Oral Dosage Form New Animal Drugs; Change of Sponsor

---
identifier: "/us/fr/2014-10415"
source: "fr"
legal_status: "authoritative_unofficial"
title: "Oral Dosage Form New Animal Drugs; Change of Sponsor"
title_number: 0
title_name: "Federal Register"
section_number: "2014-10415"
section_name: "Oral Dosage Form New Animal Drugs; Change of Sponsor"
positive_law: false
currency: "2014-05-20"
last_updated: "2014-05-20"
format_version: "1.1.0"
generator: "[email protected]"
agency: "Health and Human Services Department"
document_number: "2014-10415"
document_type: "rule"
publication_date: "2014-05-20"
agencies:
  - "Health and Human Services Department"
  - "Food and Drug Administration"
cfr_references:
  - "21 CFR Part 510"
  - "21 CFR Part 520"
fr_citation: "79 FR 28813"
fr_volume: 79
docket_ids:
  - "Docket No. FDA-2014-N-0002"
effective_date: "2014-05-20"
fr_action: "Final rule; technical amendments."
---


#  Trimeprazine and sulfadiazine powder.

**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, *[email protected]* .

**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:

| File No. | Product name |
| --- | --- |
| 006-707 | SULQUIN (sulfaquinoxaline) 6-50 Soluble Powder. |
| 006-891 | SUL-Q-NO
                            
                             (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. |
| 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. |
| 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,  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**

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

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:

**21 CFR Part 510**

**PART 510—NEW ANIMAL DRUGS**

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.

§ 510.600

2. In § 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”.

**21 CFR Part 520**

**PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS**

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

**Authority:**

21 U.S.C. 360b.

**21 CFR Part 520**

4. Revise § 520.28 to read as follows:

§ 520.28

(a) *Specifications.* A powder containing acetazolamide sodium, USP equivalent to 25 percent acetazolamide activity.

(b) *Sponsor.* See No. 054771 in § 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.

**21 CFR Part 520**

§ 520.38a

5. In paragraph (b) of § 520.38a, remove “000069” and in its place add “054771”.

**21 CFR Part 520**

§ 520.38b

6. In paragraph (b) of § 520.38b, remove “000069” and in its place add “054771”.

**21 CFR Part 520**

7. Revise § 520.62 to read as follows:

§ 520.62

(a) *Specifications.* Each tablet contains 0.2 milligram (mg) aminopentamide hydrogen sulphate.

(b) *Sponsor.* See No. 054771 in § 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.

**21 CFR Part 520**

8. Revise § 520.82 to read as follows:

§ 520.82

**21 CFR Part 520**

9. Revise § 520.82a to read as follows:

§ 520.82a

(a) *Specifications.* Each tablet contains aminopropazine fumarate equivalent to 25 percent aminopropazine base.

(b) *Sponsor.* See No. 000061 in § 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.

**21 CFR Part 520**

10. Revise § 520.82b to read as follows:

§ 520.82b

(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 § 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.

**21 CFR Part 520**

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

§ 520.88a

(a) *Specifications.* Each tablet contains amoxicillin trihydrate equivalent to 50, 100, 150, 200, or 400 milligrams (mg) amoxicillin.

(b) *Sponsor.* See No. 054771 in § 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.

**21 CFR Part 520**

12. In § 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:

§ 520.88b

(a) *Specifications.* When reconstituted, each milliliter contains  amoxicillin trihydrate equivalent to 50 milligrams (mg) amoxicillin.

(b) *Sponsor.* See No. 054771 in § 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.

**21 CFR Part 520**

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

§ 520.88c

(a) *Specifications.* Each 0.8-milliliter dose contains amoxicillin trihydrate equivalent to 40 milligrams (mg) amoxicillin.

(b) *Sponsor.* See No. 054771 in § 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.

**21 CFR Part 520**

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

§ 520.88d

(a) *Specifications.* Each gram of powder contains amoxicillin trihydrate equivalent to 115.4 milligrams (mg) amoxicillin.

(b) *Sponsor.* See No. 054771 in § 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.

**21 CFR Part 520**

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

§ 520.88e

(a) *Specifications.* Each bolus contains amoxicillin trihydrate equivalent to 400 milligrams (mg) amoxicillin.

(b) *Sponsor.* See No. 054771 in § 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.

**21 CFR Part 520**

16. Revise § 520.88f to read as follows:

§ 520.88f

(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 § 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.

**21 CFR Part 520**

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

§ 520.88g

(b) *Sponsor.* See No. 054771 in § 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.

**21 CFR Part 520**

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

§ 520.88h

(b) *Sponsor.* See No. 054771 in § 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.

**21 CFR Part 520**

§ 520.90a

19. Remove and reserve § 520.90a.

20. In § 520.90b, revise the section heading, paragraph (b), paragraph (c) heading, and paragraph (c)(3) to read as follows:

§ 520.90b

(b) *Sponsor.* See No. 054771 in § 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.

