[Federal Register Volume 79, Number 57 (Tuesday, March 25, 2014)]
[Rules and Regulations]
[Pages 16180-16198]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-06131]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
[Docket No. FDA-2014-N-0002]
Implantation or Injectable Dosage Form New Animal Drugs; Change
of Sponsor
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 a change of sponsor for 104 approved new
animal drug applications (NADAs) and 5 approved abbreviated new animal
drug applications (ANADAs) for implantation or injectable dosage form
new animal drug products from Pfizer, Inc., including its several
subsidiaries and divisions, to Zoetis, Inc. FDA is also amending the
animal drug regulations to remove entries describing conditions of use
for new animal drug products for which no NADA is approved, to make
minor corrections, and to reflect a
[[Page 16181]]
current format. This is being done to increase the accuracy and
readability of the regulations.
DATES: This rule is effective March 25, 2014.
FOR FURTHER INFORMATION CONTACT: Steven D. Vaughn, Center for
Veterinary Medicine (HFV-100), Food and Drug Administration, 7520
Standish Pl., Rockville, MD 20855; 240-276-8300,
[email protected].
SUPPLEMENTARY INFORMATION: Pfizer, Inc., 235 East 42d St., New York, NY
10017, and its wholly owned subsidiaries Alpharma, LLC; Fort Dodge
Animal Health, Division of Wyeth; Fort Dodge Animal Health, Division of
Wyeth Holdings Corp.; and its division, Pharmacia & Upjohn Co., have
informed FDA that they have transferred ownership of, and all rights
and interest in, the 104 approved NADAs and 5 approved ANADAs in table
1 to Zoetis, Inc., 333 Portage St., Kalamazoo, MI 49007 as follows:
Table 1--NADAs and ANADAs Being Transferred From Pfizer, Inc., to
Zoetis, Inc.
------------------------------------------------------------------------
File No. Product name
------------------------------------------------------------------------
006-103.................. FOLLUTEIN (chorionic gonadotropin)
Veterinary.
006-281.................. INTRAGEL (gelatin and sodium chloride)
Injectable Solution.
006-417.................. RECOVR (tripelennamine hydrochloride)
Injectable Solution.
008-769.................. LIQUAMYCIN (oxytetracycline hydrochloride)
Injectable Solution.
008-932.................. KEMITHAL L.A. (thialbarbitone sodium) Powder
for Injection.
009-576.................. SYNOVEX S and SYNOVEX C (progesterone and
estradiol benzoate) Implants.
010-809.................. SURITAL (thiamylal sodium) Injectable
Solution.
010-865.................. FERREXTRAN 100 (iron dextran complex)
Injection.
011-241.................. Promazine HCl Injectable Solution.
011-427.................. SYNOVEX H (estradiol benzoate and
testosterone propionate) Implants.
011-482.................. VETAME (Triflupromazine Hydrochloride)
Injectable Solution.
011-593.................. Solu-Delta Cortef (prednisolone sodium
succinate) Powder for Injection.
011-644.................. FELAC (colloidal ferric oxide) Injection.
011-789.................. PREDEF 2X (isoflupredone acetate) Injectable
Suspension.
011-879.................. RUBRAFER S-100 (iron dextran complex)
Injection.
011-953.................. BIOSOL (neomycin sulfate) Injectable
Solution.
012-204.................. DEPO-MEDROL (methylprednisolone acetate)
Injectable Suspension.
013-146.................. LIQUAMYCIN (oxytetracycline hydrochloride and
lidocaine) Injectable Solution.
015-126.................. Spectinomycin Tablet and Injection.
015-147.................. DARBAZINE (prochlorperazine and isopropamide)
Injection.
030-414.................. FLUCORT (flumethasone) Injectable Solution.
030-844.................. WINSTROL-V (stanozolol) Injectable
Suspension.
031-944.................. DYNAMYXIN (sulfomyxin) Injectable.
033-655.................. S.E.Z. (sulfaethoxypyridazine) Intravenous
Solution.
034-025.................. LINCOCIN (lincomycin hydrochloride)
Injectable Solution.
034-705.................. EQUIPOISE (boldenone undecylenate) Injection.
036-211.................. ANAPRIME (flumethasone) Injectable
Suspension.
036-212.................. FLUOSMIN (flumethasone acetate) Injectable
Suspension.
038-838.................. ROBAXIN-V (methocarbamol) Injectable.
039-204.................. PROTOPAM (pralidoxime chloride) Powder for
Injection.
041-245.................. AGRIBON (sulfadimethoxine) Injection 40%.
041-836.................. KANTRIM 200 (kanamycin sulfate) Injection.
043-079.................. CENTRINE (aminopentamide hydrogen sulfate)
Injectable.
043-304.................. KETASET (ketamine hydrochloride) Injection.
044-611.................. TALWIN-V (pentazocine lactate) Injection.
045-514.................. EQUIBUTE (phenylbutazone) Injection.
045-716.................. TRANVET (propiopromazine hydrochloride)
Injectable Solution.
046-788.................. Oxytocin Injection.
046-789.................. CHLOROPENT (chloral hydrate, magnesium
sulfate, and pentobarbital) Injection.
046-790.................. Sodium Thiopental Powder for Injection.
049-553.................. RIPERCOL L (levamisole phosphate) Injection.
049-948.................. AQUACHEL 100 (oxytetracycline hydrochloride)
Injectable Solution. with lidocaine.
055-064.................. PRINCILLIN (ampicillin trihydrate) Injection.
055-066.................. PRINCILLIN (ampicillin trihydrate) Injection.
055-071.................. PRINCILLIN (ampicillin trihydrate) Injection.
055-079.................. AMPI-JECT (ampicillin trihydrate) Injectable
Suspension.
055-084.................. AMP-EQUINE (ampicillin sodium) Powder for
Injection.
055-089.................. AMOXI-INJECT (amoxicillin trihydrate)
Injectable Suspension. (for Cattle).
055-091.................. AMOXI-INJECT (amoxicillin trihydrate)
Injectable Suspension. (for Dogs and Cats).
065-087.................. LONGICIL Fortified (penicillin G benzathine
and penicillin G procaine) Suspension.
065-130.................. CRYSTALLINE (penicillin G procaine)
Injectable Suspension.
065-169.................. FLO-CILLIN (penicillin G benzathine
penicillin G procaine) Injectable
Suspension.
065-174.................. CRYSTALLINE (penicillin G procaine)
Injectable Suspension.
065-463.................. MYCHEL-VET (chloramphenicol) Injection.
065-483.................. PFIZER-STREP (dihydrostreptomycin sulfate)
Injection.
091-127.................. RACHELLE OXYVET (oxytetracycline
hydrochloride) Injection.
091-192.................. RENOGRAFIN-76 (diatrizoate meglumine and
diatrizoate sodium) Injection.
091-240.................. RENOVIST (diatrizoate meglumine and
diatrizoate sodium) Injection.
092-116.................. KETASET Plus (ketamine hydrochloride,
promazine hydrochloride, and aminopentamide
hydrogen sulfate) Injection.
094-114.................. LIQUAMYCIN 100 (oxytetracycline
hydrochloride) Injectable Solution.
096-675.................. EQUIPROXEN (naproxen) 10% Injectable
Solution.
[[Page 16182]]
098-640.................. ROBIZONE (phenylbutazone) Injectable
Solution. 20%.
099-402.................. AQUACHEL 100 (oxytetracycline hydrochloride)
Injectable Solution.
100-202.................. PROSTIN F2 Alpha (dinoprost tromethamine)
Injectable Solution.
100-254.................. SYNCHROCEPT (prostalene) Injectable Solution.
100-703.................. CARBOCAINE-V (mepivacaine hydrochloride)
Injectable Solution.
101-777.................. ROBINUL-V (glycopyrrolate) Injectable.
102-437.................. TRAMISOL (levamisole phosphate) Injectable
Solution.
102-990.................. TORBUTROL (butorphanol tartrate) Injection.
104-184.................. STYQUIN (butamisole hydrochloride) Injectable
Solution.
106-111.................. TELAZOL (tiletamine hydrochloride and
zolazepam hydrochloride) for Injection.
108-901.................. LUTALYSE (dinoprost tromethamine) Injectable
Solution.
111-369.................. Dexamethasone Sterile Solution.
112-048.................. HYLARTIN V (hyaluronate sodium) Injection.
113-232.................. LIQUAMYCIN LA-200 (oxytetracycline
hydrochloride) Injectable Solution.
128-549.................. BOVILENE (fenprostalene) Injection.
128-967.................. REPOSE (dibucaine hydrochloride and
secobarbital sodium) Euthanasia Solution.
130-660.................. DEXACHEL (dexamethasone) Injection.
132-486.................. DI-TRIM (trimethoprim and sulfadiazine) 24%
Injectable Suspension.
134-778.................. DI-TRIM (trimethoprim and sulfadiazine) 48%
Injectable Suspension.
135-780.................. TORBUGESIC (butorphanol tartrate) Injection.
136-651.................. GUAILAXIN (guaifenesin) Powder for Injection.
138-903.................. PORCILENE (fenprostalene) Injection.
139-237.................. FACTREL (gonadorelin hydrochloride)
Injection.
139-913.................. EQURON (hyaluronate sodium) Injection.
140-269.................. KETOFEN (ketoprofen) Injection.
140-338.................. NAXCEL (ceftiofur sodium) Sterile Powder for
Injection.
140-890.................. EXCENEL RTU (ceftiofur hydrochloride)
Injectable Suspension.
141-043.................. SYNOVEX Choice or SYNOVEX Plus (trenbolone
acetate and estradiol benzoate) Implants.
141-047.................. TORBUGESIC-SA (butorphanol tartrate)
Injection.
141-061.................. DECTOMAX (doramectin) Injectable Solution.
141-069.................. FIRST GUARD (colistimethate sodium) Sterile
Powder.
141-077.................. ADSPEC (spectinomycin sulfate tetrahydrate)
Sterile Solution.
141-189.................. PROHEART 6 (moxidectin) Injectable
Suspension.
141-199.................. RIMADYL (carprofen) Injectable Solution.
141-207.................. ADVOCIN (danofloxacin) Injectable Solution.
141-209.................. EXCEDE (ceftiofur crystalline free acid)
Injectable Suspension.
141-235.................. EXCEDE (ceftiofur crystalline free acid)
Injectable Suspension. for Swine.
141-244.................. DRAXXIN (tulathromycin) Injectable Solution.
141-263.................. CERENIA (maropitant) Injectable Solution.
141-285.................. CONVENIA (cefovecin sodium) Powder for
Injection.
141-288.................. EXCENEL (ceftiofur hydrochloride) Injectable
Suspension.
141-303.................. PROPOCLEAR (propofol).
141-322.................. IMPROVEST (gonadotropin releasing factor-
diphtheria toxoid conjugate) Injection.
200-109.................. VELENIUM (vitamin E and sodium selenite)
Injection.
200-127.................. PROSPEC (spectinomycin sulfate tetrahydrate)
Injectable Solution.
200-142.................. Flunixin Meglumine Solution.
200-274.................. Lincomycin Injectable Solution. 30%.
200-367.................. SYNOVEX T120, T40, or T80 (trenbolone acetate
and estradiol) Implants.
------------------------------------------------------------------------
Accordingly, the Agency is amending the regulations in 21 CFR part
522 to reflect these transfers of ownership. In addition, the
regulations are being amended to make minor corrections and to reflect
a current format. This is being done to increase the accuracy and
readability of the regulations.
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 Part 522
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 part 522 is
amended as follows:
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
2. In Sec. 522.23, remove paragraphs (d) and (e); and revise
paragraphs (b) and (c) to read as follows:
Sec. 522.23 Acepromazine.
* * * * *
(b) Sponsors. See Nos. 000010 and 000859 in Sec. 510.600(c) of
this chapter:
(c) Conditions of use in dogs, cats, and horses--(1) Amount. Dogs:
0.25 to 0.5 mg per pound (/lb) of body weight; Cats: 0.5 to 1.0 mg/lb
of body weight; Horses: 2.0 to 4.0 mg per 100 lbs of body weight.
(2) Indications for use. For use as a tranquilizer and as a
preanesthetic agent.
(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.
Sec. 522.44 [Removed]
0
3. Remove Sec. 522.44.
[[Page 16183]]
0
4. Revise paragraph (b) of Sec. 522.56 to read as follows:
Sec. 522.56 Amikacin.
* * * * *
(b) Sponsor. See No. 000859 in Sec. 510.600(c) of this chapter.
