Custom-Made Drugs: New Safety and Shipping Rules
The Senate must act next: a Senate floor vote.
This bill has support from both parties and has already moved through the committee process, which is a major hurdle for most legislation.
Scores run from -100 (strongly harmful) to +100 (strongly beneficial) for each group, combining impact, certainty, scope, and duration ratings of 1-5. How impact scoring works
Compounding pharmacies and independent prescribers, many of which are small businesses, must now track and report interstate shipments, file annual reports by January 15 if more than 5 percent of their compounded drugs cross state lines, and redesign product labels. These new administrative and compliance tasks add cost and paperwork for small operators who lack large corporate compliance staff.
“each licensed pharmacist or licensed physician who compounds drug products under this section and sends, or causes to be sent, out of the State in which the compounding occurs, more than 5 percent of the total annual amount of drug products compounded by such licensed pharmacist or licensed physician shall annually submit a report”
Placed on Senate Legislative Calendar under General Orders. Calendar No. 524.
The bill is now on the schedule for the full chamber to consider. It's in line for debate and a vote.
Committee on Health, Education, Labor, and Pensions. Reported by Senator Cassidy with an amendment in the nature of a substitute. Without written report.
The committee approved this bill and is sending it to the full chamber for a vote. This is a significant step — most bills never get this far.
Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
The committee approved this bill and is sending it to the full chamber for a vote. This is a significant step — most bills never get this far.
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Sent to a congressional committee for expert review. The committee decides whether this bill moves forward.
Introduced in Senate
The bill was officially filed and given a number. It now enters the legislative queue.
The Senate HELP Committee voted 17-5 to advance the SAFE Drugs Act of 2026. The bill requires compounding pharmacies to report serious adverse events to the FDA and imposes new limits on the production of 'essentially a copy' versions of approved drugs, particularly targeting weight-loss meds.
Senators advanced the SAFE Drugs Act, a bipartisan measure led by Senators Jim Banks and Martin Heinrich. The legislation aims to increase transparency in the compounding industry by requiring pharmacies that ship significant volumes across state lines to report production data to the FDA.
The Senate HELP Committee advanced the SAFE Drugs Act, which would require pharmacies shipping more than 5% of their custom drugs across state lines to provide monthly reports to the government. The bill also mandates warning labels for all custom-made medications.
No votes recorded for this bill yet.
Document Type
Congressional Bill
Official Title
SAFE Drugs Act of 2026
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