[Federal Register Volume 81, Number 248 (Tuesday, December 27, 2016)]
[Rules and Regulations]
[Pages 94987-94991]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-31084]
[[Page 94987]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 520 and 529
[Docket No. FDA-2016-N-0002]
Oral Dosage Form New Animal Drugs; Approval of New Animal Drug
Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendment.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of 43 supplemental new animal drug
applications (NADAs) and 52 supplemental abbreviated new animal drug
applications (ANADAs) for revised labeling reflecting a change in
marketing status from over-the-counter (OTC) to prescription (Rx) for
antimicrobial drugs of importance to human medicine administered to
food-producing animals in medicated drinking water. These applications
were submitted in voluntary compliance with the goals of the FDA Center
for Veterinary Medicine's (CVM's) Judicious Use Initiative.
DATES: This rule is effective December 31, 2016.
FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for
Veterinary Medicine (HFV-6), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855, 240-402-5689,
[email protected].
SUPPLEMENTARY INFORMATION: FDA is amending the animal drug regulations
to reflect approval of 43 supplemental NADAs and 52 supplemental ANADAs
for revised labeling reflecting a change in marketing status from OTC
to Rx for antimicrobial drugs of importance to human medicine
administered to food-producing animals in medicated drinking water.
These applications were identified as being affected by guidance for
industry (GFI) #213, ``New Animal Drugs and New Animal Drug Combination
Products Administered in or on Medicated Feed or Drinking Water of
Food-Producing Animals: Recommendations for Drug Sponsors for
Voluntarily Aligning Product Use Conditions with GFI #209,'' December
2013 (http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM299624.pdf). Their
change to Rx marketing status is consistent with the FDA CVM's
initiative for the Judicious Use of Antimicrobials. The affected
applications follow:
------------------------------------------------------------------------
File No. Animal drug product Sponsor
------------------------------------------------------------------------
006-084..................... SULMET Huvepharma EOOD, 5th
(sulfamethazine) Floor, 3A Nikolay
Drinking Water Haytov Str., 1113
Solution. Sophia, Bulgaria
(Huvepharma EOOD).
006-677..................... S.Q. Huvepharma EOOD.
(sulfaquinoxaline)
20% Solution.
006-707..................... SULQUIN 6-50 Zoetis Inc., 333
(Sulfaquinoxaline). Portage St.,
Kalamazoo, MI 49007
(Zoetis Inc.).
006-891..................... SUL-Q-NOX Huvepharma EOOD.
(sulfaquinoxaline)
Solution.
007-087..................... Sulfaquinoxaline Huvepharma EOOD.
Solubilized
(Powder).
008-622..................... TERRAMYCIN Zoetis Inc.
(oxytetracycline)
Soluble Powder.
011-315..................... NEOMIX 325 Zoetis Inc.
(neomycin) Soluble
Powder.
015-160..................... Sodium Zoetis Inc.
Sulfachloropyrazine
Solution.
031-205..................... AGRIBON Zoetis Inc.
(sulfadimethoxine)
12.5% Drinking
Water Solution.
031-553..................... ESB 3 Zoetis Inc.
(sulfachloropyrazin
e) Soluble Powder/
Solution.
032-946..................... MAGNA TERRAMYCIN Zoetis Inc.
(oxytetracycline
and carbomycin)
Soluble Powder.
033-373..................... VETSULID SP Huvepharma EOOD.
(sulfachloropyridaz
ine) Soluble Powder.
035-157..................... GALLIMYCIN Cross Vetpharm Group
(erythromycin) Ltd., Broomhill
Soluble Powder. Rd., Tallaght,
Dublin 24, Ireland
(Cross Vetpharm
Group Ltd.).
038-200..................... MEDAMYCIN Phibro Animal Health
(oxytetracycline) Corp., GlenPointe
Soluble Powder. Centre East, 3d
floor, 300 Frank W.
