Regulatory Counsel

0910-AJ19 202510 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Drugs for Processing, Repacking, or Manufacturing; Exemptions for Emergency Use Authorization

In order to reduce barriers to the production of drugs intended to treat or prevent New World Screwworm, the Food and Drug Administration (FDA) is issuing a direct final rule amending its regulations to exempt drugs in bulk package (primarily active pharmaceutical ingredients for use in drug manufacturing) from the adequate directions for use requirement when they are intended to produce drugs covered by an Emergency Use Authorization (EUA). FDA’s regulations currently exempt bulk drugs intended for use in manufacturing for all other types of drugs that can be legally marketed (e.g., approved human and animal drugs, conditionally approved animal drugs, and indexed listed animal drugs), and this amendment extends the exemption to cover EUAs.

]]> Other Significant First Time Published in The Unified Agenda Proposed Rule Stage No No Other 21 CFR 201.122 21 CFR 558 21 U.S.C. 352 21 U.S.C. 360bbb-3 21 U.S.C. 360bbb-3a and 3b 21 U.S.C. 371 No NPRM 12/00/2026 Direct Final Rule 12/00/2026 No Undetermined Undetermined No No Brett Havranek Regulatory Counsel 0910 Food and Drug Administration FDA 240 402-7002 brett.havranek@fda.hhs.gov Center for Veterinary Medicine, CPK1, 5001 Campus Drive, College Park MD 20740