Document ID: FDA-2014-N-0002-0024
Agency: fda
Document Type: Rule
Title: Oral Dosage Form New Animal Drugs; Change of Sponsor
Posted Date: 2014-05-20T04:00Z

[Federal Register Volume 79, Number 97 (Tuesday, May 20, 2014)]
[Rules and Regulations]
[Pages 28813-28834]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-10415]

[[Page 28813]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 520

[Docket No. FDA-2014-N-0002]

Oral Dosage Form New Animal Drugs; Change of Sponsor

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendments.

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

SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect a change of sponsor for 172 approved new 
animal drug applications (NADAs) and 14 approved abbreviated new animal 
drug applications (ANADAs) for oral 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 current format. This is being done to 
increase the accuracy and readability of the regulations.

DATES: This rule is effective May 20, 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 E. 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 172 approved NADAs and 14 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
------------------------------------------------------------------------
006-707...........................  SULQUIN (sulfaquinoxaline) 6-50
                                     Soluble Powder.
006-891...........................  SUL-Q-NOX (sulfaquinoxaline) Liquid
                                     34%.
007-879...........................  TERRAMYCIN VET (oxytetracycline
                                     hydrochloride) Capsules.
007-981...........................  SOXISOL (sulfisoxazole) Tablets.
008-622...........................  TERRAMYCIN (oxytetracycline
                                     hydrochloride) Soluble Powder.
009-339...........................  CARAFEN (ammonium chloride and
                                     caramiphen edisylate) Cough Syrup.
009-392...........................  Primidone Tablets.
010-091...........................  MYLEPSIN (primidone) Tablets.
011-060...........................  TERRAMYCIN (oxytetracycline
                                     hydrochloride) Scour Tablets.
011-299...........................  PARVEX (piperazine and carbon
                                     disulfide) Suspension.
011-315...........................  NEOMIX 325 (neomycin sulfate)
                                     Soluble Powder.
011-403...........................  MEDROL (methylprednisolone) Tablets.
011-482...........................  VETAME (triflupromazine
                                     hydrochloride) Tablets.
011-582...........................  VETAMOX (acetazolamide sodium)
                                     Soluble Powder.
011-590...........................  PARVEX (piperazine and carbon
                                     disulfide) Bolus.
011-700...........................  CORTABA (methylprednisolone and
                                     acetylsalicylic acid) Tablets.
012-437...........................  TEMARIL-P (trimeprazine tartrate and
                                     prednisolone) Tablets.
012-656...........................  Promazine Granules.
012-956...........................  DYREX (trichlorfon) Bolus, Capsules,
                                     Granules, Tablets.
013-201...........................  DARBAZINE SPANSULE (prochlorperazine
                                     and isopropamide) Capsules.
013-248...........................  Freed No. 10 or 25 (trichlorfon and
                                     atropine).
013-957...........................  S.E.Z. (sulfaethoxypyridazine) for
                                     Drinking Water 6.25%.
014-366...........................  CYTOBIN (liothyronine sodium)
                                     Tablets.
015-102...........................  ALBON (sulfadimethoxine) Tablets.
015-126...........................  Spectinomycin Tablet and Injection.
015-154...........................  DYREX T.F. (trichlorfon,
                                     phenothiazine, and piperazine
                                     dihydrochloride) Powder.
015-160...........................  Sodium Sulfachloropyrazine Solution.
015-506...........................  WINSTROL-V (stanozolol) Tablets.
030-137...........................  MYLEPSIN (primidone) Tablets.
030-415...........................  FLUCORT (flumethasone) Tablets.
030-416...........................  MESULFIN (sulfamethizole and
                                     methenamine mandelate) Tablets.
031-205...........................  AGRIBON (sulfadimethoxine) 12.5%
                                     Drinking Water Solution.
031-448...........................  RHEAFORM (iodochlorhydroxyquin)
                                     Bolus.
031-553...........................  ESB 3 (sodium sulfachloropyrazine
                                     monohydrate) Solution and Soluble
                                     Powder.
031-715...........................  ALBON (sulfadimethoxine) Boluses.
031-914...........................  NEO-DARBAZINE SPANSULE
                                     (prochlorperazine, isopropamide,
                                     and neomycin sulfate) Capsule.
032-738...........................  PACITRAN (metoserpate
                                     hydrochloride).
032-946...........................  MAGNA TERRAMYCIN (oxytetracycline
                                     hydrochloride and carbomycin)
                                     Soluble Powder.
033-149...........................  PARVEX PLUS (piperazine, carbon
                                     disulfide, phenothiazine)
                                     Suspension.
033-342...........................  PROBAN (cythioate) Tablets 30 mg.
033-606...........................  PROBAN (cythioate) Oral Liquid.
033-653...........................  S.E.Z. (sulfaethoxypyridazine)
                                     Drinking Water Solution.
033-654...........................  S.E.Z. (sulfaethoxypyridazine)
                                     Oblets 15 G.
033-760...........................  BLOAT GUARD (poloxalene) Drench
                                     Concentrate.
033-887...........................  LINCOCIN (lincomycin hydrochloride)
                                     Tablets.
035-161...........................  TEMARIL-P SPANSULE (trimeprazine
                                     tartrate and prednisolone)
                                     Capsules.
035-650...........................  DYREX (trichlorfon and atropine)
                                     Powder.
038-160...........................  MAOLATE (chlorphenesin carbamate)
                                     Tablets.
039-356...........................  TRAMISOL (levamisole hydrochloride)
                                     Cattle Wormer Bolus.

[[Page 28814]]

 
039-357...........................  RIPERCOL L (levamisole
                                     hydrochloride) Soluble Drench
                                     Powder.
039-729...........................  THERABLOAT (poloxalene) Oral Liquid.
040-587...........................  LINCOCIN (lincomycin hydrochloride)
                                     Aquadrops.
041-629...........................  Spectinomycin Oral Liquid.
041-665...........................  TRANVET (propiopromazine
                                     hydrochloride) Chewable Tablets.
042-548...........................  AMFOROL (kanamycin sulfate,
                                     attapulgite, bismuth subcarbonate)
                                     Suspension.
042-740...........................  TRAMISOL (levamisole hydrochloride)
                                     Soluble Drench Powder for Sheep.
042-837...........................  TRAMISOL (levamisole hydrochloride)
                                     Sheep Wormer Oblets.
042-841...........................  AMFOROL (kanamycin sulfate,
                                     attapulgite, bismuth subcarbonate)
                                     Oral Tablets.
042-888...........................  BANMINTH/STRONGID (pyrantel
                                     tartrate) Pellets.
043-078...........................  CENTRINE (aminopentamide hydrogen
                                     sulfate) Oral Tablets.
043-785...........................  ALBON (sulfadimethoxine) Oral
                                     Suspension 5%.
045-513...........................  RIPERCOL L (levamisole
                                     hydrochloride) Soluble Powder.
045-515...........................  EQUIBUTE (phenylbutazone) Tablets
                                     100 mg.
045-715...........................  ROBAXIN-V (methocarbamol) Tablets.
046-109...........................  L-S 50 (lincomycin hydrochloride and
                                     spectinomycin sulfate) Water
                                     Soluble Powder.
046-285...........................  AGRIBON (sulfadimethoxine) Soluble
                                     Powder.
047-033...........................  S.E.Z. (sulfaethoxypyridazine) C-R
                                     Oblets 15 Gm.
049-892...........................  SPANBOLET II (sulfamethazine).
055-013...........................  OMNIPEN (ampicillin anhydrous)
                                     Capsules 250 mg.
055-020...........................  AUREOMYCIN (chlortetracycline
                                     bisulfate) Soluble Powder.
055-032...........................  DICLOXIN (dicloxacillin sodium
                                     monohydrate) Capsules.
055-042...........................  AMPI-TAB (ampicillin trihydrate)
                                     Tablets.
055-047...........................  CHLOROMYCETIN (chloramphenicol
                                     palmitate) Oral Suspension.
055-051...........................  CHLOROMYCETIN (chloramphenicol)
                                     Tablets.
055-060...........................  Penicillin G Potassium, USP.
055-073...........................  PANMYCIN (tetracycline
                                     hydrochloride) Tablets.
055-074...........................  AMPI-BOL (ampicillin trihydrate)
                                     Boluses.
055-076...........................  ALBAPLEX (tetracycline hydrochloride
                                     novobiocin sodium) Tablets.
055-078...........................  AMOXI-TABS (amoxicillin trihydrate)
                                     Tablets.
055-080...........................  AMOXI-DOSER (amoxicillin trihydrate)
                                     Oral Suspension.
055-081...........................  AMOXI-TABS (amoxicillin trihydrate)
                                     Tablets.
055-085...........................  AMOXI-DROP (amoxicillin trihydrate)
                                     Oral Suspension.
055-087...........................  AMOXI-BOL (amoxicillin trihydrate)
                                     Boluses.
055-088...........................  AMOXI-SOL (amoxicillin trihydrate)
                                     Soluble Powder.
055-099...........................  CLAVAMOX (amoxicillin trihydrate and
                                     clavulanate potassium) Tablets.
055-101...........................  CLAVAMOX (amoxicillin trihydrate and
                                     clavulanate potassium) Drops.
065-004...........................  PANMYCIN 500 (tetracycline
                                     hydrochloride) Bolus.
065-060...........................  PANMYCIN AQUADROPS (tetracycline
                                     hydrochloride) Liquid.
065-061...........................  TETRACHEL-VET (tetracycline
                                     hydrochloride) Drops and Syrup.
065-066...........................  TETRACHEL-VET (tetracycline
                                     hydrochloride) Tablets 100.
065-069...........................  TETRACHEL-VET (tetracycline
                                     hydrochloride) Capsules 500.
065-090...........................  DELTA ALBAPLEX (tetracycline
                                     hydrochloride, novobiocin sodium,
                                     prednisolone) Tablets.
065-099...........................  ALBAPLEX (tetracycline hydrochloride
                                     and novobiocin sodium) Capsules.
065-107...........................  ENTROMYCIN (bacitracin methylene
                                     disalicylate and streptomycin
                                     sulfate) Soluble Powder.
065-121...........................  Tetracycline-Vet (tetracycline
                                     hydrochloride) Capsules 250.
065-123...........................  Tetracycline Soluble Powder.
065-140...........................  TET-SOL 324 (tetracycline
                                     hydrochloride) Soluble Powder.
065-241...........................  MYCHEL-VET (chloramphenicol)
                                     Capsules (50 mg).
065-270...........................  POLYOTIC (tetracycline
                                     hydrochloride) Oblets.
065-280...........................  FORTRACIN (bacitracin methylene
                                     disalicyclate) Soluble.
065-313...........................  BACIFERM 50 (bacitracin zinc)
                                     Soluble Powder.
065-409...........................  PANMYCIN (tetracycline
                                     hydrochloride) Capsules.
065-410...........................  TETRA-SAL (tetracycline
                                     hydrochloride).
065-441...........................  POLYOTIC (tetracycline
                                     hydrochloride) Soluble Powder.
065-470...........................  BMD (bacitracin methylene
                                     disalicyclate) 50% Soluble Powder.
065-489...........................  MYCHEL-VET (chloramphenicol)
                                     Tablets.
091-065...........................  ROBIZONE-V (phenylbutazone) Tablets
                                     100 mg.
091-327...........................  GASTROGRAFIN (diatrizoate meglumine
                                     and diatrizoate sodium) Oral
                                     Solution.
091-739...........................  STRONGID T (pyrantel pamoate) Oral
                                     Suspension.
092-237...........................  RIPERCOL L-Piperazine (levamisole
                                     hydrochloride and piperazine
                                     dihydrochloride) Oral Solution.
093-105...........................  ROBIZONE-V (phenylbutazone) Tablets
                                     1 g.
093-107...........................  ALBON S.R. (sulfadimethoxine)
                                     Boluses.
093-512...........................  DIROCIDE (diethylcarbamazine
                                     citrate) Tablets.
093-688...........................  RIPERCOL L-Piperazine (levamisole
                                     hydrochloride and piperazine
                                     dihydrochloride) Soluble Powder.
093-903...........................  RUMATEL (morantel tartrate) Cattle
                                     Wormer Bolus.
095-333...........................  DIFOLIN (dichlorophene and toluene)
                                     Capsules.
095-641...........................  ARQUEL (meclofenamic acid) Granules.
096-509...........................  NBC Kaps Wormer (n-butyl chloride)
                                     Capsules.
096-674...........................  EQUIPROXEN (naproxen) Granules.
100-094...........................  Poultry Sulfa (sulfamerazine,
                                     sulfamethazine, sulfaquinoxaline)
                                     Soluble Powder.
100-237...........................  NEMEX (pyrantel pamoate) Oral
                                     Suspension.

[[Page 28815]]

 
100-929...........................  PRIMOR (sulfadimethoxine and
                                     ormetoprim) Tablets.
102-709...........................  CHEQUE (mibolerone) Drops.
103-390...........................  TORBUTROL (butorphanol tartrate)
                                     Tablets.
104-493...........................  FILARIBITS (diethylcarbamazine)
                                     Chewable Tablets.
107-085...........................  TRAMISOL (levamisole hydrochloride)
                                     Tablets.
108-687...........................  PET DERM III (dexamethasone)
                                     Tablets.
109-722...........................  ANTHELCIDE EQ (oxibendazole)
                                     Suspension.
110-048...........................  VALBAZEN (albendazole) Oral
                                     Suspension.
110-201...........................  ARQUEL (meclofenamic acid) Tablets.
110-776...........................  BENZELMIN (oxfendazole) Powder For
                                     Suspension.
110-777...........................  BENZELMIN (oxfendazole) Top Dress
                                     Pellets.
111-636...........................  LINCOMIX (lincomycin hydrochloride)
                                     Soluble Powder
115-578...........................  DI-TRIM (trimethoprim and
                                     sulfadiazine) Tablets.
120-161...........................  ANTIROBE (clindamycin hydrochloride)
                                     Capsules.
121-042...........................  ANTHELCIDE EQ (oxibendazole) Paste.
125-961...........................  RE-SORB Powder for Oral Solution.
126-232...........................  CALFSPAN (sulfamethazine) Tablets.
126-237...........................  TRAMISOL (levamisole hydrochloride)
                                     Gel.
128-070...........................  VALBAZEN (albendazole) Oral Paste.
128-517...........................  PET-DEC (diethylcarbamazine citrate)
                                     Tablets.
129-831...........................  BANMINTH-P/STRONGID (pyrantel
                                     pamoate) Paste.
130-435...........................  OXY-TET (oxytetracycline
                                     hydrochloride) Soluble Powder.
131-808...........................  DIROCIDE (diethylcarbamazine
                                     citrate) Syrup.
132-105...........................  BENZELMIN (oxfendazole) Equine
                                     Anthelmintic Paste.
133-841...........................  BENZELMIN (oxfendazole) Equine
                                     Anthelmintic Suspension.
134-779...........................  PARATECT FLEX (morantel Tartrate)
                                     Bolus.
135-544...........................  WINSTROL-V (stanozolol) Chewable
                                     Tablets.
135-940...........................  ANTIROBE AQUADROPS (clindamycin
                                     hydrochloride) Liquid.
136-342...........................  DI-TRIM 400 (trimethoprim and
                                     sulfadiazine) Paste.
136-483...........................  FILARIBITS PLUS (diethylcarbamazine
                                     citrate and oxibendazole) Chewable
                                     Tablets.
136-740...........................  BENZELMIN PLUS (oxfendazole and
                                     trichlorfon) Paste.
140-578...........................  SOLU-TET 324 (tetracycline
                                     hydrochloride) Soluble Powder.
140-819...........................  STRONGID C and C 2X (pyrantel
                                     tartrate) Equine Anthelminthic.
140-892...........................  SYNANTHIC (oxfendazole) Bovine
                                     Dewormer Paste 18.5%.
140-893...........................  CESTEX (epsiprantel) Tablets.
140-909...........................  SULKA-S (sulfamethazine) Bolus.
140-934...........................  VALBAZEN (albendazole) Oral
                                     Suspension.
141-004...........................  ROBAMOX-V (amoxicillin trihydrate)
                                     for Oral Suspension.
141-005...........................  ROBAMOX-V (amoxicillin trihydrate)
                                     Tablets.
141-051...........................  PROHEART (moxidectin) Tablets.
141-053...........................  RIMADYL (carprofen) Caplets for
                                     Dogs.
141-060...........................  DECCOX-M (decoquinate) Medicated
                                     Powder for Whole Milk.
141-080...........................  ANIPRYL (selegiline hydrochloride)
                                     Tablets.
141-087...........................  QUEST 2% (moxidectin) Equine Oral
                                     Gel.
141-111...........................  RIMADYL (carprofen) Chewable
                                     Tablets.
141-151...........................  ZENIQUIN (marbofloxacin) Tablets.
141-216...........................  QUEST PLUS (moxidectin and
                                     praziquantel) Gel.
141-232...........................  SIMPLICEF (cefpodoxime) Tablets.
141-260...........................  SLENTROL (dirlotapide) Oral
                                     Solution.
141-262...........................  CERENIA (maropitant) Tablets.
141-295...........................  PALLADIA (toceranib phosphate)
                                     Tablets.
200-046...........................  Neomycin Sulfate Soluble Powder.
200-106...........................  R-PEN (penicillin G potassium)
                                     Soluble Powder.
200-113...........................  BIOSOL (neomycin sulfate) Oral
                                     Liquid.
200-122...........................  SOLU-PEN (penicillin G potassium)
                                     Soluble Powder.
200-130...........................  NEO-SOL 50 (neomycin sulfate) Oral
                                     Solution.
200-189...........................  Lincomycin Soluble.
200-233...........................  LINCO Soluble.
200-244...........................  TUCOPRIM (trimethoprim and
                                     sulfadiazine) Powder.
200-441...........................  AUREOMYCYN (chlortetracycline)
                                     Soluble Powder.
------------------------------------------------------------------------