**21 CFR Part 520**

21. In § 520.90c, revise the section heading, paragraphs (b), (c)(1)(iii), and (c)(2)(iii) to read as follows:

§ 520.90c

(b) *Sponsor.* See No. 054771 in § 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.

**21 CFR Part 520**

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

§ 520.90d

(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.

**21 CFR Part 520**

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

§ 520.90e

(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.

**21 CFR Part 520**

24. In § 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:

§ 520.90f

(b) Sponsors. See sponsor numbers in § 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.

**21 CFR Part 520**

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

§ 520.110

(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.

**21 CFR Part 520**

§ 520.154a

26. In paragraph (b) of § 520.154a, remove “046573” and in its place add “054771”.

§ 520.154b

**21 CFR Part 520**

27. In paragraph (b) of § 520.154b, remove “046573” and in its place add “054771”.

§ 520.154c

**21 CFR Part 520**

28. In paragraph (b) of § 520.154c, remove “053501” and in its place add “054771”.

**21 CFR Part 520**

29. Revise § 520.246 to read as follows:

§ 520.246

(a) *Specifications.* Each tablet contains butorphanol tartrate equivalent to 1, 5, or 10 milligrams (mg) butorphanol base.

(b) *Sponsor.* See No. 054771 in § 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.

§ 520.260

**21 CFR Part 520**

30. In § 520.260, remove footnote 1 wherever it occurs; and in paragraph (b)(2), remove “000069” and in its place add “054771”.

**21 CFR Part 520**

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

§ 520.300a

(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.

**21 CFR Part 520**

32. In § 520.300b, revise paragraph (c) to read as follows:

§ 520.300b

(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.

(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.

**21 CFR Part 520**

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

§ 520.300c

(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.

§ 520.309

**21 CFR Part 520**

34. In § 520.309, in paragraph (b)(1), remove “000069” and in its place add “054771”.

§ 520.310

**21 CFR Part 520**

35. In § 520.310, in paragraph (b), remove “000856” and in its place add “054771”; and remove footnote 1 wherever it occurs.

§ 520.370

**21 CFR Part 520**

36. In § 520.370, in paragraph (b), remove “000009 and 026637” and in its place add “026637 and 054771”.

§ 520.390a

**21 CFR Part 520**

37. In § 520.390a, in paragraph (b)(1)(ii), remove “000856” and in its place add “054771”; and remove paragraph (b)(1)(iii).

§ 520.390b

**21 CFR Part 520**

38. In § 520.390b, in paragraph (b), remove “000069 and 050057” and in its place add “050057 and 054771”.

§ 520.390c

**21 CFR Part 520**

39. In § 520.390c, in paragraph (b), remove “000856” and in its place add “054771”.

§ 520.420

**21 CFR Part 520**

40. In § 520.420, remove footnote 1 wherever it occurs.

§ 520.434

**21 CFR Part 520**

41. In § 520.434, in paragraph (b), remove “000009” and in its place add “054771”; and in paragraph (c)(3), remove the first four sentences.

§ 520.441

**21 CFR Part 520**

42. In § 520.441, in paragraph (b)(2), remove “046573 and 000010” and in its place add “000010 and 054771”.

§ 520.446

**21 CFR Part 520**

43. In § 520.446, in paragraph (b)(1), remove “000009 and 000859” and in its place add “000859 and 054771”.

§ 520.447

**21 CFR Part 520**

44. In § 520.447, in paragraph (b), remove “000009, 000859, 051311” and in its place add “000859, 051311, 054771”.

§ 520.530

**21 CFR Part 520**

45. In § 520.530, in paragraph (b), remove “053501” and in its place add ” 054771”; and in paragraph (d)(3), remove the first two sentences.

**21 CFR Part 520**

46. Amend § 520.531 as follows:

a. Add paragraph (a);

b. Remove paragraph (c);

c. Redesignate paragraph (d) as paragraph (c); and

d. Revise paragraph (b) and newly redesignated paragraph (c)(3).

The addition and revision read as follows:

§ 520.531

(a) *Specifications.* Each tablet contains 30 or 90 milligrams (mg) cythioate.

(b) *Sponsors.* See sponsor numbers in § 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.

**21 CFR Part 520**

47. In § 520.534, revise paragraph (a), and in paragraph (b), remove “046573” and in its place add “054771”.

The revision reads as follows:

§ 520.534

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

**21 CFR Part 520**

48. Revise § 520.540a to read as follows:

§ 520.540a

(a) *Specifications.* Each packet contains 10 milligrams (mg) of dexamethasone.

(b) *Sponsor.* See No. 000061 in § 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.

**21 CFR Part 520**

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

§ 520.540b

(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) * * *

(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.

**21 CFR Part 520**

50. Amend § 520.540c as follows:

a. Remove footnote 1 wherever it occurs;

b. In paragraph (b), remove “000069” and in its place add “054771”; and

c. Revise paragraph (c).

The revision reads as follows:

§ 520.540c

(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.

