SAFE Drugs Act of 2025

Summary

The SAFE Drugs Act of 2025 is a bill introduced in the U.S. House of Representatives that aims to further regulate compounding pharmacies and outsourcing facilities to ensure the safety of compounded drug products.

Key Provisions:

1. Compounding Pharmacy Regulations:

   • Limits compounding pharmacies to no more than 20 times per month the compounding of drug products that are essentially copies of commercially available drug products.
   • Defines "essentially a copy of a commercially available drug product" as a drug containing any active ingredient found in a commercially available product, unless there is a significant difference for the individual patient.

2. Reporting Requirements:

   • Requires pharmacies, facilities, or physicians that compound certain drug products more than 20 times per month for out-of-state patients to submit an annual report to the Secretary of Health and Human Services.
   • The report must identify each type of compounded drug product and the monthly total number of times each was compounded.
   • Excludes hospital pharmacies compounding for hospital patients.

3. Outsourcing Facility Regulations:

   • Requires "large-scale" outsourcing facilities (those compounding more than 100 times per year) to undergo inspections prior to first-time compounding and at least biennially thereafter.
   • Eliminates the exemption from registration requirements for outsourcing facilities.

4. Establishment Fees:

   • Allows the Secretary to set the base establishment fee for outsourcing facilities at a level deemed appropriate to fund activities ensuring the safety of compounded drug products, rather than a fixed $15,000 fee.

Impact:

The SAFE Drugs Act aims to strengthen oversight and safety requirements for compounded drugs, particularly those produced in large volumes or for patients outside the state where they are compounded. This is intended to prevent the distribution of unsafe or ineffective compounded products and reduce the risk of patient harm.

The new reporting, inspection, and fee requirements for certain compounding facilities are expected to increase regulatory compliance costs, which could impact the availability and pricing of some compounded drugs. However, the bill's supporters argue these measures are necessary to protect public health.