901 to 1,200 pounds, 2 boluses.
    (2) Indications for use. For removal and control of mature 
gastrointestinal nematode infections of cattle including stomach worms 
(Haemonchus spp., Ostertagia spp., Trichostrongylus spp.), worms of the 
small intestine (Cooperia spp., Trichostrongylus spp., Nematodirus 
spp.), and worms of the large intestine (Oesophagostomum radiatum).
    (3) Limitations. Conditions of constant worm exposure may require 
retreatment in 2 to 4 weeks. Consult your veterinarian before 
administering to severely debilitated animals and for assistance in the 
diagnosis, treatment, and control of parasitism. Do not treat within 14 
days of slaughter.

[46 FR 50949, Oct. 16, 1981. Redesignated at 49 FR 47831, Dec. 7, 1984, 
and amended at 51 FR 9005, Mar. 17, 1986]



Sec. 520.1450b  Morantel tartrate cartridge.

    (a) Specifications. The drug product consists of a stainless-steel 
cylinder having both ends closed with polyethylene diffusing discs and 
containing a morantel tartrate paste. The paste contains 22.7 grams of 
morantel tartrate equivalent to 13.5 grams of morantel base.
    (b) Sponsor. See No. 000069 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.425 of this chapter.
    (d) Conditions of use--(1) Amount. Grazing cattle: Administer 1 
cartridge to each animal at the start of the grazing season.
    (2) Indications for use. For control of the adult stage of the 
following gastrointestinal nematode infections in weaned calves and 
yearling cattle weighing a minimum of 200 pounds: Ostertagia spp., 
Trichostrongylus axei, Cooperia spp., and Oesophagostomum radiatum.
    (3) Limitations. Administer orally with the dosing gun to all cattle 
that will be grazing the same pasture. Effectiveness of the drug product 
is dependent upon continuous control of the gastrointestinal parasites 
for approximately 90 days following administration. Therefore, treated 
cattle should not be moved to pastures grazed in the same grazing 
season/calendar year by untreated cattle. Do not administer to cattle 
within 106 days of slaughter. Consult your veterinarian before 
administering to severely debilitated animals and for assistance in the 
diagnosis, treatment, and control of parasitism.

[49 FR 47831, Dec. 7, 1984, as amended at 51 FR 23415, June 27, 1986; 51 
FR 41081, Nov. 13, 1986]



Sec. 520.1450c  Morantel tartrate sustained-release trilaminate 

cylinder/sheet.

    (a) Specifications. The drug product consists of a trilaminated, 
perforated, plastic sheet formed into a cylinder having plastic plugs in 
its ends. The core lamina contains 19.8 grams of morantel tartrate 
equivalent to 11.8 grams of morantel base.
    (b) Sponsor. See 000069 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.425 of this chapter.
    (d) Conditions of use--(1) Amount. Grazing cattle: Administer 1 
cartridge to each animal at the start of the grazing season.
    (2) Indications for use. For control of the adult stage of the 
following gastrointestinal nematode infections in weaned calves and 
yearling cattle weighing a minimum of 200 pounds: Ostertagia spp., 
Trichostrongylus axei, Cooperia spp., and Oesophagostomum radiatum.
    (3) Limitations. Administer orally with the dosing gun to all cattle 
that

[[Page 189]]

will be grazing the same pasture. Effectiveness of the drug product is 
dependent upon continuous control of the gastrointestinal parasites for 
approximately 90 days following administration. Therefore, treated 
cattle should not be moved to pastures grazed in the same grazing 
season/calendar year by untreated cattle. Do not administer to cattle 
within 102 days of slaughter. Consult your veterinarian before 
administering to severely debilitated animals and for assistance in the 
diagnosis, treatment, and control of parasitism.

[56 FR 13396, Apr. 2, 1991]



Sec. 520.1451  Moxidectin tablets.

    (a) Specifications. Each tablet contains 30, 68, or 136 micrograms 
of moxidectin.
    (b) Sponsor. See No. 000856 in Sec. 510.600(c) of this chapter.
    (c) [Reserved]
    (d) Conditions of use--(1) Amount. 3 micrograms per kilogram (1.36 
micrograms per pound) of body weight.-
    (2) Indications for use. To prevent infection by the canine 
heartworm Dirofilaria immitis and the subsequent development of canine 
heartworm disease.
    (3) Limitations. Use once-a-month in dogs at 8 weeks of age or 
older. Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.

[62 FR 37713, July 15, 1997]



Sec. 520.1452  Moxidectin gel.

    (a) Specifications. Each milliliter of gel contains 20 milligrams (2 
percent) moxidectin.
    (b) Sponsor. See No. 000856 in Sec. 510.600(c) of this chapter.
    (c) Special considerations. See Sec. 500.25 of this chapter.
    (d) Conditions of use in horses and ponies--(1) Amount. 0.4 
milligram moxidectin per kilogram (2.2 pounds) of body weight.
    (2) Indications for use. For the treatment and control of large 
strongyles: Strongylus vulgaris (adults and L4/L5 arterial stages), S. 
edentatus (adult and tissue stages), Triodontophorus brevicauda 
(adults), and T. serratus (adults); small strongyles (adults): 
Cyathostomum spp., including C. catinatum and C. pateratum; 
Cylicocyclus. spp., including C. insigne, C. leptostomum, C. nassatus, 
and C. radiatus; Cyliocostephanus. spp., including C. calicatus, C. 
goldi, C. longibursatus, and C. minutus; Coronocyclus spp., including C. 
coronatus, C. labiatus, and C. labratus; Gyalocephalus capitatus; and 
Petrovinema poculatus; small strongyles: undifferentiated lumenal 
larvae; encysted cyathostomes (late L3 and L4 mucosal cyathostome 
larvae); ascarids: Parascaris equorum (adults and L4 larval stages); 
pinworms: Oxyuris equi (adults and L4 larval stages); hairworms: 
Trichostrongylus axei (adults); large-mouth stomach worms: Habronema 
muscae (adults); and horse stomach bots: Gasterophilus intestinalis (2nd 
and 3rd instars) and G. nasalis (3rd instars). One dose also suppresses 
strongyle egg production for 84 days.
    (3) Limitations. For oral use in horses and ponies 6 months of age 
and older. Not for use in horses and ponies intended for food.

[62 FR 42902, Aug. 11, 1997, as amended at 64 FR 66105, Nov. 24, 1999; 
68 FR 51445, Aug. 27, 2003; 69 FR 24959, May 5, 2004; 70 FR 75017, Dec. 
19, 2005]



Sec. 520.1453  Moxidectin and praziquantel gel.

    (a) Specifications. Each milliliter of gel contains 20 milligrams 
(mg) (2.0 percent) moxidectin and 125 mg (12.5 percent) praziquantel.
    (b) Sponsor. See No. 000856 in Sec. 510.600(c) of this chapter.
    (c) Special considerations. See Sec. 500.25 of this chapter.
    (d) Conditions of use in horses and ponies--(1) Amount. Administer 
by mouth as a single dose: 0.4 mg moxidectin per kilogram and 2.5 mg 
praziquantel per kilogram (2.2 pounds) body weight.
    (2) Indications for use. For the treatment and control of large 
strongyles: Strongylus vulgaris (adults and L4/L5 arterial stages), S. 
edentatus (adult and tissue stages), Triodontophorus brevicauda 
(adults), and T. serratus (adults); small strongyles (adults): 
(Cyathostomum spp., including C. catinatum and C. pateratum; 
Cylicocyclus spp., including C. insigne, C.

[[Page 190]]

leptostomum, C. nassatus, and C. radiatus; Cylicostephanus spp., 
including C. calicatus, C. goldi, C. longibursatus, and C. minutus; 
Coronocyclus spp., including C. coronatus, C. labiatus, and C. labratus; 
Gyalocephalus capitatus; and Petrovinema poculatus; small strongyles: 
undifferentiated lumenal larvae; encysted cyathostomes (late L3 and L4 
mucosal cyathostome larvae); ascarids: Parascaris equorum (adults and L4 
larval stages); pinworms: Oxyuris equi (adults and L4 larval stages); 
hairworms: Trichostrongylus axei (adults); large-mouth stomach worms: 
Habronema muscae (adults); horse stomach bots: Gasterophilus 
intestinalis (2nd and 3rd instars) and G. nasalis (3rd instars); and 
tapeworms: Anoplocephala perfoliata (adults). One dose also suppresses 
strongyle egg production for 84 days.
    (3) Limitations. For oral use in horses and ponies 6 months of age 
and older. Not for use in horses and ponies intended for food.

[68 FR 51446, Aug. 27, 2003, as amended at 69 FR 21956, Apr. 23, 2004; 
70 FR 75017, Dec. 19, 2005]



Sec. 520.1454  Moxidectin solution.

    (a) Specifications. Each milliliter (mL) of solution contains 1 
milligram (mg) moxidectin.
    (b) Sponsor. See No. 000856 in Sec. 510.600 of this chapter.
    (c) Related tolerances. See Sec. 556.426 of this chapter.
    (d) Special considerations. See Sec. 500.25 of this section.
    (e) Conditions of use in sheep--(1) Amount. Administer 1 mL per 11 
pounds body weight (1 mL per 5 kilograms) by mouth.
    (2) Indications for use. For the treatment and control of the adult 
and L4 larval stages of Haemonchus contortus, Teladorsagia circumcincta, 
T. trifurcata, Trichostrongylus axei, T. colubriformis, T. vitrinus, 
Cooperia curticei, C. oncophora, Oesophagostomum columbianum, O. 
venulosum, Nematodirus battus, N. filicollis, and N. spathiger.
    (3) Limitations. Sheep must not be slaughtered for human consumption 
within 7 days of treatment. Because a withholding time in milk has not 
been established for this product, do not use in female sheep providing 
milk for human consumption.

[70 FR 76163, Dec. 23, 2005]



Sec. 520.1468  Naproxen granules.

    (a) Specifications. Naproxen granules contain 50 percent naproxen.
    (b) Sponsor. No. 000856 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Horses. The drug is used for the relief 
of inflammation and associated pain and lameness exhibited with 
arthritis, as well as myositis and other soft tissue diseases of the 
musculoskeletal system of the horse.
    (2)(i) For oral maintenance therapy following initial intravenous 
dosage, administer 10 milligrams naproxen per kilogram of animal body 
weight twice daily as top dressing in the animal's feed for up to 14 
consecutive days. The initial intravenous dosage is 5 milligrams per 
kilogram of body weight.
    (ii) For oral dosage only, administer 10 milligrams naproxen per 
kilogram of animal body weight twice daily as a top dressing in the 
animal's feed for up to 14 consecutive days.
    (3) Not for use in horses intended for food.
    (4) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.

[41 FR 14188, Apr. 2, 1976, as amended at 51 FR 24525, July 7, 1986; 61 
FR 5506, Feb. 13, 1996]



Sec. 520.1484  Neomycin.

    (a) Specifications--(1) Each ounce of powder contains 20.3 grams (g) 
neomycin sulfate (equivalent to 14.2 g neomycin base).
    (2) Each milliliter of solution contains 200 milligrams (mg) 
neomycin sulfate (equivalent to 140 mg neomycin base).
    (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for 
use as in paragraph (e) of this section.
    (1) Nos. 000069 and 054925 for use of product described in paragraph 
(a)(1) as in paragraph (e)(1) of this section.
    (2) Nos. 000009, 046573, 058005, and 061623 for use of product 
described in paragraph (a)(1) as in paragraphs (e)(1) and (e)(2) of this 
section.

[[Page 191]]

    (3) Nos. 000009, 054925, 058005, and 059130 for use of product 
described in paragraph (a)(2) as in paragraph (e)(1) of this section.
    (c) Related tolerances. See Sec. 556.430 of this chapter.
    (d) Special labeling considerations. Labeling shall bear the 
following warning statements: ``A withdrawal period has not been 
established for use in preruminating calves. Do not use in calves to be 
processed for veal. Use of more than one product containing neomycin or 
failure to follow withdrawal times may result in illegal drug 
residues.''
    (e) Conditions of use--(1) Cattle, swine, sheep, and goats--(i) 
Amount. 10 mg per pound (/lb) of body weight per day (22 mg per kilogram 
(/kg)) in divided doses for a maximum of 14 days.
    (ii) Indications for use. For the treatment and control of 
colibacillosis (bacterial enteritis) caused by Escherichia coli 
susceptible to neomycin sulfate.
    (iii) Limitations. Add powder to drinking water or milk; not for use 
in liquid supplements. Administer solution undiluted or in drinking 
water. Prepare a fresh solution in drinking water daily. If symptoms 
persist after using this preparation for 2 or 3 days, consult a 
veterinarian. Treatment should continue 24 to 48 hours beyond remission 
of disease symptoms, but not to exceed a total of 14 consecutive days. 
Discontinue treatment prior to slaughter as follows: Cattle, 1 day; 
sheep, 2 days; swine and goats, 3 days.
    (2) Turkeys--(i) Amount. 10 mg/lb of body weight per day (22 mg/kg) 
for 5 days.
    (ii) Indications for use. For the control of mortality associated 
with E. coli susceptible to neomycin sulfate in growing turkeys.
    (iii) Limitations. Add to drinking water; not for use in liquid 
supplements. Prepare a fresh solution daily. If symptoms persist after 
using this preparation for 2 or 3 days, consult a veterinarian. 
Treatment should continue 24 to 48 hours beyond remission of disease 
symptoms, but not to exceed a total of 5 consecutive days.

[71 FR 56866, Sept. 28, 2006, as amended at 71 FR 68738, Nov. 28, 2006]



Sec. 520.1498  Nitazoxanide paste.

    (a) Specifications. Each milligram (mg) of paste contains 0.32 mg 
nitazoxanide.
    (b) Sponsor. See No. 065274 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in horses--(1) Amount. On days 1 through 5, 
administer 11.36 mg per pound (/lb) body weight; on days 6 through 28, 
administer 22.72 mg/lb body weight.
    (2) Indications for use--For the treatment of equine protozoal 
myeloencephalitis (EPM) caused by Sarcocystis neurona.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[69 FR 500, Jan. 6, 2004]



Sec. 520.1510  Nitenpyram tablets.

    (a) Specifications. Each tablet contains 11.4 or 57 milligrams (mg) 
nitenpyram.
    (b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
    (c) Special considerations. The concurrent use of nitenpyram tablets 
and flavored milbemycin/lufenuron tablets as in paragraph (d)(1)(ii)(B) 
of this section shall be by or on the order of a licensed veterinarian.
    (d) Conditions of use--(1) Dogs--(i) Amount--(A) One 11.4-mg tablet 
for dogs weighing less than 25 pounds (lb) or one 57-mg tablet for dogs 
weighing more than 25 lb, as needed, for use as in paragraph 
(d)(1)(ii)(A) of this section.
    (B) One 11.4-mg tablet for dogs weighing less than 25 lb or one 57 
mg tablet for dogs weighing more than 25 lbs, once or twice weekly, for 
use as in paragraph (d)(1)(ii)(B) of this section.
    (ii) Indications for use--(A) For the treatment of flea infestations 
on dogs and puppies 4 weeks of age and older and 2 lbs of body weight or 
greater.
    (B) The concurrent use of nitenpyram tablets as in paragraph 
(d)(1)(i)(B) of this section with either flavored lufenuron tablets as 
in Sec. 520.1288(c)(1) of this chapter or flavored milbemycin and 
lufenuron tablets as in Sec. 520.1446(d)(1) of this chapter is 
indicated to kill adult fleas and prevent flea eggs from hatching.

[[Page 192]]

    (2) Cats--(i) Amount--(A) One 11.4-mg tablet, as needed, for use as 
in paragraph (d)(2)(ii)(A) of this section.
    (B) One 11.4-mg tablet, once or twice weekly, for use as in 
paragraph (d)(2)(ii)(B) of this section.
    (ii) Indications for use--(A) For the treatment of flea infestations 
on cats and kittens 4 weeks of age and older and 2 lbs of body weight or 
greater.
    (B) The concurrent use of nitenpyram tablets as in paragraph 
(d)(2)(i)(B) of this section with flavored lufenuron tablets as in Sec. 
520.1288(c)(2) of this chapter is indicated to kill adult fleas and 
prevent flea eggs from hatching.

[68 FR 51906, Aug. 29, 2003]



Sec. 520.1615  Omeprazole.

    (a) Specifications. Each gram of paste contains 0.37 gram 
omeprazole.
    (b) Sponsor. See No. 050604 in Sec. 510.600(c) of this chapter.
    (c) Special considerations. When labeled for use as in paragraph 
(d)(2)(i) of this section, product labeling shall bear: ``Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.''
    (d) Conditions of use in horses--(1) Amount--(i) For treatment of 
gastric ulcers, 1.8 milligrams per pound (mg/lb) of body weight (4 
milligrams per kilogram (mg/kg)) once daily for 4 weeks. For prevention 
of recurrence of gastric ulcers, 0.9 mg/lb of body weight (2 mg/kg) once 
daily for at least an additional 4 weeks.
    (ii) For prevention of gastric ulcers using the premarked syringe, 
one dose per day for 8 or 28 days. Each dose delivers at least 1 mg/kg 
of body weight. Horses over 1,200 lb body weight should receive two 
doses per day.
    (2) Indications for use. (i) For treatment and prevention of 
recurrence of gastric ulcers in horses and foals 4 weeks of age and 
older.
    (ii) For prevention of gastric ulcers in horses.
    (3) Limitations. Do not use in horses intended for human 
consumption.

[69 FR 13220, Mar. 22, 2004, as amended at 71 FR 59374, Oct. 10, 2006]



Sec. 520.1616  Orbifloxacin.

    (a) Specifications. Each tablet contains 5.7, 22.7, or 68 milligrams 
(mg) orbifloxacin.
    (b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs and cats--(1) Amount. 2.5 to 7.5 mg 
per kilogram body weight once daily.
    (2) Indications for use. For management of diseases associated with 
bacteria susceptible to orbifloxacin.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian. Federal law prohibits the extralabel 
use of this drug in food producing animals.

[71 FR 14643, Mar. 23, 2006]



Sec. 520.1628  Oxfendazole powder and pellets.

    (a) Specifications--(1) Powder for suspension. Each gram of powder 
contains 7.57 percent oxfendazole.
    (2) Pellets. Each gram of pellets contains 6.49 percent oxfendazole.
    (b) Sponsor. See No. 000856 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. 10 milligrams per kilogram of 
body weight.
    (2) Indications for use. The drug is used in horses for removal of 
the following gastrointestinal worms: Large roundworms (Parascaris 
equorum), mature and immature pinworms (Oxyuris equi), large strongyles 
(Strongylus edentatus, Strongylus vulgaris, and Strongylus equinus), and 
small strongyles.
    (3) Limitations--(i) Powder for suspension. For gravity 
administration via stomach tube or for positive administration via 
stomach tube and dose syringe. Discard unused portions of suspension 
after 24 hours. Mix drug according to directions prior to use. 
Administer drug with caution to sick or debilitated horses. Not for use 
in horses intended for food. Federal law restricts this drug to use by 
or on the order of a licensed veterinarian.
    (ii) Pellets. The drug is given by sprinkling on the grain portion 
of the ration. Withholding feed or water prior to administration is not 
necessary. Administer drug with caution to sick or debilitated horses. 
Not for use in

[[Page 193]]

horses intended for food. Consult your veterinarian for assistance in 
the diagnosis, treatment, and control of parasitism.

[44 FR 35211, June 19, 1979, as amended at 46 FR 26301, May 12, 1981; 46 
FR 60570, Dec. 11, 1981; 49 FR 28549, July 13, 1984; 61 FR 5506, Feb. 
13, 1996]



Sec. 520.1629  Oxfendazole paste.

    (a)(1) Specifications. Each gram of paste contains 0.375 gram 
oxfendazole (37.5 percent).
    (2) Sponsor. See No. 000856 in Sec. 510.600(c) of this chapter.
    (3) Conditions of use--(i) Amount. 10 milligrams per kilogram (2.2 
pounds) of body weight.
    (ii) Indications for use. The drug is used in horses for removal of 
the following gastrointestinal worms: Large roundworms (Parascaris 
equorum), mature and 4th stage larvae pinworms (Oxyuris equi), large 
strongyles (Strongylus edentatus, S. vulgaris, and S. equinus), and 
small strongyles.
    (iii) Limitations. Horses maintained on premises where reinfection 
is likely to occur should be retreated in 6 to 8 weeks. Withholding feed 
or water prior to use is unnecessary. Administer drug with caution to 
sick or debilitated horses. Not for use in horses intended for food. 
Consult your veterinarian for assistance in the diagnosis, treatment, 
and control of parasitism.
    (b)(1) Specifications. Each gram of paste contains 185 milligrams of 
oxfendazole (18.5 percent).
    (2) Sponsor. See No. 000856 in Sec. 510.600(c) of this chapter.
    (3) Related tolerances. See Sec. 556.495 of this chapter.
    (4) Conditions of use--(i) Amount. 4.5 milligrams per kilogram of 
body weight (2.05 milligrams per pound).
    (ii) Indications for use. The drug is used in cattle for the removal 
and control of the following worms: lungworms (Dictyocaulus viviparus--
adult, L4); stomach worms: barberpole worms (Haemonchus contortus and H. 
placei--adult), small stomach worms (Trichostrongylus axei--adult), 
brown stomach worms (Ostertagia ostertagi--adult, L4, inhibited L4); 
intestinal worms; nodular worms (Oesophagostomum radiatum--adult), 
hookworms (Bunostomum phlebotomum--adult), small intestinal worms 
(Cooperia punctata, C. oncophora, and C. mcmasteri--adult, L4); and 
tapeworms (Moniezia benedeni--adult).
    (iii) Limitations. For use in cattle only. Treatment may be repeated 
in 4 to 6 weeks. Cattle must not be slaughtered until 11 days after 
treatment. Do not use in female dairy cattle of breeding age. Consult a 
veterinarian for assistance in the diagnosis, treatment, and control of 
parasitism.

[49 FR 38250, Sept. 28, 1984, as amended at 58 FR 39443, July 23, 1993; 
61 FR 5506, Feb. 13, 1996]



Sec. 520.1630  Oxfendazole suspension.

    (a) Specifications. Each milliliter of suspension contains:
    (1) 90.6 milligrams (mg) oxfendazole (9.06 percent).
    (2) 225.0 mg oxfendazole (22.5 percent).
    (b) Sponsor. See 000856 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.495 of this chapter.
    (d) Special considerations. See Sec. 500.25 of this chapter. If 
labeled for administration by stomach tube: Federal law restricts this 
drug to use by or on the order of a licensed veterinarian.
    (e) Conditions of use--(1) Horses. Use the product described in 
paragraph (a)(1) of this section as follows:
    (i) Amount. 10 mg per kilogram (/kg) of body weight by stomach tube 
or dose syringe. Horses maintained on premises where reinfection is 
likely to occur should be retreated in 6 to 8 weeks.
    (ii) Indications for use. For removal of large roundworms 
(Parascaris equorum), mature and 4th stage larvae pinworms (Oxyuris 
equi), large strongyles (Strongylus edentatus, S. vulgaris, and S. 
equinus), and small strongyles.
    (iii) Limitations. Withholding feed or water prior to use is 
unnecessary. Administer drug with caution to sick or debilitated horses. 
Do not use in horses intended for human consumption.
    (2) Cattle. Use the products described in paragraphs (a)(1) and 
(a)(2) of this section as follows:
    (i) Amount. 4.5 mg/kg of body weight by dose syringe. Treatment may 
be repeated in 4 to 6 weeks.
    (ii) Indications for use. For the removal and control of: lungworms 
(Dictyocaulus viviparus--adult, L4);

[[Page 194]]

stomach worms: barberpole worms (Haemonchus contortus and H. placei--
adult), small stomach worms (Trichostrongylus axei--adult), brown 
stomach worms (Ostertagia ostertagi--adult, L4, inhibited L4); 
intestinal worms; nodular worms (Oesophagostomum radiatum--adult), 
hookworms (Bunostomum phlebotomum--adult), small intestinal worms 
(Cooperia punctata, C. oncophora, and C. mcmasteri--adult, L4), and 
tapeworms (Moniezia benedeni--adult).
    (iii) Limitations. Cattle must not be slaughtered until 7 days after 
treatment. Do not use in lactating dairy cattle.

[55 FR 46943, Nov. 8, 1990, as amended at 56 FR 8710, Mar. 1, 1991; 61 
FR 5506, Feb. 13, 1996; 72 FR 10596, Mar. 9, 2007]



Sec. 520.1631  Oxfendazole and trichlorfon paste.

    (a) Specifications. Each gram of paste contains 28.5 milligrams 
oxfendazole and 454.5 milligrams trichlorfon.
    (b) Sponsor. See 000856 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. 2.5 milligrams of oxfendazole and 
40 milligrams of trichlorfon per kilogram of body weight.
    (2) Indications for use. The drug is used in horses for removal of 
bots (Gasterophilus intestinalis, 2nd and 3rd instars; G. nasalis, 3rd 
instar) and the following gastrointestinal worms: Large roundworms 
(Parascaris equorum), pinworms (Oxyuris equi), adult and 4th stage 
larvae; large strongyles (Strongylus edentatus, S. vulgaris, and S. 
equinus); and small strongyles.
    (3) Limitations. Horses maintained on premises where reinfection is 
likely to occur should be retreated in 6 to 8 weeks. Withholding feed or 
water before use is unnecessary. Administer with caution to sick or 
debilitated horses. Not for use in horses intended for food. Do not 
administer to mares during the last month of pregnancy. Trichlorfon is a 
cholinesterase inhibitor. Do not use this product in animals 
simultaneously with, or within a few days before or after treatment with 
or exposure to, cholinesterase-inhibiting drugs, pesticides, or 
chemicals. Consult your veterinarian for assistance in the diagnosis, 
treatment, and control of parasitism.

[50 FR 50291, Dec. 10, 1985, as amended at 61 FR 5506, Feb. 13, 1996]



Sec. 520.1638  Oxibendazole paste.

    (a) Specifications. The paste contains 22.7 percent oxibendazole.
    (b) Sponsor. See 000069 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in horses--(1) Amount. For uses other than for 
threadworms (Strongyloides westeri), 10 milligrams of oxibendazole per 
kilogram of body weight; for threadworms (Strongyloides westeri), 15 
milligrams per kilogram.
    (2) Indications for use. For removal and control of large strongyles 
(Strongylus edentatus, S. equinus, S. vulgaris); small strongyles 
(genera Cylicostephanus, Cylicocyclus, Cyathostomum, Triodontophorus, 
Cylicodontophorus, and Gyalocephalus); large roundworms (Parascaris 
equorum); pinworms (Oxyuris equi) including various larval stages; and 
threadworms (Strongyloides westeri).
    (3) Limitations. Administer orally by syringe. Horses maintained on 
premises where reinfection is likely to occur should be re-treated in 6 
to 8 weeks. Not for use in horses intended for human consumption. 
Consult a veterinarian for assistance in the diagnosis, treatment, and 
control of parasitism.

[46 FR 50948, Oct. 16, 1981, as amended at 47 FR 36418, Aug. 20, 1982; 
56 FR 50653, Oct. 8, 1991; 60 FR 55659, Nov. 2, 1995; 71 FR 33237, June 
8, 2006]



Sec. 520.1640  Oxibendazole suspension.

    (a) Specifications. The suspension contains 10 percent oxibendazole.
    (b) Sponsor. See 000069 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in horses--(1) Amount. For use other than 
threadworms (Strongyloides westeri), 10 milligrams of oxibendazole per 
kilogram of body weight; for threadworms, 15 milligrams per kilogram of 
body weight.
    (2) Indications for use. For removal and control of large strongyles 
(Strongylus edentatus, S. equinus, S. vulgaris); small strongyles 
(species of the genera Cylicostephanus Cylicocyclus, Cyathostomum, 
Triodontophorus,

[[Page 195]]

Cylicodontophorus, and Gyalocephalus); large roundworms (Parascaris 
equorum); pinworms (Oxyuris equi) including various larval stages; and 
threadworms (Strongyloides westeri).
    (3) Limitations. Administer by stomach tube in 3 to 4 pints of warm 
water, or by top dressing or mixing into a portion of the normal grain 
ration. Prepare individual doses to ensure that each animal receives the 
correct amount. Horses maintained on premises where reinfection is 
likely to occur should be re-treated in 6 to 8 weeks. Not for use in 
horses intended for human consumption. Federal law restricts this drug 
to use by or on the order of a licensed veterinarian.

[45 FR 78119, Nov. 28, 1980, as amended at 47 FR 39812, Sept. 10, 1982; 
56 FR 50653, Oct. 8, 1991; 60 FR 55659, Nov. 2, 1995; 71 FR 33237, June 
8, 2006]



Sec. 520.1660  Oxytetracycline.



Sec. 520.1660a  Oxytetracycline and carbomycin in combination.

    (a) Specifications. (1) Oxytetracycline: The antibiotic substance 
produced by growth of Streptomyces rimosus or the same antibiotic 
substance produced by any other means.
    (2) Carbomycin: The antibiotic substance produced by growth of 
Streptomyces halstedii or the same antibiotic substance produced by any 
other means.
    (b) Sponsor. See No. 000069 in Sec. 510.600(c) of this chapter.
    (c) Special considerations. The quantities of oxytetracycline in 
paragraph (e) of this section refer to the activity of oxytetracycline 
hydrochloride and the quantities of carbomycin listed refer to the 
activity of an appropriate standard.
    (d) Related tolerances. See Sec. Sec. 556.110 and 556.500 of this 
chapter.
    (e) Conditions of use. It is used as oxytetracycline hydrochloride 
plus carbomycin base in drinking water of chickens as follows:
    (1) Amount. 1.0 gram of oxytetracycline and 1.0 gram carbomycin per 
gallon.
    (2) Indications for use. As an aid in the prevention and treatment 
of complicated chronic respiratory disease (air-sac infection) caused by 
Mycoplasma gallisepticum and secondary bacterial organisms associated 
with chronic respiratory disease such as E. coli.
    (3) Limitations. Administer for not more than 5 days; not for use in 
chickens producing eggs for human consumption; withdraw 24 hours before 
slaughter.



Sec. 520.1660b  Oxytetracycline hydrochloride capsules.

    (a) Specifications. The drug is in capsule form with each capsule 
containing 125 or 250 milligrams of oxytetracycline hydrochloride. 
Oxytetracycline is the antibiotic substance produced by growth of 
Streptomyces rimosus or the same antibiotic substance produced by any 
other means.
    (b) Sponsor. See No. 000069 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use. (1) It is used in dogs and cats for the 
treatment of bacterial pneumonia caused by Brucella bronchiseptica, 
tonsilitis caused by Streptococcus hemolyticus, bacterial enteritis 
caused by Escherichia coli, urinary tract infections caused by 
Escherichia coli, and wound infections caused by Staphylococcus aureus. 
\1\
---------------------------------------------------------------------------

    \1\ These conditions are NAS/NRC reviewed and deemed effective. 
Applications for these uses need not include effectiveness data as 
specified by Sec. 514.111 of this chapter, but may require 
bioequivalency and safety information.
---------------------------------------------------------------------------

    (2) The drug is administered orally to dogs and cats at a dosage 
level of 25-50 milligrams per pound of body weight per day in divided 
doses at 12-hour intervals. The drug can be used for continuation of 
compatible antibiotic therapy following parenteral oxytetracycline 
administration where rapidly attained, sustained antibiotic blood levels 
are required. The duration of treatment required to obtain favorable 
response will depend to some extent on the severity and degree of 
involvement and the susceptibility of the infectious agent. Clinical 
response to antibiotic therapy usually occurs within 48 to 72 hours. If 
improvement is not observed within that period, the diagnosis and course 
of treatment should be reconsidered. To assure adequate treatment, 
administration of the drug should continue for at least 48 hours 
following favorable clinical response.\1\

[[Page 196]]

    (3) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.\1\



Sec. 520.1660c  Oxytetracycline hydrochloride tablets/boluses.

