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HHS/FDA RIN: 0910-AH62 Publication ID: Fall 2017 
Title: ●Requirement for Access or Safe Use of Certain Nonprescription Drug Products 

The proposed rule is intended to increase access to a wider variety of nonprescription drug products.  Under the proposed rule, an applicant could submit an application to FDA for approval of a nonprescription drug product with a requirement that ensures consumers’ appropriate self-selection, appropriate actual use, or both in order to obtain the drug without a prescription.

Agency: Department of Health and Human Services(HHS)  Priority: Economically Significant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Undetermined  Unfunded Mandates: Undetermined 
EO 13771 Designation: Deregulatory 
CFR Citation: 21 CFR 314.56    21 CFR 201.67   
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 that may be included in labeling.  FDA is proposing regulations that would allow for approval of a nonprescription drug product that would have additional requirements that could be met by consumers to obtain the drug without a prescription.  The proposed rule outlines a framework for the use of innovative approaches to assist consumers with nonprescription drug product self-selection or use.  This pathway should lead to approval of a wider range of nonprescription drug products.

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  08/00/2018 
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