Document ID: FDA-2014-N-0002-0016
Agency: fda
Document Type: Rule
Title: Implantation or Injectable Dosage Form New Animal Drugs; Change of
Sponsor
Posted Date: 2014-03-25T04:00Z

[Federal Register Volume 79, Number 57 (Tuesday, March 25, 2014)]
[Rules and Regulations]
[Pages 16180-16198]
From the Federal Register Online via the Government Printing 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, 
steven.vaughn@fda.hhs.gov.

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.

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126. Revise Sec.  522.2444 to read as follows:

Sec.  522.2444  Thiopental injectable dosage forms.

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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.

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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.

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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.

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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.

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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