    Accordingly, the Agency is amending the regulations in 21 CFR part 
520 to reflect these transfers of ownership. Also, 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.
    Following this change of sponsorship, Pfizer, Inc., and its wholly 
owned subsidiaries are no longer sponsors of an approved NADA. 
Accordingly, the Agency is amending the regulations in 21 CFR 
510.600(c) to reflect this change of sponsorship.
    In addition, FDA has noticed that certain sections of part 520 
contain entries describing conditions of use for new animal drug 
products for which no NADA is approved. These errors were introduced by 
the Agency during the 1992 recodification of the regulations for 
certifiable antibiotics (57 FR 37318,

[[Page 28816]]

August 18, 1992). That rule did not identify whether particular 
regulations were the subject of an approved NADA and consequently 
resulted in codification of certain conditions of use for which there 
is no approved NADA. At this time, the Agency is amending the 
regulations to remove these entries. This action is being taken to 
improve the accuracy 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

21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling, 
Reporting and recordkeeping requirements.

21 CFR Part 520

    Animal drugs.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs and 
redelegated to the Center for Veterinary Medicine, 21 CFR parts 510 and 
520 are amended as follows:

PART 510--NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 510 continues to read as 
follows:

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

Sec.  510.600  [Amended]

0
2. In Sec.  510.600, in the table in paragraph (c)(1), remove the 
entries for ``Alpharma, LLC''; ``Fort Dodge Animal Health, Division of 
Wyeth''; ``Fort Dodge Animal Health, Division of Wyeth Holdings 
Corp.''; ``Pfizer, Inc.''; and ``Pharmacia & Upjohn Co.''; and in the 
table in paragraph (c)(2), remove the entries for ``000009'', 
``000069'', ``000856'', ``046573'', and ``053501''.

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
3. The authority citation for 21 CFR part 520 continues to read as 
follows:

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

0
4. Revise Sec.  520.28 to read as follows:

Sec.  520.28  Acetazolamide.

    (a) Specifications. A powder containing acetazolamide sodium, USP 
equivalent to 25 percent acetazolamide activity.
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer orally at a 
dosage of 5 to 15 milligrams per pound of body weight daily.
    (2) Indications for use. As an aid in the treatment of mild 
congestive heart failure and for rapid reduction of intraocular 
pressure.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

Sec.  520.38a  [Amended]

0
5. In paragraph (b) of Sec.  520.38a, remove ``000069'' and in its 
place add ``054771''.

Sec.  520.38b  [Amended]

0
6. In paragraph (b) of Sec.  520.38b, remove ``000069'' and in its 
place add ``054771''.

0
7. Revise Sec.  520.62 to read as follows:

Sec.  520.62  Aminopentamide.

    (a) Specifications. Each tablet contains 0.2 milligram (mg) 
aminopentamide hydrogen sulphate.
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs and cats--(1) Amount. Administer 
orally 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 animal weighing over 100 lbs: 0.5 mg. Dosage may be 
gradually increased up to a maximum of five times the suggested dosage. 
Oral administration of tablets may be preceded by subcutaneous or 
intramuscular use of the injectable form of the drug.
    (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
8. Revise Sec.  520.82 to read as follows:

Sec.  520.82  Aminopropazine oral dosage forms.

0
9. Revise Sec.  520.82a to read as follows:

Sec.  520.82a  Aminopropazine.

    (a) Specifications. Each tablet contains aminopropazine fumarate 
equivalent to 25 percent aminopropazine base.
    (b) Sponsor. See No. 000061 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs and cats--(1) Amount. Administer 
orally at a dosage of 1 to 2 milligrams per pound of body weight, 
repeated every 12 hours as indicated.
    (2) Indications for use. For reducing excessive smooth muscle 
contractions, such as occur in urethral spasms associated with 
urolithiasis.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

0
10. Revise Sec.  520.82b to read as follows:

Sec.  520.82b  Aminopropazine and neomycin.

    (a) Specifications. Each tablet contains aminopropazine fumarate 
equivalent to 25 percent aminopropazine base and neomycin sulfate 
equivalent to 50 milligrams (mg) of neomycin base.
    (b) Sponsor. See No. 000061 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer orally at a 
dosage of 1 to 2 mg per pound of body weight, repeated every 12 hours 
as indicated.
    (2) Indications for use. For control of bacterial diarrhea caused 
by organisms susceptible to neomycin and to reduce smooth muscle 
contractions.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

0
11. In Sec.  520.88a, revise paragraphs (a), (b), (c)(1)(i) and (iii), 
and (c)(2)(i) and (iii) to read as follows:

Sec.  520.88a  Amoxicillin trihydrate film-coated tablets.

    (a) Specifications. Each tablet contains amoxicillin trihydrate 
equivalent to 50, 100, 150, 200, or 400 milligrams (mg) amoxicillin.
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
    (c) * * *
    (1) * * *
    (i) Amount. Administer orally 5 mg per pound (/lb) of body weight, 
twice a day for 5 to 7 days.
* * * * *
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) * * *
    (i) Amount. Administer orally 5 to 10 mg/lb of body weight, once 
daily for 5 to 7 days.
* * * * *
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

0
12. In Sec.  520.88b, revise paragraphs (a), (b), (b)(1)(i)(A) and (C), 
(b)(1)(ii)(A) and (C), and (c)(1)(i) and (iii) to read as follows:

Sec.  520.88b  Amoxicillin trihydrate for oral suspension.

    (a) Specifications. When reconstituted, each milliliter contains

[[Page 28817]]

amoxicillin trihydrate equivalent to 50 milligrams (mg) amoxicillin.
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
    (1) * * *
    (i) * * *
    (A) Amount. Administer orally 5 mg per pound (/lb) of body weight, 
twice a day for 5 to 7 days.
* * * * *
    (C) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (ii) * * *
    (A) Amount. Administer orally 5 to 10 mg/lb of body weight, once 
daily for 5 to 7 days.
* * * * *
    (C) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
* * * * *
    (c) * * *
    (1) Conditions of use in dogs--(i) Amount. Administer orally 5 mg/
lb of body weight, twice a day for 5 to 7 days.
* * * * *
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
* * * * *

0
13. In Sec.  520.88c, revise paragraphs (a), (b), (d) heading, (d)(1), 
and (d)(3) to read as follows:

Sec.  520.88c  Amoxicillin trihydrate oral suspension.

    (a) Specifications. Each 0.8-milliliter dose contains amoxicillin 
trihydrate equivalent to 40 milligrams (mg) amoxicillin.
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
* * * * *
    (d) Conditions of use in swine--(1) Amount. Administer 40 mg orally 
twice a day using a dosing pump. Treat animals for 48 hours after all 
symptoms have subsided but not beyond 5 days.
* * * * *
    (3) Limitations. Do not slaughter during treatment or for 15 days 
after latest treatment. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

0
14. In Sec.  520.88d, revise paragraphs (a), (b), (d) heading, (d)(1), 
and (d)(3) to read as follows:

Sec.  520.88d  Amoxicillin trihydrate soluble powder.

    (a) Specifications. Each gram of powder contains amoxicillin 
trihydrate equivalent to 115.4 milligrams (mg) amoxicillin.
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
* * * * *
    (d) Conditions of use in preruminating calves including veal 
calves--(1) Amount. Administer 400 mg per 100 pounds of body weight 
twice daily by drench or in milk. Treatment should be continued for 48 
hours after all symptoms have subsided but not to exceed 5 days.
* * * * *
    (3) Limitations. Do not slaughter animals during treatment or for 
20 days after the latest treatment. Federal law restricts this drug to 
use by or on the order of a licensed veterinarian.

0
15. In Sec.  520.88e, revise paragraphs (a), (b), (d) heading, (d)(1), 
and(3) to read as follows:

Sec.  520.88e  Amoxicillin trihydrate boluses.

    (a) Specifications. Each bolus contains amoxicillin trihydrate 
equivalent to 400 milligrams (mg) amoxicillin.
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
* * * * *
    (d) Conditions of use in cattle--(1) Amount. Administer 400 mg per 
100 pounds of body weight twice daily. Treatment should be continued 
for 48 hours after all symptoms have subsided but not to exceed 5 days.
* * * * *
    (3) Limitations. Do not slaughter animals during treatment or for 
20 days after the latest treatment. Federal law restricts this drug to 
use by or on the order of a licensed veterinarian.

0
16. Revise Sec.  520.88f to read as follows:

Sec.  520.88f  Amoxicillin trihydrate tablets.

    (a) Specifications. Each tablet contains amoxicillin trihydrate 
equivalent to 50, 100, 200, or 400 milligrams (mg) amoxicillin.
    (b) Sponsors. See Nos. 051311 and 054771 in Sec.  510.600(c) of 
this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer 5 mg per 
pound of body weight twice daily for 5 to 7 days or 48 hours after all 
symptoms have subsided.
    (2) Indications for use. For treatment of bacterial dermatitis due 
to Staphylococcus aureus, Streptococcus spp., Staphylococcus spp., and 
Escherichia coli; and soft tissue infections (abscesses, wounds, 
lacerations) due to S. aureus, Streptococcus spp., E. coli, Proteus 
mirabilis, and Staphylococcus spp.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

0
17. In Sec.  520.88g, revise paragraphs (b), (c)(1)(i) and (iii), and 
(c)(2)(i) and (iii) to read as follows:

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

* * * * *
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
    (c) * * *
    (1) * * *
    (i) Amount. 6.25 milligrams (equivalent to 5 milligrams amoxicillin 
and 1.25 milligrams clavulanic acid) per pound of body weight twice 
daily for 5 to 7 days or for 48 hours after all signs have subsided. 
Deep pyoderma may require treatment for 21 days; do not treat for more 
than 30 days.
* * * * *
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) * * *
    (i) Amount. 62.5 milligrams (1 milliliter) (50 milligrams 
amoxicillin and 12.5 milligrams clavulanic acid) twice daily for 5 to 7 
days or for 48 hours after all signs have subsided. Urinary tract 
infections may require treatment for 10 to 14 days or longer. The 
maximum duration of treatment should not exceed 30 days.
* * * * *
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

0
18. In Sec.  520.88h, revise paragraphs (b), (c)(1)(i) and (iii), and 
(c)(2)(i) and (iii) to read as follows:

Sec.  520.88h  Amoxicillin trihydrate and clavulanate potassium for 
oral suspension.

* * * * *
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
    (c) * * *
    (1) * * *
    (i) Amount. 6.25 milligrams (equivalent to 5 milligrams amoxicillin 
and 1.25 milligrams clavulanic acid) per pound of body weight twice 
daily for 5 to 7 days or for 48 hours after all signs have subsided. 
Deep pyoderma may require treatment for 21 days; do not treat for more 
than 30 days.
* * * * *
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) * * *
    (i) Amount. 62.5 milligrams (1 milliliter) (50 milligrams 
amoxicillin and 12.5 milligrams clavulanic acid) twice daily. 
Administer 48 hours after all signs have subsided. Maximum duration of 
treatment should not exceed 30 days.
* * * * *
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

[[Page 28818]]

Sec.  520.90a  [Reserved]

0
19. Remove and reserve Sec.  520.90a.
0
20. In Sec.  520.90b, revise the section heading, paragraph (b), 
paragraph (c) heading, and paragraph (c)(3) to read as follows:

Sec.  520.90b  Ampicillin tablets.

* * * * *
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
    (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
21. In Sec.  520.90c, revise the section heading, paragraphs (b), 
(c)(1)(iii), and (c)(2)(iii) to read as follows:

Sec.  520.90c  Ampicillin capsules.

* * * * *
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
    (c) * * *
    (1) * * *
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) * * *
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

0
22. In Sec.  520.90d, revise the section heading, paragraphs (c)(1)(i) 
and (iii), and (c)(2)(i) and (iii) to read as follows:

Sec.  520.90d  Ampicillin for oral suspension.

* * * * *
    (c) * * *
    (1) * * *
    (i) Amount. Administer to 10 milligrams per pound of body weight 
orally, 2 or 3 times daily, 1 to 2 hours prior to feeding. In severe or 
acute conditions, 10 milligrams per pound of body weight 3 times daily. 
Duration of treatment is usually 3 to 5 days. Continue treatment 48 
hours after the animal's temperature has returned to normal and all 
other signs of infection have subsided.
* * * * *
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) * * *
    (i) Amount. Administer 10 to 30 milligrams per pound of body weight 
orally, 2 or 3 times daily, 1 to 2 hours prior to feeding. Duration of 
treatment is usually 3 to 5 days. Continue treatment 48 hours after the 
animal's temperature has returned to normal and all other signs of 
infection have subsided.
* * * * *
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

0
23. In Sec.  520.90e, revise the section heading and paragraph (d)(3) 
to read as follows:

Sec.  520.90e  Ampicillin for soluble powder.

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

0
24. In Sec.  520.90f, revise the section heading and revise paragraph 
(b) and in paragraphs (d)(1)(ii) and (d)(2)(ii), remove the second 
sentence..
    The revisions read as follows:

Sec.  520.90f  Ampicillin boluses.

* * * * *
    (b) Sponsors. See sponsor numbers in Sec.  510.600(c) of this 
chapter as follows:
    (1) No. 055529 for use as in paragraph (d)(1) of this section;
    (2) No. 054771 for use as in paragraph (d)(2) of this section.
* * * * *

0
25. In Sec.  520.110, revise paragraph (d) to read as follows:

Sec.  520.110  Apramycin sulfate soluble powder.

* * * * *
    (d) Conditions of use in swine--(1) Amount. Administer in drinking 
water at the rate of 12.5 milligrams of apramycin per kilogram (5.7 
milligrams per pound) of body weight per day for 7 days.
    (2) Indications for use. For the control of porcine colibacillosis 
(weanling pig scours) caused by strains of Escherichia coli sensitive 
to apramycin.
    (3) Limitations. Prepare fresh medicated water daily. Do not 
slaughter treated swine for 28 days following treatment.

