arrow_back Back to App

Extending OTC Drug User Fees: Funding FDA Oversight and Quality Standards.

This Act extends and revises the user fee program for manufacturers of over-the-counter (OTC) monograph drugs until 2030. These funds are dedicated to the Food and Drug Administration (FDA) activities related to ensuring the safety and quality of non-prescription medicines. The goal is to secure stable funding for regulatory oversight, which helps maintain high standards for the common drugs consumers purchase.
Key points
The fee program for OTC drug manufacturers is reauthorized through Fiscal Year 2030, securing dedicated funding for FDA regulatory activities.
New deadlines and fee structures are established for pharmaceutical facilities, including splitting payments for Fiscal Year 2027 and introducing workload-based adjustments.
The FDA can more easily adopt updated testing procedures for OTC drugs based on recognized national or international quality standards.
article Official text account_balance Process page
Placed on Calendar
Citizen Poll
No votes cast
Additional Information
Print number: 119_HR_4273
Sponsor: Rep. Latta, Robert E. [R-OH-5]
Process start date: 2025-07-02
Lustra uses Artificial Intelligence. Verify details in source documents.
Summarized by: gemini-flash-latest
Source data: api.congress.gov
AI work logs for this document launch

OFFICIAL LEGAL TITLE

Over-the-Counter Monograph Drug User Fee Amendments

FREQUENTLY ASKED QUESTIONS

What is the official ID of this bill?

The official print number for this legislation is 119_HR_4273.

Which chamber initiated this legislation?

This legislation was initiated in the House of Representatives.

When did the legislative process begin?

The process officially started on 2025-07-02.

What are the main provisions?

Key points include:

  • The fee program for OTC drug manufacturers is reauthorized through Fiscal Year 2030, securing dedicated funding for FDA regulatory activities.
  • New deadlines and fee structures are established for pharmaceutical facilities, including splitting payments for Fiscal Year 2027 and introducing workload-based adjustments.
  • The FDA can more easily adopt updated testing procedures for OTC drugs based on recognized national or international quality standards.
What is the specific legal status?

The current status is Placed on Calendar.

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 Rep. Latta, Robert E. [R-OH-5].

What is the latest detailed status?

The latest detailed status is: Placed on the Union Calendar, Calendar No. 254.

Is this summary verified?

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

CATEGORIES

Health Economy