* * * * *
0
5. Revise Sec. 522.62 to read as follows:
Sec. 522.62 Aminopentamide.
(a) Specifications. Each milliliter of solution contains 0.5
milligram (mg) aminopentamide hydrogen sulfate.
(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in dogs and cats--(1) Amount. Administer by
subcutaneous or intramuscular injection every 8 to 12 hours as follows:
For animals weighing up to 10 pounds (lbs): 0.1 mg; For animals
weighing 11 to 20 lbs: 0.2 mg; For animals weighing 21 to 50 lbs: 0.3
mg; For animals weighing 51 to 100 lbs: 0.4 mg; For animals weighing
over 100 lbs: 0.5 mg. 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.
(2) Indications for use. For the treatment of vomiting and/or
diarrhea, nausea, acute abdominal visceral spasm, pylorospasm, or
hypertrophic gastritis.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
6. Revise Sec. 522.82 to read as follows:
Sec. 522.82 Aminopropazine.
(a) Specifications. Each milliliter of solution contains
aminopropazine fumarate equivalent to 25 milligrams (mg) aminopropazine
base.
(b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Dogs and cats--(i) Amount. 1 to 2 mg per
pound of body weight, repeated every 12 hours as indicated, by
intramuscular or intravenous injection.
(ii) Indications for use. For reducing excessive smooth muscle
contractions, such as occur in urethral spasms associated with
urolithiasis.
(iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
(2) Horses--(i) Amount. Administer 0.25 mg per pound of body
weight, repeated every 12 hours as indicated, by intramuscular or
intravenous injection.
(ii) Indications for use. For reducing excessive smooth muscle
contractions, such as occur in colic spasms.
(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.
0
7. Revise Sec. 522.84 to read as follows:
Sec. 522.84 Beta-aminopropionitrile.
(a) Specifications. The drug is a sterile powder. Each milliliter
of constituted solution contains 0.7 milligrams (mg) beta-
aminopropionitrile fumarate.
(b) Sponsor. See No. 064146 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in horses--(1) Amount. Administer 7 mg by
intralesional injection every other day for five treatments beginning
about 30 days after initial injury.
(2) Indications for use in horses. For treatment of tendinitis of
the superficial digital flexor tendon (SDFT) in horses where there is
sonographic evidence of fiber tearing.
(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.
0
8. Revise Sec. 522.88 to read as follows:
Sec. 522.88 Amoxicillin.
(a) Specifications--(1) Each vial contains 3 grams (g) of
amoxicillin trihydrate. Each milliliter of constituted suspension
contains 100 or 250 milligrams (mg) amoxicillin trihydrate for use as
in paragraph (d)(1) of this section.
(2) Each vial contains 25 g of amoxicillin trihydrate. Each
milliliter of constituted suspension contains 250 mg amoxicillin
trihydrate for use as in paragraph (d)(2) of this section.
(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
(c) Related tolerance. See Sec. 556.38 of this chapter.
(d) Conditions of use--(1) Dogs and cats--(i) Amount. Administer 5
mg per pound of body weight daily for up to 5 days by intramuscular or
subcutaneous injection.
(ii) Indications for use--(A) Dogs. For 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.
(B) Cats. For treatment of infections caused by susceptible strains
of organisms as follows: Upper respiratory infections due to S. aureus,
Staphylococcus spp., Streptococcus spp., Haemophilus 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.
(iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
(2) Cattle--(i) Amount. Administer 3 to 5 mg per pound of body
weight daily for up to 5 days by intramuscular or subcutaneous
injection.
(ii) Indications for use. For treatment of diseases due to
amoxicillin-susceptible organisms as follows: Respiratory tract
infections (shipping fever, pneumonia) due to P. multocida, P.
hemolytica, Haemophilus spp., Staphylococcus spp., and Streptococcus
spp. and acute necrotic pododermatitis (foot rot) due to Fusobacterium
necrophorum.
(iii) Limitations. Treated animals must not be slaughtered for food
during treatment and for 25 days after the last treatment. Milk from
treated cows must not be used for human consumption during treatment or
for 96 hours (8 milkings) after last treatment. Federal law restricts
this drug to use by or on the order of a licensed veterinarian.
0
9. Revise Sec. 522.90 to read as follows:
Sec. 522.90 Ampicillin injectable dosage forms.
0
10. Revise Sec. 522.90a to read as follows:
Sec. 522.90a Ampicillin trihydrate suspension.
(a) Specifications. (1) Each milliliter contains ampicillin
trihydrate equivalent to 200 milligrams (mg) of ampicillin.
(2) Each milliliter contains ampicillin trihydrate equivalent to
150 mg of ampicillin.
(b) Sponsors. See sponsor numbers in Sec. 510.600(c) of this
chapter.
(1) No. 054771 for use of product described in paragraph (a)(1) as
in paragraphs (d)(1), (d)(2), (d)(3)(i)(A), (d)(3)(ii)(A), (d)(3)(iii),
and (d)(4) of this section.
(2) No. 054771 for use of product described in paragraph (a)(2) as
in
[[Page 16184]]
paragraphs (d)(3)(i)(B), (d)(3)(ii)(B), and (d)(3)(iii) of this
section.
(c) Related tolerances. See Sec. 556.40 of this chapter.
(d) Conditions of use--(1) Cattle--(i) Amount. For enteritis: 3 mg
per pound of body weight, intramuscularly, once or twice daily, for up
to 3 days. For pneumonia: 3 mg per pound of body weight,
intramuscularly, twice daily, for up to 3 days.
(ii) Indications for use. For treatment of bacterial enteritis in
calves caused by Escherichia coli and bacterial pneumonia caused by
Pasteurella spp. susceptible to ampicillin.
(iii) Limitations. Treated animals must not be slaughtered for food
use during treatment or for 9 days after the last treatment. Federal
law restricts this drug to use by or on the order of a licensed
veterinarian.
(2) Swine--(i) Amount. 3 mg per pound of body weight by
intramuscular injection, once or twice daily, for up to 3 days.
(ii) Indications for use. Treatment of bacterial enteritis
(colibacillosis) caused by E. coli and bacterial pneumonia caused by
Pasteurella spp. susceptible to ampicillin.
(iii) Limitations. Treated animals must not be slaughtered for food
use during treatment or for 15 days after the last treatment. Federal
law restricts this drug to use by or on the order of a licensed
veterinarian.
(3) Dogs--(i) Amount--(A) 3 to 6 mg per pound of body weight by
intramuscular injection, once or twice daily. Usual treatment is 3 to 5
days.
(B) 3 to 5 mg of ampicillin per pound of body weight, once a day
for up to 4 days.
(ii) Indications for use--(A) Treatment of respiratory tract
infections due to E. coli, Pseudomonas spp., Proteus spp.,
Staphylococcus spp., and Streptococcus spp.; tonsillitis due to E.
coli, Pseudomonas spp., Streptococcus spp., and Staphylococcus spp.;
generalized infections (septicemia) associated with abscesses,
lacerations, and wounds due to Staphylococcus spp. and Streptococcus
spp.
(B) Treatment of bacterial infections of the upper respiratory
tract (tonsillitis) due to Streptococcus spp., Staphylococcus spp., E.
coli, Proteus spp., and Pasteurella spp., and soft tissue infections
(abscesses, lacerations, and wounds) due to Staphylococcus spp.,
Streptococcus spp., and E. coli, when caused by susceptible organisms.
(iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
(4) Cats--(i) Amount. 5 to 10 mg per pound of body weight by
intramuscular or subcutaneous injection, once or twice daily. Usual
treatment is 3 to 5 days.
(ii) Indications for use. Treatment of generalized infections
(septicemia) associated with abscesses, lacerations, and wounds due to
Staphylococcus spp., Streptococcus spp., and Pasteurella spp.
(iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
11. In Sec. 522.90b, revise the section heading to read as follows:
Sec. 522.90b Ampicillin trihydrate powder for injection.
* * * * *
Sec. 522.90c [Amended]
0
12. In paragraph (b) of Sec. 522.90c, remove ``000069 and 010515'' and
in its place add ``010515 and 054771''.
0
13. Revise Sec. 522.144 to read as follows:
Sec. 522.144 Arsenamide.
(a) Specifications. Each milliliter of solution contains 10.0
milligrams arsenamide sodium.
(b) Sponsor. See No. 050604 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in dogs--(1) Amount. Administer 0.1
milliliter (mL) per pound of body weight (1.0 mL for every 10 pounds)
by intravenous injection twice a day for 2 days.
(2) Indications for use. For the treatment and prevention of canine
heartworm disease caused by Dirofilaria immitis.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
14. Revise Sec. 522.161 to read as follows:
Sec. 522.161 Betamethasone.
(a) Specifications. Each milliliter of suspension contains:
(1) Betamethasone acetate equivalent to 10.8 milligrams (mg)
betamethasone and betamethasone disodium phosphate equivalent to 3 mg
of betamethasone.
(2) Betamethasone dipropionate equivalent to 5 mg betamethasone and
betamethasone sodium phosphate equivalent to 2 mg of betamethasone.
(b) Sponsor. See sponsor numbers in Sec. 510.600(c) of this
chapter:
(1) No. 000061 for product described in paragraph (a)(1) of this
section for use as in paragraphs (c)(1), (c)(2)(i), (c)(2)(ii)(A), and
(c)(2)(iii) of this section.
(2) No. 000061 for product described in paragraph (a)(2) of this
section for use as in paragraphs (c)(1), (c)(2)(i), (c)(2)(ii)(B), and
(c)(2)(iii) of this section.
(c) Conditions of use--(1) Dogs--(i) Amount. Administer by
intramuscular injection 0.25 to 0.5 milliliter (mL) per 20 pounds of
body weight, depending on the severity of the condition. Frequency of
dosage depends on recurrence of pruritic symptoms. Dosage may be
repeated every 3 weeks or when symptoms recur, not to exceed a total of
four injections.
(ii) Indications for use. As an aid in the control of pruritus
associated with dermatoses.
(iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
(2) Horses--(i) Amount. Administer 2.5 to 5 mL by intra-articular
injection.
(ii) Indications for use--(A) For the treatment of various
inflammatory joint conditions; for example, acute and traumatic
lameness involving the carpel and fetlock joints.
(B) As an aid in the control of inflammation associated with
various arthropathies.
(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.
Sec. 522.204 [Amended]
0
15. In paragraph (b) of Sec. 522.204, remove ``053501'' and in its
place add ``054771''.
0
16. Revise Sec. 522.234 to read as follows:
Sec. 522.234 Butamisole.
(a) Specifications. Each milliliter of solution contains 11
milligrams (mg) butamisole hydrochloride.
(b) Sponsors. See Nos. 000859 and 054771 in Sec. 510.600(c) of
this chapter.
(c) Conditions of use in dogs--(1) Amount. Administer 0.1 mg per
pound of body weight by subcutaneous injection. In problem cases,
retreatment for whipworms may be necessary in approximately 3 months.
For hookworms, a second injection should be given 21 days after the
initial treatment.
(2) Indications for use. For the treatment of infections with
whipworms (Trichuris vulpis), and the hookworm (Ancylostoma caninum).
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
Sec. 522.246 [Amended]
0
17. In paragraph (b)(1) of Sec. 522.246, remove ``000856'' and in its
place add ``054771''.
0
18. In Sec. 522.275, revise the section heading to read as follows:
Sec. 522.275 N-Butylscopolammonium.
* * * * *
[[Page 16185]]
0
19. Revise Sec. 522.300 to read as follows:
Sec. 522.300 Carfentanil.
(a) Specifications. Each milliliter of solution contains 3
milligrams (mg) carfentanil citrate.
(b) Sponsor. See No. 053923 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Amount. Administer 5 to 20 micrograms
per kilogram (0.005 to 0.020 mg per kilogram) of body weight into large
muscle of the neck, shoulder, back, or hindquarter.
(2) Indications for use. For immobilizing free ranging and confined
members of the family Cervidae (deer, elk, and moose).
(3) Limitations. Do not use in domestic animals intended for food.
Do not use 30 days before or during hunting season. Federal law
restricts this drug to use by or on the order of a licensed
veterinarian. The licensed veterinarian shall be a veterinarian engaged
in zoo and exotic animal practice, wildlife management programs, or
research.
Sec. 522.304 [Amended]
0
20. In paragraph (b) of Sec. 522.304, remove ``000069'' and in its
place add ``054771''.
Sec. 522.311 [Amended]
0
21. In paragraph (b) of Sec. 522.311, remove ``000069'' and in its
place add ``054771''.
