Source: https://www.federalregister.gov/documents/2016/12/27/2016-31084/oral-dosage-form-new-animal-drugs-approval-of-new-animal-drug-applications
Timestamp: 2017-09-26 14:55:06
Document Index: 388915527

Matched Legal Cases: ['arts 520', 'art 520', '§\u2009520', '§\u2009520', '§\u2009520', '§\u2009520', '§\u2009520', '§\u2009520', '§\u2009520', '§\u2009520', '§\u2009520', '§\u2009520', '§\u2009520', '§\u2009520', '§\u2009510', '§\u2009510', '§\u2009510', '§\u2009520', '§\u2009556', '§\u2009520', '§\u2009520', '§\u2009520', '§\u2009520', '§\u2009520', '§\u2009520', '§\u2009520', '§\u2009520', '§\u2009520', 'art 529', '§\u2009529']

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