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HHS/FDA RIN: 0910-AH47 Publication ID: Spring 2018 
Title: Repeal of Regulation Requiring an Approved New Drug Application for Drugs Sterilized by Irradiation 

This would repeal 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. This would mean that FDA pre-approval would no longer be required for over-the-counter drugs sterilized by irradiation that otherwise could be marketed legally without an approved new drug application or abbreviated new drug application. FDA is taking this action because the irradiation regulation is out of date and unnecessary. The 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). Appropriate and effective sterilization, including irradiation, is adequately addressed by the CGMP requirements.

Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: Undetermined  Unfunded Mandates: No 
EO 13771 Designation: Deregulatory 
CFR Citation: Not Yet Determined     (To search for a specific CFR, visit the Code of Federal Regulations.)
Legal Authority: 21 U.S.C. 321    21 U.S.C. 331    21 U.S.C. 351 to 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   
Legal Deadline:  None
Action Date FR Cite
Direct Final Rule  05/00/2018 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Sudha Shukla
Health Science Project Manager
Department of Health and Human Services
Food and Drug Administration
10903 New Hampshire Avenue, Building 51, Room 5198,
Silver Spring, MD 20993
Phone:301 796-3345