    (a) Specifications. Each tablet or bolus contains 250, 500, or 1,000 
milligrams of oxytetracycline hydrochloride.
    (b) Sponsors. For sponsors in Sec. 510.600(c) of this chapter: See 
000010 for use of 500 and 1,000 milligram boluses. See 000069 for use of 
250 and 500 milligram tablets.
    (c) Tolerances. See Sec. 556.500 of this chapter.
    (d) Conditions of use in beef and dairy cattle--(1)(i) Amount. 250 
milligrams per 100 pounds of body weight every 12 hours (5 milligrams 
per pound of body weight daily in two doses).
    (ii) Indications for use. For control of bacterial enteritis caused 
by Salmonella typhimurium and Escherichia coli (colibacillosis) and 
bacterial pneumonia (shipping fever complex, pasteurellosis) caused by 
Pasteurella multocida.
    (2)(i) Amount. 500 milligrams per 100 pound of body weight every 12 
hours (10 milligrams per pound of body weight daily in two doses).
    (ii) Indications for use. For treatment of bacterial enteritis 
caused by Salmonella typhimurium and Escherichia coli (colibacillosis) 
and bacterial pneumonia (shipping fever complex, pasteurellosis) caused 
by Pasteurella multocida.
    (3) Limitations. Dosage should continue until the animal returns to 
normal and for 24 hours to 48 hours after symptoms have subsided. 
Treatment should not exceed 4 consecutive days. Do not exceed 500 
milligrams per 100 pounds of body weight every 12 hours (10 milligrams 
per pound daily). For sponsor 000069: Discontinue treatment 7 days prior 
to slaughter. Not for use in lactating dairy cattle. A withdrawal period 
has not been established for this product in preruminating calves. Do 
not use in calves to be processed for veal.

[46 FR 32440, June 23, 1981, as amended at 50 FR 1045, Jan. 9, 1985; 63 
FR 70334, Dec. 21, 1998; 70 FR 16394, Apr. 4, 2005]



Sec. 520.1660d  Oxytetracycline powder.

    (a) Specifications. The drug is a soluble powder distributed in 
packets or pails having several concentrations of oxytetracycline 
hydrochloride (independent of the various net weights) as follows:
    (1) Each 18.14 grams of powder contains 1 gram of oxytetracycline 
hydrochloride (OTC HCl) (packets: 4, 6.4, and 16 oz.).
    (2) Each 4.43 grams of powder contains 1 gram of OTC HCl (packets: 4 
and 16 oz.).
    (3) Each 1.32 grams of powder contains 1 gram of OTC HCl (packets: 
2.39, 4.78, and 9.55 oz.; jars: 2.25 lbs.; and pails: 4.5 lbs.).
    (4) Each 2.73 grams of powder contains 1 gram of OTC HCl (packets: 
2.46 and 9.87 oz; pail: 3.09 lb).
    (5) Each 4.2 grams of powder contains 1 gram of OTC HCl (packets: 
3.8 and 15.2 oz; pails: 4.74 and 23.7 lb).
    (6) Each 1.32 grams of powder contains 1 gram of OTC HCl (packet: 
4.78 oz.; pail: 5 lb). Each 2.73 grams of powder contains 1 gram of OTC 
HCl (packet: 9.87 oz).
    (7) Each 1.32 grams of powder contains 1 gram of OTC HCl (packet: 
4.78 and 9.6 oz.; pails: 2 and 5 lb); each 18.1 grams of powder contains 
1 gram of OTC HCl (packet: 6.4 oz.; pails: 2 and 5 lb).
    (8) Each 135.5-gram packet (4.78 ounce) contains 102.4 grams of OTC 
HCl. Each 677.5-gram packet (23.9 ounce) contains 512 grams of OTC HCl.
    (9) Each 2.73 grams of powder contains 1 gram of OTC HCl (packets: 
9.87 and, 19.75 oz, and 3.91 lb; pails: 3.09 and 5 lb).
    (10) Each 2.73 grams of powder contains 1 gram of OTC HCl (packets: 
9.87 and 19.74 oz; pails: 5 lb).
    (b) Sponsor. See sponsor numbers in Sec. 510.600(c) of this chapter 
as follows:
    (1) No. 000069 for use of OTC HCl concentrations in paragraphs 
(a)(1), (a)(2), and (a)(3) of this section in chickens, turkeys, swine, 
cattle, sheep, and honey bees.
    (2) No. 046573 for use of OTC HCl concentration in paragraph (a)(4) 
of this section in chickens, turkeys, and swine.

[[Page 197]]

    (3) No. 000010 for use of OTC HCl concentration in paragraph (a)(5) 
of this section in turkeys and chickens.
    (4) No. 057561 for use of OTC HCl concentration in paragraph (a)(6) 
of this section in chickens, turkeys, and swine.
    (5) No. 059130 for use of OTC HCl concentration in paragraph (a)(7) 
of this section in chickens, turkeys, swine, cattle, sheep, and 
honeybees.
    (6) No. 048164 for use of OTC HCl concentrations in paragraph (a)(8) 
of this section in chickens, turkeys, swine, cattle, and sheep.
    (7) No. 061623 for use of OTC HCl concentration in paragraph (a)(9) 
of this section in chickens, turkeys, and swine.
    (8) No. 059320 for use of OTC concentration in paragraph (a)(10) of 
this section in chickens, turkeys, and swine as in paragraph (d) of this 
section.
    (c) Related tolerances. See Sec. 556.500 of this chapter.
    (d) Conditions of use. (1) It is used in drinking water as follows:
    (i) Chickens--(A)(1) Amount per gallon. 200 to 400 milligrams.
    (2) Indications for use. Control of infectious synovitis caused by 
Mycoplasma synoviae susceptible to oxytetracycline.
    (3) Limitations. Prepare a fresh solution daily. Administer 7 to 14 
days. Not to be used for more than 14 consecutive days. Use as sole 
source of drinking water. Do not use in birds producing eggs for human 
consumption.
    (B)(1) Amount per gallon. 400 to 800 milligrams.
    (2) Indications for use. Control of chronic respiratory disease 
(CRD) and air sac infections caused by Mycoplasma gallisepticum and E. 
coli susceptible to oxytetracycline; control of fowl cholera caused by 
Pasteurella multocida susceptible to oxytetracycline.
    (3) Limitations. Prepare a fresh solution daily. Administer 7 to 14 
days. Not to be used for more than 14 consecutive days. Use as sole 
source of drinking water. Do not use in birds producing eggs for human 
consumption.
    (ii) Turkeys--(A)(1) Amount per gallon. 200 to 400 milligrams.
    (2) Indications for use. Control of hexamitiasis caused by Hexamita 
meleagridis susceptible to oxytetracycline.
    (3) Limitations. Prepare a fresh solution daily. Administer 7 to 14 
days. Not to be used for more than 14 consecutive days. Use as sole 
source of drinking water. Do not use in birds producing eggs for human 
consumption. Withdraw 5 days prior to slaughter those products sponsored 
by Nos. 000069, and 059130 in Sec. 510.600(c) of this chapter. Withdraw 
4 days prior to slaughter those products sponsored by No. 000010. Zero-
day withdrawal for those products sponsored by Nos. 046573, 053389, 
057561, 059320, and 061133.
    (B)(1) Amount per gallon. 400 milligrams.
    (2) Indications for use. Control of infectious synovitis caused by 
Mycoplasma synoviae susceptible to oxytetracycline.
    (3) Limitations. Prepare a fresh solution daily. Administer 7 to 14 
days. Not to be used for more than 14 consecutive days. Use as sole 
source of drinking water. Do not use in birds producing eggs for human 
consumption. Withdraw 5 days prior to slaughter those products sponsored 
by Nos. 000069, and 059130 in Sec. 510.600(c) of this chapter. Withdraw 
4 days prior to slaughter those products sponsored by No. 000010. Zero-
day withdrawal for those products sponsored by Nos. 046573, 053389, 
057561, 059320, and 061133.
    (C)(1) Amount. 25 milligrams per pound of body weight.
    (2) Indications for use. Growing turkeys. Control of complicating 
bacterial organisms associated with bluecomb (transmissible enteritis, 
coronaviral enteritis) susceptible to oxytetracycline.
    (3) Limitations. Prepare a fresh solution daily. Administer 7 to 14 
days. Not to be used for more than 14 consecutive days. Use as sole 
source of drinking water. Do not use in birds producing eggs for human 
consumption. Withdraw 5 days prior to slaughter those products sponsored 
by Nos. 000069, and 059130 in Sec. 510.600(c) of this chapter. Withdraw 
4 days prior to salughter those products sponsored by No. 000010. Zero-
day withdrawal for those products sponsored by Nos. 046573, 053389, 
057561, 059320, and 061133.

[[Page 198]]

    (iii) Swine--(A) Amount. 10 milligrams per pound of body weight 
daily.
    (B) Indications for use. Control and treatment of bacterial 
enteritis caused by Escherichia coli and Salmonella choleraesuis and 
bacterial pneumonia caused by Pasteurella multocida susceptible to 
oxytetracycline. For breeding swine: Control and treatment of 
leptospirosis (reducing the incidence of abortions and shedding of 
leptospira) caused by Leptospira pomona susceptible to oxytetracycline.
    (C) Limitations. Prepare a fresh solution daily. Use as sole source 
of OTC. Administer up to 14 days; do not use for more than 14 
consecutive days; withdraw zero days prior to slaughter those products 
sponsored by Nos. 000069 and 059130. Administer up to 5 days; do not use 
for more than 5 consecutive days; withdraw zero days prior to slaughter 
those products sponsored by Nos. 046573, 053389, 057561, 059320, and 
061133.
    (iv) Calves, beef cattle, and nonlactating dairy cattle--(A) Amount. 
10 milligrams per pound of body weight daily.
    (B) Indications for use. Control and treatment of bacterial 
enteritis caused by E. coli and bacterial pneumonia (shipping fever 
complex) caused by P. multocida susceptible to oxytetracycline.
    (C) Limitations. Prepare a fresh solution daily. Administer up to 14 
days. Do not use for more than 14 consecutive days. Use as sole source 
of oxytetracycline. Do not administer this product with milk or milk 
replacers. Administer 1 hour before or 2 hours after feeding milk or 
milk replacers. Withdraw 5 days prior to slaughter. A milk discard 
period has not been established for this product in lactating dairy 
cattle. Do not use in female dairy cattle 20 months of age or older.
    (v) Sheep--(A) Amount. 10 milligrams per pound of body weight daily.
    (B) Indications for use. Control and treatment of bacterial 
enteritis caused by E. coli and bacterial pneumonia (shipping fever 
complex) caused by P. multocida susceptible to oxytetracycline.
    (C) Limitations. Prepare a fresh solution daily. Administer up to 14 
days. Do not use for more than 14 consecutive days. Use as sole source 
of oxytetracycline. Withdraw 5 days prior to slaughter.
    (2) It is used in the food of honey bees as follows:
    (i) Amount. 200 milligrams per colony, administered via either a 1:1 
sugar syrup (equal parts of sugar and water weight to weight) or dusting 
with a powdered sugar mixture.
    (ii) Indications for use. For control of American foulbrood caused 
by Paenibacillus larvae and European foulbrood caused by Streptococcus 
pluton susceptible to oxytetracycline.
    (iii) Limitations. The drug is administered in 3 applications of 
sugar syrup or 3 dustings at 4- to 5-day intervals. The drug should be 
fed early in the spring or fall and consumed by the bees before main 
honey flow begins to avoid contamination of production honey. Remove at 
least 6 weeks prior to main honey flow.

[50 FR 32694, Aug. 14, 1985]

    Editorial Note: For Federal Register citations affecting Sec. 
520.1660d, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and on GPO Access.



Sec. 520.1696  Penicillin oral dosage forms.



Sec. 520.1696a  Buffered penicillin powder, penicillin powder with buffered 

aqueous diluent.

    (a) Specifications. When reconstituted, each milliliter contains 
penicillin G procaine equivalent to 20,000, 25,000, 40,000, 50,000, 
80,000, or 100,000 units of penicillin G.
    (b) Sponsor. [Reserved]
    (c) Related tolerances. See Sec. 556.510 of this chapter.
    (d) Conditions of use. Chickens--It is used in drinking water as 
follows:
    (1) Amount. 100,000 units per gallon.
    (i) Indications for use. Treatment of chronic respiratory disease 
(air-sac infection) and bluecomb (nonspecific infectious enteritis).
    (ii) Limitations. As penicillin G procaine; not for use in laying 
chickens; prepare fresh solution daily; withdraw 1 day before slaughter; 
as sole source of penicillin.
    (2) Amount. 50,000 to 100,000 units per gallon.

[[Page 199]]

    (i) Indications for use. Prevention of chronic respiratory disease 
(air-sac infection) and bluecomb (nonspecific infectious enteritis).
    (ii) Limitations. As penicillin G procaine; not for use in laying 
chickens; prepare fresh solution daily; withdraw 1 day before slaughter; 
as sole source of penicillin.

[57 FR 37326, Aug. 18, 1992]



Sec. 520.1696b  Penicillin G potassium in drinking water.

    (a) Specifications. When reconstituted, each milliliter contains 
penicillin G potassium equivalent to 20,000, 25,000, 40,000, 50,000, 
80,000, or 100,000 units of penicillin G.
    (b) Sponsors. See Nos. 010515, 046573, 053501, 059130, 059320, and 
061623 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use. Turkeys--(1) Amount. 1,500,000 units per 
gallon drinking water for 5 days.
    (2) Indications for use. Treatment of erysipelas caused by 
Erysipelothrix rhusiopathiae.
    (3) Limitations. Prepare concentrated stock solution for use with 
medication proportioners fresh every 24 hours. Prepare recommended use 
levels for gravity flow watering system fresh every 12 hours. For best 
results, treatment should be started at the first sign of infection. 
Discontinue treatment at least 1 day prior to slaughter. Not for use in 
turkeys producing eggs for human consumption.

[57 FR 37326, Aug. 18, 1992, as amended at 59 FR 42493, Aug. 18, 1994; 
60 FR 26359, May 17, 1995; 62 FR 55160, Oct. 23, 1997; 65 FR 10705, Feb. 
29, 2000; 66 FR 14073, Mar. 9, 2001; 68 FR 4914, Jan. 31, 2003; 68 FR 
26204, May 15, 2003; 69 FR 9946, Mar. 3, 2004; 69 FR 41428, July 9, 
2004]



Sec. 520.1696c  Penicillin V potassium for oral solution.

    (a) Specifications. When reconstituted, each milliliter contains 25 
milligrams (40,000 units) of penicillin V.
    (b) Sponsor. See No. 050604 in Sec. 510.600(c) of this chapter.
    (c) National Academy of Sciences/National Research Council (NAS/NRC) 
status. The conditions of use were NAS/NRC reviewed and found effective. 
Applications for these uses need not include effectiveness data as 
specified by Sec. 514.111 of this chapter, but may require 
bioequivalency and safety information.
    (d) Conditions of use. Dogs and cats--(1) Amount. 10 to 15 
milligrams per pound of body weight every 6 to 8 hours.
    (2) Indications for use. Treatment of respiratory, urogenital, skin, 
and soft tissue infections and septicemia caused by pathogens 
susceptible to penicillin V potassium.
    (3) Limitations. Administer orally 1 to 2 hours prior to feeding for 
maximum absorption. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[57 FR 37326, Aug. 18, 1992; 57 FR 42623, Sept. 15, 1992]



Sec. 520.1696d  Penicillin V potassium tablets.

    (a) Specifications. Each tablet contains penicillin V potassium 
equivalent to 125 milligrams (200,000 units) or 250 milligrams (400,000 
units) of penicillin V.
    (b) Sponsors. See Nos. 017144, 050604, and 053501 in Sec. 
510.600(c) of this chapter.
    (c) National Academy of Sciences/National Research Council (NAS/NRC) 
status. These conditions of use were NAS/NRC reviewed and found 
effective. Applications for these uses need not include effectiveness 
data as specified by Sec. 514.111 of this chapter, but may require 
bioequivalency and safety information.
    (d) Conditions of use. Dogs and Cats--(1) Amount. 10 to 15 
milligrams per pound of body weight every 6 to 8 hours.
    (2) Indications for use. Treatment of respiratory, urogenital, skin 
and soft tissue infections and septicemia caused by pathogens 
susceptible to penicillin V potassium.
    (3) Limitations. Administer orally 1 to 2 hours prior to feeding for 
maximum absorption. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[57 FR 37327, Aug. 18, 1992, as amended at 59 FR 58775, Nov. 15, 1994]

[[Page 200]]



Sec. 520.1720  Phenylbutazone oral dosage forms.



Sec. 520.1720a  Phenylbutazone tablets and boluses.

    (a) Specifications. Each tablet contains 100, 200, or 400 milligrams 
(mg), or 1 gram (g) phenylbutazone. Each bolus contains 2 or 4 g 
phenylbutazone.
    (b) Sponsors. See sponsor numbers in Sec. 510.600(c) of this 
chapter, as follows:
    (1) No. 000061 for use of 100- or 400-mg or 1-g tablets, or 2- or 4-
g boluses, in dogs and horses.
    (2) Nos. 000010 and 059130 for use of 100- or 200-mg or 1-g tablets 
in dogs and horses.
    (3) Nos. 000856, 058829, and 061623 for use of 100-mg or 1-g tablets 
in dogs and horses.
    (4) No. 055246 for use of 100-mg tablets in dogs.
    (5) No. 000143 for use of 1-g tablets in horses.
    (c) Conditions of use--(1) Dogs--(i) Amount. 20 mg per pound of body 
weight daily.
    (ii) Indications for use. For the relief of inflammatory conditions 
associated with the musculoskeletal system.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) Horses--(i) Amount. 1 to 2 g per 500 pounds of body weight 
daily.
    (ii) Indications for use. For the relief of inflammatory conditions 
associated with the musculoskeletal system.
    (iii) Limitations. Do not use in horses intended for human 
consumption. Federal law prohibits the use of this drug in female dairy 
cattle 20 months of age or older. Federal law restricts this drug to use 
by or on the order of a licensed veterinarian.

[73 FR 8192, Feb. 13, 2008]



Sec. 520.1720b  Phenylbutazone granules.

    (a) Specifications. The drug is in granular form. It is packaged to 
contain either 8 grams of phenylbutazone per package or 1 gram of 
phenylbutazone per package.
    (b) Sponsor. See 000061 in Sec. 510.600(c) for 8-gram package, see 
059320 for 1-gram package.
    (c) NAS/NRC status. The conditions of use have been NAS/NRC reviewed 
and found effective. NADA's for approval of drugs for these conditions 
of use need not include effectiveness data specified by Sec. 514.111 of 
this chapter, but may require bioequivalency and safety information.
    (d) Conditions of use--(1) Horses--(i) Amount. 1 to 2 grams per 500 
pounds of body weight, not to exceed 4 grams, daily, as required.
    (ii) Indications. For the treatment of inflammatory conditions 
associated with the musculoskeletal system.
    (iii) Limitations. Administer orally by adding to a portion of the 
usual grain ration. Use a relatively high dose for the first 48 hours, 
then gradually reduce to a maintenance level at the lowest level capable 
of producing the desired clinical response. Treated animals should not 
be slaughtered for food use. Federal law restricts this drug to use by 
or on the order of a licensed veterinarian.

[46 FR 18960, Mar. 27, 1981, as amended at 46 FR 48642, Oct. 2, 1981; 57 
FR 2836, Jan. 24, 1992; 61 FR 8873, Mar. 6, 1996; 62 FR 61625, Nov. 19, 
1997; 65 FR 20731, Apr. 18, 2000]



Sec. 520.1720c  Phenylbutazone paste.

    (a) Specifications--(1) Each gram of paste contains 0.2 grams 
phenylbutazone.
    (2) Each gram of paste contains 0.35 grams phenylbutazone.
    (b) Sponsors. See sponsor numbers in Sec. 510.600(c) of this 
chapter.
    (1) Nos. 000061 and 010797 for use of product described in paragraph 
(a)(1) of this section.
    (2) No. 064847 for use of product described in paragraph (a)(2) of 
this section.
    (c) Conditions of use in horses--(1) Amount. 1 to 2 grams of 
phenylbutazone per 500 pounds of body weight, not to exceed 4 grams 
daily.
    (2) Indications for use. For relief of inflammatory conditions 
associated with the musculoskeletal system.
    (3) Limitations. Use a relatively high dose for the first 48 hours, 
then gradually reduce to a maintenance level of the lowest level capable 
of producing the desired clinical response. Do not use in horses 
intended for human consumption. Federal law restricts this

[[Page 201]]

drug to use by or on the order of a licensed veterinarian.

[45 FR 84762, Dec. 23, 1980, as amended at 58 FR 29777, May 24, 1993; 61 
FR 8873, Mar. 6, 1996; 62 FR 61625, Nov. 19, 1997; 68 FR 43926, July 25, 
2003; 72 FR 60550, Oct. 25, 2007]



Sec. 520.1720d  Phenylbutazone gel.

    (a) Specifications. Each 30 grams of gel contains 4 grams of 
phenylbutazone.
    (b) Sponsor. See No. 061623 in Sec. 510.600(c) of this chapter.
    (c) NAS/NRC status. The conditions of use are NAS/NRC reviewed and 
found effective. Applications for these uses need not include 
effectiveness data as specified in Sec. 514.111 of this chapter, but 
may require bioequivalency and safety information.
    (d) Conditions of use in horses--(1) Amount. 1 to 2 grams of 
phenylbutazone per 500 pounds of body weight, not to exceed 4 grams 
daily.
    (2) Indications for use. For relief of inflammatory conditions 
associated with the musculoskeletal system of horses.
    (3) Limitations. Use a relatively high dose for the first 48 hours, 
then gradually reduce to a maintenance level at the lowest level capable 
of producing the desired clinical response. Not for use in horses 
intended for food. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[50 FR 13561, Apr. 5, 1985, as amended at 50 FR 49372, Dec. 2, 1985; 55 
FR 8462, Mar. 8, 1990; 66 FR 14073, Mar. 9, 2001; 68 FR 4915, Jan. 31, 
2003]



Sec. 520.1720e  Phenylbutazone powder.

    (a) Specifications--(1) Each 1.15 grams (g) of powder contains 1 g 
phenylbutazone.
    (2) Each 10 g of powder contains 1 g phenylbutazone.
    (b) Sponsors. See sponsor numbers in Sec. 510.600(c) of this 
chapter.
    (1) No. 027053 for use of product described in paragraph (a)(1) of 
this section.
    (2) No. 057699 for use of product described in paragraph (a)(2) of 
this section.
    (c) Conditions of use in horses--(1) Amount. Administer 1 to 2 g (1 
to 2 level scoops, using the scoop provided) per 500 pounds of body 
weight on a small amount of palatable feed, not exceed 4 g per animal 
daily.
    (2) Indications for use. For the relief of inflammatory conditions 
associated with the musculosketetal system.
    (3) Limitations. Do not use in horses intended for human 
consumption. Federal law prohibits the extralabel use of this product in 
female cattle 20 months of age or older. Federal law restricts this drug 
to use by or on the order of a licensed veterinarian.

[72 FR 27956, May 18, 2007]



Sec. 520.1780  Pimobendan.

    (a) Specifications. Each chewable tablet contains 1.25, 2.5, or 5 
milligrams (mg) pimobendan.
    (b) Sponsor. See No. 000010 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer orally at a 
total daily dose of 0.23 mg per pound (0.5 mg per kilogram) body weight, 
using a suitable combination of whole or half tablets. The total daily 
dose should be divided into two portions administered approximately 12 
hours apart.
    (2) Indications for use. For the management of the signs of mild, 
moderate, or severe (modified New York Heart Association Class II, III, 
or IV) congestive heart failure due to atrioventricular valvular 
insufficiency or dilated cardiomyopathy; for use with concurrent therapy 
for congestive heart failure as appropriate on a case-by-case basis.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[72 FR 27733, May 17, 2007]



Sec. 520.1802  Piperazine-carbon disulfide complex oral dosage forms.



Sec. 520.1802a  Piperazine-carbon disulfide complex suspension.

    (a) Specifications. Each fluid ounce of suspension contains 7.5 
grams of piperazine-carbon disulfide complex. The piperazine-carbon 
disulfide complex contains equimolar parts of piperazine and carbon 
disulfide (1 gram contains 530 mgs of piperazine and 470 mgs of carbon 
disulfide).
    (b) Sponsor. See 000009 in Sec. 510.600(c) of this chapter.

[[Page 202]]

    (c) Conditions of use. Horses and ponies--(1) Amount. One fluid 
ounce per 100 pounds of body weight.\1\
---------------------------------------------------------------------------

    \1\ These conditions are NAS/NRC reviewed and found effective. 
Applications for these uses need not include effectiveness data as 
specified by Sec. 514.111 of this chapter, but may require 
bioequivalency and safety information.
---------------------------------------------------------------------------

    (2) Indications for use. For removing ascarids (large roundworms, 
Parascaris equorum), bots (Gastrophilus spp.), small strongyles, large 
strongyles (Strongyles spp.), and pinworms (Oxyuris equi).\1\
    (3) Limitations. Administer by stomach tube or dose syringe after 
withholding feed overnight or for 8 to 10 hours. Provide water as usual. 
Resume regular feeding 4 to 6 hours after treatment. Treatment of 
debilitated or anemic animals is contraindicated. Do not administer to 
animals that are or were recently affected with colic, diarrhea, or 
infected with a serious infectious disease. As with most anthelmintics, 
drastic cathartics and other gastrointestinal irritants should not be 
administered in conjunction with this drug. Animals in poor condition or 
heavily parasitized should be given one half the recommended dose and 
treated again in 2 or 3 weeks. Federal law restricts this drug to use by 
or on the order of a licensed veterinarian.\1\

[45 FR 52781, Aug. 8, 1980]



Sec. 520.1802b  Piperazine-carbon disulfide complex boluses.

    (a) Specifications. Each bolus contains 20 grams of piperazine-
carbon disulfide complex.
    (b) Sponsor. See 000009 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use: Horses and ponies--(1) Amount. For removal of 
ascarids and small strongyles, 1 bolus (20 grams) per 500 pounds body 
weight; removal of large strongyles, pinworms, and bots, 1 bolus per 250 
pounds body weight.\1\
    (2) Indications for use. For removing ascarids (large roundworms, 
Parascaris equorum), large strongyles (Strongylus spp.) bots 
(Gastrophilus spp.), small strongyles, and pinworms (Oxyuris equi).\1\
    (3) Limitations. Withhold feed overnight or for 8 to 10 hours. Give 
water just before and/or after treatment. Resume regular feeding 4 to 6 
hours after treatment. Treatment of debilitated or anemic animals is 
contraindicated. Do not administer to animals that are or were recently 
affected with colic, diarrhea, or infected with a serious infectious 
disease. As with most anthelmintics, drastic cathartics or other 
gastrointestinal irritants should not be administered in conjunction 
with this drug. Animals in poor condition or heavily parasitized should 
be given one half the recommended dose and treated again in 2 or 3 
weeks. Consult your veterinarian for assistance in the diagnosis, 
treatment, and control of parasitism.\1\

[45 FR 52782, Aug. 8, 1980]



Sec. 520.1802c  Piperazine-carbon disulfide complex with phenothiazine 

suspension.

    (a) Specifications. Each fluid ounce contains 5 grams of piperazine-
carbon disulfide complex and 0.83 gram of phenothiazine.
    (b) Sponsor. See 000009 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use: Horses and ponies--(1) Amount. One fluid 
ounce per 100 pounds of body weight.
    (2) Indications for use. For removing ascarids (large roundworms, 
Parascaris equorum), bots (Gastrophilus spp.), small strongyles, and 
large strongyles (Strongylus spp.).
    (3) Limitations. See Sec. 520.1802a(c)(3).

[45 FR 52782, Aug. 8, 1980]



Sec. 520.1803  Piperazine citrate capsules.

    (a) Specifications. Piperazine citrate capsules contain piperazine 
citrate equivalent to 140 milligrams of piperazine base in each capsule.
    (b) Sponsor. See No. 021091 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use. (1) It is used in dogs and cats for the 
removal of large roundworms (Toxocara canis and Toxascaris leonina).
    (2) The contents of 1 capsule should be mixed with the food of the 
animal for each 5 pounds, or fraction thereof of body weight, except 
dogs weighing over 25 pounds should be given the contents of 6 capsules. 
The drug should be mixed in \1/2\ of the regular feeding and when

[[Page 203]]

the animal has finished eating the dosed food, the remainder of the food 
may be given. Dogs and cats may be wormed at 6 to 8 weeks of age. The 
first treatment should be repeated 10 days later. Reinfection may occur. 
Repeat treatment if indicated.
    (3) Severely debilitated animals should not be wormed except on the 
advice of a veterinarian.

[40 FR 13838, Mar. 27, 1975, as amended at 54 FR 38515, Sept. 19, 1989]



Sec. 520.1804  Piperazine phosphate capsules.

    (a) Specifications. Each capsule contains 120, 300, or 600 
milligrams of piperazine phosphate monohydrate.
    (b) Sponsor. See No. 051311 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. 60 milligrams of piperazine 
phosphate monohydrate per pound of body weight.\1\
---------------------------------------------------------------------------

    \1\ These conditions are NAS/NRC reviewed and deemed effective. 
Applications for these uses need not include effectiveness data as 
specified by Sec. 514.111 of this chapter, but may require 
bioequivalency and safety information.
---------------------------------------------------------------------------

    (2) Indications for use--(i) Dogs. It is used for the removal of 
large roundworms (ascarids) Toxocara canis and Toxascaris leonina. \1\
    (ii) Cats. It is used for the removal of large roundworms (ascarids) 
Toxocara mystax and Toxacaris leonina. \1\
    (3) Limitations. Administer in animal's food or milk. For animals up 
to 1 year of age administer every 2 or 3 months; for animals over 1 year 
old, administer periodically as necessary. Consult your veterinarian for 
assistance in the diagnosis, treatment, and control of parasitism.\1\

[43 FR 6941, Feb. 17, 1978; 43 FR 9804, Mar. 10, 1978, as amended at 46 
FR 20158, Apr. 3, 1981; 69 FR 31878, June 8, 2004]



Sec. 520.1805  Piperazine phosphate with thenium closylate tablets.

