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HHS/FDA RIN: 0910-AH58 Publication ID: Fall 2023 
Title: Current Good Manufacturing Practice for Positron Emission Tomography Drugs 

The Food and Drug Administration proposes to amend its current good manufacturing practice regulations for positron emission tomography (PET) drugs to delete a reference to an outdated United States Pharmacopeia (USP) chapter and to streamline these requirements to make them applicable to the production, quality assurance, holding and distribution of all PET drugs, including investigational and research PET drugs.

Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 212   
Legal Authority: 21 U.S.C. 321    21 U.S.C. 351    21 U.S.C. 352    21 U.S.C. 355    21 U.S.C. 371    21 U.S.C. 374    sec. 121, Pub. L. 105–115, 111 Stat. 2296    ...   
Legal Deadline:  None
Action Date FR Cite
NPRM  12/00/2023 
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:
Sungjoon Chi
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
10903 New Hampshire Avenue, Building 51, Room 6216,
Silver Spring, MD 20993
Phone:240 402-9674