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HHS/FDA RIN: 0910-AI70 Publication ID: Fall 2021 
Title: ●Additional Amendments to the Final Rule Regarding the List of Bulk Substances that can be used to Compound Drug Products in Accordance With Section 503A of the Federal Food, Drug and Cosmetic Act(Section 610 Review) 
Abstract:

FDA has issued a regulation creating a list of bulk drug substances (active pharmaceutical ingredients) that can be used to compound drug products in accordance with section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act), although they are neither the subject of an applicable United States Pharmacopeia (USP) or National Formulary (NF) monograph nor components of FDA-approved drug products (the 503A Bulks List). The proposed rule will identify certain bulk drug substances that FDA has considered and is proposing to place on the 503A Bulks List and certain bulk drug substances that FDA has considered and is proposing not to include on the 503A Bulks List.

 
Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
RFA Section 610 Review: Section 610 Review 
CFR Citation: 21 CFR 216.23   
Legal Authority: 21 U.S.C. 353a    21 U.S.C. 351    21 U.S.C. 371(a)    21 U.S.C. 352    21 U.S.C. 355    ...   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  11/00/2021 
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: Yes 
Agency Contact:
Alexandria Fujsaki
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