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

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

Statement of Need:

Currently, nonprescription drug products are limited to drugs that can be labeled with sufficient information for consumers to appropriately self-select and use the drug product. For certain drug products, limitations of labeling present challenges for adequate communication of information needed for consumers to appropriately self-select or use the drug product without the supervision of a healthcare practitioner. FDA is finalizing regulations that would establish the requirements for a drug product that could be marketed as a nonprescription drug product with an ACNU that an applicant must implement to ensure appropriate self-selection, appropriate actual use or both by consumers. 

Summary of the Legal Basis:

FDA’s revisions to the regulations regarding labeling and applications for nonprescription drug products 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).

Alternatives:

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 final rule would include increased consumer access to drug products and reduced access costs to these products as compared to their prescription alternatives. Benefits to industry would arise from the flexibility in drug product approval and the potential expansion of market revenue. Other benefits would include a reduction in repetitive meetings with industry and the Agency regarding this approval pathway. In addition, private and government-sponsored drug coverage plans may experience cost savings. Although applicants would incur the costs to develop and submit an application for a nonprescription drug with an ACNU, they would likely submit applications only when they expect that the profits from the approval would exceed the costs of the application. Lastly, we anticipate one-time costs of reading and understanding the rule that potential applicants would incur. 

Risks:

None

Timetable:
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:
Angela Mtungwa
Program Coordinator
Department of Health and Human Services
Food and Drug Administration
10903 New Hampshire Avenue, Building 22, Room 4393,
Silver Spring, MD 20993
Phone:301 796-9329
Email: angela.mtungwa@fda.hhs.gov