    (a) Specifications. Each scored tablet contains the equivalent of 
250 milligrams piperazine hexahydrate (as piperazine phosphate) and 125 
milligrams thenium (as thenium closylate) or 500 milligrams piperazine 
hexahydrate (as piperazine phosphate) and 250 milligrams thenium (as 
thenium closylate).
    (b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. Administer orally to dogs as 
follows:

               Number of Tablets at Each of the Two Doses
------------------------------------------------------------------------
                Animal weight (lb)                    375 mg     750 mg
------------------------------------------------------------------------
2 but less than 5.................................      \1/2\  .........
5 but less than 10................................          1      \1/2\
10 or heavier.....................................          2          1
------------------------------------------------------------------------

    (2) Indications for use. For removal of immature (fourth stage 
larvae) and adult hookworms (Ancylostoma caninum, A. braziliense, and 
Uncinaria stenocephala) and ascarids (Toxocara canis) from weaned pups 
and adult dogs.
    (3) Limitations. Do not use this product to treat dogs weighing less 
than 2 pounds, unweaned pups, or pups under 5 weeks of age. Maximum 
efficacy against hookworms necessitates two doses in 1 day of treatment. 
The interval between the doses should be not less than 4 hours or more 
than 24 hours. Administer the first dose in the morning before feeding. 
Do not permit dog to chew tablet. Feed the dog between doses. Do not 
feed milk or other fatty foods during treatment. Retreatment may be 
needed in 7 to 28 days as determined by laboratory fecal examinations or 
in animals kept in known contaminated quarters. Federal law restricts 
this drug to use by or on the order of a licensed veterinarian.

[43 FR 32747, July 28, 1978, as amended at 47 FR 55476, Dec. 10, 1982; 
61 FR 8873, Mar. 6, 1996; 62 FR 61625, Nov. 19, 1997]



Sec. 520.1806  Piperazine suspension.

    (a) Specifications. Each milliliter of suspension contains 
piperazine monohydrochloride equivalent to 33.5 milligrams (mg) 
piperazine base.
    (b) Sponsor. See No. 017135 in Sec. 510.600(c) of this chapter.
    (c) Special considerations. See Sec. 500.25(c) of this chapter.
    (d) Conditions of use in dogs--(1) Indications for use. For the 
removal of roundworms (Toxocara canisand Toxascaris leonina).

[[Page 204]]

    (2) Dosage. Administer 20 to 30 mg piperazine base per pound body 
weight as a single dose.
    (3) Limitations. Administer by mixing into the animal's ration to be 
consumed at one feeding. For animals in heavily contaminated areas, 
reworm at monthly intervals. Not for use in unweaned pups or animals 
less than 3 weeks of age.

[70 FR 17319, Apr. 6, 2005]



Sec. 520.1807  Piperazine.

    (a) Specifications. A soluble powder or liquid containing piperazine 
dihydrochloride or dipiperazine sulfate, equivalent to 17, 34, or 230 
grams of piperazine per pound or 100 milliliters.
    (b) Sponsor. See 015565 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.513 of this chapter.
    (d) Conditions of use--(1) Chickens--(i) Amount. 50 milligrams per 
bird under 6 weeks, 100 milligrams per bird over 6 weeks.
    (ii) Indications for use. For removal of large roundworm (Ascaridia 
spp.).
    (iii) Limitations. For use in drinking water or feed. Use as sole 
source of drinking water. Prepare fresh solution daily. Use as 1-day 
single treatment. Withdraw 14 days prior to slaughter. Do not use for 
chickens producing eggs for human consumption. Consult your veterinarian 
for assistance in the diagnosis, treatment, and control of parasitism.
    (2) Turkeys--(i) Amount. 100 milligrams per bird up to 12 weeks and 
200 milligrams per bird over 12 weeks.
    (ii) Indications for use. For removal of large roundworm (Ascaridia 
spp.).
    (iii) Limitations. For use in drinking water or feed. Use as sole 
source of drinking water. Prepare fresh solution daily. Use as 1-day 
single treatment. Withdraw 14 days prior to slaughter. Consult your 
veterinarian for assistance in the diagnosis, treatment, and control of 
parasitism.
    (3) Swine--(i) Amount. 50 milligrams per pound of body weight.
    (ii) Indications for use. For removal of large roundworm (Ascaris 
suum) and nodular worms (Oesophagostomum spp.).
    (iii) Limitations. For use in drinking water or feed. Use as sole 
source of drinking water. Prepare fresh solution daily. Use as 1-day 
single treatment. Withdraw 21 days prior to slaughter. Consult your 
veterinarian for assistance in the diagnosis, treatment, and control of 
parasitism.

[64 FR 23018, Apr. 29, 1999]



Sec. 520.1840  Poloxalene.

    (a) Specifications. Polyoxypropylene-polyoxyethylene glycol nonionic 
block polymer.
    (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for 
use as in paragraph (d) of this section.
    (1) No. 000069 for use as in paragraphs (d)(1) and (d)(3) of this 
section.
    (2) No. 051311 for use as in paragraph (d)(4) of this section.
    (3) No. 067949 for use as in paragraph (d)(2) of this section.
    (4) No. 066104 for use as in paragraph (d)(3) of this section.
    (c) [Reserved]
    (d) Conditions of use. (1) For treatment of legume (alfalfa, clover) 
bloat in cattle. Administer as a drench at the rate of 25 grams for 
animals up to 500 pounds and 50 grams for animals over 500 pounds of 
body weight.
    (2) For control of legume (alfalfa, clover) bloat in cattle. 
Administer, in molasses block containing 6.6 percent poloxalene, at the 
rate of 0.8 oz. of block (1.5 grams poloxalene) per 100 lbs. of body 
weight per day.
    (3) For prevention of legume (alfalfa, clover) and wheat pasture 
bloat in cattle. A 53-percent poloxalene top dressing on individual 
rations of ground feed. Dosage is 1 gram of poloxalene per 100 pounds of 
body weight daily. If bloating conditions are severe, the dose is 
doubled. Treatment should be started 2 to 3 days before exposure to 
bloat-producing conditions. Repeat use of the drug if animals are 
exposed to bloat-producing conditions for more than 12 hours after the 
last treatment. Do not exceed the double dose in any 24-hour period.
    (4) For control of legume (alfalfa, clover) and wheat pasture bloat 
in cattle. Administer in molasses block containing 6.6 percent 
poloxalene, at the rate of 0.8 ounce of block (1.5 grams of poloxalene) 
per 100 pounds of body weight per day. Provide access to

[[Page 205]]

blocks at least 7 days before exposure to bloat-producing conditions.

[40 FR 13838, Mar. 27, 1975, as amended at 40 FR 39857, Aug. 29, 1975; 
42 FR 41854, Aug. 19, 1977; 50 FR 5385, Feb. 8, 1985; 54 FR 33501, Aug. 
15, 1989; 56 FR 50653, Oct. 8, 1991; 58 FR 26523, May 4, 1993; 60 FR 
55659, Nov. 2, 1995; 66 FR 47963, Sept. 17, 2001; 69 FR 62811, Oct. 28, 
2004; 70 FR 32489, June 3, 2005]



Sec. 520.1846  Polyoxyethylene (23) lauryl ether blocks.

    (a) Specifications. Each molasses-based block contains 2.2 percent 
polyoxyethylene (23) lauryl ether.
    (b) Sponsor. See No. 067949 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. 2 grams of polyoxyethylene (23) 
lauryl ether per 100 kilograms of body weight per day (1 pound of block 
per 500 kilogram (1,100 pound) animal per day).
    (2) Indications for use. For reduction of the incidence of bloat 
(alfalfa and clover) in pastured cattle.
    (3) Limitations. Administer free-choice to beef cattle and 
nonlactating dairy cattle only. Initially, provide one block per five 
head of cattle. Start treatment 10 to 14 days before exposure to bloat-
producing pastures. Do not allow cattle access to other sources of salt 
while being fed this product. Do not feed this product to animals 
without adequate forage/roughage consumption.

[50 FR 48189, Nov. 22, 1985, as amended at 56 FR 9841, Mar. 8, 1991; 69 
FR 62811, Oct. 28, 2004]



Sec. 520.1855  Ponazuril.

    (a) Specifications. Each gram of paste contains 150 milligrams (mg) 
ponazuril.
    (b) Sponsor. See No. 000859 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in horses--(1) Amount. 5 mg per kilogram body 
weight, daily for 28 days.
    (2) Indications for use. For the treatment of equine protozoal 
myeloencephalitis caused by Sarcocystis neurona.
    (3) Limitations. Not for use in horses intended for food. Federal 
law restricts this drug to use by or on the order of a licensed 
veterinarian.

[66 FR 43774, Aug. 21, 2001]



Sec. 520.1870  Praziquantel tablets.

    (a) Specifications. Each tablet contains:
    (1) 34 milligrams (mg) praziquantel.
    (2) 11.5 or 23 mg praziquantel.
    (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter:
    (1) No. 000859 for use of the product described in paragraph (a)(1) 
of this section, as in paragraph (c)(1) of this section; and for use of 
the product described in paragraph (a)(2) of this section, as in 
paragraph (c)(2) of this section.
    (2) No. 059130 for use of the product described in paragraph (a)(1) 
of this section, as in paragraph (c)(1) of this section.
    (c) Conditions of use--(1) Dogs--(i) Amount. 5 pounds (lb) and 
under, 1/2 tablet (17 mg); 6 to 10 lb, 1 tablet (34 mg); 11 to 15 lb, 1 
1/2 tablets (51 mg); 16 to 30 lb, 2 tablets (68 mg); 31 to 45 lb, 3 
tablets (102 mg); 46 to 60 lb, 4 tablets (136 mg); over 60 lb, 5 tablets 
maximum (170 mg). Administer directly by mouth or crumbled and in feed.
    (ii) Indications for use--(A) For removal of canine cestodes 
Dipylidium caninum and Taenia pisiformis.
    (B) For removal of the canine cestode Echinococcus granulosus, and 
for removal and control of the canine cestode Echinococcus 
multilocularis.
    (iii) Limitations--(A) If labeled only for use as in paragraph 
(c)(1)(ii)(A) of this section: Not intended for use in puppies less than 
4 weeks of age. Consult your veterinarian before administering tablets 
to weak or debilitated animals and for assistance in the diagnosis, 
treatment, and control of parasitism.
    (B) If labeled for use as in paragraph (c)(1)(ii)(B) of this 
section: Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.
    (2) Cats--(i) Indications for use. For removal of feline cestodes 
Dipylidium caninum and Taenia taeniaeformis.
    (ii) Dosage. Cats 4 pounds and under, 11.5 mg; 5 to 11 pounds, 23 
mg; over 11 pounds, 34.5 mg.
    (iii) Limitations. Administer directly by mouth or crumbled and in 
feed. Not intended for use in kittens less than 6 weeks of age. For OTC 
use: Consult your veterinarian before administering tablets to weak or 
debilitated animals,

[[Page 206]]

and for assistance in the diagnosis, treatment, and control of 
parasitism.

[46 FR 60570, Dec. 11, 1981, as amended at 47 FR 26377, June 18, 1982; 
55 FR 2234, Jan. 23, 1990; 58 FR 7864, Feb. 10, 1993; 58 FR 42853, Aug. 
12, 1993; 68 FR 57351, Oct. 3, 2003; 69 FR 62181, Oct. 25, 2004]



Sec. 520.1871  Praziquantel and pyrantel.

    (a) Specifications. (1) Each tablet contains 18.2 milligrams (mg) 
praziquantel and 72.6 mg pyrantel (as pyrantel pamoate).
    (2) Each chewable tablet contains 30 mg praziquantel and 30 mg 
pyrantel pamoate or 114 mg praziquantel and 114 mg pyrantel pamoate.
    (b) Sponsors. See sponsors in Sec. 510.600(c) for use as in 
paragraph (d) of this chapter.
    (1) See No. 000859 for use of tablet described in paragraph (a)(1) 
of this section for use as in paragraph (d)(1) of this section.
    (2) See No. 051311 for use of tablets described in paragraph (a)(2) 
of this section for use as in paragraph (d)(2) of this section.
    (c) Special considerations. See Sec. 500.25 of this chapter.
    (d) Conditions of use--(1) Cats--(i) Dosage. 1.5 to 1.9 pounds, 1/4 
tablet; 2 to 3 pounds, 1/2 tablet; 4 to 8 pounds, 1 tablet; 9 to 12 
pounds, 1 1/2 tablets; 13 to 16 pounds, 2 tablets. If reinfection 
occurs, treatment may be repeated.
    (ii) Indications for use. For removal of tapeworms (Dipylidium 
caninum and Taenia taeniaeformis), hookworms (Ancylostoma tubaeforme), 
and large roundworms (Toxocara cati) in cats and kittens.
    (iii) Limitations. Not for use in kittens less than 1 month of age 
or weighing less than 1.5 pounds. May be given directly by mouth or in a 
small amount of food. Do not withhold food prior to or after treatment. 
Consult your veterinarian before giving to sick or pregnant animals.
    (2) Dogs--(i) Amount. Administer a minimum dose of 5 mg praziquantel 
and 5 mg pyrantel pamoate per kilogram body weight (2.27 mg praziquantel 
and 2.27 mg pyrantel pamoate per pound body weight) according to the 
dosing tables on labeling.
    (ii) Indications for use. For the treatment and control of 
roundworms (Toxocara canis and Toxascaris leonina), hookworms 
(Ancylostoma caninum, Ancylostoma braziliense, and Uncinaria 
stenocephala), and tapeworms (Dipylidium caninum and Taenia pisiformis) 
in dogs and puppies.

[58 FR 58652, Nov. 3, 1993, as amended at 72 FR 16270, Apr. 4, 2007]



Sec. 520.1872  Praziquantel, pyrantel pamoate, and febantel tablets.

    (a) Specifications. Each tablet or chewable tablet contains either:
    (1) Tablet No. 1: 22.7 milligrams praziquantel, 22.7 milligrams 
pyrantel base, and 113.4 milligrams febantel; or
    (2) Tablet No. 2: 68 milligrams praziquantel, 68 milligrams pyrantel 
base, and 340.2 milligrams febantel.
    (3) Tablet No. 3: 136 milligrams (mg) praziquantel, 136 mg pyrantel 
base, and 680.4 mg febantel.
    (b) Sponsor. See 000859 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Dogs--(i) Amount. Administer as a single 
dose directly by mouth or in a small amount of food as follows:

----------------------------------------------------------------------------------------------------------------
                  Weight of animal                                    Number of tablets per dose
----------------------------------------------------------------------------------------------------------------
            Kilograms                   Pounds           Tablet no. 1        Tablet no. 2        Tablet no. 3
----------------------------------------------------------------------------------------------------------------
0.9 to 1.8......................  2 to 4............  1/2...............
2.3 to 3.2......................  5 to 7............  1.................
3.6 to 5.4......................  8 to 12...........  1 1/2.............
5.9 to 8.2......................  13 to 18..........  2.................
8.6 to 11.4.....................  19 to 25..........  2 1/2.............
11.8 to 13.6....................  26 to 30..........  ..................  1.................
14.1 to 20.0....................  31 to 44..........  ..................  1 1/2.............
20.4 to 27.2....................  45 to 60..........  ..................  2.................  1
27.7 to 40.9....................  61 to 90..........  ..................  ..................  1 1/2
41.3 to 54.5....................  91 to 120.........  ..................  ..................  2
----------------------------------------------------------------------------------------------------------------

    (ii) Indications for use. For the removal of tapeworms (Dipylidium 
caninum, Taenia pisiformis, Echinococcus granulosus); hookworms 
(Ancylostoma caninum, Uncinaria stenocephala); ascarids (Toxocara canis, 
Toxascaris leonina); and whipworms (Trichuris vulpis) and for the 
removal and control of tapeworm Echinococcus multilocularis in dogs.
    (iii) Limitations. Do not use in pregnant animals. Do not use in 
dogs weighing less than 0.9 kilogram (2 pounds) or puppies less than 3 
weeks of age. Federal law restricts this drug to

[[Page 207]]

use by or on the order of a licensed veterinarian.

[59 FR 33908, July 1, 1994, as amended at 61 FR 29651, June 12, 1996; 68 
FR 22293, Apr. 28, 2003; 71 FR 6677, Feb. 9, 2006]



Sec. 520.1880  Prednisolone tablets.

    (a) Specifications. Each tablet contains 5 or 20 milligrams 
prednisolone.
    (b) Sponsor. See No. 061690 in Sec. 510.600(c)(2) of this chapter.
    (c) Special considerations. (1) Clinical and experimental data have 
demonstrated that corticosteroids administered orally or parenterally to 
animals may induce the first stage of parturition when administered 
during the last trimester of pregnancy and may precipitate parturition 
followed by dystocia, fetal death, retained placenta, and metritis.
    (2) Do not use in viral infections. Systemic therapy with 
prednisolone is contraindicated in animals with peptic ulcer, corneal 
ulcer, and Cushingoid syndrome. The presence of diabetes, osteoporosis, 
predisposition to thrombophlebitis, hypertension, congestive heart 
failure, renal insufficiency, and active tuberculosis necessitates 
carefully controlled use. Some of the above conditions occur only rarely 
in dogs but should be kept in mind.
    (3) Anti-inflammatory action of corticosteroids may mask signs of 
infection.
    (d) Conditions of use--(1) Amount. Dogs: 2.5 milligrams per 4.5 
kilograms (10 pounds) body weight per day. Administer total daily dose 
orally in equally divided doses 6 to 10 hours apart until response is 
noted or 7 days have elapsed. When response is attained, dosage should 
be gradually reduced until maintenance level is achieved.
    (2) Indications for use. For use in dogs as an anti-inflammatory 
agent.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[57 FR 4718, Feb. 7, 1992, as amended at 60 FR 57832, Nov. 22, 1995; 63 
FR 148, Jan. 5, 1998]



Sec. 520.1900  Primidone tablets.

    (a) Specifications. Each tablet contains 50 or 250 milligrams of 
primidone.
    (b) Sponsor. See No. 000010 in Sec. 510.600(c) of this chapter for 
use of 250 milligram tablets; see No. 000856 in Sec. 510.600(c) of this 
chapter for use of 50 and 250 milligram tablets.
    (c) Conditions of use in dogs--(1) Amount. Twenty-five milligrams of 
primidone per pound of body weight (55 milligrams per kilogram of body 
weight) daily.\1\
---------------------------------------------------------------------------

    \1\ These conditions are NAS/NRC reviewed and deemed effective. 
Applications for these uses need not include effectiveness data as 
specified by Sec. 514.111 of this chapter, but may require 
bioequivalency and safety information.
---------------------------------------------------------------------------

    (2) Indications for use. For the control of convulsions associated 
with idiopathic epilepsy, epileptiform convulsions, viral encephalitis, 
distemper, and hardpad disease that occurs as a clinically recognizable 
lesion in certain entities in dogs.\1\
    (3) Limitations. The tablets may be administered whole or crushed 
and mixed with the food. When convulsions are frequent, the dosage 
should be divided and administered at intervals. Reduction in dosage 
should be made gradually and never be abruptly discontinued. Do not use 
in feline species, as primidone appears to have a specific neurotoxicity 
in cats. Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.\1\

[42 FR 61594, Dec. 6, 1977, as amended at 43 FR 55386, Nov 28, 1978; 46 
FR 8467, Jan. 27, 1981; 46 FR 57477, Nov. 24, 1981; 53 FR 40727, Oct. 
18, 1988; 56 FR 37473, Aug. 7, 1991; 62 FR 35076, June 30, 1997]



Sec. 520.1920  Prochlorperazine, isopropamide sustained release capsules.

    (a) Specifications. Prochlorperazine, isopropamide sustained release 
capsules contain either:
    (1) 3.33 milligrams of prochlorperazine (as the dimaleate) and 1.67 
milligrams of isopropamide (as the iodide), or
    (2) 10 milligrams of prochlorperazine (as the dimaleate) and 5 
milligrams of isopropamide (as the iodide).
    (b) Sponsor. See No. 000069 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use. (1) The drug is used for the treatment of 
dogs in which

[[Page 208]]

gastrointestinal disturbances are associated with emotional stress.
    (2)(i) Capsules described in paragraph (a)(1) of this section are 
administered orally to dogs weighing from 4 to 15 pounds at the rate of 
1 capsule twice daily. These capsules are administered orally to dogs 
weighing from 16 to 30 pounds at the rate of 1 or 2 capsules twice 
daily. For dogs weighing less than 4 pounds, administer orally an 
appropriate fraction of the contents of one of these capsules.
    (ii) Capsules described in paragraph (a)(2) of this section are 
given to dogs weighing 30 pounds and over at the rate of 1 capsule twice 
daily.
    (3) For use only by or on the order of a licensed veterinarian.

[40 FR 13838, Mar. 27, 1975, as amended at 56 FR 50653, Oct. 8, 1991; 60 
FR 55659, Nov. 2, 1995]



Sec. 520.1921  Prochlorperazine, isopropamide, with neomycin sustained-release 

capsules.

    (a) Specifications. Each capsule contains either:
    (1) Capsule No. 1: 3.33 milligrams of prochlorperazine (as the 
dimaleate), 1.67 milligrams of isopropamide (as the iodide), and 25 
milligrams of neomycin base (as the sulfate); or
    (2) Capsule No. 3: 10 milligrams of prochlorperazine (as the 
dimaleate), 5 milligrams of isopropamide (as the iodide), and 75 
milligrams of neomycin base (as the sulfate).
    (b) Sponsor. See No. 000069 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. Administer capsules orally twice 
daily to dogs as follows:

------------------------------------------------------------------------
                                                      Number of capsules
                                                           per dose
               Animal weight (pounds)                -------------------
                                                       Capsule   Capsule
                                                        No. 1     No. 3
------------------------------------------------------------------------
10 to 20............................................         1
20 to 30............................................         2
Over 30.............................................         3         1
Over 60.............................................                   2
------------------------------------------------------------------------

    (2) Indications for use. For treatment of dogs in which infectious 
bacterial gastroenteritis is associated with emotional stress.
    (3) Limitations. Do not continue medication longer than 5 days. 
Overdosage or prolonged administration may produce nephrotoxicity as 
manifested by albuminuria, presence of granular casts and depressed 
urinary output. If it is desirable to administer a vasoconstrictor, 
norepinephrine is the drug of choice. Federal law restricts this drug to 
use by or on the order of a licensed veterinarian.

[49 FR 14103, Apr. 10, 1984, as amended at 56 FR 50653, Oct. 8, 1991; 60 
FR 55659, Nov. 2, 1995]



Sec. 520.1962  Promazine hydrochloride.

    (a)(1) Chemical name. 10-[3-(Dimethylamino)propyl]phenothiazine 
monohydrochloride.
    (2) Specifications. Conforms to N.F. XII.
    (3) Sponsor. See No. 000856 in Sec. 510.600(c) of this chapter.
    (4) [Reserved]
    (5) Conditions of use. (i) The drug is used for quieting excitable, 
unruly, or intractable horses. It is administered at a dosage level of 
0.45 to 0.9 milligrams of promazine hydrochloride per pound of body 
weight mixed with an amount of feed that will be readily consumed.
    (ii) Do not use in horses intended for food.
    (iii) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.
    (b) [Reserved]

[40 FR 13838, Mar. 27, 1975, as amended at 43 FR 55386, Nov. 28, 1978; 
59 FR 5705, Feb. 8, 1994]



Sec. 520.2002  Propiopromazine hydrochloride.

    (a) Chemical name. 1-Propanone, 1-[10-[3-(dimethylamino) propyl] 
phenothiazine-2-yl]-, monohydrochloride.
    (b) Specifications. The drug is administered in a chewable tablet 
containing 10 to 20 milligrams of propiopromazine hydrochloride.
    (c) Sponsor. See No. 000856 in Sec. 510.600(c) of this chapter.
    (d) Conditions of use. (1) The drug is intended for oral 
administration to dogs as a tranquilizer. It is used as an aid in 
handling difficult, excited, and unruly dogs, and in controlling 
excessive kennel barking, car sickness, and severe dermatitis. It is 
also indicated for use in minor surgery and prior to

[[Page 209]]

routine examinations, laboratory procedures, and diagnostic procedures.
    (2) It is administered at the rate of 0.5 to 2 milligrams of 
propiopromazine hydrochloride per pound of body weight once or twice 
daily depending upon the degree of tranquilization desired.

    Note: Not for use with organophosphates and/or procaine 
hydrochloride, as phenothiazine may potentiate the toxicity of 
organophosphates and the activity of procaine hydrochloride. Overdosage 
may produce significant depression.

    (3) For use only by or on the order of a licensed veterinarian.

[40 FR 13838, Mar. 27, 1975, as amended at 46 FR 60570, Dec. 11, 1981; 
61 FR 5506, Feb. 13, 1996]



Sec. 520.2041  Pyrantel pamoate chewable tablets.

    (a) Specifications. Each tablet contains pyrantel pamoate equivalent 
to 22.7 or 113.5 milligrams pyrantel base.
    (b) Sponsor. See Nos. 017135 and 051311 in Sec. 510.600(c) of this 
chapter.
    (c) Conditions of use--(1) Amount. Provides at least 2.27 milligrams 
pyrantel base per pound body weight for dogs weighing more than 5 
pounds, and at least 4.54 milligrams of pyrantel base per pound body 
weight for dogs weighing 5 pounds or less.
    (2) Indications for use--(i) In dogs and puppies. For removal of 
ascarids (Toxocara canis; Toxascaris leonina) and hookworms (Ancylostoma 
caninum; Uncinaria stenocephala).
    (ii) In puppies and adult dogs and in lactating bitches after 
whelping. To prevent reinfection of Toxocara canis.
    (3) Limitations. Administer to puppies at 2, 3, 4, 6, 8, and 10 
weeks of age. Administer to lactating bitches 2 to 3 weeks after 
whelping. Retreatment of adult dogs may be necessary at monthly 
intervals as determined by laboratory fecal examinations. Consult your 
veterinarian for assistance in the diagnosis, treatment, and control of 
parasitism.

[52 FR 37937, Oct. 13, 1987, as amended at 57 FR 48163, Oct. 22, 1992; 
58 FR 44611, Aug. 24, 1993; 66 FR 9650, Feb. 9, 2001; 67 FR 21996, May 
2, 2002]



Sec. 520.2042  Pyrantel pamoate tablets.

    (a) Specifications. Each tablet contains pyrantel pamoate equivalent 
to 22.7, 45.4, or 113.5 milligrams of pyrantel base.
    (b) Sponsor. See No. 017135 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use. It is used for dogs as follows:
    (1) Amount. For dogs weighing over 5 pounds, use at least 2.27 
milligrams of pyrantel base per pound of body weight; for dogs weighing 
5 pounds or less, use at least 4.54 milligrams of pyrantel base per 
pound of body weight.
    (2) Indications for use. For removal and control of large roundworms 
(ascarids) (Toxocara canis and Toxascaris leonina), and hookworms 
(Ancylostoma caninum and Uncinaria stenocephala).
    (3) Limitations. Administer orally directly or in a small amount of 
food. To prevent reinfection of T. canis in puppies, lactating bitches 
after whelping, and adult dogs; treat puppies 2, 3, 4, 6, 8, and 10 
weeks of age; treat lactating bitches 2 to 3 weeks after whelping; 
routinely treat adult dogs monthly. Do not withhold food prior to or 
after treatment. The presence of these parasites should be confirmed by 
laboratory fecal examination. A followup fecal examination should be 
conducted 2 to 4 weeks after first treatment regimen to determine the 
need for re-treatment. Consult your veterinarian for assistance in the 
diagnosis, treatment, and control of parasitism.

[43 FR 52700, Nov. 14, 1978, as amended at 49 FR 22073, May 25, 1984; 57 
FR 48163, Oct. 22, 1992; 58 FR 44611, Aug. 24, 1993]



Sec. 520.2043  Pyrantel pamoate suspension.

    (a) Specifications. (1) Each milliliter (mL) contains pyrantel 
pamoate equivalent to 50 milligrams (mg) pyrantel base.
    (2) Each mL contains pyrantel pamoate equivalent to 2.27 or 4.54 mg 
pyrantel base.
    (3) Each mL contains pyrantel pamoate equivalent to 4.54 mg pyrantel 
base.
    (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for 
uses as in paragraph (d) of this section.

[[Page 210]]

    (1) Nos. 000069, 058829, and 059130 for use of the product described 
in paragraph (a)(1) as in paragraph (d)(1) of this section.
    (2) Nos. 000069, 010237, 058829, and 059130 for use of the products 
described in paragraph (a)(2) as in paragraph (d)(2) of this section.
    (3) No. 023851 for use of the product described in paragraph (a)(3) 
as in paragraph (d)(2) of this section.
    (c) Special considerations. See Sec. 500.25 of this chapter.
    (d) Conditions of use--(1) Horses and ponies. It is used as follows:
    (i) Amount. 3 mg per pound (/lb) body weight as a single dose mixed 
with the usual grain ration, or by stomach tube or dose syringe.
    (ii) Indications for use. For the removal and control of mature 
infections of large strongyles (Strongylus vulgaris, S. edentatus, S. 
equinus); pinworms (Oxyuris equi); large roundworms (Parascaris 
equorum); and small strongyles.
    (iii) Limitations. Not for use in horses and ponies to be 
slaughtered for food purposes. When the drug is for administration by 
stomach tube, it shall be labeled: ``Federal law restricts this drug to 
use by or on the order of a licensed veterinarian.''
    (2) Dogs. It is used as follows:
    (i) Dogs and puppies--(A) Amount. 2.27 mg/lb body weight as a single 
dose in the animal's feed bowl by itself or mixed in a small quantity of 
food.
    (B) Indications for use. For the removal of large roundworms 
(Toxocara canis and Toxascaris leonina) and hookworms (Ancylostoma 
caninum and Uncinaria stenocephala).
    (C) Limitations. Additional treatment may be required and should be 
confirmed by fecal examination within 2 to 4 weeks.
    (ii) Dogs, puppies, and lactating bitches after whelping--(A) 
Amount. 2.27 mg/lb body weight.
    (B) Indications for use. To prevent reinfections of T. canis.
    (C) Limitations. Administer to puppies at 2, 3, 4, 6, 8, and 10 
weeks of age. Administer to lactating bitches 2 to 3 weeks after 
whelping. Adult dogs kept in heavily contaminated quarters may be 
treated at monthly intervals.

[67 FR 43248, June 27, 2002, as amended at 68 FR 54803, Sept. 19, 2003; 
68 FR 55199, Sept. 23, 2003; 68 FR 55825, Sept. 29, 2003]



Sec. 520.2044  Pyrantel pamoate paste.

    (a) Specifications--(1) Each milliliter (mL) contains 180 milligrams 
(mg) pyrantel base (as pyrantel pamoate).
    (2) Each mL contains 226 mg pyrantel base (as pyrantel pamoate).
    (3) Each mL contains 171 mg pyrantel base (as pyrantel pamoate).
    (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter.
    (1) No. 000069 for use of product described in paragraph (a)(1) of 
this section as in paragraph (d)(1)(i) and (d)(2) of this section.
    (2) No. 059130 for use of product described in paragraph (a)(2) of 
this section as in paragraph (d) of this section.
    (3) No. 061623 for use of product described in paragraph (a)(3) of 
this section as in paragraph (d)(1)(i) and (d)(2) of this section.
    (c) Special considerations. See Sec. 500.25 of this chapter.
    (d) Conditions of use. It is used in horses and ponies as follows:
    (1) Amounts and indications for use--(i) 3 mg per pound (/lb) body 
weight as single oral dose for removal and control of infections from 
the following mature parasites: large strongyles (Strongylus vulgaris, 
S. edentatus, S. equinus); small strongyles; pinworms (Oxyuris equi); 
and large roundworms (Parascaris equorum).
    (ii) 6 mg/lb body weight as single oral dose for the removal and 
control of mature infections of tapeworms (Anoplocephala perfoliata).
    (2) Limitations. Not for use in horses intended for food.

