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Food and Drug Administration, HHS.
Final rule; technical amendments.
The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs), abbreviated new animal drug applications (ANADAs), and conditionally approved new animal drug applications (CNADAs) during January, February, and March 2026. The animal drug regulations are also being amended to improve their accuracy and readability.
This rule is effective July 7, 2026.
James Delaney, Center for Veterinary Medicine, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, James.Delaney@fda.hhs.gov, 240-402-5677.
FDA is amending the animal drug regulations to reflect approval actions for NADAs, ANADAs, and CNADAs during January, February, and March 2026, as listed in table 1. Documentation of environmental review required under the National Environmental Policy Act, summaries of the basis of approval under the Freedom of Information Act (FOIA summaries), and marketing exclusivity and patent information are available at Animal Drugs @FDA: https://animaldrugsatfda.fda.gov/adafda/views/#/search.
| Date of approval | Application No. | Sponsor (drug labeler code 1 ) | Product name | Effect of the action | 21 CFR sections |
|---|---|---|---|---|---|
| December 4, 2025 | 141-167 | Intervet, Inc. (000061) | EXZOLT CATTLE-CA (fluralaner topical solution) | Conditional approval | 516.900 556.290(b)(2) |
| January 9, 2026 | 200-828 | Parnell Technologies Pty. Ltd. (068504) | nixiFLOR (florfenicol and flunixin meglumine) injectable solution | Original approval as a generic copy of NADA 141-299 | 522.956 |
| January 9, 2026 | 141-615 | Pegasus Laboratories, Inc. (055246) | KBROVET (potassium bromide chewable tablets) | Original approval | 516.1858 520.1858 |
| January 12, 2026 | 200-833 | Felix Pharmaceuticals Pvt. Ltd. (086101) | Maropitant Citrate Chewable Tablets | Original approval as a generic copy of NADA 141-262 | 520.1315 |
| January 13, 2026 | 200-831 | Norbrook Laboratories Ltd. | Defendazole (fenbendazole) | Original approval as a generic copy of RLNAD NADA 128-620 | 520.905a |
| January 13, 2026 | 141-518 | Intervet, Inc. (000061) | BRAVECTO PLUS (fluralaner and moxidectin topical solution) | Supplemental approval | 524.1001 |
| January 15, 2026 | 141-575 | Boehringer Ingelheim Animal Health USA, Inc. (000010) | VETMEDIN Solution (pimobendan oral solution) | Supplemental approval | 520.1782 |
| January 20, 2026 | 141-554 | Boehringer Ingelheim Animal Health USA, Inc. (000010) | NEXGARD PLUS (afoxolaner, moxidectin, and pyrantel chewable tablets) | Supplemental approval | 520.35 |
| January 29, 2026 | 200-761 | Cronus Pharma Specialities India Private Ltd. (069043) | Cronoquin Tablets (marbofloxacin tablets) | Original approval as a generic copy of NADA 141-151 | 520.1310 |
| January 30, 2026 | 200-830 | Parnell Technologies Pty. Ltd. (068504) | Sevoflurane (sevoflurane) | Original approval as a generic copy NADA 141-103 | 529.2110 |
| February 6, 2026 | 200-838 | Felix Pharmaceuticals Pvt. Ltd. (086101) | Atipamezole Hydrochloride Injection (atipamezole hydrochloride) sterile injectable solution | Original approval as a generic copy of NADA 141-033 | 522.147 |
| February 23, 2026 | 200-822 | Baxter Healthcare Corporation (010019) | ANIRANE (isoflurane) | Original approval as a generic copy of NADA 135-773 | 529.1186 |
| February 23, 2026 | 200-841 | Felix Pharmaceuticals Pvt. Ltd. (086101) | Firocoxib Tablets for Horses (firocoxib) | Original approval as a generic copy of NADA 141-458 | 520.928 |
| March 9, 2026 | 200-804 | Cronus Pharma Specialities India Private Ltd. (069043) | Robenacoxib Injection (robenacoxib) Injectable Solution | Original approval as a generic copy of NADA 141-443 | 522.2075 |
| March 10, 2026 | 095-735 | Elanco, US Inc, (058198) | Rumensin 113 (monensin Type A medicated article) | Supplemental approval | 558.355 |
| March 16, 2026 | 141-599 | Intervet, Inc. (000061) | BRAVECTO QUANTUM (fluralaner for extended-release injectable suspension) | Supplemental approval | 522.998 |
| March 23, 2026 | 141-616 | Zoetis (054771) | DECTOMAX -CA1 (doramectin injection) | Supplemental approval | 516.570 |
| 1 See 21 CFR 510.600(c) for sponsor addresses. | |||||
Dechra, Ltd., Snaygill Industrial Estate, Keighley Rd., Skipton, North Yorkshire, BD23 2RW, United Kingdom (drug labeler code 043264), requested that FDA withdraw approval of two NADAs listed in table 2 because these products are no longer marketed. Med-Pharmex, Inc., 2727 Thompson Creek Rd., Pomona, CA 91767-1861 (drug labeler code 054925), requested that FDA withdraw approval of four ANADAs listed in table 2 because these products are no longer marketed. As provided in the regulatory text of this document, the animal drug regulations are amended to reflect these actions.