Burr Blvd., suite
21, Teaneck, NJ
07666 (Phibro
Animal Health
Corp.).
038-661..................... SPECTOGARD Cross Vetpharm Group
(spectinomycin) Ltd.
Water Soluble
Powder.
046-109..................... L-S 50 (lincomycin Zoetis Inc.
and spectinomycin)
Water Soluble
Powder.
046-285..................... AGRIBON Zoetis Inc.
(sulfadimethoxine)
Soluble Powder.
055-012..................... CHLORONEX SULMET Huvepharma EOOD.
(chlortetracycline
bisulfate and
sulfamethazine)
Soluble Powder.
055-020..................... AUREOMYCIN Zoetis Inc.
(chlortetracycline)
Soluble Powder.
055-060..................... Penicillin G Zoetis Inc.
Potassium, USP.
065-071..................... AUREOMYCIN Huvepharma EOOD.
(chlortetracycline)
Soluble Powder.
065-123..................... Tetracycline Soluble Zoetis Inc.
Powder.
065-140..................... TET-SOL 324 Huvepharma EOOD.
(tetracycline)
Soluble Powder.
065-178..................... FERMYCIN Phibro Animal Health
(chlortetracycline) Corp.
Soluble.
065-256..................... CHLORO-SOLUBLE-O Pharmgate LLC, 1015
(chlortetracycline) Ashes Dr., suite
Soluble Powder. 102, Wilmington, NC
28405 (Pharmgate
LLC).
065-269..................... POLYOTIC Huvepharma EOOD.
(tetracycline)
Soluble Powder.
065-410..................... TETRA-SAL Zoetis Inc.
(tetracycline)
Soluble Powder.
065-440..................... CHLORONEX Huvepharma EOOD.
(chlortetracycline)
Soluble Powder.
065-441..................... POLYOTIC Zoetis Inc.
(tetracycline)
Soluble Powder
Concentrate.
065-480..................... Chlortetracycline Pharmgate LLC.
Soluble Powder.
065-486..................... Chlortetracycline Strategic Veterinary
Bisulfate Soluble Pharmaceuticals,
Powder. Inc., 100 NW.
Airport Rd., St.
Joseph, MO 64503
(Strategic Vet.
Pharm., Inc.).
065-496..................... Tetracycline Soluble Phibro Animal Health
Powder. Corp.
091-191..................... GENTOCIN Intervet, Inc., 2
(gentamicin) Oral Giralda Farms,
Solution. Madison, NJ 07940
(Intervet, Inc.).
100-094..................... POULTRY SULFA Huvepharma EOOD.
(sulfamerazine,
sulfamethazine, and
sulfaquinoxaline)
Soluble Powder.
106-964..................... APRALAN (apramycin) Elanco US Inc.
Soluble Powder.
111-636..................... LINCOMIX Zoetis Inc.
(lincomycin)
Soluble Powder.
[[Page 94988]]
122-272..................... SULMET Huvepharma EOOD.
(sulfamethazine)
Soluble Powder.
130-435..................... OXY-TET Huvepharma EOOD.
(oxytetracycline)
Soluble Powder.
133-836..................... GARACIN (gentamicin) Intervet, Inc.
Soluble Powder.
140-578..................... SOLU-TET 324 Zoetis Inc.
(tetracycline)
Soluble Powder.
200-026..................... PENNOX 343 Pharmgate LLC.
(oxytetracycline).
200-030..................... Sulfadimethoxine Agri Laboratories,
12.5% Oral Solution. Ltd., P.O. Box
3103, St. Joseph,
MO 64503 (Agri
Laboratories,
Ltd.).
200-031..................... Sulfadimethoxine Agri Laboratories,
Antibacterial Ltd.
Soluble Powder.
200-046..................... Neomycin Soluble Zoetis Inc.
Powder.
200-049..................... Tetracycline Agri Laboratories,
Hydrochloride Ltd.
Soluble Powder-324.