Sec.  520.154a  [Amended]

0
26. In paragraph (b) of Sec.  520.154a, remove ``046573'' and in its 
place add ``054771''.

Sec.  520.154b  [Amended]

0
27. In paragraph (b) of Sec.  520.154b, remove ``046573'' and in its 
place add ``054771''.

Sec.  520.154c  [Amended]

0
28. In paragraph (b) of Sec.  520.154c, remove ``053501'' and in its 
place add ``054771''.

0
29. Revise Sec.  520.246 to read as follows:

Sec.  520.246  Butorphanol tablets.

    (a) Specifications. Each tablet contains butorphanol tartrate 
equivalent to 1, 5, or 10 milligrams (mg) butorphanol base.
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer 0.25 mg 
butorphanol base per pound of body weight. Repeat at intervals of 6 to 
12 hours as required. Treatment should not normally be required for 
longer than 7 days.
    (2) Indications for use. For the relief of chronic nonproductive 
cough associated with tracheobronchitis, tracheitis, tonsillitis, 
laryngitis, and pharyngitis associated with inflammatory conditions of 
the upper respiratory tract.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

Sec.  520.260  [Amended]

0
30. In Sec.  520.260, remove footnote 1 wherever it occurs; and in 
paragraph (b)(2), remove ``000069'' and in its place add ``054771''.

0
31. In Sec.  520.300a, revise paragraph (c) to read as follows:

Sec.  520.300a  Cambendazole suspension.

* * * * *
    (c) Conditions of use in horses--(1) Amount. Administer by stomach 
tube or as a drench at a dose of 0.9 gram of cambendazole per 100 
pounds of body weight (20 milligrams per kilogram).
    (2) Indications for use. For the control of large strongyles 
(Strongylus vulgaris, S. edentatus, S. equinus); small strongyles 
(Trichonema, Poteriostomum, Cylicobrachytus, Craterostomum, 
Oesophagodontus); roundworms (Parascaris); pinworms (Oxyuris); and 
threadworms (Strongyloides).
    (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. In Sec.  520.300b, revise paragraph (c) to read as follows:

Sec.  520.300b  Cambendazole pellets.

* * * * *
    (c) Conditions of use in horses--(1) Amount. Administer 20 
milligrams cambendazole per kilogram body weight (6 ounces per 1,000 
pounds) by mixing with normal grain ration given at one feeding. Doses 
for individual horses should be mixed and fed separately to assure that 
each horse will consume the correct amount. For animals maintained on 
premises where reinfection is likely to occur, re-treatments may be 
necessary. For most effective results, re-treat in 6 to 8 weeks.

[[Page 28819]]

    (2) Indications for use. For the control of large strongyles 
(Strongylus vulgaris, S. edentatus, S. equinus); small strongyles 
(Trichonema, Poteriostomum, Cylicobrachytus, Craterostomum, 
Oesophagodontus); roundworms (Parascaris); pinworms (Oxyuris); and 
threadworms (Strongyloides).
    (3) Limitations. Do not administer to pregnant mares during first 3 
months of pregnancy. Do not use in horses intended for human 
consumption. Consult your veterinarian for assistance in the diagnosis, 
treatment, and control of parasitism.

0
33. In Sec.  520.300c, revise paragraph (c) to read as follows:

Sec.  520.300c  Cambendazole paste.

* * * * *
    (c) Conditions of use in horses--(1) Amount. Administer 20 
milligrams cambendazole per kilogram body weight (5 grams per 550 
pounds (250 kilograms)) by depositing the paste on the back of the 
tongue using a dosing gun. For animals maintained on premises where 
reinfection is likely to occur, re-treatments may be necessary. For 
most effective results, re-treat in 6 to 8 weeks.
    (2) Indications for use. For the control of large strongyles 
(Strongylus vulgaris, S. edentatus, S. equinus); small strongyles 
(Trichonema, Poteriostomum, Cylicobrachytus, Craterostomum, 
Oesophagodontus); roundworms (Parascaris); pinworms (Oxyuris); and 
threadworms (Strongyloides).
    (3) Limitations. Do not administer to pregnant mares during first 3 
months of pregnancy. Do not use in horses intended for human 
consumption. Consult your veterinarian for assistance in the diagnosis, 
treatment, and control of parasitism.

Sec.  520.309  [Amended]

0
34. In Sec.  520.309, in paragraph (b)(1), remove ``000069'' and in its 
place add ``054771''.

Sec.  520.310  [Amended]

0
35. In Sec.  520.310, in paragraph (b), remove ``000856'' and in its 
place add ``054771''; and remove footnote 1 wherever it occurs.

Sec.  520.370  [Amended]

0
36. In Sec.  520.370, in paragraph (b), remove ``000009 and 026637'' 
and in its place add ``026637 and 054771''.

Sec.  520.390a  [Amended]

0
37. In Sec.  520.390a, in paragraph (b)(1)(ii), remove ``000856'' and 
in its place add ``054771''; and remove paragraph (b)(1)(iii).

Sec.  520.390b  [Amended]

0
38. In Sec.  520.390b, in paragraph (b), remove ``000069 and 050057'' 
and in its place add ``050057 and 054771''.

Sec.  520.390c  [Amended]

0
39. In Sec.  520.390c, in paragraph (b), remove ``000856'' and in its 
place add ``054771''.

Sec.  520.420  [Amended]

0
40. In Sec.  520.420, remove footnote 1 wherever it occurs.

Sec.  520.434  [Amended]

0
41. In Sec.  520.434, in paragraph (b), remove ``000009'' and in its 
place add ``054771''; and in paragraph (c)(3), remove the first four 
sentences.

Sec.  520.441  [Amended]

0
42. In Sec.  520.441, in paragraph (b)(2), remove ``046573 and 000010'' 
and in its place add ``000010 and 054771''.

Sec.  520.446  [Amended]

0
43. In Sec.  520.446, in paragraph (b)(1), remove ``000009 and 000859'' 
and in its place add ``000859 and 054771''.

Sec.  520.447  [Amended]

0
44. In Sec.  520.447, in paragraph (b), remove ``000009, 000859, 
051311'' and in its place add ``000859, 051311, 054771''.

Sec.  520.530  [Amended]

0
45. In Sec.  520.530, in paragraph (b), remove ``053501'' and in its 
place add '' 054771''; and in paragraph (d)(3), remove the first two 
sentences.

0
46. Amend Sec.  520.531 as follows:
0
a. Add paragraph (a);
0
b. Remove paragraph (c);
0
c. Redesignate paragraph (d) as paragraph (c); and
0
d. Revise paragraph (b) and newly redesignated paragraph (c)(3).
    The addition and revision read as follows:

Sec.  520.531  Cythioate tablets.

    (a) Specifications. Each tablet contains 30 or 90 milligrams (mg) 
cythioate.
    (b) Sponsors. See sponsor numbers in Sec.  510.600(c) of this 
chapter as follows:
    (1) No. 000859 for use of 30- and 90-mg tablets;
    (2) No. 054771 for use of the 30-mg tablet.
    (c) * * *
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

0
47. In Sec.  520.534, revise paragraph (a), and in paragraph (b), 
remove ``046573'' and in its place add ``054771''.
    The revision reads as follows:

Sec.  520.534  Decoquinate.

    (a) Specifications. Each gram of powder contains 8 milligrams (0.8 
percent) decoquinate.
* * * * *

0
48. Revise Sec.  520.540a to read as follows:

Sec.  520.540a  Dexamethasone powder.

    (a) Specifications. Each packet contains 10 milligrams (mg) of 
dexamethasone.
    (b) Sponsor. See No. 000061 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in cattle and horses--(1) Amount. Administer 
5 to 10 mg per animal the first day then 5 mg per day as required by 
drench or by sprinkling on a small amount of feed.
    (2) Indications for use. As supportive therapy following parenteral 
steroid administration for management or inflammatory conditions such 
as acute arthritic lameness, and for various stress conditions where 
corticosteroids are required while the animal is being treated for a 
specific condition.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian. A withdrawal period has not been 
established for this product in preruminating calves. Do not use in 
calves to be processed for veal. Do not use in horses intended for 
human consumption.

0
49. In Sec.  520.540b, remove footnote 1 wherever it occurs; and revise 
paragraphs (a)(3) and (b)(3) to read as follows:

Sec.  520.540b  Dexamethasone tablets and boluses.

    (a) * * *
    (3) Conditions of use in cattle and horses--(i) Amount. Administer 
orally 5 to 10 milligrams on the first day, then 5 milligrams per day 
as required.
    (ii) Indications for use. As supportive therapy following 
parenteral steroid administration for management or inflammatory 
conditions such as acute arthritic lameness, and for various stress 
conditions where corticosteroids are required while the animal is being 
treated for a specific condition.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian. A withdrawal period has not been 
established for this product in preruminating calves. Do not use in 
calves to be processed for veal. Do not use in horses intended for 
human consumption.
    (b) * * *

[[Page 28820]]

    (3) Conditions of use in dogs and cats--(i) Amount. Dogs: 
Administer orally 0.25 to 1.25 milligrams per day for up to 7 days. 
Cats: Administer orally 0.125 to 0.5 milligrams per day for up to 7 
days.
    (ii) Indications for use. As an anti-inflammatory agent.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

0
50. Amend Sec.  520.540c as follows:
0
a. Remove footnote 1 wherever it occurs;
0
b. In paragraph (b), remove ``000069'' and in its place add ``054771''; 
and
0
c. Revise paragraph (c).
    The revision reads as follows:

Sec.  520.540c  Dexamethasone chewable tablets.

* * * * *
    (c) Conditions of use in dogs--(1) Amount. Administer by free-
choice feeding or crumbled over food 0.25 to 1.25 milligrams daily in 
single or two divided doses until response is noted or 7 days have 
elapsed. When response is attained, dosage should be gradually reduced 
by 0.125 milligram per day until maintenance level is achieved.
    (2) Indications for use. As supportive therapy in nonspecific 
dermatosis and inflammatory conditions.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

Sec.  520.550  [Removed]

0
51. Remove Sec.  520.550.

0
52. In Sec.  520.563, revise the section heading, remove ``053501'' in 
paragraph (b) and in its place add ``054771'', and revise paragraph 
(c).
    The revisions read as follows:

Sec.  520.563  Dexamethasone chewable tablets.

* * * * *
    (c) Conditions of use in dogs and cats--(1) Amount. Administer 
orally 0.5 to 1.0 milliliter per pound of body weight by gavage or 
stomach tube. Administered rectally 0.5 to 1.0 milliliter per pound of 
body weight diluted with 1 part of the drug to 5 parts of water.
    (2) Indications for use. For radiography of the gastrointestinal 
tract.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

Sec.  520.580  [Amended]

0
53. In Sec.  520.580, in paragraph (b)(2), remove ``054628'' and in its 
place add ``054771''.

0
54. In Sec.  520.608, revise the section heading and paragraphs (b) and 
(c) to read as follows:

Sec.  520.608  Dicloxacillin.

* * * * *
    (b) Sponsor. See No. 054771 in Sec.  510.600 (c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer orally 5 to 
10 milligrams per pound of body weight, three times daily. In severe 
cases, up to 25 milligrams per pound of body weight three times daily.
    (2) Indications for use. For the treatment of pyoderma (pyogenic 
dermatitis) due to penicillinase-producing staphylococci sensitive to 
dicloxacillin.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

Sec.  520.622a  [Amended]

0
55. In Sec.  520.622a, in paragraph (a)(2), remove ``053501'' and in 
its place add ``054771''.

Sec.  520.622b  [Amended]

0
56. In Sec.  520.622b, in paragraph (a)(2), remove ``053501'' and in 
its place add ``054771''.

Sec.  520.622c  [Amended]

0
57. In Sec.  520.622c, in paragraph (b)(2), remove ``000069'' and in 
its place add ``054771''.

0
58. In Sec.  520.623, revise the section heading and paragraphs (b) and 
(c)(3) to read as follows:

Sec.  520.623  Diethylcarbamazine and oxibendazole chewable tablets.

* * * * *
    (b) Sponsor. See No. 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.

Sec.  520.666  [Amended]

0
59. In Sec.  520.666, in paragraph (b), remove ``000069'' and in its 
place add ``054771''.

0
60. Revise Sec.  520.763 to read as follows:

Sec.  520.763  Dithiazanine oral dosage forms.

0
61. Revise Sec.  520.763a to read as follows:

Sec.  520.763a  Dithiazanine tablets.

    (a) Specifications. Each tablet contains 10, 50, 100, or 200 
milligrams (mg) dithiazanine iodide.
    (b) Sponsor. See No. 054628 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Indications for use and amount. 
Administer orally immediately after feeding as follows:
    (i) For large roundworms (Toxocara canis, Toxascaris leonina): 10 
mg per pound (/lb) of body weight for 3 to 5 days;
    (ii) For hookworms (Ancylostoma caninum, Uncinaria stenocephala) 
and whipworms (Trichuris vulpis): 10 mg/lb of body weight for 7 days;
    (iii) For Strongyloides (Strongyloides canis, Strongyloides 
stercoralis): 10 mg/lb of body weight for 10 to 12 days;
    (iv) For heartworm microfilariae (Dirofilaria immitus): 3 to 5 mg/
lb of body weight for 7 to 10 days. Treatment for heartworm 
microfilariae should follow 6 weeks after therapy for adult worms.
    (2) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

0
62. Revise Sec.  520.763b to read as follows:

Sec.  520.763b  Dithiazanine powder.

    (a) Specifications. Each tablespoon of powder contains 200 
milligrams (mg) dithiazanine iodide.
    (b) Sponsor. See No. 000010 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Indications for use and amount. 
Administer orally by mixing in food as follows:
    (i) For large roundworms (Toxocara canis, Toxascaris leonina): 10 
mg per pound (/lb) of body weight for 3 to 5 days;
    (ii) For hookworms (Ancylostoma caninum, Uncinaria stenocephala) 
and whipworms (Trichuris vulpis): 10 mg/lb of body weight for 7 days;
    (iii) For Strongyloides (Strongyloides canis, Strongyloides 
stercoralis): 10 mg/lb of body weight for 10 to 12 days;
    (iv) For heartworm microfilariae (Dirofilaria immitus): 3 to 5 mg/
lb of body weight for 7 to 10 days. Treatment for heartworm 
microfilariae should follow 6 weeks after therapy for adult worms.
    (2) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

0
63. In Sec.  520.763c, redesignate paragraph (d) as paragraph (c); and 
revise paragraphs (a), (b), and the redesignated paragraph (c) heading 
to read as follows:

Sec.  520.763c  Dithiazanine and piperazine suspension.

    (a) Specifications. Each milliliter of suspension contains 69 
milligrams (mg) dithiazanine iodide and 83 mg piperazine base (as 
piperazine citrate).
    (b) Sponsor. See No. 054628 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in horses--
* * * * *

[[Page 28821]]

0
64. Amend Sec.  520.784 by revising the section heading and paragraph 
(c) to read as follows:

Sec.  520.784  Doxylamine.

* * * * *
    (c) Conditions of use--(1) Amount. Horses: Administer orally 1 to 2 
milligrams (mg) per pound (/lb) of body weight per day divided into 3 
or 4 equal doses. Dogs and cats: Administer orally 2 to 3 mg/lb of body 
weight per day divided into 3 or 4 equal doses.
    (2) Indications for use. For use when 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
65. Revise Sec.  520.804 to read as follows:

Sec.  520.804  Enalapril.

    (a) Specifications. Each tablet contains 1.0, 2.5, 5.0, 10, or 20 
milligrams (mg) of enalapril maleate.
    (b) Sponsor. See No. 050604 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs--(i) Amount. Administer orally 0.5 to 
1.0 mg of enalapril maleate per kilogram of body weight per day.
    (ii) Indications for use. For the treatment of mild, moderate, and 
severe (modified New York Heart Association Class II, III, IV) heart 
failure in dogs.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

0
66. In Sec.  520.816, revise the section heading and paragraphs (b) and 
(c)(3) to read as follows:

Sec.  520.816  Epsiprantel.

