Study Finds Clinics Continue to Prescribe Compounded GLP-1s
A new study published in JAMA Health Forum found that many medical spas and weight-loss clinics continue to offer compounded semaglutide and tirzepatide despite the resolution of federal shortages that initially enabled widespread compounding of the drugs.
Researchers from the University of Colorado Anschutz Medical Campus used “secret shoppers” to evaluate 75 brick-and-mortar weight-loss clinics and medical spas in Oklahoma and West Virginia. They found that 92% offered compounded semaglutide and nearly 87% offered compounded tirzepatide after the FDA declared the shortages resolved.
The study also identified 23 compounding suppliers serving those businesses. According to the researchers, four lacked licenses required for sterile compounding and four had been subject to disciplinary action. The study did not evaluate the quality or safety of medications dispensed by those suppliers.
More than half of businesses offering compounded GLP-1 medications reported formulations combined with B vitamins, while others included ingredients such as glycine or levocarnitine. Researchers suggested the trend may reflect efforts to market products as individualized formulations to get around the FDA’s restrictions on compounded copies of commercially available drugs.
The FDA has stated that, now that shortages have been resolved, compounded versions that are essentially copies of commercially available drugs generally do not qualify for compounding exemptions unless specific legal requirements are met. The agency has also indicated that simply adding ingredients such as vitamin B12 may not automatically establish a clinically meaningful difference from an FDA-approved product.
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“Since the compounding exception due to the GLP-1 shortage hasn’t been available for some time, compounding for GLP-1s is only permitted by FDA rules in a limited set of circumstances,” says Patrick O’Brien, JD, general counsel for the American Med Spa Association. “These are tied to patient specific needs. To offer these treatment options compliantly, it is essential that practices adopt appropriate SOPs and partner with a reputable pharmacy that understands and strictly follows these patient driven exceptions.”
Practices that continue to offer compounded products should ensure they understand current FDA guidance, verify the credentials and compliance history of compounding pharmacies, and maintain documentation supporting any patient-specific rationale for compounded medications.
