FDA Amends Animal Drug Approval and Withdrawal Rules
Summary
The Food and Drug Administration (FDA) has amended regulations concerning the approval and withdrawal of new animal drug applications. These changes are effective February 6, 2026, and impact the procedures for drug sponsors and the handling of drug approvals.
What changed
The Food and Drug Administration (FDA) has issued a final rule amending regulations under 21 CFR Parts 516, 520, 522, 529, 556, and 558. These amendments pertain to the approval of new animal drug applications, the withdrawal of such approvals, and changes related to the sponsor of an application, including changes in sponsor address. The rule aims to streamline and clarify existing processes within the Center for Veterinary Medicine.
This rule is effective February 6, 2026. Entities involved in the development, approval, or sponsorship of new animal drugs should review the updated regulations to ensure ongoing compliance. While no specific compliance deadline beyond the effective date is mentioned, affected parties must adhere to the revised procedures for any new applications or changes to existing ones from February 6, 2026, onwards. Failure to comply with updated FDA regulations could lead to application deficiencies or other enforcement actions.
What to do next
- Review amendments to 21 CFR Parts 516, 520, 522, 529, 556, and 558.
- Update internal procedures for new animal drug applications and sponsor changes.
- Ensure all new applications and changes to existing ones comply with the revised rules effective February 6, 2026.
Source document (simplified)
Legal Status This site displays a prototype of a “Web 2.0” version of the daily
Federal Register. It is not an official legal edition of the Federal
Register, and does not replace the official print version or the official
electronic version on GPO’s govinfo.gov.
The documents posted on this site are XML renditions of published Federal
Register documents. Each document posted on the site includes a link to the
corresponding official PDF file on govinfo.gov. This prototype edition of the
daily Federal Register on FederalRegister.gov will remain an unofficial
informational resource until the Administrative Committee of the Federal
Register (ACFR) issues a regulation granting it official legal status.
For complete information about, and access to, our official publications
and services, go to About the Federal Register on NARA's archives.gov.
The OFR/GPO partnership is committed to presenting accurate and reliable
regulatory information on FederalRegister.gov with the objective of
establishing the XML-based Federal Register as an ACFR-sanctioned
publication in the future. While every effort has been made to ensure that
the material on FederalRegister.gov is accurately displayed, consistent with
the official SGML-based PDF version on govinfo.gov, those relying on it for
legal research should verify their results against an official edition of
the Federal Register. Until the ACFR grants it official status, the XML
rendition of the daily Federal Register on FederalRegister.gov does not
provide legal notice to the public or judicial notice to the courts.
Legal Status
Rule
New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Application; Change of Sponsor; Change of Sponsor Address
A Rule by the Food and Drug Administration on 02/06/2026
- 1.
1.
Document Details Published Content - Document Details Agencies Department of Health and Human Services Food and Drug Administration Agency/Docket Number Docket No. FDA-2025-N-0002 CFR 21 CFR 516 21 CFR 520 21 CFR 522 21 CFR 529 21 CFR 556 21 CFR 558 Document Citation 91 FR 5299 Document Number 2026-02331 Document Type Rule Pages 5299-5303
(5 pages) Publication Date 02/06/2026 Published Content - Document DetailsPDF Official Content
- View printed version (PDF) Official Content
Document Details Published Content - Document Details Agencies Department of Health and Human Services Food and Drug Administration Agency/Docket Number Docket No. FDA-2025-N-0002 CFR 21 CFR 516 21 CFR 520 21 CFR 522 21 CFR 529 21 CFR 556 21 CFR 558 Document Citation 91 FR 5299 Document Number 2026-02331 Document Type Rule Pages 5299-5303
(5 pages) Publication Date 02/06/2026 Published Content - Document DetailsDocument Dates Published Content - Document Dates Effective Date 2026-02-06 Dates Text This rule is effective February 6, 2026. Published Content - Document Dates
Table of Contents Enhanced Content - Table of Contents This table of contents is a navigational tool, processed from the
headings within the legal text of Federal Register documents.
