SAFE Drugs Act of 2026
Latest action. Placed on Senate legislative calendarThe list of measures reported out of committee and eligible for floor action. Being on the calendar is not a promise of a vote.Read the full definition (opens a new tab) under General Orders. Calendar No. 524.
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.
Written by analysts at the Congressional Research Service and published on Congress.gov, not by Civibrief. Summarized at the "Introduced in Senate" stage on February 5, 2026. It describes the bill, it is not the legal text.
Where is it in the process, and what happens next?
4 steps remain before this bill could become law.
The record's latest action, on July 27, 2026: Placed on Senate Legislative Calendar under General Orders. Calendar No. 524.
- Clearing the committees it was referred to, and being scheduled for a floor vote
- Passage by the Senate
- Passage by the House
- The President's signature. If the President vetoes it, two-thirds of both chambers must vote to override.
How likely is it to become law?
Civibrief does not forecast outcomes and this page has no opinion about this one. What the record supports is a base rate, which is a fact about the whole pile, not a prediction about this measure.
In the 118th Congress (2023-24), 274 of the 16,565 bills and joint resolutions introduced became law, about 1.7 percent. That count covers every measure at every stage, including the many that never left committee.
This one is not there yet: 4 steps are still outstanding, listed above.
Has anyone actually voted on it?
No. No roll call in this Congress cites this measure. That is the ordinary outcome: most measures never reach a recorded floor vote, and a committee ends most of them simply by not acting.
A vote is not the only thing that happens to a measure. Hearings, markups, and referrals are all recorded actions, and none of them is a vote of the full chamber.
Who is behind it?
Jim Banks (R-IN) introduced it on February 5, 2026, and 1 member has since signed on as a cosponsor.
They are 1 Democrat.
Cosponsoring is a formal signature on the text. It is not a commitment to vote for the measure, it does not bind anyone's party, and a long list of cosponsors is a measure of attention rather than of prospects.
How long has it been in play?
It was introduced on February 5, 2026, 217 days ago. The most recent recorded action was 45 days ago, on July 27, 2026.
Measures do not carry over. Anything the 119th Congress has not finished by January 3, 2027 dies when the term ends, and has to be introduced again from the start in the next Congress.
Every answer above is assembled from this measure's own record on Congress.gov and from published counts of what Congress has passed before. Civibrief does not predict outcomes and takes no position on any measure.
Vote history
- SenateIn committee, no floor vote yet
- HouseAwaits Senate passage
- PresidentAwaits both chambers