Compounding pharmacies — pharmacies that mix custom drug formulations for specific patients — face new federal oversight requirements under this bill. Pharmacies and facilities that compound more than 20 batches per month of any drug containing an FDA-approved active ingredient for out-of-state patients must submit an annual report to the FDA. Large outsourcing facilities, defined as those compounding more than 100 drug products per year, must undergo FDA inspection before operating and at least every two years afterward. The bill also removes an existing registration exemption that allowed outsourcing facilities to avoid standard FDA oversight, and replaces the fixed $15,000 base establishment fee with a flexible amount set by the Secretary of Health and Human Services.
Transparency & Accountability
- Compounding pharmacy reporting — Annual FDA reports required for high-volume out-of-state compounding
- Large outsourcing facility inspections — Mandatory pre-operation and biennial inspections added for facilities compounding 100+ products/year
- FDA registration coverage — Outsourcing facilities removed from registration exemption, subject to standard facility oversight
Congressional Summary
Safeguarding Americans from Fraudulent and Experimental Drugs Act of 2026 or the SAFE Drugs Act of 2026This 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
- Senate
- Status
- summarized
- Action
- Introduced in Senate
- Action Date
- 2026-02-05
- Date Added
- 2026-06-30
- Source
- Congress.gov →
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