| Date of withdrawal of approval | Application No. | Product name | 21 CFR section |
|---|---|---|---|
| February 27, 2026 | 047-955 | ROMPUN 20 mg/mL | 522.2662 |
| February 27, 2026 | 200-408 | Butorphanol Tartrate Injection 2 mg/mL | 522.246 |
| February 27, 2026 | 200-183 | Vet Beta-Gen (gentamicin sulfate, betamethasone valerate) | 524.1044b |
| February 27, 2026 | 200-188 | Betagen Topical Spray (gentamicin sulfate, betamethasone valerate) | 524.1044f |
| February 27, 2026 | 200-196 | Miconosol (miconazole nitrate lotion/spray 1%) | 524.1443 |
| February 27, 2026 | 200-229 | TRI-OCTIC Ointment (gentamicin sulfate, betamethasone valerate, clotrimazole) | 524.1044g |
The sponsors of the approved applications listed in table 3 have informed FDA that they have transferred ownership of, and all rights and interest in, these applications to another sponsor. The regulations cited in table 3 are amended to reflect these actions.
| Application No. | Product name | Transferring sponsor (drug labeler code) | New sponsor (drug labeler code) | 21 CFR section |
|---|---|---|---|---|
| 200-771 | Methimazole solution | Norbrook Laboratories Ltd. (055529) | Virbac AH, Inc. (051311) | 520.1376 |
| 141-614 | LAVERDIA (verdinexor tablets) | Anivive Lifesciences Inc. (086121) | Dechra, Ltd. (043264) | 520.2700 |
| 200-683 | CYCLEGUARD and MONOVET (melengestrol acetate Type A liquid medicated article and monensin Type A medicated article | Zoetis (054771) | Phibro (066104) | 558.342 |
| 139-235 | BIO-COX and BACIFERM (salinomycin sodium Type A medicated article and bacitracin zinc Type A medicated article to be used in the manufacture of Type C medicated feeds | Do | Do | 558.550 |
| 114-794 | AMPROL HI-E and BACIFERM (amprolium with ethopabate Type A medicated article and bacitracin zinc Type A medicated article) | Do | Do | 558.58 |
| 134-830 | Coban and Albac (monensin Type A medicated article and bacitracin zinc Type A medicated article) | Do | Do | 558.355 |
FDA is making the following amendments to improve the accuracy and readability of the animal drug regulations.
This final rule is issued under section 512(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360b(i)). Although deemed a rule under the FD&C Act, this document does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a “rule of particular applicability” and is not subject to the congressional review requirements in 5 U.S.C. 801-808. Likewise, this is not a rule subject to Executive Order 12866.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 516, 520, 522, 524, 529, 556, and 558 are amended as follows:
1. The authority citation for part 516 continues to read as follows:
2. In § 516.570, revise paragraph (c)(2) to read as follows:
(c) * * *
(2) Indications for use. For prevention and treatment of infestations caused by New World screwworm ( Cochliomyia ( printed page 41559) hominivorax ) larvae (myiasis), and prevention of reinfestation for 21 days.
3. Add § 516.900 to subpart E to read as follows:
(a) Specifications. Each milliliter (mL) of solution contains 50 milligrams (mg) of fluralaner
(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.
(c) Conditions of use —(1) Amount. 2.5 mg per kilogram (1.13 mg per one pound).