This repetition of headings to form internal navigation links
has no substantive legal effect.- AGENCY:
- ACTION:
- SUMMARY:
- DATES:
- FOR FURTHER INFORMATION CONTACT:
- SUPPLEMENTARY INFORMATION:
- I. Approval of Applications
- II. Withdrawal of Approval of Applications
- III. Changes of Sponsor
- IV. Legal Authority
- List of Subjects
- 21 CFR Part 516
- 21 CFR Parts 520, 522, and 529
- 21 CFR Part 556
- 21 CFR Part 558
- PART 516—NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES
- PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS
- PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
- PART 529—CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS
- PART 556—TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD
- PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS Enhanced Content - Table of Contents
Related Documents Enhanced Content - Related Documents FederalRegister.gov uses the agency dockets published with the document to display related documents.
| Docket No. FDA-2025-N-0002
(4 Documents) | | | |
| --- | | | |
| Date | | Action | Title |
| | 2026-02-06 | Final rule; technical amendments. | New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Application; Change of Sponsor; Change of Sponsor Address |
| | 2025-09-19 | Final rule; correction. | New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor Address; Correction |
| | 2025-08-22 | Final rule; technical amendments. | New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor Address |
| | 2025-05-09 | Final rule; technical amendments. | New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Application; Change of Sponsor |
Enhanced Content - Related Documents
- Public Comments Enhanced Content - Public Comments Comments are no longer being accepted. See DATES for details.
Enhanced Content - Public Comments
- Regulations.gov Data Enhanced Content - Regulations.gov Data
FederalRegister.gov retrieves relevant information about this document
from Regulations.gov to provide users with additional context. This
information is not part of the official Federal Register document.
NADA/ANADA Notices
Docket ID FDA-2025-N-0002 Supporting Documents No supporting documents available Enhanced Content - Regulations.gov Data
- Sharing Enhanced Content - Sharing Shorter Document URL https://www.federalregister.gov/d/2026-02331 Email Email this document to a friend Enhanced Content - Sharing
- Print Enhanced Content - Print
- Print this document Enhanced Content - Print
- Document Statistics Enhanced Content - Document Statistics Document page views are updated periodically throughout the day and are cumulative counts for this document. Counts are subject to sampling, reprocessing and revision (up or down) throughout the day.
Page views 145
as of
02/26/2026 at 8:15 am EST Enhanced Content - Document Statistics
- Other Formats Enhanced Content - Other Formats This document is also available in the following formats:
JSON Normalized attributes and metadata XML Original full text XML MODS Government Publishing Office metadata More information and documentation can be found in our developer tools pages.
Enhanced Content - Other Formats
- Public Inspection Public Inspection This PDF is FR Doc. 2026-02331 as it appeared on Public Inspection on
02/05/2026 at 8:45 am.
It was viewed
21
times while on Public Inspection.
If you are using public inspection listings for legal research, you
should verify the contents of the documents against a final, official
edition of the Federal Register. Only official editions of the
Federal Register provide legal notice of publication to the public and judicial notice
to the courts under 44 U.S.C. 1503 & 1507. Learn more here.
Public Inspection
Published Document: 2026-02331 (91 FR 5299) This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.
Document Headings Document headings vary by document type but may contain
the following:
- the agency or agencies that issued and signed a document
- the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to
- the agency docket number / agency internal file number
- the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details.
Department of Health and Human Services
Food and Drug Administration
- 21 CFR Parts 516, 520, 522, 529, 556, and 558
- [Docket No. FDA-2025-N-0002]
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Final rule; technical amendments.
SUMMARY:
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 July, August, and September 2025. The animal drug regulations are also being amended to improve their accuracy and readability.
DATES:
This rule is effective February 6, 2026.
FOR FURTHER INFORMATION CONTACT:
Cathie Marshall, Center for Veterinary Medicine, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, cathie.marshall@fda.hhs.gov, 240-402-5693.
