Regulatory Counsel

0910-AH47 201704 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Withdrawal of Regulation Requiring an Approved New Drug Applications for Drugs Sterilized by Irradiation

This would remove a requirement that any drug sterilized by irradiation is considered a new drug and subject to the approval requirements of a new drug and not to be produced under an OTC monograph. FDA is proposing to take this action now because the science, data and technology of controlled nuclear radiation is better-understood. Other FDA regulations require drugs marketed pursuant to an OTC drug monograph be manufactured in compliance with current good manufacturing practices (CGMPs).

]]> Substantive, Nonsignificant First Time Published in The Unified Agenda Proposed Rule Stage Undetermined No Not Yet Determined 21 U.S.C. 321 21 U.S.C. 331 21 U.S.C. 351 21 U.S.C. 352 21 U.S.C. 353 21 U.S.C. 355 21 U.S.C. 360 21 U.S.C. 371 21 U.S.C. 374 42 U.S.C. 264 No NPRM 03/00/2018 No No None No No No No Kate Greenwood Regulatory Counsel 0910 Food and Drug Administration FDA 204 402-1748 kate.greenwood@fda.hhs.gov 10903 New Hampshire Avenue, Building 51, Room 6286, Silver Spring MD 20993