Online Sellers of Compounded GLP-1s Often Don’t Mention Risks

Many online sellers of compounded GLP-1 receptor agonists may be misleading customers, a cross-sectional study suggested.

Out of 79 websites that sold a compounded GLP-1 agent, 11 (13.9%) failed to mention the medications were compounded versions and seven (8.9%) wrongfully referred to them as generics, Alissa Chen, MD, MPH, of Yale University School of Medicine in New Haven, Connecticut, and colleagues detailed in a research letter in JAMA Health Forum.

Half of the websites (49.4%) failed to mention risks including adverse effects, warnings and precautions, and contraindications, and 40.5% advertised an efficacy claim not in the authorized label of the FDA-approved branded GLP-1 agent.

A total of 34 websites (43%) stated the compounded medications weren’t FDA approved, while 29 (36.7%) stated or implied they were.

“Compounded medications contain the same active ingredients as in branded medications but may contain different inactive ingredients and are not FDA approved,” Chen’s group pointed out. “U.S. federal law requires advertising of all prescriptions, including compounded medications, to be ‘truthful, non-misleading, and accurate’; however, the extent to which compounded medication advertising meets this mandate is unclear.”

An estimated 11% of GLP-1 users obtain their prescription through an online provider or website, so it is important online sellers use non-misleading advertising, they added.

But compound pharmacies and their products “fall into a regulatory gray zone,” noted accompanying viewpoint authors T. Joseph Mattingly II, PharmD, MBA, PhD, of the University of Utah College of Pharmacy in Salt Lake City, and Rena Conti, PhD, of Boston University.

“Since compounded products are copies of originator products, the pharmacy references the FDA-approved label attesting to safety and efficacy, but unlike the originator, the pharmacy does not technically attest to their manufacturing according to Current Good Manufacturing Practice,” they explained. “Moreover, unlike originator products, the 2002 Thompson v. Western States Medical Center Supreme Court decision ruled that advertising prohibitions on compound pharmacies and their products are a violation of the First Amendment.”

Although their advertising may not necessarily be illegal, they do appear to violate Congress’s intent to support patient access to safe and effective drugs, added Mattingly and Conti.

In an editor’s note, Julie Donohue, PhD, of the University of Pittsburgh, said it’s “unclear” if FDA regulations intended to apply to advertising by manufacturers should also apply to compound pharmacies.

While compounders won’t be able to make copies of GLP-1 agents as shortages start to resolve, resolving the shortage “will not prevent questionable marketing practices of online pharmacies and others, nor will it resolve the illegal trade of counterfeit or adulterated products,” Mattingly and Conti said.

In order to better protect consumers, they recommended more advertising requirements for compounders, “aggressive” prosecution of counterfeiters, and an independent task force to determine when to add or remove a drug from the drug shortages list.

Chen and co-authors initially reviewed 98 websites that sold GLP-1 agents from July through September 2024. Of these, 79 websites sold compounded semaglutide (Ozempic, Wegovy, Rybelsus), tirzepatide (Mounjaro, Zepbound), or liraglutide (Victoza, Saxenda), or a prescription for such. All websites sold compounded semaglutide, 72.2% sold compounded tirzepatide, and 3.8% sold compounded liraglutide.

A total of 52 websites (65.8%) featured a mark of certification, 50 of which displayed LegitScript certification. Two websites didn’t provide prescriptions for compounded GLP-1 drugs and required a prior prescription.

All but one website required clinician involvement to obtain the medication and 63.3% required a completion of a questionnaire reviewed by a clinician. Five websites required an in-person visit, eight required lab work, and 31 required a telehealth visit.

Including discounts, the median first month’s price for the compounded medication was $231 for semaglutide, $330 for tirzepatide, and $248 for liraglutide.

The researchers pointed out that because they reviewed all information reported on websites, including on subpages and linked blogs, there’s a good chance they overestimated the amount of information that typical consumers review.

Please enable JavaScript to view the comments powered by Disqus.