§ 520.550

**21 CFR Part 520**

51. Remove § 520.550.

**21 CFR Part 520**

52. In § 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:

§ 520.563

(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.

§ 520.580

**21 CFR Part 520**

53. In § 520.580, in paragraph (b)(2), remove “054628” and in its place add “054771”.

**21 CFR Part 520**

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

§ 520.608

(b) *Sponsor.* See No. 054771 in § 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.

**21 CFR Part 520**

§ 520.622a

55. In § 520.622a, in paragraph (a)(2), remove “053501” and in its place add “054771”.

§ 520.622b

**21 CFR Part 520**

56. In § 520.622b, in paragraph (a)(2), remove “053501” and in its place add “054771”.

§ 520.622c

**21 CFR Part 520**

57. In § 520.622c, in paragraph (b)(2), remove “000069” and in its place add “054771”.

**21 CFR Part 520**

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

§ 520.623

(b) *Sponsor.* See No. 054771 in § 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.

**21 CFR Part 520**

§ 520.666

59. In § 520.666, in paragraph (b), remove “000069” and in its place add “054771”.

**21 CFR Part 520**

60. Revise § 520.763 to read as follows:

§ 520.763

**21 CFR Part 520**

61. Revise § 520.763a to read as follows:

§ 520.763a

(a) *Specifications.* Each tablet contains 10, 50, 100, or 200 milligrams (mg) dithiazanine iodide.

(b) *Sponsor.* See No. 054628 in § 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.

**21 CFR Part 520**

62. Revise § 520.763b to read as follows:

§ 520.763b

(a) *Specifications.* Each tablespoon of powder contains 200 milligrams (mg) dithiazanine iodide.

(b) *Sponsor.* See No. 000010 in § 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.

**21 CFR Part 520**

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

§ 520.763c

(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 § 510.600(c) of this chapter.

(c) *Conditions of use in horses* —

**21 CFR Part 520**

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

§ 520.784

(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.

**21 CFR Part 520**

65. Revise § 520.804 to read as follows:

§ 520.804

(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 § 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.

**21 CFR Part 520**

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

§ 520.816

(b) *Sponsor.* See No. 050604 in § 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.

**21 CFR Part 520**

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

§ 520.823

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

**21 CFR Part 520**

68. Amend § 520.863 as follows:

a. Revise the section heading;

b. Remove footnote 1 wherever it occurs; and

c. Revise paragraph (c).

The revisions read as follows:

§ 520.863

(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.

**21 CFR Part 520**

69. In § 520.870, add paragraph (c) and remove paragraph (d).

The addition reads as follows:

§ 520.870

(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.

**21 CFR Part 520**

70. Revise § 520.903a to read as follows:

§ 520.903a

(a) *Specifications.* Each gram of paste contains 455 milligrams (45.5 percent) febantel.

(b) *Sponsor.* See No. 000859 in § 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.

**21 CFR Part 520**

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

§ 520.903b

(a) *Specifications.* Each ounce of suspension contains 2.75 grams (9.3 percent ounce) febantel.

(b) *Sponsor.* See No. 000859 in § 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.

**21 CFR Part 520**

72. In § 520.903d, revise the section heading and paragraph (c)(3) and remove paragraph (c)(4).

The revisions read as follows:

§ 520.903d

(c) * * *

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

**21 CFR Part 520**

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

§ 520.903e

(b) *Sponsor.* See No. 000859 in § 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.

**21 CFR Part 520**

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

§ 520.960

(b) *Sponsor.* See No. 054771 in § 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.

**21 CFR Part 520**

75. Add § 520.1060 to read as follows:

§ 520.1060

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

**21 CFR Part 520**

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

§ 520.1100

(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.

**21 CFR Part 520**

77. Amend § 520.1120a as follows:

a. Remove paragraph (a);

b. Redesignate paragraphs (b) through (f) as paragraphs (a) through (e), respectively; and

c. Revise newly redesignated paragraphs (a) and (e).

The revisions read as follows:

§ 520.1120a

(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.

**21 CFR Part 520**

78. Amend § 520.1120b as follows:

a. Remove paragraph (a);

b. Redesignate paragraphs (b) through (e) as paragraphs (a) through (d), respectively; and

c. Revise newly redesignated paragraph (d).

The revisions read as follows:

§ 520.1120b

(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.

**21 CFR Part 520**

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

§ 520.1157

(c) * * *

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

**21 CFR Part 520**

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

§ 520.1158

(b) *Sponsor.* See No. 054771 in § 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.

**21 CFR Part 520**

81. In § 520.1196, revise the section heading and paragraphs (c)(1)(i) and (iii) to read as follows:

§ 520.1196

(c) * * *

(1) * * *

(i) *Amount.* Administer a minimum of 6 µg of ivermectin and 5 mg of pyrantel per kilogram (2.72 µg 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.

