H.R. 6509: Safeguarding Americans from Fraudulent and Experimental Drugs Act of 2025

This bill, known as the Safeguarding Americans from Fraudulent and Experimental Drugs Act of 2025 or the SAFE Drugs Act of 2025, proposes several amendments to the Federal Food, Drug, and Cosmetic Act concerning the regulation of compounding pharmacies and outsourcing facilities.

Overview of Key Provisions

1. Definitions of Compounding

The bill seeks to clarify the definition of compounding drug products. Specifically, it limits pharmacies from compounding drugs that are essentially copies of commercially available products more than 20 times in a month. This aims to ensure that compounded drugs are made for specific patients and offer significant differences from existing commercial products.

2. Reporting Requirements

Pharmacies and facilities that compound drugs will have to report to the Secretary of Health and Human Services if they compound more than 20 times monthly for patients living outside the state of the compounding facility. Reports must be submitted annually and should include details on the types of compounded drugs and the quantity compounded each month.

3. Inspections of Large-Scale Outsourcing Facilities

The bill mandates risk-based inspections of large-scale outsourcing facilities, which are defined as those that compound more than 100 times a year. Inspections will occur before they compound any new drug and will be required at least every two years thereafter.

4. Registration and Reporting for Outsourcing Facilities

It modifies the registration and reporting processes for outsourcing facilities, stipulating that the exemption from certain requirements does not apply to these facilities, ensuring stricter oversight.

5. Fees for Oversight

The bill also addresses the establishment fee associated with ensuring the safety of compounded drug products, allowing the Secretary of Health and Human Services to determine the base amount instead of a fixed fee of $15,000.

Implementation Timeline

The amendments regarding inspections and registration will apply six months after the bill is enacted.

Relevant Companies

• TEVA: As a large pharmaceutical company involved in generics, Teva may be impacted due to changes in compounding regulations that could affect their ability to provide compounded drugs or their positioning against compounding pharmacies.
• MGPI: This company focuses on developing and manufacturing various pharmaceuticals, including compounded products, and may need to adapt their practices to comply with the new reporting and inspection requirements.