Sec. 522.313a [Amended]
0
22. In paragraph (b) of Sec. 522.313a, remove ``000009'' and in its
place add ``054771''.
Sec. 522.313c [Amended]
0
23. In paragraph (b) of Sec. 522.313c, remove ``000009, 000409, and
068330'' and in its place add ``000409, 054771, and 068330''.
0
24. Revise Sec. 522.380 to read as follows:
Sec. 522.380 Chloral hydrate, pentobarbital, and magnesium sulfate.
(a) Specifications. Each milliliter of solution contains 42.5
milligrams (mg) of chloral hydrate, 8.86 mg of pentobarbital, and 21.2
mg of magnesium sulfate.
(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Amount. For general anesthesia:
Administer 20 to 50 milliliters per 100 pounds of body weight by
intravenous injection until the desired effect is produced. Cattle
usually require a lower dosage on the basis of body weight. As a
sedative-relaxant: Administer at a level of one-fourth to one-half of
the anesthetic dosage level.
(2) Indications for use. For general anesthesia and as a sedative-
relaxant in cattle and horses.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
25. In Sec. 522.390, revise the section heading and paragraphs (a),
(b), and (c)(3) to read as follows:
Sec. 522.390 Chloramphenicol.
(a) Specifications. Each milliliter of solution contains 100
milligrams of chloramphenicol.
(b) Sponsor. See Nos. 000859 and 054771 in Sec. 510.600(c) of this
chapter.
(c) * * *
(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.
0
26. Revise Sec. 522.460 to read as follows:
Sec. 522.460 Cloprostenol.
(a) Specifications. Each milliliter of solution contains
cloprostenol sodium equivalent to:
(1) 125 micrograms ([micro]g) of cloprostenol; or
(2) 250 [mu]g of cloprostenol.
(b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter.
(1) No. 000061 for use of product described in paragraph (a)(1) of
this section as in paragraphs (c)(1)(i) and (c)(2) of this section.
(2) Nos. 000061 and 068504 for use of product described in
paragraph (a)(2) as in paragraphs (c)(1)(ii), (c)(1)(iii), and (c)(2)
of this section.
(c) Conditions of use in cattle--(1) Amount and indications for
use--(i) Administer 375 [micro]g by intramuscular injection to induce
abortion in pregnant feedlot heifers from 1 week after mating until 4
1/2 months of gestation.
(ii) Administer 500 [mu]g by intramuscular injection for
terminating unwanted pregnancies from mismatings from 1 week after
mating until 5 months after conception; for treating unobserved
(nondetected) estrus, mummified fetus, and luteal cysts; and for the
treatment of pyometra.
(iii) Administer 500 [mu]g by intramuscular injection as a single
injection regimen or double injection regimen with a second injection
11 days after the first, for scheduling estrus and ovulation to control
the time at which cycling cows or heifers can be bred.
(2) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
Sec. 522.468 [Amended]
0
27. In paragraph (b) of Sec. 522.468, remove ``046573'' and in its
place add ``054771''.
0
28. Revise Sec. 522.480 to read as follows:
Sec. 522.480 Corticotropin.
(a) Specifications. Each milliliter of aqueous solution contains 40
or 80 U.S.P. (I.U.) units of repository corticotropin.
(b) Sponsor. See sponsors in Sec. 510.600(c) of this chapter.
(1) No. 061623 for use as in paragraphs (c)(1) and (2) of this
section.
(2) No. 026637 for use as in paragraph (c)(2) and (3) of this
section.
(c) Conditions of use--(1) Dogs--(i) Amount. Administer one unit
per pound of body weight by intramuscular injection.
(ii) Indications for use. As a diagnostic aid to test for adrenal
dysfunction.
(iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
(2) Dogs and cats--(i) Amount. Administer one unit per pound of
body weight by intramuscular or subcutaneous injection, to be repeated
as indicated.
(ii) Indications for use. For stimulation of the adrenal cortex
where there is a general deficiency of corticotropin (ACTH).
(iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
(3) Cattle--(i) Amount. Administer 200 to 600 units by
intramuscular or subcutaneous injection as an initial dose, followed by
a dose daily or every other day of 200 to 300 units.
(ii) Indications for use. As a therapeutic agent for primary bovine
ketosis; and for stimulation of the adrenal cortex where there is a
general deficiency of ACTH.
(iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
Sec. 522.522 [Amended]
0
29. In paragraph (b) of Sec. 522.522, remove ``000069'' and in its
place add ``054771''.
0
30. Amend Sec. 522.535 as follows:
0
a. Redesignate paragraph (d) as paragraph (c);
0
b. Revise the section heading, and paragraphs (a) and newly designated
(c)(1)(iii).
The revisions read as follows:
[[Page 16186]]
Sec. 522.535 Desoxycorticosterone.
(a) Specifications. Each milliliter of suspension contains 25
milligrams of desoxycorticosterone pivalate.
* * * * *
(c) * * *
(1) * * *
(iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
* * * * *
0
31. Revise Sec. 522.536 to read as follows:
Sec. 522.536 Detomidine.
(a) Specification. Each milliliter of solution contains 10
milligrams of detomidine hydrochloride.
(b) Sponsor. See No. 052483 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in horses--(1) Amount. For sedation,
analgesia, or sedation and analgesia: 20 or 40 micrograms per kilogram
(0.2 or 0.4 milliliter per 100 kilogram or 220 pounds) by body weight,
depending on depth and duration required. For sedation, administer by
intraveneous (IV) or intramuscular (IM) injection; for analgesia,
administer by IV injection; for both sedation and analgesia, administer
by IV injection.
(2) Indication for use. As a sedative and analgesic to facilitate
minor surgical and diagnostic procedures in mature horses and
yearlings.
(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.
0
32. Amend Sec. 522.540 as follows:
0
a. In paragraph (d)(2)(i), remove ``000069 and 000859'' and in its
place add ``000859 and 054771'';
0
b. In paragraph (d)(2)(ii), remove ``000069'' and in its place add
``054771''; and
0
c. Revise the section heading and paragraphs (a)(3)(iii), (b)(1),
(b)(3), (c)(1), (c)(3), (d)(1), (d)(3), (e)(1), and (e)(3).
The revisions read as follows:
Sec. 522.540 Dexamethasone solution.
(a) * * *
(3) * * *
(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.
(b)(1) Specifications. Each milliliter of solution contains 2.0 mg
of dexamethasone or 4.0 mg of dexamethasone sodium phosphate
(equivalent to 3.0 mg dexamethasone).
* * * * *
(3) Conditions of use--(i) Amount. Administer 0.25 to 1 mg by
intravenous injection, repeated for 3 to 5 days or until a response is
noted.
(ii) Indications for use. For use in dogs for the treatment of
inflammatory conditions, as supportive therapy in canine posterior
paresis, as supportive therapy before or after surgery to enhance
recovery of poor surgical risks, and as supportive therapy in
nonspecific dermatosis.
(iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
(c)(1) Specifications. Each milliliter of solution contains 2.0 mg
of dexamethasone or 4.0 mg of dexamethasone sodium phosphate
(equivalent to 3.0 mg of dexamethasone).
* * * * *
(3) Conditions of use--(i) Amount. Administer 2.5 to 5.0 mg by
intravenous injection.
(ii) Indications for use. For use in horses as a rapid adrenal
glucocorticoid and/or anti-inflammatory agent.
(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.
(d)(1) Specifications. Each milliliter of solution contains 2.0 mg
of dexamethasone or 4.0 mg of dexamethasone sodium phosphate
(equivalent to 3.0 mg of dexamethasone).
* * * * *
(3) Conditions of use--(i) Amount. Administer by intravenous or
intramuscular injection as follows:
(A) Dogs: 0.25 to 1 mg.
(B) Cats: 0.125 to 0.5 mg.
(C) Horses: 2.5 to 5 mg.
(ii) Indications for use. For use in dogs, cats, and horses as an
anti-inflammatory agent.
(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.
(e)(1) Specifications. Each milliliter of solution contains 4.0 mg
of dexamethasone sodium phosphate (equivalent to 3.0 mg dexamethasone).
* * * * *
(3) Conditions of use--(i) Amount. Administer by intravenous
injection as follows:
(A) Dogs: 0.25 to 1 mg; may be repeated for 3 to 5 days.
(B) Horses: 2.5 to 5 mg.
(ii) Indications for use. For use in dogs and horses for
glucocorticoid and anti-inflammatory effect.
(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.
0
33. Revise Sec. 522.542 to read as follows:
Sec. 522.542 Dexamethasone suspension.
(a) Specifications. Each milliliter of suspension contains 1
milligram (mg) of dexamethasone-21-isonicotinate.
(b) Sponsor. No. 000010 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Amount. Administer by intramuscular
injection as follows: Dogs: 0.25 to 1 mg; cats: 0.125 to 0.5 mg;
horses: 5 to 20 mg. Dosage may be repeated.
(2) Indications for use. For the treatment of various inflammatory
conditions associated with the musculoskeletal system in dogs, cats,
and horses.
(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.
0
34. Revise Sec. 522.563 to read as follows:
Sec. 522.563 Diatrizoate.
(a) Specifications. Each milliliter of solution contains 34.3
percent diatrizoate meglumine and 35 percent diatrizoate sodium, or 66
percent diatrizoate meglumine and 10 percent diatrizoate sodium.
(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in dogs and cats--(1) Amount. For excretion
urography, administer 0.5 to 1.0 milliliter (mL) per pound of body
weight to a maximum of 30 mL intravenously. For cystography, remove
urine, administer 5 to 25 mL directly into the bladder via catheter.
For urethrography, administer 1.0 to 5 mL via catheter into the urethra
to provide desired contrasts delineation. For angiocardiography
(including aortography) rapidly inject 5 to 10 mL directly into the
heart via catheter or intraventricular puncture. For cerebral
angiography, rapid injection of 3 to 10 mL via carotid artery. For
peripheral arteriography and/or venography and selective coronary
arteriography, rapidly inject 3 to 10 mL intravascularly into the
vascular bed to be delineated. For lymphography, slowly inject 1.0 to
10 mL directly into the lymph vessel to be delineated. For
arthrography, slowly inject 1.0 to 5 mL directly into the joint to be
delineated. For discography, slowly inject 0.5 to 1.0 mL directly into
the disc to be delineated. For sialography, slowly inject 0.5 to 1.0 mL
into the duct to be delineated. For
[[Page 16187]]
delineation of fistulous tracts, slowly inject quantity necessary to
fill the tract. For delineation of peritoneal hernias, inject 0.5 to
1.0 mL per pound of body weight directly into the peritoneal cavity.
(2) Indications for use. For visualization in excretion urography,
including renal angiography, uretography, cystography, and
urethrography; aortography; angiocardiography, peripheral
arteriography, and venography; selective coronary arteriography;
cerebral angiography; lymphography; arthrography; discography; and
sialography; and as an aid in delineating peritoneal hernias and
fistulous tracts.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
35. In Sec. 522.650, revise paragraphs (b), (c), (d)(1), and (d)(3) to
read as follows:
Sec. 522.650 Dihydrostreptomycin sulfate injection.
* * * * *
(b) Sponsors. See Nos. 054771 and 055529 in Sec. 510.600(c) of
this chapter.
(c) Related tolerance. See Sec. 556.200 of this chapter.
(d) * * *
(1) Amount. Administer 5 milligrams per pound of body weight by
deep intramuscular injection every 12 hours, for 3 to 5 days or until
the urine is free of leptospira for at least 72 hours as measured by
darkfield microscopic examination.
* * * * *
(3) Limitations. Discontinue use 30 days before slaughter for food.
Not for use in animals producing milk because use of the drug will
contaminate the milk. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
Sec. 522.690 [Amended]
0
36. In paragraph (b) of Sec. 522.690, remove ``000009'' and in its
place add ``054771''.
0
37. Revise Sec. 522.723 to read as follows:
Sec. 522.723 Diprenorphine.
(a) Specifications. Each milliliter of solution contains 2
milligrams of diprenorphine hydrochloride.
(b) Sponsors. See No. 053923 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Amount. It is administered
intramuscularly or intravenously at a suitable dosage level depending
upon the species.
(2) Indications for use. The drug is used for reversing the effects
of etorphine hydrochloride injection, veterinary, the use of which is
provided for in Sec. 522.883, in wild and exotic animals.