* * * * *
    (b) Sponsor. See No. 050604 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.

0
67. In Sec.  520.823, revise the section heading and paragraph (a) to 
read as follows:

Sec.  520.823  Erythromycin.

    (a) Specifications. Each gram of powder contains erythromycin 
phosphate equivalent to 0.89 gram of erythromycin master standard.
* * * * *

0
68. Amend Sec.  520.863 as follows:
0
a. Revise the section heading;
0
b. Remove footnote 1 wherever it occurs; and
0
c. Revise paragraph (c).
    The revisions read as follows:

Sec.  520.863  Ethylisobutrazine.

* * * * *
    (c) Conditions of use in dogs--(1) Amount. Administer orally 2 to 5 
milligrams per pound of body weight once daily.
    (2) Indications for use. As a tranquilizer.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

0
69. In Sec.  520.870, add paragraph (c) and remove paragraph (d).
    The addition reads as follows:

Sec.  520.870  Etodolac.

* * * * *
    (c) Conditions of use in dogs--(1) Amount. Administer 10 to 15 mg 
per kilogram (4.5 to 6.8 mg per pound) of body weight per day orally.
    (2) Indications for use. For the management of pain and 
inflammation associated with osteoarthritis.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

0
70. Revise Sec.  520.903a to read as follows:

Sec.  520.903a  Febantel paste.

    (a) Specifications. Each gram of paste contains 455 milligrams 
(45.5 percent) febantel.
    (b) Sponsor. See No. 000859 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in horses--(1) Amount. Administer paste 
orally at 6 milligrams per kilogram (2.73 milligrams per pound) of body 
weight on the base of the tongue or well mixed into a portion of the 
normal grain ration. For animals maintained on premises where 
reinfection is likely to occur, retreatment may be necessary. For most 
effective results, retreat in 6 to 8 weeks.
    (2) Indications for use. For removal of large strongyles 
(Strongylus vulgaris, S. edentatus, S. equinus); ascarids (Parascaris 
equorum--sexually mature and immature); pinworms (Oxyuris equi--adult 
and 4th stage larva); and various small strongyles in horses, foals, 
and ponies.
    (3) Limitations. Do not use in horses intended for human 
consumption. Consult your veterinarian for assistance in the diagnosis, 
treatment, and control of parasitism.

0
71. In Sec.  520.903b, revise paragraphs (a), (b), and (c) to read as 
follows:

Sec.  520.903b  Febantel suspension.

    (a) Specifications. Each ounce of suspension contains 2.75 grams 
(9.3 percent ounce) febantel.
    (b) Sponsor. See No. 000859 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in horses--(1) Amount. 3 milliliters per 100 
pounds body weight or 1 fluid ounce per 1000 pounds (6 milligrams per 
kilogram body weight). Administer by stomach tube or drench, or by 
mixing well into a portion of the normal grain ration. For animals 
maintained on premises where reinfection is likely to occur, 
retreatment may be necessary. For most effective results, retreat in 6 
to 8 weeks.
    (2) Indications for use. For removal of ascarids (Parascaris 
equorum--adult and sexually immature), pinworms (Oxyuris equi--adult 
and 4th stage larvae), large strongyles (Strongylus vulgaris, S. 
edentatus, S. equinus), and various small strongyles in horses, 
breeding stallions and mares, pregnant mares, foals, and ponies.
    (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
72. In Sec.  520.903d, revise the section heading and paragraph (c)(3) 
and remove paragraph (c)(4).
    The revisions read as follows:

Sec.  520.903d  Febantel and praziquantel paste.

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

0
73. In Sec.  520.903e, revise paragraphs (b) and (c)(3) to read as 
follows:

Sec.  520.903e  Febantel tablets.

* * * * *
    (b) Sponsor. See No. 000859 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.

0
74. In Sec.  520.960, revise the section heading and paragraphs (b) and 
(c)(3) to read as follows:

Sec.  520.960  Flumethasone.

* * * * *
    (b) Sponsor. See No. 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.

0
75. Add Sec.  520.1060 to read as follows:

Sec.  520.1060  Glucose and glycine.

    (a) Specifications. Each packet of powder contains 8.82 grams 
sodium chloride, 4.20 grams potassium

[[Page 28822]]

phosphate, 0.5 gram citric acid anhydrous, 0.12 gram potassium citrate, 
6.36 grams aminoacetic acid (glycine), and 44.0 grams glucose.
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in calves--(1) Amount. Dissolve each packet 
in 2 quarts of warm water and administer to each calf as follows:
    (i) Scouring and/or dehydrated calves. Feed 2 quarts of solution, 
twice daily for 2 days (four feedings). No milk or milk replacer should 
be fed during this period. For the next four feedings (days 3 and 4), 
use 1 quart of solution together with 1 quart of milk replacer. 
Thereafter, feed as normal.
    (ii) Newly purchased calves. Feed 2 quarts of solution instead of 
milk as the first feed upon arrival. For the next scheduled feeding, 
use 1 quart of solution mixed together with 1 quart of milk or milk 
replacer. Thereafter, feed as normal.
    (2) Indications for use. For control of dehydration associated with 
diarrhea (scours); and as an early treatment at the first signs of 
scouring. It may also be used as followup treatment following 
intravenous fluid therapy.
    (3) Limitations. The product should not be used in animals with 
severe dehydration (down, comatose, or in a state of shock). Such 
animals need intravenous therapy. A veterinarian should be consulted in 
severely scouring calves. The product is not nutritionally complete if 
administered by itself for long periods of time. It should not be 
administered beyond the recommended treatment period without the 
addition of milk or milk replacer.

0
76. In Sec.  520.1100, revise paragraphs (d)(1)(ii) and (d)(2)(i)(A) to 
read as follows:

Sec.  520.1100  Griseofulvin.

* * * * *
    (d) * * *
    (1) * * *
    (ii) Limitations. Do not use in horses intended for human 
consumption.
    (2) * * *
    (i) * * *
    (A) Daily (single or divided) dose as follows: For animals weighing 
up to 6 pounds: 62.5 milligrams; for animals weighing 6 to 18 pounds: 
125 milligrams; for animals weighing 18 to 36 pounds: 250 milligrams; 
for animals weighing 36 to 48 pounds: 375 milligrams; for animal 
weighing 48 to 75 pounds: 500 milligrams.
* * * * *

0
77. Amend Sec.  520.1120a as follows:
0
a. Remove paragraph (a);
0
b. Redesignate paragraphs (b) through (f) as paragraphs (a) through 
(e), respectively; and
0
c. Revise newly redesignated paragraphs (a) and (e).
    The revisions read as follows:

Sec.  520.1120a  Haloxon drench.

* * * * *
    (a) Specifications. Each packet contains 141.5 grams haloxon.
* * * * *
    (e) Conditions of use in cattle--(1) Amount. Dissolve each packet 
in 32 fluid ounces of water and administer as follows: For animals 
weighing up to 100 pounds: 1/2 fluid ounce; for animals weighing 100 to 
150 pounds: 3/4 fluid ounce; for animals weighing 150 to 200 pounds: 1 
fluid ounce; for animals weighing 200 to 300 pounds: 1 1/2 fluid 
ounces; for animals weighing 300 to 450 pounds: 2 fluid ounces; for 
animals weighing 450 to 700 pounds: 3 fluid ounces; for animals 
weighing 700 to 1,000 pounds: 4 fluid ounces; for animals weighing 
1,000 to 1,200 pounds: 5 fluid ounces; for animals weighing over 1,200 
pounds: 6 fluid ounces. Retreat in 3 to 4 weeks.
    (2) Indications for use. For control of gastrointestinal roundworms 
of the genera Haemonchus, Ostertagia, Trichostrongylus, and Cooperia.
    (3) Limitations. Do not treat dairy animals of breeding age. Do not 
treat within 1 week of slaughter.

0
78. Amend Sec.  520.1120b as follows:
0
a. Remove paragraph (a);
0
b. Redesignate paragraphs (b) through (e) as paragraphs (a) through 
(d), respectively; and
0
c. Revise newly redesignated paragraph (d).
    The revisions read as follows:

Sec.  520.1120b  Haloxon boluses.

* * * * *
    (d) Conditions of use in cattle--(1) Amount. Administered one bolus 
per 500 pounds body weight (35 to 50 milligrams per kilogram of body 
weight). Retreat in 3 to 4 weeks.
    (2) Indications for use. For control of gastrointestinal roundworms 
of the genera Haemonchus, Ostertagia, Trichostrongylus, and Cooperia.
    (3) Limitations. Do not treat dairy animals of breeding age or 
older. Do not treat within 1 week of slaughter.

0
79. In Sec.  520.1157, revise the section heading and paragraph (c)(3) 
to read as follows:

Sec.  520.1157  Iodinated casein.

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

0
80. In Sec.  520.1158, revise the section heading and paragraphs (b) 
and (c)(3) to read as follows:

Sec.  520.1158  Iodochlorhydroxyquin.

* * * * *
    (b) Sponsor. See No. 054771 in Sec.  510.600 (c) of this chapter.
    (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
81. In Sec.  520.1196, revise the section heading and paragraphs 
(c)(1)(i) and (iii) to read as follows:

Sec.  520.1196  Ivermectin and pyrantel tablets.

* * * * *
    (c) * * *
    (1) * * *
    (i) Amount. Administer a minimum of 6 [micro]g of ivermectin and 5 
mg of pyrantel per kilogram (2.72 [micro]g and 2.27 mg per pound) of 
body weight monthly.
* * * * *
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
* * * * *

Sec.  520.1199  [Amended]

0
82. In Sec.  520.1199, in paragraph (b), remove ``Sponsors'' and in its 
place add ``Sponsor''.

Sec.  520.1204  [Amended]

0
83. In Sec.  520.1204, in paragraph (b), remove ``000856'' and in its 
place add ``054771''.

Sec.  520.1242a  [Amended]

0
84. In Sec.  520.1242a, in paragraph (b)(2), remove ``053501'' and in 
its place add ``054771''.

0
85. Revise Sec.  520.1242b to read as follows:

Sec.  520.1242b  Levamisol boluses or oblets.

    (a) Specifications. Each bolus contains 2.19 grams levamisol 
hydrochloride. Each oblet contains 0.184 grams levamisol hydrochloride.
    (b) Sponsors. See Nos. 000061 and 054771 in Sec.  510.600(c) of 
this chapter.
    (c) Required labeling. Consult your veterinarian for assistance in 
the diagnosis, treatment, and control of parasitism.
    (d) Related tolerances. See Sec.  556.350 of this chapter.
    (e) Conditions of use--(1) Cattle--(i) Amount. Administer orally 
2.19-gram boluses as a single dose as follows: 250 to 450 pounds, \1/2\ 
bolus; 450 to 750 pounds, 1 bolus; and 750 to 1,050 pounds, 1\1/2\ 
boluses.

[[Page 28823]]

    (ii) Indications for use. Anthelmintic effective against the 
following nematode infections: Stomach worms (Haemonchus, 
Trichostrongylus, Ostertagia), intestinal worms (Trichostrongylus, 
Cooperia, Nematodirus, Bunostomum, Oesophagostomum), and lungworms 
(Dictyocaulus).
    (iii) Limitations. Conditions of constant helminth exposure may 
require re-treatment within 2 to 4 weeks after the first treatment. Do 
not slaughter for food within 48 hours of treatment. Not for use in 
dairy animals of breeding age. Consult veterinarian before using in 
severely debilitated animals.
    (2) Sheep--(i) Amount. Administer orally one 0.184-gram oblet for 
each 50 pounds of body weight.
    (ii) Indications for use. Anthelmintic effective against the 
following nematode infections: Stomach worms (Haemonchus, 
Trichostrongylus, Ostertagia), intestinal worms (Trichostrongylus, 
Cooperia, Nematodirus, Bunostomum, Oesophagostomum, Chabertia), and 
lungworms (Dictyocaulus).
    (iii) Limitations. Conditions of constant helminth exposure may 
require re-treatment within 2 to 4 weeks after the first treatment. Do 
not slaughter for food within 72 hours of treatment. Consult a 
veterinarian before using in severely debilitated animals.

0
86. Revise Sec.  520.1242c to read as follows:

Sec.  520.1242c  Levamisol and piperazine.

    (a) Specifications. (1) Each ounce of solution contains 0.36 gram 
of levamisole hydrochloride and piperazine dihydrochloride equivalent 
to 3.98 grams of piperazine base.
    (2) A soluble powder which when constituted with water contains in 
each fluid ounce 0.45 gram of levamisole hydrochloride and piperazine 
dihydrochloride equivalent to 5.0 grams of piperazine base.
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in horses--(1) Amount. Aqueous solution: 
administer by stomach tube or drench 1 fluid ounce per 100 pounds of 
body weight. Reconstituted soluble powder: administer by stomach tube 1 
fluid ounce per 125 pounds of body weight. If reinfection occurs, re-
treat animals at 6- to 8-week intervals.
    (2) Indications for use. An anthelmintic effective against 
infections of large strongyles (Strongylus vulgaris, S. edentatus), 
small strongyles (Cylicocercus spp., Cylicocyclus spp., 
Cylicodontophorus spp., Cylicostephanus spp., Cylicotetrapedon spp.), 
ascarids (Parascaris equorum), and pinworms (Oxyuris 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.

Sec.  520.1242e  [Amended]

0
87. In paragraph (b) of Sec.  520.1242e, remove ``053501'' and in its 
place add ``054771''.

0
88. In Sec.  520.1242f, revise the section heading and paragraphs (a) 
and (b) to read as follows:

Sec.  520.1242f  Levamisol gel.

    (a) Specifications. Each gram of gel contains 115 milligrams (11.5 
percent) levamisol hydrochloride.
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
* * * * *

0
89. Amend Sec.  520.1242g as follows:
0
a. Remove paragraph (a);
0
b. Redesignate paragraphs (b) through (f) as paragraphs (a) through 
(e); and
0
c. Revise newly redesignated paragraph (d).
    The revision reads as follows:

Sec.  520.1242g  Levamisole resinate and famphur paste.

* * * * *
    (d) Related tolerances. See Sec. Sec.  556.273 and 556.350 of this 
chapter.
* * * * *

0
90. Revise Sec.  520.1263a to read as follows:

Sec.  520.1263a  Lincomycin tablets and syrup.

    (a) Specifications. (1) Each ounce of syrup contains lincomycin 
hydrochloride equivalent to either 25 or 50 milligrams (mg) lincomycin.
    (2) Each tablet contains lincomycin hydrochloride equivalent to 
either 25 or 50 mg lincomycin.
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs and cats--(1) Amount. Administer 
orally 10 mg per pound of body weight every 12 hours, or 7 mg per pound 
of body weight every 8 hours, for up to 12 days.
    (2) Indications for use. For infections caused by gram-positive 
organisms which are sensitive to its action, particularly streptococci 
and staphylococci.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

Sec.  520.1263c  [Amended]

0
91. In Sec.  520.1263c, in paragraph (b)(1) remove ``000009'' and in 
its place add ``054771''; and in paragraph (b)(2) remove ``046573'' and 
in its place add ``054771''.

Sec.  520.1265  [Amended]

0
92. In Sec.  520.1265, in paragraph (b)(1) remove ``000009'' and in its 
place add ``054771''.

0
93. Revise Sec.  520.1284 to read as follows:

Sec.  520.1284  Liothyronine.

