Increasing the Clarity and Predictability of the Process for Developing Applications for Rx-To-Nonprescription Switches
Section 6507 · Sec. 6507 ·
What this chapter is about
A drug sold only by prescription can be moved to the open shelf. This part lets a firm ask for a meeting first. It makes the agency write guidance and a plan. And it asks a watchdog office how the switches have gone.
The document says “can”Who acts: persons planning an applicationHow: statuteSec. 6507 in the PDF
What the document says
“Any person planning to submit an application for an Rx-to-nonprescription switch may submit to the Secretary a written request for a meeting, for purposes of developing a plan for such application that addresses the potential risks to public health of such switch and the evidence necessary to support such application”
The Secretary may grant the meeting as appropriate, consistent with the established procedures for meetings and written responses, and each meeting has to be documented in minutes.
What the document actually says
“Any person planning to submit an application for an Rx-to-nonprescription switch may submit to the Secretary a written request for a meeting, for purposes of developing a plan for such application that addresses the potential risks to public health of such switch and the evidence necessary to support such application”
That sentence, in plain words
A firm that plans to ask for a switch may ask for a meeting first. The meeting is to plan the request.
What this is about
A switch means a drug moves from behind the counter to the shelf. The meeting is where the firm and the agency agree what proof is needed.
No action is recorded against this proposal. That is not evidence that none has been taken, and nobody has yet read it against the record. See what the tracker does not yet cover.
The document says “shall”Who acts: Secretary of Health and Human ServicesHow: statuteSec. 6507 in the PDF
What the document says
“Not later than 18 months after the date of enactment of this paragraph, the Secretary shall issue guidance to increase the clarity and predictability of the process and standards for approval of applications for nonprescription drugs under this section”
The guidance has to describe how published reports, past findings of safety or effectiveness, human experience and unpublished studies may support an application, set out how to request a meeting, describe what evidence is expected, and recommend how tools such as mobile applications and decision aids can be used alongside the drug facts label.
What the document actually says
“Not later than 18 months after the date of enactment of this paragraph, the Secretary shall issue guidance to increase the clarity and predictability of the process and standards for approval of applications for nonprescription drugs under this section”
That sentence, in plain words
Within eighteen months the agency must write guidance. It must make the path to approval clearer.
What this is about
Firms say they cannot tell what proof the agency wants. Guidance is not a rule, but it says what the agency expects.
No action is recorded against this proposal. That is not evidence that none has been taken, and nobody has yet read it against the record. See what the tracker does not yet cover.
The document says “shall”Who acts: Secretary of Health and Human ServicesHow: statuteSec. 6507 in the PDF
What the document says
“Not later than 1 year after the date of enactment of this paragraph, the Secretary shall develop and make publicly available on the website of the Food and Drug Administration a plan to engage stakeholders on steps and factors for application holders and other stakeholders to consider in identifying approved prescription drugs that may be promising candidates for applications for an Rx-to-nonprescription switch.”
The plan is about finding candidates rather than judging any one of them. It has to be posted on the agency's website.
What the document actually says
“Not later than 1 year after the date of enactment of this paragraph, the Secretary shall develop and make publicly available on the website of the Food and Drug Administration a plan to engage stakeholders on steps and factors for application holders and other stakeholders to consider in identifying approved prescription drugs that may be promising candidates for applications for an Rx-to-nonprescription switch.”
That sentence, in plain words
Within one year the agency must post a plan. The plan is about how to spot drugs that could move to the shelf.
What this is about
Not every prescription drug is safe to sell on the shelf. Some are. This asks the agency to work with others to find those.
No action is recorded against this proposal. That is not evidence that none has been taken, and nobody has yet read it against the record. See what the tracker does not yet cover.
The document says “shall”Who acts: Comptroller General of the United StatesHow: statuteSec. 6507 in the PDF
What the document says
“Not later than 1 year after the date of enactment of this Act, the Comptroller General of the United States shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report that evaluates--”
The report has to count the switch applications approved since October 1, 2022, how many carried an added condition, how long review took on average, how many partial switches were approved and how many were not, what stands in the way of timely review, how the agency engages the public, and where it might work with the Centers for Medicare and Medicaid Services on claims data.
What the document actually says
“Not later than 1 year after the date of enactment of this Act, the Comptroller General of the United States shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report that evaluates--”
That sentence, in plain words
Within a year a watchdog office must report to Congress. It must say how these switches have gone.
What this is about
The office counts how many drugs moved to the shelf and how long each took. It also looks for what slows the work down.
No action is recorded against this proposal. That is not evidence that none has been taken, and nobody has yet read it against the record. See what the tracker does not yet cover.
Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026, Public Law 119-37, sec. 6507, 139 Stat. 645 (2025). https://www.govinfo.gov/content/pkg/PLAW-119publ37/html/PLAW-119publ37.htm
This page
“Increasing the Clarity and Predictability of the Process for Developing Applications for Rx-To-Nonprescription Switches,” Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026, section 6507. Read the Mandate, https://readthemandate.org/continuing-appropriations-agriculture-legislative/section-6507/ (retrieved August 26, 2026).
Cite the document when the claim is about what the document says. Cite this page when the indexing, the wording or the record of what has happened is what is being relied on.
What This Page Covers, and What It Leaves Out
The four things the section creates: the meeting request, the guidance due in 18 months, the stakeholder plan due in one year, and the report by the Comptroller General.
The definition of a full and a partial switch, and the rule of construction that protects the Secretary's authority over monograph drugs and confidential information.
The section works by amending section 505(b) of the Federal Food, Drug, and Cosmetic Act. That law is not indexed here, so this file does not say what an application has to contain today.
