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HHS/FDA RIN: 0910-AH62 Publication ID: Fall 2021 
Title: Nonprescription Drug Product With an Additional Condition for Nonprescription Use 

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: Undetermined 
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

Statement of Need:

Nonprescription products have traditionally been limited to drugs that can be labeled with information for consumers to safely and appropriately self-select and use the drug product without supervision of a health care provider.  There are certain prescription medications that may have comparable risk-benefit profiles to over-the-counter medications in selected populations. However, appropriate consumer selection and use may be difficult to achieve in the nonprescription setting based solely on information included in labeling. FDA is proposing regulations that would establish the requirement 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 or appropriate actual use or both for consumers.  

Summary of the Legal Basis:

FDA’s proposed revisions to the regulations regarding labeling and applications for nonprescription drug products labeling are authorized by the FD&C Act (21 U.S.C. 321 et seq.) and by the Public Health Service Act (42 U.S.C. 262 and 264).


FDA evaluated various requirements for new drug applications to assess flexibility of nonprescription drug product design through drug labeling for appropriate self-selection and appropriate use.

Anticipated Costs and Benefits:

The benefits of the proposed rule would include increased consumer access to drug products, which could translate to a reduction in under treatment of certain diseases and conditions. Benefits to industry would arise from the flexibility in drug product approval. The proposed rule would impose costs arising from the development of an innovative approach to assist consumers with nonprescription drug product self-selection or use. 



Action Date FR Cite
NPRM  12/00/2021 
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