HR 6509 119th Congress
SAFE Drugs Act of 2025
To amend the Federal Food, Drug, and Cosmetic Act to further regulate compounding pharmacies and outsourcing facilities, and for other purposes.
Official Title as Introduced Congress.gov
Open official Congress.gov recordSource-linked procedural record
Bill journey
This is a chronology, not a progress score. Politically.com does not classify stages or infer what comes next. Records sharing a date are grouped because not every source field supplies a time.
Congress.gov Recently refreshed
U.S. Senate XML Recently refreshed
-
Introduction Congress.gov
Introduced
Introduced in the House.
Open bill recordOfficial action Congress.gov
Referred to the House Committee on Energy and Commerce.
Open bill recordOfficial action Congress.gov
Introduced in House
Open bill recordOfficial action Congress.gov
Introduced in House
Open bill recordText version Congress.gov
Introduced in House
A dated text-version record is available.
Open text record
View the complete bill journey as an accessible table
| Date and time | Record | Official detail | Source |
|---|---|---|---|
| IntroductionIntroduced | Introduced in the House. | Congress.gov | |
| Official actionReferred to the House Committee on Energy and Commerce. | No additional detail supplied.IntroReferral · House floor actions · Code H11100 | Congress.gov | |
| Official actionIntroduced in House | No additional detail supplied.IntroReferral · Library of Congress · Code Intro-H | Congress.gov | |
| Official actionIntroduced in House | No additional detail supplied.IntroReferral · Library of Congress · Code 1000 | Congress.gov | |
| Text versionIntroduced in House | A dated text-version record is available. | Congress.gov |
House roll calls join only on matching Congress, legislation type, and number. Senate roll calls join only on matching source-supplied document type and number, not question text. Committee and related-measure relationships have no date in their relationship records and therefore are counted above but never placed on the chronology.
Congressional Research Service
CRS 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.
Official documents
Text versions
- Introduced in HouseDec 9, 2025