(2) Indications for use. For the prevention and treatment of infestations caused by New World screwworm ( Cochliomyia hominivorax) larvae (myiasis) and treatment and control of cattle fever tick ( Rhipicephalus microplus) in beef cattle 2 months of age and older and replacement dairy heifers less than 20 months of age.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Environmental temperature affects the withdrawal period. Cattle must not be slaughtered for human consumption within 98 days of treatment. If cattle are continuously exposed to temperatures at or above 60 °F after product administration, then cattle may be slaughtered for human consumption 44 days after treatment. Violative residues may result if cattle are exposed to temperatures below 60 °F after administration and are slaughtered at 44 days. Not for use in female dairy cattle 20 months of age or older, including dry dairy cows: use in these cattle may cause drug residues in milk and/or calves born to these cows or heifers. Not for use in beef calves less than 2 months of age, dairy calves, and veal calves. A withdrawal period has not been established for this product in pre-ruminating calves.
4. Remove § 516.1858.
5. The authority citation for part 520 continues to read as follows:
6. In § 520.35, revise paragraph (c)(2) to read as follows:
(c) * * *
(2) Indications for use. For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of adult hookworm ( Ancylostoma caninum, Ancylostoma braziliense, and Uncinaria stenocephala) and roundworm ( Toxocara canis and Toxascaris leonina) infections. Kills adult fleas and is indicated for the treatment and prevention of flea infestations ( Ctenocephalides felis) and the treatment and control of Ixodes scapularis (black-legged tick), Rhipicephalus sanguineus (brown dog tick), Dermacentor variabilis (American dog tick), Amblyomma americanum (lone star tick), Amblyomma maculatum (Gulf Coast tick), and Haemaphysalis longicornis (longhorned tick) infestations for 1 month in dogs and puppies 8 weeks of age and older, weighing 4 pounds of body weight or greater. For the prevention of Borrelia burgdorferi infections as a direct result of killing Ixodes scapularis vector ticks.
7. In § 520.43, revise paragraph (c)(2) to read as follows:
(c) * * *
(2) Indications for use. Kills adult fleas and for the treatment and prevention of flea infestations ( Ctenocephalides felis); and the treatment and control of Ixodes scapularis (black-legged tick), Dermacentor variabilis (American dog tick), Amblyomma americanum (lone star tick), Amblyomma maculatum (Gulf Coast tick), Rhipicephalus sanguineus (brown dog tick), and Haemaphysalis longicornis (longhorned tick) infestations in dogs and puppies 8 weeks of age and older, weighing 4 pounds of body weight or greater, for 1 month; and for the prevention of Borrelia burgdorferi infections as a direct result of killing Ixodes scapularis vector ticks.
8. Add § 520.136 to read as follows:
(a) Specifications. Each tablet contains 4.8, 7.2, 21.6, or 31.6 milligrams (mg) of atinvicitinib.
(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.
(c) Conditions of use —(1) Amount. Administer 0.36 to 0.54 mg atinvicitinib per pound (0.8 to 1.2 mg atinvicitinib per kilogram) of body weight, once daily, with food.
(2) Indications for use. For the control of pruritus associated with allergic dermatitis in dogs 6 months of age and older.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
9. In § 520.522, revise paragraph (d)(1) introductory text to read as follows:
(d) * * *
(1) Dogs. Use capsules described in paragraph (a)(1) of this section or solution as described in paragraph (a)(2) of this section as follows:
10. In § 520.905a, revise paragraph (b) to read as follows:
(b) Sponsors. See sponsors in § 510.600(c) of this chapter as follows:
(1) No. 000061 as in paragraph (e) of this section.
(2) No. 055529 as in paragraphs (e)(2) and (4) of this section.
11. In § 520.928, revise paragraph (b)(2) to read as follows:
(b) * * *
(2) Nos. 000010, 055246, and 086101 for use of the product described in paragraph (a)(2) of this section as in paragraph (c)(2) of this section.
12. In § 520.1310, in paragraph (b)(1), remove “Nos. 017033, 054771, and 086117” and in its place add “Nos. 017033, 054771, 069043, and 086117”.
13. In § 520.1315, revise paragraphs (a) and (b) to read as follows:
(a) Specifications. (1) Each tablet contains 16, 24, 60, or 160 milligrams (mg) maropitant as maropitant citrate.
