Compound Crackdown: The FDA Tightens up on Restrictions for Compounded Drug Ingredients and Advertisements June 23, 2026 Member Benefits, Practice Management, RCMA/CMA, Resources, Risk Management ProAssurance, RCMA, Resources, Risk Management 0 This informative article is provided by ProAssurance Download Article By Kaelin O’Reilly and Anne Marie Lyddy In response to known risks about misuse, and unverified claims about quality, efficacy, and safety, the FDA is taking actions to impose more restrictions regarding non-approved and mass-marketed compounded medications, including certain GLP-1 products. The administration will address both usage of active ingredients in GLP-1s and the misleading advertising and marketing surrounding these drugs. Restriction of Active Pharmaceutical Ingredients Compounding pharmacies, which produce customized, low-cost versions of highly popular medications (like Wegovy), will now meet resistance from the FDA. This follows from a DOJ investigation after the launch of a compounded pill by the telehealth company Hims & Hers, which prompted a lawsuit by Wegovy manufacturer Novo Nordisk for intellectual property infringement and unlawful mass production of its product. As a result of the investigation, the FDA announced it would take steps to regulate the compounding of GLP-1 medications in the U.S. market and enforce restrictions on GLP-1 active pharmaceutical ingredients (APIs). The FDA has warned consumers in the past about the potential risks of using compounded versions of FDA-approved medications. The raw materials used in the compounded versions do not require FDA approval or a premarket review for safety, effectiveness, and quality. The agency also warns that misuse or unnecessary use of non-FDA approved drugs can lead to serious patient harm, or even death. Reports to U.S. poison centers have shown an increase in medical issues related to compounded GLP-1 drugs, including overdoses and dosing errors, and the FDA identified instances of improper storage and inadequate refrigeration in shipments of these drugs, potentially compromising drug quality. It is important to remember that not all compounding pharmacies are created equal. The FDA sees reports of marketing for counterfeit drugs, use of harmful or wrong ingredients, and illegal online sales. However, legitimate compounders work to fill gaps in the supply, providing versions of approved medications for consumers when the FDA-approved drugs are unavailable, or when patients need alternative forms of delivery (e.g., orally vs. intravenously) or more specific dosages. According to Janice Jin Hwang, clinician and endocrinologist at the University of North Carolina at Chapel Hill, these legitimate pharmacies “have very good quality-control standards.” The FDA’s compounding program “aims to protect patients from poor quality compounded drugs, while preserving access to lawfully marketed compounded drugs.” Earlier in 2025, the FDA released an import alert blocking potentially unsafe APIs—manufactured for the production of GLP-1 drugs—from entering the U.S. Market. The alert established a vetted “green list” of foreign manufacturers that passed safety and quality standards, and any APIs imported from sources outside that list (or those failing to meet FDA standards) are at risk of detention at the border. FDA Commissioner Marty Makary stated that the FDA will narrow the focus on importation of these unapproved APIs, likely by increasing inspections or border restrictions. For those who fear limited access or resistance might prevent them from obtaining their weight-loss medications, a new government website, TrumpRx, allows patients to access partnered pharmaceutical manufacturers and direct-to-customer programs for certain eligible prescription drugs. These medications include GLP-1 medications like Wegovy (in both pen and pill form), Ozempic, and Zepbound, available at a lower cost through pricing agreements. Unreliable Advertising Claims On September 9, 2025, President Trump issued a memorandum calling on FDA Commissioner Makary and the U.S. Department of Health and Human Services (HHS) to begin efforts enforcing prescription drug advertising laws and regulations on compounded GLP-1 drugs. The FDA also announced that it would take steps to “rein in misleading direct-to-consumer pharmaceutical advertisements.” By the end of the quarter, the FDA issued over 40 warning letters and more than 100 cease-and-desist letters to compounding pharmacies and other related entities for deceptive, misleading, or inappropriate advertising practices related to compounded drugs. The warning letters cited four categories of inappropriate advertising claims around compounded drugs or compounded drug products. The FDA warned pharmaceutical companies to comply with regulatory standards and that the administration would take enforcement actions to address these issues. The FDA specified that enforcement measures would include reviews of drug advertisements and implementation of artificial intelligence and tech-enabled tools for surveillance. The Trump administration, including HHS Secretary Robert F. Kennedy, Jr., relayed that the primary goal of their efforts is to bring back transparency, accountability, and trust in healthcare, and to protect both patients and public health. The President’s memorandum emphasized a push for more truthful messaging in drug advertisements, with more comprehensive disclosure about safety and drug risks. He stated that the aim was to prevent these advertisements from compromising the doctor-patient relationship, from “promoting medication over lifestyle improvements,” and from pushing the more expensive versions of these medications without informing patients. Further, the FDA criticizes the loophole created by the “adequate provision” requirement (1997), a provision requiring drug advertisements for TV and radio to direct consumers to separate sources for complete drug risks and safety facts. The loophole, the agency argues, enables pharmaceutical companies to downplay the risks of their product, overstate its benefits, and push the consumer to find the important safety information elsewhere. The FDA argues this shift is happening in digital and social media today with paid influencers blurring the line between evidence-based information and a desire to simply push products. "Regulatory scrutiny of compounded GLP-1 products is intensifying,” said Anne Marie Lyddy, Senior Risk Management Consultant with ProAssurance, who weighed in on the regulations: We are watching how evolving rules will redefine acceptable practices. The ongoing balance between innovation and compliance will continue to shape the risk for clinicians and patients. A proactive approach that is grounded in rigorous governance, meticulous documentation, and transparent patient communication will be critical to navigate the complexities going forward. If you would like more information, please contact Andrea Linder at (800) 282-6242 or andrealinder@proassurance.com. Comments are closed.
