FDA has increasingly focused on escalating its enforcement activity against compounded GLP-1 drugs following US President Donald Trump’s September 9, 2025, memorandum on prescription drug advertisements, which called on the FDA commissioner and the secretary of the US Department of Health and Human Services (HHS) to take actions to enforce prescription drug advertising laws and regulations. That same day, FDA announced its intent to take aggressive steps to “rein in misleading direct-to-consumer pharmaceutical advertisements.” Throughout the remainder of the quarter, FDA issued more than 40 warning letters and more than 100 cease-and-desist letters to compounding pharmacies and related entities for deceptive advertising.

Just a day before FDA’s most recent announcement, the Trump administration launched a new government website for TrumpRx, through which patients can access partnered pharmaceutical manufacturer direct-to-consumer programs for eligible drug products, including brand-name GLP-1 products.

The same day, telehealth company Hims & Hers announced the addition of a compounded pill version of GLP-1 medications to its product line. The launch of the compounded pill was met with a renewed lawsuit against Hims & Hers by the brand manufacturer for allegations of intellectual property infringement, and a notice from the HHS Office of General Counsel that it had referred the matter to the US Department of Justice (DOJ) for investigation. The next day, on February 6, 2026, FDA issued its enforcement announcement, marking the latest in FDA’s ongoing efforts to regulate the compounding of GLP-1 medications. Shortly thereafter, Hims & Hers announced it would remove its compounded GLP-1 pill from the market.

FDA’s statement was not limited to Hims & Hers; the agency noted it would take decisive steps to restrict the GLP-1 APIs themselves. This focus is not new. In 2025, FDA launched an import alert to block potentially unsafe GLP-1 APIs from entering the US market. The import alert established a “green list” of FDA-vetted foreign manufacturers whose GLP-1 APIs meet safety and quality standards. Pursuant to the import alert, APIs imported from non-green-list sources are subject to detention without physical examination at the border. That move targeted foreign-sourced APIs used in compounding, especially those from manufacturers not meeting FDA standards. Additionally, on February 18, 2026, FDA Commissioner Marty Makary stated in an interview with CNBC that FDA will focus on importation of unapproved APIs. Accordingly, FDA likely intends to increase its focus on API sources through increased inspection activity, border restrictions, or both.

FDA also emphasized that it intends to take enforcement actions against misleading direct-to-consumer advertising and marketing, referring back to the warning letters FDA issued in fall 2025. These warning letters flagged four general categories of inappropriate advertising claims related to the compounded drugs:

• Claims stating that compounded drug products have the same active ingredients as FDA-approved drugs.
• Claims implying that compounded drugs are the equivalent of their FDA-approved counterparts.
• Claims suggesting that compounded drugs are “clinically proven” or otherwise efficacious.
• Claims implying that the compounded drugs are FDA approved.

States have also implemented their own regulatory requirements that adopt and, in some cases, expand on FDA’s compounding regulations. For example, in June 2025, California updated its compounding regulations to require pharmacists to verify and document that compounded products produce a clinically significant difference, although pharmacists are not required to make independent clinical determinations. As the focus on compounding practices continues to grow, it is possible that states will implement increasingly more rigorous compounding regulations.

At the federal level, members of Congress have introduced two prominent pieces of legislation that attempt to address some of these issues. Representatives Diana Harshbarger (R-TN) and Buddy Carter (R-GA) introduced the Drug Shortage Compounding Patient Access Act (H.R. 5316) in September 2025. This legislation would:

• Allow state-licensed 503A pharmacies to compound shortage drugs for urgent hospital or clinical use with physician certification, with a 60-day transition period after a drug leaves the FDA shortage list.
• Require drug manufacturers to notify FDA of anticipated disruptions, and direct FDA to also consider shortage data from hospitals, clinicians, and patients.
• Mandate annual updates to FDA’s bulk drug substances list, removal of outdated labeling restrictions, and provision of a 180-day transition period when shortages end.
• Require clear labeling to indicate when a medication has been compounded.

Representatives Rudy Yakym (R-IN) and André Carson (D-IN) also introduced the Safeguarding Americans from Fraudulent and Experimental (SAFE) Drugs Act (H.R. 6509) in December 2025. This legislation would:

• Codify the definition of “essentially a copy” to prevent illegal mass compounding of unapproved versions of FDA-approved drugs.

• Require any compounding pharmacy that ships more than 20 out-of-state prescriptions of a drug to report that activity to FDA.

• Require FDA inspection of outsourcing facilities before they begin compounding new products, with re-inspections at least every two years.

• Promote compliance with current good manufacturing practices (cGMPs) through more frequent engagement between FDA and outsourcing facilities.

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

Senators Jim Banks (R-IN) and Jim Heinrich (D-NM) introduced the Senate version of the SAFE Drugs Act (S. 3794) on February 5, 2026.

Banks also sent a letter to FDA on February 9, 2026, that urged the agency to “aggressively enforce restrictions” on compounded weight-loss drugs that are widely marketed by telehealth platforms and online pharmacies, and to provide more information on any agency actions. Banks asked FDA to describe which websites the agency and the DOJ believe are violating federal drug law and to consider “the feasibility of requiring more explicit warnings on such websites.”

Next steps

FDA has made clear that it will take decisive steps toward regulating compounded GLP-1 medications. However, the exact form of these steps remains unclear. Based on the focus of the announcement, the agency will likely use its inspection authority on manufacturers of GLP-1 APIs and increase enforcement against imported APIs. Stakeholders also can expect that FDA will continue to issue warning letters for misleading claims in advertising and marketing materials. During the CNBC interview, FDA Commissioner Makary remarked that he hopes 2026 will see the end of unlawful mass compounding of GLP-1s.

While it is unclear if any legislative efforts will succeed, the introduction of the bipartisan bills, as well as formal inquiries from members of Congress to FDA, represent a heightened interest and awareness of the sensitivities in compounding policy.

Accordingly, stakeholders should:

• Ensure APIs are sourced from green-list-approved facilities and manufactured in accordance with cGMPs.
• Refrain from using claims that state or imply compounded drugs are equivalent to FDA-approved products.
• Include appropriate disclaimers noting that FDA has not approved or otherwise reviewed compounded GLP-1 products.
• Closely monitor FDA’s enforcement actions for additional guidance on current agency thinking.
• Monitor federal efforts, including legislation, hearings, and formal inquiries.
• Track state laws and regulations concerning compounding practices for additional regulatory regimes.

The McDermott difference

We will continue to monitor FDA’s oversight of compounding pharmacies and broader efforts to address deceptive prescription drug advertising. If you have questions about how these developments may affect your business, please contact a member of McDermott Will & Schulte’s Food, Drug & Medical Device Group or McDermott+.