200-050..................... NEOMED (neomycin) Cross Vetpharm Group
Soluble Powder. Ltd.
200-066..................... AGRIMYCIN-343 Agri Laboratories,
(oxytetracycline) Ltd.
Soluble Powder.
200-103..................... PENAQUA SOL-G Cross Vetpharm Group
(penicillin G Ltd.
potassium) Soluble
Powder.
200-106..................... R-PEN (penicillin G Huvepharma EOOD.
potassium) Soluble
Powder.
200-113..................... BIOSOL[supreg] Zoetis Inc.
(neomycin) Liquid.
200-118..................... Neomycin Oral Huvepharma EOOD.
Solution.
200-122..................... SOLU-PEN (penicillin Zoetis Inc.
G potassium)
Soluble Powder.
200-130..................... NEO-SOL 50 Zoetis Inc.
(neomycin) Soluble
Powder.
200-136..................... Tetracycline Quo Vademus, LLC,
Hydrochloride 277 Faison McGowan
Soluble Powder-324. Rd., Kenansville,
NC 28349 (Quo
Vademus, LLC).
200-144..................... Oxytetracycline HCl Cross Vetpharm Group
Soluble Powder. Ltd.
200-146..................... TETROXY 25 Cross Vetpharm Group
(oxytetracycline). Ltd.
200-153..................... NEO 200 (neomycin) Huvepharma EOOD.
Oral Solution.
200-165..................... SDM Strategic Vet.
(sulfadimethoxine) Pharm., Inc.
12.5% Oral Solution.
200-185..................... GEN-GARD (Gentamicin Agri Laboratories,
sulfate) Soluble Ltd.
Powder.
200-189..................... Lincomycin Soluble.. Huvepharma EOOD.
200-190..................... GENTORAL (gentamicin Med-Pharmex, Inc.,
sulfate) Oral 2727 Thompson Creek
Solution. Rd., Pomona, CA
91767-1861 (Med-
Pharmex, Inc.).
200-192..................... Sulfadimethoxine Huvepharma EOOD.
12.5% Oral Solution.
200-197..................... Streptomycin Oral Huvepharma EOOD.
Solution w/STREP
SOL (RLNAD 065-252).
200-233..................... LINCO (lincomycin) Zoetis Inc.
Soluble Powder.
200-234..................... TETRASOL Med-Pharmex, Inc.
(tetracycline)
Soluble Powder.
200-235..................... NEOSOL (neomycin) Med-Pharmex, Inc.
Soluble Powder.
200-236..................... Chlortetracycline Quo Vademus, LLC.
HCL Soluble Powder.
200-238..................... SULFASOL Med-Pharmex, Inc.
(sulfadimethoxine)
Soluble Powder.
200-241..................... LINCOSOL Med-Pharmex, Inc.
(lincomycin)
Soluble Powder.
200-247..................... TETROXY 343 Cross Vetpharm Group
(oxytetracycline) Ltd.
Soluble Powder.
200-251..................... SULFORAL Med-Pharmex, Inc.
(Sulfadimethoxine)
Soluble Powder.
200-258..................... Sulfadimethoxine Phibro Animal Health
Soluble Powder. Corp.
200-289..................... NEOSOL-ORAL Med-Pharmex, Inc.
(neomycin) Soluble
Powder.
200-295..................... PENNCHLOR 64 Pharmgate LLC.
(chlortetracycline)
Soluble Powder.
200-303..................... Lincomycin Quo Vademus, LLC.
Hydrochloride
Soluble Powder.
200-345..................... Lincomycin- Phibro Animal Health
Spectinomycin Corp.
Soluble Powder.
200-347..................... Penicillin G Quo Vademus, LLC.
Potassium USP.
200-372..................... HAN-PEN (penicillin G.C. Hanford
G potassium) Manufacturing Co.,
Soluble Powder. P.O. Box 1017,
Syracuse, NY 13201
(G.C. Hanford Mfg.