[70 FR 29447, May 23, 2005]



Sec. 520.2045  Pyrantel tartrate powder; pyrantel tartrate pellets.

    (a) Specifications. (1) Pyrantel tartrate powder horse wormer 
contains 11.3 percent and swine wormer 10.6 percent pyrantel tartrate.
    (2) Pyrantel tartrate pellets colt and horse wormer contains 1.25 
percent pyrantel tartrate.

[[Page 211]]

    (b) Sponsor. (1) See No. 000069 in Sec. 510.600(c) of this chapter 
for conditions of use provided for in paragraphs (d) (1) and (2) of this 
section.
    (2) See No. 051311 in Sec. 510.600(c) of this chapter, for 
conditions of use provided for in paragraph (d)(3) of this section.
    (c) Related tolerances. See Sec. 556.560 of this chapter.
    (d) Conditions of use. It is used in: (1) Horses and ponies:
    (i) For the removal and control of infections from the following 
mature parasites: Large strongyles (Strongylus vulgaris, Strongylus 
edentatus, Strongylus equinus), small strongyles (Trichonema spp., 
Triodontophorus), pinworms (Oxyuris), and large roundworms (Parascaris).
    (ii) It is administered as a single dose at 0.57 gram of pyrantel 
tartrate per 100 pounds of body weight mixed with the usual grain 
ration.
    (iii) It is recommended that severely debilitated animals not be 
treated with this drug. Do not administer by stomach tube or dose 
syringe. The drug should be used immediately after the package is 
opened.
    (iv) Warning: Not for use in horses and ponies to be slaughtered for 
food purposes.
    (2) Swine:
    (i) For the removal and control of large roundworms (Ascaris suum) 
and nodular worm (Oesophagostomum) infections.
    (ii) It is added to feed at 0.4 gram pyrantel tartrate per pound of 
nonpelleted ration. The ration is administered as a single treatment as 
the sole ration at the rate of 1 pound per 40 pounds of animal weight 
for animals up to 200 pounds. Animals 200 pounds and over are 
administered 5 pounds of ration per animal.
    (iii) Fast pigs over night for optimum results. Water should be made 
available to animals during fasting and treatment periods. Consult 
veterinarian before using in severely debilitated animals. The drug 
should be used immediately after the package is opened.
    (iv) Warning: Do not treat within 24 hours of slaughter.
    (3) Horses and colts:
    (i) For the removal and control of infections from the following 
mature parasites: Large strongyles (Strongylus vulgaris, Strongylus 
edentatus, Strongylus equinus), small strongyles (Trichonema spp., 
Triodontophorus), pinworms (Oxyuris), and large roundworms (Parascaris).
    (ii) It is administered as a single dose at 12.5 milligrams of 
pyrantel tartrate per 2.2 pounds of body weight mixed with the usual 
grain ration.
    (iii) It is recommended that severely debilitated animals not be 
treated with this drug.
    (iv) Warning: Do not use in horses or colts intended for food.

[40 FR 13838, Mar. 27, 1975, as amended at 59 FR 28769, June 3, 1994; 69 
FR 41427, July 9, 2004]



Sec. 520.2087  Roxarsone soluble powder.

    (a) Specifications. Each ounce (avoirdupois) of soluble powder 
contains 21.7 grams of roxarsone (monosodium 3-nitro-4-
hydroxyphenylarsonate).
    (b) Sponsor. See No. 046573 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.60 of this chapter.
    (d) NAS/NRC status. These conditions of use are NAS/NRC reviewed and 
found effective. NADA's for these uses need not include effectiveness 
data as specified by Sec. 514.111 of this chapter, but may require 
bioequivalency and safety information.
    (e) Conditions of use--(1) Growing chickens and growing turkeys--(i) 
Amount. 0.002 percent roxarsone in drinking water (one packet per each 
250 gallons of drinking water).
    (ii) Indications for use. For increased rate of weight gain, 
improved feed efficiency, and improved pigmentation.
    (iii) Limitations. Administer continuously throughout growing 
period. Withdraw 5 days before slaughter. Use as sole source of organic 
arsenic.
    (2) Swine--(i) Amount. 0.01 percent roxarsone in drinking water (one 
packet per each 50 gallons of drinking water); or 30 milliliters of a 
1.55 percent roxarsone solution (one packet per 3 pints of water) per 50 
pounds of body weight as a drench.
    (ii) Indications for use. As an aid in the treatment of swine 
dysentery (hemorrhagic enteritis or bloody scours).

[[Page 212]]

    (iii) Limitations. Administer drinking water continuously for not 
more than 6 days. Administer drench once daily for 1 or 2 days. If no 
improvement is observed, consult a veterinarian. Treatment may be 
repeated after 5 days. Withdraw 5 days before slaughter. Use as sole 
source of organic arsenic.

[46 FR 41039, Aug. 14, 1981, as amended at 55 FR 8460, Mar. 8, 1990; 57 
FR 8577, Mar. 11, 1992; 69 FR 41427, July 9, 2004]



Sec. 520.2088  Roxarsone tablets.

    (a)(1) Specifications. Each tablet contains 36 milligrams of 
roxarsone (3-nitro-4-hydroxyphenylarsonic acid).
    (2) Sponsor. See No. 046573 in Sec. 510.600(c) of this chapter.
    (3) Related tolerances. See Sec. 556.60 of this chapter.
    (4) NAS/NRC status. The weight gain, feed efficiency, and 
pigmentation claims are NAS/NRC reviewed and found effective. NADA's for 
these uses need not include effectiveness data as specified by Sec. 
514.111 of this chapter, but may require bioequivalency and safety 
information.
    (5) Conditions of use--(i) Growing chickens and growing turkeys--(a) 
Amount. Dissolve 2 tablets in each gallon of drinking water (0.002 
percent roxarsone).
    (b) Indications for use. For increased rate of weight gain, improved 
feed efficiency, and improved pigmentation.
    (c) Limitations. Administer continuously throughout growing period. 
Withdraw 5 days before slaughter. Use as sole source of organic arsenic.
    (ii) Growing chickens--(a) Amount. Dissolve 8 tablets in each gallon 
of drinking water (0.008 percent roxarsone).
    (b) Indications for use. As an aid in the prevention of coccidiosis 
due to Eimeria tenella.
    (c) Limitations. Administer for not more than 10 consecutive days. 
Treatment may be repeated after 5 days off medication. Withdraw 5 days 
before slaughter. Use as sole source of organic arsenic.
    (b)(1) Specifications. Each tablet contains 400 milligrams of 
roxarsone (3-nitro-4-hydroxyphenylarsonic acid).
    (2) Sponsor. See No. 046573 in Sec. 510.600(c) of this chapter.
    (3) Related tolerances. See Sec. 556.60 of this chapter.
    (4) NAS/NRC status. These conditions are NAS/NRC reviewed and found 
effective. NADA's for these uses need not include effectiveness data as 
specified by Sec. 514.111 of this chapter, but may require 
bioequivalency and safety information.
    (5) Conditions of use--(i) Swine--(a) Amount. 1 tablet (400 
milligrams) per gallon of drinking water for no more than 6 days, or 1 
tablet (400 milligrams) per 2 fluid ounces of warm water per 50 pounds 
of body weight as a drench once daily for 1 to 2 days.
    (b) Indications for use. As an aid in the treatment of swine 
dysentery (hemorrhagic enteritis or bloody scours).
    (c) Limitations. Treatment may be repeated after 5 days off 
medication. If no improvement is observed, consult a veterinarian. 
Treated animals must consume enough medicated water to provide a 
therapeutic dose. Withdraw 5 days before slaughter. Use as sole source 
of organic arsenic.
    (ii) [Reserved]
    (c)(1) Specifications. Each tablet contains 72 milligrams of 
roxarsone (3-nitro-4-hydroxyphenylarsonic acid).
    (2) Sponsor. See No. 046573 in Sec. 510.600(c) of this chapter.
    (3) Related tolerances. See Sec. 556.60 of this chapter.
    (4) Conditions of use in growing chickens and growing turkeys--(i) 
Amount. 1 tablet in each gallon of drinking water (0.002 percent 
roxarsone).
    (ii) Indications for use. For improved rate of weight gain, improved 
feed efficiency, and improved pigmentation.
    (iii) Limitations. Administer continuously throughout growing 
period. Do not administer to chickens producing eggs for human 
consumption. Withdraw 5 days before slaughter. Use as sole source of 
organic arsenic. Overdosage or the lack of water intake may result in 
weakness or paralysis of legs.

[46 FR 41040, Aug. 14, 1981, as amended at 46 FR 42448, Aug. 21, 1981; 
47 FR 15238, Apr. 9, 1982; 55 FR 8460, Mar. 8, 1990; 57 FR 8577, Mar. 
11, 1992; 58 FR 65664, Dec. 16, 1993; 65 FR 10705, Feb. 29, 2000]

[[Page 213]]



Sec. 520.2089  Roxarsone liquid.

    (a) Specifications. Each teaspoon (5 milliliters) of solution 
contains 72 milligrams of roxarsone (3-nitro-4-hydroxyphenylarsonic 
acid).
    (b) Sponsor. See No. 046573 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.60 of this chapter.
    (d) Conditions of use in growing chickens and growing turkeys--(1) 
Amount. 1 teaspoon (5 milliliters) to each gallon of drinking water 
(0.002 percent roxarsone).
    (2) Indications for use. For improved rate of weight gain, improved 
feed efficiency, and improved pigmentation.
    (3) Limitations. Administer continuously throughout growing period. 
Do not administer to chickens producing eggs for human consumption. 
Withdraw 5 days before slaughter. Use as sole source of organic arsenic. 
Overdosage or the lack of water intake may result in weakness or 
paralysis of legs.

[58 FR 65665, Dec. 16, 1993, as amended at 65 FR 10705, Feb. 29, 2000]



Sec. 520.2098  Selegiline hydrochloride tablets.

    (a) Specifications. Each tablet contains either 2, 5, 10, 15, or 30 
milligrams of selegiline hydrochloride.
    (b) Sponsor. See No. 000069 in Sec. 510.600(c) of this chapter.
    (c) [Reserved]
    (d) Conditions of use--Dogs--(1) Dosage. 1 milligram per kilogram 
(0.45 milligram per pound) of body weight.
    (i) Indications for use. For control of clinical signs associated 
with uncomplicated pituitary-dependent hyperadrenocorticism in dogs.
    (ii) Limitations. Administer orally once daily. If no improvement in 
clinical signs or physical examination findings after 2 months of 
therapy, increase dose to a maximum of 2 milligrams per kilogram once 
daily. Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.
    (2) Dosage. 0.5 to 1.0 milligram per kilogram of body weight once 
daily.
    (i) Indications for use. For the control of clinical signs 
associated with canine cognitive dysfunction syndrome.
    (ii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

[62 FR 34632, June 27, 1997; 62 FR 55159, Oct. 23, 1997, as amended at 
63 FR 29551, June 1, 1998; 64 FR 2122, Jan. 13, 1999]



Sec. 520.2100  Selenium, vitamin E capsules.

    (a) Specifications. The capsules contain 2.19 milligrams of sodium 
selenite (equivalent to 1 milligram of selenium) and 56.2 milligrams of 
vitamin E (68 I.U.) (as d-alpha tocopheryl acid succinate) or 0.548 
milligram of sodium selenite (equivalent to .25 milligram of selenium 
and 14 milligrams of vitamin E (17 I.U.) (as d-alpha tocopheryl acid 
succinate.)
    (b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use. (1) The drug is intended for use as an aid in 
alleviating and controlling inflammation, pain, and lameness associated 
with certain arthropathies in dogs.
    (2) The capsules are administered orally with the larger capsules 
administered at a dosage level of 1 capsule per 20 pounds of body weight 
to a maximum of 5 capsules with the dosage repeated at 3 day intervals 
until a satisfactory therapeutic response is observed. A maintenance 
dosage is then administered consisting of 1 capsule per 40 pounds of 
body weight, with a minimum of 1 capsule per 40 pounds of body weight, 
with a minimum of 1 capsule, given every 3 days, or 7 days, or longer, 
as required to maintain improvement or an asymptomatic condition. For 
dogs under 20 pounds of body weight, the small capsules are administered 
orally at a dosage level of 1 per 5 pounds of body weight with a minimum 
of 1 capsule which dosage is repeated at 3 day intervals until a 
satisfactory response is observed then a maintenance regimen is 
initiated with 1 capsule per 10 pounds of body weight, minimum of 1 
capsule, every 3 days, or 7 days, or longer as required to maintain 
continued improvement or an asymptomatic condition.

[[Page 214]]

    (3) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.

[40 FR 13838, Mar. 27, 1975, as amended at 52 FR 7832, Mar. 13, 1987; 52 
FR 9756, Mar. 26, 1987]



Sec. 520.2123  Spectinomycin oral dosage forms.



Sec. 520.2123a  Spectinomycin tablets.

    (a) Specifications. Each tablet contains spectinomycin 
dihydrochloride pentahydrate equivalent to 100 milligrams (mg) 
spectinomycin.
    (b) Sponsor. See No. 061623 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer orally to 
provide 10 mg per pound (lb) of body weight twice daily. Dosage may be 
continued for 4 consecutive days.
    (2) Indications for use. For the treatment of infectious diarrhea 
and gastroenteritis caused by organisms susceptible to spectinomycin.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[73 FR 6607, Feb. 5, 2008]



Sec. 520.2123b  Spectinomycin powder.

    (a) Specifications. Each gram (g) of powder contains spectinomycin 
dihydrochloride pentahydrate equivalent to 0.5 g spectinomycin.
    (b) Sponsor. See No. 061623 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.600 of this chapter.
    (d) Conditions of use in chickens. It is administered in the 
drinking water of growing chickens as follows:
    (1) Indications for use and amounts--(i) For increased rate of 
weight gain and improved feed efficiency in broiler chickens, administer 
0.5 g per gallon of water as the only source of drinking water for the 
first 3 days of life and for 1 day following each vaccination.
    (ii) As an aid in controlling infectious synovitis due to Mycoplasma 
synoviae in broiler chickens, administer 1 g per gallon of water as the 
only source of drinking water for the first 3 to 5 days of life.
    (iii) As an aid in the prevention or control of losses due to CRD 
associated with M. gallisepticum (PPLO) in growing chickens, administer 
2 g per gallon of water as the only source of drinking water for the 
first 3 days of life and for 1 day following each vaccination.
    (2) Limitations. Do not administer to laying chickens. Do not 
administer within 5 days of slaughter.

[73 FR 6607, Feb. 5, 2008]



Sec. 520.2123c  Spectinomycin solution.

    (a) Specifications. Each milliliter of solution contains 
spectinomycin dihydrochloride pentahydrate equivalent to 50 milligrams 
(mg) spectinomycin.
    (b) Sponsors. See Nos. 000856, 059130, and 061623 in Sec. 
510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.600 of this chapter.
    (d) Conditions of use in swine--(1) Amount. Administer 5 mg per 
pound (lb) of body weight orally twice daily for 3 to 5 days.
    (2) Indications for use. For the treatment and control of porcine 
enteric colibacillosis (scours) caused by E. coli susceptible to 
spectinomycin in pigs under 4 weeks of age.
    (3) Limitations. Do not administer to pigs over 15 lb body weight or 
over 4 weeks of age. Do not administer within 21 days of slaughter.

[73 FR 6607, Feb. 5, 2008]



Sec. 520.2130  Spinosad.

    (a) Specifications. Each chewable tablet contains 140, 270, 560, 
810, or 1620 milligrams (mg) spinosad.
    (b) Sponsor. See No. 000986 in Sec. 510.600 of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer tablets once a 
month at a recommended minimum dosage of 13.5 mg per pound (30 mg per 
kilogram) of body weight.
    (2) Indications for use. To kill fleas and for the prevention and 
treatment of flea infestations (Ctenocephalides felis) on dogs for 1 
month.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[72 FR 60551, Oct. 25, 2007]

[[Page 215]]



Sec. 520.2150  Stanozolol oral dosage forms.



Sec. 520.2150a  Stanozolol tablets.

    (a) Specifications. Each tablet contains 2 milligrams of stanozolol.
    (b) Sponsor. No. 000009 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use. (1) Used as an anabolic steroid treatment in 
dogs and cats.
    (2) Administered orally to cats and small breeds of dogs, \1/2\ to 1 
tablet twice daily for several weeks; to large breeds of dogs, 1 to 2 
tablets twice daily for several weeks. The tablets may be crushed and 
administered in feed.
    (3) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.

[40 FR 46101, Oct. 6, 1975, as amended at 42 FR 36995, July 19, 1977. 
Redesignated at 50 FR 38114, Sept. 20, 1985, and amended at 55 FR 23076, 
June 6, 1990]



Sec. 520.2150b  Stanozolol chewable tablets.

    (a) Specifications. Each chewable tablet contains 2 milligrams of 
stanozolol.
    (b) Sponsor. No. 000009 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use. (1) Used as an anabolic steroid treatment in 
dogs.
    (2) Administered orally to small breeds of dogs, \1/2\ to 1 tablet 
twice daily for several weeks; to large breeds of dogs, 1 to 2 tablets 
twice daily for several weeks.
    (3) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.

[50 FR 38114, Sept. 20, 1985, as amended at 55 FR 23076, June 6, 1990]



Sec. 520.2158  Streptomycin/dihydrostreptomycin oral dosage forms.



Sec. 520.2158a  Streptomycin sulfate oral solution.

    (a) Specifications. Solution containing 25 percent streptomycin 
sulfate.
    (b) Sponsor. See Nos. 033008 and 055462 in Sec. 510.600(c) of this 
chapter.
    (c) Related tolerances. See Sec. 556.610 of this chapter.
    (d) Conditions of use. Use in drinking water as follows:
    (1) Calves and swine--(i) Amount. 10 to 15 milligrams per pound (mg/
pound) of body weight (1.0 to 1.5 grams per gallon).
    (ii) Indications for use. Treatment of bacterial enteritis caused by 
Escherichia coli and Salmonella spp. susceptible to streptomycin.
    (iii) Limitations. Calves: Do not administer for more than 5 days. 
Swine: Do not administer for more than 4 days. Prepare fresh solution 
daily. Calves: Withdraw 2 days before slaughter. As sole source of 
streptomycin. Warning: Certain strains of bacteria may develop a 
tolerance for streptomycin. Consult a veterinarian or animal pathologist 
for diagnosis.
    (2) Chickens--(i) Amount. 10 to 15 mg/pound of body weight (0.6 to 
0.9 grams per gallon).
    (ii) Indications for use. Treatment of nonspecific infectious 
enteritis caused by organisms susceptible to streptomycin.
    (iii) Limitations. Chickens: Do not administer for more than 5 days. 
Withdraw 4 days before slaughter. Do not administer to chickens 
producing eggs for human consumption. Prepare fresh solution daily. As 
sole source of streptomycin. Warning: Certain strains of bacteria may 
develop a tolerance for streptomycin. Consult a veterinarian or animal 
pathologist for diagnosis.

[57 FR 37327, Aug. 18, 1992, as amended at 58 FR 47211, Sept. 8, 1993; 
63 FR 51821, Sept. 29, 1998]



Sec. 520.2158b  Dihydrostreptomycin tablets.

    (a) Specifications. Each tablet contains 37.5 milligrams 
dihydrostreptomycin (as the sulfate) with 375 milligrams chlorhexidine 
dihydrochloride.
    (b) Sponsor. See No. 000856 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. Sec. 556.120 and 556.200 of this 
chapter.
    (d) Conditions of use. Calves--(1) Amount. 150 milligrams of 
dihydrostreptomycin and 1.5 grams of chlorhexidine dihydrochloride per 
100 pounds of body weight per day.
    (2) Indications for use. Treatment of bacterial scours in calves.

[[Page 216]]

    (3) Limitations. Administer orally once a day for 5 days; withdraw 3 
days before slaughter.

[57 FR 37327, Aug. 18, 1992; 57 FR 42623, Sept. 15, 1992]



Sec. 520.2158c  Dihydrostreptomycin oral suspension.

    (a) Specifications. Each milliliter contains 1.25 milligrams 
dihydrostreptomycin (as the sulfate) with 12.5 milligrams chlorhexidine 
dihydrochloride.
    (b) Sponsor. See No. 000856 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. Sec. 556.120 and 556.200 of this 
chapter.
    (d) Conditions of use. Calves--(1) Amount. 150 milligrams of 
dihydrostreptomycin and 1.5 grams of chlorhexidine dihydrochloride per 
100 pounds of body weight per day.
    (2) Indications for use. Treatment of bacterial scours in calves.
    (3) Limitations. Administer orally once a day for 5 days; withdraw 3 
days before slaughter.

[57 FR 37327, Aug. 18, 1992]



Sec. 520.2160  Styrylpyridinium, diethylcarbamazine oral dosage forms.



Sec. 520.2170  Sulfabromomethazine sodium boluses.

    (a) Specifications. Each bolus contains 15 grams of 
sulfabromomethazine sodium.
    (b) Related tolerance. See Sec. 556.620 of this chapter.
    (c) Sponsor. See No. 050604 in Sec. 510.600(c) of this chapter.
    (d) NAS/NRC status. These conditions of use are NAS/NRC reviewed and 
found effective. NADA's for these uses need not include effectiveness 
data as specified by Sec. 514.111 of this chapter, but may require 
bioequivalency and safety information.
    (e) Conditions of use. Cattle--(1) Amount. 90 milligrams per pound 
body weight.
    (2) Indications for use. Treatment of necrotic pododermatitis (foot 
rot) and calf diphtheria caused by Fusobacterium necrophorum; 
colibacillosis (scours) caused by Escherichia coli; bacterial pneumonia 
and bovine respiratory disease complex (shipping fever complex) 
associated with Pasteurella spp.; acute metritis and acute mastitis 
caused by Streptococcus spp.
    (3) Limitations. Administer orally; repeat in 48 hours if necessary; 
milk taken from animals within 96 hours (8 milkings) of latest treatment 
must not be used for food; do not administer within 18 days of 
slaughter; discontinue use if hematuria, crystalluria or severe 
depression are noticed; if signs persist after 2 or 3 days consult a 
veterinarian.

[47 FR 30243, July 13, 1982, as amended at 62 FR 63270, Nov. 28, 1997]



Sec. 520.2184  Sodium sulfachloropyrazine monohydrate.

    (a) Chemical name. 2-Sulfamido-6-chloroxyrazine, sodium.
    (b) Sponsor. See Nos. 053501 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.625 of this chapter.
    (d) Conditions of use. It is used in the drinking water of broilers, 
breeder flocks, and replacement chickens as follows:
    (1) Amount. 0.03 percent.
    (2) Indications for use. Treatment of coccidiosis.
    (3) Limitations. Administer in drinking water for 3 days as sole 
source of drinking water and sulfonamide medication; withdraw 4 days 
prior to slaughter; not to be administered to chickens producing eggs 
for human consumption.

[40 FR 13838, Mar. 27, 1975, as amended at 50 FR 41489, Oct. 11, 1985; 
54 FR 12188, Mar. 24, 1989; 55 FR 8460, Mar. 8, 1990; 64 FR 15684, Apr. 
1, 1999; 67 FR 78355, Dec. 24, 2002]



Sec. 520.2200  Sulfachlorpyridazine oral dosage forms.



Sec. 520.2200a  Sulfachlorpyridazine bolus.

    (a) Chemical name. N'-6-(Chloro-3-pyridazinyl) sulfanilamide.
    (b) Specifications. Melting point range: 190 [deg]C to 191 [deg]C.
    (c) Sponsor. See No. 053501 in Sec. 510.600(c) of this chapter.
    (d) Related tolerances. See Sec. 556.630 of this chapter.
    (e) Conditions of use. It is used in calves as follows:
    (1) Amount. 30 to 45 milligrams per pound body weight per day.

[[Page 217]]

    (2) Indications for use. Treatment of diarrhea caused or complicated 
by E. coli (colibacillosis).
    (3) Limitations. Administer in a bolus containing 2 grams of 
sulfachlorpyridazine for 1 to 5 days in divided doses twice daily; 
treated calves must not be slaughtered for food during treatment or for 
7 days after the last treatment. A withdrawal period has not been 
established for this product in preruminating calves. Do not use in 
calves to be processed for veal.

[40 FR 13838, Mar. 27, 1975, as amended at 50 FR 41489, Oct. 11, 1985; 
70 FR 16934, Apr. 4, 2005]



Sec. 520.2200b  Sulfachlorpyridazine medicated milk and drinking water.

    (a) Chemical name. N'-(6-Chloro-3-pyridazinyl) sulfanilamide.
    (b) Specifications. Melting point range: 190 [deg]C to 191 [deg]C.
    (c) Sponsor. See No. 053501 in Sec. 510.600(c) of this chapter.
    (d) Related tolerances. See Sec. 556.630 of this chapter.
    (e) Conditions of use. It is used as follows:
    (1) Calves--(i) Amount. 30 to 45 milligrams per pound body weight 
per day.
    (ii) Indications for use. Treatment of diarrhea caused or 
complicated by E. coli (colibacillosis).
    (iii) Limitations. Administer as the sodium salt of 
sulfachlorpyridazine in milk or milk-replacer formulations for 1 to 5 
days in divided doses twice daily; treated calves must not be 
slaughtered for food during treatment or for 7 days after the last 
treatment. A withdrawal period has not been established for this product 
in preruminating calves. Do not use in calves to be processed for veal.
    (2) Swine--(i) Amount. 20 to 35 milligrams per pound body weight per 
day.
    (a) Indications for use. Treatment of diarrhea caused or complicated 
by E. coli (colibacillosis).
    (b) Limitations. Administer as the sodium salt of 
sulfachlorpyridazine in drinking water for 1 to 5 days; for individual 
treatment, administer orally in divided doses twice daily; treated swine 
must not be slaughtered for food during treatment or for 4 days after 
the last treatment.
    (ii) Amount. 20 to 35 milligrams per pound body weight per day.
    (a) Indications for use. Treatment of diarrhea caused or complicated 
by E. coli (colibacillosis).
    (b) Limitations. Administer individually in an oral suspension 
containing 50 milligrams of sulfachlorpyridazine per milliliter in 
divided doses twice daily for 1 to 5 days; treated swine must not be 
slaughtered for food during treatment or for 4 days after the last 
treatment.

[40 FR 13838, Mar. 27, 1975, as amended at 50 FR 41489, Oct. 11, 1985; 
70 FR 16934, Apr. 4, 2005]



Sec. 520.2200c  Sulfachlorpyridazine tablets.

    (a) Specifications. Sulfachlorpyridazine tablets contain 250 
milligrams of sulfachlorpyridazine per tablet.
    (b) Sponsor. See No. 053501 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use. (1) The drug is used in dogs as a broad 
spectrum antibacterial agent to aid in the treatment of infectious 
tracheobronchitis and infections caused by E. coli. It can also be used 
in the treatment of infections caused by other gram-positive and gram-
negative organisms that are susceptible to sulfonamide therapy.
    (2) It is administered orally at a dosage level of 500 milligrams 
per 10 to 15 pounds of body weight daily, in two or three divided doses.
    (3) The administration of the drug should be discontinued if a 
response is not noted within 7 to 10 days.
    (4) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.

[43 FR 36622, Aug. 18, 1978, as amended at 50 FR 41489, Oct. 11, 1985]



Sec. 520.2215  Sulfadiazine/pyrimethamine suspension.

    (a) Specifications. Each milliliter (mL) of suspension contains 250 
milligrams (mg) sulfadiazine (as the sodium salt) and 12.5 mg 
pyrimethamine.
    (b) Sponsor. See No. 068718 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in horses--(1) Amount. Administer orally 20 mg 
sulfadiazine per kilogram (kg) body weight and 1 mg/kg pyrimethamine 
daily.

[[Page 218]]

    (2) Indications for use. For the treatment of equine protozoal 
myeloencephalitis (EPM) caused by Sarcocystis neurona.
    (3) Limitations. Not for use in horses intended for food. Federal 
law restricts this drug to use by or on the order of a licensed 
veterinarian.

[69 FR 70054, Dec. 2, 2004]



Sec. 520.2218  Sulfamerazine, sulfamethazine, and sulfaquinoxaline powder.

    (a) Specifications. Each 195-gram (g) packet of powder contains 78 g 
sulfamerazine, 78 g sulfamethazine, and 39 g sulfaquinoxaline.
    (b) Sponsor. See No. 046573 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. Sec. 556.670 and 556.685 of this 
chapter.
    (d) Conditions of use--(1) Chickens--(i) Amounts and indications for 
use--(A) As an aid in the control of coccidiosis caused by Eimeria 
tenella and E. necatrix susceptible to sulfamerazine, sulfamethazine, 
and sulfaquinoxaline: provide medicated water (0.4 percent solution) for 
2 to 3 days, then plain water for 3 days, then medicated water (0.25 
percent solution) for 2 days. If bloody droppings appear, repeat at 0.25 
percent level for 2 more days. Do not change litter.
    (B) As an aid in the control of acute fowl cholera caused by 
Pasteurella multocida susceptible to sulfamerazine, sulfamethazine, and 
sulfaquinoxaline: provide medicated water (0.4 percent solution) for 2 
to 3 days. If disease recurs, repeat treatment.
    (ii) Limitations. Make fresh solution daily. Do not treat chickens 
within 14 days of slaughter for food. Do not medicate chickens producing 
eggs for human consumption.
    (2) Turkeys--(i) Amounts and indications for use--(A) As an aid in 
the control of coccidiosis caused by Eimeria meleagrimitis and E. 
adenoeides susceptible to sulfamerazine, sulfamethazine, and 
sulfaquinoxaline: provide medicated water (0.25 percent solution) for 2 
days, then plain water for 3 days, then medicated water (0.25 percent 
solution) for 2 days, then plain water for 3 days, then medicated water 
(0.25 percent solution) for 2 days. Repeat if necessary. Do not change 
litter.
    (B) As an aid in the control of acute fowl cholera caused by 
Pasteurella multocida susceptible to sulfamerazine, sulfamethazine, and 
sulfaquinoxaline: provide medicated water (0.4 percent solution) for 2 
to 3 days. If disease recurs, repeat treatment.
    (ii) Limitations. Make fresh solution daily. Do not treat turkeys 
within 14 days of slaughter for food. Do not medicate turkeys producing 
eggs for human consumption.

[71 FR 13001, Mar. 14, 2006]



Sec. 520.2220  Sulfadimethoxine oral dosage forms.



Sec. 520.2220a  Sulfadimethoxine oral solution and soluble powder.

