For people living with the chronic disease of obesity, GLP-1 medications have been life-changing. Research shows that sustained use reduces the risk of cardiovascular disease and other obesity-related complications while improving overall health and lowering hospitalizations and medical costs.
Yet, at the same time, access to these medications remains uneven. Many state Medicaid programs — including California’s Medi-Cal — do not cover GLP-1 therapies for obesity treatment, leaving many patients without affordable options and pushing some toward a rapidly expanding market of risky alternatives.
A Gray Market with Real Patient Safety Consequences.
Across the country, telehealth companies, med spas, and large compounding pharmacies are marketing compounded GLP-1 products as “personalized” treatments. Unlike FDA-approved medicines, compounded versions are not reviewed by the U.S. Food and Drug Administration for safety, effectiveness, or quality before they are sold to patients.
Evidence of safety concerns is growing, and the patient safety risks associated with these products are becoming impossible to ignore.
Investigators documented cases in which patients reported severe nausea, vomiting, and headaches after receiving compounded GLP-1 formulations, including incidents that required urgent medical care. The California State Board of Pharmacy’s filing also describes instances such as medications being dispensed at concentrations significantly higher than prescribed, and the pharmacy allegedly failing to disclose complaints involving product quality and adverse effects.
As of July 2025, the FDA has received more than 1,100 adverse events linked to compounded GLP-1s, while research has shown that patients taking certain compounded versions face more than twice the hospitalization risk compared to those using FDA-approved versions. Many of the med spas and wellness clinics making and marketing these drugs operate without pharmacy-level oversight and obtain ingredients from unregistered foreign suppliers – raising the risk of contaminated or counterfeit products.
A Path Forward: Expanding Access and Protecting Patients.
Protecting patients requires both improving access to approved treatments and closing regulatory gaps that allow unsafe practices to flourish.
In California, Medi-Cal coverage for FDA-approved obesity management medications ended on January 1. Reversing course would give patients access to clinically validated treatments — reducing the incentive to consider compounded alternatives.
At the federal level, Congress has an opportunity to directly crack down on inappropriate mass-compounding practices. The bipartisan SAFE Drugs Act (H.R. 6509), introduced by Representatives Rudy Yakym (R-IN) and André Carson (D-IN), is a critical piece of patient safety legislation that prevents unlawful mass compounding of unapproved drugs, improves transparency through reporting requirements, and strengthens oversight of large-scale facilities through more routine FDA inspections.
People living with obesity deserve medications they can trust. Providing coverage through Medicaid and implementing common-sense reforms is essential to preventing dangerous practices and protecting the evidence-based obesity care Californians, and patients across the country, depend on.
Research shows that sustained use reduces the risk of cardiovascular disease and other obesity-related complications while improving overall health and lowering hospitalizations and medical costs.
Yet, at the same time, access to these medications remains uneven. Many state Medicaid programs — including California’s Medi-Cal — do not cover GLP-1 therapies for obesity treatment, leaving many patients without affordable options and pushing some toward a rapidly expanding market of risky alternatives.
A Gray Market with Real Patient Safety Consequences.
Across the country, telehealth companies, med spas, and large compounding pharmacies are marketing compounded GLP-1 products as “personalized” treatments. Unlike FDA-approved medicines, compounded versions are not reviewed by the U.S. Food and Drug Administration for safety, effectiveness, or quality before they are sold to patients.
Evidence of safety concerns is growing, and the patient safety risks associated with these products are becoming impossible to ignore.
Investigators documented cases in which patients reported severe nausea, vomiting, and headaches after receiving compounded GLP-1 formulations, including incidents that required urgent medical care. The board’s filing also describes instances such as medications being dispensed at concentrations significantly higher than prescribed, and the pharmacy allegedly failing to disclose complaints involving product quality and adverse effects.
As of July 2025, the FDA has received more than 1,100 adverse events linked to compounded GLP-1s, while research has shown that patients taking certain compounded versions face more than twice the hospitalization risk compared to those using FDA-approved versions. Many of the med spas and wellness clinics making and marketing these drugs operate without pharmacy-level oversight and obtain ingredients from unregistered foreign suppliers – raising the risk of contaminated or counterfeit products.
A Path Forward: Expanding Access and Protecting Patients.
Protecting patients requires both improving access to approved treatments and closing regulatory gaps that allow unsafe practices to flourish.
In California, Medi-Cal coverage for FDA-approved obesity management medications ended on January 1. Reversing course would give patients access to clinically validated treatments — reducing the incentive to consider compounded alternatives.
At the federal level, Congress has an opportunity to directly crack down on inappropriate mass-compounding practices. The bipartisan SAFE Drugs Act (H.R. 6509), introduced by Representatives Rudy Yakym (R-IN) and André Carson (D-IN), is a critical piece of patient safety legislation that prevents unlawful mass compounding of unapproved drugs, improves transparency through reporting requirements, and strengthens oversight of large-scale facilities through more routine FDA inspections.
People living with obesity deserve medications they can trust. Providing coverage through Medicaid and implementing common-sense reforms is essential to preventing dangerous practices and protecting the evidence-based obesity care Californians and patients across the country depend on.