S 3794
Advanced toward a vote
Requires pharmacists and physicians who compound drugs and ship them out of state to report serious adverse events and annual shipment volumes to federal and state health authorities, and requires labels on those compounded drugs to disclose that the FDA has not approved them.
Official title: SAFE Drugs Act of 2026
Timeline each lane is a chamber; dates pull from congress.gov actions
Senate
Introduced
05-FEB-2026
Referred
05-FEB-2026
Approved by committee
22-JUL-2026
Reported
27-JUL-2026
On the calendar
27-JUL-2026
- Requires compounders who send drugs out of their state to report serious adverse events to the FDA, the state where the drugs are made, and each state that receives them.
- Requires annual reports, due by January 15, when more than 5 percent of a compounder's yearly drug output goes out of state, listing product types and monthly unit counts by destination state.
- Exempts hospital pharmacies that compound drugs for their own patients and preserves any stricter state reporting rules.
- Requires labels on compounded drugs to state that the FDA has not approved the medication and to list FDA MedWatch contact information for adverse event reports.
Covers an older version. The newest CRS summary describes the bill as of "Introduced in Senate" (05-FEB-2026); the text has changed since (Reported to Senate, 27-JUL-2026).
CRS is the Library of Congress's nonpartisan research office. Read it on congress.govHealth
■ 1 D
1 Democrat