    (a) Approvals. (1) For oral solution containing 12.5 percent (3.75 
grams per ounce) sulfadimethoxine, see Nos. 000010, 000069, 054925, 
057561, and 059130 in Sec. 510.600(c).
    (2) For soluble powder, each 107 grams contain the equivalent of 
94.6 grams of sulfadimethoxine (as the sodium salt); see Nos. 000069, 
054925, 057561, 059130, and 061623 in Sec. 510.600(c) of this chapter.
    (b) Special considerations. Federal law prohibits the extralabel use 
of this product in lactating dairy cattle.
    (c) Related tolerances. See Sec. 556.640 of this chapter.
    (d) Conditions of use. The oral solution is administered as a cattle 
drench or diluted as directed to prepare drinking water. The powder is 
used to prepare a drench or drinking water. The concentrations and uses 
of the various solutions are as follows:
    (1) Broiler and replacement chickens only--(i) Amount. 1.875 (0.05 
percent) grams per gallon.
    (ii) Indications for use. Treatment of disease outbreaks of 
coccidiosis, fowl cholera, and infectious coryza.
    (iii) Limitations. Administer for 6 consecutive days; do not 
administer to chickens over 16 weeks of age; as sole source of drinking 
water and sulfonamide medication; as sulfadimethoxine solution or 
sulfadimethoxine soluble sodium salt; withdraw 5 days before slaughter.
    (2) Meat-producing turkeys only--(i) Amount. 0.938 (0.025 percent) 
grams per gallon.

[[Page 219]]

    (ii) Indications for use. Treatment of disease outbreaks of 
coccidiosis and fowl cholera.
    (iii) Limitations. Administer for 6 consecutive days; do not 
administer to turkeys over 24 weeks of age; as sole source of drinking 
water and sulfonamide medication; as sulfadimethoxine solution or 
sulfadimethoxine soluble sodium salt; withdraw 5 days before slaughter.
    (3) Dairy calves, dairy heifers, and beef cattle only--(i) Amount. 
1.18 to 2.36 (0.031 to 0.062 percent) grams per gallon.
    (ii) Indications for use. Treatment of shipping fever complex, 
bacterial pneumonia, calf diphtheria, and foot rot.
    (iii) Administer 2.5 grams per 100 pounds of body weight for first 
day, then 1.25 grams per 100 pounds of body weight per day for the next 
4 consecutive days; in drinking water or drench; available as a 
sulfadimethoxine soluble powder or a 12.5 percent sulfadimethoxine 
sodium solution (3.75 grams sulfadimethoxine per fluid ounce); if no 
improvement within 2 to 3 days, reevaluate diagnosis; do not treat 
beyond 5 days; withdraw 7 days before slaughter. A withdrawal period has 
not been established for this product in preruminating calves. Do not 
use in calves to be processed for veal.

[40 FR 13838, Mar. 27, 1975, as amended at 58 FR 6092, Jan. 26, 1993; 59 
FR 56000, Nov. 10, 1994; 61 FR 4875, Feb. 9, 1996; 62 FR 8371, Feb. 25, 
1997; 62 FR 23357, Apr. 30, 1997; 62 FR 35076, June 30, 1997; 62 FR 
40932, July 31, 1997; 63 FR 59714, Nov. 5, 1998; 64 FR 18572, Apr. 15, 
1999; 70 FR 73137, Dec. 9, 2005; 71 FR 13542, Mar. 16, 2006]



Sec. 520.2220b  Sulfadimethoxine tablets and boluses.

    (a) Sponsors. Approval to firms identified in Sec. 510.600(c) of 
this chapter as follows:
    (1) To 000069, approval for use as in paragraphs (d)(1), (d)(2), and 
(d)(3) of this section.
    (2) To 000061, approval for use as in paragraph (d)(2).
    (b) Related tolerances. See Sec. 556.640 of this chapter.
    (c) [Reserved]
    (d) It is used as follows:
    (1) Cattle--(i) Amount. 1.25 to 2.5 grams per 100 pounds body 
weight.
    (ii) Indications for use. Treatment of foot rot, bacterial 
pneumonia, shipping fever, and calf diphtheria.
    (iii) Limitations. Administer 2.5 grams per 100 pounds body weight 
for 1 day followed by 1.25 grams per 100 pounds body weight per day; 
treat from 4 to 5 days; do not administer within 7 days of slaughter; 
milk that has been taken from animals during treatment and 60 hours (5 
milkings) after the latest treatment must not be used for food. A 
withdrawal period has not been established for this product in 
preruminating calves. Do not use in calves to be processed for veal.
    (2) Dogs and cats. (i) Amount. 12.5 to 25 milligrams per pound of 
body weight.
    (ii) Indications for use. Treatment of sulfadimethoxine-susceptible 
bacterial infections.
    (iii) Limitations. Administer 25 milligrams per pound of body weight 
on the first day followed by 12.5 milligrams per pound of body weight 
per day until the animal is free of symptoms for 48 hours. Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.
    (3) Beef cattle and nonlactating dairy cattle--(i) Amount. 12.5-
gram-sustained-release bolus.
    (ii) Indications for use. Treatment of shipping fever complex and 
bacterial pneumonia associated with organisms such as Pasteurella spp. 
sensitive to sulfadimethoxine; calf diphtheria and foot rot associated 
with Sphaerophorus necrophorus sensitive to sulfadimethoxine.
    (iii) Limitations. Administer one bolus for the nearest 200 pounds 
of body weight, i.e., 62.5 milligrams per pound of body weight. Do not 
repeat treatment for 7 days. Do not use in lactating dairy cattle. Do 
not administer within 12 days of slaughter. During treatment make 
certain that animals maintain adequate water intake. Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.

[40 FR 13838, Mar. 27, 1975, as amended at 40 FR 43488, Sept. 22, 1975; 
49 FR 36830, Sept. 20, 1984; 59 FR 56000, Nov. 10, 1994; 61 FR 4875, 
Feb. 9, 1996; 62 FR 61625, Nov. 19, 1997; 64 FR 15684, Apr. 1, 1999; 70 
FR 16934, Apr. 4, 2005]

[[Page 220]]



Sec. 520.2220c  Sulfadimethoxine oral suspension.

    (a) Chemical name. N'-(2,6-Dimethoxy-4-pyrimidinyl) sulfanilamide.
    (b) Specifications. Each milliliter of the drug contains 50 
milligrams of sulfadimethoxine.
    (c) Sponsor. See Nos. 000061 and 000069 in Sec. 510.600(c) of this 
chapter.
    (1) It is intended for use in the treatment of sulfonamide 
susceptible bacterial infections in dogs and cats and enteritis 
associated with coccidiosis in dogs.
    (2) On the first day of treatment administer an oral dose of 25 
milligrams per pound of body weight, then follow with a daily dosage of 
12.5 milligrams per pound of body weight. Length of treatment will 
depend upon clinical response. Continue treatment until patient is 
asymptomatic for 48 hours. Maintain adequate water intake during the 
treatment period.
    (3) For use only by or on the order of a licensed veterinarian.

[40 FR 13838, Mar. 27, 1975, as amended at 59 FR 56000, Nov. 10, 1994; 
61 FR 4875, Feb. 9, 1996; 62 FR 61625, Nov. 19, 1997]



Sec. 520.2220d  Sulfadimethoxine-ormetoprim tablets.

    (a) Specifications. Each tablet contains 120 milligrams (100 
milligrams of sulfadimethoxine and 20 milligrams of ormetoprim), 240 
milligrams (200 milligrams of sulfadimethoxine and 40 milligrams of 
ormetoprim), 600 milligrams (500 milligrams of sulfadimethoxine and 100 
milligrams of ormetoprim), or 1200 milligrams (1,000 milligrams of 
sulfadimethoxine and 200 milligrams of ormetoprim).
    (b) Sponsor. See No. 000069 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. On the first day of treatment, 
administer 25 milligrams per pound (55 milligrams per kilogram) of body 
weight. Then follow with a daily dosage of 12.5 milligrams per pound 
(27.5 milligrams per kilogram) of body weight.
    (2) Indications of use. Treatment of skin and soft tissue infections 
(wounds and abscesses) in dogs caused by strains of Staphylococcus 
aureus and Escherichia coli and urinary tract infections caused by 
Escherichia coli, Staphlococcus spp., and Proteus mirabilus susceptible 
to ormetoprim-potentiated sulfadimethoxine.
    (3) Limitations. Continue treatment until patient is asymptomatic 
for 48 hours, but do not exceed a total of 21 consecutive days. Maintain 
adequate water intake during the treatment period. Safety in breeding 
animals has not been established. Federal law restricts this drug to use 
by or on the order of a licensed veterinarian.

[54 FR 48593, Nov. 24, 1989, as amended at 59 FR 56000, Nov. 10, 1994; 
61 FR 4875, Feb. 9, 1996; 61 FR 46719, Sept. 5, 1996]



Sec. 520.2240  Sulfaethoxypyridazine.



Sec. 520.2240a  Sulfaethoxypyridazine drinking water.

    (a) Chemical name. N'-(6-Ethoxy-3-pyridazinyl) sulfanilamide.
    (b) Specifications. Melting point range of 180 [deg]C. to 186 
[deg]C.
    (c) Sponsor. See No. 053501 in Sec. 510.600(c) of this chapter.
    (d) Related tolerances. See Sec. 556.650 of this chapter.
    (e) Conditions of use. It is used as follows:
    (1) Swine--(i) Amount. 1.9 to 3.8 grams per gallon (0.05 percent to 
0.1 percent).
    (ii) Indications for use. Treatment of bacterial scours pneumonia 
enteritis, bronchitis, septicemia accompanying Salmonella cholerasuis 
infection.
    (iii) Limitations. Administer 3.8 grams per gallon for first day 
followed by 1.9 grams per gallon for not less than 3 days nor more than 
9 days as sodium sulfaethoxypyridazine; do not treat within 10 days of 
slaughter; as sole source of sulfonamide; for use by or on the order of 
a licensed veterinarian.
    (2) Cattle--(i) Amount. 2.5 grams per gallon (0.066 percent).
    (ii) Indications for use. Treatment of respiratory infections 
(pneumonia, shipping fever), foot rot, calf scours; as adjunctive 
therapy in septicemia accompanying mastitis and metritis.
    (iii) Limitations. Administer at the rate of 1 gallon per 100 pounds 
of body weight per day for 4 days; as sodium sulfaethoxypyridazine; do 
not treat within 16 days of slaughter; as sole source of sulfonamide; 
for use by or on the order of a licensed veterinarian; milk that has 
been taken from animals during treatment and for 72 hours (6

[[Page 221]]

milkings) after latest treatment must not be used for food.

[40 FR 13838, Mar. 27, 1975, as amended at 67 FR 78355, Dec. 24, 2002]



Sec. 520.2240b  Sulfaethoxypyridazine tablets.

    (a) Chemical name. N'-(6-Ethoxy-3-pyridazinyl) sulfanilamide.
    (b) Specifications. Melting point range of 180 [deg]C to 186 [deg]C.
    (c) Sponsor. See No. 053501 in Sec. 510.600(c) of this chapter.
    (d) Related tolerances. See Sec. 556.650 of this chapter.
    (e) Conditions of use. It is used for cattle as follows:
    (1) Amount. 2.5 or 15 grams per tablet.
    (i) Indications for use. Treatment of respiratory infections 
(pneumonia, shipping fever), foot rot, calf scours; as adjunctive 
therapy in septicemia accompanying mastitis and metritis.
    (ii) Limitations. Administer 25 milligrams per pound of animal 
weight per day for 4 days; do not treat within 16 days of slaughter; as 
sole source of sulfonamide; milk that has been taken from animals during 
treatment and for 72 hours (6 milkings) after the latest treatment must 
not be used for food; for use only by or on the order of a licensed 
veterinarian.
    (2) Amount. 15-gram controlled release tablets.
    (i) Indications for use. Treatment of foot rot and respiratory 
infections (shipping fever and pneumonia) caused by sulfonamide-
susceptible pathogens (E. coli, streptococci, staphylococci, 
Sphaerophorus necrophorus and Gram-negative rods including Pasteurella); 
for use prophylactically in cattle during periods of stress for reducing 
losses due to sulfonamide sensitive disease conditions.
    (ii) Limitations. Administer 100 milligrams per pound of body 
weight; do not treat within 16 days of slaughter; as sole source of 
sulfonamide; not for use in lactating dairy cows; Federal law restricts 
this drug to use by or on the order of a licensed veterinarian.

[40 FR 13838, Mar. 27, 1975, as amended at 67 FR 78355, Dec. 24, 2002]



Sec. 520.2260  Sulfamethazine oral dosage forms.



Sec. 520.2260a  Sulfamethazine oblet, tablet, and bolus.

    (a)(1) Sponsor. See No. 053501 in Sec. 510.600(c) of this chapter 
for use of 2.5-, 5-, and 15-gram sulfamethazine oblet in beef cattle, 
nonlactating dairy cattle, and horses. See No. 061690 in Sec. 
510.600(c) of this chapter for use of 5-, 15-, and 25-gram tablet in 
beef and nonlactating dairy cattle.
    (2) Related tolerance in edible products. See Sec. 556.670 of this 
chapter.
    (3) Conditions of use--(i) Amount. Administer as a single dose 100 
milligrams of sulfamethazine per pound of body weight the first day and 
50 milligrams per pound of body weight on each following day.
    (ii) Indications for use. For treatment of diseases caused by 
organisms susceptible to sulfamethazine.
    (A) Beef cattle and nonlactating dairy cattle. Treatment of 
bacterial pneumonia and bovine respiratory disease complex (shipping 
fever complex) (Pasteurella spp.), colibacillosis (bacterial scours) 
(Escherichia coli), necrotic pododermatitis (foot rot) (Fusobacterium 
necrophorum), calf diphtheria (Fusobacterium necrophorum), acute 
mastitis (Streptococcus spp.), acute metritis (Streptococcus spp.), 
coccidiosis (Eimeria bovis and Eimeria zurnii).
    (B) Horses. Treatment of bacterial pneumonia (secondary infections 
associated with Pasteurella spp.), strangles (Streptococcus equi), and 
bacterial enteritis (Escherichia coli).
    (iii) Limitations. Administer daily until animal's temperature and 
appearance are normal. If symptoms persist after using for 2 or 3 days 
consult a veterinarian. Fluid intake must be adequate. Treatment should 
continue 24 to 48 hours beyond the remission of disease symptoms, but 
not to exceed 5 consecutive days. Follow dosages carefully. Not for use 
in lactating dairy animals. Do not treat cattle within 10 days of 
slaughter. Not to be used in horses intended for food.
    (b)(1) Sponsor. See No. 053501 in Sec. 510.600(c) of this chapter 
for use of 5-gram sulfamethazine bolus.

[[Page 222]]

    (2) Related tolerances in edible products. See Sec. 556.670 of this 
chapter.
    (3) Conditions of use--(i) Amount. Administer 10 grams (2 boluses) 
of sulfamethazine per 100 pounds of body weight the first day, then 5 
grams (1 bolus) of sulfamethazine per 100 pounds of body weight daily 
for up to 4 additional consecutive days.
    (ii) Indications for use. Ruminating beef and dairy calves. For 
treatment of the following diseases caused by organisms susceptible to 
sulfamethazine: bacterial scours (colibacilloosis) caused by E. coli; 
necrotic pododermatitis (foot rot) and calf diphtheria caused by F. 
necrophorum; bacterial pneumonia associated with Pasteurella spp.; and 
coccidiosis caused by E. bovis and E. zurnii.
    (iii) Limitations. Do not administer for more than 5 consecutive 
days. Do not treat calves within 11 days of slaughter. Do not use in 
calves to be slaughtered under 1 month of age or in calves being fed an 
all milk diet. Do not use in female dairy cattle 20 months of age or 
older; such use may cause drug residues in milk. Administer with 
adequate supervision. Follows recomended dosages carefully. Fluid intake 
must be adequate. If symptoms persist after 2 or 3 days, consult a 
veterinarian.

[54 FR 15751, Apr. 19, 1989; 54 FR 19283, May 4, 1989, as amended at 56 
FR 50653, Oct. 8, 1991; 59 FR 22754, May 3, 1994; 61 FR 4875, Feb. 9, 
1996; 64 FR 66383, Nov. 26, 1999; 67 FR 78355, Dec. 24, 2002]



Sec. 520.2260b  Sulfamethazine sustained-release boluses.

    (a)(1) Sponsor. See No. 000859 in Sec. 510.600(c) of this chapter 
for use of a 22.5-gram sulfamethazine prolonged-release bolus.
    (2) Conditions of use--(i) Amount. Depending on the duration of 
therapeutic levels desired, administer boluses as a single dose as 
follows: 3\1/2\ days--1 bolus (22.5 grams) per 200 pounds of body 
weight; 5 days--1 bolus per 100 pounds of body weight.
    (ii) Indications for use. Beef and nonlactating cattle for sustained 
treatment of shipping fever pneumonia caused or complicated by 
Pasteurella multocida; as an aid in the treatment of foot rot, mastitis, 
pneumonia, metritis, bacterial enteritis, calf diphtheria, and 
septicemia when caused or complicated by bacteria susceptible to 
sulfamethazine.
    (iii) Limitations. Cattle that are acutely ill should be treated 
parenterally with a suitable antibacterial product to obtain immediate 
therapeutic blood levels; do not slaughter animals for food within 16 
days of treatment; do not use in lactating dairy cattle; Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.
    (b)(1) Sponsor. See No. 053501 in Sec. 510.600(c) of this chapter 
for use of a 27-gram sulfamethazine sustained-release bolus.
    (2) Conditions of use--(i) Amount. 27 grams (1 bolus) for each 150 
pounds of body weight as a single dose.
    (ii) Indications for use. For nonlactating cattle for the treatment 
of infections caused by organisms sensitive to sulfamethazine such as 
hemorrhagic septicemia (shipping fever complex), bacterial pneumonia, 
foot rot, and calf diphtheria and as an aid in the control of bacterial 
diseases usually associated with shipping and handling of cattle.
    (iii) Limitations. If no response within 2 to 3 days, reevaluate 
therapy; do not crush tablets; treated animals must not be slaughtered 
for food within 28 days after the latest treatment; Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.
    (c)(1) Sponsor. See No. 061623 in Sec. 510.600(c) of this chapter 
for use of a 32.1-gram sustained-release bolus.
    (2) Conditions of use--(i) Amount. 32.1 grams (1 bolus) per 200 
pounds of body weight.\1\
---------------------------------------------------------------------------

    \1\ These conditions are NAS/NRC reviewed and found effective. 
Applications for these uses need not inlcude effectiveness data as 
specified by Sec. 514.111 of this chapter, but may require 
bioequivalency and safety information.
---------------------------------------------------------------------------

    (ii) Indications for use. For beef and nonlactating dairy cattle for 
the treatment of diseases caused by sulfamethazine-sensitive organisms 
as follows: bacterial pneumonia and bovine respiratory disease complex 
(shipping fever complex) caused by Pasteurella spp., colibacillosis 
(bacterial scours) caused by E. coli, necrotic pododermatitis (foot rot) 
and calf diphtheria caused by Fusobacterium

[[Page 223]]

necrophorum, and acute mastitis and acute metritis caused by 
Streptococcus spp.)\1\
    (iii) Limitations. After 72 hours, all animals should be reexamined 
for persistence of observable disease signs. If signs are present, 
consult a veterinarian. It is strongly recommended that a second dose be 
given to provide for an additional 72 hours of therapy, particularly in 
more severe cases. The dosage schedule should be used at each 72-hour 
interval. Animals should not receive more than 2 doses because of the 
possibility of incurring residue violations. This drug, like all 
sulfonamides, may cause toxic reactions and irreparable injury unless 
administered with adequate and continuous supervision; follow dosages 
carefully. Fluid intake must be adequate at all times throughout the 3-
day therapy, Do not use in lactating dairy cattle. Do not treat animals 
within 12 days of slaughter.
    (d)(1) Sponsor. See 000859 in Sec. 510.600(c) of this chapter for 
use of a 22.5-gram sulfamethazine sustained release bolus.
    (2) Conditions of use--(i) Amount. Administer 1 bolus (22.5 grams) 
per 200 pounds of body weight, as a single dose.
    (ii) Indications for use. Beef and nonlactating dairy cattle for the 
prolonged treatment of the following diseases when caused by one or more 
of the listed pathogenic organisms sensitive to sulfamethazine: bovine 
respiratory disease complex (shipping fever complex) (Pasteurella spp.), 
bacterial pneumonia (Pasteurella spp.), necrotic pododermatitis (foot 
rot) (Fusobacterium necrophorum), colibacillosis (bacterial scours) 
(Escherichia coli), calf diphtheria (Fusobacterium necrophorum), acute 
mastitis (Streptococcus spp.) and acute metritis (Streptococcus spp.).
    (iii) Limitations. Cattle that are acutely ill should be treated by 
injection with a suitable antibacterial product to obtain immediate 
therapeutic blood levels; do not slaughter animals for food within 16 
days of treatment; do not use in lactating diary cattle; if treated 
animals do not respond within 2 to 3 days, consult a veterinarian.
    (e)(1) Sponsor. See No. 061623 in Sec. 510.600(c) of this chapter 
for use of an 8.02-gram sulfamethazine sustained-release bolus.
    (2) Conditions of use--(i) Amount. Administer 2 boluses (8.02 grams 
per bolus) per 100 pounds of body weight, as a single dose.
    (ii) Indications for use. Administer orally to ruminating calves for 
the prolonged treatment of the following diseases when caused by one or 
more of the listed pathogenic organisms sensitive to sulfamethazine: 
bacterial pneumonia (Pasteurella spp.), colibacillosis (bacterial 
scours) (E. coli), and calf diptheria (Fusobacterium necrophorum).
    (iii) Limitations. For use in ruminating replacement calves only; 72 
hours after dosing all animals should be reexamined for persistence of 
disease signs; if signs are present, consult a veterinarian; do not 
slaughter animals for food for at least 12 days after the last dose; 
this product has not been shown to be effective for nonruminating 
calves; exceeding two consecutive doses may cause violative tissue 
residue to remain beyond the withdrawal time; do not use in calves under 
1 month of age or calves being fed an all milk diet.
    (f)(1) Sponsor. See No. 059130 in Sec. 510.600(c) of this chapter 
for use of a 30-gram sulfamethazine sustained-release bolus.
    (2) Conditions of use--(i) Amount. Administer at the rate of 1 bolus 
(30 grams per bolus) per 200 pounds of body weight, as a single dose.
    (ii) Indications for use. Administer orally to beef cattle and 
nonlactating dairy cattle for the treatment of the following diseases 
when caused by one or more of the listed pathogenic organisms sensitive 
to sulfamethazine: bovine respiratory disease complex (shipping fever 
complex) associated with Pasteurella spp.; bacterial pneumonia 
associated with Pasteurell spp.; necrotic pododermatitis (foot rot) and 
calf diphtheria caused by Fusobacterium necrophorum; colibacillosis 
(bacterial scours) caused by Escherichia coli; coccidiosis caused by 
Eimeria bovis and E. zurnii; acute mastitis and metritis caused by 
Streptococcus spp.
    (iii) Limitations. For use in beef cattle and nonlactating dairy 
cattle only; if symptoms persist for 2 or 3 days after

[[Page 224]]

use, consult a veterinarian; do not slaughter animals for food for at 
least 8 days after the last dose; do not use in lactating dairy cattle; 
do not administer more than two consecutive doses.
    (g) Related tolerances. See Sec. 556.670 of this chapter.
    (h)(1) Sponsor. See No. 000010 in Sec. 510.600(c) of this chapter 
for use of an 8.25-gram sulfamethazine sustained-release bolus.
    (2) Conditions of use--(i) Amount. Administer at the rate of 1 bolus 
(8.25 grams per bolus) per 50 pounds of body weight, as a single dose. 
If signs of disease are significantly reduced, it is recommended that a 
second dose be given to provide an additional 72 hours of therapy.
    (ii) Indications for use. Administer orally to ruminating beef and 
dairy calves for treatment of the following diseases when caused by one 
or more of the listed pathogenic organisms susceptible to 
sulfamethazine: bacterial pneumonia associated with Pasteurella spp.; 
colibacillosis (bacterial scours) caused by Escherichia coli; 
coccidiosis caused by Eimeria bovis and E. zurnii; and calf diphtheria 
caused by Fusobacterium necrophorum.
    (iii) Limitations. Do not use in calves to be slaughtered under 1 
month of age or calves being fed an all milk diet. Do not use in female 
dairy cattle 20 months of age or older. If symptoms persist after 3 
days, consult a veterinarian. Do not administer more than 2 consecutive 
doses. Do not slaughter animals for food for at least 8 days after the 
last dose. Do not crush bolus.

[46 FR 36132, July 14, 1981, as amended at 48 FR 18803, Apr. 26, 1983; 
48 FR 32760, July 19, 1983; 49 FR 29057, July 18, 1984; 50 FR 49372, 
Dec. 2, 1985; 51 FR 30212, Aug. 25, 1986; 53 FR 40727, Oct. 18, 1988; 54 
FR 14341, Apr. 11, 1989; 55 FR 8462, Mar. 8, 1990; 56 FR 50653, Oct. 8, 
1991; 59 FR 22754, May 3, 1994; 61 FR 4875, Feb. 9, 1996; 62 FR 35076, 
June 30, 1997; 66 FR 14073, Mar. 9, 2001; 68 FR 4915, Jan. 31, 2003; 70 
FR 8290, Feb. 18, 2005]



Sec. 520.2260c  Sulfamethazine sustained-release tablets.

    (a) Sponsor. See No. 053501 in Sec. 510.600(c) of this chapter for 
use of an 8-gram sulfamethazine sustained-release tablet.
    (b) Conditions of use--(1) Amount. 8 grams (1 tablet) per 45 pounds 
of body weight as a single dose.
    (2) Indications for use. In calves for sustained treatment of 
pneumonia caused by Pasteurella spp., colibacillosis (bacterial scours) 
caused by Escherichia coli; and calf diptheria caused by Fusobacterium 
necrophorum.
    (3) Limitations. If there is no response within 2 to 3 days, 
reevaluate therapy. Do not crush tablets. Treated animals must not be 
slaughtered for food within 18 days after the latest treatment. Federal 
law restricts this drug to use by or on the order of a licensed 
veterinarian.

[48 FR 26763, June 10, 1983, as amended at 56 FR 50653, Oct. 8, 1991; 59 
FR 22754, May 3, 1994; 61 FR 4875, Feb. 9, 1996]



Sec. 520.2261  Sulfamethazine sodium oral dosage forms.



Sec. 520.2261a  Sulfamethazine sodium drinking water solution.

    (a) Sponsors. See Nos. 051311 and 053501 in Sec. 510.600(c) of this 
chapter for use of a 12.5-percent sulfamethazine sodium solution.
    (b) Related tolerances in edible products. See Sec. 556.670 of this 
chapter.
    (c) Conditions of use--(1) Amount. Administer in drinking water to 
provide: Cattle and swine 112.5 milligrams of sulfamethazine sodium per 
pound of body weight per day on the first day and 56.25 milligrams per 
pound of body weight on subsequent days; Chickens, 61 to 89 milligrams 
of sulfamethazine sodium per pound of body weight per day, and turkeys 
53 to 130 milligrams of sulfamethazine sodium per pound of body weight 
per day, depending upon the dosage, age, and class of chickens or 
turkeys, ambient temperature, and other factors.
    (2) Indications for use. For treatment and control of diseases 
caused by organisms sensitive to sulfamethazine.
    (i) Beef and nonlactating dairy cattle. Treatment of bacterial 
pneumonia and bovine respiratory disease complex (shipping fever 
complex) (Pasteurella spp.), colibacillosis (bacterial scours) 
(Escherichia coli), necrotic pododermatitis (foot rot) (Fusobacterium 
necrophorum), calf diphtheria (Fusobacterium necrophorum),

[[Page 225]]

acute mastitis (Streptococcus spp.), and acute metritis (Streptococcus 
spp.).
    (ii) Swine. Treatment of porcine colibacillosis (bacterial scours) 
(Escherichia coli), and bacterial pneumonia (Pasteurella spp.).
    (iii) Chickens and turkeys. In chickens for control of infectious 
coryza (Haemophilus gallinarum), coccidiosis (Eimeria tenella, Eimeria 
necatrix), acute fowl cholera (Pasteurella multocida), and pullorum 
disease (Salmonella pullorum). In turkeys for control of coccidiosis 
(Eimeria meleagrimitis, Eimeria adenoeides). Medicate as follows: 
Infectious coryza in chickens, medicate for 2 consecutive days; acute 
fowl cholera and pullorum disease, in chickens, medicate for 6 
consecutive days; coccidiosis, in chickens and turkeys, medicate as in 
paragraph (c) of this section, then reduce amount of medication to one-
half for 4 additional days.
    (3) Limitations. Add the required dose to that amount of water that 
will be consumed in 1 day. Consumption should be carefully checked. Have 
only medicated water available during treatment. Withdraw medication 
from cattle, chickens, and turkeys 10 days prior to slaughter for food. 
Withdraw medication from swine 15 days before slaughter for food. Not 
for use in lactating dairy cattle. Do not medicate chickens or turkeys 
producing eggs for human consumption. Treatment of all diseases should 
be instituted early. Treatment should continue 24 to 48 hours beyond the 
remission of disease symptoms, but not to exceed a total of 5 
consecutive days in cattle or swine. Medicated cattle, swine, chickens, 
and turkeys must actually consume enough medicated water which provides 
the recommended dosages.
    (d) NAS/NRC status. The conditions of use specified in this section 
have been reviewed by NAS/NRC and are found effective. Applications for 
these uses need not include effectiveness data as specified by Sec. 
514.111 of this chapter, but may require bioequivalency and safety 
information.

[47 FR 25322, June 11, 1982, as amended at 47 FR 25735, June 15, 1982; 
67 FR 78355, Dec. 24, 2002; 70 FR 32489, June 3, 2005]



Sec. 520.2261b  Sulfamethazine powder.

