Senate HELP Committee Advances Sen. Banks’ SAFE Drugs Act

WASHINGTON, D.C. - Yesterday, the Senate Health, Education, Labor, and Pensions (HELP) Committee voted to advance the SAFE Drugs Act of 2026, introduced by Sen. Jim Banks (R-Ind.) and Sen. Martin Heinrich (D-N.M.). The bipartisan legislation would strengthen patient safety and increase transparency in the pharmacy compounding industry. The SAFE Drugs Act passed the Committee with a vote of 17-5 and now heads to the Senate floor.

Sen. Jim Banks (R-Ind.): "Americans deserve to know their medications are safe and coming from legitimate sources. The SAFE Drugs Act makes online pharmacies more transparent and helps the FDA hold compounding pharmacies accountable if they break the rules."

Sen. Martin Heinrich (D-N.M.): "New Mexicans deserve to know when a medication is not FDA-approved and may carry serious risks. Our SAFE Drug Act helps protect patients by requiring compounders to clearly label medications that are not FDA-approved and report when things go wrong. Advancing this legislation out of committee is an important first step toward increasing transparency, strengthening oversight of pharmacy compounders, and better protecting patients."

Key Provisions of SAFE Drugs Act of 2026:

• Requires 503A compounding pharmacies to report serious adverse events associated with their drug products to the Food and Drug Administration (FDA).
• Requires all compounded drug products to be clearly labeled so patients can distinguish them from FDA-approved medications.
• Requires 503A compounders that ship significant volumes across state lines to report production volumes to the FDA.
• Modernizes federal pharmacy compounding law while preserving patient access to customized medications.
• Aligns key safety safeguards between 503A compounding pharmacies and 503B outsourcing facilities.

Background:

Compounding is an important part of the pharmacy profession that provides tailored medications to patients with unique needs. The substantial growth in pharmacy compounding activity associated with the expansion of telehealth and online prescribing necessitates modernizing the Federal Food, Drug, and Cosmetic Act's pharmacy compounding procedures. Patients must know the medications they are getting are safe.

Statements from key supporting organizations:

"Manufacturers were glad to see the Senate HELP Committee advance the SAFE Drugs Act, a bill the NAM supported. This is an important step toward protecting patients from potentially unsafe, non-FDA-approved drugs produced by underregulated compounding pharmacies. Congress should move quickly to pass it." -National Association of Manufacturers, Managing VP of Policy, Charles Crain. "

"The ADA is pleased an amended version of the SAFE Drugs Act passed out the Senate Health, Education, Labor, and Pensions Committee today and appreciates the bipartisan support and work to improve patient safety. Compounded medications play an important role in our health care system, but ongoing concerns have been raised of the widespread availability and promotion of non-FDA approved compounded GLP-1 class of medication to treat obesity directly to patients. The amended SAFE Drugs Acttakes an important step to improve transparency, labeling disclosures and adverse event and volume reporting for compounded medications. These are needed changes to address current gaps in transparency for patients, and health professionals."- Catherine Ferguson, Senior Vice President, American Diabetes Association.

"The Alliance for Safe Online Pharmacies is grateful to Senator Banks and Heinrich for their leadership in advancing the SAFE Drugs Act. This legislation will help close loopholes that allow unsafe, unapproved medicines to reach patients, including through illegal online sellers. We look forward to working with Congress to advance these protections."- Leigh Verbois, ASOP Global Board Chair.

Full bill text can be found here.

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