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Enhanced Safety and Oversight for Compounded Drugs and Pharmacies.

This law tightens regulations on compounding pharmacies and large outsourcing facilities that create custom medications. It limits the mass production of drugs that are essentially copies of commercial products and mandates stricter, more frequent safety inspections for high-volume facilities. These changes aim to ensure that custom-made drugs are safe, necessary, and tailored specifically to individual patient needs.
Key points
Pharmacies are restricted from mass-producing drugs that are essentially copies of commercially available medications (limited to 20 times per month).
Large-scale compounding facilities (producing over 100 drugs annually) must undergo mandatory, more frequent safety inspections (at least biennially).
New reporting requirements are established for facilities that ship compounded drugs across state lines, increasing federal oversight.
article Official text account_balance Process page
Introduced
Citizen Poll
No votes cast
Additional Information
Print number: 119_HR_6509
Sponsor: Rep. Yakym, Rudy [R-IN-2]
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Summarized by: gemini-flash-latest
Source data: api.congress.gov
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OFFICIAL LEGAL TITLE

SAFE Drugs Act of 2025

FREQUENTLY ASKED QUESTIONS

What is the official ID of this bill?

The official print number for this legislation is 119_HR_6509.

Which chamber initiated this legislation?

This legislation was initiated in the House of Representatives.

What are the main provisions?

Key points include:

  • Pharmacies are restricted from mass-producing drugs that are essentially copies of commercially available medications (limited to 20 times per month).
  • Large-scale compounding facilities (producing over 100 drugs annually) must undergo mandatory, more frequent safety inspections (at least biennially).
  • New reporting requirements are established for facilities that ship compounded drugs across state lines, increasing federal oversight.
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 Rep. Yakym, Rudy [R-IN-2].

What is the latest detailed status?

The latest detailed status is: Referred to the House Committee on Energy and Commerce.

Is this summary verified?

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

CATEGORIES

Health