JAMA Health Forum secret-shopper study finds compounded GLP-1s still widely sold

Researchers who posed as customers calling weight-loss clinics and medical spas in two states found that compounded GLP-1 drugs were still widely for sale in late 2025, months after federal shortages ended and the FDA's deadline for compounding semaglutide and tirzepatide passed. The study was published in JAMA Health Forum ^[1][3].

The FDA removed tirzepatide (Mounjaro/Zepbound) from its drug shortage list in December 2024 and semaglutide (Ozempic/Wegovy) in February 2025, and prohibited distribution of compounded versions after May 22, 2025 ^[2]. The secret-shopper calls ran from August to October 2025 ^[1].

What the callers found

An initial search using a web mapping application identified 103 businesses in West Virginia and Oklahoma, two states chosen for their obesity rates and insurance mix; 75 confirmed by phone that they were selling compounded GLP-1 receptor agonists and were included in the analysis ^[1][3].

Of those 75 businesses, 92.0% (69) offered compounded semaglutide and 86.7% (65) offered compounded tirzepatide ^[1][3]. Seven businesses (9.3%) reported offering oral or sublingual compounded formulations ^[3]. One business offered an unnamed triple receptor agonist ^[2].

More than half — 58.7%, or 44 businesses — said their product was compounded with an added ingredient. B vitamins were by far the most common (56.0%, 42 businesses), followed by levocarnitine (6.7%, 5) and glycine (5.3%, 4). For 22.7% of businesses, the additive was unknown or not identified ^[1][3]. Adding ingredients has been one way compounders argue a product is "personalized" rather than a copy of an approved drug. "Many people expected this compounding to continue, but shifted toward products ostensibly tailored to meet specific patient needs, for example by adding B vitamins or glycine," study author Michael J. DiStefano, PhD, of the University of Colorado Anschutz Medical Campus told Healio ^[2].

Care varied. Nurse practitioners or physician assistants handled consultations at 56.0% of businesses, physicians (MD or DO) at 40.0%, and a registered nurse at 1.3% ^[1][2]. In-person visits were required at 69.3% of clinics, 22.7% allowed either in-person or virtual, and 5.3% were virtual only ^[1]. Monthly or more frequent follow-up was required by 61.3%; 18.7% required less than monthly follow-up, 9.3% left it up to the patient or clinician, and 4% required no follow-up at all ^[1][2].

Who is making the drugs

The callers identified 24 compounding pharmacies as suppliers; 23 were analyzed after excluding one multistate facility ^[3]. Of those 23, 95.6% held an active state license and 13.0% were registered with the FDA as 503B outsourcing facilities ^[1][2].

Among the 21 state-licensed facilities where sterile-compounding status could be confirmed, 4 (19.0%) were not licensed to perform sterile compounding ^[1][3]. Since 2023, one facility (4.3%) had received two FDA warning letters, both citing sterile compounding violations; 3 of 22 (13.6%) had faced state-level disciplinary action, two of those citing sterile compounding ^[3]. Three of 23 facilities had an open FDA Form 483 since 2023, all referring to sterile compounding practices ^[1].

Why it matters for patients

Injectable GLP-1 products are sterile drugs. The study's finding that roughly one in five identified state-licensed suppliers lacked a sterile compounding license, and that several had inspection or disciplinary histories tied to sterile practices, points to uneven quality control behind products that look similar from the customer's side of the counter ^[1][3].

The study authors wrote that clinicians or patients considering these products "should verify the compounding facility's licensure status with either the FDA or the relevant state board of pharmacy and contact the facility directly to determine whether the bulk drug substance is manufactured in an FDA-registered facility that can provide a valid certificate of analysis" ^[3]. DiStefano added that, in his opinion, buyers should not purchase from a vendor unwilling to name the supplying pharmacy, because knowing the pharmacy lets someone check with the state board ^[2].

The findings also show how diffuse this market is. "There are so many different types of providers and individual compounding pharmacies involved. This definitely poses a challenge for regulators," DiStefano said ^[2].

Limits and open questions

The results describe only August through October 2025 and should not be generalized beyond that window, the researchers noted. Businesses may have given callers incorrect information, the location-based search may have missed some clinics, and the findings may not apply to online-only telehealth platforms ^[3]. Prices were not reported in the sources.

The study was funded by the National Institute for Health Care Management ^[3]. Note that the sources list author credit differently: the journal page names Harry Gyimah Gyamfi, Gina D. Moore and Kavita V. Nair ^[1], while Healio and Medscape describe DiStefano as the lead author ^[2][3]. Whether enforcement has changed the picture since October 2025 is not yet known from these sources.