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S-3794Senate2026-02-05Health

SAFE Drugs Act of 2026

YourVoice.Now Summary

Transparency & AccountabilityCorporate Benefits

A drug mixed just for you would say so on the label — and out-of-state shipments would get reported.

Transparency & Accountability

Safety reports on custom-compounded drugs — FDA and states told

A pharmacist who mixes drugs to order and ships them out of state would pass on serious side-effect reports. Copies would go to the FDA, to their home state, and to each state that got the drug.

Yearly reports from compounding pharmacies shipping out of state

Pharmacists and doctors who send more than 5 percent of their yearly output out of state would file a report. It is due each January 15. It lists their license and how many units went to each state.

Label warning that the FDA never approved your drug

Compounded drugs are made for one patient and skip FDA review. The label would have to say that in plain words.

Way to report bad reactions — FDA hotline printed on the label

The label would also carry the FDA's MedWatch website and its 1-800 number. The FDA could order more label information later.

Corporate Benefits

Hospital pharmacies' exemption from new reports — for their own patients

A hospital pharmacy that mixes drugs on site for its own patients is left out of the new reports. Other pharmacies are not.

Compounding pharmacies' freedom from federal paperwork — new yearly filings

Compounding pharmacies file nothing like this today. The FDA would have to run a shared system to route the reports and hold down the added work.

More about this bill

If you take a drug your pharmacy mixes to order, the label would change. It would have to say the medicine was compounded for one patient and never approved by the FDA. Compounded drugs are mixed or altered to fit one person, so they skip FDA review. The label would also list the FDA's MedWatch website and 1-800 line for reporting a bad reaction. Nothing about your cost or coverage changes. Pharmacists and doctors who ship compounded drugs across state lines would take on new duties. They would pass along any serious side-effect report they get, to the FDA and to each state involved. Those who send more than 5 percent of their output out of state would also file a yearly report. The first would be due January 15 of the first full year after the law takes effect. Hospital pharmacies mixing drugs for their own patients are left out. States could still demand more. The version reported by committee is much narrower than the bill as introduced. Gone are a limit on copying commercial drugs, required inspections of big compounders, and a change to an FDA fee.

Congressional Summary

Congress's official summary of this bill still describes an earlier version of the text, so we have left it out here. You can read it on Congress.gov.

Congress.gov →

Details

Congress
119th
Chamber
Senate
Status
summarized
Action
Introduced in Senate
Action Date
2026-02-05
Date Added
2026-06-30
Source
Congress.gov →

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