**21 CFR Part 520**

§ 520.1199

82. In § 520.1199, in paragraph (b), remove “ *Sponsors”* and in its place add “ *Sponsor”.*

**21 CFR Part 520**

§ 520.1204

83. In § 520.1204, in paragraph (b), remove “000856” and in its place add “054771”.

**21 CFR Part 520**

§ 520.1242a

84. In § 520.1242a, in paragraph (b)(2), remove “053501” and in its place add “054771”.

**21 CFR Part 520**

85. Revise § 520.1242b to read as follows:

§ 520.1242b

(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 § 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 § 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.

(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.

**21 CFR Part 520**

86. Revise § 520.1242c to read as follows:

§ 520.1242c

(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 § 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.

**21 CFR Part 520**

§ 520.1242e

87. In paragraph (b) of § 520.1242e, remove “053501” and in its place add “054771”.

**21 CFR Part 520**

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

§ 520.1242f

(a) *Specifications.* Each gram of gel contains 115 milligrams (11.5 percent) levamisol hydrochloride.

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

**21 CFR Part 520**

89. Amend § 520.1242g as follows:

a. Remove paragraph (a);

b. Redesignate paragraphs (b) through (f) as paragraphs (a) through (e); and

c. Revise newly redesignated paragraph (d).

The revision reads as follows:

§ 520.1242g

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

**21 CFR Part 520**

90. Revise § 520.1263a to read as follows:

§ 520.1263a

(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 § 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.

**21 CFR Part 520**

§ 520.1263c

91. In § 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”.

§ 520.1265

**21 CFR Part 520**

92. In § 520.1265, in paragraph (b)(1) remove “000009” and in its place add “054771”.

**21 CFR Part 520**

93. Revise § 520.1284 to read as follows:

§ 520.1284

(a) *Specifications.* Each tablet contains 60 or 120 micrograms (µg) liothyronine as the sodium salt.

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

(c) *Conditions of use in dogs* —(1) *Amount.* Administer orally to dogs at levels up to 12.8 µg 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 µg/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.

**21 CFR Part 520**

94. In § 520.1310, in paragraph (b), remove “000069” and in its place add “054771”; and revise the section heading to read as follows:

§ 520.1310

**21 CFR Part 520**

§ 520.1315

95. In paragraph (b) of § 520.1315, remove “000069” and in its place add “054771”.

**21 CFR Part 520**

96. Revise § 520.1320 to read as follows:

§ 520.1320

(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 § 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  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.

**21 CFR Part 520**

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

§ 520.1326a

(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.

**21 CFR Part 520**

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

§ 520.1326b

(c) *Conditions of use in horses* —

**21 CFR Part 520**

99. Revise § 520.1330 to read as follows:

§ 520.1330

(a) *Specifications.* Each gram of granules contains 5 milligrams (5 percent) meclofenamic acid.

(b) *Sponsor.* See No. 054771 in § 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.

**21 CFR Part 520**

100. In § 520.1331 revise paragraphs (b) and (c)(3) to read as follows:

§ 520.1331

(b) *Sponsor.* See No. 054771 in § 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.

**21 CFR Part 520**

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

§ 520.1341

(b) *Sponsor.* See No. 000061 in § 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.

**21 CFR Part 520**

102. Revise § 520.1380 to read as follows:

§ 520.1380

(a) *Specifications.* Each tablet contains 500 milligrams (mg) of methocarbamol.

(b) *Sponsor.* See No. 054771 in § 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.

**21 CFR Part 520**

103. Revise § 520.1408 to read as follows:

§ 520.1408

(a) *Specifications.* Each tablet contains 1, 2, or 4 milligrams (mg) of methylprednisolone.

(b) *Sponsors.* See sponsors in § 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.

**21 CFR Part 520**

104. Amend § 520.1409 as follows:

a. Revise the section heading and paragraph (b);

b. Remove paragraphs (c) and (d);

c. Redesignate paragraph (e) as paragraph (c); and

d. Revise newly redesignated paragraph (c).

The revisions read as follows:

§ 520.1409

(b) *Sponsor.* See No. 054771 in § 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.

**21 CFR Part 520**

§ 520.1422

105. In § 520.1422, in paragraph (b), remove “053501” and in its place add “054771”.

**21 CFR Part 520**

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

§ 520.1430

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

(c) *Conditions of use in dogs* —(1) *Amount.* 30 micrograms for animals  weighing 1 to 25 pounds; 60 micrograms for animals weighing 26 to 50 pounds; 120 micrograms for animals weighing 51 to 100 pounds; 180 micrograms for animals weighing over 100 pounds, German Shepherds, or German Shepherd mix. 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.

