SAFE Drugs Act of 2026
Sponsored By: Senator Banks, Jim [R-IN]
Introduced
Summary
This bill would tighten compounding rules and expand oversight of large-scale outsourcing facilities. It would also add cross-state reporting for frequent compounders and let the Secretary set a variable base fee to fund safety work.
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- Patients and hospitals: Patients would see fewer compounded copies of commercially available drugs. The bill would bar compounding an "essentially a copy" more than 20 times in a single month and keeps an on‑site hospital pharmacy exception for hospital patients.
- Pharmacies and prescribers: Pharmacies, facilities, or physicians that compound more than 20 times in a month for patients who live out of state would have to report each drug type and monthly counts to the Secretary starting in calendar year 2025.
- Outsourcing facilities and FDA funding: Facilities that compound more than 100 times per year would face an inspection before first compounding and reinspection at least every two years. The bill would also replace the fixed $15,000 base establishment fee with an amount set by the Secretary to fund safety activities.
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Bill Overview
Analyzed Economic Effects
3 provisions identified: 0 benefits, 1 costs, 2 mixed.
Higher base fee for compounding facilities
If enacted, the bill would strike the fixed $15,000 base establishment fee and let the Secretary of Health set a base amount to fund safety activities for compounded drug products. Compounding and outsourcing facilities required to pay the section 744K base fee could therefore face a different, potentially higher, base fee set by the Secretary. This change would take effect upon enactment.
New inspections for large outsourcing facilities
If enacted, six months after the bill becomes law an outsourcing facility that compounds a product more than 100 times in a calendar year would be a "large-scale" facility. Large-scale facilities would need an FDA inspection before they compound any product for the first time and a reinspection at least every two years. The bill would also remove a prior exemption so outsourcing facilities must follow section 510 registration and reporting rules.
New limits and reports for pharmacies
If enacted, the bill would stop a pharmacy, facility, or practitioner from compounding a drug that is "essentially a copy" of a commercial drug more than 20 times in one month. A drug would be "essentially a copy" if it uses the same active ingredient and the prescriber does not request a patient-specific change that makes a big difference. For calendar year 2025 and each year after, if in any month an entity compounds more than 20 times for patients who live in another State, the entity would file an annual report by the end of that calendar year listing each product type and monthly totals. Compounding for hospital patients by a pharmacy located on hospital premises would be excluded from the reporting rule.
Sponsors & CoSponsors
Sponsor
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.
View on Congress.gov