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S. 3794 119th Congress Senate

SAFE Drugs Act of 2026

Official title: A bill to amend the Federal Food, Drug, and Cosmetic Act to further regulate compounding pharmacies and outsourcing facilities, and for other purposes.

Introduced: February 5, 2026 Introduced by: Jim Banks Republican · Indiana See on congress.gov
Health Administrative law and regulatory proceduresDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationFood and Drug Administration (FDA)
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 Everywhere this bill has been 5 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Jul 27, 2026
Committee on Health, Education, Labor, and Pensions. Reported by Senator Cassidy with an amendment in the nature of a substitute. Without written report.
Jul 27, 2026
Placed on Senate Legislative Calendar under General Orders. Calendar No. 524.
Jul 22, 2026
Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
Feb 5, 2026
Introduced in Senate
Feb 5, 2026
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
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What's happening now July 27, 2026

Placed on Senate Legislative Calendar under General Orders. Calendar No. 524.

 Plain-English summary Congressional Research Service

Safeguarding Americans from Fraudulent and Experimental Drugs Act of 2026 or the SAFE Drugs Act of 2026

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.

 Hearings & markups 1
 Related & companion bills 1
 Bill text 2 versions

Source documents hosted by congress.gov.

 Committees of jurisdiction 1
 Lobbying activity 28

Registered lobbyists who named this bill in their disclosure filings. Source: federal Lobbying Disclosure Act filings.

Bodies those filers lobbied

A filing lists the bills it worked on and the parts of government it contacted in separate sections, so these are the bodies those filers named anywhere in the filing, not a per-bill breakdown.

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 Cosponsors 1
All 1 Democratic 1
D
Heinrich, Martin
New Mexico · Feb 5, 2026
Cite this page click to expand
APA
U.S. Congress. (2026). S. 3794: SAFE Drugs Act of 2026. 119th Congress. Open America. https://openamerica.io/bill/119-S-3794/
MLA
"S. 3794: SAFE Drugs Act of 2026." 119th Congress, 2026, Open America, https://openamerica.io/bill/119-S-3794/.
Bluebook (legal)
S. 3794, 119th Cong. (2026), https://openamerica.io/bill/119-S-3794/.
Markdown link
[S. 3794: SAFE Drugs Act of 2026](https://openamerica.io/bill/119-S-3794/)
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