**21 CFR Part 520**

§ 520.1450a

107. In § 520.1450a, in paragraph (b), remove “000069” and in its place add “054771”.

**21 CFR Part 520**

§ 520.1450b

108. In § 520.1450b, in paragraph (b), remove “000069” and in its place add “054771”.

**21 CFR Part 520**

§ 520.1450c

109. In § 520.1450c, in paragraph (b), remove “000069” and in its place add “054771”.

**21 CFR Part 520**

§ 520.1451

110. In § 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.

**21 CFR Part 520**

111. In § 520.1452, in paragraph (b), remove “000856” and in its place add “054771”; and revise paragraph (d)(3) to read as follows:

§ 520.1452

(d) * * *

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

**21 CFR Part 520**

112. In § 520.1453, in paragraph (b), remove “000856” and in its place add “054771”; and revise paragraph (d)(3) to read as follows:

§ 520.1453

(d) * * *

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

**21 CFR Part 520**

113. Revise § 520.1468 to read as follows:

§ 520.1468

(a) *Specifications.* Each gram of granules contains 500 milligrams (mg) (50 percent) naproxen.

(b) *Sponsor.* See No. 054771 in § 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.

**21 CFR Part 520**

§ 520.1484

114. In § 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,”.

**21 CFR Part 520**

§ 520.1628

115. In paragraph (b) of § 520.1628, remove “000856” and in its place add “054771”.

**21 CFR Part 520**

§ 520.1629

116. In § 520.1629, in paragraphs (a)(2) and (b)(2), remove “000856” and in its place add “054771”.

**21 CFR Part 520**

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

§ 520.1630

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

**21 CFR Part 520**

§ 520.1631

118. In § 520.1631, in paragraph (b), remove “000856” and in its place add “054771”.

**21 CFR Part 520**

119. Revise § 520.1638 to read as follows:

§ 520.1638

(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 § 510.600(c) of this chapter.

(c) *Special considerations* —(1) See § 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.

**21 CFR Part 520**

§ 520.1640

120. Remove § 520.1640.

**21 CFR Part 520**

§ 520.1660a

121. In paragraph (b) of § 520.1660a, remove “000069” and in its place add “054771”.

**21 CFR Part 520**

§ 520.1660b

122. In § 520.1660b, in paragraph (b), remove “000069” and in its place add “054771”; and in paragraph (c), wherever it occurs, remove footnote 1.

**21 CFR Part 520**

§ 520.1660c

123. In § 520.1660c, in paragraphs (b) and (d)(3), remove “000069” and in its place add “No. 054771”.

**21 CFR Part 520**

§ 520.1660d

124. In § 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”.

**21 CFR Part 520**

§ 520.1696b

125. In § 520.1696b, in paragraph (b), remove “046573, 053501” and in its place add “054771”.

**21 CFR Part 520**

126. Amend § 520.1696c as follows:

a. Remove paragraph (c);

b. Redesignate paragraph (d) as paragraph (c); and

c. Revise newly redesignated paragraph (c) heading and (c)(3).

The revisions read as follows:

§ 520.1696c

(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.

**21 CFR Part 520**

127. Amend § 520.1696d as follows:

a. Revise paragraph (b);

b. Remove paragraph (c);

c. Redesignate paragraph (d) as paragraph (c);

d. Revise newly redesignated paragraph (c) heading and (c)(3).

The revisions read as follows:

**21 CFR Part 520**

§ 520.1696d

(b) *Sponsors.* See Nos. 050604 and 054771 in § 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.

**21 CFR Part 520**

§ 520.1720a

128. In § 520.1720a, in paragraph (b)(3), remove “000856” and in its place add “054771”.

129. Revise § 520.1720b to read as follows:

**21 CFR Part 520**

§ 520.1720b

(a) *Specifications.* Each package of granules contains 1 or 8 grams of phenylbutazone.

(b) *Sponsors.* See sponsors in § 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.

**21 CFR Part 520**

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

§ 520.1720c

(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.

**21 CFR Part 520**

131. Amend § 520.1720d as follows:

a. Remove paragraph (c);

b. Redesignate paragraph (d) as paragraph (c); and

c. Revise newly redesignated paragraph (c)(3).

The revisions read as follows:

§ 520.1720d

(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.

**21 CFR Part 520**

132. Amend § 520.1802a as follows:

a. In paragraph (b), remove “000009” and in its place add “No. 054771”;

b. Remove footnote 1 wherever it appears in paragraph (c); and

c. Revise the paragraph (c) heading and paragraphs (c)(1) and (3)

The revisions read as follows:

§ 520.1802a

(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.

**21 CFR Part 520**

133. Amend § 520.1802b as follows:

a. In paragraph (b), remove “000009” and in its place add “No. 054771”;

b. Revise the paragraph (c) heading; and

c. Remove footnote 1 wherever it appears in paragraph (c).

The revision reads as follows:

§ 520.1802b

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

**21 CFR Part 520**

134. In § 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:

§ 520.1802c

(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.

**21 CFR Part 520**

135. In § 520.1803, revise paragraphs (a) and (c) to read as follows:

§ 520.1803

(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.

**21 CFR Part 520**

§ 520.1804

136. In § 520.1804, in paragraph (b), remove “051311” and in its place add “054771”; and in paragraph (c) remove footnote 1 wherever it appears.