Co.).
200-374..................... TETRAMED 324 HCA Cross Vetpharm Group
(tetracycline) Ltd.
Soluble Powder.
200-376..................... SULFAMED-G Cross Vetpharm Group
(sulfadimethoxine) Ltd.
Soluble Powder.
200-377..................... LINXMED-SP Cross Vetpharm Group
(lincomycin and Ltd.
spectinomycin)
Soluble Powder.
200-378..................... Neomycin Sulfate 325 Sparhawk
Soluble Powder. Laboratories, Inc.,
12340 Santa Fe
Trail Dr., Lenexa,
KS 66215 (Sparhawk
Laboratories,
Inc.).
200-379..................... Neomycin Liquid..... Sparhawk
Laboratories, Inc.
200-380..................... SPECLINX-50 Cross Vetpharm Group
(lincomycin and Ltd.
spectinomycin)
Soluble Powder.
200-407..................... Lincomycin- Agri Laboratories,
Spectinomycin Water Ltd.
Soluble Powder.
200-434..................... SMZ-MED 454 Cross Vetpharm Group
(sulfamethazine) Ltd.
Soluble Powder.
200-441..................... AUREOMYCIN Huvepharma EOOD.
(chlortetracycline)
Soluble Powder.
200-443..................... Sulfadimethoxine First Priority,
Soluble Powder. Inc., 1590 Todd
Farm Dr., Elgin, IL
60123.
200-460..................... TETROXY AQUATIC Cross Vetpharm Group
(oxytetracycline) Ltd.
Soluble Powder.
200-494..................... GENTAMED Cross Vetpharm Group
(gentamicin) Ltd.
Soluble Powder.
------------------------------------------------------------------------
The animal drug regulations are also being amended to reflect
several non-substantive changes in format. These technical amendments
are being made to improve the consistency and readability of the
regulations.
Elsewhere in this issue of the Federal Register, FDA is amending
the animal drug regulations to reflect approval of similar supplemental
NADAs and ANADAs changing the marketing status of antimicrobial drugs
administered to food-producing animals in medicated feed.
This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.
List of Subjects in 21 CFR Parts 520 and 529
Animal drugs.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR parts 520 and
529 are amended as follows:
[[Page 94989]]
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
1. The authority citation for part 520 continues to read as follows:
Authority: 21 U.S.C. 360b.
Sec. 520.110 [Amended]
0
2. In Sec. 520.110, in paragraph (d)(3), remove ``Prepare fresh
medicated water daily.'' and as the last sentence add ``Federal law
restricts this drug to use by or on the order of a licensed
veterinarian.''
Sec. 520.441 [Amended]
0
3. In Sec. 520.441, in paragraphs (d)(1)(i)(A)(2), (d)(2)(i)(A)(2),
(d)(4)(i)(A)(2), (d)(4)(i)(B)(2), (d)(4)(ii)(A)(2), (d)(4)(ii)(B)(2),
(d)(4)(iii)(C), (d)(4)(iv)(C), (d)(5)(i)(A)(2), (d)(5)(ii)(A)(2),
(d)(5)(iii)(C), and (d)(5)(iv)(C), as the last sentence add ``Federal
law restricts this drug to use by or on the order of a licensed
veterinarian.''
Sec. 520.445 [Amended]
0
4. In Sec. 520.445, in paragraph (d)(3), as the last sentence add
``Federal law restricts this drug to use by or on the order of a
licensed veterinarian.''
0
5. In Sec. 520.823, revise paragraphs (d)(1)(i), (d)(1)(iii),
(d)(2)(i), (d)(2)(iii), (d)(3)(i), and (d)(3)(iii) to read as follows:
Sec. 520.823 Erythromycin.
* * * * *
(d) * * *
(1) * * *
(i) Amount. Administer 0.500 gram per gallon for 5 days.
* * * * *
(iii) Limitations. Do not use in replacement pullets over 16 weeks
of age. Do not use in chickens producing eggs for human consumption.
