Compounded GLP-1 receptor agonists, such as semaglutide and tirzepatide, remain widely available at weight-loss clinics and medical spas despite the official resolution of drug shortages. A secret shopper study published in JAMA Health Forum found that 92% of clinics surveyed offered compounded semaglutide and 86.7% offered compounded tirzepatide, with many suppliers modifying formulas by adding ingredients like B vitamins to bypass federal enforcement of the Federal Food, Drug and Cosmetic Act (FDCA).
Compounded Drug Availability After Shortages
The FDA declared that shortages of tirzepatide and semaglutide resolved in December 2024 and February 2025, respectively. Under the FDCA, once a drug is no longer in shortage, pharmacies are generally prohibited from compounding copies of FDA-approved products. Despite this, a study led by Michael J. DiStefano, PhD, of the University of Colorado Anschutz Medical Campus, revealed that the market for these drugs persists.
In a secret shopper investigation of 75 brick-and-mortar clinics across two states, researchers found that the vast majority of facilities continued to provide compounded versions of these medications. DiStefano noted that his team did not anticipate the end of the shortage to significantly reduce the market. Instead, the data suggests a shift in product composition rather than a decline in availability.
Did you know? Researchers estimate that there could be more than 4,000 businesses across the United States currently offering compounded GLP-1 drugs for weight loss.
The Rise of “Personalized” GLP-1 Formulas
To navigate the FDA’s resumption of enforcement, many compounders have altered their products by adding ingredients such as B vitamins, levocarnitine, or glycine. The study found that 56% of the surveyed clinics offered these combination products. While some suppliers market these as “personalized” versions, manufacturers like Eli Lilly have warned that these additions are attempts to circumvent regulations.
In March, Eli Lilly issued an open letter advising consumers against using compounded tirzepatide containing vitamin B12, citing safety concerns. Conversely, the Alliance for Pharmacy Compounding has defended the use of B12, describing it as a well-studied and benign ingredient. DiStefano suggests that as long as brand-name drug prices remain high, demand for these compounded alternatives is unlikely to diminish.
Regulatory and Safety Risks in Compounding
The secret shopper study identified significant regulatory discrepancies among the 23 unique compounding pharmacies supplying the clinics. Of the 21 state-licensed facilities whose credentials could be verified, four lacked active sterile compounding licenses. Furthermore, investigators found that three pharmacies had open FDA Form 483s—documents detailing objectionable conditions—yet these facilities remained operational.
Researchers emphasized that the production of GLP-1 agonists requires sterile environments. “Our findings indicate that patients using these products may be exposed to fibers, particles, or microorganisms that could increase the risks of infection and adverse events,” the authors wrote. The FDA has recently taken steps to crack down on these practices, including a proposal to remove specific GLP-1 drugs from the 503B bulks list, citing a lack of clinical necessity for compounding them.
Pro Tip: If you are considering a compounded GLP-1 medication, DiStefano suggests reaching out directly to a licensed pharmacist or your state board of pharmacy to verify the credentials and safety history of the supplier.
Frequently Asked Questions
Are compounded GLP-1 drugs FDA-approved?
No. Compounded drugs are not FDA-approved, meaning the agency has not verified their quality, safety, or efficacy before they reach the patient.
Why are some compounded drugs mixed with B vitamins?
According to the study, some compounders add ingredients like B12, levocarnitine, or glycine to differentiate their products and potentially circumvent FDA restrictions on compounding copies of drugs that are no longer in shortage.
How can I verify a compounding pharmacy?
You can check if a facility has an active sterile compounding license through your state’s board of pharmacy. You can also search the FDA’s database for warning letters or Form 483 inspection reports associated with specific pharmacy names.
Will demand for compounded weight-loss drugs decrease?
DiStefano notes that demand is unlikely to slow down as long as brand-name options remain expensive. Additionally, as new medications reach the market, the demand may simply shift toward those newer, potentially more effective options.
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