SUPPLEMENTARY INFORMATION:
I. Approval of Applications
FDA is amending the animal drug regulations to reflect approval actions for NADAs, ANADAs, and CNADAs during July, August, and September 2025, 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 |
| --- | --- | --- | --- | --- | --- |
| July 8, 2025 | 200-807 | Huvepharma EOOD (016592) | MGA (melengestrol acetate Type A medicated article) and EXPERIOR (lubabegron Type A medicated article) and MONOVET (monensin Type A medicated article) | Original approval as a generic copy of NADA 141-590 | 558.330 |
| July 8, 2025 | 200-808 | Huvepharma EOOD (016592) | MGA (melengestrol acetate Type A medicated article) and EXPERIOR (lubabegron Type A medicated article) and MONOVET (monensin Type A medicated article) and TYLOVET (tylosin phosphate Type A medicated article) | Original approval as a generic copy of NADA 141-591 | 558.625 |
| July 8, 2025 | 200-815 | Felix Pharmaceuticals Pvt. Ltd. (086101) | Cefpodoxime Proxetil Tablets (cefpodoxime proxetil tablets) | Original approval as a generic copy of NADA 141-232 | 520.370 |
| July 10, 2025 | 141-599 | Intervet, Inc. (000061) | BRAVECTO QUANTUM (fluralaner for extended-release injectable suspension) | Original approval | 522.998 |
| July 11, 2025 | 200-816 | Cronus Pharma Specialities India Private Ltd. (069043) | Meloxisol (meloxicam oral suspension 1.5 mg/mL) | Original approval as a generic copy of NADA 141-213 | 520.1367 |
| July 17, 2025 | 141-607 | Intervet, Inc. (000061) | EXZOLT (fluralaner oral solution) | Original approval | 520.999
556.290 |
| July 18, 2025 | 200-759 | ZyVet Animal Health, Inc. (086117) | Furosemide Tablets (furosemide tablets) | Original approval as a generic copy of NADA 034-621 | 520.1010 |
| July 21, 2025 | 200-817 | Felix Pharmaceuticals Pvt. Ltd. (086101) | Meloxicam Oral Suspension (meloxicam oral suspension 1.5mg/mL) | Original approval as a generic copy of NADA 141-213 | 520.1367 |
| August 5, 2025 | 200-818 | Bimeda Animal Health Ltd. (061133) | MOXICLOPRID for dogs (imidacloprid and moxidectin) | Original approval as a generic copy of NADA (141-251) | 524-1146 |
| August 14, 2025 | 200-794 | Cronus Pharma Specialities India Private Ltd. (069043) | MELOXISOL (meloxicam oral suspension 0.5mg/mL) | Original approval as a generic copy of NADA 141-213 | 520.1367 |
| August 28, 2025 | 200-821 | Parnell Technologies Pty. Ltd. (068504) | Isoflurane (isoflurane liquid) | Original approval as a generic copy of NADA 135-773 | 529.1186 |
| August 28, 2025 | 200-819 | Bimeda Animal Health Ltd. (061133) | GAMROZYNE (gamithromycin) | Original approval as a generic copy of NADA 141-328 | 522.1014 |
| September 19, 2025 | 200-824 | Felix Pharmaceuticals Pvt. Ltd. (086101) | Dexmedetomidine (dexmedetomidine hydrochloride sterile injectable solution) | Original approval as a generic copy of NADA 141-267 | 522.558 |
| September 30, 2025 | 141-616 | Zoetis Inc., (054771) | DECTOMAX-CA1 (doramectin injectable solution) | Conditional approval | 516.570 |
| 1 See 21 CFR 510.600(c) for sponsor addresses. | | | | | |
II. Withdrawal of Approval of Applications
Elanco US Inc., 450 Elanco Circle, Indianapolis, IN 46211 (drug labeler code 058198) requested that FDA withdraw approval of the NADA listed in table 2 because the product information has been combined with NADA 010-918. No change to the regulatory text is required. ( printed page 5300)
| Date of withdrawal of approval | Application
No. | Product name | 21 CFR
section |
| --- | --- | --- | --- |
| August 02, 2023 1 | 011-948 | HYGROMIX 2.5 (hygromycin B Type A medicated article) | 558.274 |
| 1 This withdrawal was not previously published. | | | |
III. Changes of Sponsor
The sponsor of the approved applications listed in table 3 has 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 |
| --- | --- | --- | --- | --- |
| 141-136 | BIO-COX (salinomycin sodium Type A medicated article) and BMD (bacitracin methylenedisalicylate Type A medicated article) | Zoetis Inc. (054771) | Phibro Animal Health Corp. (066104) | 558.550 |
| 091-749 | TYLAN 10 SULFA-G and TYLAN 40 SULFA-G (tylosin phosphate Type A medicated article and sulfamethazine Type A medicated article) | Do | Do | 558.630 |
IV. Legal Authority
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.
