2:11 PM, Feb. 21, 2026

Glucagon-like peptide-1 agonists (“GLP-1”) weight-loss drugs have become massively popular in the last few years driven, in part, by online telehealth platforms. These telehealth platforms are able to utilize limited-time shortage rules and personalized medicine exceptions for compound pharmacies under Section 503A of the Federal Food, Drug, and Cosmetic Act. However, recent guidance by the Food and Drug Administration (“FDA”) may significantly limit future access to GLP-1 weight-loss drugs for telehealth platforms exploiting compounding exceptions.

The two main GLP-1 weight-loss drugs, Novo Nordisk’s Wegovy and Eli Lilly’s Zepbound, were both massive clinical successes. For example, Wegovy promised an impressive fifteen percent weight-loss in overweight and obese adults. Due to significant demand, Wegovy and Zepbound faced shortages shortly after their approvals: the FDA added Wegovy to the shortage list in 2022 and Zepbound in 2024.

To keep up with demand for GLP-1 weight loss drugs, online compounding pharmacies began creating identical versions of popular weight loss drugs. Under limited-time shortage rules, compounding pharmacies are able to make identical GLP-1 weight-loss drugs despite lacking the rights to the drug. The central policy of the rule is that, if a drugmaker cannot meet demand, compounding pharmacies can make up the supply difference. Compounded drugs are distinct from generic drugs. While generic drugs are reviewed and approved by the FDA to meet certain requirements, compounded drugs are not approved or reviewed by the FDA. But by early 2025, Eli Lilly and Novo Nordisk had resolved the shortage issues, and the FDA removed Wegovy and Zepbound from its shortage list.

Despite the end of the shortage, many online telehealth platforms continue selling compounded versions of these GLP-1 drugs. Federal law stipulates that compounding pharmacies may compound a licensed drug if “there is a change, made for an identified individual patient, which produces for that patient a significant difference, as determined by the prescribing practitioner, between the compounded drug and the comparable commercially available drug product.” The FDA notes that this regulation is intended to protect patients for whom commercially available drugs are not viable, such as people with an allergy to a non-active ingredient or people who need a higher dose than the commercially available product.

Online telehealth platforms have exploited this exception by continuing to sell unbranded GLP-1 drugs by prescribing “personalized” plans to be filled by compounding pharmacies. Typically, these compounded versions are identical to the branded GLP-1 products but are often sold for as low as 10% of the price. Compound pharmacies filled over eighty million doses of semaglutide [Wegovy] just in 2024.

In February 2026, the FDA announced new restrictions on compounding pharmacies operating under this exception. The FDA is pointing to concerns surrounding quality, safety, and efficacy of these compounded drugs. As a result, telehealth sites have indicated they will restrict sales of GLP-1 drugs. For example, telehealth company Hims & Hers cancelled plans to sell a new GLP-1 oral pill similar to the recently FDA-approved oral Wegovy. The response from drugmakers has been positive as an Eli Lilly spokesperson applauded the FDA action.

Recent guidance by the Food and Drug Administration may significantly limit future access to GLP-1 weight-loss drugs through online telehealth platforms exploiting compounding pharmacy exceptions.

The new restrictions implicate concerns on both sides. Protecting drugmakers’ intellectual property is crucial in encouraging future development of medical breakthroughs. On the other hand, it is controversial to cut off patients relying on the low prices offered by compounded drugs. U.S. medical insurance policies rarely cover GLP-1 drugs, thus raising their price—sometimes to thousands of dollars per month.

While drugmakers have attempted to competitively price their products via promotions, it remains unclear if affordable supply will meet the demand first generated by compounding pharmacies. Thousands may be unable to afford the non-compounded versions of GLP-1s and effectively kicked off their prescribed medication. Moving forward, regulators must balance the availability of affordable drugs with protecting the intellectual property of pharmaceutical companies.

Matthew Winget

Prior to law school, Matthew spent six years in the clinical research industry, where he gained firsthand experience with the regulatory and operational challenges of global drug development. He is currently a second-year student at the University of North Carolina School of Law and is a member of the Holderness Moot Court Team and a Staff Member on the North Carolina Journal of Law and Technology.