    (a) Specifications. Each tablet contains 60 or 120 micrograms 
([micro]g) liothyronine as the sodium salt.
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer orally to 
dogs at levels up to 12.8 [micro]g per kilogram (/kg) of body weight 
per day. Dosage should be adjusted according to the severity of the 
condition and the response of the patient. Dosage at the total 
replacement level (12.8 [micro]g/kg of body weight) should be 
considered for initiating therapy and then titrated downward for 
optimum maintenance effect. Twice daily administration is recommended.
    (2) Indications for use. For treatment of hypothyroidism in dogs.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

0
94. In Sec.  520.1310, in paragraph (b), remove ``000069'' and in its 
place add ``054771''; and revise the section heading to read as 
follows:

Sec.  520.1310  Marbofloxacin.

* * * * *

Sec.  520.1315  [Amended]

0
95. In paragraph (b) of Sec.  520.1315, remove ``000069'' and in its 
place add ``054771''.

0
96. Revise Sec.  520.1320 to read as follows:

Sec.  520.1320  Mebendazole.

    (a) Specifications. (1) Each gram of powder contains either 40 or 
166.7 milligrams of mebendazole.
    (2) Each gram of paste contains 200 milligrams of mebendazole.
    (3) Each milliliter of suspension contains 33.3 milligrams of 
mebendazole.
    (b) Sponsor. See No. 000061 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Horses--(i) Amount. 1 gram of 
mebendazole per 250 pounds of body weight per dose, as an oral powder, 
paste or suspension.
    (ii) Indications for use. For treatment of infections caused by 
large roundworms (Parascaris equorum); large strongyles (Strongylus 
edentatus, S. equinus, S. vulgaris); small

[[Page 28824]]

strongyles; and mature and immature (4th larval stage) pinworms 
(Oxyuris equi).
    (iii) Limitations. The drug is compatible with carbon disulfide. 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 100 milligrams of mebendazole per 
10 pounds of body weight, once daily for 3 days, as an oral powder by 
mixing with a small quantity of food, preferably before the regular 
meal.
    (ii) Indications for use. The drug is used for treatment of 
infections of roundworms (Toxocara canis), hookworms (Ancylostoma 
caninum, Uncinaria stenocephala), whipworms (Trichuris vulpis), and 
tapeworms (Taenia pisiformis).
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

0
97. In Sec.  520.1326a revise the paragraph (c) heading and paragraph 
(c)(3) to read as follows:

Sec.  520.1326a  Mebendazole and trichlorfon powder.

* * * * *
    (c) Conditions of use 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.

0
98. In Sec.  520.1326b revise the paragraph (c) heading to read as 
follows:

Sec.  520.1326b  Mebendazole and trichlorfon paste.

* * * * *
    (c) Conditions of use in horses--
* * * * *

0
99. Revise Sec.  520.1330 to read as follows:

Sec.  520.1330  Meclofenamic acid granules.

    (a) Specifications. Each gram of granules contains 5 milligrams (5 
percent) meclofenamic acid.
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in horses--(1) Amount. Administer 1 milligram 
per pound of body weight (1 gram per 1000 pounds) once daily for 5 to 7 
days by addition to the daily grain ration.
    (2) Indications for use. For the treatment of acute or chronic 
inflammatory diseases involving the musculoskeletal system.
    (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
100. In Sec.  520.1331 revise paragraphs (b) and (c)(3) to read as 
follows:

Sec.  520.1331  Meclofenamic acid tablets.

* * * * *
    (b) Sponsor. See No. 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.

0
101. In Sec.  520.1341, revise the section heading and paragraphs (b) 
and (c) to read as follows:

Sec.  520.1341  Megestrol.

* * * * *
    (b) Sponsor. See No. 000061 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer orally, 
intact, or crushed and mixed with food as follows:
    (i) For the postponement of estrus by proestrus treatment: 1 
milligram per pound of body weight per day for 8 days.
    (ii) For the postponement of estrus by anestrus treatment: 0.25 
milligram per pound of body weight per day for 32 days.
    (iii) For alleviation of false pregnancy: 1 milligram per pound of 
body weight per day for 8 days.
    (2) Indications for use. For the postponement of estrus and the 
alleviation of false pregnancy in female dogs.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

0
102. Revise Sec.  520.1380 to read as follows:

Sec.  520.1380  Methocarbamol.

    (a) Specifications. Each tablet contains 500 milligrams (mg) of 
methocarbamol.
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs and cats--(1) Amount. Administer 60 
mg per pound of body weight in two or three equally divided doses, 
followed each following day by 30 to 60 mg per pound of body weight, 
usually not to exceed 14 to 21 days.
    (2) Indications for use. As an adjunct to therapy for acute 
inflammatory and traumatic conditions of the skeletal muscles in order 
to reduce muscular spasms.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

0
103. Revise Sec.  520.1408 to read as follows:

Sec.  520.1408  Methylprednisolone.

    (a) Specifications. Each tablet contains 1, 2, or 4 milligrams (mg) 
of methylprednisolone.
    (b) Sponsors. See sponsors in Sec.  510.600(c) of this chapter.
    (1) No. 054628 for use of 1- and 2-mg tablets.
    (2) No. 054771 for use of 1- and 4-mg tablets.
    (c) Conditions of use in dogs and cats--(1) Amount. 5 to 15 pounds 
(lbs): 2 mg; 15 to 40 lbs: 2 to 4 mg; 40 to 80 lbs: 4 to 8 mg. 
Administer total daily dose orally in equally divided doses 6 to 10 
hours apart until response is noted or 7 days have elapsed.
    (2) Indications for use. As an anti-inflammatory agent.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

0
104. Amend Sec.  520.1409 as follows:
0
a. Revise the section heading and paragraph (b);
0
b. Remove paragraphs (c) and (d);
0
c. Redesignate paragraph (e) as paragraph (c); and
0
d. Revise newly redesignated paragraph (c).
    The revisions read as follows:

Sec.  520.1409  Methylprednisolone and aspirin.

* * * * *
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Under 15 pounds, \1/4\ 
to 1 tablet daily; 15 to 60 pounds, 1 to 2 tablets daily; 60 pounds and 
over, 2 tablets daily. Administer total daily dose in divided doses 6 
to 10 hours apart, with a light feeding. When response is attained, 
dosage should be gradually reduced until maintenance level is achieved.
    (2) Indications for use. As an anti-inflammatory and analgesic 
agent.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

Sec.  520.1422  [Amended]

0
105. In Sec.  520.1422, in paragraph (b), remove ``053501'' and in its 
place add ``054771''.

0
106. In Sec.  520.1430 revise the section heading and paragraphs (b) 
and (c) to read as follows:

Sec.  520.1430  Megestrol acetate tablets.

* * * * *
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. 30 micrograms for 
animals

[[Page 28825]]

weighing 1 to 25 pounds; 60 micrograms for animals weighing 26 to 50 
pounds; 120 micrograms for animals weighing 51 to 100 pounds; 180 
micrograms for animals weighing over 100 pounds, German Shepherds, or 
German Shepherd mix. Administer daily, orally or in a small amount of 
food, at least 30 days before expected initiation of heat, and continue 
daily as long as desired, but not for more than 24 months.
    (2) Indications for use. For the prevention of estrus (heat) in 
adult female dogs not intended primarily for breeding purposes.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

Sec.  520.1450a  [Amended]

0
107. In Sec.  520.1450a, in paragraph (b), remove ``000069'' and in its 
place add ``054771''.

Sec.  520.1450b  [Amended]

0
108. In Sec.  520.1450b, in paragraph (b), remove ``000069'' and in its 
place add ``054771''.

Sec.  520.1450c  [Amended]

0
109. In Sec.  520.1450c, in paragraph (b), remove ``000069'' and in its 
place add ``054771''.

Sec.  520.1451  [Amended]

0
110. In Sec.  520.1451, in paragraph (b), remove ``000856'' and in its 
place add ``054771''; remove paragraph (c); redesignate paragraph (d) 
as paragraph (c); and in newly redesignated paragraph (c)(3), remove 
the first sentence.

0
111. In Sec.  520.1452, in paragraph (b), remove ``000856'' and in its 
place add ``054771''; and revise paragraph (d)(3) to read as follows:

Sec.  520.1452  Moxidectin gel.

* * * * *
    (d) * * *
    (3) Limitations. Do not use in horses intended for human 
consumption.

0
112. In Sec.  520.1453, in paragraph (b), remove ``000856'' and in its 
place add ``054771''; and revise paragraph (d)(3) to read as follows:

Sec.  520.1453  Moxidectin and praziquantel gel.

* * * * *
    (d) * * *
    (3) Limitations. Do not use in horses intended for human 
consumption.

0
113. Revise Sec.  520.1468 to read as follows:

Sec.  520.1468  Naproxen.

    (a) Specifications. Each gram of granules contains 500 milligrams 
(mg) (50 percent) naproxen.
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in horses--(1) Amount. 10 mg per kilogram of 
body weight twice daily top dressed on feed for up to 14 consecutive 
days.
    (2) Indications for use. For the relief of inflammation and 
associated pain and lameness exhibited with arthritis, as well as 
myositis and other soft tissue diseases of the musculoskeletal system.
    (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.  520.1484  [Amended]

0
114. In Sec.  520.1484, in paragraph (b)(1) remove ``000069'' and in 
its place add ``054771''; in paragraph (b)(2) remove ``000009, 
046573,'' and in its place add ``054771,''; and in paragraph (b)(3) 
remove ``000009, 000859,'' and in its place add ``000859, 054771,''.

Sec.  520.1628  [Amended]

0
115. In paragraph (b) of Sec.  520.1628, remove ``000856'' and in its 
place add ``054771''.

Sec.  520.1629  [Amended]

0
116. In Sec.  520.1629, in paragraphs (a)(2) and (b)(2), remove 
``000856'' and in its place add ``054771''.

0
117. Revise paragraph (b) of Sec.  520.1630 to read as follows:

Sec.  520.1630  Oxfendazole suspension.

* * * * *
    (b) Sponsor. See Nos. 000010 and 054771 in Sec.  510.600(c) of this 
chapter.
* * * * *

Sec.  520.1631  [Amended]

0
118. In Sec.  520.1631, in paragraph (b), remove ``000856'' and in its 
place add ``054771''.

0
119. Revise Sec.  520.1638 to read as follows:

Sec.  520.1638  Oxibendazole.

    (a) Specifications--(1) Each gram of paste contains 227 milligrams 
(mg) (22.7 percent) oxibendazole.
    (2) Each milliliter of suspension contains 100 mg (10 percent) 
oxibendazole.
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
    (c) Special considerations--(1) See Sec.  500.25 of this chapter.
    (2) Suspension product described in paragraph (a)(2) of this 
section shall be labeled: ``Federal law restricts this drug to use by 
or on the order of a licensed veterinarian.''
    (d) Conditions of use in horses--(1) Amount. For uses other than 
for threadworms (Strongyloides westeri), 10 mg oxibendazole per 
kilogram (/kg) body weight; for threadworms (Strongyloides westeri), 15 
mg/kg. Horses maintained on premises where reinfection is likely to 
occur should be re-treated in 6 to 8 weeks. Administer suspension 
product by stomach tube in 3 to 4 pints of warm water, or by top 
dressing or mixing into a portion of the normal grain ration.
    (2) Indications for use. For removal and control of large 
strongyles (Strongylus edentatus, S. equinus, S. vulgaris); small 
strongyles (genera Cylicostephanus, Cylicocyclus, Cyathostomum, 
Triodontophorus, Cylicodontophorus, and Gyalocephalus); large 
roundworms (Parascaris equorum); pinworms (Oxyuris equi) including 
various larval stages; and threadworms (Strongyloides westeri).
    (3) Limitations. Do not use in horses intended for human 
consumption.

Sec.  520.1640  [Removed]

0
120. Remove Sec.  520.1640.

Sec.  520.1660a  [Amended]

0
121. In paragraph (b) of Sec.  520.1660a, remove ``000069'' and in its 
place add ``054771''.

Sec.  520.1660b  [Amended]

0
122. In Sec.  520.1660b, in paragraph (b), remove ``000069'' and in its 
place add ``054771''; and in paragraph (c), wherever it occurs, remove 
footnote 1.

Sec.  520.1660c  [Amended]

0
123. In Sec.  520.1660c, in paragraphs (b) and (d)(3), remove 
``000069'' and in its place add ``No. 054771''.

Sec.  520.1660d  [Amended]

0
124. In Sec.  520.1660d, in paragraphs (b)(1), (d)(1)(ii)(A)(3), 
(d)(1)(ii)(B)(3), (d)(1)(ii)(C)(3), and (d)(1)(iii)(C), remove 
``000069'' and in its place add ``054771''; in paragraph (b)(2), remove 
``046573'' and in its place add ``054771''; in paragraphs 
(d)(1)(ii)(A)(3), (d)(1)(ii)(B)(3), (d)(1)(ii)(C)(3), and 
(d)(1)(iii)(C), remove ``046573, 053389'' and in its place add 
``048164, 054771''; and in paragraph (d)(1)(ii)(C)(3), in the seventh 
sentence, remove ``salughter'' and in its place add ``slaughter''.

Sec.  520.1696b  [Amended]

0
125. In Sec.  520.1696b, in paragraph (b), remove ``046573, 053501'' 
and in its place add ``054771''.

[[Page 28826]]

0
126. Amend Sec.  520.1696c as follows:
0
a. Remove paragraph (c);
0
b. Redesignate paragraph (d) as paragraph (c); and
0
c. Revise newly redesignated paragraph (c) heading and (c)(3).
    The revisions read as follows:

Sec.  520.1696c  Penicillin V powder.

* * * * *
    (c) Conditions of use in dogs and cats--
* * * * *
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

0
127. Amend Sec.  520.1696d as follows:
0
a. Revise paragraph (b);
0
b. Remove paragraph (c);
0
c. Redesignate paragraph (d) as paragraph (c);
0
d. Revise newly redesignated paragraph (c) heading and (c)(3).
    The revisions read as follows:

Sec.  520.1696d  Penicillin V tablets.

* * * * *
    (b) Sponsors. See Nos. 050604 and 054771 in Sec.  510.600(c) of 
this chapter.
    (c) Conditions of use in dogs and cats--
* * * * *
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

Sec.  520.1720a  [Amended]

0
128. In Sec.  520.1720a, in paragraph (b)(3), remove ``000856'' and in 
its place add ``054771''.
0
129. Revise Sec.  520.1720b to read as follows:

Sec.  520.1720b  Phenylbutazone granules.

    (a) Specifications. Each package of granules contains 1 or 8 grams 
of phenylbutazone.
    (b) Sponsors. See sponsors in Sec.  510.600(c) of this chapter.
    (1) No. 000061 for 8-gram package.
    (2) No. 059320 for 1-gram package.
    (c) Conditions of use in horses--(1) Amount. Administer 1 to 2 
grams per 500 pounds of body weight, not to exceed 4 grams, daily as 
required. by adding to a portion of the usual grain ration.
    (2) Indications for use. For the treatment of inflammatory 
conditions associated with the musculoskeletal system.
    (3) Limitations. Do not use in horses intended for human 
consumption. Federal law prohibits the use of this drug in female dairy 
cattle 20 months of age or older. Federal law restricts this drug to 
use by or on the order of a licensed veterinarian.

0
130. In Sec.  520.1720c, revise paragraph (c)(3) to read as follows:

Sec.  520.1720c  Phenylbutazone paste.

* * * * *
    (c) * * *
    (3) Limitations. Do not use in horses intended for human 
consumption. Federal law prohibits the use of this drug in female dairy 
cattle 20 months of age or older. Federal law restricts this drug to 
use by or on the order of a licensed veterinarian.

0
131. Amend Sec.  520.1720d as follows:
0
a. Remove paragraph (c);
0
b. Redesignate paragraph (d) as paragraph (c); and
0
c. Revise newly redesignated paragraph (c)(3).
    The revisions read as follows:

Sec.  520.1720d  Phenylbutazone gel.

* * * * *
    (c) * * *
    (3) Limitations. Do not use in horses intended for human 
consumption. Federal law prohibits the use of this drug in female dairy 
cattle 20 months of age or older. Federal law restricts this drug to 
use by or on the order of a licensed veterinarian.