(2) Each chewable tablet contains 16, 24, 60, or 160 mg maropitant as maropitant citrate.
(b) Sponsors. See sponsors in § 510.600(c) of this chapter:
(1) Nos. 054771, 086101, and 086117 for use of the product described in paragraph (a)(1) of this section as in paragraph (c) of this section.
(2) No. 086101 for use of the product described in paragraph (a)(2) of this section as in paragraph (c) of this section.
14. In § 520.1376, in paragraph (b), remove “055529” and in its place add “051311”.
15. In § 520.1782, revise paragraph (c)(2) to read as follows:
(c) * * *
(2) Indications for use. For the delay of onset of congestive heart failure (CHF) in dogs with Stage B2 preclinical myxomatous mitral valve disease (MMVD). Stage B2 preclinical MMVD refers to dogs with asymptomatic MMVD that have a moderate or loud mitral murmur due to mitral regurgitation and cardiomegaly. For the management of the signs of mild, moderate, or severe CHF in dogs due to clinical MMVD or dilated cardiomyopathy (DCM); for use with concurrent therapy for CHF ( e.g., furosemide, etc.) as appropriate on a case-by-case basis.
16. Add § 520.1858 to read as follows:
(a) Specifications. Each chewable tablet contains 250 or 500 milligrams (mg) potassium bromide.
(b) Sponsor. See No. 055246 in § 510.600(c) of this chapter.
(c) Conditions of use— (1) Amount. Administer 25 to 68 mg per kilogram (11 to 31 mg per pound) of body weight. The dosage should be adjusted based on monitoring of clinical response of the individual patient.
(2) Indications for use. For the control of seizures associated with idiopathic epilepsy in dogs.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
17. In § 520.2700, in paragraph (b), remove “086121” and in its place add “043264”.
18. The authority citation for part 522 continues to read as follows:
19. In § 522.147, in paragraph (b), remove “Nos. 015914, 052483, 068504, and 069043” and in its place add “Nos. 015914, 052483, 068504, 069043, and 086101”.
20. In § 522.246:
a. Remove paragraph (b)(2);
b. Redesignate paragraph (b)(3) as paragraph (b)(2); and
c. Revise newly redesignated paragraph (b)(2).
The revision reads as follows:
(b) * * *
(2) Nos. 000061, 017033, and 059399 for use of the product described in paragraph (a)(3) of this section as in paragraph (d)(3) of this section.
21. In § 522.533, remove and reserve paragraphs (a)(2), (b)(2), and (c)(2).
22. Remove § 522.728.
23. In § 522.956, in paragraph (b), remove “No. 000061” and in its place add “Nos. 000061 and 068504”.
24. In § 522.998, revise paragraph (c)(2) to read as follows:
(c) * * *
(2) Indications for use. Kills adult fleas and for the treatment and prevention of flea infestations ( Ctenocephalides felis); for the treatment and control of tick infestations Ixodes scapularis (black-legged tick), Dermacentor variabilis (American dog tick), Rhipicephalus sanguineus (brown dog tick), and Amblyomma maculatum (Gulf Coast tick) for 12 months in dogs and puppies 6 months of age and older; and for the treatment and control of Amblyomma americanum (lone star tick) infestations for 8 months in dogs and puppies 6 months of age and older.
25. In § 522.2075, in paragraph (b), remove “No. 058198” and in its place add “Nos. 058198 and 069043”.
26. In § 522.2662, in paragraph (b)(3), remove “Nos. 043264 and 061651” and in its place add “No. 061651”.
27. The authority citation for part 524 continues to read as follows:
28. In § 524.1001, revise paragraph (c)(2) to read as follows:
(c) * * *
(2) Indications for use. For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment of infections with intestinal roundworm ( Toxocara cati, fourth-stage larvae, immature adults, and adults) and hookworm ( Ancylostoma tubaeforme, fourth-stage larvae, immature adults, and adults); kills adult fleas and is indicated for the treatment and prevention of flea infestations ( Ctenocephalides felis) and the treatment and control of tick infestations ( Ixodes scapularis (black-legged tick), Dermacentor variabilis (American dog tick), Haemaphysalis longicornis (Asian longhorned tick), and Amblyomma maculatum (Gulf Coast tick)) for 2 months in cats and kittens 6 months of age and older and weighing 2.6 lb or greater.