    (a) Specifications. A soluble powder composed of 100 percent 
sulfamethazine sodium.
    (b) Sponsors. See Nos. 053501 and 061623 in Sec. 510.600(c) of this 
chapter.
    (c) Related tolerances. See Sec. 556.670 of this chapter.
    (d) Conditions of use--(1) Chickens--(i) Amount. Administer in 
drinking water to provide 58 to 85 milligrams (mg) per pound (/lb) of 
body weight per day.
    (ii) Indications for use. For control of infectious coryza 
(Haemophilus gallinarum), coccidiosis (Eimeria tenella, E. necatrix), 
acute fowl cholera (Pasteurella multocida), and pullorum disease 
(Salmonella pullorum).
    (iii) Limitations. Add the required dose to that amount of water 
that will be consumed in 1 day. Consumption should be carefully checked. 
Have only medicated water available during treatment. Withdraw 
medication 10 days prior to slaughter for food. Do not medicate chickens 
producing eggs for human consumption. Treatment of all diseases should 
be instituted early. Treatment should continue 24 to 48 hours beyond the 
remission of disease symptoms. Medicated chickens must actually consume 
enough medicated water which provides the recommended dosages.
    (2) Turkeys--(i) Amount. Administer in drinking water to provide 50 
to 124 mg/lb of body weight per day
    (ii) Indications for use. For control of coccidiosis (E. 
meleagrimitis, E. adenoeides).
    (iii) Limitations. Add the required dose to that amount of water 
that will be consumed in 1 day. Consumption should be carefully checked. 
Have only medicated water available during treatment. Withdraw 
medication 10 days prior to slaughter for food. Do not medicate turkeys 
producing eggs for human consumption. Treatment of all diseases should 
be instituted early. Treatment should continue 24 to 48 hours beyond the 
remission of disease symptoms. Medicated turkeys must actually consume 
enough medicated water which provides the recommended dosages.
    (3) Swine--(i) Amount. Administer in drinking water, or as a drench, 
to provide 108 mg/lb of body weight on the

[[Page 226]]

first day and 54 mg/lb of body weight per day on the second, third, and 
fourth days of administration.
    (ii) Indications for use. For treatment of porcine colibacillosis 
(bacterial scours) (E. coli), and bacterial pneumonia (Pasteurella 
spp.).
    (iii) Limitations. Add the required dose to that amount of water 
that will be consumed in 1 day. Consumption should be carefully checked. 
Have only medicated water available during treatment. Withdraw 
medication 15 days prior to slaughter for food. Treatment of all 
diseases should be instituted early. Treatment should continue 24 to 48 
hours beyond the remission of disease symptoms, but not to exceed a 
total of 5 consecutive days. Medicated swine must actually consume 
enough medicated water which provides the recommended dosages.
    (4) Cattle--(i) Amount. Administer in drinking water, or as a 
drench, to provide 108 mg/lb of body weight on the first day and 54 mg/
lb of body weight per day on the second, third, and fourth days of 
administration.
    (ii) Indications for use in beef and nonlactating dairy cattle. 
Treatment of bacterial pneumonia and bovine respiratory disease complex 
(shipping fever complex) (Pasteurella spp.), colibacillosis (bacterial 
scours) (E. coli), necrotic pododermatitis (foot rot) (Fusobacterium 
necrophorum), calf diphtheria (F. necrophorum), acute mastitis 
(Streptococcus spp.), and acute metritis (Streptococcus spp.)
    (iii) Limitations. Add the required dose to that amount of water 
that will be consumed in 1 day. Consumption should be carefully checked. 
Have only medicated water available during treatment. Withdraw 
medication 10 days prior to slaughter for food. Treatment of all 
diseases should be instituted early. Treatment should continue 24 to 48 
hours beyond the remission of disease symptoms, but not to exceed a 
total of 5 consecutive days. Medicated cattle must actually consume 
enough medicated water which provides the recommended dosages.

[71 FR 70303, Dec. 4, 2006]



Sec. 520.2280  Sulfamethizole and methenamine mandelate tablets.

    (a) Specifications. Each tablet contains 250 milligrams of 
sulfamethizole and 250 milligrams of methenamine mandelate.
    (b) Sponsor. See No. 000856 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use. (1) The drug is indicated for the treatment 
of urinary tract infections in dogs and cats such as cystitis, 
nephritis, prostatitis, urethritis, and pyelonephritis. It is also used 
as an aid in the management of complications resulting from surgical 
manipulations of the urinary tract such as removal of calculi from the 
bladder, in ureterostomies, and in instrumentation of the urethra and 
bladder.
    (2) It is administered at a dosage level of one tablet for each 20 
pounds of body weight given three times per day. The drug should be 
given until all signs are alleviated. To reduce the possibility of a 
relapse, it is suggested that therapy be continued for a further period 
of a week to 10 days.
    (3) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.

[40 FR 13838, Mar. 27, 1975, as amended at 50 FR 13561, Apr. 5, 1985]



Sec. 520.2320  Sulfanitran and aklomide in combination.

    (a) Chemical names. (1) Sulfanitran: Acetyl-(p-nitrophenyl)-
sulfanilamide.
    (2) Aklomide: 2-Chloro-4-nitrobenzamide.
    (b) Specifications. (1) Sulfanitran conforms to the following 
specifications:
    (i) Melting point range: 260 [deg]C. to 261 [deg]C.
    (ii) Assay (by sodium nitrite titration): 97 to 100.5 percent.
    (iii) Moisture (Method No. 6.123, ``Toluene Distillation Method--
Official Final Action'' in ``Official Methods of Analysis of the 
Association of Official Analytical Chemists,'' 13th Ed., 1980, p. 83. 
Copies are available from the AOAC INTERNATIONAL, 481 North Frederick 
Ave., suite 500, Gaithersburg, MD 20877, or at the National Archives and 
Records Administration (NARA). For information on the availability of 
this material at NARA, call 202-741-6030, or go to: http://
www.archives.gov/

[[Page 227]]

federal--register/code--of--federal--regulations/ibr--locations.html. : 
Not more than 2.0 percent.
    (iv) Molecular weight: 335.34.
    (v) Soluble in 0.1N sodium hydroxide, reprecipitating unchanged on 
acidification.
    (2) Aklomide conforms to the following specifications:
    (i) Minimum melting point: 170 [deg]C.
    (ii) Moisture content: Not to exceed 1.0 percent.
    (iii) Purity: Not less than 98 percent on an anhydrous basis.
    (c) Sponsor. See No. 053501 in Sec. 510.600(c) of this chapter.
    (d) Related tolerances. See Sec. Sec. 556.30 and 556.680 of this 
chapter.
    (e) Conditions of use. It is used in the drinking water of chickens 
as follows:
    (1) Amount. 374-747 milligrams of sulfanitran with 477-954 
milligrams of aklomide.
    (2) Indications for use. As an aid in the treatment of coccidiosis 
caused by E. tenella, E. necatrix, and E. acervulina.
    (3) Limitations. Administer for 2 days at 747 milligrams of 
sulfanitran per gallon and 954 milligrams of aklomide per gallon, 
followed by 5 days at 374 milligrams of sulfanitran per gallon and 477 
milligrams of aklomide per gallon; do not treat birds over 6 weeks of 
age; do not administer within 5 days of slaughter; not for laying 
chickens.

[40 FR 13838, Mar. 27, 1975, as amended at 47 FR 9396, Mar. 5, 1982; 54 
FR 18280, Apr. 28, 1989; 55 FR 8460, Mar. 8, 1990; 70 FR 40880, July 15, 
2005; 70 FR 67651, Nov. 8, 2005]



Sec. 520.2325  Sulfaquinoxaline oral dosage forms.



Sec. 520.2325a  Sulfaquinoxaline drinking water.

    (a) Sponsor. See Sec. 510.600(c) of this chapter for identification 
of the sponsors.
    (1) To No. 059130 for use of a 25-percent sulfaquinoxaline soluble 
powder and a 20-percent sulfaquinoxaline sodium solution as provided for 
in paragraph (c) of this section.
    (2) To No. 051311 for use of 3.44- and 12.85-percent 
sulfaquinoxaline sodium solutions as provided for in paragraphs (c)(1), 
(c)(2), (c)(3), (c)(4)(i), and (c)(4)(ii) of this section.
    (3) To No. 046573 for use of a 31.92-percent sulfaquinoxaline 
solution (sodium and potassium salts) as provided for in paragraphs 
(c)(1), (c)(2), (c)(3), (c)(4)(i), and (c)(4)(ii) of this section.
    (4) No. 053501 for use of a 28.62-percent sulfaquinoxaline sodium 
solution as provided in paragraphs (c)(1), (c)(2), and (c)(3) of this 
section.
    (b) Related tolerances. See Sec. 556.685 of this chapter.
    (c) Conditions of use. It is used in drinking water as follows:
    (1) Chickens. (i) As an aid in the control of outbreaks of 
coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. 
maxima, and E. brunetti.
    (ii) Administer at the 0.04 percent level for 2 or 3 days, skip 3 
days then administer at the 0.025 percent level for 2 more days. If 
bloody droppings appear, repeat treatment at the 0.025 percent level for 
2 more days. Do not change litter unless absolutely necessary. Do not 
give flushing mashes.
    (2) Turkeys. (i) As an aid in the control of outbreaks of 
coccidiosis caused by Eimeria meleagrimitis and E. adenoeides.
    (ii) Administer at the 0.025 percent level for 2 days, skip 3 days, 
give for 2 days, skip 3 days and give for 2 more days. Repeat if 
necessary. Do not change litter unless absolutely necessary. Do not give 
flushing mashes.
    (3) Chickens and turkeys. (i) As an aid in the control of acute fowl 
cholera caused by Pasteurella multocida susceptible to sulfaquinoxaline 
and fowl typhoid caused by Salmonella gallinarum susceptible to 
sulfaquinoxaline.
    (ii) Administer at the 0.04 percent level for 2 or 3 days. Move 
birds to clean ground. If disease recurs, repeat treatment. If cholera 
has become established as the respiratory or chronic form, use feed 
medicated with sulfaquinoxaline. Poultry which have survived typhoid 
outbreaks should not be kept for laying house replacements or breeders 
unless tests show they are not carriers.
    (4) Cattle and calves. (i) For the control and treatment of 
outbreaks of coccidiosis caused by Eimeria bovis or E. zurnii.
    (ii) Administer at the 0.015-percent level for 3 to 5 days in 
drinking water

[[Page 228]]

medicated with sulfaquinoxaline solution.
    (iii) In lieu of treatment as provided in paragraph (e)(4)(ii) of 
this section, administer 1 teaspoon of 25-percent sulfaquinoxaline 
soluble powder per day for each 125 pounds of body weight for 3 to 5 
days in drinking water.
    (d) Limitations. Consult a veterinarian or poultry pathologist for 
diagnosis. May cause toxic reactions unless the drug is evenly mixed in 
water at dosages indicated and used according to directions. For control 
of outbreaks of disease, medication should be initiated as soon as the 
diagnosis is determined. Medicated chickens, turkeys, cattle, and calves 
must actually consume enough medicated water which provides a 
recommended dosage of approximately 10 to 45 milligrams per pound per 
day in chickens, 3.5 to 55 milligrams per pound per day in turkeys, and 
approximately 6 milligrams per pound per day in cattle and calves 
depending on the age, class of animal, ambient temperature, and other 
factors. A withdrawal period has not been established for 
sulfaquinoxaline in preruminating calves. Do not use in calves to be 
processed for veal. Not for use in lactating dairy cattle. Do not give 
to chickens, turkeys or cattle within 10 days of slaughter for food. Do 
not medicate chickens or turkeys producing eggs for human consumption. 
Make fresh drinking water daily.

[48 FR 3964, Jan. 28, 1983, as amended at 48 FR 26762, June 10, 1983; 55 
FR 29843, July 23, 1990; 59 FR 28769, June 3, 1994; 59 FR 33197, June 
28, 1994; 61 FR 24443, May 15, 1996; 61 FR 63711, Dec. 2, 1996; 62 FR 
37712, July 15, 1997; 65 FR 10705, Feb. 29, 2000; 69 FR 41427, July 9, 
2004; 69 FR 60547, Oct. 12, 2004]



Sec. 520.2325b  Sulfaquinoxaline drench.

    (a)-(b) [Reserved]
    (c) Sponsor. See No. 050749 in Sec. 510.600(c) of this chapter.
    (d) NAS/NRC status. The conditions of use specified in this section 
have been reviewed by NAS/NRC and are found effective. Applications for 
these uses need not include effectiveness data as specified by Sec. 
514.111 of this chapter, but may require bioequivalency information. 
Applications must be accompanied by a written commitment to undertake 
the human safety studies required by FDA.
    (e) Conditions of uses. As a 25-percent sulfaquinoxaline soluble 
powder.
    (1) For the control and treatment of outbreaks of coccidiosis in 
cattle and calves caused by Eimeria bovis or E. zurnii.
    (2) Give one teaspoon of 25 percent sulfaquinoxaline soluble powder 
for each 125 pounds of body weight for 3 to 5 days as a drench.
    (f) Limitations. For control of outbreaks of disease, medication 
should be initiated as soon as the diagnosis is determined. Consult a 
veterinarian for diagnosis. Do not give to cattle within 10 days of 
slaughter for food. Not for use in lactating dairy cattle.

[48 FR 3964, Jan. 28, 1983, as amended at 55 FR 29843, July 23, 1990; 59 
FR 33197, June 28, 1994]



Sec. 520.2330  Sulfisoxazole tablets.

    (a) Specifications. Each tablet contains 260 milligrams (4 grains) 
of sulfisoxazole.
    (b) Sponsor. See No. 000856 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. Administer one tablet orally per 
4 pounds of body weight. \1\
---------------------------------------------------------------------------

    \1\ These conditions are NAS/NRC reviewed and deemed effective. 
Applications for these uses need not include effectiveness data as 
specified by Sec. 514.111 of this chapter, but may require 
bioequivalency and safety information.
---------------------------------------------------------------------------

    (2) Indications for use. Use in dogs and cats as an aid in treatment 
of bacterial pneumonia and bacterial enteritis when caused by organisms 
sensitive to sulfisoxazole. \1\
    (3) Limitations. Repeat dosage at 24-hour intervals until 2 to 3 
days after disappearance of clinical symptoms. (Administration of one-
half daily dosage at 12-hour intervals or one-third daily dosage at 8-
hour intervals will provide a more constant blood level.) Provide 
adequate supply of drinking water. If symptoms persist after using this 
preparation for 2 or 3 days, consult a veterinarian. \1\

[43 FR 60895, Dec. 29, 1978]

[[Page 229]]



Sec. 520.2340  Tepoxalin.

    (a) Specifications. Each tablet contains 30, 50, 100, or 200 
milligrams (mg) tepoxalin.
    (b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. 10 mg per kilogram (/kg) 
daily; or 20 mg/kg on the initial day of treatment, followed by 10 mg/kg 
daily.
    (2) Indications for use. For the control of pain and inflammation 
associated with osteoarthritis.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[68 FR 34795, June 11, 2003]



Sec. 520.2345  Tetracycline oral dosage forms.



Sec. 520.2345a  Tetracycline hydrochloride capsules.

    (a) Specifications. Each capsule contains 50, 100, 125, 250, or 500 
milligrams (mg) tetracycline hydrochloride.
    (b) Sponsor. See sponsors in Sec. 510.600(c) of this chapter for 
use as in paragraph (c) of this section:
    (1) No. 000009: 250 mg per capsule.
    (2) No. 000069: 125, 250, or 500 mg per capsule.
    (3) No. 000185: 50, 100, 250, or 500 mg per capsule.
    (c) Conditions of use in dogs--(1) Amount. 25 mg per pound of body 
weight per day in divided doses every 6 hours.
    (2) Indications for use. For treatment of infections caused by 
organisms sensitive to tetracycline hydrochloride, such as bacterial 
gastroenteritis due to E. coli and urinary tract infections due to 
Staphylococcus spp. and E. coli.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[70 FR 50182, Aug. 26, 2005]



Sec. 520.2345b  Tetracycline tablets.

    (a) Specifications. Each tablet contains 100, 250, or 500 milligrams 
of tetracycline (as the hydrochloride).
    (b) Sponsor. For 100, 250, or 500 milligrams per tablet, see No. 
000069 in Sec. 510.600(c) of this chapter. For 250 milligrams per 
tablet, see No. 000009 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use. Dogs--(1) Amount. 25 milligrams per pound of 
body weight per day in divided doses every 6 hours.
    (2) Indications for use. Treatment of infections caused by organisms 
sensitive to tetracycline hydrochloride, such as bacterial 
gastroenteritis due to E. coli and urinary tract infections due to 
Staphylococcus spp. and E. coli.
    (3) Limitations. Administer orally; continue treatment until 
symptoms of the disease have subsided and temperature is normal for 48 
hours; not for use in animals raised for food production; Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.

[57 FR 37327, Aug. 18, 1992]



Sec. 520.2345c  Tetracycline boluses.

    (a) Specifications. Each bolus contains 500 milligrams of 
tetracycline (as the hydrochloride).
    (b) Sponsors. See No. 053501 in Sec. 510.600(c) of this chapter for 
use as in paragraph (d)(1) of this section. See No. 000009 in Sec. 
510.600(c) of this chapter for use as in paragraph (d)(2) of this 
section.
    (c) Related tolerances. See Sec. 556.720 of this chapter.
    (d) Conditions of use. Calves--(1) Amount. 10 milligrams per pound 
of body weight per day in divided doses.
    (i) Indications for use. Control and treatment of bacterial 
enteritis (scours) caused by E. coli and bacterial pneumonia caused by 
Pasteurella spp., Hemophilus spp., and Klebsiella spp.
    (ii) Limitations. Administer orally for 3 to 5 days; do not 
slaughter animals for food within 14 days of treatment; use as sole 
source of tetracycline.
    (iii) National Academy of Sciences/National Research Council (NAS/
NRC) status. The conditions of use specified in paragraph (d)(1)(i) of 
this section were NAS/NRC reviewed and found effective. Applications for 
these uses need not include effectiveness data as specified in Sec. 
514.111 of this chapter, but may require bioequivalency and safety 
information.
    (2) Amount. 10 milligrams per pound of body weight per day in two 
divided doses.

[[Page 230]]

    (i) Indications for use. Treatment of bacterial pneumonia caused by 
organisms susceptible to tetracycline, bacterial enteritis caused by E. 
coli, and salmonella organisms susceptible to tetracycline.
    (ii) Limitations. Administer orally for not more than 5 days; do not 
slaughter animals for food within 12 days of treatment; use as sole 
source of tetracycline.

[57 FR 37328, Aug. 18, 1992, as amended at 67 FR 78355, Dec. 24, 2002]



Sec. 520.2345d  Tetracycline powder.

    (a) Specifications. Each pound of powder contains 25, 102.4, or 324 
grams tetracycline hydrochloride.
    (b) Sponsors. See sponsors listed in Sec. 510.600(c) of this 
chapter for conditions of use as in paragraph (d) of this section:
    (1) No. 000069: 25 grams per pound as in paragraphs (d)(3) and 
(d)(4) of this section.
    (2) Nos. 000010 and 046573: 102.4 and 324 grams per pound as in 
paragraph (d) of this section.
    (3) No. 053501: 102.4 and 324 grams per pound as in paragraphs 
(d)(1) and (d)(2) of this section.
    (4) No. 046573: 102.4 and 324 grams per pound as in paragraph (d)(3) 
of this section.
    (5) Nos. 054925, 057561, 059130, and 061623: 324 grams per pound as 
in paragraph (d) of this section.
    (c) Related tolerances. See Sec. 556.720 of this chapter.
    (d) Conditions of use. It is administered in drinking water as 
follows:
    (1) Calves--(i) Amount. 10 milligrams per pound of body weight per 
day in divided doses.
    (ii) Indications for use. Control and treatment of bacterial 
enteritis (scours) caused by Escherichia coli and bacterial pneumonia 
(shipping fever complex) associated with Pasteurella spp., 
Actinobacillus pleuropneumoniae (Hemophilus spp.), and Klebsiella spp., 
susceptible to tetracycline.
    (iii) Limitations. Administer for 3 to 5 days; do not slaughter 
animals for food within 4 days of treatment for sponsor No. 053501 and 
within 5 days of treatment for sponsor Nos. 000010, 046573, 054925, 
057561, 059130, and 061623; prepare a fresh solution daily; use as the 
sole source of tetracycline. A withdrawal period has not been 
established for this product in preruminating calves. Do not use in 
calves to be processed for veal.
    (2) Swine--(i) Amount. 10 milligrams per pound of body weight per 
day in divided doses.
    (ii) Indications for use. Control and treatment of bacterial 
enteritis (scours) caused by E. coli and bacterial pneumonia associated 
with Pasteurella spp., A. pleuropneumoniae (Hemophilus spp.), and 
Klebsiella spp., susceptible to tetracycline.
    (iii) Limitations. Administer for 3 to 5 days; do not slaughter 
animals for food within 7 days of treatment for sponsor No. 053501 and 
within 4 days of treatment for sponsor Nos. 000010, 046573, 054925, 
057561, 059130, and 061623; prepare a fresh solution daily; use as the 
sole source of tetracycline.
    (3) Chickens--(i) Amount. Chronic respiratory disease: 400 to 800 
milligrams per gallon. Infectious synovitis: 200 to 400 milligrams per 
gallon.
    (ii) Indications for use. Control of chronic respiratory disease 
(CRD or air-sac disease) caused by Mycoplasma gallisepticum and E. coli; 
control of infectious synovitis caused by M. synoviae susceptible to 
tetracycline.
    (iii) Limitations. Administer for 7 to 14 days; do not slaughter for 
food within 4 days of treatment; not for use in chickens producing eggs 
for human consumption; prepare a fresh solution daily; use as the sole 
source of tetracycline.
    (4) Turkeys--(i) Amount. For infectious synovitis: 400 milligrams 
per gallon. For complicating bacterial organisms associated with 
bluecomb (transmissible enteritis or coronaviral enteritis): 25 
milligrams per pound of body weight per day.
    (ii) Indications for use. Control of infectious synovitis caused by 
M. synoviae; control of bluecomb complicated by organisms sensitive to 
tetracycline.
    (iii) Limitations. Administer for 7 to 14 days; do not slaughter for 
food within 4 days of treatment; not for use in turkeys producing eggs 
for human consumption; prepare a fresh solution

[[Page 231]]

daily; use as the sole source of tetracycline.

[59 FR 17693, Apr. 14, 1994, as amended at 59 FR 19133, Apr. 22, 1994; 
62 FR 5319, Feb. 5, 1997; 62 FR 35076, June 30, 1997; 62 FR 46668, Sept. 
4, 1997; 62 FR 55160, Oct. 23, 1997; 64 FR 37673, July 13, 1999; 67 FR 
78355, Dec. 24, 2002; 70 FR 16934, Apr. 4, 2005; 70 FR 67353, Nov. 7, 
2005; 71 FR 13542, Mar. 16, 2006]



Sec. 520.2345e  Tetracycline oral liquid.

    (a) Specifications. Each milliliter contains the equivalent of 
either 25 or 100 milligrams of tetracycline hydrochloride.
    (b) Sponsor. See No. 000069, in Sec. 510.600(c) of this chapter for 
use of 25 or 100 milligrams per milliliter liquid in dogs as in 
paragraph (c)(1) of this section; see No. 000009 in Sec. 510.600(c) of 
this chapter for use of 100 milligrams per milliliter liquid in dogs and 
cats as in paragraph (c)(2).
    (c) Conditions of use--(1) Dogs--(i) Amount. 25 milligrams per pound 
of body weight per day in divided doses every 6 hours.
    (ii) Indications for use. Treatment of infections caused by 
organisms sensitive to tetracycline hydrochloride, such as bacterial 
gastroenteritis due to Escherichia coli and urinary tract infections due 
to Staphylococcus spp. and E. coli.
    (iii) Limitations. Administer orally; continue treatment until 
symptoms have subsided and the temperature is normal for 48 hours; not 
for use in animals which are raised for food production; Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.
    (iv) National Academy of Sciences/National Research Council (NAS/
NRC) status. These conditions were NAS/NRC reviewed and found effective. 
Applications for these uses need not include effectiveness data as 
specified by Sec. 514.111 of this chapter, but may require 
bioequivalency and safety information.
    (2) Dogs and cats--(i) Amount. 25 milligrams per pound of body 
weight per day in divided doses every 6 hours.
    (ii) Indications for use. Treatment of infections caused by 
organisms susceptible to tetracycline hydrochloride, such as bacterial 
gastroenteritis due to E. coli and urinary tract infections due to 
Staphylococcus spp. and E. coli.
    (iii) Limitations. Administer orally; continue treatment until the 
temperature has been normal for 48 hours; not for use in food-producing 
animals; Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.

[57 FR 37329, Aug. 18, 1992]



Sec. 520.2345f  Tetracycline phosphate complex and sodium novobiocin capsules.

    (a) Specifications. Each capsule contains the equivalent of 60 
milligrams of tetracycline hydrochloride and 60 milligrams of 
novobiocin.
    (b) Sponsor. No. 000009 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use. Dogs--(1) Amount. 10 milligrams of each 
antibiotic per pound of body weight (1 capsule for each 6 pounds) every 
12 hours.
    (2) Indications for use. Treatment of acute or chronic canine 
respiratory infections such as tonsillitis, bronchitis, and 
tracheobronchitis when caused by pathogens susceptible to tetracycline 
and/or novobiocin, such as Staphylococcus spp. and Escherichia coli.
    (3) Limitations. Continue treatment for at least 48 hours after the 
temperature has returned to normal and all evidence of infection has 
disappeared. As with all antibiotics, appropriate in vitro culturing and 
susceptibility tests of samples taken before treatment should be 
conducted. Federal law restricts this drug to use by or on the order of 
a licensed veterinarian.

[57 FR 37329, Aug. 18, 1992]



Sec. 520.2345g  Tetracycline hydrochloride and sodium novobiocin tablets.

    (a) Specifications. Each tablet contains the equivalent of 60 
milligrams of tetracycline hydrochloride and 60 milligrams of 
novobiocin, or 180 milligrams of tetracycline hydrochloride and 180 
milligrams of novobiocin.
    (b) Sponsor. No. 000009 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use. Dogs--(1) Amount. 10 milligrams of each 
antibiotic per pound of body weight (one single-strength tablet for each 
6 pounds or one triple-strength tablet for each 18 pounds).

[[Page 232]]

    (2) Indications for use. Treatment of acute or chronic canine 
respiratory infections such as tonsillitis, bronchitis, and 
tracheobronchitis when caused by pathogens susceptible to tetracycline 
and/or novobiocin, such as Staphylococcus spp. and Escherichia coli.
    (3) Limitations. Continue treatment for at least 48 hours after the 
temperature has returned to normal and all evidence of infection has 
disappeared. As with all antibiotics, appropriate in vitro culturing and 
susceptibility tests of samples taken before treatment should be 
conducted. Federal law restricts this drug to use by or on the order of 
a licensed veterinarian.

[57 FR 37329, Aug. 18, 1992]



Sec. 520.2345h  Tetracycline hydrochloride, sodium novobiocin, and 

prednisolone tablets.

    (a) Specifications. Each tablet contains the equivalent of 60 
milligrams of tetracycline hydrochloride, 60 milligrams of novobiocin, 
and 1.5 milligrams of prednisolone or 180 milligrams of tetracycline 
hydrochloride, 180 milligrams of novobiocin, and 4.5 milligrams of 
prednisolone.
    (b) Sponsor. See No. 000009 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use. Dogs--(1) Amount. 10 milligrams of each 
antibiotic and 0.25 milligram of prednisolone per pound of body weight 
(one single-strength tablet for each 6 pounds or one triple-strength 
tablet for each 18 pounds) every 12 hours for 48 hours. Treatment is to 
be continued with novobiocin and tetracycline alone at the same dose 
schedule for an additional 3 days or longer as needed.
    (2) Indications for use. Treatment of acute and chronic canine 
respiratory infections such as tonsillitis, bronchitis, and 
tracheobronchitis when caused by pathogens susceptible to tetracycline 
and/or novobiocin, such as Staphylococcus spp. and Escherichia coli, 
when it is necessary to initially reduce the severity of associated 
clinical signs.
    (3) Limitations. As with all antibiotics, appropriate in vitro 
culturing and susceptibility tests of samples taken before treatment 
should be conducted. Administer for 48 hours only. Continue treatment if 
needed with tetracycline/novobiocin alone. The product is 
contraindicated in animals with tuberculosis, hyperadrenocorticalism, or 
peptic ulcers. Clinical and experimental data have demonstrated that 
corticosteroids administered orally or parenterally to animals may 
induce the first stage of parturition when administered during the last 
trimester of pregnancy and may precipitate premature parturition 
followed by dystocia, fetal death, retained placenta, and metritis. 
Federal law restricts this drug to use by or on the order of a licensed 
veterinarian.

[57 FR 37329, Aug. 18, 1992]



Sec. 520.2362  Thenium closylate tablets.

    (a) Chemical name. (N,N-Dimethyl-N-2-phenoxyethyl-N-2'-thenylammo-
nium)-p-chlorobenzene-sulfonate.
    (b) Specifications. Thenium closylate tablets contain thenium 
closylate equivalent to 500 milligrams thenium as base in each tablet.
    (c) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
    (d) Conditions of use. (1) The tablets are administered orally to 
dogs as a single day treatment of canine ancylostomiasis by the removal 
from the intestines of the adult forms of the species Ancylostoma 
caninum and Uncinaria stenocephala (hookworms). Dogs weighing 10 pounds 
and over are administered 1 tablet as a single dose. Dogs weighing 5 to 
10 pounds are administered one-half tablet twice during a single day. 
All dosages are given for 1 day only. The treatment should be repeated 
after 2 or 3 weeks.
    (2) Suckling puppies or recently weaned puppies weighing less than 5 
pounds should not be treated with the drug. Animals that are severely 
infected, exhibiting evidence of intestinal hemorrhage, debilitation, 
and anemia, should be given supportive treatment.
    (3) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.

[40 FR 13838, Mar. 27, 1975, as amended at 41 FR 53477, Dec. 7, 1976; 46 
FR 48642, Oct. 2, 1981; 61 FR 8873, Mar. 6, 1996; 62 FR 61625, Nov. 19, 
1997]

[[Page 233]]



Sec. 520.2380  Thiabendazole oral dosage forms.



Sec. 520.2380a  Thiabendazole top dressing and mineral protein block.

    (a) Chemical name. 2-(4-Thiazolyl)-benzimidazole.
    (b) Specifications. Conforms to N.F. XII.
    (c) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for 
use as in paragraph (e) of this section.
    (1) No. 051311 for use as in paragraph (e)(1)(i) of this section.
    (2) No. 050604 for use as in paragraph (e)(1)(ii) of this section.
    (3) No. 021930 for use as in paragraph (e)(2) of this section.
    (d) Related tolerances. See Sec. 556.730 of this chapter.
    (e) Conditions of use. It is used as follows:
    (1) Horses--(i) Route of administration. In feed, as a top dressing.
    (a) Amount. 2 grams per 100 pounds of body weight.
    (b) Indications for use. For control of large strongyles, small 
strongyles, pinworms, and threadworms (including members of the genera 
Strongylus, Cyathostomum, Cylicobrachytus, and related genera, 
Craterostomum, Oesophagodontus, Poteriostomum, Oxyuris, and 
Strongyloides).
    (c) Limitations. Add to the usual feed of horses mixed into that 
amount of the feed normally consumed at one feeding. Warning: Not for 
use in horses intended for food.
    (ii) Route of administration. In feed.
    (a) Amount. 2 grams per 100 pounds of body weight.
    (1) Indications for use. For control of large and small strongyles, 
Strongyloides, and pinworms of the genera Strongylus, Cyathostomum, 
Cylicobrachytus and related genera, Craterostomum, Oesophagodontus, 
Poteriostomum, Oxyuris, and Strongyloides.
    (2) Limitations. Administer in a single dosage mixed with the normal 
grain ration given at one feeding. Warning: Not for use in horses 
intended for food.
    (b) Amount. 4 grams per 100 pounds of body weight.
    (1) Indications for use. For control of ascarids of the genus 
Parascaris.
    (2) Limitations. Administer in a single dosage mixed with the normal 
grain ration given at one feeding. Warning: Not for use in horses 
intended for food.
    (2) Cattle--(i) Route of administration. In feed block.
    (ii) Amount. 3.3 percent block consumed at the recommended level of 
0.11 pound per 100 pounds of body weight per day.
    (iii) Indications for use. For control of infections of 
gastrointestinal roundworms (Trichostrongylus, Haemonchus, Ostertagia 
and Cooperia).
    (iv) Limitations. Administer to cattle on pasture or range 
accustomed to mineral protein block feeding for 3 days. Milk taken from 
animals during treatment and within 96 hours (8 milkings) after the 
latest treatment must not be used for food. Do not treat cattle within 3 
days of slaughter. For a satisfactory diagnosis, a microscopic fecal 
examination should be performed by a veterinarian or diagnostic 
laboratory prior to worming. Animals maintained under conditions of 
constant worm exposure may require re-treatment within 2 to 3 weeks. 
Animals that are severely parasitized, sick, or off feed should be 
isolated and a veterinarian consulted for advice concerning treatment.

