Specialty pharmacies that mix custom medications — known as compounding pharmacies — would face tighter federal limits under the SAFE Drugs Act of 2025. Any pharmacy that compounds more than 20 copies per month of a drug that is already commercially available would be in violation of federal law, unless the prescribing doctor certifies the custom version produces a significant clinical difference for that specific patient. Pharmacies shipping compounded drugs containing commercially available ingredients to out-of-state patients more than 20 times a month must file an annual report with the FDA listing what they compounded and how often. Large outsourcing facilities — those compounding more than 100 drug products in a single calendar year — would face a required FDA inspection before they begin operating and a mandatory reinspection at least every two years.
Transparency & Accountability
- Cross-state compounding pharmacy reporting — High-volume out-of-state compounders must file annual FDA disclosures identifying drugs and quantities
- Large outsourcing facility inspection requirement — Mandatory pre-operation FDA inspection and biennial reinspection for facilities compounding 100+ products per year
Congressional Summary
Safeguarding Americans from Fraudulent and Experimental Drugs Act of 2025 or the SAFE Drugs Act of 2025This 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.
Details
- Congress
- 119th
- Chamber
- House
- Status
- summarized
- Action
- Introduced in House
- Action Date
- 2025-12-09
- Date Added
- 2026-06-19
- Source
- Congress.gov →
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