SAFE Drugs Act of 2026
Latest action (22 Jul 2026): Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
What this bill does
**S. 3794 — SAFE Drugs Act of 2026**
This bill amends the Federal Food, Drug, and Cosmetic Act to add new reporting and labeling requirements for compounded drugs sent across state lines. As reported by the committee (replacing the original text), it requires licensed pharmacists and physicians who compound drugs and send them out of the state where compounding occurs to report serious adverse events to the FDA and relevant states. It also requires those who send more than 5 percent of their annual compounded drug volume across state lines to file annual reports identifying themselves and detailing the types and quantities of drugs shipped to each state, using an information-sharing system the FDA must establish. Compounded drug labels must state that the product has not been FDA-approved and include FDA MedWatch contact information for reporting adverse events. Hospital pharmacies compounding for hospital patients are excluded, and states remain free to impose additional reporting requirements.
The bill primarily affects licensed pharmacists and physicians engaged in drug compounding, particularly those who ship compounded products to patients in other states, as well as state health regulators and the FDA, which will administer the new reporting system and set specific formatting and content requirements. Patients receiving compounded medications would see new labeling disclosures.
The bill was introduced in the Senate on February 5, 2026, by Senator Banks, with Senator Heinrich as a cosponsor, and referred to the Committee on Health, Education, Labor, and Pensions. On July 22, 2026, the committee voted to report the bill favorably with an amendment in the nature of a substitute, meaning the original text (which included provisions on defining "essentially a copy" of commercially available drugs, outsourcing facility inspections, and FDA fee structures) was replaced with the narrower reporting and labeling provisions described above. The bill now awaits further action by the full Senate.
Plain-English summary generated by Bill100 AI from the official record. Always verify against the source below.
Official summary
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.
Timeline
22 Jul 2026
Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
Common questions
- What does S. 3794 do?
- **S. 3794 — SAFE Drugs Act of 2026** This bill amends the Federal Food, Drug, and Cosmetic Act to add new reporting and labeling requirements for compounded drugs sent across state lines. As reported by the committee (replacing the original text), it requires licensed pharmacists and physicians who compound drugs and send them out of the state where compounding occurs to report serious adverse events to the FDA and relevant states. It also requires those who send more than 5 percent of their annual compounded drug volume across state lines to file annual reports identifying themselves and detailing the types and quantities of drugs shipped to each state, using an information-sharing system the FDA must establish. Compounded drug labels must state that the product has not been FDA-approved and include FDA MedWatch contact information for reporting adverse events. Hospital pharmacies compounding for hospital patients are excluded, and states remain free to impose additional reporting requirements. The bill primarily affects licensed pharmacists and physicians engaged in drug compounding, particularly those who ship compounded products to patients in other states, as well as state health regulators and the FDA, which will administer the new reporting system and set specific formatting and content requirements. Patients receiving compounded medications would see new labeling disclosures. The bill was introduced in the Senate on February 5, 2026, by Senator Banks, with Senator Heinrich as a cosponsor, and referred to the Committee on Health, Education, Labor, and Pensions. On July 22, 2026, the committee voted to report the bill favorably with an amendment in the nature of a substitute, meaning the original text (which included provisions on defining "essentially a copy" of commercially available drugs, outsourcing facility inspections, and FDA fee structures) was replaced with the narrower reporting and labeling provisions described above. The bill now awaits further action by the full Senate.
- Has S. 3794 become law?
- Not yet. As of 22 Jul 2026, S. 3794 is ordered reported.
- Who sponsored S. 3794?
- S. 3794 was sponsored by Sen. Jim Banks [R-IN] (Republican-IN), with 1 cosponsor.
- What's the latest action on S. 3794?
- Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably. (22 Jul 2026).
Related bills in Health
Expressing support for the designation of September 22, 2026, as “National Hispanic Nurses Day” and recognizing the National Association of Hispanic Nurses as the leading organization representing and advocating for Hispanic nurses.
Recognizing the importance of protecting continuous Medicaid coverage for individuals undergoing active cancer treatment.
Wildland Firefighter Health and Safety Act
Expressing support for the designation of the third week of September as “Fungal Disease Awareness Week” and encouraging efforts to improve awareness, diagnosis, treatment, surveillance, and prevention of fungal diseases in the United States.
Bill100 mirrors the public U.S. legislative record from Congress.gov and GovTrack and adds plain-English AI summaries. It is an information tool, not legal, compliance or lobbying advice, and it is not affiliated with the U.S. Congress or any government agency. AI summaries can simplify or omit detail — every bill links to the official source; verify there before you rely on it.