[40 FR 13838, Mar. 27, 1975, as amended at 41 FR 9149, Mar. 3, 1976; 62 
FR 63271, Nov. 28, 1997; 70 FR 32489, June 3, 2005]



Sec. 520.2380b  Thiabendazole drench or oral paste.

    (a) Chemical name. 2-(4-Thiazolyl) benzimidazole.
    (b) Specifications. Conforms to N.F. XII.
    (c) Sponsor. See No. 050604 in Sec. 510.600(c) of this chapter for 
the sponsor of the usages provided for by paragraph (e) of this section.
    (d) Related tolerances. See Sec. 556.730 of this chapter.
    (e) Conditions of use. It is used as follows:
    (1) Horses. As a single liquid oral dose, administered as a drench 
or by stomach tube; or as an oral paste.
    (i) Amount. 2 grams per 100 pounds of body weight.
    (a) Indications for use. For the control of infections of large 
strongyles (Strongylus vulgaris, Strongylus

[[Page 234]]

endentatus), small strongyles (Cyathastomum, Cylicobrachytus and related 
genera, Craterostomum, Oesophagodontus, Poteriostomum), pinworms 
(Oxyuris), and threadworms (Strongyloides).
    (b) Limitations. Not for use in horses to be slaughtered for food 
purposes. When administered by stomach tube, for use only by or on the 
order of a licensed veterinarian. When for use as a liquid oral drench 
or an oral paste, consult your veterinarian for assistance in the 
diagnosis, treatment, and control of parasitism.
    (ii) Amount. 4 grams per 100 pounds of body weight.
    (a) Indications for use. For control of infections of ascardis 
(Parascaris).
    (b) Limitations. Not for use in horses to be slaughtered for food 
purposes. When administered by stomach tube, use only by or on the order 
of a licensed veterinarian. When for use as a liquid oral drench or an 
oral paste, consult your veterinarian for assistance in the diagnosis, 
treatment, and control of parasitism.
    (2) Pigs. As an oral paste.
    (i) Amount. 200 milligrams for each 5 to 7 pounds of body weight per 
dose.
    (ii) Indications for use. For control of infections with 
Strongyloides ransomi. These infections are commonly found in 
Southeastern United States.
    (iii) Limitations. Administer to baby pigs (1 to 8 weeks of age). 
Treatment may be repeated in 5 to 7 days if necessary. Before treatment, 
obtain an accurate diagnosis from a veterinarian or diagnostic 
laboratory. Do not treat within 30 days of slaughter.
    (3) Cattle. Orally as a drench and in paste form using a dosing gun 
designed for the product.
    (i) Amount. 3 grams per 100 pounds of body weight.
    (a) Indications for use. Control of infections of gastrointestinal 
roundworms (Trichostrongylus spp., Haemonchus spp., Nematodirus spp., 
Ostertagia spp., and Oesophagostomum radiatum).
    (b) Limitations. For most effective results, severely parasitized 
animals or those constantly exposed to helminth infection should be re-
treated every 2 to 3 weeks. Milk taken from treated animals within 96 
hours (8 milkings) after the latest treatment must not be used for food. 
Do not treat cattle within 3 days of slaughter. For a satisfactory 
diagnosis, a microscopic fecal examination should be performed prior to 
worming.
    (ii) Amount. 5 grams per 100 pounds of body weight.
    (a) Indications for use. Control of infections of Cooperia spp. or 
severe infections of other species in paragraph (e)(3)(i)(a) of this 
section.
    (b) Limitations. For most effective results, severely parasitized 
animals or those constantly exposed to helminth infection should be re-
treated every 2 to 3 weeks. Milk taken from treated animals within 96 
hours (8 milkings) after the latest treatment must not be used for food. 
Do not treat cattle within 3 days of slaughter. For a satisfactory 
diagnosis, a microscopic fecal examination should be performed prior to 
worming.
    (4) Sheep and goats. Orally, as a drench.
    (i) Amount. 2 grams per 100 pounds of body weight.
    (ii) Indications for use. Control of infections of gastrointestinal 
roundworms in sheep and goats. (Trichostrongylus spp., Haemonchus spp., 
Ostertagia spp., Cooperia spp., Nematodirus spp., Bunostomum spp., 
Strongyloides spp., Chabertia spp., and Oesophagostomum spp. ); also 
active from 3 hours to 3 days following treatment against ova and larvae 
passed by sheep (good activity against Trichostrongylus colubriformis 
and axei, Ostertagia spp., Bunostomum spp., Nematodirus spp., and 
Strongyloides spp.; less effective against Haemonchus contortus and 
Oesophagostomum spp. ).
    (iii) Limitations. As a single oral dose; do not treat animals 
within 30 days of slaughter; milk taken from treated animals within 96 
hours (8 milkings) after the latest treatment must not be used for food; 
in severe infections in sheep, treatment should be repeated in 2 to 3 
weeks.
    (5) Goats. Orally, as a drench.
    (i) Amount. 3 grams per 100 pounds of body weight.
    (ii) Indications for use. Control of severe infections of 
gastrointestinal roundworms (Trichostrongylus spp., Haemonchus spp., 
Ostertagia spp.,

[[Page 235]]

Cooperia spp., Nematodirus spp., Bunostomum spp., Strongyloides spp., 
Chabertia spp., and Oesophagostomum spp. ).
    (iii) Limitations. As a single oral dose; do not treat animals 
within 30 days of slaughter; milk taken from treated animals within 96 
hours (8 milkings) after the latest treatment must not be used for food; 
treatment should be repeated in 2 to 3 weeks.

[40 FR 13838, Mar. 27, 1975, as amended at 41 FR 9149, Mar. 3, 1976; 41 
FR 47424, Oct. 29, 1976; 62 FR 63271, Nov. 28, 1997]



Sec. 520.2380c  Thiabendazole bolus.

    (a) Chemical name. 2-(4-Thiazolyl) benzimidazole.
    (b) Specifications. Conforms to N.F. XII.
    (c) Sponsor. See No. 050604 in Sec. 510.600(c) of this chapter.
    (d) Related tolerances. See Sec. 556.730 of this chapter.
    (e) Conditions of use. It is used as follows:
    (1) Cattle. In a bolus.
    (i) Amount. 3 grams per 100 pounds of body weight.
    (a) Indications for use. Control of infections of gastrointestinal 
roundworms (general Trichostrongylus spp., Haemonchus spp., Nematodirus 
spp., Ostertagia spp., and Oesophagostomum radiatum).
    (b) Limitations. As a single oral dose; may repeat once in 2 to 3 
weeks; do not treat animals within 3 days of slaughter; milk taken from 
treated animals within 96 hours (8 milkings) after the latest treatment 
must not be used for food.
    (ii) Amount. 5 grams per 100 pounds of body weight.
    (a) Indications for use. Control of severe infections of 
gastrointestinal roundworms (genera Trichostrongylus spp., Haemonchus 
spp., Nematodirus spp., Ostertagia spp., and Oesophagostomum radiatum). 
Control of infections with Cooperia spp.
    (b) Limitations. As a single oral dose; as a drench or bolus; may 
repeat once in 2 to 3 weeks; do not treat animals within 3 days of 
slaughter; milk taken from treated animals within 96 hours (8 milkings) 
after the latest treatment must not be used for food.
    (2) Sheep and goats. In a bolus.
    (i) Amount. 2 grams per 100 pounds of body weight.
    (ii) Indications for use. Control of infections of gastrointestinal 
roundworms in sheep and goats (general Trichostrongylus spp., Haemonchus 
spp., Ostertagia spp., Cooperia spp., Nematodirus spp., Bunostomum spp., 
Strongyloides spp., Chabertia spp., and Oesophagostomum spp. ); also 
active from 3 hours to 3 days following treatment against ova and larvae 
passed by sheep (good activity against T. colubriformis and axei, 
Ostertagia spp., Bunostomum spp., Nematodirus spp., and Strongyloides 
spp.; less effective against Haemonchus contortus and Oesophagostomum 
spp. ).
    (iii) Limitations. As a single oral dose; do not treat animals 
within 30 days of slaughter; milk taken from treated animals within 96 
hours (8 milkings) after the latest treatment must not be used for food; 
in severe infections in sheep, treatment should be repeated in 2 to 3 
weeks.
    (3) Goats. In a bolus.
    (i) Amount. 3 grams per 100 pounds of body weight.
    (ii) Indications for use. Control of severe infections of 
gastrointestinal roundworms (genera Trichostrongylus spp., Haemonchus 
spp., Ostertagia spp., Cooperia spp., Nematodirus spp., Bunostomum spp., 
Strongyloides spp., Chabertia spp., and Oesophagostomum spp. ).
    (iii) Limitations. As a single oral dose; do not treat animals 
within 30 days of slaughter; milk taken from treated animals within 96 
hours (8 milkings) after the latest treatment must not be used for food; 
treatment should be repeated in 2 to 3 weeks.

[40 FR 13838, Mar. 27, 1975, as amended at 41 FR 9149, Mar. 3, 1976; 62 
FR 63271, Nov. 28, 1997]



Sec. 520.2380d  Thiabendazole, piperazine citrate suspension.

    (a) Specifications. Each fluid ounce of suspension contains 2 grams 
of thiabendazole and 2.5 grams of piperazine (from piperazine citrate).
    (b) Sponsor. See No. 050604 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use. (1) It is administered to horses by stomach 
tube or as a drench at the rate of 1 fluid ounce of

[[Page 236]]

suspension per 100 pounds of body weight for the control of large 
strongyles, small strongyles, pinworms, Strongyloides and ascarids 
(including members of the genera Strongylus spp., Cyathostomum spp., 
Cylicobrachytus spp. and related genera Craterostomum spp., 
Oesophagodontus spp., Poteriostomum spp., Oxyuris spp., Strongyloides 
spp., and Parascaris spp. ).
    (2) Do not use in horses intended to be used for food purposes.
    (3) For use by or on the order of a licensed veterinarian.

[40 FR 13838, Mar. 27, 1975, as amended at 62 FR 63271, Nov. 28, 1997]



Sec. 520.2380e  Thiabendazole with trichlorfon.

    (a) Specifications. The drug contains 5 grams of thiabendazole with 
4.5 grams of trichlorfon, or 20 grams of thiabendazole with 18 grams of 
trichlorfon.
    (b) Sponsor. See No. 017135 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use. (1) Used for the treatment and control of 
bots (Gasterophilus spp. ), large strongyles (Strongylus spp. ), small 
strongyles (genera Cyathostomum, Cylicobrachytus, Craterostomum, 
Oesophagodontus, Poteriostomum), pinworms (Oxyuris spp., Strongyloides 
spp. ), and ascarids (Parascaris spp. ) in horses.
    (2) Administer 2 grams of thiabendazole with 1.8 grams of 
trichlorfon per 100 pounds of body weight sprinkled on the animals' 
usual daily ration of feed, or may be mixed in 5 to 10 fluid ounces of 
water and administered by stomach tube or drench.
    (3) Do not re-treat more than once every 30 days, preferably every 6 
to 8 weeks.
    (4) Do not treat animals if sick or debilitated; less than 4 months 
of age; or mares in last month of pregnancy.
    (5) Do not administer intravenous anesthetics, especially muscle 
relaxants, within 2 weeks of use.
    (6) Not for animals intended for food use.
    (7) Do not use within a few days before or after treatment with or 
exposure to cholinesterase-inhibiting drugs, pesticides, or chemicals.
    (8) If the label bears directions for administration of the drug by 
stomach tube or drench it shall also bear the statement: Caution; 
Federal law restricts this drug to use by or on the order of a licensed 
veterinarian.

[40 FR 23071, May 28, 1975, as amended at 48 FR 48229, Oct. 18, 1983]



Sec. 520.2380f  Thiabendazole, piperazine phosphate powder.

    (a) Specifications. Each ounce of water dispersible powder contains 
6.67 grams of thiabendazole and 8.33 grams of piperazine (as piperazine 
phosphate).
    (b) Sponsor. See No. 050604 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. 2 grams of thiabendazole and 2.5 
grams of piperazine (0.3 ounce of powder) per 100 pounds of body weight.
    (2) Indications for use. Treatment of infections of large strongyles 
(genus Strongylus), small strongyles (genera Cyathostomum, 
Cylicobrachytus, and related genera Craterostomum, Oesophagodontus, 
Poteriostomum), pinworms (Oxyuris), threadworms (Strongyloides), and 
ascarids (Parascaris) in horses.
    (3) Limitations. Use a single oral dose. Administer as a drench or 
by stomach tube suspended in 1 pint of warm water; by dose syringe 
suspended in \1/2\ ounce of water for each 100 pounds of body weight; or 
sprinkled over a small amount of daily feed. Not for animals intended 
for food use. If the label bears directions for administration by 
stomach tube or drench, it shall also bear the statement ``Caution: 
Federal law restricts this drug to use by or on the order of a licensed 
veterinarian;'' if not labeled for use by stomach tube or drench, the 
label shall bear the statement, ``Consult your veterinarian for 
assistance in the diagonosis, treatment, and control of parasitism.''

[46 FR 18963, Mar 27, 1981, as amended at 46 FR 52330, Oct. 27, 1981; 62 
FR 63271, Nov. 28, 1997]



Sec. 520.2455  Tiamulin.

    (a) Specifications. (1) Each ounce of concentrate solution contains 
3.64 grams (12.3 percent) tiamulin hydrogen fumarate.
    (2) Each gram of soluble powder contains 450 milligrams (mg) 
tiamulin hydrogen fumarate.

[[Page 237]]

    (b) Sponsors. See Nos. 058198 and 059130 in Sec. 510.600(c) of this 
chapter.
    (c) Related tolerances. See Sec. 556.738 of this chapter.
    (d) Special considerations. (1) Swine being treated with tiamulin 
should not have access to feeds containing polyether ionophores (e.g., 
lasalocid, monensin, narasin, salinomycin, or semduramycin) as adverse 
reactions may occur.
    (2) Do not use in swine weighing over 250 pounds (lb).
    (e) Conditions of use in swine--(1) Amounts and indications for use. 
Administer in drinking water for 5 consecutive days:
    (i) 3.5 mg per (/) lb of body weight daily for treatment of swine 
dysentery associated with Brachyspira hyodysenteriae susceptible to 
tiamulin.
    (ii) 10.5 mg/lb of body weight daily for treatment of swine 
pneumonia due to Actinobacillus pleuropneumoniae susceptible to 
tiamulin.
    (2) Limitations. Withdraw medication 3 days before slaughter 
following treatment at 3.5 mg/lb and 7 days before slaughter following 
treatment at 10.5 mg/lb of body weight. Prepare fresh medicated water 
daily. Use as only source of drinking water.

[70 FR 75017, Dec. 19, 2005]



Sec. 520.2473  Tioxidazole oral dosage forms.



Sec. 520.2473a  Tioxidazole granules.

    (a) Specifications. Each gram of granules contains 200 milligrams of 
tioxidazole.
    (b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Horses--(i) Amount. 5 milligrams per 
pound of body weight as a single dose.
    (ii) Indications for use. Removal of mature large strongyles 
(Strongylus edentatus, S. equinus, and S. vulgaris), mature ascarids 
(Parascaris equorum), mature and immature (4th larval stage) pinworms 
(Oxyuris equi), and mature small strongyles (Triodontophorus spp.).
    (iii) Limitations. For administration with feed: Sprinkle required 
amount of granules on a small amount of the usual grain ration and mix. 
Prepare for each horse individually. Withholding of feed or water not 
necessary. Not for use in horses intended for food. The reproductive 
safety of tioxidazole in breeding animals has not been determined. 
Consult your veterinarian for assistance in the diagnosis, treatment, 
and control of parasitism. It is recommended that this drug be 
administered with caution to sick or debilitated horses.
    (2) [Reserved]

[50 FR 52772, Dec. 26, 1985; 51 FR 2693, Jan. 21, 1986, as amended at 52 
FR 7832, Mar. 13, 1987]



Sec. 520.2473b  Tioxidazole paste.

    (a) Specifications. Each plastic syringe contains 6.25 grams of 
tioxidazole.
    (b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Horses--(i) Amount. 5 milligrams of 
tioxidazole per pound of body weight as a single dose.
    (ii) Indications for use. Removal of mature large strongyles 
(Strongylus edentatus, S. equinus, and S. vulgaris), mature ascarids 
(Parascaris equorum), mature and immature (4th larval stage) pinworms 
(Oxyuris equi), and mature small strongyles (Triodontophorus spp.).
    (iii) Limitations. Administer orally by inserting the nozzle of the 
syringe through the space between front and back teeth and deposit the 
required dose on the base of the tongue. Before dosing, make sure the 
horse's mouth contains no feed. Not for use in horses intended for food. 
The reproductive safety of tioxidazole in breeding animals has not been 
determined. Consult your veterinarian for assistance in the diagnosis, 
treatment, and control of parasitism. It is recommended that this drug 
be administered with caution to sick or debilitated horses.
    (2) [Reserved]

[52 FR 43059, Nov. 9, 1987]



Sec. 520.2481  Triamcinolone acetonide tablets.

    (a) Specifications. Each tablet contains either 0.5 milligram or 1.5 
milligrams of the drug.
    (b) Sponsor. See Nos. 000010 and 053501 in Sec. 510.600(c) of this 
chapter.
    (c) NAS/NRC status. The conditions of use specified in this section 
are NAS/

[[Page 238]]

NRC reviewed and found effective. Applications for these uses need not 
include effectiveness data as specified by Sec. 514.111 of this 
chapter, but may require bioequivalency and safety information.
    (d) Conditions of use. (1) The drug is indicated for use in dogs and 
cats for its anti-inflammatory activity.
    (2) An initial daily dosage of 0.05 milligram per pound of body 
weight is usually sufficient to control symptoms, although up to 0.1 
milligram per pound of body weight may be given daily if response to the 
smaller dose is inadequate. As soon as feasible, and in any case within 
2 weeks, dosage should be reduced gradually to maintenance levels of 
0.0125 to 0.025 milligram per pound of body weight per day. Therapy 
should be discontinued by a gradual reduction in dosage after the 
condition has been controlled for several days. Therapy may be initiated 
with a single dose of sterile triamcinolone acetonide suspension 
veterinary in which case the tablet dosage should be administered 
beginning 5 to 7 days after the injection or when symptoms reappear.
    (3) The labeling shall comply with the requirements of Sec. 510.410 
of this chapter.
    (4) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.

[40 FR 13838, Mar. 27, 1975, as amended at 51 FR 26002, July 18, 1986; 
53 FR 40727, Oct. 18, 1988; 62 FR 35076, June 30, 1997]



Sec. 520.2482  Triamcinolone acetonide oral powder.

    (a) Specifications. Each 15 grams of triamcinolone acetonide oral 
powder contains 10 milligrams of triamcinolone acetonide.
    (b) Sponsor. See No. 053501 in Sec. 510.600(c) of this chapter.
    (c) NAS/NRC status. The conditions of use specified in this section 
are NAS/NRC reviewed and found effective. Applications for these uses 
need not include effectiveness data as specified by Sec. 514.111 of 
this chapter, but may require bioequivalency and safety information.
    (d) Conditions of use. (1) The drug is used as an anti-inflammatory 
agent for horses.
    (2) It is administered at a dosage of 0.005 to 0.01 milligram 
triamcinolone acetonide per pound of body weight twice daily, sprinkled 
(top-dressed) on a small portion of feed. Treatment may be initiated 
with a single dose of sterile triamcinolone acetonide suspension USP 
followed after 3 or 4 days with the use of triamcinolone acetonide oral 
powder.
    (3) The labeling shall comply with the requirements of Sec. 510.410 
of this chapter.
    (4) Not for use in horses intended for food.
    (5) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.

[41 FR 24884, June 21, 1976, as amended at 50 FR 41489, Oct. 11, 1985; 
51 FR 26002, July 18, 1986]



Sec. 520.2520  Trichlorfon oral dosage forms.



Sec. 520.2520b  Trichlorfon and atropine.

    (a) Chemical name. (1) For trichlorfon: O,O-Dimethyl 2,2,2-
trichloro-1-hydroxyethyl phosphonate.
    (2) For atropine: Atropine N.F.
    (b) Sponsor. See No. 000856 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use. (1) The drug is used for the treatment of 
Syphacia obvelata (pinworm) in laboratory mice.
    (2) It is administered in distilled water as sole source of drinking 
water continuously for 7 to 14 days at 1.67 grams of trichlorfon and 7.7 
milligrams of atropine per liter.
    (3) Prepare fresh solution every 3 days. Do not use simultaneously 
with other drugs, insecticides, pesticides, or chemicals having 
cholinesterase activity, nor within 7 days before or after treatment 
with any other cholinesterase inhibitor.
    (4) Restricted to use by or on the order of a licensed veterinarian.



Sec. 520.2520e  Trichlorfon boluses.

    (a) Specifications. Each bolus contains either 7.3, 10.9, 14.6, or 
18.2 g of trichlorfon.
    (b) Sponsor. See 000856 in Sec. 510.600(c) of this chapter.
    (c) Special considerations. Trichlorfon is a cholinesterase 
inhibitor. Do not

[[Page 239]]

use this product on animals simultaneously with, or within 2 weeks, 
before or after treatment with or exposure to, neuromuscular 
depolarizing agents (i.e., succinylcholine) or to cholinesterase-
inhibiting drugs, pesticides, or chemicals.
    (d) NAS/NRC status. Use of this drug has been NAS/NRC reviewed and 
found effective. Applications for these uses need not include 
effectiveness data as specified by Sec. 514.111 of this chapter.
    (e) Conditions of use--(1) Amount. 18.2 milligrams per pound of body 
weight, except for strongyles use 36.4 milligrams per pound of body 
weight.
    (2) Indications for use. For horses for removal of bots 
(Gastrophilus nasalis, Gastrophilus intestinalis), large strongyles 
(Strongylus vulgaris), small strongyles, large roundworms (ascarids, 
Parascaris equorum), and pinworms (Oxyuris equi).
    (3) Limitations. Do not fast horses before or after treatment. 
Treatment of mares in late pregnancy is not recommended. Surgery or any 
severe stress should be avoided for at least 2 weeks before or after 
treatment. Do not administer to sick, toxic, or debilitated horses. Not 
to be used in horses intended for use as food. Federal law restricts 
this drug to use by or on the order of a licensed veterinarian.

[45 FR 48127, July 18, 1980]



Sec. 520.2520f  Trichlorfon granules.

    (a) Specifications. Each package contains either 18.2 or 36.4 g of 
trichlorfon.
    (b) Sponsor. See 000856 in Sec. 510.600(c) of this chapter.
    (c) Special considerations. Trichlorfon is a cholinesterase 
inhibitor. Do not use this product on animals simultaneously with, or 
within 2 weeks before or after treatment with or exposure to 
neuromuscular depolarizing agents (i.e., succinylcholine) or to 
cholinesterase-inhibiting drugs, pesticides, or chemicals.
    (d) NAS/NRC status. Use of this drug has been NAS/NRC reviewed and 
found effective. Applications for these uses need not include 
effectiveness data as specified by Sec. 514.111 of this chapter.
    (e) Conditions of use--(1) Amount. 18.2 milligrams per pound of body 
weight.
    (2) Indications for use. For horses for removal of bots 
(Gastrophilus nasalis, Gastrophilus intestinalis), large roundworms 
(ascarids, Parascaris equorum), and pinworms (Oxyuris equi).
    (3) Limitations. Do not fast horses before or after treatment. 
Treatment of mares in late pregnancy is not recommended. Surgery or any 
severe stress should be avoided for at least 2 weeks before or after 
treatment. Do not administer to sick, toxic, or debilitated horses. Not 
to be used in horses intended for use as food. Federal law restricts 
this drug to use by or on the order of a licensed veterinarian.

[45 FR 48128, July 18, 1980]



Sec. 520.2520g  Trichlorfon, phenothiazine, and piperazine dihydrochloride 

powder.

    (a) Specifications. Each 54.10 grams (1.91 ounces) of water 
dispersible powder contains 9.10 grams of trichlorfon, 6.25 grams of 
phenothiazine, and the equivalent of 20.0 grams of piperazine base (as 
piperazine dihydrochloride).
    (b) Sponsor. See No. 000856 in Sec. 510.600(c) of this chapter.
    (c) Special considerations. Labeling shall bear the following 
statements: The drug is a cholinesterase inhibitor. Do not use this 
product in horses simultaneously with, or within 2 weeks before or after 
treatment with, or exposure to, neuromuscular depolarizing agents (e.g., 
succinylcholine) or to cholinesterase-inhibiting drugs, pesticides, or 
chemicals.
    (d) Conditions of use--(1) Amount. 18.2 milligrams of trichlorfon, 
12.5 milligrams of phenothiazine, and 40.0 milligrams of piperazine base 
per pound of body weight.
    (2) Indications for use. For horses for removal of bots 
(Gastrophilus nasalis, Gastrophilus intestinalis), large strongyles 
(Strongylus vulgaris), small strongyles, large roundworms (ascarids, 
Parascaris equorum), and pinworms (Oxyuris equi).
    (3) Limitations. Mix powder and vial contents together in warm water 
to form suspension. Administer by stomach tube. Do not fast horses 
before or after treatment. Treatment of mares in late pregnancy is not 
recommended. Surgery or any severe stress should be avoided for at least 
2 weeks before or after treatment. Do not administer to sick, toxic, or 
debilitated horses. Not

[[Page 240]]

to be used in horses intended for use as food. Federal law restricts 
this drug to use by or on the order of a licensed veterinarian.

[48 FR 2757, Jan. 21, 1983]



Sec. 520.2582  Triflupromazine hydrochloride tablets.

    (a) Specifications. Each tablet contains either 10 milligrams or 25 
milligrams of triflupromazine hydrochloride.
    (b) Sponsor. See No. 053501 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use. (1) The drug is used in dogs and cats to 
relieve anxiety and to help control psychomotor overactivity as well as 
to increase the tolerance of animals to pain and pruritus. The drug is 
indicated in various office and clinical procedures which require the 
aid of a tranquilizer, antiemetic, or preanesthetic.\1\
    (2) The drug is administered orally to dogs and cats at a dosage 
level of 1 to 2 milligrams per pound of body weight daily; an initial 
dosage at the 2-milligrams level is suggested followed by daily doses at 
the 1-milligram level. Frequently, the drug may be withdrawn after 4 to 
5 days, with drug effect continuing after withdrawal.\1\
    (3) Do not use in conjunction with organophosphates and/or procaine 
hydrochloride, because phenothiazines may potentiate the toxicity of 
organophosphates and the activity of procaine hydrochloride.\1\
    (4) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.\1\

[40 FR 13838, Mar. 27, 1975, as amended at 50 FR 41489, Oct. 11, 1985]



Sec. 520.2604  Trimeprazine tartrate and prednisolone tablets.

    (a) Specifications. Each tablet contains: trimeprazine tartrate, 5 
milligrams; and prednisolone, 2 milligrams.
    (b) Sponsor. See No. 000069 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use. (1) The drug is administered orally to dogs 
for the relief of itching regardless of cause; reduction of inflammation 
commonly associated with most skin disorders of dogs such as eczema, 
caused by internal disorders, otitis, and dermatitis, allergic, 
parasitic, pustular and nonspecific. It is also used in dogs as 
adjunctive therapy in various cough conditions including treatment of 
``kennel cough'' or tracheobronchitis, bronchitis including allergic 
bronchitis, in tonsillitis, acute upper respiratory infections and 
coughs of nonspecific origin. The product may also be administered to 
dogs suffering from acute or chronic bacterial infections, provided the 
infection is controlled by appropriate antibiotic or chemotherapeutic 
agents.\1\
    (2) The drug is administered orally at an initial dosage level of 
\1/2\ tablet twice daily to dogs weighing up to 10 pounds, one tablet 
twice daily to dogs weighing 11 to 20 pounds, two tablets twice daily to 
dogs weighing 21 to 40 pounds, and three tablets twice daily to dogs 
weighing over 40 pounds. After 4 days, the dosage is reduced to 
approximately \1/2\ the initial dosage or to an amount just sufficient 
to maintain remission of symptoms. Dosages in individual cases may vary 
and should be adjusted until proper response is obtained.\1\
    (3) Do not use the drug in cases of viral infections involving 
corneal ulceration or dendritic ulceration of the cornea.\1\
    (4) Clinical and experimental data have demonstrated that 
corticosteroids administered orally or parenterally to animals may 
induce the first stage of parturition when administered during the last 
trimester of pregnancy and may precipitate premature parturition 
followed by dystocia, fetal death, retained placenta, and metritis.\1\
    (5) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.\1\
---------------------------------------------------------------------------

    \1\ These conditions are NAS/NRC reviewed and deemed effective. 
Applications for these uses need not include effectiveness data as 
specified by Sec. 514.111 of this chapter, but may require 
bioequivalency and safety information.

[40 FR 13838, Mar. 27, 1975, as amended at 56 FR 50653, Oct. 8, 1991; 60 
FR 55659, Nov. 2, 1995]

[[Page 241]]



Sec. 520.2605  Trimeprazine tartrate and prednisolone capsules.

    (a) Specifications. Each capsule contains 3.75 milligrams of 
trimeprazine in sustained released form (as the tartrate) and 1 
milligram of prednisolone (capsule no. 1) or 7.5 milligrams of 
trimeprazine in sustained release form (as the tartrate) and 2 
milligrams of prednisolone (capsule no. 2).
    (b) Sponsor. See 000069 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. Administer either capsule orally 
once daily to dogs as follows:

------------------------------------------------------------------------
                                                     Number of capsules
                                                          per dose
              Animal weight (pounds)               ---------------------
                                                     Capsule    Capsule
                                                      No. 1      No. 2
------------------------------------------------------------------------
Up to 10..........................................          1  .........
11 to 20..........................................          2          1
21 to 40..........................................          4          2
Over 40...........................................          6          3
------------------------------------------------------------------------

    (2) Indications for use. For the relief of itching regardless of 
cause, reduction of inflammation commonly associated with most skin 
disorders of dogs such as eczema caused by internal disorders, otitis, 
and dermatitis (allergic, parasitic, pustular, and nonspecific). It is 
also used in dogs as adjunctive therapy in various cough conditions 
including treatment of ``kennel cough'' or tracheobronchitis, bronchitis 
including allergic bronchitis, tonsillitis, acute upper respiratory 
infections, and coughs of nonspecific origin. The product may also be 
administered to dogs suffering from acute or chronic bacterial 
infections, provided the infection is controlled by appropriate 
antibiotic or chemotherapeutic agents.
    (3) Limitations. After 4 days, reduce dosage to one-half the initial 
dose or to an amount sufficient to maintain remission of symptoms. 
Dosages in individual cases may vary and should be adjusted until proper 
response is obtained. Do not use the drug in cases of viral infections 
involving corneal ulceration or dendritic ulceration of the cornea. 
Clinical and experimental data have demonstrated that corticosteroids 
administered orally or parenterally to animals may induce the first 
stage of parturition when administered during the last trimester of 
pregnancy and may precipitate premature parturition followed by 
dystocia, fetal death, retained placenta, and metritis. Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.

