FDA regulatory gaps fuel unsafe compounded GLP-1 drugs

Regulatory gaps in compounded GLP-1 production

In general, compounded drugs are intended to address specific medical needs that cannot be met by approved medications. According to Section 503A of the Food, Drug, and Cosmetic Act (FDCA), these drugs must be tailored to individual patients and cannot be "essentially a copy" of commercially available products.

In certain circumstances, such as during a national drug shortage, compounded drugs can be produced to fill the gap. However, the FDA ended compounding policies tied to the national GLP-1 drug shortage earlier this year.

Yet, the July report draws attention to how some compounding pharmacies are exploiting regulatory loopholes to mass-produce unapproved GLP-1 drugs under misleading claims of customization or personalization. These pharmacies bypass FDA rules by slightly altering formulations, adjusting dosages or adding inactive ingredients, effectively creating drugs that mimic branded medications.

Despite FDA assurances that shortages of GLP-1 drugs like Ozempic, Wegovy (semaglutide), Mounjaro and Zepbound (tirzepatide) have been resolved, the widespread production of non-FDA-approved formulations remains a significant concern, raising alarms about patient safety and regulatory oversight.

"No one should be playing Russian Roulette with unapproved, untested or unregulated drugs," the author of the report wrote.

Safety risks of foreign APIs

The risks associated with unapproved compounded GLP-1 versions go beyond gaps in domestic regulatory oversight. As noted in the report, compounded GLP-1 drugs frequently utilize APIs sourced from unregistered and unregulated facilities, primarily in China.

The Federal FDCA requires all domestic and foreign drug and API manufacturing facilities to register with the FDA and list their products. Shipments from unregistered facilities should be classified as adulterated or misbranded and are subject to rejection or detention.

However, over 80% of unregistered API shipments continue to enter the U.S. without proper FDA oversight or inspection. Some of these APIs are labeled “research only,” unfit for human use or intended for veterinary applications.

In one case, Empower Pharmacy, a large U.S. compounder, received multiple FDA warning letters for using food-grade ingredients and failing to meet sterile compounding standards. The company later recalled more than 8,000 vials of testosterone.

In another case, Fullerton Wellness compounded GLP-1 drugs with non-sterile ingredients and "took no steps to sterilize them," prompting an FDA safety alert. According to a Binghamton University study cited in the report, adverse events from compounded GLP-1 drugs were nearly 2.5 times more likely to result in hospitalization than those from FDA-approved versions.

Accidental overdoses have also surged. Poison control centers reported a 1,500% increase in GLP-1-related calls from 2019 to 2023. In some cases, independent lab tests revealed compounded drugs with up to 250% of the listed potency.

Misleading marketing fuels patient misconception

Operating outside FDA regulations, compounding pharmacies are also misleading consumers about the safety of their GLP-1 products.

For instance, a 2025 JAMA Health Forum study found that many websites failed to disclose that compounded GLP-1 drugs are unapproved. Some even falsely claimed FDA endorsement or implied that their products were generic equivalents.

The public remains largely unaware of the dangers tied to compounded GLP-1 drugs. According to a National Consumers League survey, 71% of respondents mistakenly believed these compounded GLP-1 versions undergo FDA testing and approval. Aggressive marketing strategies, including Super Bowl ads and collaborations with social media influencers, often omit critical risk information, further obscuring the distinction between FDA-approved therapies and compounded imitations.

Policy recommendations

To close regulatory loopholes and protect patients, the CMPI report recommends immediately implementing the following:

• Strict enforcement. The FDA must enforce regulations prohibiting mass compounding disguised as "personalization," clarifying that minor formulation tweaks do not constitute legitimate patient customization.
• Registration requirements. Compounding pharmacies operating at scale should register as drug manufacturers, subjecting them to commercial drug oversight.
• Import restrictions. The FDA and U.S. Customs and Border Protection must enforce laws restricting API imports from unregistered foreign entities.
• Interstate distribution limits. Congress must enforce the "5% rule," limiting interstate distribution of compounded medications.
• Increased funding. Congress needs to allocate additional funding to enhance the FDA's enforcement capabilities and compliance programs.

Growing concerns

The CMPI findings echo a chorus of warnings from healthcare, governmental and consumer advocacy groups. A bipartisan coalition of 38 state attorneys general and federal lawmakers, including Senators Thom Tillis (R-NC) and Jim Banks (R-IN), has already expressed concerns and urged stricter enforcement to curb the proliferation of illegal compounded GLP-1 medications.

"Corporate compounding pharmacies are illegal and unregulated pharmaceutical companies. 'Buyer beware' is not smart or acceptable healthcare policy," Pitts advised. "Failure to act risks eroding trust in our healthcare system."

Alivia Kaylor is a scientist and the senior site editor of Pharma Life Sciences.