0910-AJ32 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 Amendments to 21 CFR Parts 201, 314, and 601 to Promote Supply Chain Transparency in Human Drug Labeling; Identifying API and FDF Manufacturing Sites

The Food and Drug Administration (FDA) is proposing to require brand and generic pharmaceutical manufacturers to improve transparency of pharmaceutical manufacturing information. The amendments are intended to enhance FDA oversight of the drug supply chain.

]]> Substantive, Nonsignificant First Time Published in The Unified Agenda Proposed Rule Stage Undetermined Undetermined Regulatory 21 CFR 201 21 CFR 314 21 CFR 601t 21 U.S.C. 321 21 U.S.C. 331 21 U.S.C. 343 21 U.S.C. 351 21 U.S.C. 352 21 U.S.C. 353 21 U.S.C. 355 21 U.S.C. 355a 21 U.S.C. 355f 21 U.S.C. 356 21 U.S.C. 356a 21 U.S.C. 356b 21 U.S.C. 356c 21 U.S.C. 356e 21 U.S.C. 358 21 U.S.C. 360 21 U.S.C. 360b 21 U.S.C. 360cc 21 U.S.C. 360ccc 21 U.S.C. 360ccc-1 21 U.S.C. 360ee 21 U.S.C. 360gg-360ss 21 U.S.C. 371 21 U.S.C. 374 21 U.S.C. 379e 21 U.S.C. 379k-1 42 U.S.C. 216 42 U.S.C. 241 42 U.S.C. 262 42 U.S.C. 264 No NPRM 07/00/2026 Undetermined Undetermined Undetermined No No Lowell Zeta Deputy Commissioner of Strategic Initiatives 0910 Food and Drug Administration FDA 301 332-8931 lowell.zeta@fda.hhs.gov 10903 New Hampshire Avenue, WO Building 1, Room 2314, Silver Spring MD 20993