(3) Limitations. For use in wild or exotic animals only. Do not use
in domestic food-producing animals. Do not use 30 days before, or
during, the hunting season in free-ranging wild animals that might be
used for food. Federal law restricts this drug to use by or on the
order of a licensed veterinarian. Distribution is restricted to
veterinarians engaged in zoo and exotic animal practice, wildlife
management programs, and researchers.
Sec. 522.770 [Amended]
0
38. In Sec. 522.770, in paragraph (a), remove ``sterile aqueous''; and
in paragraph (b), remove ``000069'' and in its place add ``054771''.
Sec. 522.778 [Removed]
0
39. Remove Sec. 522.778.
0
40. Revise Sec. 522.784 to read as follows:
Sec. 522.784 Doxylamine.
(a) Specifications. Each milliliter contains 11.36 milligrams (mg)
of doxylamine succinate.
(b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Amount--(i) Horses: Administer 25 mg per
hundred pounds of body weight by intramuscular, subcutaneous, or slow
intravenous injection.
(ii) Dogs and cats: Administer 0.5 to 1 mg per pound of body weight
by intramuscular or subcutaneous injection. Doses may be repeated at 8
to 12 hours, if necessary, to produce desired effect.
(2) Indications for use. For use in conditions in which
antihistaminic therapy may be expected to alleviate some signs of
disease in horses, dogs, and cats.
(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.
0
41. Revise Sec. 522.800 to read as follows:
Sec. 522.800 Droperidol and fentanyl.
(a) Specifications. Each milliliter of solution contains 20
milligrams (mg) of droperidol and 0.4 mg of fentanyl citrate.
(b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Amount.
(i) For analgesia and tranquilization, administer as follows:
(A) 1 milliliter (mL) per 15 to 20 pounds (lbs) of body weight by
intramuscular injection in conjunction with atropine sulfate
administered at the rate of 0.02 mg per pound of body weight; or
(B) 1 mL per 25 to 60 lbs of body weight by intravenous injection
in conjunction with atropine sulfate administered at the rate of 0.02
mg per pound of body weight.
(ii) For general anesthesia, administer as follows:
(A) Administer 1 mL per 40 lbs of body weight by intramuscular
injection in conjunction with atropine sulfate administered at the rate
of 0.02 mg per pound of body weight and followed in 10 minutes by an
intravenous administration of sodium pentobarbital at the rate of 3 mg
per pound of body weight; or
(B) Administer 1 mL per 25 to 60 lbs of body weight by intravenous
injection in conjunction with atropine sulfate administered at the rate
of 0.02 mg per pound of body weight and followed within 15 seconds by
an intravenous administration of sodium pentobarbital at the rate of 3
mg per pound of body weight.
(2) Indications for use. As an analgesic and tranquilizer and for
general anesthesia.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
42. In Sec. 522.820, redesignate paragraphs (a) and (b) as paragraphs
(b) and (a) respectively; and revise paragraphs (d)(1) introductory
text, (d)(2) introductory text, and (d)(3) introductory text to read as
follows:
Sec. 522.820 Erythromycin.
* * * * *
(d) * * *
(1) Dog. Administer product described in paragraph (a)(1) of this
section as follows:
* * * * *
(2) Cats. Administer product described in paragraph (a)(1) of this
section as follows:
* * * * *
(3) Cattle. Administer products described in paragraph (a) of this
section as follows:
* * * * *
Sec. 522.842 [Amended]
0
43. In paragraph (a)(1) of Sec. 522.842, remove ``000856'' and in its
place add ``054771''.
0
44. Revise Sec. 522.863 to read as follows:
Sec. 522.863 Ethylisobutrazine.
(a) Specifications. Each milliliter of solution contains 50
milligrams (mg) of ethylisobutrazine hydrochloride.
[[Page 16188]]
(b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in dogs--(1) Amount. Administer 2 to 5 mg per
pound of body weight by intramuscular injection for profound
tranquilization. Administer 1 to 2 mg per pound of body weight by
intravenous injection to effect.
(2) Indications for use. For use as a tranquilizer.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
45. Revise Sec. 522.883 to read as follows:
Sec. 522.883 Etorphine.
(a) Specifications. Each milliliter of solution contains 1
milligram of etorphine hydrochloride.
(b) Sponsor. See No. 053923 in Sec. 510.600(c) of this chapter.
(c) Special considerations. Distribution is restricted to
veterinarians engaged in zoo and exotic animal practice, wildlife
management programs, and researchers.
(d) Conditions of use--(1) Amount. Administered intramuscularly by
hand syringe or syringe dart at a suitable dosage level depending upon
the species.
(2) Indications for use. For the immobilization of wild and exotic
animals.
(3) Limitations. Do not use in domestic food-producing animals. Do
not use 30 days before, or during, the hunting season in free-ranging
wild animals that might be used for food. Federal law restricts this
drug to use by or on the order of a licensed veterinarian.
Sec. 522.900 [Amended]
0
46. In paragraph (b)(2) of Sec. 522.900, remove ``000856'' and in its
place add ``054771''.
0
47. Revise Sec. 522.914 to read as follows:
Sec. 522.914 Fenprostalene.
(a) Specifications. (1) Each milliliter of solution contains 0.5
milligram (mg) fenprostalene.
(2) Each milliliter of solution contains 0.25 mg fenprostalene.
(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter for
use of product described in paragraph (a)(1) as in paragraph (e)(1) of
this section; and for use of product described in paragraph (a)(2) as
in paragraph (e)(2) of this section.
(c) Related tolerances. See Sec. 556.277 of this chapter.
(d) Special considerations. Labeling shall bear the following
statements: Women of childbearing age, asthmatics, and persons with
bronchial and other respiratory problems should exercise extreme
caution when handling this product. It is readily absorbed through the
skin and may cause abortion and/or bronchiospasms. Accidental spillage
on the skin should be washed off immediately with soap and water.
(e) Conditions of use--(1) Cattle--(i) Indications for use and
amount--(A) For feedlot heifers to induce abortion when pregnant 150
days or less, administer 1 mg (2 milliliter (mL)) subcutaneously.
(B) For beef or nonlactating dairy cattle for estrus
synchronization, administer a single or two 1-mg (2-mL) doses
subcutaneously, 11 to 13 days apart.
(ii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
(2) Swine--(i) Amount. Administer a single injection of 0.25 mg (1
mL) subcutaneously.
(ii) Indications for use. For the induction of parturition in sows
and gilts pregnant at least 112 days.
(iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
48. Revise Sec. 522.960 to read as follows:
Sec. 522.960 Flumethasone injectable dosage forms.
0
49. Revise Sec. 522.960a to read as follows:
Sec. 522.960a Flumethasone suspension.
(a) Specifications. Each milliliter of suspension contains 2
milligrams (mg) of flumethasone.
(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in horses--(1) Amount. Administer 6 to 10 mg
by intra-articular injection. Dosage is limited to a single injection
per week in any one synovial structure.
(2) Indications for use. For use in the various disease states
involving synovial structures (joints) of horses where excessive
synovial fluid of inflammatory origin is present and where permanent
structural changes do not exist. Such conditions include arthritis,
carpitis, and osselets.
(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.
0
50. Revise Sec. 522.960b to read as follows:
Sec. 522.960b Flumethasone acetate solution.
(a) Specifications. Each milliliter of solution contains 2
milligrams (mg) of flumethasone acetate.
(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in dogs--(1) Amount. Administer by
intramuscular injection as follows: Dogs weighing up to 10 pounds
(lbs): 2 mg; dogs weighing 10 to 25 lbs: 4 mg; dogs weighing over 25
lbs: 8 mg. Dosage should be adjusted according to the weight of the
animal, the severity of the symptoms, and the response noted. Dosage by
injection should not exceed 3 days of therapy. With chronic conditions
intramuscular therapy may be followed by oral administration of
flumethasone tablets at a daily dose of from 0.0625 to 0.25 mg per
animal.
(2) Indications for use. For use in certain acute and chronic
canine dermatoses of varying etiology to help control the pruritus,
irritation, and inflammation associated with these conditions.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
51. Revise Sec. 522.960c to read as follows:
Sec. 522.960c Flumethasone solution.
(a) Specifications. Each milliliter of solution contains 0.5
milligrams (mg) of flumethasone.
(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
(c) Conditions of use. It is used as follows:
(1) Horses--(i) Amount. Administer 1.25 to 2.5 milligrams (mg)
daily by intravenous, intramuscular, or intra-articular injection.
(ii) Indications for use. For use in the treatment of
musculoskeletal conditions due to inflammation, where permanent
structural changes do not exist, e.g., bursitis, carpitis, osselets,
and myositis; and allergic states, e.g., hives, urticaria, and insect
bites.
(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) Dogs--(i) Amount. Administer 0.0625 to 0.25 mg daily by
intravenous, intramuscular, or subcutaneous injection; 0.125 to 1.0 mg
daily by intra-lesional injection, depending on the size and location
of the lesion; or 0.166 to 1.0 mg daily by intra-articular injection,
depending on the severity of the condition and the size of the involved
joint.
(ii) Indications for use. For use in the treatment of
musculoskeletal conditions
[[Page 16189]]
due to inflammation of muscles or joints and accessory structures where
permanent structural changes do not exist, e.g., arthritis,
osteoarthritis, disc syndrome, and myositis (in septic arthritis,
appropriate antibacterial therapy should be concurrently administered);
certain acute and chronic dermatoses of varying etiology to help
control associated pruritus, irritation, and inflammation; otitis
externa in conjunction with topical medication; allergic states, e.g.,
hives, urticaria, and insect bites; and shock and shock-like states by
intravenous administration.
(iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
(3) Cats--(i) Amount. Administer 0.03125 to 0.125 mg daily by
intravenous, intramuscular, or subcutaneous injection.
(ii) Indications for use. For use in the treatment of certain acute
and chronic dermatoses of varying etiology to help control associated
pruritus, irritation, and inflammation.
(iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
Sec. 522.970 [Amended]
0
52. In paragraph (b)(2) of Sec. 522.970, remove ``000856'' and in its
place add ``054771''.
0
53. Revise Sec. 522.995 to read as follows:
Sec. 522.995 Fluprostenol.
(a) Specifications. Each milliliter of solution contains
fluprostenol sodium equivalent to 50 micrograms ([micro]g) of
fluprostenol.
(b) Sponsor. See No. 000859 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in horses--(1) Amount. Administer 0.55
[micro]g fluprostenol per kilogram of body weight by intramuscular
injection.
(2) Indications for use. For use in mares for its luteolytic effect
to control the timing of estrus in estrous cycling and in clinically
anestrous mares that have a corpus luteum.
(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.
0
54. In Sec. 522.1010, revise paragraphs (d)(2)(i)(B) and (d)(2)(ii)(B)
to read as follows:
Sec. 522.1010 Furosemide.
* * * * *
(d) * * *
(2) * * *
(i) * * *
(B) Limitations. Do not use in horses intended for human
consumption.
(ii) * * *
(B) Limitations. Do not use in horses intended for human
consumption.
* * * * *
0
55. Revise Sec. 522.1020 to read as follows:
Sec. 522.1020 Gelatin.
(a) Specifications. Each 100 milliliters contains 8 grams of
gelatin in a 0.85 percent sodium chloride solution.
(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Amount. The exact dosage to be
administered must be determined after evaluating the animal's condition
and will vary according to the size of the animal and the degree of
shock. A suggested dosage range for small animals such as dogs is 4 to
8 cubic centimeters per pound body weight. The suggested dosage range
for large animals such as sheep, calves, cows, or horses is 2 to 4
cubic centimeters per pound of body weight.
(2) Indications for use. For use to restore circulatory volume and
maintain blood pressure in animals being treated for shock.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
Sec. 522.1066 [Amended]
0
56. In paragraph (b) of Sec. 522.1066, remove ``Nos. 000856 and
000859'' and in its place add ``Nos. 000859 and 054771''.
Sec. 522.1081 [Amended]
0
57. In paragraph (b)(1) of Sec. 522.1081, remove ``053501'' and in its
place add ``054771''.
Sec. 522.1083 [Amended]
0
58. In paragraph (b) of Sec. 522.1083, remove ``000069'' and in its
place add ``054771''; and in paragraph (c)(3), remove the first two
sentences.
0
59. Revise Sec. 522.1085 to read as follows:
Sec. 522.1085 Guaifenesin powder for injection.
(a) Specifications. The product is a sterile powder containing
guaifenesin. A solution is prepared by dissolving the drug in sterile
water for injection to make a solution containing 50 milligrams of
guaifenesin per milliliter of solution.