**21 CFR Part 520**

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

§ 520.1805

(c) * * *

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

**21 CFR Part 520**

§ 520.1807

138. In § 520.1807, in paragraph (b), remove “015565” and in its place add “No. 015565”.

**21 CFR Part 520**

§ 520.1840

139. In § 520.1840, in paragraph (b)(1), remove “000069” and in its place add “054771”.

**21 CFR Part 520**

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

§ 520.1855

(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.

**21 CFR Part 520**

141. Amend § 520.1860 as follows:

a. Remove paragraph (c);

b. Redesignate paragraph (d) as paragraph (c); and

c. Add paragraph (c)(3).

The addition reads as follows:

§ 520.1860

(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.

**21 CFR Part 520**

142. Amend § 520.1880 as follows:

a. Revise the section heading;

b. Remove paragraph (c);

c Redesignate paragraph (d) as paragraph (c); and

d. Revise the newly redesignated paragraph (c) heading and paragraphs (c)(1) and (2).

The revisions read as follows:

§ 520.1880

(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.

**21 CFR Part 520**

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

§ 520.1900

(b) *Sponsors.* See sponsor numbers in § 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.

**21 CFR Part 520**

144. Revise § 520.1920 to read as follows:

§ 520.1920

(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 § 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.

**21 CFR Part 520**

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

§ 520.1921

(b) *Sponsor.* See No. 054771 in § 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.

**21 CFR Part 520**

146. Revise § 520.1962 to read as follows:

§ 520.1962

(a) *Specifications.* Conforms to N.F. XII for promazine hydrochloride.

(b) *Sponsor.* See No. 054771 in § 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.

**21 CFR Part 520**

147. Revise § 520.2002 to read as follows:

§ 520.2002

(a) *Specifications.* Each chewable tablet contains 10 or 20 milligrams of propiopromazine hydrochloride.

(b) *Sponsor.* See No. 054771 in § 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.

**21 CFR Part 520**

§ 520.2043

148. In § 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”.

**21 CFR Part 520**

§ 520.2044

149. In § 520.2044, in paragraph (b)(1),remove “000069” and in its place add “054771”.

**21 CFR Part 520**

150. Revise § 520.2045 to read as follows:

§ 520.2045

(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 § 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.

(c) *Related tolerances.* See § 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.

**21 CFR Part 520**

151. Add § 520.2046 to read as follows:

§ 520.2046

(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 § 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.

**21 CFR Part 520**

152. Revise § 520.2098 to read as follows:

§ 520.2098

(a) *Specifications.* Each tablet contains 2, 5, 10, 15, or 30 milligrams (mg) selegiline hydrochloride.

(b) *Sponsor.* See No. 054771 in § 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.

**21 CFR Part 520**

153. Revise § 520.2100 to read as follows:

§ 520.2100

(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 § 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.

**21 CFR Part 520**

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

§ 520.2123a

(a) *Specifications.* Each tablet contains spectinomycin dihydrochloride equivalent to 100 milligrams (mg) spectinomycin.

(b) *Sponsors.* See Nos. 054771 and 061623 in § 510.600(c) of this chapter.

**21 CFR Part 520**

§ 520.2123c

155. In § 520.2123c, in paragraph (b), remove “0000856, 000859, and 061623” and in its place add “000859, 054771, and 061623”.

**21 CFR Part 520**

156. Revise § 520.2150 to read as follows:

§ 520.2150

(a) *Specifications.* Each tablet or chewable tablet contains 2 milligrams stanozolol.

(b) *Sponsor.* No. 054771 in § 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.

**21 CFR Part 520**

§ 520.2150a

157. Remove § 520.2150a.

**21 CFR Part 520**

§ 520.2150b

158. Remove § 520.2150b.

**21 CFR Part 520**

§ 520.2158

159. Remove § 520.2158.

§ 520.2158a

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

§ 520.2158

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

**21 CFR Part 520**

§ 520.2158b

162. Remove § 520.2158b.

**21 CFR Part 520**

§ 520.2158c

163. Remove § 520.2158c.

**21 CFR Part 520**

§ 520.2160

164. Remove § 520.2160.

**21 CFR Part 520**

165. Amend § 520.2170 as follows:

a. Revise the section heading;

b. Remove paragraph (d);

c. Redesignate paragraphs (b), (c), and (e) as paragraphs (c), (b), and (d), respectively; and

d. Revise newly redesignated paragraph (d) heading and paragraphs (d)(1) and (3).

The revisions read as follows:

§ 520.2170

(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.

**21 CFR Part 520**

166. Revise § 520.2184 to read as follows:

§ 520.2184

(a) *Specifications.* Each gram of powder contains 476 milligrams of sodium sulfachloropyrazine monohydrate.

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

(c) *Related tolerance.* See § 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.

**21 CFR Part 520**

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

§ 520.2200

(d) * * *

(3) * * *

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

§ 520.2218

**21 CFR Part 520**

168. In § 520.2218, in paragraph (b), remove “046573” and in its place add “054771”.

**21 CFR Part 520**

169. Revise § 520.2220a to read as follows:

§ 520.2220a

(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 § 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 § 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.