0
132. Amend Sec.  520.1802a as follows:
0
a. In paragraph (b), remove ``000009'' and in its place add ``No. 
054771'';
0
b. Remove footnote 1 wherever it appears in paragraph (c); and
0
c. Revise the paragraph (c) heading and paragraphs (c)(1) and (3)
    The revisions read as follows:

Sec.  520.1802a  Piperazine-carbon disulfide complex suspension.

* * * * *
    (c) Conditions of use in horses and ponies--(1) Amount. Administer 
1 fluid ounce per 100 pounds of body weight by stomach tube or dose 
syringe after withholding feed overnight or for 8 to 10 hours.
* * * * *
    (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
133. Amend Sec.  520.1802b as follows:
0
a. In paragraph (b), remove ``000009'' and in its place add ``No. 
054771'';
0
b. Revise the paragraph (c) heading; and
0
c. Remove footnote 1 wherever it appears in paragraph (c).
    The revision reads as follows:

Sec.  520.1802b  Piperazine-carbon disulfide complex boluses.

* * * * *
    (c) Conditions of use in horses and ponies--
* * * * *

0
134. In Sec.  520.1802c, in paragraph (b), remove ``000009'' and in its 
place add ``No. 054771''; and revise the paragraph (c) heading and 
paragraphs (c)(1) and (3) to read as follows:

Sec.  520.1802c  Piperazine-carbon disulfide complex with phenothiazine 
suspension.

* * * * *
    (c) Conditions of use in horses and ponies--(1) Amount. Administer 
1 fluid ounce per 100 pounds of body weight by stomach tube or dose 
syringe after withholding feed overnight or for 8 to 10 hours.
* * * * *
    (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
135. In Sec.  520.1803, revise paragraphs (a) and (c) to read as 
follows:

Sec.  520.1803  Piperazine citrate capsules.

    (a) Specifications. Each capsule contains piperazine citrate 
equivalent to 140 milligrams of piperazine base.
* * * * *
    (c) Conditions of use in dogs and cats--(1) Amount. The contents of 
1 capsule should be mixed with the food of the animal for each 5 
pounds, or fraction thereof of body weight, except dogs weighing over 
25 pounds should be given the contents of 6 capsules. The drug should 
be mixed in 1/2 of the regular feeding and when the animal has finished 
eating the dosed food, the remainder of the food may be given. Dogs and 
cats may be wormed at 6 to 8 weeks of age. The first treatment should 
be repeated 10 days later. Reinfection may occur. Repeat treatment if 
indicated.
    (2) Indications for use. For the removal of large roundworms 
(Toxocara canis and Toxascaris leonina).
    (3) Limitations. Severely debilitated animals should not be treated 
except on the advice of a veterinarian.

Sec.  520.1804  [Amended]

0
136. In Sec.  520.1804, in paragraph (b), remove ``051311'' and in its 
place add ``054771''; and in paragraph (c) remove footnote 1 wherever 
it appears.

0
137. In Sec.  520.1805, revise paragraph (c)(3) to read as follows:

Sec.  520.1805  Piperazine phosphate and thenium closylate tablets.

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

[[Page 28827]]

Sec.  520.1807  [Amended]

0
138. In Sec.  520.1807, in paragraph (b), remove ``015565'' and in its 
place add ``No. 015565''.

Sec.  520.1840  [Amended]

0
139. In Sec.  520.1840, in paragraph (b)(1), remove ``000069'' and in 
its place add ``054771''.

0
140. In Sec.  520.1855, revise paragraph (c)(3) to read as follows:

Sec.  520.1855  Ponazuril.

* * * * *
    (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
141. Amend Sec.  520.1860 as follows:
0
a. Remove paragraph (c);
0
b. Redesignate paragraph (d) as paragraph (c); and
0
c. Add paragraph (c)(3).
    The addition reads as follows:

Sec.  520.1860  Pradofloxacin.

* * * * *
    (c) * * *
    (3) Limitations. Federal law prohibits the extralabel use of this 
drug in food-producing animals. Federal law restricts this drug to use 
by or on the order of a licensed veterinarian.

0
142. Amend Sec.  520.1880 as follows:
0
a. Revise the section heading;
0
b. Remove paragraph (c);
0
c Redesignate paragraph (d) as paragraph (c); and
0
d. Revise the newly redesignated paragraph (c) heading and paragraphs 
(c)(1) and (2).
    The revisions read as follows:

Sec.  520.1880  Prednisolone.

* * * * *
    (c) Conditions of use in dogs--(1) Amount. Administer 2.5 
milligrams per 4.5 kilograms (10 pounds) body weight per day. 
Administer total daily dose orally in equally divided doses 6 to 10 
hours apart until response is noted or 7 days have elapsed. When 
response is attained, dosage should be gradually reduced until 
maintenance level is achieved.
    (2) Indications for use. For use as an anti-inflammatory agent.
* * * * *

0
143. In Sec.  520.1900, revise the section heading and paragraphs (b) 
and (c)(3) to read as follows:

Sec.  520.1900  Primidone.

* * * * *
    (b) Sponsors. See sponsor numbers in Sec.  510.600(c) of this 
chapter.
    (1) No. 054628 for use of 250 milligram tablets.
    (2) No. 054771 for use of 50 and 250 milligram tablets.
    (c) * * *
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

0
144. Revise Sec.  520.1920 to read as follows:

Sec.  520.1920  Prochlorperazine and isopropamide.

    (a) Specifications. Each capsules contains either:
    (1) 3.33 milligrams of prochlorperazine (as the dimaleate) and 1.67 
milligrams of isopropamide (as the iodide); or
    (2) 10 milligrams of prochlorperazine (as the dimaleate) and 5 
milligrams of isopropamide (as the iodide).
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. (i) Capsules described 
in paragraph (a)(1) of this section are administered orally to dogs 
weighing from 4 to 15 pounds at the rate of 1 capsule twice daily. 
These capsules are administered orally to dogs weighing from 16 to 30 
pounds at the rate of 1 or 2 capsules twice daily. For dogs weighing 
less than 4 pounds, administer orally an appropriate fraction of the 
contents of one of these capsules.
    (ii) Capsules described in paragraph (a)(2) of this section are 
given to dogs weighing 30 pounds and over at the rate of 1 capsule 
twice daily.
    (2) Indications for use. For the treatment of gastrointestinal 
disturbances associated with emotional stress.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

0
145. In Sec.  520.1921, revise the section heading, paragraph (b), the 
paragraph (c) heading, and paragraphs (c)(2) and (3) to read as 
follows:

Sec.  520.1921  Prochlorperazine, isopropamide, and neomycin.

* * * * *
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs--
* * * * *
    (2) Indications for use. For the treatment infectious bacterial 
gastroenteritis associated with emotional stress.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

0
146. Revise Sec.  520.1962 to read as follows:

Sec.  520.1962  Promazine.

    (a) Specifications. Conforms to N.F. XII for promazine 
hydrochloride.
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in horses--(1) Amount. Administer 0.45 to 0.9 
milligrams per pound of body weight mixed with an amount of feed that 
will be readily consumed.
    (2) Indications for use. For quieting excitable, unruly, or 
intractable 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
147. Revise Sec.  520.2002 to read as follows:

Sec.  520.2002  Propiopromazine.

    (a) Specifications. Each chewable tablet contains 10 or 20 
milligrams of propiopromazine hydrochloride.
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer 0.5 to 2.0 
milligrams per pound of body weight once or twice daily, depending upon 
the degree of tranquilization desired.
    (2) Indications for use. For oral administration as a tranquilizer. 
As an aid in handling difficult, excited, and unruly dogs, and in 
controlling excessive kennel barking, car sickness, and severe 
dermatitis. It is also indicated for use in minor surgery and prior to 
routine examinations, laboratory procedures, and diagnostic procedures.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

Sec.  520.2043  [Amended]

0
148. In Sec.  520.2043, in paragraph (b)(1), remove ``000069, 000859'' 
and in its place add ``000859, 054771''; and in paragraph (b)(2), 
remove ``000069'' and in its place add ``054771''.

Sec.  520.2044  [Amended]

0
149. In Sec.  520.2044, in paragraph (b)(1),remove ``000069'' and in 
its place add ``054771''.

0
150. Revise Sec.  520.2045 to read as follows:

Sec.  520.2045  Pyrantel tartrate powder.

    (a) Specifications. Each gram of powder contains 106 milligrams 
(10.6 percent) or 113 milligrams (11.3 percent) pyrantel tartrate.
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter for 
use of 11.3 percent powder as in paragraph (d)(1) and 10.6 percent 
powder as in paragraph (d)(2) and of this section.

[[Page 28828]]

    (c) Related tolerances. See Sec.  556.560 of this chapter.
    (d) Conditions of use--(1) Horses--(i) Amount. Administer as a 
single dose at 0.57 gram of pyrantel tartrate per 100 pounds of body 
weight mixed with the usual grain ration. Do not administer by stomach 
tube or dose syringe.
    (ii) Indications for use. For the removal and control of infections 
from the following mature parasites: Large strongyles (Strongylus 
vulgaris, S. edentatus, S. equinus), small strongyles (Trichonema spp., 
Triodontophorus), pinworms (Oxyuris), and large roundworms 
(Parascaris).
    (iii) Limitations. Do not treat severely debilitated animals with 
this drug. Do not use in horses intended for human consumption.
    (2) Swine--(i) Amount. Add to feed at 0.4 gram pyrantel tartrate 
per pound of non-pelleted ration. The ration is administered as a 
single treatment as the sole ration at the rate of 1 pound per 40 
pounds of animal weight for animals up to 200 pounds. Animals 200 
pounds and over are administered 5 pounds of ration per animal.
    (ii) Indications for use. For the removal and control of large 
roundworms (Ascaris suum) and nodular worm (Oesophagostomum) 
infections.
    (iii) Limitations. Consult veterinarian before using in severely 
debilitated animals. Do not treat within 24 hours of slaughter.

0
151. Add Sec.  520.2046 to read as follows:

Sec.  520.2046  Pyrantel tartrate pellets.

    (a) Specifications. (1) Each gram of pellets contains 12.5 
milligrams (mg) (1.25 percent) pyrantel tartrate; or
    (2) Each gram of pellets contains 21.1 mg (2.11 percent) pyrantel 
tartrate.
    (b) Sponsors. See sponsor numbers in Sec.  510.600(c) of this 
chapter:
    (1) No. 054771 for use of products described in paragraph (a) as in 
paragraph (c) of this section.
    (2) No. 061623 for use of product described in paragraph (a)(1) as 
in paragraph (c) of this section.
    (c) Conditions of use in horses--(1) Amount. Administer as a single 
dose at 12.5 mg per 2.2 pounds of body weight mixed with the usual 
grain ration.
    (2) Indications for use. For the removal and control of infections 
from the following mature parasites: Large strongyles (Strongylus 
vulgaris, S. edentatus, S. equinus), small strongyles (Trichonema spp., 
Triodontophorus), pinworms (Oxyuris), and large roundworms 
(Parascaris).
    (3) Limitations. Do not treat severely debilitated animals with 
this drug. Do not use in horses intended for human consumption.

0
152. Revise Sec.  520.2098 to read as follows:

Sec.  520.2098  Selegiline.

    (a) Specifications. Each tablet contains 2, 5, 10, 15, or 30 
milligrams (mg) selegiline hydrochloride.
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amounts and indications for use. 
(i) Administer 1 mg per kilogram (0.45 mg per pound) of body weight 
once daily for control of clinical signs associated with uncomplicated 
pituitary-dependent hyperadrenocorticism in dogs.
    (ii) Administer 0.5 to 1.0 mg per kilogram of body weight once 
daily for the control of clinical signs associated with canine 
cognitive dysfunction syndrome.
    (2) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

0
153. Revise Sec.  520.2100 to read as follows:

Sec.  520.2100  Selenium and vitamin E.

    (a) Specifications. Each capsule contains:
    (1) 2.19 milligrams (mg) sodium selenite (equivalent to 1 mg 
selenium) and 56.2 mg (68 I.U.) vitamin E as d-alpha tocopheryl acid 
succinate; or
    (2) 0.548 mg sodium selenite (equivalent to 0.25 mg selenium) and 
14 mg (17 I.U.) vitamin E as d-alpha tocopheryl acid succinate.
    (b) Sponsor. See No. 000061 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. (i) Dogs over 20 pounds: 
Administer 1 capsule described in paragraph (a)(1) per 20 pounds of 
body weight to a maximum of 5 capsules. Repeat at 3 day intervals until 
a satisfactory therapeutic response is observed. Maintenance dosage is 
1 capsule per 40 pounds of body weight every 3 to 7 days, or longer, as 
required.
    (ii) Dogs under 20 pounds: Administer 1 capsule described in 
paragraph (a)(2) per 5 pounds of body weight with a minimum of 1 
capsule. Repeat at 3-day intervals until a satisfactory response is 
observed. Maintenance dosage is 1 capsule per 10 pounds of body weight 
every 3 to 7 days, or longer, as required.
    (2) Indications for use. As an aid in alleviating and controlling 
inflammation, pain, and lameness associated with certain arthropathies.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

0
154. In Sec.  520.2123a, revise paragraphs (a) and (b) to read as 
follows:

Sec.  520.2123a  Spectinomycin tablets.

    (a) Specifications. Each tablet contains spectinomycin 
dihydrochloride equivalent to 100 milligrams (mg) spectinomycin.
    (b) Sponsors. See Nos. 054771 and 061623 in Sec.  510.600(c) of 
this chapter.
* * * * *

Sec.  520.2123c  [Amended]

0
155. In Sec.  520.2123c, in paragraph (b), remove ``0000856, 000859, 
and 061623'' and in its place add ``000859, 054771, and 061623''.

0
156. Revise Sec.  520.2150 to read as follows:

Sec.  520.2150  Stanozolol.

    (a) Specifications. Each tablet or chewable tablet contains 2 
milligrams stanozolol.
    (b) Sponsor. No. 054771 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs and cats--(1) Amount--(i) Dogs: 
Administered orally to small breeds, \1/2\ to 1 tablet twice daily for 
several weeks; to large breeds, 1 to 2 tablets twice daily for several 
weeks. The tablets may be crushed and administered in feed.
    (ii) Cats: Administered orally \1/2\ to 1 tablet twice daily for 
several weeks.
    (2) Indications for use. As an anabolic steroid treatment.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

Sec.  520.2150a  [Removed]

0
157. Remove Sec.  520.2150a.

Sec.  520.2150b  [Removed]

0
158. Remove Sec.  520.2150b.

Sec.  520.2158  [Removed]

0
159. Remove Sec.  520.2158.

Sec.  520.2158a  as [Redesignated asSec.  520.2158]

0
160-161. Redesignate Sec.  520.2158a as Sec.  520.2158 and revise the 
section heading and paragraph (a) to read as follows:

Sec.  520.2158  Streptomycin.

    (a) Specifications. Each milliliter of solution contains 250 
milligrams (25 percent) streptomycin sulfate.
* * * * *

Sec.  520.2158b  [Removed]

0
162. Remove Sec.  520.2158b.

Sec.  520.2158c  [Removed]

0
163. Remove Sec.  520.2158c.

[[Page 28829]]

Sec.  520.2160  [Removed]

0
164. Remove Sec.  520.2160.

0
165. Amend Sec.  520.2170 as follows:
0
a. Revise the section heading;
0
b. Remove paragraph (d);
0
c. Redesignate paragraphs (b), (c), and (e) as paragraphs (c), (b), and 
(d), respectively; and
0
d. Revise newly redesignated paragraph (d) heading and paragraphs 
(d)(1) and (3).
    The revisions read as follows:

Sec.  520.2170  Sulfabromomethazine.

* * * * *
    (d) Conditions of use in cattle--(1) Amount. Administer 90 
milligrams per pound body weight orally. Repeat in 48 hours if 
necessary
* * * * *
    (3) Limitations. Milk taken from animals within 96 hours (8 
milkings) of latest treatment must not be used for food. Do not 
administer within 18 days of slaughter.