(b) Sponsors. See Nos. 037990 and 054771 in Sec. 510.600(c) of
this chapter.
(c) Conditions of use in horses--(1) Amount. Administer 1
milliliter of prepared solution per pound of body weight by rapid
intravenous infusion.
(2) Indications for use. For use as a muscle relaxant.
(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.
0
60. Revise Sec. 522.1086 to read as follows:
Sec. 522.1086 Guaifenesin solution.
(a) Specifications. Each milliliter of solution contains 50
milligrams (mg) of guaifenesin and 50 mg of dextrose.
(b) Sponsors. See Nos. 000859 and 037990 in Sec. 510.600(c) of
this chapter.
(c) Conditions of use in horses--(1) Amount. Administer 1
milliliter per pound of body weight by rapid intravenous infusion.
(2) Indications for use. For use as a skeletal muscle relaxant.
(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.
Sec. 522.1125 [Amended]
0
61. In paragraph (d)(3) of Sec. 522.1125, remove the first two
sentences.
0
62. Amend Sec. 522.1145 as follows:
0
a. In paragraph (a)(2), remove ``000009'' and in its place add
``054771'';
0
b. In paragraph (b)(2), remove ``053501'' and in its place add
``054771'';
0
c. Revise the section heading and paragraphs (a)(3)(i), (a)(3)(iii),
(b)(3)(i), (b)(3)(iii), (c)(3), (d)(3)(iii), (f)(3)(i), and
(f)(3)(iii).
The revisions read as follows:
Sec. 522.1145 Hyaluronate.
(a) * * *
(3) * * *
(i) Amount. Small and medium-size joints (carpal, fetlock): 20 mg;
larger joint (hock): 40 mg. Treatment may be repeated at weekly
intervals for a total of three treatments.
* * * * *
(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.
(b) * * *
(3) * * *
(i) Amount. Small and medium-size joints (carpal, fetlock): 10 mg;
larger joint (hock): 20 mg. Treatment may be repeated at weekly
intervals for a total of four treatments.
* * * * *
(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.
[[Page 16190]]
(c) * * *
(3) Conditions of use--(i) Amount. Small and medium-size joints
(carpal, fetlock): 20 mg. Treatment may be repeated after 1 or more
weeks but not to exceed 2 injections per week for a total of 4 weeks.
(ii) Indications for use. For the intra-articular treatment of
carpal or fetlock joint dysfunction in horses due to acute or chronic,
non-infectious synovitis associated with equine osteoarthritis.
(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.
(d) * * *
(3) * * *
(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.
* * * * *
(f) * * *
(3) * * *
(i) Amount. Small and medium-size joints (carpal, fetlock): 22 mg;
larger joint (hock): 44 mg. Treatment may be repeated at weekly
intervals for a total of three treatments.
* * * * *
(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.
0
63. In Sec. 522.1150, remove footnote 1, and revise the section
heading and paragraphs (a) and (c)(3) to read as follows:
Sec. 522.1150 Hydrochlorothiazide.
(a) Specifications. Each milliliter of solution contains 25
milligrams of hydrochlorothiazide.
* * * * *
(c) * * *
(3) Limitations. Milk taken from dairy animals during treatment and
for 72 hours (6 milkings) after the latest treatment must not be used
for food. Federal law restricts this drug to use by or on the order of
a licensed veterinarian.
0
64. Revise Sec. 522.1155 to read as follows:
Sec. 522.1155 Imidocarb powder for injection.
(a) Specifications. The product is a sterile powder containing
imidocarb dipropionate. Each milliliter of constituted solution
contains 100 milligrams (mg) of imidocarb base.
(b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
(c) Special considerations. Imidocarb dipropionate is sold only
under permit issued by the Director of the National Program Planning
Staff, Veterinary Services, Animal and Plant Health Inspection Service,
U.S. Department of Agriculture, to licensed or full-time State,
Federal, or military veterinarians.
(d) Conditions of use in horses and zebras--(1) Amount. For Babesia
caballi infections, administer 2 mg of imidocarb base per kilogram of
body weight by intramuscular injection in the neck region, repeating
dosage once after 24 hours. For Babesia equi infections, administer 4
mg of imidocarb base per kilogram of body weight by intramuscular
injection in the neck region, repeating dosage four times at 72-hour
intervals.
(2) Indications for use. For the treatment of babesiosis
(piroplasmosis) caused by Babesia caballi and Babesia equi.
(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.
0
65. Revise Sec. 522.1156 to read as follows:
Sec. 522.1156 Imidocarb solution.
(a) Specifications. Each milliliter of solution contains 120
milligrams (mg) of imidocarb dipropionate.
(b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in dogs--(1) Amount. Administer 6.6 mg per
kilogram (3 mg per pound) of body weight by intramuscular injection.
Repeat the dose after 2 weeks for a total of two treatments.
(2) Indications for use. For the treatment of clinical signs of
babesiosis and/or demonstrated Babesia organisms in the blood.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
Sec. 522.1182 [Amended]
0
66. In Sec. 522.1182, in paragraph (b)(2), remove ``000856'' and in
its place add ``054771''; and in paragraphs (b)(4) introductory text
and (b)(5) introductory text, remove ``053501'' and in its place add
``054771.
0
67. Add Sec. 522.1185 to read as follows:
Sec. 522.1185 Isoflupredone.
(a) Specifications. Each milliliter of suspension contains 2
milligrams (mg) of isoflupredone acetate.
(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Cattle--(i) Amount. Administer 10 to 20
mg by intramuscular injection.
(ii) Indications for use. For use in the treatment of bovine
ketosis. For alleviation of pain associated with generalized and acute
localized arthritic conditions; for treating acute hypersensitivity
reactions; and as an aid in correcting circulatory defects associated
with severe toxicity and shock.
(iii) Limitations. Animals intended for human consumption should
not be slaughtered within 7 days of 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. Federal law restricts this
drug to use by or on the order of a licensed veterinarian.
(2) Horses and swine--(i) Amount--(A) Horses. Administer 5 to 20 mg
by intramuscular injection for systemic effect or by intrasynovial
injection into a joint cavity, tendon sheath, or bursa for local
effect.
(B) Swine. The usual dose for a 300-pound animal is 5 mg by
intramuscular injection.
(ii) Indications for use. For alleviation of pain associated with
generalized and acute localized arthritic conditions; for treating
acute hypersensitivity reactions; and as an aid in correcting
circulatory defects associated with severe toxicity and shock.
(iii) Limitations. Animals intended for human consumption should
not be slaughtered within 7 days of last treatment. Federal law
restricts this drug to use by or on the order of a licensed
veterinarian.
0
68. Revise Sec. 522.1204 to read as follows:
Sec. 522.1204 Kanamycin.
(a) Specifications. Each milliliter of solution contains 50 or 200
milligrams (mg) of kanamycin as kanamycin sulfate.
(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in dogs and cats--(1) Amount. Administer by
subcutaneous or intramuscular injection 5 mg per pound of body weight
per day in equally divided doses at 12-hour intervals.
(2) Indications for use. For the treatment of bacterial infections
due to kanamycin sensitive organisms in dogs and cats.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
Sec. 522.1222 [Removed]
0
69. Remove Sec. 522.1222.
[[Page 16191]]
Sec. 522.1222a [Redesignated as Sec. 522.1222 and Amended]
0
70. Redesignate Sec. 522.1222a as Sec. 522.1222 and in newly
designated Sec. 522.1222, in paragraph (b), add ``054771,'' after
``054668,''.
Sec. 522.1222b [Redesignated as Sec. 522.1223 and Revised]
0
71. Redesignate Sec. 522.1222b as Sec. 522.1223 and revise it to read
as follows:
Sec. 522.1223 Ketamine, promazine, and aminopentamide.
(a) Specifications. Each milliliter of solution contains ketamine
hydrochloride equivalent to 100 milligrams (mg) ketamine base activity,
7.5 (mg) of promazine hydrochloride, and 0.0625 mg of aminopentamide
hydrogen sulfate.
(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in cats--(1) Amount. Administer by
intramuscular injection 15 to 20 mg ketamine base per pound of body
weight, depending on the effect desired.
(2) Indications for use. It is used in cats as the sole anesthetic
agent for ovariohysterectomy and general surgery.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
72. Revise Sec. 522.1225 to read as follows:
Sec. 522.1225 Ketoprofen.
(a) Specifications. Each milliliter of solution contains 100
milligrams (mg) of ketoprofen.
(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in horses--(1) Amount. Administer by
intravenous injection 1.0 mg per pound of body weight once daily for up
to 5 days.
(2) Indications for use. For alleviation of inflammation and pain
associated with musculoskeletal disorders in horses.
(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.
Sec. 522.1228 [Removed]
0
73. Remove reserved Sec. 522.1228.
Sec. 522.1244 [Redesignated as Sec. 522.1242 and Amended]
0
74. Redesignate Sec. 522.1244 as Sec. 522.1242 and amend it as
follows:
0
a. In paragraph (a), remove ``sterile aqueous'';
0
b. In paragraph (b), remove ``053501'' and in its place add ``054771'';
and
0
c. Revise the section heading to read as follows:
Sec. 522.1242 Levamisole.
* * * * *
Sec. 522.1260 [Amended]
0
75. In Sec. 522.1260, in paragraph (b)(1), remove ``000009'' and in
its place add ``054771''; and in paragraph (b)(3), remove ``046573''
and in its place add ``054771''.
0
76. Revise Sec. 522.1289 to read as follows:
Sec. 522.1289 Lufenuron.
(a) Specifications. Each milliliter of suspension contains 10
milligrams (mg) of lufenuron.
(b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in cats--(1) Amount. 10 mg per kilogram (4.5
mg per pound) of body weight every 6 months, by subcutaneous injection.
(2) Indications for use. For control of flea populations in cats 6
weeks of age and older.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
Sec. 522.1315 [Amended]
0
77. In paragraph (b) of Sec. 522.1315, remove ``000069'' and in its
place add ``054771''.
0
78. In Sec. 522.1335, revise the section heading and paragraphs (a)
and (c)(3) to read as follows:
Sec. 522.1335 Medetomidine.
(a) Specifications. Each milliliter of solution contains 1.0
milligrams of medetomidine hydrochloride.
* * * * *
(c) * * *
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
79. In Sec. 522.1362, revise the section heading and paragraphs (c)(1)
and (3) to read as follows:
Sec. 522.1362 Melarsomine powder for injection.
* * * * *
(c) * * *
(1) Amount. Administer only by deep intramuscular injection in the
lumbar muscles (L3-L5).
* * * * *
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
Sec. 522.1372 [Amended]
0
80. In paragraph (b) of Sec. 522.1372, remove ``000009'' and in its
place add ``054771''.
0
81. Revise Sec. 522.1380 to read as follows:
Sec. 522.1380 Methocarbamol.
(a) Specifications. Each milliliter of solution contains 100
milligrams (mg) of methocarbamol.
(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Amount--(i) Dogs and cats. Administer by
intravenous injection 20 mg per pound of body weight for moderate
conditions or 25 to 100 mg per pound of body weight for severe
conditions (tetanus and strychnine poisoning). The total cumulative
dose should not to exceed 150 mg per pound of body weight.
(ii) Horses. Administer by intravenous injection 2 to 10 mg per
pound of body weight for moderate conditions or 10 to 25 mg per pound
of body weight for severe conditions (tetanus). Additional amounts may
be needed to relieve residual effects and to prevent recurrence of
symptoms.
(2) Indications for use. As an adjunct for treating acute
inflammatory and traumatic conditions of the skeletal muscles and to
reduce muscular spasms.
(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.
Sec. 522.1410 [Amended]
0
82. In paragraph (b) of Sec. 522.1410, remove ``000009 and 054628''
and in its place add ``054628 and 054771''.
0
83. In Sec. 522.1451, in paragraph (b), remove ``000856'' and in its
place add ``054771''; and revise the section heading to read as
follows:
Sec. 522.1451 Moxidectin microspheres for injection.
* * * * *
0
84. In Sec. 522.1452, revise the section heading, paragraph (a), the
heading of paragraph (c), and paragraph (c)(3) to read as follows:
Sec. 522.1452 Nalorphine.
(a) Specifications. Each milliliter of solution contains 5
milligrams of nalorphine hydrochloride.
* * * * *
(c) Conditions of use in dogs--
* * * * *
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
85. In Sec. 522.1465, in paragraph (c)(3), remove the first two
sentences; and revise the section heading and paragraph (a) to read as
follows:
[[Page 16192]]
Sec. 522.1465 Naltrexone.
