Regulatory Counsel

0910-AI71 202304 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Distribution of Compounded Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act

The Food and Drug Administration is proposing rulemaking regarding statutory requirements under section 503A of the Federal Food, Drug, and Cosmetic Act for certain distributions of compounded human drug products. The proposed rule, if finalized, will include provisions regarding a standard memorandum of understanding (MOU) that describes the responsibilities of a State Board of Pharmacy or other appropriate State agency that chooses to sign the standard MOU in investigating complaints related to drug products compounded in such State and distributed outside such State and in addressing the interstate distribution of inordinate amounts of compounded human drug products. It will also, if finalized, include provisions regarding the statutory 5 percent limit on distribution of compounded human drug products out of the State in which they are compounded in States that do not sign the standard MOU. The rule, will also, if finalized, address communication with State boards of pharmacy.

]]> Other Significant Previously Published in The Unified Agenda Proposed Rule Stage No No Section 610 Review 21 CFR 216 21 U.S.C. 351 21 U.S.C. 352 21 U.S.C. 353a 21 U.S.C. 353a-1 21 U.S.C. 355 21 U.S.C. 371 No NPRM 10/00/2023 Yes Businesses State No No Yes No Dominic Markwordt Regulatory Counsel 0910 Food and Drug Administration FDA 301 796-9349 dominic.markwordt@fda.hhs.gov Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Building 51, Room 5104, Silver Spring MD 20993