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119-s-3794119th CongressWALLET

SAFE Drugs Act of 2026

Sponsored By: Senator Banks, Jim [R-IN]

In Committee

Summary

Mandatory interstate reporting and clear warning labels for compounded drugs. This bill would require compounding pharmacists and physicians who ship drugs across state lines to report serious adverse events and to file annual interstate shipment summaries, and it would force labels to warn patients the product is compounded and not FDA approved.

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  • Patients: Labels must state the medication was compounded and is not FDA approved. Labels must also include info to report side effects like the FDA MedWatch website and a toll free number.
  • Compounding practitioners: Licensed pharmacists and physicians would have to report serious adverse events to three recipients and annually report if more than 5 percent of their compounded drugs are sent out of state. Reports must list practitioner details and monthly units sent to each State.
  • States and regulators: The Secretary would build an information sharing system to send reports to the Secretary and each receiving State. States may keep or add stricter reporting rules and hospital on‑premises compounding is excluded from these interstate rules.

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Bill Overview

Analyzed Economic Effects

2 provisions identified: 1 benefits, 0 costs, 1 mixed.

Warning labels for compounded medicines

If enacted, labels on drugs compounded for individual patients would have to say the medication was compounded for one patient and is not approved by the FDA. Labels would also have to list how to report bad effects, for example the FDA MedWatch website and a toll-free number like 1-800-FDA-1088. The FDA Secretary could require additional label information by order to help adverse-event reporting.

New reporting rules for compounded drugs

If enacted, this bill would require compounding pharmacists and physicians who send compounded drugs across State lines to file new reports. They would have to send any serious adverse event reports they receive to the FDA Secretary, the State where compounding occurred, and each State receiving the drugs. Starting the first calendar year after enactment, practitioners who send more than 5% of their annual compounded drugs out of State would also file an annual interstate report by January 15. Reports must include practitioner name, address, license number and month-by-month units sent by product type. Hospital on-premises compounding for hospital patients is excluded. The Secretary would set the report format and provide an information-sharing system to reduce burden, and States could keep stricter rules.

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.

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