(a) Specifications. Each milliliter of solution contains 50
milligrams of naltrexone hydrochloride.
* * * * *
Sec. 522.1468 [Amended]
0
86. In paragraph (b) of Sec. 522.1468, remove ``000856'' and in its
place add ``054771''.
0
87. Revise Sec. 522.1484 to read as follows:
Sec. 522.1484 Neomycin.
(a) Specifications. Each milliliter of solution contains 50
milligrams (mg) of neomycin sulfate (equivalent to 35 mg of neomycin
base).
(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in dogs and cats--(1) Amount. Administer 5 mg
per pound of body weight daily by intramuscular or intravenous
injection, divided into portions administered every 6 to 8 hours for 3
to 5 days.
(2) Indications for use. For the treatment of acute and chronic
bacterial infections due to organisms susceptible to neomycin.
(3) Limitations. Not for parenteral use in food-producing animals
because of prolonged residues in edible tissues. Federal law restricts
this drug to use by or on the order of a licensed veterinarian.
0
88. In Sec. 522.1503, revise the section heading and paragraphs (a)
and (c) to read as follows:
Sec. 522.1503 Neostigmine.
(a) Specifications. Each milliliter of solution contains 2
milligrams (mg) neostigmine methylsulfate.
* * * * *
(c) Conditions of use--(1) Amount. Administer to cattle and horses
at a dosage level of 1 mg per (/) 100 pounds (lbs) of body weight
subcutaneously. Administer to sheep at a dosage level of 1 to 1\1/2\
mg/100 lbs body weight subcutaneously. Administer to swine at a dosage
level of 2 to 3 mg/100 lbs body weight intramuscularly. These doses may
be repeated as indicated.
(2) Indications for use. For treating rumen atony; initiating
peristalsis which causes evacuation of the bowel; emptying the urinary
bladder; and stimulating skeletal muscle contractions.
(3) Limitations. Not for use in animals producing milk, since this
use will result in contamination of the milk. Federal law restricts
this drug to use by or on the order of a licensed veterinarian.
0
89. In Sec. 522.1610, revise the section heading and paragraphs (a)
and (c) to read as follows:
Sec. 522.1610 Oleate sodium.
(a) Specifications. Each milliliter of solution contains 50
milligrams (mg) of sodium oleate.
* * * * *
(c) Conditions of use in horses--(1) Amount. Administer by
parenteral injection depending on the area of response desired. An
injection of 1 milliliter (mL) will produce a response of approximately
15 square centimeters. Do not inject more than 2 mL per injection site.
Regardless of the number of injection sites, the total volume used
should not exceed 10 mL.
(2) Indications for use. It is used in horses to stimulate
infiltration of cellular blood components that subsequently
differentiate into fibrous and/or fibrocartilagenous tissue.
(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.
0
90. In Sec. 522.1620, revise paragraph (c) to read as follows:
Sec. 522.1620 Orgotein for injection.
* * * * *
(c) Conditions of use--(1) Horses--(i) Amount. Administer by deep
intramuscular injection at a dosage level of 5 milligrams (mg) every
other day for 2 weeks and twice weekly for 2 to 3 more weeks. Severe
cases, both acute and chronic, may benefit more from daily therapy
initially. Dosage may be continued beyond 5 weeks if satisfactory
improvement has not been achieved.
(ii) Indications for use. It is used in the treatment of soft
tissue inflammation associated with the musculoskeletal system.
(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) Dogs--(i) Amount. Administer by subcutaneous injection 5 mg
daily for 6 days, and thereafter, every other day for 8 days. In less
severe conditions, shorter courses of therapy may be indicated.
(ii) Indications for use. It is used for the relief of inflammation
associated with ankylosing spondylitis, spondylosis, and disc disease.
When severe nerve damage is present, response will occur much more
slowly, if at all.
(iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
91. In Sec. 522.1660a, in paragraph (b), remove ``000069'' and add
``054771'' after ``048164''; and in paragraph (e)(1)(ii), revise the
last sentence to read as follows:
Sec. 522.1660a Oxytetracycline solution, 200 milligrams/milliliter.
* * * * *
(e) * * *
(1) * * *
(ii) * * * Milk taken from animals during treatment and for 96
hours after the last treatment must not be used for food.
* * * * *
Sec. 522.1662a [Amended]
0
92. In Sec. 522.1662a, in paragraphs (c)(2), (d)(2), and (e)(2),
remove ``000069'' and in its place add ``054771''; and in paragraph
(h)(2), remove ``055529 and 059130'' and in its place add ``000859 and
055529''.
Sec. 522.1662b [Amended]
0
93. In paragraph (b) of Sec. 522.1662b, remove ``000069'' and in its
place add ``054771''.
0
94. In Sec. 522.1664, revise paragraph (d)(3) to read as follows:
Sec. 522.1664 Oxytetracycline and flunixin.
* * * * *
(d) * * *
(3) Limitations. Discontinue treatment at least 21 days prior to
slaughter of cattle. This drug product is not approved for use in
female dairy cattle 20 months of age or older, including dry dairy
cows. Use in these cattle may cause drug residues in milk and/or in
calves born to these cows. A withdrawal period has not been established
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.
Sec. 522.1680 [Amended]
0
95. In paragraph (b) of Sec. 522.1680, remove ``000856,'' and add
``054771'' after ``045628,''.
0
96. Revise Sec. 522.1696 to read as follows:
Sec. 522.1696 Penicillin G procaine injectable dosage forms.
Sec. 522.1696a [Amended]
0
97. In Sec. 522.1696a, in paragraphs (b)(1) and (3), remove ``000856''
and in its place add ``054771''; and in paragraph (d)(2)(iii), remove
``055529, 059130, and 061623'' and in its place add ``000859, 055529,
and 061623''.
Sec. 522.1696b [Amended]
0
98. In Sec. 522.1696b, in paragraphs (b)(1), (d)(2)(i)(A), and
(d)(2)(iii)(A),
[[Page 16193]]
remove ``053501'' and in its place add ``054771''.
Sec. 522.1696c [Amended]
0
99. In Sec. 522.1696c, in paragraph (b), remove ``053501'' and in its
place add ``054771''; remove paragraph (c); and redesignate paragraph
(d) as paragraph (c).
0
100. In Sec. 522.1698, revise the section heading and paragraphs (a),
(b), (c)(1)(i), (c)(1)(iii), (c)(2)(i), and (c)(2)(iii) to read as
follows:
Sec. 522.1698 Pentazocine.
(a) Specifications. Each milliliter of solution contains
pentazocine lactate equivalent to 30 milligrams (mg) of pentazocine
base.
(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
(c) * * *
(1) * * *
(i) Amount. Administer 0.15 mg pentazocine base per pound of body
weight daily by intravenous or intramuscular injection. In cases of
severe pain, a second dose is recommended by intramuscular injection 10
to 15 minutes after the initial dose at the same level.
* * * * *
(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) * * *
(i) Amount. Administer 0.75 to 1.50 mg of pentazocine base per
pound of body weight by intramuscular injection.
* * * * *
(iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
101. Revise Sec. 522.1704 to read as follows:
Sec. 522.1704 Pentobarbital.
(a) Specifications. Each milliliter of solution contains 64.8
milligrams (mg) of sodium pentobarbital.
(b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Amount. The drug is administered
intravenously ``to effect''. For general surgical anesthesia, the usual
dose is 11 to 13 mg per pound of body weight. For sedation, the usual
dose is approximately 2 mg per pound of body weight. For relieving
convulsive seizures caused by strychnine in dogs, the injection should
be administered intravenously ``to effect''. The drug may be
administered intraperitoneally. When given intraperitoneally, it is
administered at the same dosage level as for intravenous
administration.
(2) Indications for use. The drug is indicated for use as a general
anesthetic in dogs and cats. Although it may be used as a general
surgical anesthetic for horses, it is usually given at a lower dose to
cause sedation and hypnosis and may be supplemented with a local
anesthetic. It may also be used in dogs for the symptomatic treatment
of strychnine poisoning.
(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.
0
102. Revise Sec. 522.1720 to read as follows:
Sec. 522.1720 Phenylbutazone.
(a) Specifications--(1) Each milliliter of solution contains 100
milligrams (mg) of phenylbutazone.
(2) Each milliliter of solution contains 200 mg of phenylbutazone.
(b) Sponsors. See sponsor numbers in Sec. 510.600(c) of this
chapter for use as in paragraph (c) of this section:
(1) No. 054771 for use of product described in paragraph (a)(1) as
in paragraph (c) of this section.
(2) Nos. 000061, 000859, 054771, and 061623 for use of product
described in paragraph (a)(2) as in paragraph (c) of this section.
(3) Nos. 054628 and 058005 for use of product described in
paragraph (a)(2) as in paragraph (c)(2) of this section.
(c) Conditions of use--(1) Dogs--(i) Amount. Administer by
intravenous injection 10 mg per pound of body weight daily in three
divided doses, not to exceed 800 mg daily regardless of weight. Limit
intravenous administration to 2 successive days. Oral medication may
follow.
(ii) Indications for use. It is used 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. Administer by intravenous injection 1 to 2
grams (g) per 1,000 pounds of body weight daily in three divided doses,
not to exceed 4 g daily. Limit intravenous administration to not more
than 5 successive days.
(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 restricts this drug to use by or on the order
of a licensed veterinarian.
0
103. In Sec. 522.1820, revise the section heading and paragraph (c) to
read as follows:
Sec. 522.1820 Pituitary luteinizing hormone powder for injection.
* * * * *
(c) Conditions of use--(1) Amount. Cattle and horses: 25
milligrams; swine: 5 milligrams; sheep: 2.5 milligrams; and dogs: 1.0
milligram. Preferably given by intravenous injection, it may be
administered subcutaneously. Treatment may be repeated in 1 to 4 weeks,
or as indicated.
(2) Indications for use. As an aid in the treatment of breeding
disorders related to pituitary hypofunction in cattle, horses, swine,
sheep, and dogs.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
104. Revise Sec. 522.1862 to read as follows:
Sec. 522.1862 Pralidoxime powder for injection.
(a) Specifications. Each vial contains 1 gram (g) of pralidoxime
chloride powder for mixing with 20 cubic centimeters of sterile water
for injection. Each milliliter of constituted solution contains 50
milligrams (mg) pralidoxime chloride.
(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Amount. Administer as soon as possible
after exposure to the poison. Before administration of the sterile
pralidoxime chloride, atropine is administered intravenously at a
dosage rate of 0.05 mg per pound of body weight, followed by
administration of an additional 0.15 mg of atropine per pound of body
weight administered intramuscularly. Then the appropriate dosage of
sterile pralidoxime chloride is administered slowly intravenously. The
dosage rate for sterile pralidoxime chloride when administered to
horses is 2 g per horse. When administered to dogs and cats, it is 25
mg per pound of body weight. For small dogs and cats, sterile
pralidoxime chloride may be administered either intraperitoneally or
intramuscularly. A mild degree of atropinization should be maintained
for at least 48 hours. Following severe poisoning, a second dose of
sterile pralidoxime chloride may be given after 1 hour if muscle
weakness has not been relieved.
(2) Indications for use. It is used in horses, dogs, and cats as an
antidote in the treatment of poisoning due to those pesticides and
chemicals of the organophosphate class which have anticholinesterase
activity in horses, dogs, and cats.
[[Page 16194]]
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
105. Revise Sec. 522.1881 to read as follows:
Sec. 522.1881 Prednisolone acetate.
(a) Specifications. Each milliliter of suspension contains 25
milligrams (mg) of prednisolone acetate.
(b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Amount. The drug is administered to
horses intra-articularly at a dosage level of 50 to 100 mg. The dose
may be repeated when necessary. The drug is administered to dogs and
cats intramuscularly at a dosage level of 10 to 50 mg. The dosage may
be repeated when necessary. If the condition is of a chronic nature, an
oral corticosteroid may be given as a maintenance dosage. The drug may
be given intra-articularly to dogs and cats at a dosage level of 5 to
25 mg. The dose may be repeated when necessary after 7 days for two or
three doses.
(2) Indications for use. The drug is indicated in the treatment of
dogs, cats, and horses for conditions requiring an anti-inflammatory
agent. The drug is indicated for the treatment of acute musculoskeletal
inflammations such as bursitis, carpitis, and spondylitis. The drug is
indicated as supportive therapy in nonspecific dermatosis such as
summer eczema and atopy. The drug may be used as supportive therapy
pre- and postoperatively and for various stress conditions when
corticosteroids are required while the animal is being treated for a
specific condition.
