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HHS/FDA RIN: 0910-AI31 Publication ID: Spring 2021 
Title: Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A and 503B of the Federal Food Drug and Cosmetic Act  

Sections 503A and 503B of the FD&C Act require compounded drug products to satisfy several conditions to qualify for certain statutory exemptions listed under each section. Both sections 503A and 503B contain conditions that concern whether a compounded drug product is one that the Agency has identified as presenting demonstrable difficulties for compounding. FDA is proposing to establish the criteria by which drug products and categories of drug products will be evaluated for inclusion on the list of drug products and categories of drug products that present demonstrable difficulties for compounding under section 503A and the Difficult to Compound List for 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. 353a    21 U.S.C. 353b    21 U.S.C. 371(a)   
Legal Deadline:  None
Action Date FR Cite
NPRM  12/00/2021 
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:
Alexandria Fujisaki
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
10903 New Hampshire Avenue, Building 51, Room 5169, Center for Drug Evaluation and Research,
Silver Spring, MD 20993
Phone:240 402-4078