119th Congress Health
H.R. 6509: SAFE Drugs Act of 2025
Introduced
- Introduced (completed)
- Passed House (not reached)
- Passed Senate (not reached)
- To the President (not reached)
- Became law (not reached)
Summary
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.)
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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.
Written by the Congressional Research Service, Library of Congress.
Roll calls
No roll call votes have been held on this bill.
Amendments
No amendments were offered to this bill.
Cosponsors
- André Carson D-INOriginal
- John McGuire R-VA
- Eugene Vindman D-VA
- Nathaniel Moran R-TX
- Deborah Ross D-NC
- Carol Miller R-WV
- Claudia Tenney R-NY
- Addison McDowell R-NC
- Aaron Bean R-FL
- Mike Kelly R-PA
- James Baird R-IN
- Erin Houchin R-IN
- Vince Fong R-CA
- Jefferson Shreve R-IN
- Mark Messmer R-IN
- Charles (Chuck) Edwards R-NC
- Frank Mrvan D-IN
- Marlin Stutzman R-IN
- Donald Davis D-NC
- Derrick Van Orden R-WI
Who scored on this bill
- 1Rudy Yakym SponsorDrew cross-party cosponsors, introduced2 events+6
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Introductions and cosponsorships count toward weekly caps and show no points.
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History
- Introduced in the House by Rudy Yakym.
Show the full action history (2 actions)
- Introduced in House
- Referred to the House Committee on Energy and Commerce.