List of Subjects
21 CFR Part 516
- Administrative practice and procedure
- Animal drugs
- Confidential business information
- Reporting and recordkeeping requirements
21 CFR Parts 520, 522, and 529
- Animal drugs
21 CFR Part 556
- Animal drugs
- Dairy products
- Foods
- Meat and meat products
21 CFR Part 558
- Animal drugs
- Animal feeds 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, 529, 556, and 558 are amended as follows:
PART 516—NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES
- The authority citation for part 516 continues to read as follows:
Authority: 21 U.S.C. 360ccc-1, 360ccc-2, 371.
- Add § 516.570 to read as follows:
§ 516.570 Doramectin. (a) Specifications. Each milliliter of solution contains 10 milligrams of doramectin.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use in cattle —(1) Amount. 200 micrograms per kilogram (10 milligrams per 110 pounds).
(2) Indications for use. For prevention and treatment of infestations caused by larvae of Cochliomyia hominivorax (myiasis), and prevention of reinfestation for 21 days in cattle.
(3) Limitations. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. Administer as a single subcutaneous or intramuscular injection. Do not slaughter cattle for human consumption within 35 days of treatment. Not for use in female dairy cattle 20 months of age or older. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.
PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS
- The authority citation for part 520 continues to read as follows:
Authority: 21 U.S.C. 360b.
§ 520.370 [Amended] 4. In § 520.370, in paragraph (b)(1), remove the text “No. 017033” and in its place add the text “Nos. 017033 and 086101”.
- Revise the heading of § 520.998 to read as follows:
§ 520.998 Fluralaner chewable tablets. * * * * * 6. Add § 520.999 to read as follows:
§ 520.999 Fluralaner oral solution. (a) Specifications. Each milliliter (mL) of solution contains 10 milligrams (mg) fluralaner.
(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.
(c) Conditions of use in laying hens and replacement chickens —(1) Amount. Administer orally to chickens via the drinking water as 2 single doses, spaced 7 days apart, with each dose consumed over a period of 6 to 24 hours. Each dose is 0.5 mg fluralaner/kilogram (kg) (0.227 mg/pound (mg/lb)) body weight, equivalent to 0.05 mL fluralaner oral solution/kg body weight (0.023 mL/lb).
(2) Indications for use. For the treatment and control of northern fowl mites (Ornithonyssus sylviarum).
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Chickens must not be slaughtered for human consumption for 11 days after the last treatment. No egg discard is required when used according to the labeling.
§ 520.1010 [Amended] 7. In § 520.1010, in paragraph (b)(1), remove the text “No. 000010” and in its place add the text “Nos. 000010 and 086117”.
( printed page 5301) 8. In § 520.1367, revise paragraphs (b)(1) and (2) and the last sentence in paragraph (c)(1) to read as follows:
§ 520.1367 Meloxicam. * * * * * (b) * * *
(1) Nos. 000010 and 069043 for use of the products described in paragraph (a) of this section; and
(2) Nos. 013744, 055529, and 086101 for use of the product described in paragraph (a)(2) of this section.
(c) * * *
(1) * * * For all treatments after day 1, administer 0.045 mg/lb (0.1 mg/kg) body weight once daily.
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
- The authority citation for part 522 continues to read as follows:
Authority: 21 U.S.C. 360b.
§ 522.558 [Amended] 10. In § 522.558, in paragraph (b)(1), remove the text “and 086117” and in its place add the text “086101, and 086117”.
- Add § 522.998 to read as follows:
§ 522.998 Fluralaner. (a) Specifications. The product is supplied in two vials, one vial containing 2.51 grams of sterile fluralaner and one vial containing the required 15 milliliters (mL) of sterile vehicle for constitution. Each mL of constituted suspension contains 150 milligrams (mg) fluralaner.
(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.
(c) Conditions of use— (1) Amount. Administer as a single subcutaneous dose every 12 months or every 8 months in the case of potential exposure to Amblyomma americanum ticks. The subcutaneous dose volume is 0.1 mL of the constituted suspension/kilogram (kg) body weight (0.045 mL per pound (mL/lb)). This volume provides a dose of 15 mg fluralaner per kilogram body weight (6.8 mg/lb).
(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), and Rhipicephalus sanguineus (brown dog 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.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 522.1014 [Amended] 12. In § 522.1014, in paragraph (b), remove the text “No. 000010” and in its place add the text “Nos. 000010 and 061133”.
