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Streamlining Rx-to-OTC Drug Switches: Faster Access to Nonprescription Medicines.

This bill aims to simplify and accelerate the process of switching prescription-only drugs (Rx) to over-the-counter status (OTC). For citizens, this means potentially faster access to safe and established medications without needing a doctor's visit, which could save time and reduce healthcare costs. The FDA is required to issue new guidance to make this regulatory process clearer and more predictable.
Key points
Improved Drug Access: Prescription drugs with well-established safety profiles may become available over-the-counter more quickly, increasing convenience and lowering access barriers.
Increased Process Clarity: The FDA must establish clear guidelines on how pharmaceutical companies can apply for a drug status switch, including how to demonstrate that consumers can safely self-select and use the drug.
New Information Tools: FDA guidance will consider the use of modern tools, such as mobile applications, to help consumers safely and appropriately use OTC medications.
article Official text account_balance Process page
Introduced
Citizen Poll
No votes cast
Additional Information
Print number: 119_S_2529
Sponsor: Sen. Husted, Jon [R-OH]
Process start date: 2025-07-30
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Summarized by: gemini-flash-latest
Source data: api.congress.gov
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OFFICIAL LEGAL TITLE

A bill to increase the clarity and predictability of the process for developing applications for Rx-to-nonprescription switches.

FREQUENTLY ASKED QUESTIONS

What is the official ID of this bill?

The official print number for this legislation is 119_S_2529.

Which chamber initiated this legislation?

This legislation was initiated in the Senate.

When did the legislative process begin?

The process officially started on 2025-07-30.

What are the main provisions?

Key points include:

  • Improved Drug Access: Prescription drugs with well-established safety profiles may become available over-the-counter more quickly, increasing convenience and lowering access barriers.
  • Increased Process Clarity: The FDA must establish clear guidelines on how pharmaceutical companies can apply for a drug status switch, including how to demonstrate that consumers can safely self-select and use the drug.
  • New Information Tools: FDA guidance will consider the use of modern tools, such as mobile applications, to help consumers safely and appropriately use OTC medications.
What is the specific legal status?

The current status is Introduced.

Where can I read the full text of this legislation?

The full official text is available at: View full text

Who is the primary sponsor?

The primary sponsor is Sen. Husted, Jon [R-OH].

What is the latest detailed status?

The latest detailed status is: Introduced in Senate

Is this summary verified?

Yes. This content was analyzed by AI and verified by the Lustra Judge System on 2025-12-31.

CATEGORIES

Health