Withdraw 1 day before slaughter. Federal law restricts this drug to use
by or on the order of a licensed veterinarian.
(2) * * *
(i) Amount. Administer 0.500 gram per gallon for 7 days.
* * * * *
(iii) Limitations. Do not use in replacement pullets over 16 weeks
of age. Do not use in chickens producing eggs for human consumption.
Withdraw 1 day before slaughter. Federal law restricts this drug to use
by or on the order of a licensed veterinarian.
(3) * * *
(i) Amount. Administer 0.500 gram per gallon for 7 days.
* * * * *
(iii) Limitations. Do not use in turkeys producing eggs for human
consumption. Withdraw 1 day before slaughter. Federal law restricts
this drug to use by or on the order of a licensed veterinarian.
0
6. In Sec. 520.1044a, revise paragraph (d)(3) to read as follows:
Sec. 520.1044a Gentamicin sulfate oral solution.
* * * * *
(d) * * *
(3) Limitations. Do not slaughter treated swine for food for at
least 3 days following treatment. Federal law restricts this drug to
use by or on the order of a licensed veterinarian.
0
7. In Sec. 520.1044c, remove paragraph (d)(4) and revise paragraph
(d)(3) to read as follows:
Sec. 520.1044c Gentamicin sulfate powder.
* * * * *
(d) * * *
(3) Limitations. Withdrawal period: 10 days. Federal law restricts
this drug to use by or on the order of a licensed veterinarian.
Sec. 520.1263c [Amended]
0
8. In Sec. 520.1263c, in paragraph (b)(1), remove ``No. 016592'' and
in its place add ``Nos. 016592 and 054771''; in paragraph (d)(1)(iii),
remove ``051259'' and in its place add ``054925'', and as the last
sentence add ``Federal law restricts this drug to use by or on the
order of a licensed veterinarian.''; and in paragraphs (d)(2)(iii) and
(d)(3)(iii), add ``Federal law restricts this drug to use by or on the
order of a licensed veterinarian.''
0
9. In Sec. 520.1265, add paragraph (d)(3) to read as follows:
Sec. 520.1265 Lincomycin and spectinomycin powder.
* * * * *
(d) * * *
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
10. In Sec. 520.1484, revise paragraphs (e)(1)(iii) and (e)(2)(iii) to
read as follows:
Sec. 520.1484 Neomycin.
* * * * *
(e) * * **
(1) * * *
(iii) Limitations. Discontinue treatment prior to slaughter as
follows: Cattle, 1 day; sheep, 2 days; swine and goats, 3 days. Federal
law restricts this drug to use by or on the order of a licensed
veterinarian.
(2) * * *
(iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
11. In Sec. 520.1660a, revise the section heading and paragraphs
(e)(1) and (e)(3) to read as follows:
Sec. 520.1660a Oxytetracycline and carbomycin.
* * * * *
(e) * * *
(1) Amount. Administer 1.0 gram of oxytetracycline and 1.0 gram
carbomycin per gallon for not more than 5 days.
* * * * *
(3) Limitations. Not for use in chickens producing eggs for human
consumption. Withdraw 24 hours before slaughter. Federal law restricts
this drug to use by or on the order of a licensed veterinarian.
0
12. In Sec. 520.1660d, revise paragraphs (d)(1)(i)(A)(1),
(d)(1)(i)(A)(3), (d)(1)(i)(B)(1), (d)(1)(i)(B)(3), (d)(1)(ii)(A)(1),
(d)(1)(ii)(A)(3), (d)(1)(ii)(B)(1), (d)(1)(ii)(B)(3), (d)(1)(ii)(C)(1),
(d)(1)(ii)(C)(3), (d)(1)(iii)(A), (d)(1)(iii)(C), (d)(1)(iv)(A),
(d)(1)(iv)(C), (d)(1)(v)(A), (d)(1)(v)(C), (d)(2)(i), and (d)(2)(iii)
to read as follows:
Sec. 520.1660d Oxytetracycline powder.