29. In § 524.1044b, in paragraph (b), remove “Nos. 000061 and 054925” and in its place add “No. 000061”.
30. In § 524.1044f, in paragraph (b), remove “Nos. 000061, 017033, 054925, 058005, and 058829” and in its place add “Nos. 000061, 017033, 058005, and 058829”.
31. In § 524.1044g:
a. Remove paragraph (b)(2);
b. Redesignate paragraphs (b)(3) and (4) as paragraphs (b)(2) and (3), respectively, and
c. Revise paragraph (c)(1)(i).
The revision reads as follows:
(c) * * *
(1) * * *
(i) From 7.5- or 15-g tubes; 10-, 12.5-, or 30-g bottles: 4 drops for dogs weighing less than 30 pounds (lb) or 8 drops for dogs weighing 30 lb or more.
32. In § 524.1443, in paragraph (b)(2), remove “Nos. 054925 and 058829” and in its place add “No. 058829”.
33. The authority citation for part 529 continues to read as follows:
34. In § 529.1186, in paragraph (b), remove “Nos. 017033, 054771, and 065085” and in its place add “Nos. 010019, 017033, 054771, and 065085”.
35. In § 529.2110, in paragraph (b), remove “Nos. 017033, 054771, and 065085” and in its place add “Nos. 017033, 054771, 065085, and 068504”.
36. The authority citation for part 556 continues to read as follows:
37. In § 556.290, add paragraph (b)(2) and revise paragraph (c) to read as follows:
(b) * * *
(2) Cattle. (i) Liver (target tissue): 500 ppb.
(ii) Muscle: 350 ppb.
(c) Related conditions of use. See §§ 516.900 and 520.999 of this chapter.
38. The authority citation for part 558 continues to read as follows:
39. In § 558.58, revise paragraph (e)(4) to read as follows:
(e) * * *
| Amprolium and ethopabate in grams per ton | Combination in grams per ton | Indications for use | Limitations | Sponsor |
|---|---|---|---|---|
| * * * * * * * | ||||
| (4) Amprolium 113.5 and ethopabate 36.3 | Bacitracin (as feed grade bacitracin zinc) 4 to 50 | 2. Broiler chickens: As an aid in prevention of coccidiosis where severe exposure to coccidiosis from Eimeria acervulina, E. maxima, and E. brunetti is likely to occur; for improved feed efficiency | Feed as the sole ration from the time birds are placed on litter until past the time when coccidiosis is ordinarily a hazard, up to 16 weeks of age. If losses exceed 0.5% in a 2-day period, obtain an accurate diagnosis and follow the instructions of your veterinarian or poultry pathologist. Do not feed to chickens producing eggs for human consumption. Not for chickens over 16 weeks of age. Do not feed as a treatment for outbreaks of coccidiosis. Do not change the litter while giving this feed unless absolutely necessary. Use as the sole source of amprolium. Do not use in feeds containing bentonite. Bacitracin zinc as provided by No. 054771 in § 510.600(c) of this chapter. | 066104 |
| * * * * * * * | ||||
40. In § 558.342, revise paragraph (e)(1)(iv) to read as follows:
(e) * * *
(1) * * *
| Melengestrol acetate in mg/head/day | Combination in grams/ton | Indications for use | Limitations | Sponsor |
|---|---|---|---|---|
| * * * * * * * | ||||
| (iv) 0.25 to 0.5 | Monensin, 10 to 40 | Growing beef heifers fed in confinement for slaughter: For increased rate of weight gain, improved feed efficiency, and suppression of estrus (heat); and for the prevention and control of coccidiosis due to Eimeria bovis and E. zuernii | At the rate of 0.5 to 2.0 lb/head/day, a Type C top-dress medicated feed containing 0.25 to 2 g melengestrol acetate per ton must be top dressed onto or mixed at feeding with a Type C medicated feed containing 10 to 40 g of monensin per ton to provide 0.25 to 0.5 mg melengestrol acetate/head/day and 0.14 to 0.42 mg monensin/lb body weight, depending on severity of coccidiosis challenge, up to 480 mg monensin/head/day. See § 558.355(d) of this chapter. Monensin as provided by No. 016592 or 058198; melengestrol acetate as provided by No. 016952, 066104, or 058198 in § 510.600(c) of this chapter | 016592 066104 058198 |
41. In § 558.355, revise paragraphs (a), (e)(1)(xi), (e)(4)(v) introductory text, and (e)(4)(v)(A) to read as follows:
(a) Specifications. Type A medicated articles containing 45, 60, 90.7, 110, or 113.4 grams monensin, USP, per pound.
