Regulatory Counsel

0910-AH58 201804 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Current Good Manufacturing Practice for Positron Emission Tomography Drugs

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good manufacturing processes regulations for positron emission tomography (PET) drugs to delete a reference to an outdated United States Pharmacopeia (USP) chapter and to streamline these requirements to make them applicable to the production, quality assurance, holding and distribution of all PET drugs This proposed rule removes outdated references, thus bringing the regulations in line with current industry practices.

]]> Substantive, Nonsignificant Previously Published in The Unified Agenda Proposed Rule Stage Undetermined No Regulatory 21 CFR 212 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 ... No NPRM 12/00/2018 No None No No No No Meadow Platt Regulatory Counsel 0910 Food and Drug Administration FDA 301 796-1830 meadow.platt@fda.hhs.gov 10903 New Hampshire Avenue, Building 51, Room 6228, Silver Spring MD 20993