0910-AH62 202210 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Nonprescription Drug Product With an Additional Condition for Nonprescription Use

The final rule is intended to increase access to nonprescription drug products. The final 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.

]]> Other Significant Previously Published in The Unified Agenda Final Rule Stage No No 21 CFR 201.67 21 CFR 314.56 21 CFR 314.81 21 CFR 314.125 21 CFR 314.127 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 ... Yes

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 additional condition that an applicant must implement to ensure appropriate self-selection, appropriate actual use or both by consumers. 

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FDA’s 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).

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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.

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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. 

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]]> NPRM 06/28/2022 87 FR 38313 NPRM Comment Period End 10/26/2022 Final Rule 10/00/2023 No Businesses None No No No No Chris Wheeler Supervisory Project Manager 0910 Food and Drug Administration FDA 301 796-0151 cderomp@fda.hhs.gov 10903 New Hampshire Avenue, Building 51, Room 3330, Silver Spring MD 20993