* * * * *
(d) * * *
(1) * * *
(i) * * *
(A) * * *
(1) Amount. Administer 200 to 400 milligrams/gallon for 7 to 14
days. Not to be used for more than 14 consecutive days.
* * * * *
(3) Do not use in birds producing eggs for human consumption.
Federal law restricts this drug to use by or on the order of a licensed
veterinarian.
(B) * * *
(1) Amount. Administer 400 to 800 milligrams/gallon for 7 to 14
days. Not to be used for more than 14 consecutive days.
* * * * *
(3) Do not use in birds producing eggs for human consumption.
Federal law restricts this drug to use by or on the order of a licensed
veterinarian.
(ii) * * *
(A) * * *
(1) Amount. Administer 200 to 400 milligrams/gallon for 7 to 14
days. Not to be used for more than 14 consecutive days.
* * * * *
(3) Do not use in birds producing eggs for human consumption.
Withdraw 5 days prior to slaughter those products sponsored by Nos.
054771 and 061623 in Sec. 510.600(c) of this chapter. Withdraw 4 days
prior to slaughter
[[Page 94990]]
those products sponsored by No. 054628. Zero-day withdrawal for those
products sponsored by Nos. 057561 and 069254. Federal law restricts
this drug to use by or on the order of a licensed veterinarian.
(B) * * *
(1) Amount. Administer 400 milligrams/gallon for 7 to 14 days. Not
to be used for more than 14 consecutive days.
* * * * *
(3) Do not use in birds producing eggs for human consumption.
Withdraw 5 days prior to slaughter those products sponsored by Nos.
054771 and 061623 in Sec. 510.600(c) of this chapter. Withdraw 4 days
prior to slaughter those products sponsored by No. 054628. Zero-day
withdrawal for those products sponsored by Nos. 057561 and 069254.
Federal law restricts this drug to use by or on the order of a licensed
veterinarian.
(C) * * *
(1) Amount. Administer 25 milligrams per pound of body weight daily
for 7 to 14 days. Not to be used for more than 14 consecutive days.
* * * * *
(3) Do not use in birds producing eggs for human consumption.
Withdraw 5 days prior to slaughter those products sponsored by Nos.
054771 and 061623 in Sec. 510.600(c) of this chapter. Withdraw 4 days
prior to slaughter those products sponsored by No. 054628. Zero-day
withdrawal for those products sponsored by Nos. 057561 and 069254.
Federal law restricts this drug to use by or on the order of a licensed
veterinarian.
(iii) * * *
(A) Amount. Administer 10 milligrams per pound of body weight daily
for up to 14 days. Do not use for more than 14 consecutive days.
* * * * *
(C) Withdraw zero days prior to slaughter those products sponsored
by Nos. 054771, 057561, 061623, and 069254 in Sec. 510.600(c) of this
chapter. Withdraw 4 days prior to slaughter those products sponsored by
No. 054628. Federal law restricts this drug to use by or on the order
of a licensed veterinarian.
(iv) * * *
(A) Amount. Administer 10 milligrams per pound of body weight daily
for up to 14 days. Do not use for more than 14 consecutive days.
* * * * *
(C) 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. Federal law
restricts this drug to use by or on the order of a licensed
veterinarian.
(v) * * *
(A) Amount. Administer 10 milligrams per pound of body weight daily
for up to 14 days. Not to be used for more than 14 consecutive days.
* * * * *
(C) Withdraw 5 days prior to slaughter. Federal law restricts this
drug to use by or on the order of a licensed veterinarian.
(2) * * *
(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. The drug is administered in 3
applications of sugar syrup or 3 dustings at 4- to 5-day intervals.
* * * * *
(iii) 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. Federal law restricts this drug to use by or on the
order of a licensed veterinarian.
