FDA 发布非处方药产品上市利益相关方参与计划

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Nonprescription drug products are important for the treatment of many common medical conditions and diseases. Unlike prescription drug products, nonprescription drug products may be accessed and used by consumers without the supervision of a licensed healthcare provider. Consumers typically purchase nonprescription drug products at pharmacies, supermarkets, or other retail locations, and online. Increasing access to appropriate, safe, and effective nonprescription drug products allows for consumer self-care that could improve public health.

FDA is committed to working with stakeholders and drug developers to identify and develop safe and effective nonprescription drug products, including through the drug application process. FDA developed and is executing a plan to engage stakeholders on bringing nonprescription drug products to market, including on steps and factors for application holders and other stakeholders to consider in identifying approved prescription drugs that may be promising candidates for nonprescription availability. 

Stakeholder Engagement Plan

This engagement plan includes issuing requests for information to the public, holding public meetings accompanied by public comment periods, initiating a pilot program for nonprescription drug product development programs, and issuing draft guidance with a public comment period.

Request for Information ✓

On December 2, 2025, FDA issued a request for information titled “Increasing Access to Nonprescription Drugs (90 FR 55316). FDA requested that interested parties and the public share their perspectives with FDA on how to increase access to nonprescription drug products. Among the list of information requested, FDA specifically asked for input on specific diseases or conditions that have not, traditionally, been treated with nonprescription drugs products for which nonprescription drug products could potentially be safely and effectively used without the supervision of a licensed healthcare practitioner.

For more information, see the public comments.

December 2025 Public Meeting ✓

On December 16, 2025, FDA held a public meeting titled, “Improving Anaphylaxis Outcomes: Approaches for Enhancing Access to Epinephrine” (90 FR 52958, November 24, 2025). The meeting discussed expanding epinephrine accessibility and use, including in the nonprescription setting, to improve anaphylaxis outcomes.

For more information, see the full transcripts and meeting materials.

April 2026 Public Meeting ✓

On April 23, 2026, FDA held a public meeting titled, “Increasing Access to Nonprescription Drugs” (91 FR 20170, April 15, 2026). The public meeting focused on the practical considerations related to access, innovative strategies to increase access, and how increased access may affect individual and public health outcomes. The meeting convened drug developers, health care providers, patient and consumer representatives, and other stakeholders to discuss opportunities to increase access to nonprescription drugs through the drug application process. Among other things, participants considered how to identify drugs that are best suited for prescription-to-nonprescription switches, evidence necessary to demonstrate safety and effectiveness in the nonprescription setting, and innovation to enable increased access to nonprescription drug products such as with an additional condition for nonprescription use (ACNU).

FDA also reopened the public docket associated with the December 2025 request for information to collect further insight from interested parties on specific topics covered at the public meeting or about increasing access to nonprescription drugs generally.

For more information, see the public comments and full transcripts and meeting materials.

Pilot Program

In Calendar Year 2026, FDA intends to announce a pilot program to support the development of nonprescription drug products, including prescription to nonprescription switches. It is intended to provide a structured opportunity for comprehensive discussions between sponsors and FDA early in a nonprescription development program with the goal of increasing the efficiency of nonprescription drug development.

Guidance for Industry

FDA intends to issue guidance on the development of nonprescription drugs, including considerations for identifying a potential drug product for nonprescription development. The public will be able to comment on the draft guidance, which FDA will take into consideration when finalizing the guidance.

Questions & Answers

Why is FDA posting this plan?

FDA is committed to working with stakeholders and drug developers to identify and develop safe and effective nonprescription drug products, including through the drug application process.  

The Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extension Act, 2026 (Public Law 119-37, 139 Stat. 645, 646), enacted November 12, 2025, added Section 505(b)(7) to the Federal Food, Drug, and Cosmetic Act (FD&C Act). Under section 505(b)(7)(C) of the FD&C Act, FDA is required to develop and make publicly available a plan to engage stakeholders on steps and factors for application holders and other stakeholders to consider in identifying approved prescription drug products that may be promising candidates for a Rx-to-nonprescription switch.

What are the pathways to bring a nonprescription drug product to market?

There are two regulatory pathways to bring a nonprescription drug product to market in the United States: (1) the over-the-counter (OTC) drug review process under section 505G of the FD&C Act; and (2) the application process under section 505 of the FD&C Act. Additional information about the pathways to bring a nonprescription drug product to market can be found at Over-the-Counter (OTC) | Nonprescription Drugs.

What is the drug application process?

Under the drug application process in section 505 of the FD&C Act, an applicant submits an application for a drug product to FDA for approval. FDA could approve a drug product as either prescription or nonprescription (see section 503(b)(1) of the FD&C Act). A drug product cannot be marketed until FDA approves the application. Additional information can be found at Drug Application Process for Nonprescription Drugs.

What is a prescription-to-nonprescription switch?

FDA uses the term prescription-to-nonprescription switch when the applicant of an approved prescription drug seeks approval to market a drug product as nonprescription. A prescription-to-nonprescription switch can either be a full switch, where the applicant seeks to change the marketing status for all the conditions in the approved application, or a partial switch, where the applicant seeks to change the marketing status of certain conditions in the approved application. Additional information can be found at Prescription-to-Nonprescription (Rx-to-OTC) Switches. A listing of nonprescription drug products that have successfully gone through the switch process can be found at Prescription to Nonprescription Switch List.

For the purposes of section 505(b)(7) of the FD&C Act, including this engagement plan, Congress defined the term “Rx-to-nonprescription switch” more broadly to include prescription-to-nonprescription switches and nonprescription drug products with an ACNU.

What is a nonprescription drug product with an additional condition for nonprescription use (ACNU)?

For certain nonprescription drug products, labeling alone may not adequately communicate the information needed for consumers to self-select or use the drug product appropriately. A nonprescription drug product approved with an ACNU has an additional condition (or conditions), beyond labeling, that allows consumers to self-select the drug product appropriately or use the drug product appropriately, or both, without the supervision of a licensed healthcare practitioner. Additional information can be found at Nonprescription Drug Product with an Additional Condition for Nonprescription Use.

What are other ways that the public can engage with FDA?

In addition to the above listed avenues for stakeholder engagement, FDA encourages interested parties to stay informed of relevant FDA news and engage with the FDA through the following mechanisms:

• For specific information about the regulation of nonprescription drugs, see Over-the-Counter (OTC) Nonprescription Drugs and OTC Monographs@FDA.
• For major announcements including final rules, guidance documents, requests for information, and public meeting notices, see Press Releases and Public Notifications, Public Meetings and Hybrid Events, and Federal Register.
• To subscribe to FDA’s varied listservs and social media, see Email Listserv / Bulletins and Social Media.
• For webinars on drug regulation and medication safety topics that include nonprescription drug issues, see FDA Drug Topics Webinars and SBIA website.
• To contact us about nonprescription drug products, see Office of Drug information.