SAFE Drugs Act of 2025
Official title: To amend the Federal Food, Drug, and Cosmetic Act to further regulate compounding pharmacies and outsourcing facilities, and for other purposes.
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Referred to the House Committee on Energy and Commerce.
Safeguarding Americans from Fraudulent and Experimental Drugs Act of 2025 or the SAFE Drugs Act of 2025
This bill provides for increased oversight of drug compounding and imposes statutory limits on compounded drugs that are essentially copies of commercially available drugs.
Currently, subject to certain requirements, compounded drugs (i.e., drugs that are mixed or altered to meet patient needs) do not require Food and Drug Administration (FDA) approval. Additional limits apply to the compounding of drugs that are essentially copies of commercially available drug products.
Under the bill, a compounded drug is essentially a copy of a commercially available drug product if (1) the compounded drug contains any active ingredient found in a commercially available drug product, and (2) there is no change made for an individual patient that results in a significant difference between the compounded drug and the commercially available drug. (The FDA’s current definition of the term also addresses dosage strength and route of administration.)
The bill increases the frequency at which a licensed pharmacist or physician may compound a drug that is essentially a copy of a commercially available drug to 20 times per month. Current FDA policy allows four such prescriptions per month.
The bill also imposes annual reporting requirements on physicians, facilities, and pharmacies (except hospital-based pharmacies) that compound certain drug products for out-of-state patients more than 20 times per month. Further, the bill subjects certain large-scale outsourcing facilities (i.e., FDA-registered facilities that compound in bulk) to regular inspection and reporting requirements.
- Introduced in House Formatted Text PDF Formatted XML
- NATIONAL COMMUNITY PHARMACISTS ASSOCIATION
- WILLIAMS AND JENSEN, PLLC
- PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
- WILLIAMS AND JENSEN, PLLC
- GSK (FKA GLAXOSMITHKLINE INC.)
- HIMS & HERS HEALTH, INC.
Bodies those filers lobbied
- HOUSE OF REPRESENTATIVES
- SENATE
- Centers For Medicare and Medicaid Services (CMS)
- Food & Drug Administration (FDA)
- Health & Human Services, Dept of (HHS)
- Executive Office of the President (EOP)
- White House Office
- Labor, Dept of (DOL)
Cite this page
U.S. Congress. (2026). H.R. 6509: SAFE Drugs Act of 2025. 119th Congress. Open America. https://openamerica.io/bill/119-HR-6509/
"H.R. 6509: SAFE Drugs Act of 2025." 119th Congress, 2026, Open America, https://openamerica.io/bill/119-HR-6509/.
H.R. 6509, 119th Cong. (2026), https://openamerica.io/bill/119-HR-6509/.
[H.R. 6509: SAFE Drugs Act of 2025](https://openamerica.io/bill/119-HR-6509/)