New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Application; Change of Sponsor; Change of Sponsor Address
Published Date: 2/6/2026
Rule
Summary
The FDA updated rules for new animal drugs approved between July and September 2025, including approvals, withdrawals, and sponsor changes. These updates affect drug makers, vets, and farmers by keeping drug info accurate and easy to find. The changes take effect February 6, 2026, helping everyone stay on the same page without extra costs.
Analyzed Economic Effects
3 provisions identified: 2 benefits, 1 costs, 0 mixed.
New drug use and withdrawal limits
The rule adds specific conditions of use for certain drugs. For doramectin in cattle, you may not slaughter treated cattle for human consumption within 35 days of treatment, it is not for use in female dairy cattle 20 months of age or older, no withdrawal period is established for preruminating calves, and do not use in calves to be processed for veal. For fluralaner oral solution in chickens, treated chickens must not be slaughtered for human consumption for 11 days after the last treatment, and no egg discard is required when used according to labeling.
Animal drug rules updated (July–Sept 2025)
The FDA amended animal drug regulations to reflect approvals, withdrawals, and sponsor changes for new animal drug applications during July, August, and September 2025. The rule is effective February 6, 2026. FDA says these updates affect drug makers, veterinarians, and farmers by keeping drug information accurate and easy to find and that the changes take effect without extra costs.
Fluralaner food-residue limits set
FDA established an acceptable daily intake (ADI) for total fluralaner residue of 10 micrograms per kilogram of body weight per day and tolerances for parent fluralaner in chickens: liver 320 ppb, muscle 110 ppb, and eggs 2500 ppb. These tolerances are tied to the fluralaner chicken use described in Sec. 520.999.
Your PRIA Score
Personalized for You
How does this regulation affect your finances?
Sign up for a PRIA Policy Scan to see your personalized alignment score for this federal register document and every other regulation we track. We analyze your financial profile against policy provisions to show you exactly what matters to your wallet.
Key Dates
Department and Agencies
Related Federal Register Documents
2026-09767 — Oscar Bobo: Final Debarment Order
Oscar Bobo is officially banned for 5 years from importing any drugs into the U.S. because he repeatedly brought in mislabeled medicines that don’t follow FDA rules. He ignored the chance to defend himself, so the ban started on May 15, 2026. This means no drug imports from him for a while, but he can apply to end the ban anytime if he meets FDA’s conditions.
2026-09543 — Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarketing Adverse Experience Reporting
The FDA wants your thoughts on how drug companies report problems after their products hit the market. This affects drug makers and healthcare folks who keep track of side effects. They’re asking for comments by July 13, 2026, to help improve the process without adding extra costs or paperwork.
2026-09544 — Modified Risk Tobacco Product Application: Renewal Applications for VLN® King and VLN® Menthol King, Cigarette Products Submitted by 22nd Century Group Inc.
The FDA is inviting the public to comment on the renewal of special approval for two cigarette products by 22nd Century Group Inc. These products claim to lower health risks compared to regular cigarettes. If approved, the renewal keeps these products on the market with their modified risk status, affecting smokers and the tobacco industry starting May 13, 2026.
2026-09448 — Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; The Real Cost Campaign Outcomes Evaluation Study: Cohort 3
The FDA is asking for approval to collect info for the third group in its Real Cost Campaign, which teaches kids about the dangers of tobacco. This helps the FDA improve its anti-smoking messages and protect young people’s health. Comments on this info collection are open until June 12, 2026, with no new costs for participants.
2026-09368 — Enforcement Priorities for Certain New Tobacco Products Marketed Without Premarket Authorization; Guidance for Industry; Availability
The FDA is setting clear rules for certain new tobacco products like e-cigarettes and nicotine pouches that don’t have official approval yet. Companies selling these products without permission might face enforcement actions starting now, so they need to get authorized or risk penalties. This helps protect public health and keeps the market fair and safe.
2026-09335 — Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Identify Microorganism Nucleic Acids and Resistance Markers From Patients With Suspected Orthopedic Infection
Hey there! This update is all about a new medical device that helps doctors quickly find germs and their resistance traits in people who might have bone infections. It affects hospitals and labs by officially classifying this device, making it easier and faster to diagnose tough infections. The change kicks in soon, helping patients get the right treatment without delay—and it could save money by avoiding wrong meds!
Previous / Next Documents
Previous: 2026-02326 — Appellate Procedures for the Board of Immigration Appeals
Starting March 9, 2026, the Board of Immigration Appeals will change how it reviews cases from Immigration Judges. Now, the Board can choose which cases to review fully, set clear deadlines for briefs, and speed up decisions to cut down the backlog. These updates affect immigrants appealing decisions and aim to make the process faster without extra costs.
Next: 2026-02335 — Safety Zone; Chicago Sanitary and Ship Canal, Chicago, IL
From February 7 to 22, 2026, the Coast Guard will block off a 2-mile stretch of the Chicago Sanitary and Ship Canal for electric fish barrier testing. Boats can’t enter or anchor there during certain morning and afternoon hours unless they get special permission. This keeps everyone safe while the testing happens, so plan your trips accordingly!