**21 CFR Part 520**

170. Revise § 520.2220b to read as follows:

§ 520.2220b

(a) *Specifications.* Each milliliter of suspension contains 50 milligrams (mg) sulfadimethoxine.

(b) *Sponsors.* See Nos. 000061 and 054771 in § 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.

**21 CFR Part 520**

171. Revise § 520.2220c to read as follows:

§ 520.2220c

(a) *Specifications.* Each tablet contains 125, 250, or 500 milligrams (mg) sulfadimethoxine.

(b) *Sponsors.* See Nos. 000061 and 054771 in § 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.

**21 CFR Part 520**

172. Revise § 520.2220d to read as follows:

§ 520.2220d

(a) *Specifications.* Each bolus contains 2.5, 5, or 15 grams sulfadimethoxine.

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

(c) *Related tolerances.* See § 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  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.

**21 CFR Part 520**

173. Add § 520.2220e to read as follows:

§ 520.2220e

(a) *Specifications.* Each extended-release bolus contains 12.5 grams sulfadimethoxine.

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

(c) *Related tolerances.* See § 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.

**21 CFR Part 520**

174. Add § 520.2220f to read as follows:

§ 520.2220f

(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 § 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.

**21 CFR Part 520**

175. Revise § 520.2240a to read as follows:

§ 520.2240a

(a) *Specifications.* Each milliliter of solution contains 62.5 milligrams (mg) sodium sulfaethoxypyridazine.

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

(c) *Related tolerances.* See § 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.

**21 CFR Part 520**

176. Revise § 520.2240b to read as follows:

§ 520.2240b

(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 § 510.600(c) of this chapter.

(c) *Related tolerances.* See § 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.

§ 520.2260a

**21 CFR Part 520**

177. In § 520.2260a, in paragraph (b)(1), remove “053501” and in its place add “054771”.

**21 CFR Part 520**

178. Amend § 520.2260b as follows:

a. In paragraph (b)(1), remove “053501” and in its place add “054771”;

b. In paragraph (c)(2), remove footnote 1 wherever it occurs; and

c. In paragraph (c)(2)(iii), remove the eighth sentence and in its place add two sentences.

The additions read as follows:

§ 520.2260b

(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. * * *

**21 CFR Part 520**

179. Amend § 520.2260c as follows:

a. Redesignate paragraphs (a) and (b) as paragraphs (b) and (d), respectively;

b. Add new paragraphs (a) and (c); and

c. Revise newly redesignated paragraphs (b) and (d)(3).

The additions and revisions read as follows:

§ 520.2260c

(a) *Specifications.* Each extended-release tablet contains 8 grams sulfamethazine.

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

(c) *Related tolerances.* See § 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.

**21 CFR Part 520**

180. Amend § 520.2261a as follows:

a. Remove paragraph (d);

b. Redesignate paragraphs (a), (b), and (c) as paragraphs (b), (c), and (d), respectively;

c. Add new paragraph (a);

d. Revise newly redesignated paragraphs (b) and (c); and

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:

§ 520.2261a

(a) *Specifications.* Each milliliter of solution contains 125 milligrams (12.5 percent) sulfamethazine sodium.

(b) *Sponsors.* See Nos. 000010 and 061623 in § 510.600(c) of this chapter.

(c) *Related tolerances.* See § 556.670 of this chapter.

**21 CFR Part 520**

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

§ 520.2261b

(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.

**21 CFR Part 520**

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

§ 520.2280

(b) *Sponsor.* See No. 054771 in § 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.

**21 CFR Part 520**

183. In § 520.2325a, revise the section heading and in paragraph (a)(3), remove “046573” and in its place add “054771”.

The revision reads as follows:

§ 520.2325a

**21 CFR Part 520**

184. Revise § 520.2325b to read as follows:

§ 520.2325b

(a) *Specifications.* A soluble powder containing 25 percent sulfaquinoxaline.

(b) *Sponsor.* See No. 050749 in § 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.

§ 520.2330

**21 CFR Part 520**

185. In paragraph (b) of § 520.2330, remove “000856” and in its place add “054771”; and in paragraph (c), remove footnote 1 wherever it occurs.

**21 CFR Part 520**

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

§ 520.2345a

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

**21 CFR Part 520**

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

§ 520.2345b

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

**21 CFR Part 520**

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

§ 520.2345c

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

**21 CFR Part 520**

189. Amend § 520.2345d as follows;

a. In paragraph (b)(1), remove “000069” and in its place add “054771”;

b. In paragraphs (b)(3), (d)(1)(iii), and (d)(2)(iii), remove “046573” and in its place add “054771”; and

c. Add paragraph (b)(5).

