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HHS/FDA

RIN: 0910-AJ32

Publication ID: 2026

Title: ●Amendments to 21 CFR Parts 201, 314, and 601 to Promote Supply Chain Transparency in Human Drug Labeling; Identifying API and FDF Manufacturing Sites
Abstract: 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.
Agency: Department of Health and Human Services(HHS)	Priority: Substantive, Nonsignificant
RIN Status: First time published in the Unified Agenda	Agenda Stage of Rulemaking: Proposed Rule Stage
Major: Undetermined	Unfunded Mandates: Undetermined
EO 14192 Designation: Regulatory
CFR Citation: 21 CFR 201 21 CFR 314 21 CFR 601t (To search for a specific CFR, visit the Code of Federal Regulations.)
Legal Authority: 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

Legal Deadline: None

Timetable:

Action	Date	FR Cite
NPRM	07/00/2026

Regulatory Flexibility Analysis Required: Undetermined	Government Levels Affected: Undetermined
Federalism: Undetermined
Included in the Regulatory Plan: No
RIN Data Printed in the FR: No
Agency Contact: Lowell Zeta Deputy Commissioner of Strategic Initiatives Department of Health and Human Services Food and Drug Administration 10903 New Hampshire Avenue, WO Building 1, Room 2314, Silver Spring, MD 20993 Phone:301 332-8931 Email: lowell.zeta@fda.hhs.gov