COMPOUNDED GLP-1 PRODUCT QUALITY AND SAFETY: EVIDENCE FROM A SECRET SHOPPER STUDY
Author(s)
Michael J. DiStefano, PhD, Adeleine Tilley, BS, Harry Gyimah Gyamfi, MSc, Deepika Paratane, MS, Gina Moore, PharmD MBA, Kavita V. Nair, PhD;
University of Colorado Anschutz Medical Campus, Aurora, CO, USA
University of Colorado Anschutz Medical Campus, Aurora, CO, USA
OBJECTIVES: The unprecedented scale of the compounded GLP-1 market raised concerns regarding drug quality and safety. This study identified pharmacy facilities supplying compounded GLP-1s to clinics and medical spas and described facility characteristics pertaining to drug quality and safety.
METHODS: We identified facilities supplying compounded GLP-1s through a cross-sectional secret shopper study of weight loss clinics and medical spas advertising GLP-1s for weight loss. Clinics and spas were identified using location-based Google searches centered on Core-Based Statistical Areas. Searches focused on two states, purposively chosen based on obesity rate and insurance mix to represent areas of high-demand for compounded GLP-1s. Secret shopper calls used a standardized script refined through piloting. The script included a question regarding which pharmacy the business obtained compounded GLP-1s from. For identified pharmacies, we collected publicly available information regarding facility type, status of facility licenses, and disciplinary actions. Calls were conducted from August-October 2025.
RESULTS: We identified 103 clinics and spas advertising compounded GLP-1s for weight loss. Among 78 that responded to calls, we identified 22 facilities that supplied compounded GLP-1s. Two facilities were neither licensed as a 503A facility nor were registered as a 503B facility. Three 503A facilities did not possess an active sterile compounding license. One facility had received FDA warning letters and two had been subject to state-level disciplinary action since 2023. Two of these disciplinary actions referred to sterile compounding violations. Three facilities had received a Form FDA 483 since 2023, all referring to objectionable sterile compounding practices.
CONCLUSIONS: Across two states likely representing high-demand, sourcing of compounded GLP-1s by weight loss clinics and medical spas is highly diverse. The FDA and state boards of pharmacy should increase their oversight of compounding facilities. Clinicians and policymakers should communicate to patients interested in compounded GLP-1s how to assess the quality of facilities that produce these products.
METHODS: We identified facilities supplying compounded GLP-1s through a cross-sectional secret shopper study of weight loss clinics and medical spas advertising GLP-1s for weight loss. Clinics and spas were identified using location-based Google searches centered on Core-Based Statistical Areas. Searches focused on two states, purposively chosen based on obesity rate and insurance mix to represent areas of high-demand for compounded GLP-1s. Secret shopper calls used a standardized script refined through piloting. The script included a question regarding which pharmacy the business obtained compounded GLP-1s from. For identified pharmacies, we collected publicly available information regarding facility type, status of facility licenses, and disciplinary actions. Calls were conducted from August-October 2025.
RESULTS: We identified 103 clinics and spas advertising compounded GLP-1s for weight loss. Among 78 that responded to calls, we identified 22 facilities that supplied compounded GLP-1s. Two facilities were neither licensed as a 503A facility nor were registered as a 503B facility. Three 503A facilities did not possess an active sterile compounding license. One facility had received FDA warning letters and two had been subject to state-level disciplinary action since 2023. Two of these disciplinary actions referred to sterile compounding violations. Three facilities had received a Form FDA 483 since 2023, all referring to objectionable sterile compounding practices.
CONCLUSIONS: Across two states likely representing high-demand, sourcing of compounded GLP-1s by weight loss clinics and medical spas is highly diverse. The FDA and state boards of pharmacy should increase their oversight of compounding facilities. Clinicians and policymakers should communicate to patients interested in compounded GLP-1s how to assess the quality of facilities that produce these products.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
HPR136
Topic
Health Policy & Regulatory
Disease
SDC: Diabetes/Endocrine/Metabolic Disorders (including obesity)