FDA Tinkers With Animal Feed Record Rules
Published Date: 6/18/2026
Notice
Summary
The FDA is updating how companies that make special animal medicines and feeds keep their records and follow quality rules. This affects manufacturers of Type A medicated articles and medicated feeds, helping ensure safe and reliable products for animals. Comments on these changes are open until July 20, 2026, and the updates aim to keep things clear without adding extra costs.
Analyzed Economic Effects
6 provisions identified: 2 benefits, 4 costs, 0 mixed.
Recordkeeping Burden: Registered Licensed Feed Mills
Registered licensed commercial feed mills (768 respondents) have estimated total annual responses of 2,241,792 and an average burden of 0.305 hours (18.3 minutes) per response, for a total of 683,747 hours annually under 21 CFR part 225 recordkeeping requirements.
Recordkeeping Burden: Type A Medicated Article Manufacturers
Manufacturers of Type A medicated articles (65 respondents) have an estimated 1,370 disclosures per respondent for a total of 89,050 annual disclosures and an average burden of about 1 hour per disclosure, totaling 89,050 hours annually under 21 CFR part 226.
Net Reduction in Estimated Recordkeeping Burden
FDA updated its inventory and reduced the number of medicated feed mill recordkeepers by 2,722, which corresponds to a reduction of 13,731,017 records and a decrease of 913,153 recordkeeping hours in its estimates.
Recordkeeping Burden: Non-licensed Commercial Feed Mills
Nonregistered, non-licensed commercial feed mills (1,658 recordkeepers) have an estimated 150,878 total annual records, an average burden of 1.44 hours per record, and a total of 217,265 recordkeeping hours annually under 21 CFR part 225.
Recordkeeping Burden: Non-licensed Mixer/Feeders
Nonregistered, non-licensed mixer/feeders (3,400 respondents) are estimated to have 309,400 total annual disclosures with an average burden of 1.36 hours per disclosure, totaling 420,784 hours annually for recordkeeping under 21 CFR part 225.
OMB Collections Consolidated into 0910-0152
The FDA is consolidating reporting for current good manufacturing practices (CGMPs) for Type A medicated articles and medicated feeds into one OMB control number (0910-0152) and will discontinue OMB control number 0910-0154. The agency requests public comments by July 20, 2026.
Personalized for You
How does this regulation affect your finances?
Personalize government policy and PRIA will tell you what this federal register document means for your household, plus every other regulation we track. PRIA reads each provision against your financial profile to show you exactly what matters to your wallet.
Key Dates
Department and Agencies
Related Federal Register Documents
2026-14073, Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments
The FDA wants to make it easier for drug makers who work in several locations to register as one company instead of many. They’re also updating rules for foreign drug companies to match new laws about handling health threats. If you’re in drug manufacturing, get ready to comment by September 11, 2026, and keep an eye on possible paperwork changes that could affect your business.
2026-13047, Establishment Registration and Product Listing for Tobacco Products
The FDA wants to make sure all tobacco product makers, both in the U.S. and abroad, register their businesses and list their products. This new rule closes a big gap by including foreign companies, helping the FDA keep better track of tobacco products for public health. Comments on this proposal are open until September 14, 2026, so affected businesses should get ready to update their info and possibly face new costs.
2026-15636, Ricardo Andres Acuna: Final Debarment Order
The Food and Drug Administration (FDA or the Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Ricardo Andres Acuna from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Ricardo Andres Acuna was convicted of a felony under Federal law for conduct relating to the development or approval, including the process for development or approval, of any drug product. Mr. Acuna was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. As of May 6, 2026 (30 days after receipt of the notice), Mr. Acuna has not responded. Mr. Acuna's failure to respond and request a hearing constitutes a waiver of Mr. Acuna's right to a hearing concerning this matter.
2026-15613, Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry titled "Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs." This guidance provides recommendations for the design and conduct of studies evaluating the adhesion performance of a transdermal or topical delivery system (collectively referred to as TDS). Depending on the objectives of a generic TDS product development program, applicants may choose to evaluate TDS adhesion in studies performed to evaluate TDS adhesion only, or in studies performed with a combined purpose (e.g., for the simultaneous evaluation of adhesion and bioequivalence (BE) with pharmacokinetic (PK) endpoints). The recommendations in this guidance relate to studies submitted in support of an abbreviated new drug application (ANDA). The guidance replaces the draft guidance (Revision 2) "Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs," issued on April 13, 2023.
2026-15635, Angela Anatilde Baquero: Final Debarment Order
The Food and Drug Administration (FDA or the Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Angela Anatilde Baquero from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Angela Anatilde Baquero was convicted of a felony under Federal law for conduct relating to the development or approval, including the process for development or approval, of any drug product. Mrs. Baquero was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. As of May 6, 2026 (30 days after receipt of the notice), Mrs. Baquero has not responded. Mrs. Baquero's failure to respond and request a hearing constitutes a waiver of Mrs. Baquero's right to a hearing concerning this matter.
2026-15612, Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs; Revised Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry titled "Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs." This revised draft guidance provides recommendations for the design and conduct of studies to evaluate the in vivo skin irritation (and sensitization, if applicable) potential of a proposed transdermal or topical delivery system (collectively referred to as TDS). The recommendations in this revised draft guidance relate to studies submitted in support of an abbreviated new drug application (ANDA). The revised draft guidance is intended to clarify FDA's recommendations and expectations related to in vivo skin irritation and in vivo combined skin irritation and sensitization studies. This draft guidance replaces the draft guidance "Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs" (April 2023).
Previous / Next Documents
Previous: 2026-12236, SpecGx LLC; Withdrawal of Approval of Abbreviated New Drug Application for Methylphenidate Hydrochloride Extended-Release Tablets, 27 Milligrams, 36 Milligrams, and 54 Milligrams
SpecGx LLC has asked the FDA to withdraw its approval for three strengths (27 mg, 36 mg, and 54 mg) of its methylphenidate extended-release tablets, effective June 18, 2026. This means these specific versions of the medicine will no longer be allowed on the market. Patients and pharmacies using these doses should look for alternatives, but no extra costs or penalties are mentioned.
Next: 2026-12238, Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements
The FDA is asking for public feedback by July 20, 2026, on their rules that keep dietary supplements safe and made right. These rules affect companies that make, package, label, or store supplements, helping ensure products are high quality without adding extra costs. This review keeps the safety standards up-to-date and clear for everyone involved.