(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.
0
106. Revise Sec. 522.1884 to read as follows:
Sec. 522.1884 Prednisolone sodium succinate.
(a) Specifications. Each milliliter of prednisolone sodium
succinate injection contains: Prednisolone sodium succinate equivalent
in activity to 10, 20, or 50 milligrams (mg) of prednisolone.
(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter for
products containing 10, 20, and 50 mg equivalent prednisolone activity
per milliliter for use in horses, dogs, and cats as provided in
paragraphs (c)(1)(i), (ii), and (iii) of this section.
(c) Conditions of use--(1) Amount and indications for use--(i)
Horses. Administer 50 to 100 mg as an initial dose by intravenous
injection over a period of one-half to 1 minute, or by intramuscular
injection, and may be repeated in inflammatory, allergic, or other
stress conditions at intervals of 12, 24, or 48 hours, depending upon
the size of the animal, the severity of the condition and the response
to treatment.
(ii) Dogs. Administer by intravenous injection at a range of 2.5 to
5 mg per pound of body weight as an initial dose followed by
maintenance doses at 1, 3, 6, or 10 hour intervals, as determined by
the condition of the animal, for treatment of shock.
(iii) Dogs and cats. Administer by intramuscular injection for
treatment of inflammatory, allergic, and less severe stress conditions,
where immediate effect is not required, at 1 to 5 mg ranging upward to
30 to 50 mg in large breeds of dogs. Dosage may be repeated in 12 to 24
hours and continued for 3 to 5 days if necessary. If permanent
corticosteroid effect is required, oral therapy with prednisolone
tablets may be substituted.
(2) 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.
0
107. Revise Sec. 522.1885 to read as follows:
Sec. 522.1885 Prednisolone tertiary butylacetate.
(a) Specifications. Each milliliter of suspension contains 20
milligrams (mg) of prednisolone tertiary butylacetate.
(b) Sponsor. See No. 050604 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Amount--(i) Horses: Administer by
intramuscular injection 100 to 300 mg or by intrasynovial injection at
a dosage level of 50 to 100 mg. Retreatment of horses in 24 to 48 hours
may be necessary, depending on the general condition of the animal and
the severity and duration of the disease.
(ii) Dogs and cats: Administer by intramuscular injection 1 mg per
5 pounds of body weight or intrasynovially at a dosage level of 10 to
20 mg.
(2) Indications for use. It is used as an anti-inflammatory agent
in horses, dogs, and cats.
(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.
0
108. Revise Sec. 522.1890 to read as follows:
Sec. 522.1890 Sterile prednisone suspension.
(a) Specifications. Each milliliter of suspension contains 10 to 40
milligrams (mg) of prednisone.
(b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Amount--(i) Horses. Administer 100 to
400 mg by intramuscular injection, repeating if necessary.
(ii) Dogs and cats. Administer 0.25 to 1.0 mg per pound of body
weight by intramuscular injection for 3 to 5 days or until a response
is noted. Treatment may be continued with an orally administered dose.
(2) Indications for use. It is used for conditions requiring an
anti-inflammatory agent.
(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.
0
109. Revise Sec. 522.1920 to read as follows:
Sec. 522.1920 Prochlorperazine and isopropamide.
(a) Specifications. Each milliliter of solution contains
prochlorperazine edisylate equivalent to 4 milligrams (mg)
prochlorperazine and isopropamide iodide equivalent to 0.28 mg of
isopropamide.
(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Amount. (i) Dosage is administered by
subcutaneous injection twice daily as follows:
------------------------------------------------------------------------
Dosage in
Weight of animal in pounds milliliters
------------------------------------------------------------------------
Up to 4................................................. 0.25
5 to 14................................................. 0.5-1
15 to 30................................................ 2-3
30 to 45................................................ 3-4
45 to 60................................................ 4-5
Over 60................................................. 6
------------------------------------------------------------------------
(ii) Following the last injection, administer prochlorperazine and
isopropamide sustained release capsules as indicated.
(2) Indications for use. For use in dogs and cats in which
gastrointestinal disturbances are associated with emotional stress.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
Sec. 522.1940 [Amended]
0
110. In Sec. 522.1940, in paragraph (a)(1), remove ``000856'' and in
its place add ``054771''.
0
111. In Sec. 522.1962, in paragraph (b)(1), remove ``000856'' and in
its place add
[[Page 16195]]
``054771''; and revise the section heading and paragraph (c)(1)(iii) to
read as follows:
Sec. 522.1962 Promazine.
* * * * *
(c) * * *
(1) * * *
(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.
0
112. Revise Sec. 522.2002 to read as follows:
Sec. 522.2002 Propiopromazine.
(a) Specifications. Each milliliter of solution contains 5 or 10
milligrams (mg) propiopromazine hydrochloride.
(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in dogs and cats--(1) Amounts and indications
for use. Administer 0.05 to 0.5 mg per pound of body weight by
intravenous or intramuscular injection for tranquilization. Administer
0.25 mg per pound of body weight by intravenous injection as a
preanesthetic.
(2) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
113. In Sec. 522.2005, in paragraph (b)(3), remove ``000856'' and in
its place add ``054771''; and add paragraph (c)(3) to read as follows:
Sec. 522.2005 Propofol.
* * * * *
(c) * * *
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
114. Revise Sec. 522.2012 to read as follows:
Sec. 522.2012 Prostalene.
(a) Specifications. Each milliliter of solution contains 1
milligram of prostalene.
(b) Sponsor. No. 054771 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in horses--(1) Amount. Administer 5
micrograms per kilogram of body weight as a single subcutaneous
injection.
(2) Indications for use. For the control of estrus in mares.
(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.
0
115. Revise Sec. 522.2063 to read as follows:
Sec. 522.2063 Pyrilamine.
(a) Specifications. Each milliliter of solution contains 20
milligrams (mg) of pyrilamine maleate.
(b) Sponsors. See sponsor numbers in Sec. 510.600(c) of this
chapter for uses in paragraph (c) of this section.
(1) No. 000061 for use as in paragraph (c)(1)(i), (2), and (3) of
this section.
(2) No. 061623 for use as in paragraph (c)(1)(ii), (2), and (3) of
this section.
(c) Conditions of use--(1) Amount--(i) Horses, 40 to 60 mg per 100
pounds (lbs) body weight; foals, 20 mg/100 lbs body weight. Administer
by intramuscular, subcutaneous, or intravenous injection. Dosage may be
repeated every 6 to 12 hours whenever necessary.
(ii) Horses, 40 to 60 mg/100 lbs body weight; foals, 20 mg/100 lbs
body weight. Administer by slow intravenous injection. Dosage may be
repeated every 6 to 12 hours if necessary.
(2) Indications for use. It is intended for treating horses in
conditions in which antihistaminic therapy may be expected to lead to
alleviation of some signs of disease.
(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.
0
116. In Sec. 522.2076, revise paragraph (c)(3) to read as follows:
Sec. 522.2076 Romifidine.
* * * * *
(c) * * *
(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.
0
117. In Sec. 522.2100, revise the section heading and paragraphs
(a)(1), (a)(3), (b)(1), (b)(3), and (d)(2) to read as follows:
Sec. 522.2100 Selenium and vitamin E.
(a)(1) Specifications. Each milliliter of emulsion contains 5.48
milligrams (mg) sodium selenite (equivalent to 2.5 mg selenium) and 50
mg of vitamin E (68 I.U.) (as d-alpha tocopheryl acetate).
* * * * *
(3) Conditions of use in horses--(i) Amount. Administer 1
milliliter (mL) per (/) 100 pounds (lbs) of body weight by intravenous
injection or by deep intramuscular injection in divided doses in two or
more sites in the gluteal or cervical muscles. Administration may be
repeated at 5 to 10 day intervals.
(ii) Indications for use. For the prevention and treatment of
selenium-tocopherol deficiency syndrome in horses.
(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.
(b)(1) Specifications. Each milliliter contains 2.19 mg of sodium
selenite (equivalent to 1 mg of selenium), 50 mg of vitamin E (68 I.U.)
(as d-alpha tocopheryl acetate).
* * * * *
(3) Conditions of use in dogs--(i) Amount. Administer by
subcutaneous or intramuscular injection in divided doses in two or more
sites at 1 mL/20 lbs of body weight with a minimum dosage of \1/4\ mL
and a maximum dosage of 5 mL. The dose is repeated at 3-day intervals
until a satisfactory therapeutic response is observed. A maintenance
regimen is then initiated which consists of 1 mL per 40 lbs of body
weight with a minimum dosage of \1/4\ mL which is repeated every 3 days
or 7 days, or longer, as required to maintain continued improvement or
an asymptomatic condition; or the drug may be used in capsule form for
oral maintenance therapy.
(ii) Indications for use. As an aid in alleviating and controlling
inflammation, pain, and lameness associated with certain arthropathies
in dogs.
(iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
* * * * *
(d) * * *
(2) Sponsors. See Nos. 000061 and 054771 in Sec. 510.600(c) of
this chapter.
* * * * *
Sec. 522.2120 [Amended]
0
118. In paragraph (b) of Sec. 522.2120, remove ``000009'' and in its
place add ``054771''.
Sec. 522.2121 [Amended]
0
119. In paragraph (b) of Sec. 522.2121, remove ``000009'' and in its
place add ``054771''.
0
120. Revise Sec. 522.2150 to read as follows:
Sec. 522.2150 Stanozolol.
(a) Specifications. Each milliliter of suspension contains 50
milligrams (mg) of stanozolol.
(b) Sponsor. No. 054771 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Amount--(i) Dogs and cats. For cats and
small breeds of dogs: 25 mg. For larger dogs: 50 mg. Administer by deep
intramuscular injection in the thigh at weekly intervals, for several
weeks.
[[Page 16196]]
(ii) Horses. Administer 25 mg per 100 pounds of body weight by deep
intramuscular injection in the gluteal region at weekly intervals, for
not more than 4 weeks.
(2) Indications for use. For use as an anabolic steroid treatment.
(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.
0
121. Revise Sec. 522.2220 to read as follows:
Sec. 522.2220 Sulfadimethoxine.
(a) Specifications. Each milliliter of solution contains:
(1) 100 milligrams (mg) of sulfadimethoxine sodium.
(2) 400 mg of sulfadimethoxine sodium.
(b) Sponsors. See sponsor numbers in Sec. 510.600(c) of this
chapter for use as in paragraph (d) of this section.
(1) No. 054628 for use of the product described in paragraph (a)(1)
as in paragraph (d)(1) of this section.
(2) No. 054771 for use of the product described in paragraph (a)(2)
as in paragraphs (d)(2), (3), and (4) of this section.
(3) Nos. 000859, 057561, and 061623 for use of the product
described in paragraph (a)(2) as in paragraph (d)(4) of this section.
(c) Related tolerances. See Sec. 556.640 of this chapter.
(d) Conditions of use--(1) Dogs--(i) Amount. Administer by
subcutaneous, intramuscular, or intravenous injection at an initial
dose of 25 mg per pound of body weight followed by 12.5 mg per pound of
body weight every 24 hours thereafter. Continue treatment until the
animal is free from symptoms for 48 hours.
(ii) Indications for use. For use in the treatment of
sulfadimethoxine-susceptible bacterial infections in dogs.
(iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
(2) Dogs and cats--(i) Amount. Administer by intravenous or
subcutaneous injection at an initial dose of 55 mg per kilogram of body
weight followed by 27.5 mg per kilogram of body weight every 24 hours.
(ii) Indications for use. For the treatment of respiratory,
genitourinary tract, enteric, and soft tissue infections when caused by
Streptococci, Staphylococci, Escherichia, Salmonella, Klebsiella,
Proteus, or Shigella organisms sensitive to sulfadimethoxine, and in
the treatment of canine bacterial enteritis associated with coccidiosis
and canine Salmonellosis.
(iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
(3) Horses--(i) Amount. Administer by intravenous injection at an
initial dose of 55 mg per kilogram of body weight followed by 27.5 mg
per kilogram of body weight every 24 hours until the patient is
asymptomatic for 48 hours.
(ii) Indications for use. For the treatment of respiratory disease
caused by Streptococcus equi (strangles).
(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.
(4) Cattle--(i) Amount. Administer an initial dose of 25 mg per
pound of body weight by intravenous injection followed by 12.5 mg per
pound of body weight every 24 hours until the animal is asymptomatic
for 48 hours.
