Compounded Semaglutide, Tirzepatide Sold After FDA Limits Ended
Key Takeaways
- Compounded semaglutide and tirzepatide remained commercially available through businesses in Oklahoma and West Virginia after shortage-related flexibility ended.
- Among businesses offering compounded obesity medications, 92% offered compounded semaglutide and 86.7% offered compounded tirzepatide.
- Compounded products with additives were offered by 58.7% of businesses, and vitamin B was the most common additive.
- Consultations for compounded obesity medications were most often handled by nurse practitioners or physician assistants, with physicians less common and registered nurses rare.
- Most identified suppliers held active state licenses, but some state-licensed facilities were not permitted to perform sterile compounding.
In a JAMA Health Forum secret-shopper study, investigators contacted businesses advertising obesity medications in Oklahoma and West Virginia from August to October 2025 and asked whether medications were available, whether they were compounded, which agents were offered, and whether additives were included. They confirmed that 75 businesses were selling compounded medications, identified 23 supplying pharmacies, and checked business information against the Food and Drug Administration (FDA) database of 503B outsourcing facilities and state board of pharmacy databases. FDA removed tirzepatide from the shortage list in December 2024, semaglutide in February 2025, and prohibited distribution of compounded forms after May 22, 2025.
Semaglutide and tirzepatide dominated the compounded offerings, with one business also listing an unnamed triple receptor agonist. Additives were commonly presented as part of ostensibly tailored products, with glycine cited as one example alongside the more frequently offered vitamin B. Among supplying facilities, 95.6% had an active state license, 13% were registered as 503B outsourcing facilities, and 19% of state-licensed facilities were not permitted to perform sterile compounding. Several supplying facilities also had FDA or state disciplinary actions related to sterile compounding.
Nurse practitioners or physician assistants provided consultations at 56% of businesses, compared with 40% for physicians and 1.3% for registered nurses. Most clinics required in-person visits, and monthly follow-up was the most common schedule at 61.3% of businesses.
The observations were limited to businesses and suppliers identified in Oklahoma and West Virginia, and the available reporting supports conclusions about market availability, additive use, consultation patterns, and supplier regulatory status rather than product efficacy or comparative safety outcomes. Michael J. DiStefano, PhD, and colleagues described the compounded glucagon-like peptide-1 (GLP-1) market and supply chain as diffuse and challenging for regulators. The investigators also raised concerns about exposure to unsafe or ineffective products, while stopping short of reporting outcome data on those risks.
Months after FDA deadlines took effect, the analysis described a market that remained active and was characterized by additive-containing products, mixed consultation models, and a diffuse supplier network. The broader enforcement challenge reflected the investigators’ interpretation of a market that remained active after shortage-era compounding allowances had ended.
Clinician Questions
How was post-shortage availability of compounded semaglutide and tirzepatide evaluated in Oklahoma and West Virginia?
Investigators conducted a secret-shopper study published in JAMA Health Forum. They contacted businesses advertising obesity medications in Oklahoma and West Virginia from August to October 2025, asked whether medications were available, whether they were compounded, which agents were offered, and whether additives were included, and checked business information against the FDA 503B outsourcing facility database and state board of pharmacy databases.
What additives were reported in compounded semaglutide and tirzepatide products after shortage-related compounding limits ended?
At 58.7% of businesses, compounded medications were sold with additives, and vitamin B was the most commonly offered additive.
Who provided consultations for compounded obesity medications, and what follow-up pattern was most common?
Consultations for compounded obesity medications were provided by nurse practitioners or physician assistants at 56% of businesses, physicians at 40%, and registered nurses at 1.3%, and monthly follow-up appointments were the most common pattern at 61.3% of businesses; most clinics required in-person visits.
What regulatory issues were identified among pharmacies supplying compounded GLP-1 obesity drugs?
Investigators identified 23 supplying pharmacies, 95.6% had an active state license, 13% were registered with the FDA as 503B outsourcing facilities, and 19% of state-licensed facilities were not permitted to perform sterile compounding; one facility had two FDA warning letters for sterile compounding violations, two facilities had state sanctions for sterile compounding violations, and a third had another state disciplinary action.
Recommended Reading
- For more on GLP-1 therapy considerations: Contraceptive Counseling in the Era of GLP-1 Therapies
- For more on the broader GLP-1 landscape: How GLP-1s Provide New Options to Manage Heart Disease