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HHS/FDA RIN: 0910-AH58 Publication ID: Fall 2020 
Title: Current Good Manufacturing Practice for Positron Emission Tomography Drugs 
Abstract:

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good manufacturing practice regulations for positron emission tomography (PET) drugs to delete a reference to an outdated United States Pharmacopeia (USP) chapter and to streamline these requirements to make them applicable to the production, quality assurance, holding and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 investigational and research PET drugs. This proposed rule removes outdated references, thus bringing the regulations in line with current industry practices.

 
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 
EO 13771 Designation: Fully or Partially Exempt 
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
Timetable:
Action Date FR Cite
NPRM  07/00/2021 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
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
Email: sungjoon.chi@fda.hhs.gov