0
166. Revise Sec.  520.2184 to read as follows:

Sec.  520.2184  Sulfachloropyrazine.

    (a) Specifications. Each gram of powder contains 476 milligrams of 
sodium sulfachloropyrazine monohydrate.
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
    (c) Related tolerance. See Sec.  556.625 of this chapter.
    (d) Conditions of use in chickens. It is used in the drinking water 
of broilers, breeder flocks, and replacement chickens as follows:
    (1) Amount. Administer in drinking water as 0.03 percent solution 
for 3 days.
    (2) Indications for use. For the treatment of coccidiosis.
    (3) Limitations. Administer as sole source of drinking water and of 
sulfonamide medication. Withdraw 4 days prior to slaughter. Do not use 
in chickens producing eggs for human consumption.

0
167. In Sec.  520.2200, revise paragraph (d)(3)(iii) to read as 
follows:

Sec.  520.2200  Sulfachlorpyridazine.

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

Sec.  520.2218  [Amended]

0
168. In Sec.  520.2218, in paragraph (b), remove ``046573'' and in its 
place add ``054771''.

0
169. Revise Sec.  520.2220a to read as follows:

Sec.  520.2220a  Sulfadimethoxine solution and soluble powder.

    (a) Specifications. (1) Each ounce of solution contains 3.75 grams 
(12.5 percent) sulfadimethoxine.
    (2) Each 107 grams of powder contains the equivalent of 94.6 grams 
sulfadimethoxine as sulfadimethoxine sodium.
    (b) Sponsors. See sponsor numbers in Sec.  510.600(c) of this 
chapter:
    (1) Nos. 000859, 054628, 054771, 054925, and 057561 for use of the 
product described in paragraph (a)(1) of this section.
    (2) Nos. 054771, 054925, 057561, 058829, 061623, and 066104 for use 
of the product described in paragraph (a)(2) of this section.
    (c) Related tolerances. See Sec.  556.640 of this chapter.
    (d) Conditions of use--(1) Broiler and replacement chickens--(i) 
Amount. Administer 1.875 grams per gallon (0.05 percent) of drinking 
water for 6 consecutive days.
    (ii) Indications for use. For treatment of outbreaks of 
coccidiosis, fowl cholera, and infectious coryza.
    (iii) Limitations. Do not administer to chickens over 16 weeks of 
age. As sole source of drinking water and sulfonamide medication. 
Withdraw 5 days before slaughter.
    (2) Turkeys--(i) Amount. Administer 0.938 grams per gallon (0.025 
percent) of drinking water for 6 consecutive days.
    (ii) Indications for use. Growing turkeys: For treatment of disease 
outbreaks of coccidiosis and fowl cholera.
    (iii) Limitations. Do not administer to turkeys over 24 weeks of 
age. Use as the sole source of drinking water and sulfonamide 
medication. Withdraw 5 days before slaughter.
    (3) Cattle--(i) Amount. 1.18 to 2.36 grams per gallon (0.031 to 
0.062 percent) of drinking water. As a drench, administer 2.5 grams per 
100 pounds of body weight for first day, then 1.25 grams per 100 pounds 
of body weight per day for the next 4 consecutive days. If no 
improvement within 2 to 3 days, reevaluate diagnosis. Do not treat 
beyond 5 days.
    (ii) Indications for use. Dairy calves, dairy heifers, and beef 
cattle: For the treatment of shipping fever complex and bacterial 
pneumonia associated with Pasteurella spp. sensitive to 
sulfadimethoxine; and calf diphtheria and foot rot associated with 
Fusobacterium necrophorum (Sphaerophorus necrophorus) sensitive to 
sulfadimethoxine.
    (iii) Limitations. Withdraw 7 days before slaughter. A withdrawal 
period has not been established for this product in preruminating 
calves. Do not use in calves to be processed for veal. Federal law 
prohibits the extralabel use of this product in lactating dairy cattle.

0
170. Revise Sec.  520.2220b to read as follows:

Sec.  520.2220b  Sulfadimethoxine suspension.

    (a) Specifications. Each milliliter of suspension contains 50 
milligrams (mg) sulfadimethoxine.
    (b) Sponsors. See Nos. 000061 and 054771 in Sec.  510.600(c) of 
this chapter.
    (c) Conditions of use in dogs and cats--(1) Amount. Administer 
orally 25 mg per pound of body weight, followed by 12.5 mg per pound of 
body weight daily.
    (2) Indications for use. For the treatment of sulfonamide 
susceptible bacterial infections in dogs and cats and enteritis 
associated with coccidiosis in dogs.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

0
171. Revise Sec.  520.2220c to read as follows:

Sec.  520.2220c  Sulfadimethoxine tablet.

    (a) Specifications. Each tablet contains 125, 250, or 500 
milligrams (mg) sulfadimethoxine.
    (b) Sponsors. See Nos. 000061 and 054771 in Sec.  510.600(c) of 
this chapter.
    (c) [Reserved]
    (d) Conditions of use in dogs and cats--(1) Amount. Administer 25 
milligrams (mg) per pound of body weight on the first day followed by 
12.5 milligrams (mg) per pound of body weight per day until the animal 
is free of symptoms for 48 hours.
    (2) Indications for use. Treatment of sulfadimethoxine-susceptible 
bacterial infections.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

0
172. Revise Sec.  520.2220d to read as follows:

Sec.  520.2220d  Sulfadimethoxine bolus.

    (a) Specifications. Each bolus contains 2.5, 5, or 15 grams 
sulfadimethoxine.
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.640 of this chapter.
    (d) Conditions of use in cattle--(1) Amount. Administer 2.5 grams 
per 100 pounds body weight for 1 day followed by 1.25 grams per 100 
pounds body weight per day; treat for 4 to 5 days.
    (2) Indications for use. For the treatment of shipping fever 
complex and bacterial pneumonia associated with Pasteurella spp. 
sensitive to

[[Page 28830]]

sulfadimethoxine; and calf diphtheria and foot rot associated with 
Fusobacterium necrophorum sensitive to sulfadimethoxine.
    (3) Limitations. Do not administer within 7 days of slaughter; milk 
that has been taken from animals during treatment and 60 hours (5 
milkings) after the latest treatment must not be used for food. A 
withdrawal period has not been established for this product in 
preruminating calves. Do not use in calves to be processed for veal.

0
173. Add Sec.  520.2220e to read as follows:

Sec.  520.2220e  Sulfadimethoxine extended-release bolus.

    (a) Specifications. Each extended-release bolus contains 12.5 grams 
sulfadimethoxine.
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.640 of this chapter.
    (d) Conditions of use in beef cattle and non-lactating dairy 
cattle--(1) Amount. Administer one 12.5-gram-sustained-release bolus 
for the nearest 200 pounds of body weight, i.e., 62.5 milligrams per 
pound of body weight. Do not repeat treatment for 7 days.
    (2) Indications for use. For the treatment of shipping fever 
complex and bacterial pneumonia associated with Pasteurella spp. 
sensitive to sulfadimethoxine; and calf diphtheria and foot rot 
associated with Fusobacterium necrophorum sensitive to 
sulfadimethoxine.
    (3) Limitations. Do not use in female dairy cattle 20 months of age 
or older. Do not administer within 12 days of slaughter. Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.

0
174. Add Sec.  520.2220f to read as follows:

Sec.  520.2220f  Sulfadimethoxine and ormetoprim tablet.

    (a) Specifications. Each tablet contains 120 milligrams (mg) (100 
mg sulfadimethoxine and 20 mg ormetoprim), 240 mg (200 mg 
sulfadimethoxine and 40 mg ormetoprim), 600 mg (500 mg sulfadimethoxine 
and 100 mg ormetoprim), or 1200 mg (1000 mg sulfadimethoxine and 200 mg 
ormetoprim).
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. On the first day of 
treatment, administer 25 mg per pound (55 mg per kilogram) of body 
weight. Then follow with a daily dosage of 12.5 mg per pound (27.5 mg 
per kilogram) of body weight. Do not exceed a total of 21 consecutive 
days.
    (2) Indications of use. Treatment of skin and soft tissue 
infections (wounds and abscesses) in dogs caused by strains of 
Staphylococcus aureus and Escherichia coli and urinary tract infections 
caused by E. coli, Staphylococcus spp., and Proteus mirabilus 
susceptible to ormetoprim-potentiated sulfadimethoxine.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

0
175. Revise Sec.  520.2240a to read as follows:

Sec.  520.2240a  Sulfaethoxypyridazine solution.

    (a) Specifications. Each milliliter of solution contains 62.5 
milligrams (mg) sodium sulfaethoxypyridazine.
    (b) Sponsor. See No. 054771 Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.650 of this chapter.
    (d) Conditions of use--(1) Swine--(i) Amount. Administer 3.8 grams 
per gallon for first day followed by 1.9 grams per gallon for not less 
than 3 days nor more than 9 days. Use as the sole source of 
sulfonamide.
    (ii) Indications for use. For treatment of bacterial scours 
pneumonia enteritis, bronchitis, septicemia accompanying Salmonella 
choleraesuis infection.
    (iii) Limitations. Do not treat within 10 days of slaughter. 
Federal law restricts this drug to use by or on the order of a licensed 
veterinarian.
    (2) Cattle--(i) Amount. For use at 2.5 grams per gallon. Administer 
at the rate of 1 gallon per 100 pounds of body weight per day for 4 
days. Use as the sole source of sulfonamide.
    (ii) Indications for use. For treatment of respiratory infections 
(pneumonia, shipping fever), foot rot, calf scours; and as adjunctive 
therapy in septicemia accompanying mastitis and metritis.
    (iii) 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 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
176. Revise Sec.  520.2240b to read as follows:

Sec.  520.2240b  Sulfaethoxypyridazine tablets.

    (a) Specifications--(1) Each tablet contains 2.5 or 15 grams 
sulfaethoxypyridazine.
    (2) Each extended-release tablet contains 5 grams 
sulfaethoxypyridazine.
    (b) Sponsor. See No. 054771 Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.650 of this chapter.
    (d) Conditions of use in cattle--(1) 2.5- or 15-gram tablets--(i) 
Amount. Administer 25 milligrams per pound of body weight per day for 4 
days. Use as the sole source of sulfonamide.
    (ii) Indications for use. For treatment of respiratory infections 
(pneumonia, shipping fever), foot rot, calf scours; as adjunctive 
therapy in septicemia accompanying mastitis and metritis.
    (iii) 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 latest treatment must not be used for food. Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.
    (2) 15-gram extended-release tablets--(i) Amount. Administer 100 
milligrams per pound of body weight. Use as the sole source of 
sulfonamide.
    (ii) Indications for use. For treatment of foot rot and respiratory 
infections (shipping fever and pneumonia) caused by sulfonamide-
susceptible pathogens (E. coli, Streptococci, Staphylococci, 
Sphaerophorus necrophorus and Gram-negative rods including 
Pasteurella); and for use prophylactically during periods of stress for 
reducing losses due to sulfonamide sensitive disease conditions.
    (iii) Limitations. Do not treat within 16 days of slaughter. Not 
for use in lactating dairy cows. Federal law restricts this drug to use 
by or on the order of a licensed veterinarian.

Sec.  520.2260a  [Amended]

0
177. In Sec.  520.2260a, in paragraph (b)(1), remove ``053501'' and in 
its place add ``054771''.

0
178. Amend Sec.  520.2260b as follows:
0
a. In paragraph (b)(1), remove ``053501'' and in its place add 
``054771'';
0
b. In paragraph (c)(2), remove footnote 1 wherever it occurs; and
0
c. In paragraph (c)(2)(iii), remove the eighth sentence and in its 
place add two sentences.
    The additions read as follows:

Sec.  520.2260b  Sulfamethazine extended-release boluses.

* * * * *
    (c) * * *
    (2) * * *
    (iii) * * * Do not use in female dairy cattle 20 months of age or 
older. Use of sulfamethazine in this class of cattle may cause milk 
residues. * * *
* * * * *

0
179. Amend Sec.  520.2260c as follows:
0
a. Redesignate paragraphs (a) and (b) as paragraphs (b) and (d), 
respectively;

[[Page 28831]]

0
b. Add new paragraphs (a) and (c); and
0
c. Revise newly redesignated paragraphs (b) and (d)(3).
    The additions and revisions read as follows:

Sec.  520.2260c  Sulfamethazine extended-release tablets.

    (a) Specifications. Each extended-release tablet contains 8 grams 
sulfamethazine.
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.670 of this chapter.
    (d) * * *
    (3) Limitations. Treated animals must not be slaughtered for food 
within 18 days after the latest treatment. Federal law restricts this 
drug to use by or on the order of a licensed veterinarian.

0
180. Amend Sec.  520.2261a as follows:
0
a. Remove paragraph (d);
0
b. Redesignate paragraphs (a), (b), and (c) as paragraphs (b), (c), and 
(d), respectively;
0
c. Add new paragraph (a);
0
d. Revise newly redesignated paragraphs (b) and (c); and
0
e. In newly redesignated paragraph (d)(2)(iii), remove ``Salmonella 
pullorum'' and in its place add ``Salmonella Pullorum''.
    The addition and revisions read as follows:

Sec.  520.2261a  Sulfamethazine solution.

    (a) Specifications. Each milliliter of solution contains 125 
milligrams (12.5 percent) sulfamethazine sodium.
    (b) Sponsors. See Nos. 000010 and 061623 in Sec.  510.600(c) of 
this chapter.
    (c) Related tolerances. See Sec.  556.670 of this chapter.
* * * * *

0
181. In Sec.  520.2261b, revise paragraph (d)(1)(ii) and add four 
sentences to paragraph (d)(4)(iii) to read as follows:

Sec.  520.2261b  Sulfamethazine powder.

* * * * *
    (d) * * *
    (1) * * *
    (ii) Indications for use. For control of infectious coryza 
(Avibacterium paragallinarum), coccidiosis (Eimeria tenella, E. 
necatrix), acute fowl cholera (Pasteurella multocida), and pullorum 
disease (Salmonella Pullorum).
* * * * *
    (4) * * *
    (iii) * * * Do not use in female dairy cattle 20 months of age or 
older. Use of sulfamethazine in this class of cattle may cause milk 
residues. A withdrawal period has not been established in preruminating 
calves. Do not use in calves to be processed for veal.

0
182. In Sec.  520.2280, revise the section heading and paragraphs (b) 
and (c) to read as follows:

Sec.  520.2280  Sulfamethizole and methenamine.

* * * * *
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs and cats--(1) Amount. Administer 
orally 1 tablet per 20 pounds of body weight 3 times per day until 
clinical signs are alleviated. To reduce the possibility of relapse, 
continue therapy for a week to 10 days.
    (2) Indications for use. For treatment of urinary tract infections 
such as cystitis, nephritis, prostatitis, urethritis, and 
pyelonephritis. As an aid in the management of complications resulting 
from surgical manipulations of the urinary tract such as removal of 
calculi from the bladder, in ureterostomies, and in instrumentation of 
the urethra and bladder.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

0
183. In Sec.  520.2325a, revise the section heading and in paragraph 
(a)(3), remove ``046573'' and in its place add ``054771''.
    The revision reads as follows:

Sec.  520.2325a  Sulfaquinoxaline powder and solution.

* * * * *

0
184. Revise Sec.  520.2325b to read as follows:

Sec.  520.2325b  Sulfaquinoxaline drench.

    (a) Specifications. A soluble powder containing 25 percent 
sulfaquinoxaline.
    (b) Sponsor. See No. 050749 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in cattle--(1) Amount. Administer 1 teaspoon 
of 25 percent sulfaquinoxaline soluble powder for each 125 pounds of 
body weight for 3 to 5 days as a drench.
    (2) Indications for use. For the control and treatment of outbreaks 
of coccidiosis in cattle and calves caused by Eimeria bovis or E. 
zuernii.
    (3) Limitations. Do not give to cattle within 10 days of slaughter 
for food. Not for use in lactating dairy cattle.

