Connecticut Attorney General (AG) William Tong has launched a series of enforcement actions aimed at curbing the distribution and online sale of both “research use only” (RUO) and compounded GLP-1 weight loss drugs. The Connecticut AG’s office has filed a lawsuit against Triggered Brand, a Florida-based company accused of violating the Connecticut Unfair Trade Practices Act (CUTPA) and operating as an unlicensed pharmacy. Triggered Brand allegedly marketed and sold “research grade” GLP-1 peptides directly to Connecticut consumers for weight loss, circumventing the need for prescriptions or medical supervision. Additionally, a Civil Investigative Demand has been issued to Made In China, an international trade platform that advertises and sells similar “research grade” GLP-1 products to U.S. consumers. The investigation seeks information regarding the marketing, sales, and manufacturing of these products, which are often shipped in packaging designed to evade customs enforcement. Both of these actions targeting sale of RUO GLPs and sale of GLPs directly to consumers without a prescription are in the interest of patient safety. Additionally, the Connecticut AG has expanded enforcement initiatives, targeting the advertising, distribution, and compounding of compounded GLP-1 drugs as well.
Legitimate vs. Overly Broad and Prohibitive Warnings to Healthcare Providers
In addition to the two above-detailed enforcement actions, the Connecticut AG recently issued Warning Letters to weight loss clinics and medical spas across Connecticut, instructing them to stop marketing and prescribing GLP-1 drugs produced by compounding pharmacies. The Warning Letters refer to the misrepresentation of compounded GLP-1s as either FDA-approved or ‘generic’ versions of commercially available brands like Ozempic®, Wegovy®, Mounjaro®, or Zepbound®. The AG emphasized that these practices may violate state consumer protection laws, specifically CUPTA, and signaled a willingness to pursue further legal action against violators. Again, a Warning Letter to address such practices is well within the AG’s purview in the interest of patient safety.
However, the Warning Letters may have gone too far, as it appears that legitimate pharmacy compounding by 503As is also being labeled as dangerous, citing FDA concerns and attempting to limit patient access to compounded GLP-1 medications. The AG Letter states that Weight Loss clinics and medical spas can no longer advertise and prescribe that they offer compounded GLP-1s, allegedly because they have been removed from the FDA 506e shortage list.
The advertising of compounded drugs was decided by the Supreme Court decades ago and is permitted. Additionally, 503A pharmacy compounders may continue to compound GLP-1s as they do any other drug but may not compound ‘essentially a copy’ as articulated in FDA Guidance. Under FDA Guidance documents, the FDA’s explicit limit to compounding in bulk specifically pertains to the compounding of versions that are ‘essentially a copy.’ A pharmacy may still engage in anticipatory compounding. Indeed, the USP chapters which provide for Best Compounding Practices limit batches to 250 units.
The AG’s Letter appears to suggest that compounded versions cannot be advertised or prescribed due to their lack of FDA approval, or because they contain vitamins that are not FDA-approved. Importantly, this interpretation may not fully reflect the regulatory framework governing compounded medications. Compounds are by statutory definition, not FDA-approval. In fact, they are statutorily exempt from that requirement pursuant to Section 503A of the Federal Food, Drug & Cosmetic Act. Vitamins are also considered as Dietary Supplements, and by definition, are not required to undergo FDA approval. Finally, the AG’s Letter appears to misinterpret the FDA’s position regarding the approval of compounds for cosmetic purposes, as well as the scope of the FDA-approved indication for chronic weight management in adults. Specifically, the AG’s Letter suggests that such approval is limited to adults diagnosed with obesity or those who are overweight with a related comorbidity, such as hypertension or cardiovascular disease. The Letter goes on to state that GLP-1s are not FDA-approved for ‘cosmetic’ purposes, implying that they cannot be prescribed or compounded for off label uses. Physicians may write for off label use of any drug and the art and practice of medicine permits off label use, including for cosmetic purposes. The AG’s assertion appears to impose a restriction that may be broader than necessary, potentially impacting both compounding and the art/practice of medicine.
Call for Enhanced Federal Oversight
AG Tong, together with a bipartisan coalition representing 38 states and territories, has called on the FDA to strengthen enforcement against the illegal sale of counterfeit and unapproved (i.e. RUO) GLP-1 drugs. The coalition’s Letter underscores the dangers posed by online retailers selling active GLP-1 ingredients under the pretense of “research purposes” and urges greater collaboration between the FDA and state pharmacy boards to ensure the safety and legitimacy of compounded medications. Certainly, these are important consumer protection initiatives.
Guidance for Consumers
AG Tong and Department of Consumer Protection Commissioner Bryan T. Cafferelli have both stressed the importance of obtaining GLP-1 medications exclusively from legitimate, licensed pharmacies and under the supervision of a qualified healthcare provider. They strongly warn against purchasing medications from unlicensed online sources, highlighting the risks of contamination, overdose, and other serious health complications. Again, these are important consumer protection initiatives.
How Frier Levitt Can Assist Pharmacies Facing Board of Pharmacy Actions
Frier Levitt represents pharmacies nationwide in challenging actions taken by Boards of Pharmacy. Our attorneys—including pharmacists and former state licensing board attorneys—possess extensive experience navigating complex state and federal pharmacy laws and advocating for the rights of pharmacies. If your pharmacy is facing adverse action from a Board of Pharmacy, Frier Levitt can provide guidance and representation from a knowledgeable Board of Pharmacy attorney. Contact us.
