SAFE Drugs Act of 2026
Sponsored By: Senator Sen. Banks, Jim [R-IN]
Introduced
Summary
Tighten oversight of compounding pharmacies to curb near‑copies of commercial drugs. This bill would limit how often pharmacies, facilities, or physicians can make compounded products that are essentially copies of commercially available drugs and add reporting, inspections, and fee changes to strengthen safety.
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- Families and patients: Would limit compounding of drugs that are essentially the same as commercial products to no more than 20 times in a single month by a single pharmacy, facility, or physician.
- Pharmacies and prescribers: Would require annual reporting to the Secretary for any product compounded more than 20 times in a month for out‑of‑state patients, listing product types and monthly counts. Hospital pharmacies on the hospital premises are excluded from this reporting.
- Outsourcing facilities and regulators: Defines a "large‑scale outsourcing facility" as one that compounds more than 100 times in a calendar year and would require an inspection before first compounding and at least biennial reinspections.
- Funding and fees: Replaces a fixed $15,000 base establishment fee with a base amount the Secretary deems appropriate to fund activities to ensure safety of compounded drug products.
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Bill Overview
Analyzed Economic Effects
2 provisions identified: 0 benefits, 0 costs, 2 mixed.
Limits on pharmacies compounding copy drugs
If enacted, the bill would bar a pharmacy, compounding facility, or doctor from compounding the same drug more than 20 times in a single month when that drug is "essentially a copy" of a commercially sold product. A drug would be an "essentially a copy" if it uses any active ingredient found in a commercially available U.S. product and the prescriber finds no patient-specific change that makes it significantly different for that patient. "Commercially available" would mean a drug sold in the U.S. commercial marketplace and made in facilities required to meet certain manufacturing standards. The monthly 20-count limit would take effect on enactment.
New inspections for large compounding facilities
If enacted, the bill would define a "large-scale outsourcing facility" as one that compounds more than 100 times in a single calendar year. The FDA would have to inspect such a facility before it compounds any drug product for the first time and reinspect it at least once every two years. The bill would also make clear that those large facilities must register and report (removing a prior exemption). These inspection and registration rules would begin six months after enactment.
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Sponsors & CoSponsors
Sponsor
Sen. Banks, Jim [R-IN]
IN • R
Cosponsors
Sen. Heinrich, Martin [D-NM]
NM • D
Sponsored 2/5/2026
Roll Call Votes
No roll call votes available for this bill.
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