Sec.  520.2330  [Amended]

0
185. In paragraph (b) of Sec.  520.2330, remove ``000856'' and in its 
place add ``054771''; and in paragraph (c), remove footnote 1 wherever 
it occurs.

0
186. In Sec.  520.2345a, revise the section heading and paragraph (b) 
to read as follows:

Sec.  520.2345a  Tetracycline capsules.

* * * * *
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
* * * * *

0
187. In Sec.  520.2345b, revise paragraph (b) to read as follows:

Sec.  520.2345b  Tetracycline tablets.

* * * * *
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
* * * * *

0
188. In Sec.  520.2345c, revise paragraph (b) to read as follows:

Sec.  520.2345c  Tetracycline boluses.

* * * * *
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
* * * * *

0
189. Amend Sec.  520.2345d as follows;
0
a. In paragraph (b)(1), remove ``000069'' and in its place add 
``054771'';
0
b. In paragraphs (b)(3), (d)(1)(iii), and (d)(2)(iii), remove 
``046573'' and in its place add ``054771''; and
0
c. Add paragraph (b)(5).
    The addition reads as follows:

Sec.  520.2345d  Tetracycline powder.

* * * * *
    (b) * * *
    (5) No. 000010: 25 grams per pound as in paragraphs (d)(1) and 
(d)(2) of this section.
* * * * *

0
190. In Sec.  520.2345e, revise the section heading and paragraph (b) 
and remove paragraph (c)(1)(iv).
    The revisions read as follows:

Sec.  520.2345e  Tetracycline solution.

* * * * *
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
* * * * *

0
191. In Sec.  520.2345f, in paragraph (b), remove ``No. 000009'' and in 
its place add ``See No. 054771''; and revise the paragraph (c) heading 
and paragraph (c)(3) to read as follows:

Sec.  520.2345f  Tetracycline phosphate complex and sodium novobiocin 
capsules.

* * * * *
    (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
192. In Sec.  520.2345g, in paragraph (b), remove ``No. 000009'' and in 
its place add ``See No. 054771''; and revise the paragraph (c) heading 
and paragraph (c)(3) to read as follows:

Sec.  520.2345g  Tetracycline hydrochloride and sodium novobiocin 
tablets.

* * * * *

[[Page 28832]]

    (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
193. In Sec.  520.2345h, in paragraph (b), remove ``000009'' and in its 
place add ``054771''; and revise the paragraph (c) heading and 
paragraph (c)(3) to read as follows:

Sec.  520.2345h  Tetracycline hydrochloride, sodium novobiocin, and 
prednisolone tablets.

* * * * *
    (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
194. Amend Sec.  520.2362 as follows:
0
a. Revise the section heading;
0
b. Remove paragraph (a);
0
c. Redesignate paragraphs (b), (c), and (d) as paragraphs (a), (b), and 
(c), respectively; and
0
d. Revise newly redesignated paragraphs (a) and (c).
    The revisions read as follows:

Sec.  520.2362  Thenium closylate.

    (a) Specifications. Each tablet contains thenium closylate 
equivalent to 500 milligrams thenium base.
* * * * *
    (c) Conditions of use in dogs--(1) Amount. Dogs weighing over 10 
pounds: Administer 1 tablet as a single dose. Dogs weighing 5 to 10 
pounds: Administered one-half tablet twice during a single day. Repeat 
treatment after 2 or 3 weeks.
    (2) Indications for use. For treatment of canine ancylostomiasis by 
the removal from the intestines of the adult forms of the species 
Ancylostoma caninum and Uncinaria stenocephala (hookworms).
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

0
195. Amend Sec.  520.2380a as follows:
0
a. Remove paragraph (a);
0
b. Redesignate paragraphs (b) through (e) as paragraphs (a) through 
(d), respectively; and
0
c. Revise newly redesignated paragraph (b).
    The revision reads as follows:

Sec.  520.2380a  Thiabendazole top dressing and mineral protein block.

* * * * *
    (b) Sponsors. See sponsors in Sec.  510.600(c) of this chapter for 
use as in paragraph (d) of this section.
    (1) No. 051311 for use as in paragraph (d)(1)(i) of this section.
    (2) No. 050604 for use as in paragraph (d)(1)(ii) of this section.
    (3) No. 012286 for use as in paragraph (d)(2) of this section.
* * * * *

0
196. Amend Sec.  520.2380b as follows:
0
a. Revise the section heading;
0
b. Remove paragraph (a);
0
c. Redesignate paragraphs (b) through (e) as paragraphs (a) through 
(d), respectively; and
0
d. Revise newly redesignated paragraph (b).
    The revisions read as follows:

Sec.  520.2380b  Thiabendazole drench or paste.

* * * * *
    (b) Sponsor. See No. 050604 in Sec.  510.600(c) of this chapter.
* * * * *

Sec.  520.2380c  [Amended]

0
197. In Sec.  520.2380c, remove paragraph (a); and redesignate 
paragraphs (b) through (e) as paragraphs (a) through (d), respectively.

0
198. In Sec.  520.2380d, revise the section heading and paragraph (c) 
to read as follows:

Sec.  520.2380d  Thiabendazole and piperazine citrate.

* * * * *
    (c) Conditions of use in horses--(1) Amount. Administer 1 ounce of 
suspension per 100 pounds of body weight by stomach tube or as a 
drench.
    (2) Indications for use. For the control of large strongyles, small 
strongyles, pinworms, Strongyloides and ascarids (including members of 
the genera Strongylus spp., Cyathostomum spp., Cylicobrachytus spp. and 
related genera Craterostomum spp., Oesophagodontus spp., Poteriostomum 
spp., Oxyuris spp., Strongyloides spp., and Parascaris spp.).
    (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
199. In Sec.  520.2380e, revise the section heading and paragraph (c) 
to read as follows:

Sec.  520.2380e  Thiabendazole and triclorfon.

* * * * *
    (c) Conditions of use in horses--(1) Amount. Administer 2 grams of 
thiabendazole with 1.8 grams of trichlorfon per 100 pounds of body 
weight sprinkled on the animals' usual daily ration of feed, or may be 
mixed in 5 to 10 fluid ounces of water and administered by stomach tube 
or drench.
    (2) Indications for use. For the treatment and control of bots 
(Gasterophilus spp.), large strongyles (Strongylus spp.), small 
strongyles (genera Cyathostomum, Cylicobrachytus, Craterostomum, 
Oesophagodontus, Poteriostomum), pinworms (Oxyuris spp., Strongyloides 
spp.), and ascarids (Parascaris spp.).
    (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
200. In Sec.  520.2380f, revise the section heading, the paragraph (c) 
heading, and paragraphs (c)(1) and (3) to read as follows:

Sec.  520.2380f  Thiabendazole and piperazine phosphate.

* * * * *
    (c) Conditions of use in horses--(1) Amount. 2 grams of 
thiabendazole and 2.5 grams of piperazine (0.3 ounce of powder) per 100 
pounds of body weight. Use a single oral dose. Administer as a drench 
or by stomach tube suspended in 1 pint of warm water; by dose syringe 
suspended in \1/2\ ounce of water for each 100 pounds of body weight; 
or sprinkled over a small amount of daily feed.
* * * * *
    (3) Limitations. Do not use in horses intended for human 
consumption. If the label bears directions for administration by 
stomach tube or drench, it shall also bear the statement ``Caution: 
Federal law restricts this drug to use by or on the order of a licensed 
veterinarian.''; if not labeled for use by stomach tube or drench, the 
label shall bear the statement, ``Consult your veterinarian for 
assistance in the diagnosis, treatment, and control of parasitism.''

Sec.  520.2475  [Amended]

0
201. In Sec.  520.2475, in paragraph (b), remove ``000009'' and in its 
place add ``054771''.

Sec.  520.2520b  [Redesignated as Sec.  520.2520a]

0
202. Redesignate Sec.  520.2520b as Sec.  520.2520a; and revise it to 
read as follows:

Sec.  520.2520a  Trichlorfon and atropine.

    (a) Specifications. (1) For trichlorfon: O,O-Dimethyl 2,2,2-
trichloro-1-hydroxyethyl phosphonate.
    (2) For atropine: Atropine N.F.
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in mice--(1) Amount. Administer 1.67 grams of 
trichlorfon and 7.7 milligrams of atropine per liter continuously for 7 
to 14 days as the sole source of drinking water.

[[Page 28833]]

    (2) Indications for use. For the treatment of Syphacia obvelata 
(pinworm) in laboratory mice.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

Sec.  520.2520e  [Redesignated as Sec.  520.2520b]

0
203a. Redesignate Sec.  520.2520e as Sec.  520.2520b.

0
203b. Amend newly redesignated Sec.  520.2520b as follows:
0
a. Revise paragraph (b);
0
b. Remove paragraphs (c) and (d);
0
c. Redesignate paragraph (e) as paragraph (c); and
0
d. Revise the newly redesignated paragraph (c) heading and paragraph 
(c)(3).
    The revisions read as follows:

Sec.  520.2520b  Trichlorfon boluses.

* * * * *
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use 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.  520.2520f  [Redesignated as Sec.  520.2520c]

0
204a. Redesignate Sec.  520.2520f as Sec.  520.2520c.

0
204b. Amend newly redesignated Sec.  520.2520c as follows:
0
a. Revise paragraph (b);
0
b. Remove paragraphs (c) and (d);
0
c. Redesignate paragraph (e) as paragraph (c); and
0
d. Revise the newly redesignated paragraph (c) heading and paragraph 
(c)(3).
    The revisions read as follows:

Sec.  520.2520c  Trichlorfon granules.

* * * * *
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use 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.  520.2520g  [Redesignated as Sec.  520.2520d]

0
205a. Redesignate Sec.  520.2520g as Sec.  520.2520d.

0
205b. Amend newly redesignated Sec.  520.2520d as follows:
0
a. Revise paragraph (b);
0
b. Remove paragraphs (c) and (d);
0
c. Redesignate paragraph (e) as paragraph (c); and
0
d. Revise the newly redesignated paragraph (c) heading and paragraph 
(c)(3).
    The revisions read as follows:

Sec.  520.2520d  Trichlorfon, phenothiazine, and piperazine.

* * * * *
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use 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.

0
206. Revise Sec.  520.2582 to read as follows:

Sec.  520.2582  Triflupromazine.

    (a) Specifications. Each tablet contains 10 or 25 milligrams (mg) 
triflupromazine hydrochloride.
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs and cats--(1) Amount. Administer 
orally 1 to 2 mg per pound of body weight daily, followed by 1 mg 
daily.
    (2) Indications for use. For relief of anxiety, to help control 
psychomotor over-activity, and to increase the tolerance of animals to 
pain and pruritus. For use in various clinical procedures which require 
the aid of a tranquilizer, antiemetic, or preanesthetic.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

0
207. Revise Sec.  520.2604 to read as follows:

Sec.  520.2604  Trimeprazine and prednisolone tablets.

    (a) Specifications. Each tablet contains 5 milligrams (mg) 
trimeprazine tartrate and 2 mg prednisolone.
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer orally an 
initial dosage: for dogs weighing up to 10 pounds, \1/2\ tablet twice 
daily; for dogs weighing 11 to 20 pounds, 1 tablet twice daily; for 
dogs weighing 21 to 40 pounds, 2 tablets twice daily; and for dogs 
weighing over 40 pounds, 3 tablets twice daily. After 4 days, reduce 
dosage to one-half the initial dose or to an amount sufficient to 
maintain remission of symptoms.
    (2) Indications for use. For the relief of itching regardless of 
cause; and for reduction of inflammation commonly associated with most 
skin disorders of dogs such as eczema, caused by internal disorders, 
otitis, and dermatitis, allergic, parasitic, pustular and nonspecific. 
As adjunctive therapy in various cough conditions including treatment 
of ``kennel cough'' or tracheobronchitis, bronchitis including allergic 
bronchitis, in tonsillitis, acute upper respiratory infections and 
coughs of nonspecific origin.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

0
208. Revise Sec.  520.2605 to read as follows:

Sec.  520.2605  Trimeprazine and prednisolone capsules.

    (a) Specifications. Each capsule contains:
    (1) 3.75 milligrams (mg) trimeprazine in sustained released form 
(as trimeprazine tartrate) and 1 mg prednisolone (Capsule No. 1); or
    (2) 7.5 mg trimeprazine in sustained release form (as trimeprazine 
tartrate) and 2 mg prednisolone (Capsule No. 2).
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer orally once 
daily an initial dosage:
    (i) For dogs weighing up to 10 pounds: one Capsule No. 1;
    (ii) For dogs weighing 11 to 20 pounds, one Capsule No. 2 or two 
Capsule No. 1;
    (iii) For dogs weighing 21 to 40 pounds, two Capsule No. 2 or four 
Capsule No. 1; and
    (iv) For dogs weighing over 40 pounds, three Capsule No. 2 or six 
Capsule No. 1.
    After 4 days, the dosage is reduced to approximately \1/2\ the 
initial dosage or to an amount just sufficient to maintain remission of 
symptoms.
    (2) Indications for use. For the relief of itching regardless of 
cause; and for reduction of inflammation commonly associated with most 
skin disorders of dogs such as eczema, caused by internal disorders, 
otitis, and dermatitis, allergic, parasitic, pustular and nonspecific. 
As adjunctive therapy in various cough conditions including treatment 
of ``kennel cough'' or tracheobronchitis, bronchitis including allergic 
bronchitis, in tonsillitis, acute upper respiratory infections and 
coughs of nonspecific origin.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

0
209. Revise Sec.  520.2610 to read as follows:

Sec.  520.2610  Trimethoprim and sulfadiazine tablets.

    (a) Specifications. Each tablet contains 30 milligrams (mg) (5 mg

[[Page 28834]]

trimethoprim and 25 mg sulfadiazine), 120 mg (20 mg trimethoprim and 
100 mg sulfadiazine), 480 mg (80 mg trimethoprim and 400 mg 
sulfadiazine) or 960 mg (160 mg trimethoprim and 800 mg sulfadiazine).
    (b) Sponsors. See Nos. 000061 and 054771 in Sec.  510.600(c) of 
this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer orally at 30 
mg per kilogram of body weight (14 milligrams per pound) once daily. 
Alternatively, especially in severe infections, the initial dose may be 
followed by one-half the recommended daily dose every 12 hours. 
Administer for 2 to 3 days after symptoms have subsided. Do not treat 
for more than 14 consecutive days.
    (2) Indications for use. The drug is used in dogs where systemic 
antibacterial action against sensitive organisms is required, either 
alone or as an adjunct to surgery or debridement with associated 
infection. The drug is indicated where control of bacterial infection 
is required during the treatment of acute urinary tract infections, 
acute bacterial complications of distemper, acute respiratory tract 
infections, acute alimentary tract infections, wound infections, and 
abscesses.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

Sec.  520.2611  [Amended]

0
210. In Sec.  520.2611, in paragraph (b)(1), remove ``000856'' and in 
its place add ``054771''.

0
211. In Sec.  520.2613, revise paragraphs (a) and (b), the paragraph 
(c) heading, and paragraphs (c)(1) and (3) to read as follows:

Sec.  520.2613  Trimeprazine and sulfadiazine powder.

    (a) Specifications. Each gram of powder contains 67 milligrams (mg) 
trimethoprim and 333 mg sulfadiazine.
    (b) Sponsors. See Nos. 054771 and 058711 in Sec.  510.600(c) of 
this chapter.
    (c) Conditions of use in horses--(1) Amount. Administer orally 3.75 
grams of powder per 110 pounds (50 kilograms) of body weight in a small 
amount of feed, as a single daily dose, for 5 to 7 days.
* * * * *
    (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.

    Dated: April 29, 2014.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 2014-10415 Filed 5-19-14; 8:45 am]
BILLING CODE 4160-01-P