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Postshortage Compounded GLP-1 RA Market in 2 States With Potentially High Demand
Michael J DiStefano1,2, Adeleine Tilley1, Deepika Paratane1
1Department of Clinical Pharmacy, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado Anschutz Medical Campus, Aurora.
Compounded glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are widely available despite shortages ending. Many compounding facilities lack sterile compounding licenses or have faced disciplinary actions, posing risks.
Area of Science:
- Pharmaceutical Sciences
- Clinical Pharmacy
- Regulatory Science
Background:
- The market for compounded glucagon-like peptide-1 receptor agonists (GLP-1 RAs) grew due to supply issues, high costs, and limited insurance coverage.
- An assessment of compounded GLP-1 RA products is needed following the resolution of semaglutide and tirzepatide shortages.
Purpose of the Study:
- To characterize compounded GLP-1 RA products available in the market.
- To describe patient care and monitoring practices for compounded GLP-1 RAs.
- To identify the pharmacies supplying compounded GLP-1 RA products.
Main Methods:
- A cross-sectional secret shopper study was conducted from August to October 2025.
- Weight-loss clinics and medical spas advertising compounded GLP-1 RAs were identified in West Virginia and Oklahoma.
- Investigators assessed product offerings, patient care aspects, and supplier characteristics, including licensing and disciplinary actions.
Main Results:
- 75 clinics/spas offered compounded GLP-1 RAs; 9.3% offered oral formulations, and 56.0% offered products with added B vitamins.
- 23 compounding facilities supplied these products; 19.0% were not licensed for sterile compounding.
- Since 2023, one facility received FDA warning letters, and 13.6% faced state-level disciplinary actions.
Conclusions:
- Compounding facilities continue to produce GLP-1 RAs with added ingredients post-shortage.
- The diverse sourcing of compounded GLP-1 RAs includes unlicensed or recently disciplined facilities.
- This landscape presents significant clinical and regulatory challenges.
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