[48 FR 19367, Apr. 29, 1983, as amended at 56 FR 50653, Oct. 8, 1991; 60 
FR 55659, Nov. 2, 1995]



Sec. 520.2610  Trimethoprim and sulfadiazine tablets.

    (a) Specifications. Each tablet contains 30 milligrams (5 milligrams 
of trimethoprim and 25 milligrams of sulfadiazine), 120 milligrams (20 
milligrams of trimethoprim and 100 milligrams of sulfadiazine), 480 
milligrams (80 milligrams of trimethoprim and 400 milligrams of 
sulfadiazine) or 960 milligrams (160 milligrams of trimethoprim and 800 
milligrams of sulfadiazine).
    (b) Sponsor. See Nos. 000061 and 000856 in Sec. 510.600(c) of this 
chapter.
    (c) Conditions of use. (1) The drug is used in dogs where systemic 
antibacterial action against sensitive organisms is required, either 
alone or as an adjunct to surgery or debridement with associated 
infection. The drug is indicated where control of bacterial infection is 
required during the treatment of acute urinary tract infections, acute 
bacterial complications of distemper, acute respiratory tract 
infections, acute alimentary tract infections, wound infections, and 
abscesses.
    (2) The drug is given orally at 30 milligrams per kilogram of body 
weight per day (14 milligrams per pound per day), or as follows:

------------------------------------------------------------------------
                                                               Number of
                 Animal body weight (pounds)                    tablets
------------------------------------------------------------------------
                              30 mg tablets
------------------------------------------------------------------------
2.2.........................................................           1
4.4.........................................................           2
6.6.........................................................           3
8.8.........................................................           4
------------------------------------------------------------------------
                             120 mg tablets
------------------------------------------------------------------------
Up to 9.....................................................           1
10 to 19....................................................           2
20 to 29....................................................           3
30 to 40....................................................           4
------------------------------------------------------------------------
                             480 mg tablets
------------------------------------------------------------------------
30 to 40....................................................           1
40 to 60....................................................      1\1/2\
60 to 80....................................................           2
80 to 110...................................................           3
Over 110....................................................           4
------------------------------------------------------------------------


[[Page 242]]

    (3) The drug is given once daily. Alternatively, especially in 
severe infections, the initial dose may be followed by one-half the 
recommended daily dose every 12 hours. If no improvement is seen in 3 
days, discontinue therapy and reevaluate diagnosis.
    (4) Administer for 2 to 3 days after symptoms have subsided. Do not 
treat for more than 14 consecutive days.
    (5) During long term treatment, periodic platelet counts and white 
and red blood cell counts are recommended.
    (6) The drug should not be used in patients showing marked liver 
parenchymal damage or blood dyscrasia, nor in those with a history of 
sulfonamide sensitivity.
    (7) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.

[41 FR 3853, Jan. 27, 1976, as amended at 44 FR 32214, June 5, 1979; 46 
FR 23231, Apr. 24, 1981; 47 FR 36814, Aug. 24, 1982; 50 FR 9800, Mar. 
12, 1985; 50 FR 11852, Mar. 26, 1985; 61 FR 5506, Feb. 13, 1996; 61 FR 
8873, Mar. 6, 1996; 62 FR 61625, Nov. 19, 1997]



Sec. 520.2611  Trimethoprim and sulfadiazine paste.

    (a) Specifications. Each gram (g) of paste contains 67 milligrams 
(mg) trimethoprim and 333 mg sulfadiazine.
    (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter:
    (1) No. 000856 for product administered as in paragraph (c)(1)(i) of 
this section.
    (2) No. 000061 for product administered as in paragraph (c)(1)(ii) 
of this section.
    (c) Conditions of use in horses--(1) Amount. Administer orally as a 
single daily dose for 5 to 7 days:
    (i) 5 g of paste (335 mg trimethoprim and 1,665 mg sulfadiazine) per 
150 pounds (68 kilograms) of body weight per day.
    (ii) 3.75 g of paste (250 mg trimethoprim and 1,250 mg sulfadiazine) 
per 110 pounds (50 kilograms) of body weight per day.
    (2) Indications for use. For use where systemic antibacterial action 
against sensitive organisms is required during treatment of acute 
strangles, respiratory infections, acute urogenital infections, and 
wound infections and abscesses.
    (3) Limitations. Not for use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

[71 FR 30802, May 31, 2006]



Sec. 520.2612  Trimethoprim and sulfadiazine oral suspension.

    (a) Specifications. Each milliliter of oral suspension contains 60 
milligrams of drug (10 milligrams of trimethoprim and 50 milligrams of 
sulfadiazine).
    (b) Sponsor. See No. 000061 in Sec. 510.600 of this chapter.
    (c) Conditions of use. Dogs--(1) Dosage. 1 milliliter (10 milligrams 
of trimethoprim and 50 milligrams of sulfadiazine) per 5 pounds of body 
weight.
    (2) Indications for use. The drug is used in dogs where systemic 
antibacterial action against sensitive organisms is required, either 
alone or as an adjunct to surgery or debridement with associated 
infection. The drug is indicated where control of bacterial infection is 
required during the treatment of acute urinary tract infections, acute 
bacterial complications of distemper, acute respiratory tract 
infections, acute alimentary tract infections, wound infections, and 
abscesses.
    (3) Limitations. For oral use only. Administer the recommended dose 
once daily or one-half the recommended daily dose every 12 hours. 
Administer for 2 to 3 days after symptoms have subsided. If no 
improvement is seen in 3 days, discontinue therapy and reevaluate 
diagnosis. Do not treat for more than 14 consecutive days. During long-
term treatment, a complete blood count is recommended. The drug should 
not be used in patients showing marked liver parenchymal damage or blood 
dyscrasia, nor in those with a history of sulfonamide sensitivity. 
Federal law restricts this drug to use by or on the order of a licensed 
veterinarian.

[50 FR 19168, May 7, 1985, as amended at 61 FR 8873, Mar. 6, 1996; 62 FR 
61625, Nov. 19, 1997]



Sec. 520.2613  Trimethoprim and sulfadiazine powder.

    (a) Specifications. Each gram of powder contains 67 milligrams of 
trimethoprim and 333 milligrams of sulfadiazine.

[[Page 243]]

    (b) Sponsor. See No. 000009 and 058711 in Sec. 510.600(c) of this 
chapter.
    (c) Conditions of use: Horses--(1) Dosage. 3.75 grams of powder per 
110 pounds (50 kilograms) of body weight per day.
    (2) Indications for use. For control of bacterial infections of 
horses during treatment of acute strangles, respiratory tract 
infections, acute urogenital infections, wound infections, and 
abscesses.
    (3) Limitations. Administer orally in a small amount of feed, as a 
single daily dose, for 5 to 7 days. Continue therapy for 2 to 3 days 
after clinical signs have subsided. If no improvement is seen in 3 to 5 
days, reevaluate diagnosis. A complete blood count should be done 
periodically with prolonged use. Not for use in horses intended for 
food. Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.

[58 FR 36135, July 6, 1993, as amended by 64 FR 68289, Dec. 7, 1999]



Sec. 520.2640  Tylosin.

    (a) Specifications. Tylosin is the antibiotic substance produced by 
growth of Streptromyces fradiae or the same antibiotic substance 
produced by any other means. Tylosin, present as the tartrate salt, 
conforms to the appropriate antibiotic standard. Tylosin contains at 
least 95 percent tylosin as a combination of tylosin A, tylosin B, 
tylosin C, and tylosin D of which at least 80 percent is tylosin A as 
determined by a method entitled ``Determination of Factor Content in 
Tylosin by High Performance Liquid Chromatography,'' which is 
incorporated by reference. Copies are available from the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852, or at the National Archives and 
Records Administration (NARA). For information on the availability of 
this material at NARA, call 202-741-6030, or go to: http://
www.archives.gov/federal--register/code--of--federal--regulations/ibr--
locations.html.
    (b) Sponsor. See No. 000986 in Sec. 510.600(c) of this chapter.
    (c) Special considerations. The quantities of antibiotic in 
paragraph (e) of this section refer to the activity of the appropriate 
standard.
    (d) Related tolerances. See Sec. 556.740 of this chapter.
    (e) Conditions of use--(1) Chickens--(i) Amount. 2 grams per gallon.
    (ii) Indications for use. Aid in the treatment of chronic 
respiratory disease (CRD) caused by Mycoplasma gallisepticum sensitive 
to tylosin in broiler and replacement chickens. For the control of 
chronic respiratory disease (CRD) caused by Mycoplasma gallisepticum 
sensitive to tylosin at time of vaccination or other stress in chickens. 
For the control of chronic respiratory disease (CRD) caused by 
Mycoplasma synoviae sensitive to tylosin in broiler chickens.
    (iii) Limitations. Do not use in layers producing eggs for human 
consumption; administer from 1 to 5 days as sole source of drinking 
water; treated chickens should consume enough medicated drinking water 
to provide 50 milligrams of tylosin per pound of body weight per day; 
prepare a fresh solution every 3 days; do not administer within 24 hours 
of slaughter .
    (2) Turkeys--(i) Amount. 2 grams per gallon.
    (ii) Indications for use. Maintaining weight gains and feed 
efficiency in the presence of infectious sinusitis caused by Mycoplasma 
gallisepticum sensitive to tylosin.
    (iii) Limitations. Do not use in layers producing eggs for human 
consumption; administer from 2 to 5 days as sole source of drinking 
water; treated turkeys should consume enough medicated drinking water to 
provide 60 milligrams of tylosin per pound of body weight per day; 
prepare a fresh solution every 3 days; when sinus swelling is present, 
inject the sinus with tylosin injectable simultaneously with the 
drinking water treatment; do not administer within 5 days of slaughter.
    (3) Swine--(i) Amount. 0.25 gram per gallon.
    (ii) Indications for use. For the control and treatment of swine 
dysentery (bloody scours) caused by pathogens sensitive to tylosin.
    (iii) Limitations. As only source of drinking water for 3 to 10 
days, depending on the severity of the condition being treated: mix 
fresh solution daily; medication must be withheld from animals 48 hours 
prior to slaughter.

[[Page 244]]

    (4) Honey bees--(i) Amount. Mix 200 milligrams tylosin in 20 grams 
confectioners'/powdered sugar. Use immediately. Apply (dust) this 
mixture over the top bars of the brood chamber once weekly for 3 weeks.
    (ii) Indications for use. For the control of American foulbrood 
(Paenibacillus larvae).
    (iii) Limitations. The drug should be fed early in the spring or 
fall and consumed by the bees before the main honey flow begins, to 
avoid contamination of production honey. Complete treatments at least 4 
weeks before main honey flow.

[40 FR 13838, Mar. 27, 1975, as amended at 50 FR 49841, Dec. 5, 1985; 59 
FR 14365, Mar. 28, 1994; 62 FR 39443, July 23, 1997; 68 FR 24879, May 9, 
2003; 70 FR 69439, Nov. 16, 2005]



PART 522_IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS--Table of 

Contents




Sec.
522.23 Acepromazine maleate injection.
522.44 Sterile sodium acetazolamide.
522.46 Alfaprostol.
522.56 Amikacin sulfate injection.
522.62 Aminopentamide hydrogen sulfate injection.
522.82 Aminopropazine fumarate sterile solution injection.
522.84 Beta-aminopropionitrile fumarate.
522.88 Sterile amoxicillin trihydrate for suspension.
522.90 Ampicillin implantation and injectible dosage forms.
522.90a Ampicillin trihydrate sterile suspension.
522.90b Ampicillin trihydrate for sterile suspension.
522.90c Ampicillin sodium.
522.144 Arsenamide sodium aqueous injection.
522.147 Atipamezole.
522.150 Azaperone injection.
522.161 Betamethasone acetate and betamethasone disodium phosphate 
          aqueous suspension.
522.163 Betamethasone dipropionate and betamethasone sodium phosphate 
          aqueous suspension.
522.204 Boldenone.
522.234 Butamisole hydrochloride.
522.246 Butorphanol.
522.275 N-Butylscopolammonium bromide.
522.311 Carfentanil citrate injection.
522.312 Carprofen.
522.313 Ceftiofur injectable dosage forms.
522.313a Ceftiofur crystalline free acid.
522.313b Ceftiofur hydrochloride.
522.313c Ceftiofur sodium.
522.380 Chloral hydrate, pentobarbital, and magnesium sulfate sterile 
          aqueous solution.
522.390 Chloramphenicol injection.
522.460 Cloprostenol sodium.
522.468 Colistimethate sodium powder for injection.
522.480 Repository corticotropin injection.
522.518 Cupric glycinate injection.
522.522 Danofloxacin.
522.533 Deslorelin acetate.
522.535 Desoxycorticosterone pivalate.
522.536 Detomidine hydrochloride injection.
522.540 Dexamethasone injection.
522.542 Dexamethasone-21-isonicotinate suspension.
522.558 Dexmedetomidine.
522.563 Diatrizoate meglumine and diatrizoate sodium injection.
522.650 Dihydrostreptomycin sulfate injection.
522.690 Dinoprost solution.
522.723 Diprenorphine hydrochloride injection.
522.770 Doramectin.
522.775 Doxapram.
522.778 Doxycycline hyclate.
522.784 Doxylamine succinate injection.
522.800 Droperidol and fentanyl citrate injection.
522.810 Embutramide, chloroquine, and lidocaine solution.
522.812 Enrofloxacin.
522.820 Erythromycin.
522.840 Estradiol.
522.842 Estradiol benzoate and testosterone propionate.
522.850 Estradiol valerate and norgestomet in combination.
522.863 Ethylisobutrazine hydrochloride injection.
522.870 Etodolac.
522.883 Etorphine hydrochloride injection.
522.900 Euthanasia solution.
522.914 Fenprostalene solution.
522.955 Florfenicol.
522.960 Flumethasone implantation or injectable dosage forms.
522.960a Flumethasone suspension.
522.960b Flumethasone acetate injection.
522.960c Flumethasone solution.
522.970 Flunixin.
522.995 Fluprostenol sodium injection.
522.1002 Follicle stimulating hormone.
522.1004 Fomepizole.
522.1010 Furosemide.
522.1020 Gelatin solution.
522.1044 Gentamicin.
522.1066 Glycopyrrolate.
522.1077 Gonadorelin injectable.
522.1078 Gonadorelin diacetate tetrahydrate.
522.1079 Serum gonadotropin and chorionic gonadotropin.
522.1081 Chorionic gonadotropin for injection; chorionic gonadotropin 
          suspension.

[[Page 245]]

522.1085 Guaifenesin sterile powder.
522.1086 Guaifenesin injection.
522.1125 Hemoglobin glutamer-200 (bovine).
522.1145 Hyaluronate sodium.
522.1150 Hydrochlorothiazide injection.
522.1155 Imidocarb dipropionate sterile powder.
522.1156 Imidocarb dipropionate solution.
522.1160 Insulin.
522.1182 Iron injection.
522.1192 Ivermectin.
522.1193 Ivermectin and clorsulon.
522.1204 Kanamycin sulfate injection.
522.1222 Ketamine hydrochloride injectable dosage forms.
522.1222a Ketamine.
522.1222b Ketamine hydrochloride with promazine hydrochloride and 
          aminopentamide hydrogen sulfate injection.
522.1225 Ketoprofen solution.
522.1228 [Reserved]
522.1244 Levamisole phosphate injection.
522.1260 Lincomycin.
522.1289 Lufenuron suspension.
522.1290 Luprostiol sterile solution.
522.1315 Maropitant.
522.1335 Medetomidine hydrochloride injection.
522.1350 Melatonin implant.
522.1362 Melarsomine dihydrochloride for injection.
522.1367 Meloxicam.
522.1372 Mepivacaine.
522.1380 Methocarbamol injection.
522.1410 Sterile methylprednisolone acetate suspension.
522.1450 Moxidectin solution.
522.1451 Moxidectin for suspension.
522.1452 Nalorphine hydrochloride injection.
522.1462 Naloxone hydrochloride injection.
522.1465 Naltrexone hydrochloride injection.
522.1468 Naproxen for injection.
522.1484 Neomycin sulfate sterile solution.
522.1503 Neostigmine methylsulfate injection.
522.1610 Oleate sodium solution.
522.1620 Orgotein for injection.
522.1642 Oxymorphone hydrochloride injection.
522.1660 Oxytetracycline injectable dosage forms.
522.1660a Oxytetracycline solution, 200 milligrams/milliliter.
522.1660b Oxytetracycline solution, 300 milligrams/milliliter.
522.1662 Oxytetracycline hydrochloride implantation or injectable dosage 
          forms.
522.1662a Oxytetracycline hydrochloride injection.
522.1662b Oxytetracycline hydrochloride with lidocaine injection.
522.1680 Oxytocin injection.
522.1696 Penicillin G procaine implantation and injectable dosage forms.
522.1696a Penicillin G benzathine and penicillin G procaine suspension.
522.1696b Penicillin G procaine aqueous suspension.
522.1696c Penicillin G procaine in oil.
522.1698 Pentazocine lactate injection.
522.1704 Sodium pentobarbital injection.
522.1720 Phenylbutazone injection.
522.1820 Pituitary luteinizing hormone for injection.
522.1850 Polysulfated glycosaminoglycan.
522.1862 Sterile pralidoxime chloride.
522.1870 Praziquantel injectable solution.
522.1881 Sterile prednisolone acetate aqueous suspension.
522.1883 Prednisolone sodium phosphate.
522.1884 Prednisolone sodium succinate injection.
522.1885 Prednisolone tertiary butylacetate suspension.
522.1890 Sterile prednisone suspension.
522.1920 Prochlorperazine, isopropamide for injection.
522.1940 Progesterone and estradiol benzoate.
522.1962 Promazine hydrochloride.
522.2002 Propiopromazine hydrochloride injection.
522.2005 Propofol injection.
522.2012 Prostalene solution.
522.2063 Pyrilamine maleate injection.
522.2076 Romifidine.
522.2100 Selenium, vitamin E injection.
522.2112 Sometribove zinc suspension.
522.2120 Spectinomycin dihydrochloride injection.
522.2121 Spectinomycin sulfate.
522.2150 Stanozolol sterile suspension.
522.2200 Sulfachlorpyridazine.
522.2220 Sulfadimethoxine injection.
522.2240 Sulfaethoxypyridazine.
522.2260 Sulfamethazine injectable solution.
522.2340 Sulfomyxin.
522.2404 Thialbarbitone sodium for injection.
522.2424 Sodium thiamylal for injection.
522.2444 Sodium thiopental implantation or injectable dosage forms.
522.2444a Sodium thiopental for injection.
522.2444b Sodium thiopental, sodium pentobarbital for injection.
522.2470 Tiletamine hydrochloride and zolazepam hydrochloride for 
          injection.
522.2471 Tilmicosin.
522.2474 Tolazoline hydrochloride injection.
522.2476 Trenbolone acetate.
522.2477 Trenbolone acetate and estradiol.
522.2478 Trenbolone acetate and estradiol benzoate.
522.2483 Sterile triamcinolone acetonide suspension.
522.2582 Triflupromazine hydrochloride injection.
522.2610 Trimethoprim and sulfadiazine.
522.2615 Tripelennamine hydrochloride injection.
522.2630 Tulathromycin.
522.2640 Tylosin injectable dosage forms.
522.2640a Tylosin injection.

[[Page 246]]

522.2662 Xylazine.
522.2670 Yohimbine injectable.
522.2680 Zeranol.
522.2690 Zinc gluconate.

    Authority: 21 U.S.C. 360b.

    Source: 40 FR 13858, Mar. 27, 1975, unless otherwise noted.



Sec. 522.23  Acepromazine maleate injection.

    (a) Specifications. Each milliliter of sterile aqueous solution 
contains 10 milligrams of acepromazine maleate.
    (b) Conditions of use. See No. 000010, 000856 and 059130 in Sec. 
510.600(c) of this chapter for use in dogs, cats, and horses as follows:
    (1) Indications for use. It is used in dogs, cats, and horses as a 
tranquilizer.
    (2) Amount. Dogs: 0.25 to 0.5 milligram per pound of body weight; 
Cats: 0.5 to 1.0 milligram per pound of body weight; Horses: 2.0 to 4.0 
milligrams per 100 pounds of body weight.
    (c) Conditions of use. See No. 000010 in Sec. 510.600(c) of this 
chapter for use in dogs as follows:
    (1) Indications for use. It is used in dogs as an aid in 
tranquilization and as a preanesthetic agent.
    (2) Amount. Dogs: 0.25 to 0.5 milligram per pound of body weight.
    (3) Limitations. The drug is administered intravenously, 
intramuscularly or subcutaneously with the dosage individualized 
depending upon the degree of tranquilization required. Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.

[46 FR 43831, Sept. 1, 1981, as amended at 53 FR 40727, Oct. 18, 1988; 
62 FR 35076, June 30, 1997; 68 FR 33856, June 6, 2003; 69 FR 33840, June 
17, 2004]



Sec. 522.44  Sterile sodium acetazolamide.

    (a) Specifications. Sterile sodium acetazolamide contains 
acetazolamide sodium complying with United States Pharmacopeia as a 
sterile powder with directions for reconstituting the product with 
sterile distilled water to furnish a product having a concentration of 
100 milligrams acetazolamide activity per milliliter.
    (b) Sponsor. See No. 010042 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use. (1) It is used as an aid in the treatment of 
dogs with mild congestive heart failure and for rapid reduction of 
intraocular pressure.\1\
---------------------------------------------------------------------------

    \1\ These conditions are NAS/NRC reviewed and deemed effective. 
Applications for these uses need not include effectiveness data as 
specified by Sec. 514.111 of this chapter, but may require 
bioequivalency and safety information.
---------------------------------------------------------------------------

    (2) It is administered intramuscularly or intraperitoneally to dogs 
at a level of 5 to 15 milligrams per pound of body weight daily 
preferably administered in two or more divided doses.\1\
    (3) For use only by or on the order of a licensed veterinarian.\1\



Sec. 522.46  Alfaprostol.

    (a) Specifications. Each milliliter of sterile solution contains 1 
milligram of alfaprostol.
    (b) Sponsor. No. 055882 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use. It is used in horses as follows:
    (1) Amount. For average mature mares, 6.0 micrograms per kilogram of 
body weight.
    (2) Indications for use. To cause luteolysis in mares with active 
corpora lutea.
    (3) Limitations. For intramuscular or subcutaneous use as a single 
injection. Not for horses intended for food. Alfaprostol is readily 
absorbed through the skin and can cause abortion and/or bronchial 
spasms. Women of childbearing age, asthmatics, and persons with 
bronchial and other respiratory problems should exercise extreme caution 
when handling this product. Federal law restricts this drug to use by or 
on the order of a licensed veterinarian.

[48 FR 43300, Sept. 23, 1983, as amended at 53 FR 40057, Oct. 13, 1988]



Sec. 522.56  Amikacin sulfate injection.

    (a) Specifications. Each milliliter of sterile aqueous solution 
contains 50 milligrams of amikacin (as the sulfate).
    (b) Sponsor. See Nos. 000856 and 059130 in Sec. 510.600(c) of this 
chapter.
    (c) Conditions of use--(1) Amount. 5 milligrams per pound of body 
weight twice daily.

[[Page 247]]

    (2) Indications for use. The drug is used in dogs for treatment of 
genitourinary tract infections (cystitis) caused by susceptible strains 
of Escherichia coli and Proteus spp. and skin and soft tissue infections 
caused by susceptible strains of Pseudomonas spp. and E. coli.
    (3) Limitations. The drug is administered intramuscularly or 
subcutaneously. Treat dogs with skin and soft tissue infections for a 
minimum of 7 days and those with genitourinary infections for 7 to 21 
days or until culture is negative and asymptomatic. If no response is 
observed after 3 days of treatment, therapy should be discontinued and 
the case reevaluated. Maximum duration of therapy should not exceed 30 
days. Systemic aminoglycoside therapy is contraindicated in dogs with 
seriously impaired renal function. Not for use in breeding dogs as 
reproductive studies have not been conducted. Use with extreme caution 
in dogs in which hearing acuity is required for functioning. Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.

[52 FR 11816, Apr. 13, 1987; 52 FR 15412, Apr. 28, 1987, as amended at 
53 FR 27851, July 25, 1988; 62 FR 23357, Apr. 30, 1997]



Sec. 522.62  Aminopentamide hydrogen sulfate injection.

    (a) Chemical name. 4-(Dimethylamino)-2,2-diphenylvaleramide hydrogen 
sulfate.
    (b) Specifications. It is sterile and each milliliter of aqueous 
solution contains 0.5 milligram of the drug.
    (c) Sponsor. See No. 000856 in Sec. 510.600(c) of this chapter.
    (d) Conditions of use. (1) It is intended for use in dogs and cats 
only for the treatment of vomiting and/or diarrhea, nausea, acute 
abdominal visceral spasm, pylorospasm, or hypertrophic gastritis.

    Note: Not for use in animals with glaucoma because of the occurrence 
of mydriasis.

    (2) Dosage is administered by subcutaneous or intramuscular 
injection every 8 to 12 hours, as follows:

------------------------------------------------------------------------
                                                               Dosage in
                 Weight of animal in pounds                   milligrams
------------------------------------------------------------------------
Up to 10....................................................         0.1
11 to 20....................................................         0.2
21 to 50....................................................         0.3
51 to 100...................................................         0.4
Over 100....................................................         0.5
------------------------------------------------------------------------


Dosage may be gradually increased up to a maximum of five times the 
suggested dosage. Following parenteral use dosage may be continued by 
oral administration of tablets.
    (3) For use only by or on the order of a licensed veterinarian.

[40 FR 13858, Mar. 27, 1975, as amended at 53 FR 27851, July 25, 1988]



Sec. 522.82  Aminopropazine fumarate sterile solution injection.

    (a) Specifications. Each milliliter of aminopropazine fumarate 
sterile aqueous solution, veterinary, contains aminopropazine fumarate 
equivalent to 25 milligrams of aminopropazine base.
    (b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use. (1) The drug is used for reducing excessive 
smooth muscle contractions, such as occur in urethral spasms associated 
with urolithiasis in cats and dogs and in colic spasms in horses.\1\
---------------------------------------------------------------------------

    \1\ These conditions are NAS/NRC reviewed and deemed effective. 
Applications for these uses need not include effectiveness data as 
specified by Sec. 514.111 of this chapter, but may require 
bioequivalency and safety information.
---------------------------------------------------------------------------

    (2) It is administered intramuscularly or intravenously to dogs and 
cats at a level of 1 to 2 milligrams per pound of body weight. It is 
administered intramuscularly or intravenously to horses at a level of 
0.25 milligrams per pound of body weight. Dosage can be repeated every 
12 hours, as indicated.\1\
    (3) Not for use in animals intended for food purposes.\1\
    (4) For use only by or on the order of a licensed veterinarian.\1\

[40 FR 13858, Mar. 27, 1975, as amended at 46 FR 48642, Oct. 2, 1981; 61 
FR 8873, Mar. 6, 1996; 62 FR 61625, Nov. 19, 1997]



Sec. 522.84  Beta-aminopropionitrile fumarate.

    (a) Specifications. Each vial contains 7.0 milligrams of beta-

[[Page 248]]

aminopropionitrile fumarate sterile lyophilized powder which is 
reconstituted for injection with 10 milliliters of sterile physiologic 
saline, USP.
    (b) Sponsor. See No. 064146 in Sec. 510.600(c) of this chapter.
    (c) [Reserved]
    (d) Conditions of use--(1) Horses--(i) Amount. 7 milligrams (10 
milliliters) intralesionally every other day for 5 treatments beginning 
about 30 days after initial injury.
    (ii) Indications for use. For treatment of tendinitis of the 
superficial digital flexor tendon (SDFT) in the adult horse where there 
is sonographic evidence of fiber tearing.
    (iii) Limitations. Single dose container for intralesional 
injection. Do not use in horses with dermal irritation or open skin 
lesions in the injection area. Do not administer intraarticularly, into 
the tendon sheath, or in the presence of concurrent limb fractures. Do 
not use in breeding animals since the effects on fertility, pregnancy, 
or fetal health have not been determined. Not for use in horses intended 
for food. Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.
    (2) [Reserved]

[63 FR 44382, Aug. 19, 1998]



Sec. 522.88  Sterile amoxicillin trihydrate for suspension.

    (a)(1) Specifications. Each vial contains 3 grams of amoxicillin as 
the trihydrate. The powder is reconstituted with sterile water for 
injection USP to a concentration of 100 or 250 milligrams per milliliter 
for use as in paragraph (d) of this section.
    (2) Each vial contains 25 grams of amoxicillin as the trihydrate. 
The powder is reconstituted with sterile water for injection USP to a 
concentration of 250 milligrams per milliliter for use as in paragraph 
(e).
    (b) Sponsor. See 000069 in Sec. 510.600(c) of this chapter.
    (c) Related tolerance. See Sec. 556.38 of this chapter.
    (d) Conditions of use in dogs and cats--(1) Amount. 5 milligrams per 
pound of body weight daily.
    (2) Indications for use--(i) Dogs. Treatment of infections caused by 
susceptible strains of organisms as follows: Respiratory infections 
(tonsillitis, tracheobronchitis) due to Staphylococcus aureus, 
Streptococcus spp., Escherichia coli, and Proteus mirabilis; 
genitourinary infections (cystitis) due to S. aureus, Streptococcus 
spp., E. coli, and P. mirabilis; gastrointestinal infections (bacterial 
gastroenteritis) due to S. aureus, Streptococcus spp., E. coli, and P. 
mirabilis; bacterial dermatitis due to S. aureus, Streptococcus spp., 
and P. mirabilis; soft tissue infections (abscesses, lacerations, and 
wounds), due to S. aureus, Streptococcus spp., E. coli, and P. 
mirabilis.
    (ii) Cats. Treatment of infections caused by susceptible strains of 
organisms as follows: Upper respiratory infections due to S. aureus, 
Staphylococcus spp., Streptococcus spp., Hemophilus spp., E. coli, 
Pasteurella spp., and P. mirabilis; genitourinary infections (cystitis) 
due to S. aureus, Streptococcus spp., E. coli, P. mirabilis, and 
Corynebacterium spp.; gastrointestinal infections due to E. coli, 
Proteus spp., Staphylococcus spp., and Streptococcus spp.; skin and soft 
tissue infections (abscesses, lacerations, and wounds) due to S. aureus, 
Staphylococcus spp., Streptococcus spp., E. coli, and Pasteurella 
multocida.
    (3) Limitations. For use in dogs and cats only. Administer once 
daily for up to 5 days by intramuscular or subcutaneous injection. 
Continue treatment for 48 hours after the animal has become afebrile or 
asymptomatic. If no improvement is seen within 5 days, review the 
diagnosis and change therapy. As with all antibiotics, appropriate in 
vitro culturing susceptibility testing of samples taken before treatment 
should be conducted. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.
    (e) Condition of use. Cattle--(1) Amount. 3 to 5 milligrams per 
pound of body weight once a day according to the animal being treated, 
the severity of infection, and the animal's response.