Yakym, Carson Introduce Bill to Protect Patients from Unsafe Compounded Drugs

WASHINGTON, D.C. - Today, Congressman Rudy Yakym (R-IN-02) and Congressman André Carson (D-IN-07) introduced the "Safeguarding Americans from Fraudulent and Experimental (SAFE) Drugs Act of 2025" to protect patients from untested, unapproved, and potentially dangerous mass compounded drugs.

"Americans deserve confidence that their prescription medicines are safe, effective, and made to highest quality standards," Rep. Yakym said. "This bill restores that confidence by requiring regular inspections of compounding facilities, enhancing transparency through stronger reporting requirements, and ensuring the FDA has the resources it needs to safeguard consumers."

"Hoosiers and Americans across the country trust that the medicines they take are safe and effective," Rep. Carson said. "We all rely on the FDA to ensure that manufacturers produce quality medications. Unfortunately, some companies ignore the rules and sell substandard, risky products. To address this problem, I've worked with my fellow Hoosier, Congressman Yakym, on a new bill, the SAFE Drug Act, which will ensure medicines contain high-quality ingredients that are safe and not knock-offs. Our bill helps strengthen production standards and guardrails, oversight, and facility inspections. I'm proud to work with my Hoosier colleague on the SAFE Drug Act to ensure medicines contain high-quality ingredients."

Additionally, this bill has garnered support from some of the country's top patient advocacy organizations.

"While compounded medications play a critical role in our health care system, concerns have emerged regarding the widespread availability and promotion of non-FDA approved compounded GLP-1 and dual GIP/GLP-1 RA medication classes to treat obesity directly to patients," Rita Kalyani, Chief Scientific and Medical Officer with the American Diabetes Association said. "The American Diabetes Association (ADA) issued a statement recommending against the usage of compounded GLP and dual GIP/GLP-1 RA medications due to uncertainty about their content, safety, quality and effectiveness. The ADA is committed to ensuring patients have access to safe and effective FDA approved medications to treat their diabetes and obesity. Additional FDA oversight is needed regarding these compounding practices for these medication classes and entities manufacturing them to protect patients with diabetes and obesity."

"Patients living with obesity deserve access to treatments that have been rigorously tested for safety and quality," Joe Nadglowski, President & CEO, Obesity Action Coalition said. "OAC supports updating policies to ensure that level of transparency is the standard. This includes strengthening inspection and reporting requirements for compounding pharmacies so patients and providers know exactly what ingredients are used, how products are prepared, and whether safety or quality issues have been identified. Clear, consistent reporting is essential to protect patients and ensure all treatments meet appropriate standards."

"We have repeatedly raised warnings about the dangers of mass-produced compounded injectable drugs and voiced our concerns about illegal and uninspected foreign ingredients in these products," Shabbir Safdar, executive director of the Partnership for Safe Medicines said. "The SAFE Drugs Act will aim to curb illegal mass compounding while protecting the ability of hospital pharmacies and 503B outsourcing facilities to meet patient needs. The reporting and inspection requirements will provide much needed transparency into inappropriately mass marketed compounded drugs and help to improve compliance at outsourcing facilities. Congress must act quickly to pass this bill and provide these important safeguards to patients."

Background:

"FDA approved" is the global gold standard for drug safety. Yet many Americans are being exposed to mass compounded drugs, which bypass FDA's approval process and, as the FDA warns, "pose a higher risk" to patients. While compounding serves important individualized medical needs, some entities are exploiting it to illegally manufacture and sell untested, unapproved drugs at scale. These products endanger patients, undermine trust in FDA-approved medicines, and weaken incentives to develop new treatments.

The need for stronger safeguards has grown amid a surge in mass produced, medically unnecessary unapproved versions of popular drugs for obesity, hair loss, erectile dysfunction, and other conditions. Because compounders are not required to report their activities, FDA lacks visibility into how widely these drugs are being made and shipped. FDA has received more than 1,000 adverse event reports linked to compounded GLP-1 drugs, including cases involving dangerous dosing errors and the use of unsafe ingredients sourced from unregulated foreign factories, many of which are located in China.

The SAFE Drugs Act will restore safety and accountability by restricting mass compounding of unapproved drugs, improving transparency into interstate distribution, and strengthening oversight of large-scale facilities through more routine FDA inspections.

Key provisions of the SAFE Drugs Act:

Protects Patients from Unsafe Drugs

• Codifies the definition of "essentially a copy" to prevent illegal mass compounding of unapproved versions of FDA-approved drugs.

Enhances Transparency Through Reporting

• Requires any compounding pharmacy that ships more than 20 out of state prescriptions of a drug to report that activity to FDA, closing a major blind spot in current oversight.

Strengthens Oversight of Large Scale Facilities

• Requires FDA inspection of outsourcing facilities before they begin compounding new products, with reinspections at least every two years.

• Promotes compliance with current Good Manufacturing Practices (cGMP) through more frequent engagement between FDA and outsourcing facilities.

Bolsters FDA Resources

• Allows FDA to adjust outsourcing facility user fees to support timely, regular inspections.

Full text of the legislation is available here and a one-pager is available here.

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