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HHS/FDA RIN: 0910-AI31 Publication ID: Spring 2023 
Title: Drug Products or Categories of Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act 

Compounded drug products must satisfy the conditions of section 503A or section 503B of the FD&C Act to qualify for certain statutory exemptions listed under each section. Both sections 503A and 503B provide that a compounded drug is not eligible for those exemptions if it is identified by FDA as presenting demonstrable difficulties for compounding. FDA is proposing to establish the criteria by which it would evaluate drug products and categories of drug products for inclusion on the list of drug products and categories of drug products that present demonstrable difficulties for compounding under section 503A and/or under section 503B. Based on the results of its evaluation of nominated categories of drug products to date, as well as consultation with the Pharmacy Compounding Advisory Committee (PCAC), FDA is also proposing to include certain categories of drug products on these lists.

Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 216.25   
Legal Authority: 21 U.S.C. 351    21 U.S.C. 352    21 U.S.C. 353a    21 U.S.C. 353b    21 U.S.C. 355    21 U.S.C. 371   
Legal Deadline:  None
Action Date FR Cite
NPRM  10/00/2023 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Ian Reynolds
Consumer Safety Officer
Department of Health and Human Services
Food and Drug Administration
10903 New Hampshire Avenue, Center for Drug Evaluation and Research, Building 51, Room 5104,
Silver Spring, MD 20993
Phone:240 402-7079