TOPLINE

After shortages of semaglutide and tirzepatide ended, a secret shopper study of 75 brick-and-mortar weight-loss clinics and medical spas in West Virginia and Oklahoma found that compounding facilities continued to manufacture GLP-1 receptor agonists (RAs) with added ingredients, most frequently B vitamins. Some compounding pharmacy facilities lacked licenses to perform sterile compounding or had recently faced disciplinary actions.

METHODOLOGY

• Supply shortages, high costs, and limited insurance coverage created a robust market for compounded GLP-1 RAs. With the shortages of semaglutide and tirzepatide resolved and the FDA resuming enforcement of laws restricting compounding of these drugs, a current market assessment was needed.
• Researchers conducted a cross-sectional secret shopper study of brick-and-mortar weight-loss clinics and medical spas advertising GLP-1 RAs for weight loss in two states with potentially high demand — West Virginia and Oklahoma — from August to October 2025.
• An initial search identified 103 businesses via a web mapping application; after secret shopper calls, 75 were confirmed as offering compounded GLP-1 RAs and included in the analysis.
• Secret shopper calls collected standardized information including available compounded medications, oral formulations, additives, whether an initial consultation was required and whether it was in person or virtual, required follow-up frequency, the types of healthcare professionals conducting consultations, and the name of the source compounding pharmacy.
• A total of 24 compounding pharmacies were identified as suppliers; 23 (excluding one multistate facility) were analyzed for facility type, sterile-compounding license status, objectionable conditions noted by investigators, and disciplinary actions since 2023.

TAKEAWAY

• Of the 75 businesses, 92.0% (n = 69) offered compounded semaglutide, 86.7% (n = 65) offered compounded tirzepatide, and 9.3% (n = 7) offered oral or sublingual compounded formulations.
• Overall, 58.7% of businesses (n = 44) confirmed their GLP-1 RAs were compounded with an additive: B vitamins were the most common additive (56.0%; n = 42), whereas levocarnitine (6.7%; n = 5) and glycine (5.3%; n = 4) were less common.
• Among 21 state-licensed compounding facilities for which the presence or absence of an active sterile compounding license could be confirmed, 19.0% (n = 4) were not licensed to perform sterile compounding.
• Since 2023, 1 of 23 facilities (4.3%) had received two FDA warning letters, both citing violations of sterile compounding practices; 3 of 22 (13.6%) had been subject to state-level disciplinary action, with two actions citing sterile compounding violations.

IN PRACTICE

“Clinicians or patients who are considering prescribing or using 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,” the authors of the study wrote.

SOURCE

The study was led by Michael J. DiStefano, PhD, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado Anschutz Medical Campus, Aurora, Colorado. It was published online in JAMA Health Forum.

LIMITATIONS

These cross-sectional findings applied only to August-October 2025 and should not be generalized beyond that timeframe. Respondents may have provided incorrect information during the secret shopper calls. The location-based search strategy may have missed relevant businesses. Moreover, the findings may not be generalizable to online-only telehealth platforms.

DISCLOSURES

The study was funded by the National Institute for Health Care Management. One author disclosed grants from the National Institute for Health Care Management Foundation, the Institute for Clinical and Economic Review, the National Pharmaceutical Council, and the PhRMA Foundation; another disclosed speaking fees from Sanofi, Amgen, MJH Life Sciences, Eli Lilly and Company, and the American Academy of Neurology.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.