(ii) Indications for use. For the treatment of bovine respiratory
disease complex (shipping fever complex) and bacterial pneumonia
associated with Pasteurella spp. sensitive to sulfadimethoxine;
necrotic pododermatitis (foot rot) and calf diphtheria caused by
Fusobacterium necrophorum sensitive to sulfadimethoxine.
(iii) Limitations. Milk taken from animals during treatment and for
60 hours (5 milkings) after the latest treatment must not be used for
food. Do not administer within 5 days of slaughter. A withdrawal period
has not been established for this product in preruminating calves. Do
not use in calves to be processed for veal.
0
122. Revise Sec. 522.2240 to read as follows:
Sec. 522.2240 Sulfaethoxypyridazine.
(a) Specifications. The drug is an aqueous solution of
sulfaethoxypyridazine.
(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
(c) Related tolerances. See Sec. 556.650 of this chapter.
(d) Conditions of use in cattle--(1) Amount. Administer 2.5 grams
per 100 pounds of body weight per day by intravenous injection for not
more than 4 days; or first treatment may be followed by 3 days of
treatment with sulfaethoxypyridazine in drinking water or tablets in
accordance with Sec. Sec. 520.2240a(e) and 520.2240b(e) of this
chapter.
(2) Indications for use. For treatment of respiratory infection
(pneumonia, shipping fever), foot rot, calf scours; as adjunctive
therapy in septicemia accompanying mastitis and metritis.
(3) Limitations. Do not treat within 16 days of slaughter. 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. Federal
law restricts this drug to use by or on the order of a licensed
veterinarian.
Sec. 522.2340 [Amended]
0
123. In paragraph (b) of Sec. 522.2340, remove ``000069'' and in its
place add ``054771''.
Sec. 522.2404 [Amended]
0
124. In paragraph (b) of Sec. 522.2404, remove ``000856'' and in its
place add ``054771''.
0
125. Revise Sec. 522.2424 to read as follows:
Sec. 522.2424 Thiamylal.
(a) Specifications. The drug is a sterile powder. It is
reconstituted with sterile distilled water, water for injection, or
sodium chloride injection, to a desired concentration of 0.5 to 4
percent sodium thiamylal.
(b) Sponsors. See Nos. 054628 and 054771 in Sec. 510.600(c) of
this chapter.
(c) Conditions of use--(1) Amount. Administer by intravenous
injection to effect. The average single dose is:
(i) Dogs and cats: 8 milligrams (mg) per pound of body weight (when
used with a preanesthetic, generally one-half the normal dose).
(ii) Swine: 40 mg per 5 pounds (lbs) of body weight.
(iii) Horses: Light anesthesia, 1 gram per 500 lbs to 1,100 lbs of
body weight; deep anethesia, 1 gram per 300 lbs of body weight (40 mg/
12 lbs of body weight).
(iv) Cattle: Short duration, 20 mg/5 lbs of body weight; longer
duration, 40 mg/7 lbs of body weight.
(2) Indications for use. It is used as an ultra-short-acting
anesthetic in dogs, cats, swine, horses, and cattle.
(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.
0
126. Revise Sec. 522.2444 to read as follows:
Sec. 522.2444 Thiopental injectable dosage forms.
0
127. Revise Sec. 522.2444a to read as follows:
Sec. 522.2444a Thiopental powder for injection.
(a) Specifications. The drug contains sodium thiopental powder for
constitution with sterile water for injection.
[[Page 16197]]
(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in dogs and cats--(1) Amount. Administer by
intravenous injection as follows:
(i) 6 to 9 milligrams (mg) per pound of body weight for brief
anesthesia (6 to 10 minutes).
(ii) 10 to 12 mg per pound of body weight for anesthesia of 15 to
25 minutes duration.
(2) Indications for use. It is used as an anesthetic for
intravenous administration to dogs and cats during short to moderately
long surgical and other procedures. It is also used to induce
anesthesia in dogs and cats which then have surgical anesthesia
maintained by use of a volatile anesthetic.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
128. Revise Sec. 522.2444b to read as follows:
Sec. 522.2444b Thiopental and pentobarbital powder for injection.
(a) Specifications. Each gram of powder contains 750 milligrams
(mg) of sodium thiopental and 250 mg of sodium pentobarbital powder for
dilution with sterile water for injection.
(b) Sponsor. See No. 061623 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Amount. For total anesthesia, it is
given at approximately 10 to 12 mg per pound of body weight over a
period of 3.5 to 5 minutes. When preanesthetic medication is used, wait
at least an hour before administering thiopental and sodium
pentobarbital for injection, and the dosage necessary for anesthesia is
reduced. Usually \1/2\ to \2/3\ the normal amount is adequate.
(2) Indications for use. It is used as an anesthetic for
intravenous administration to dogs and cats during short to moderately
long surgical procedures.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
129. Revise Sec. 522.2470 to read as follows:
Sec. 522.2470 Tiletamine and zolazepam for injection.
(a) Specifications. The drug is a sterile powder. Each milliliter
of constituted solution contains tiletamine hydrochloride equivalent to
50 milligrams (mg) of tiletamine base and zolazepam hydrochloride
equivalent to 50 mg of zolazepam base.
(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in dogs and cats--(1) Amount. Expressed as
milligrams of the drug combination:
(i) Healthy dogs: An initial intramuscular dosage of 3 to 4.5 mg
per pound of body weight for diagnostic purposes; 4.5 to 6 mg per pound
of body weight for minor procedures of short duration such as repair of
lacerations and wounds, castrations, and other procedures requiring
mild to moderate analgesia. Supplemental doses when required should be
less than the initial dose and the total dose given should not exceed
12 mg per pound of body weight. The maximum total safe dose is 13.6
milligrams per pound of body weight.
(ii) Healthy cats: An initial intramuscular dosage of 4.4 to 5.4 mg
per pound of body weight for such procedures as dentistry, treatment of
abscesses, foreign body removal, and related types of surgery; 4.8 to
5.7 mg per pound of body weight for minor procedures requiring mild to
moderate analgesia, such as repair of lacerations, castrations, and
other procedures of short duration. Initial dosages of 6.5 to 7.2 mg
per pound of body weight are recommended for ovariohysterectomy and
onychectomy. When supplemental doses are required, such individual
supplemental doses should be given in increments that are less than the
initial dose, and the total dose given (initial dose plus supplemental
doses) should not exceed the maximum allowable safe dose of 32.7 mg per
pound of body weight.
(2) Indications for use. For restraint or for anesthesia combined
with muscle relaxation in cats and in dogs for restraint and minor
procedures of short duration (30 minutes) requiring mild to moderate
analgesia.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
130. Revise Sec. 522.2474 to read as follows:
Sec. 522.2474 Tolazoline.
(a) Specifications. Each milliliter of solution contains tolazoline
hydrochloride equivalent to 100 milligrams (mg) of base activity.
(b) Sponsor. See No. 061690 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in horses--(1) Amount. Administer slowly by
intravenous injection 4 mg per kilogram of body weight or 1.8 mg per
pound (4 milliliters (mL) per 100 kilograms or 4 mL per 220 pounds).
(2) Indications for use. For use in horses when it is desirable to
reverse the effects of sedation and analgesia caused by xylazine.
(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.
Sec. 522.2477 [Amended]
0
131. In paragraph (b)(3) of Sec. 522.2477, remove ``000856'' and in
its place add ``054771''.
Sec. 522.2478 [Amended]
0
132. In paragraph (b) of Sec. 522.2478, remove ``000856'' and in its
place add ``054771''.
0
133. Revise Sec. 522.2582 to read as follows:
Sec. 522.2582 Triflupromazine.
(a) Specifications. Each milliliter of solution contains 20
milligrams (mg) of triflupromazine hydrochloride.
(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Amount--(i) Dogs. Administer by
intravenous injection at a dosage of 0.5 to 1 mg per pound of body
weight daily, or by intramuscular injection at a dosage of 1 to 2 mg
per pound of body weight daily.
(ii) Cats. Administer by intramuscular injection at a dosage of 2
to 4 mg per pound of body weight daily.
(iii) Horses. Administer by intravenous or intramuscular injection
at a dosage of 10 to 15 mg per 100 pounds of body weight daily to a
maximum dose of 100 mg.
(2) Indications for use. For use in dogs, cats, and horses 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.
(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.
0
134. In Sec. 522.2610, in paragraph (b), remove ``000856'' and in its
place add ``054771''; remove paragraph (c); redesignate paragraph (d)
as paragraph (c); add new paragraph (c)(1)(iii); and revise newly
redesignated paragraph (c)(2)(iii) to read as follows:
Sec. 522.2610 Trimethoprim and sulfadiazine.
* * * * *
(c) * * *
(1) * * *
(iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
(2) * * *
(iii) Limitations. Do not use in horses intended for human
consumption.
[[Page 16198]]
Federal law restricts this drug to use by or on the order of a licensed
veterinarian.
0
135. In Sec. 522.2615, revise the section heading and paragraphs (a),
(b), and (d) to read as follows:
Sec. 522.2615 Tripelennamine.
(a) Specifications. Each milliliter of solution contains 20
milligrams (mg) of tripelennamine hydrochloride.
(b) Sponsors. See Nos. 000859 and 054771 in Sec. 510.600(c) of
this chapter.
* * * * *
(d) Conditions of use--(1) Dogs and cats--(i) Amount. Administer
0.5 mg per pound of body weight by intramuscular injection.
(ii) Indications for use. For use in treating conditions in which
antihistaminic therapy may be expected to lead to alleviation of some
signs of disease.
(iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
(2) Horses--(i) Amount. Administer 0.5 mg per pound of body weight
by intramuscular injection.
(ii) Indications for use. For use in treating conditions in which
antihistaminic therapy may be expected to lead to alleviation of some
signs of disease.
(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.
(3) Cattle--(i) Amount. Administer 0.5 mg per pound of body weight
by intravenous or intramuscular injection.
(ii) Indications for use. For use in treating conditions in which
antihistaminic therapy may be expected to lead to alleviation of some
signs of disease.
(iii) Limitations. Treated cattle must not be slaughtered for food
during treatment and for 4 days following the last treatment. Milk that
has been taken during treatment and for 24 hours (two milkings) after
the last 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. Federal law restricts this drug
to use by or on the order of a licensed veterinarian.
0
136. In Sec. 522.2640, redesignate paragraphs (d) and (e) as
paragraphs (c) and (d), respectively; and revise paragraphs (a), (b),
and newly designated (d)(1)(iii), (d)(3)(i), and (d)(3)(iii) to read as
follows:
Sec. 522.2640 Tylosin.
(a) Specifications. Each milliliter of solution contains 50 or 200
milligrams of tylosin activity (as tylosin base).
(b) Sponsors. See sponsor numbers in Sec. 510.600(c) of this
chapter for use as in paragraph (d) of this section.
(1) No. 000986 for use in paragraphs (d)(1), (2), and (3) of this
section.
(2) No. 000010 for use as in paragraphs (d)(1) and (2) of this
section.
* * * * *
(d) * * *
(1) * * *
(iii) Limitations. Administer intramuscularly for not more than 5
consecutive days. Continue treatment 24 hours after symptoms disappear.
Use a 50-milligram-per-milliliter solution for calves weighing less
than 200 pounds. Do not inject more than 10 milliliters per site. Do
not administer within 21 days of slaughter. This drug product is not
approved for use in female dairy cattle 20 months of age or older,
including dry dairy cows. Use in these cattle may cause drug residues
in milk and/or in calves born to these cows. A withdrawal period has
not been established for this product in preruminating calves. Do not
use in calves to be processed for veal.
* * * * *
(3) * * *
(i) Amount. Administer 3 to 5 milligrams per pound of body weight
by intramuscular injection at 12- to 24-hour intervals. Use 50
milligram per milliliter solution only.
* * * * *
(iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
137. In Sec. 522.2662, revise paragraph (d)(2)(iii) to read as
follows:
Sec. 522.2662 Xylazine.
* * * * *
(d) * * *
(2) * * *
(iii) Limitations. Do not use in horses intended for human
consumption.
* * * * *
0
138. In Sec. 522.2670, revise the section heading and paragraph (a) to
read as follows:
Sec. 522.2670 Yohimbine.
(a) Specifications. Each milliliter of solution contains either 2
or 5 milligrams of yohimbine (as hydrochloride).
* * * * *
Dated: March 13, 2014.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 2014-06131 Filed 3-24-14; 8:45 am]
BILLING CODE 4160-01-P