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HHS/FDA RIN: 0910-AH62 Publication ID: Spring 2022 
Title: Nonprescription Drug Product With an Additional Condition for Nonprescription Use 
Abstract:

The proposed rule is intended to increase access to nonprescription drug products. The proposed rule would establish requirements for a drug product that could be marketed as a nonprescription drug product with an additional condition that an applicant must implement to ensure appropriate self-selection, appropriate actual use, or both by consumers.

 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 201.67    21 CFR 314.56    21 CFR 314.81    21 CFR 314.125    21 CFR 314.127   
Legal Authority: 21 U.S.C. 321    21 U.S.C. 352    21 U.S.C. 355    21 U.S.C. 371    42 U.S.C. 262    42 U.S.C. 264    ...   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  06/00/2022 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: Yes 
RIN Data Printed in the FR: No 
Agency Contact:
Chris Wheeler
Supervisory Project Manager
Department of Health and Human Services
Food and Drug Administration
10903 New Hampshire Avenue, Building 51, Room 3330,
Silver Spring, MD 20993
Phone:301 796-0151
Email: chris.wheeler@fda.hhs.gov