The addition reads as follows:

§ 520.2345d

(b) * * *

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

**21 CFR Part 520**

190. In § 520.2345e, revise the section heading and paragraph (b) and remove paragraph (c)(1)(iv).

The revisions read as follows:

§ 520.2345e

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

**21 CFR Part 520**

191. In § 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:

§ 520.2345f

(c) *Conditions of use in dogs* —

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

**21 CFR Part 520**

192. In § 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:

§ 520.2345g

(c) *Conditions of use in dogs* —

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

**21 CFR Part 520**

193. In § 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:

§ 520.2345h

(c) *Conditions of use in dogs* —

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

**21 CFR Part 520**

194. Amend § 520.2362 as follows:

a. Revise the section heading;

b. Remove paragraph (a);

c. Redesignate paragraphs (b), (c), and (d) as paragraphs (a), (b), and (c), respectively; and

d. Revise newly redesignated paragraphs (a) and (c).

The revisions read as follows:

§ 520.2362

(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.

**21 CFR Part 520**

195. Amend § 520.2380a as follows:

a. Remove paragraph (a);

b. Redesignate paragraphs (b) through (e) as paragraphs (a) through (d), respectively; and

c. Revise newly redesignated paragraph (b).

The revision reads as follows:

§ 520.2380a

(b) *Sponsors.* See sponsors in § 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.

**21 CFR Part 520**

196. Amend § 520.2380b as follows:

a. Revise the section heading;

b. Remove paragraph (a);

c. Redesignate paragraphs (b) through (e) as paragraphs (a) through (d), respectively; and

d. Revise newly redesignated paragraph (b).

The revisions read as follows:

§ 520.2380b

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

§ 520.2380c

**21 CFR Part 520**

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

**21 CFR Part 520**

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

§ 520.2380d

(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.

**21 CFR Part 520**

199. In § 520.2380e, revise the section heading and paragraph (c) to read as follows:

§ 520.2380e

(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.

**21 CFR Part 520**

200. In § 520.2380f, revise the section heading, the paragraph (c) heading, and paragraphs (c)(1) and (3) to read as follows:

§ 520.2380f

(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.”

§ 520.2475

**21 CFR Part 520**

201. In § 520.2475, in paragraph (b), remove “000009” and in its place add “054771”.

§ 520.2520b

**21 CFR Part 520**

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

§ 520.2520a

(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 § 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.

(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.

§ 520.2520e

203a. Redesignate § 520.2520e as § 520.2520b.

**21 CFR Part 520**

203b. Amend newly redesignated § 520.2520b as follows:

a. Revise paragraph (b);

b. Remove paragraphs (c) and (d);

c. Redesignate paragraph (e) as paragraph (c); and

d. Revise the newly redesignated paragraph (c) heading and paragraph (c)(3).

The revisions read as follows:

**21 CFR Part 520**

§ 520.2520b

(b) *Sponsor.* See No. 054771 in § 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.

**21 CFR Part 520**

§ 520.2520f

204a. Redesignate § 520.2520f as § 520.2520c.

**21 CFR Part 520**

204b. Amend newly redesignated § 520.2520c as follows:

a. Revise paragraph (b);

b. Remove paragraphs (c) and (d);

c. Redesignate paragraph (e) as paragraph (c); and

d. Revise the newly redesignated paragraph (c) heading and paragraph (c)(3).

The revisions read as follows:

§ 520.2520c

(b) *Sponsor.* See No. 054771 in § 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.

**21 CFR Part 520**

§ 520.2520g

205a. Redesignate § 520.2520g as § 520.2520d.

**21 CFR Part 520**

205b. Amend newly redesignated § 520.2520d as follows:

a. Revise paragraph (b);

b. Remove paragraphs (c) and (d);

c. Redesignate paragraph (e) as paragraph (c); and

d. Revise the newly redesignated paragraph (c) heading and paragraph (c)(3).

The revisions read as follows:

§ 520.2520d

(b) *Sponsor.* See No. 054771 in § 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.

**21 CFR Part 520**

206. Revise § 520.2582 to read as follows:

§ 520.2582

(a) *Specifications.* Each tablet contains 10 or 25 milligrams (mg) triflupromazine hydrochloride.

(b) *Sponsor.* See No. 054771 in § 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.

**21 CFR Part 520**

207. Revise § 520.2604 to read as follows:

§ 520.2604

(a) *Specifications.* Each tablet contains 5 milligrams (mg) trimeprazine tartrate and 2 mg prednisolone.

(b) *Sponsor.* See No. 054771 in § 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.

**21 CFR Part 520**

208. Revise § 520.2605 to read as follows:

§ 520.2605

(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 § 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.

**21 CFR Part 520**

209. Revise § 520.2610 to read as follows:

§ 520.2610

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

**21 CFR Part 520**

§ 520.2611

210. In § 520.2611, in paragraph (b)(1), remove “000856” and in its place add “054771”.

**21 CFR Part 520**

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

§ 520.2613

(a) *Specifications.* Each gram of powder contains 67 milligrams (mg) trimethoprim and 333 mg sulfadiazine.

(b) *Sponsors.* See Nos. 054771 and 058711 in § 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.