(e) * * *
(1) * * *
( printed page 41562)| Monensin in grams/ton | Combination in grams/ton | Indications for use | Limitations | Sponsor |
|---|---|---|---|---|
| * * * * * * * | ||||
| (xi) 90 to 110 | Bacitracin (as feed grade bacitracin zinc), 4 to 50 | Broiler chickens: As an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima, and for increased rate of weight gain and improved feed efficiency | Feed as the sole ration. Do not allow horses, other equines, mature turkeys, or guinea fowl access to feed containing monensin. Ingestion of monensin by horses and guinea fowl has been fatal. In the absence of coccidiosis in broiler chickens, the use of monensin with no withdrawal period may limit feed intake resulting in reduced weight gain. Not for broiler breeder replacement chickens. Bacitracin zinc as provided by No. 054771 in 510.600(c) of this chapter | 066104 |
| * * * * * * * | ||||
(4) * * *
| Monensin amount | Indications for use | Limitations | Sponsor |
|---|---|---|---|
| * * * * * * * | |||
| (v) 1,620 grams per ton of mineral granules as specified in paragraph (e)(4)(v)(A) of this section | Growing beef steers and heifers on pasture (stocker, feeder, and slaughter) or in a dry lot and replacement beef and dairy heifers: For increased rate of weight gain, and for prevention and control of coccidiosis due to Eimeria bovis and E. zuernii | Feed at a rate of 50 to 200 milligrams per head per day. During the first 5 days of feeding, cattle should receive no more than 100 milligrams per day. Do not feed additional salt or minerals. Do not mix with grain or other feeds. Monensin is toxic to cattle when consumed at higher than approved levels. Stressed and/or feed- and/or water-deprived cattle should be adapted to the pasture and to unmedicated mineral supplement before using the monensin mineral supplement | 016592 058198 |
(A) Specifications. Use as free-choice Type C medicated feed formulated as mineral granules as follows:
| Ingredient | Percent | International feed No. |
|---|---|---|
| Monocalcium phosphate (21% phosphorus, 15% calcium) | 29.49 | 6-01-082 |
| Sodium chloride (salt) | 24.37 | 6-04-152 |
| Dried cane molasses | 20.0 | 4-04-695 |
| Ground limestone (33% calcium) or calcium carbonate (38% calcium) | 13.75 | 6-02-632 |
| Cane molasses | 3.0 | 4-04-696 |
| Processed grain by-products (as approved by AAFCO) | 5.0 | |
| Vitamin/trace mineral premix1 | 2.5 | |
| Monensin Type A article, 90.7 grams per pound2 | 0.89 | |
| Antidusting oil | 1.0 | |
| 1 Content of vitamin and trace mineral premixes may be varied. However, they should be comparable to those used for other free-choice feeds. Formulation modifications require FDA approval prior to marketing. Selenium must comply with 21 CFR 573.920. Ethylenediamine dihydroiodide should comply with FDA Compliance Policy Guide Sec. 651.100 (CPG 7125.18). | ||
| 2 To provide 1,620 g monensin per ton, use 17.8 lb (0.89%) of a monensin Type A medicated article containing 90.7 g monensin per pound. If using a monensin Type A medicated article containing 113.4 grams monensin per pound, use 14.2 lb (0.71%), subtracting ground limestone. | ||
42. In § 558.550, revise paragraph (e)(1)(v) to read as follows:
(e) * * *
(1) * * * ( printed page 41563)
| Salinomycin in grams/ton | Combination in grams/ton | Indications for use | Limitations | Sponsor |
|---|---|---|---|---|
| * * * * * * * | ||||
| (v) 40 to 60 | Bacitracin (as feed grade bacitracin zinc), 10 to 50 | Broiler chickens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, and for increased rate of weight gain | Feed as the sole ration. The dosage of salinomycin sodium should be adjusted to meet the severity of coccidial challenge, which varies with environmental and management conditions. Do not feed to chickens producing eggs for human consumption. May be fatal if accidently fed to adult turkeys or horses. Do not use in Type C medicated feeds containing pellet binders. Bacitracin zinc as provided by No. 054771 in § 510.600(c) of this chapter | 016592 066104 |
| * * * * * * * | ||||
