0910-AH56 202404 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Certain Requirements Regarding Prescription Drug Marketing (203 Amendment)

The final rule amends Food and Drug Administration (FDA) regulations at 21 CFR 203 to remove provisions no longer in effect and incorporate conforming changes following enactment of the Drug Supply Chain Security Act (DSCSA). The final rule amends the regulations to clarify provisions and avoid causing confusion with the new standards for wholesale distribution established by DSCSA.

]]> Substantive, Nonsignificant Previously Published in The Unified Agenda Long-Term Actions No No 21 CFR 203 Section 503 and related provisions of the FD&C Act, as amended by Pub. L. 113-54 No NPRM 02/04/2022 87 FR 6443 NPRM Comment Period End 04/05/2022 Final Rule 05/00/2026 YES Businesses State Undetermined No Yes No Aaron Weisbuch Regulatory Counsel 0910 Food and Drug Administration FDA 301 796-9362 aaron.weisbuch@fda.hhs.gov Center for Drug Evaluation and Research, Building 51, Room 4261, 10903 New Hampshire Avenue, Silver Spring MD 20993