0910-AH62 201710 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 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.

]]> Economically Significant First Time Published in The Unified Agenda Proposed Rule Stage Undetermined Undetermined Deregulatory 21 CFR 314.56 21 CFR 201.67 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

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.

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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).

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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 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. 

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]]> NPRM 08/00/2018 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