SAFE Drugs Act of 2025
Latest action · Dec 9, 2025 Referred to the House Committee on Energy and Commerce.
Progress
Where this bill reached, and when. A stage with no date was not reached; one that failed a vote and later carried shows the date it carried.
- IntroducedDec 9, 2025
- Passed HouseNot reached
- Passed SenateNot reached
- To the PresidentNot reached
- Became lawNot reached
Summary
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.
Cosponsors 20
Members who signed on, in the order they did. Signatures ran from Dec 9, 2025 to Sep 16, 2026; 1 is an original cosponsor, there from the day it was introduced.
| Seat | Cosponsor | Signed on | |
|---|---|---|---|
| D-IN | André Carson | Original | Dec 9, 2025 |
| D-VA | Eugene Simon Vindman | Jan 30, 2026 | |
| R-VA | John J. McGuire III | Jan 30, 2026 | |
| D-NC | Deborah K. Ross | Feb 11, 2026 | |
| R-TX | Nathaniel Moran | Feb 11, 2026 | |
| R-WV | Carol D. Miller | Mar 3, 2026 | |
| R-NY | Claudia Tenney | Mar 3, 2026 | |
| R-NC | Addison P. McDowell | Mar 5, 2026 | |
| R-FL | Aaron Bean | Mar 17, 2026 | |
| R-PA | Mike Kelly | Mar 18, 2026 | |
| R-IN | James R. Baird | Apr 13, 2026 | |
| R-IN | Erin Houchin | Apr 15, 2026 | |
| R-IN | Jefferson Shreve | May 12, 2026 | |
| R-CA | Vince Fong | May 12, 2026 | |
| R-IN | Mark B. Messmer | May 20, 2026 |
Committees 1
Where it was sent and what each committee and subcommittee did with it, in order.
| Chamber | Committee | What it did |
|---|---|---|
| House | Energy and Commerce Committee | Referred Dec 9, 2025 |
Actions 2
Everything that happened, newest first.
- Dec 9, 2025Introduced in House
- Dec 9, 2025Referred to the House Committee on Energy and Commerce.
Research
What has been written about this bill: committee reports, cost estimates, the sponsor’s authority statement, printed hearings and the Congressional Research Service’s work.
Constitutional authority
The sponsor’s statement, as printed in the Congressional Record, vol. 171, no. 207, December 9, 2025, page H5112.
Related bills 1
Companion bills and other measures the record links to this one.
| Bill | Title | Relationship | Latest action |
|---|---|---|---|
| S 3794 | SAFE Drugs Act of 2026 | Related bill | Jul 27, 2026 |
Titles 3
Every title it has carried, official and short, at each stage.
- Official Title as Introduced
- To amend the Federal Food, Drug, and Cosmetic Act to further regulate compounding pharmacies and outsourcing facilities, and for other purposes.
- Short Title(s) as Introduced
- SAFE Drugs Act of 2025
- Safeguarding Americans from Fraudulent and Experimental Drugs Act of 2025
Subjects
Assigned by the Library of Congress. Policy area: Health.
Text 1
Each version as it was printed, newest first.
- Dec 9, 2025Introduced in House
Everything here is as published by Congress: the summary is the Congressional Research Service's, the action wording is the clerks', and the subjects are the Library of Congress's. How far it got is read from the actions themselves, taking the most recent one of each kind, so a bill that failed a vote and later passed is shown as having passed. Records come from this bill on Congress.gov and govinfo.gov; cost estimates are the Congressional Budget Office's, and the hearings are the printed hearings GovInfo publishes, which can appear months after the hearing.
