SAFE Drugs Act of 2026
What does the SAFE Drugs Act of 2026 do?
S 3794 is a Senate bill sponsored by Sen. Jim Banks (R-IN). Pharmacies and doctors can mix custom versions of drugs, called compounding, without FDA approval as long as they meet the conditions in Section 503A of the food and drug law. This bill adds two more conditions: a compounder who sends drugs out of State must pass on any serious adverse event report it receives and, once out-of-State shipments top 5 percent of what it compounds in a year, file an annual report; and every compounded drug label must say the drug has not been approved by the Food and Drug Administration and carry the FDA adverse-event website and phone number.
Did S 3794 pass? Where it stands
As of September 1, 2026, S 3794 has been placed on the Senate calendar and is awaiting a floor vote.
Status: On Senate Calendar
Outlook: Possible
Key provisions
- Adverse Event Reporting
- Serious adverse event reports must go to the Secretary and both States
- Applies to compounders who send drug products out of State
- Uses the existing federal adverse-event report content and format
- Annual Interstate Report
- Triggered above 5 percent of annual compounded volume sent out of State
- Due by January 15 each year to the Secretary and the receiving State
- Lists name, address, license number, and monthly units by product type
- Hospital pharmacies compounding for hospital patients are excluded
- Label Warning
- Label must state the drug has not been approved by the FDA
- Label must carry the FDA adverse-event website and phone number
- Becomes one of the conditions for compounding under Section 503A
- State Law Preserved
- Stricter or supplementary State reporting requirements are not preempted
Last updated September 1, 2026