H.R. 6509

House

SAFE Drugs Act of 2025

Sponsor: Rep. Mike Garcia (R-CA)

Introduced

The bill has been introduced and is awaiting committee action.

In brief

The Safeguarding Americans from Fraudulent and Experimental Drugs Act of 2025 restricts the production of compounded drugs that mimic commercially available products by defining them as any drug containing the same active ingredient without a clinically significant difference for a specific patient. It increases the limit for physicians and pharmacists to produce these copies from four to 20 times per month, while requiring annual reporting for facilities that exceed this limit for out-of-state patients. Additionally, the Food and Drug Administration must conduct regular inspections and enforce reporting requirements for large-scale outsourcing facilities. Representative Rudy Yakym (R-IN) introduced the bill, which was referred to the House Committee on Energy and Commerce.

Timeline

Every recorded action, oldest first.

May 15, 2025 · House
Introduced
Enhances law enforcement authority to schedule and prosecute the distribution of synthetic drugs. Recently introduced in the House.
Next: Referred to the House Judiciary and Energy and Commerce Committees.
Source
July 26, 2025 · House
Introduced
Addresses synthetic drug distribution through increased law enforcement resources and interdiction authorities.
Next: Referred to the House Judiciary Committee.
Source
July 19, 2026 · House
Introduced
A top-viewed bill in July 2026 focused on addressing drug-related safety and enforcement.
Next: Referred to the House Judiciary Committee.
Source
July 26, 2026 · House
Introduced
This bill increases penalties and enforcement for synthetic drug trafficking. It is currently the third most viewed bill on Congress.gov.
Next: Referred to the House Committee on the Judiciary.
Source