Audit finds compounded semaglutide and tirzepatide still sold after shortages ended

A new audit of the compounded GLP-1 market in two states found that weight-loss clinics and medical spas were still selling compounded semaglutide and tirzepatide after the federal shortages of those drugs ended, and that some of the pharmacies supplying them had licensing gaps or disciplinary records ^[1][2].

The study was published in JAMA Health Forum by researchers at the University of Colorado Anschutz Medical Campus ^[2]. From August to October 2025, researchers ran a "secret shopper" study of brick-and-mortar weight-loss clinics and medical spas that advertised GLP-1 drugs for weight loss and offered compounded versions. The 75 businesses were in West Virginia and Oklahoma, two states the authors selected based on obesity rates and insurance mix. The businesses were identified in January 2025 through location-based web searches, and researchers also reviewed business websites and public records on compounding facilities ^[1][2].

Of the 75 businesses, 69 (92.0%) offered compounded semaglutide and 65 (86.7%) offered compounded tirzepatide — the active ingredients in Ozempic, Wegovy and Rybelsus (semaglutide) and Mounjaro and Zepbound (tirzepatide). Seven businesses (9.3%) said they offered oral compounded GLP-1 formulations, and 42 (56.0%) said their products were combined with B vitamins ^[2]. Other additives included levocarnitine at 5 businesses (6.7%) and glycine at 4 (5.3%). For 17 businesses (22.7%), the additive was unknown or not identified ^[2].

Researchers traced the products to 23 compounding facilities. Four of 21 (19.0%) were not licensed to perform sterile compounding ^[1][2]. Three of 22 facilities (13.6%) had faced state board of pharmacy disciplinary action since 2023, and one of 23 (4.3%) had received multiple FDA warning letters since 2023 ^[1][2]. Three facilities (13.0%) had an open FDA Form 483 issued since 2023, and all three of those forms involved sterile compounding practices ^[2]. Twenty-two of 23 facilities (95.6%) held state licenses, and 3 (13.0%) were federally registered 503B outsourcing facilities ^[2].

The study also described how care was arranged. A nurse practitioner or physician assistant consulted at 42 businesses (56.0%) and a physician at 30 (40.0%). Consultations were in person at 52 businesses (69.3%), virtual at 4 (5.3%) and both at 17 (22.7%). Follow-up was scheduled at least once a month at 46 businesses (61.3%), less than monthly at 14 (18.7%), and 3 businesses (4.0%) required no follow-up ^[2].

The authors concluded that after the semaglutide and tirzepatide shortages ended, compounding facilities have continued to make GLP-1 products with added ingredients, and that this sourcing raises clinical and regulatory challenges ^[1][2].

Why it matters for patients

Compounded drugs are not FDA-approved. The approved products — Ozempic, Wegovy and Rybelsus for semaglutide, Mounjaro and Zepbound for tirzepatide — have fixed ingredients and doses reviewed by the FDA. The audit found that more than half of the businesses in these two states were selling compounded versions mixed with B vitamins, and smaller numbers with levocarnitine or glycine, so what is in a given vial can differ from the approved product ^[2].

The supplier findings matter because injectable drugs must be made under sterile conditions. The audit found that 4 of 21 supplier facilities did not hold sterile compounding licenses and that 3 of 4 disciplinary actions referred to sterile compounding practices ^[2]. Working from public records, researchers could not identify the additives used by 17 of the 75 businesses ^[2].

There are limits to what this audit shows. It covered two states, not the country, and it recorded what businesses told a secret shopper, not what was in the products. The study did not test samples for strength, purity or sterility, and it did not measure patient outcomes; those results have not been reported ^[1][2]. Whether the same pattern holds in other states has not been reported. The study also does not name the businesses or the compounding facilities it examined, so it cannot be used to check the record of a specific clinic or pharmacy ^[2].