- In § 522.2680 revise paragraphs (d)(1)(ii)(A) and (B) as follows:
§ 522.2680 Zeranol. * * * * * (d) * * *
(1) * * *
(ii) * * *
(A) For increased rate of weight gain and improved feed efficiency in growing beef steers and heifers fed in confinement for slaughter.
(B) For increased rate of weight gain in beef calves 2 months of age or older, in growing beef steers and heifers on pasture (stocker, feeder, and slaughter), and in growing beef steers and heifers in a dry lot.
PART 529—CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS
- The authority citation for part 529 continues to read as follows:
Authority: 21 U.S.C. 360b.
§ 529.1186 [Amended] 15. In § 529.1186, in paragraph (b), remove the text “See Nos. 017033, 054771, and 065085” and in its place add the text “See Nos. 017033, 054771, 065085, and 068504”.
PART 556—TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD
- The authority citation for part 556 continues to read as follows:
Authority: 21 U.S.C. 342, 360b, 371.
- Add § 556.290 to read as follows:
§ 556.290 Fluralaner. (a) Acceptable daily intake (ADI). The ADI for total residue of fluralaner is 10 µg/kg of body weight per day.
(b) Tolerances. The tolerances for parent fluralaner (marker residue) are:
(1) Chickens. (i) Liver (target tissue): 320 ppb.
(ii) Muscle: 110 ppb.
(iii) Eggs: 2500 ppb.
(2) [Reserved]
(c) Related conditions of use. See § 520.999 of this chapter.
PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
- The authority citation for part 558 continues to read as follows:
Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.
- In § 558.330, revise paragraph (e)(1)(v) to read as follows:
§ 558.330 Lubabegron. * * * * * (e) * * *
(1) * * *
( printed page 5302)
| Lubabegron
(as lubabegron fumarate)
in grams/ton | Combination in grams/ton | Indications for use | Limitations | Sponsors |
| --- | --- | --- | --- | --- |
| | | | | |
| * | | | | |
| (v) 1.25 to 4.54 | Monensin, 10 to 40 and melengestrol acetate, 0.25 to 2 | Growing beef heifers fed in confinement for slaughter: For increased rate of weight gain, improved feed efficiency, suppression of estrus (heat), for reduction of ammonia gas emissions per pound of live weight and hot carcass weight, and for the prevention and control of coccidiosis caused by Eimeria bovis and Eimeria zuernii during the last 14 to 91 days on feed | Melengestrol acetate Type C top-dress medicated feed (0.5 to 2 lb(s) per head per day) must be top dressed onto or mixed at feeding with a Type C medicated feed containing 1.25 to 4.54 g/ton lubabegron and 10 to 40 g/ton monensin, to provide 0.25 to 0.5 mg melengestrol acetate and 13 to 90 mg lubabegron per head per day, and 0.14 to 0.42 mg monensin per pound of body weight per day, depending upon severity of challenge, up to a maximum of 480 mg monensin per head per day. Feed as the sole ration during the last 14 to 91 days on feed. See special labeling considerations in paragraph (d) of this section, and in §§ 558.342(d) and 558.355(d). Lubabegron fumarate as provided by No. 058198; monensin as provided by No. 058198 or 016592; melengestrol acetate as provided by No. 054771 in § 510.600(c) of this chapter | 058198
016592 |
* * * * * 20. In § 558.550, revise paragraphs (e)(1)(ii) through (iv) to read as follows:
§ 558.550 Salinomycin. * * * * * (e) * * *
(1) * * *
| Salinomycin
sodium activity
in grams/ton | Combination in grams/ton | Indications for use | Limitations | Sponsor |
| --- | --- | --- | --- | --- |
| | | | | |
| * | | | | |
| (ii) 40 to 60 | Bacitracin (as feed grade bacitracin methylenedisalicylate) 4 to 50 | Broiler chickens and replacement chickens. Not for use in laying hens: 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 and improved feed efficiency | Feed continuously as sole ration. Discontinue use prior to sexual maturity. The dosage of salinomycin sodium should be adjusted to meet the severity of the coccidial challenge, which varies with environmental and management conditions. May be fatal if fed to adult turkeys or horses. Salinomycin as provided by No. 016592; bacitracin methylenedisalicylate as provided by No. 066104 in § 510.600(c) of this chapter | 016592
066104 |