43. In § 558.625, revise paragraphs (e)(1)(v), (x), and (xiii) to read as follows:
(e) * * *
(1) * * *
| Tylosin in grams/ton | Combination in grams/ton | Indications for use | Limitations | Sponsors |
|---|---|---|---|---|
| * * * * * * * | ||||
| (v) 40 or 100 | Ractopamine hydrochloride, 4.5 to 9 | For increased rate of weight gain, improved feed efficiency, increased carcass leanness, control of swine dysentery associated with Brachyspira hyodysenteriae, and control of porcine proliferative enteropathies (PPE, ileitis) associated with Lawsonia intracellularis in finishing swine weighing at least 150 lb and fed a complete ration containing at least 16% crude protein for the last 45 to 90 lb of gain prior to slaughter. Not for use in swine intended for breeding | Feed as the sole ration to finishing swine weighing at least 150 lb for the last 45 to 90 lb (group average) of weight gain prior to slaughter. Feed 100 g of tylosin per ton of complete feed for at least three weeks, followed by 40 g tylosin per ton of complete feed until pigs reach market weight. Ractopamine hydrochloride use may increase the number of injured, lame, and/or fatigued pigs during marketing. Behavioral signs such as hyperactivity, anxiety, and aggression have been reported in pigs fed ractopamine hydrochloride. Tylosin phosphate as provided by Nos. 058198 and 016592; ractopamine hydrochloride as provided by Nos. 058198 and 054771 in § 510.600(c) of this chapter | 016592 054771 058198 |
| ( printed page 41564) | ||||
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| (x) 40 to 100 | Ractopamine hydrochloride, 4.5 to 9 | For increased rate of weight gain, improved feed efficiency, increased carcass leanness, the treatment and control of swine dysentery associated with Brachyspira hyodysenteriae, and control of porcine proliferative enteropathies (PPE, ileitis) associated with Lawsonia intracellularis immediately after medicating with tylosin in drinking water in finishing swine weighing at least 150 lb and fed a complete ration containing at least 16% crude protein for the last 45 to 90 lb of gain prior to slaughter. Not for use in swine intended for breeding | Feed as the sole ration to finishing swine weighing at least 150 lb for the last 45 to 90 lb (group average) of weight gain prior to slaughter. Feed 40 to 100 grams of tylosin per ton of complete feed for 2 to 6 weeks immediately after medicating with tylosin in drinking water (250 mg tylosin per gallon) for 3 to 10 days as in § 520.2640(e)(3) of this chapter. Ractopamine hydrochloride use may increase the number of injured, lame, and/or fatigued pigs during marketing. Behavioral signs such as hyperactivity, anxiety, and aggression have been reported in pigs fed ractopamine hydrochloride. Tylosin phosphate as provided by Nos. 058198 and 016592; ractopamine hydrochloride as provided by Nos. 058198 and 054771 in § 510.600(c) of this chapter | |
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| (xiii) 100 | Ractopamine hydrochloride, 4.5 to 9 | For increased rate of weight gain, improved feed efficiency, increased carcass leanness, and control of porcine proliferative enteropathies (PPE, ileitis) associated with Lawsonia intracellularis in finishing swine weighing at least 150 lb and fed a complete ration containing at least 16% crude protein for the last 45 to 90 lb of gain prior to slaughter. Not for use in swine intended for breeding | Feed as the sole ration to finishing swine weighing at least 150 lb for the last 45 to 90 lb (group average) of weight gain prior to slaughter. Feed 100 g of tylosin per ton of complete feed for 21 days. Ractopamine hydrochloride use may increase the number of injured, lame, and/or fatigued pigs during marketing. Behavioral signs such as hyperactivity, anxiety, and aggression have been reported in pigs fed ractopamine hydrochloride. Tylosin phosphate as provided by Nos. 058198 and 016592; ractopamine hydrochloride as provided by Nos. 058198 and 054771 in § 510.600(c) of this chapter | 016592 054771 058198 |
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-13716 Filed 7-6-26; 8:45 am]
BILLING CODE 4164-01-P