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HHS/FDA RIN: 0910-AI31 Publication ID: Spring 2019 
Title: ●Drug Products That Present Demonstrable Difficulties for Compounding Under Section 503A and 503B of the Federal Food Drug and Cosmetic Act  

Both sections 503A and 503B require compounded drug products to satisfy several conditions to qualify for the statutory exemptions from the FD&C Act. One of those conditions is that the compounded drug product is not a drug product that presents 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 Difficult to Compound List. Based on the results of its evaluation of nominated difficult to compound 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 the list.

Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Prerule Stage 
Major: No  Unfunded Mandates: No 
EO 13771 Designation: Regulatory 
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
ANPRM  12/00/2019 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Alexandria Fukisaki
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