0
13. In Sec. 520.1696b, redesignate paragraph (c) as paragraph (d) and
add new paragraph (c), and revise redesignated paragraph (d)(3) to read
as follows:
Sec. 520.1696b Penicillin G powder.
* * * * *
(c) Related tolerances. See Sec. 556.510 of this chapter.
* * * * *
(d) * * *
(3) Limitations. Discontinue treatment at least 1 day prior to
slaughter. Not for use in turkeys producing eggs for human consumption.
Federal law restricts this drug to use by or on the order of a licensed
veterinarian.
Sec. 520.2123b [Amended]
0
14. In Sec. 520.2123b, remove paragraph (d)(1)(i); redesignate
paragraphs (d)(1)(ii) and (iii) as paragraphs (d)(1)(i) and (ii); and
in paragraph (d)(2), as the last sentence add ``Federal law restricts
this drug to use by or on the order of a licensed veterinarian.''
Sec. 520.2184 [Amended]
0
15. In Sec. 520.2184, in paragraph (d)(3), remove the first sentence,
and as the last sentence add ``Federal law restricts this drug to use
by or on the order of a licensed veterinarian.''
Sec. 520.2200 [Amended]
0
16. In Sec. 520.2200, in paragraphs (d)(1)(iii) and (d)(2)(iii), as
the last sentence add ``Federal law restricts this drug to use by or on
the order of a licensed veterinarian.''
Sec. 520.2218 [Amended]
0
17. In Sec. 520.2218, in paragraphs (d)(1)(ii) and (d)(2)(ii), remove
the first sentence, and as the last sentence add ``Federal law
restricts this drug to use by or on the order of a licensed
veterinarian.''
0
18. In Sec. 520.2220a, revise the section heading and paragraphs
(d)(1)(iii), (d)(2)(iii), and (d)(3)(iii) to read as follows:
Sec. 520.2220a Sulfadimethoxine oral solution and soluble powder.
* * * * *
(d) * * *
(1) * * *
(iii) Limitations. Withdraw 5 days before slaughter. Federal law
restricts this drug to use by or on the order of a licensed
veterinarian.
(2) * * *
(iii) Limitations. Withdraw 5 days before slaughter. Federal law
restricts this drug to use by or on the order of a licensed
veterinarian.
(3) * * *
(iii) Limitations. 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. Federal law
restricts this drug to use by or on the order of a licensed
veterinarian. Federal law prohibits the extralabel use of this product
in lactating dairy cattle.
Sec. 520.2261a [Amended]
0
19. In Sec. 520.2261a, in paragraph (d)(3), as the last sentence add
``Federal law restricts this drug to use by or on the order of a
licensed veterinarian.''
Sec. 520.2261b [Amended]
0
20. In Sec. 520.2261b, in paragraphs (d)(1)(iii), (d)(2)(iii),
(d)(3)(iii), and (d)(4)(iii), as the last sentence add ``Federal law
restricts this drug to use by or on the order of a licensed
veterinarian.''
Sec. 520.2325a [Amended]
0
21. In Sec. 520.2325a, in paragraph (d), remove the first sentence,
and as the last sentence add ``Federal law restricts this drug to use
by or on the order of a licensed veterinarian.''
Sec. 520.2345d [Amended]
0
22. In Sec. 520.2345d, in paragraphs (d)(1)(iii), (d)(2)(iii),
(d)(3)(iii), and (d)(4)(iii), as the last sentence add ``Federal law
restricts this drug to use by or on the order of a licensed
veterinarian.''
[[Page 94991]]
PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS
0
23. The authority citation for part 529 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
24. In Sec. 529.1660, add paragraph (d)(3) to read as follows:
Sec. 529.1660 Oxytetracycline.
* * * * *
(d) * * *
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
Dated: December 20, 2016.
Tracey H. Forfa,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. 2016-31084 Filed 12-23-16; 8:45 am]
BILLING CODE 4164-01-P