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HHS/FDA RIN: 0910-AH58 Publication ID: Spring 2018 
Title: Current Good Manufacturing Practice for Positron Emission Tomography Drugs 
Abstract:

The Food and Drug Administration proposes to amend its current good manufacturing processes regulations for positron emission tomography (PET) drugs to delete a reference to an outdated United States Pharmacopeia (USP) chapter and to streamline these requirements to make them applicable to the production, quality assurance, holding and distribution of all PET drugs This proposed rule removes outdated references, thus bringing the regulations in line with current industry practices.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: Undetermined  Unfunded Mandates: No 
EO 13771 Designation: Regulatory 
CFR Citation: 21 CFR 212   
Legal Authority: 21 U.S.C. 321    21 U.S.C. 351    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  12/00/2018 
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:
Meadow Platt
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
10903 New Hampshire Avenue, Building 51, Room 6228,
Silver Spring, MD 20993
Phone:301 796-1830
Email: meadow.platt@fda.hhs.gov