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HHS/FDA RIN: 0910-AH62 Publication ID: Spring 2023 
Title: Nonprescription Drug Product With an Additional Condition for Nonprescription Use 

The final rule is intended to increase options for applicants to develop and market safe and effective nonprescription drug products, which could improve public health by broadening the types of nonprescription drug products available to consumers. The final rule would establish requirements for a drug product that could be marketed as a nonprescription drug product with an additional condition for nonprescription use (ACNU) 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: Final 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
Action Date FR Cite
NPRM  06/28/2022  87 FR 38313   
NPRM Comment Period End  10/26/2022 
NPRM Comment Period Extended  10/24/2022  87 FR 64178   
NPRM Comment Period Extended End  11/25/2022 
Final Rule  04/00/2024 
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