| (iii) 40 to 60 | Bacitracin (as feed grade bacitracin methylenedisalicylate) 50 | Broiler chickens and replacement chickens. Not for use in laying hens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, and as an aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin methylenedisalicylate | Feed continuously as sole ration. Discontinue use prior to sexual maturity. The dosage of salinomycin sodium should be adjusted to meet the severity of the coccidial challenge, which varies with environmental and management conditions. May be fatal if fed to adult turkeys or horses. Salinomycin as provided by No. 016592; bacitracin methylenedisalicylate as provided by No. 066104 in § 510.600(c) of this chapter | 066104 |
| (iv) 40 to 60 | Bacitracin (as feed grade bacitracin methylenedisalicylate) 100 to 200 | Broiler chickens and replacement chickens. Not for use in laying hens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, and as an aid in the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin methylenedisalicylate | Feed continuously as the sole ration. Discontinue use prior to sexual maturity. The dosage of salinomycin sodium should be adjusted to meet the severity of the coccidial challenge, which varies with environmental and management conditions. To control a necrotic enteritis outbreak, start medication at the first clinical signs of disease. The bacitracin methylenedisalicylate dosage range permitted provides for different levels based on severity of the infection. Consult a poultry diagnostic laboratory or pathologist to determine the diagnosis and advice regarding the optimal level of bacitracin methylenedisalicylate. Administer continuously for 5-7 days or as long as clinical signs persist, and then reduce bacitracin methylenedisalicylate dosage to prevention level (50 g/ton). May be fatal if fed to adult turkeys or to horses. Salinomycin as provided by No. 016592; bacitracin methylenedisalicylate as provided by No. 066104 in § 510.600(c) in this chapter | 066104 |
| | | | | |
| * | | | | |
* * * * * ( printed page 5303) 21. In § 558.625, revise paragraph (e)(2)(ix) to read as follows:
§ 558.625 Tylosin. * * * * * (e) * * *
(2) * * *
| Tylosin in grams/ton | Combination in grams/ton | Indications for use | Limitations | Sponsors |
| --- | --- | --- | --- | --- |
| | | | | |
| * | | | | |
| (ix) 8 to 10 | Monensin, 10 to 40 plus lubabegron (as lubabegron fumarate), 1.25 to 4.54, plus melengestrol acetate, 0.25 to 2.0 | Growing beef heifers fed in confinement for slaughter: For increased rate of weight gain, improved feed efficiency, suppression of estrus (heat), for reduction of ammonia gas emissions per pound of live weight and hot carcass weight, for the prevention and control of coccidiosis caused by Eimeria bovis and Eimeria zuernii, and for reduction of incidence of liver abscesses associated with Fusobacterium necrophorum and Arcanobacterium pyogenes during the last 14 to 91 days on feed | Feed as the sole ration during the last 14 to 91 days on feed. Melengestrol acetate Type C top-dress medicated feed (0.5 to 2.0 lb per head per day) must be top dressed onto or mixed at feeding with a Type C medicated feed containing 8 to 10 g/ton tylosin, 1.25 to 4.54 g/ton lubabegron, and 10 to 40 g/ton monensin, to provide 0.25 to 0.5 mg melengestrol acetate, 60 to 90 mg tylosin per head per day, 13 to 90 mg lubabegron per head per day, and 0.14 to 0.42 mg monensin per pound of body weight per day, depending on severity of challenge, up to 480 mg monensin per head per day. See special labeling considerations in §§ 558.330(d), 558.342(d), and 558.355(d). Tylosin and monensin as provided by No. 058198 or 016592; lubabegron fumarate as provided by No. 058198; melengestrol acetate as provided in No. 054771 in § 510.600(c) of this chapter | 058198
016592 |
| | | | | |
| * | | | | |
§ 558.630 [Amended] 22. In § 558.630:
a. In paragraph (b)(2), remove the text “054771” and in its place add the text “066104”; and
b. In the table in paragraph (e)(2), in the “Sponsor” column, remove the text “054771” and in its place add the text “066104”.
Lowell M. Zeta,
Acting Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-02331 Filed 2-5-26; 8:45 am]
BILLING CODE 4164-01-P
Published Document: 2026-02331 (91 FR 5299)
Related changes
Source
Classification
Who this affects
Taxonomy
Browse Categories
Get Legislation alerts
Weekly digest. AI-summarized, no noise.
Free. Unsubscribe anytime.
Get alerts for this source
We'll email you when FDA Rules & Proposed Rules publishes new changes.