FDA Warns on Certain Forms of Compounded Semaglutide

Certain compounded forms of semaglutide may not contain the same active ingredient as the approved versions for type 2 diabetes and weight-loss, the FDA warned earlier this week.

Due to unprecedented demand for the GLP-1 receptor agonist, supply shortages of the injectable forms (Ozempic, Wegovy) have resulted in more and more compounded versions of the drug popping up on the market, and the agency said it has received reports of adverse events associated with these formulations, along with reports of compounders using semaglutide sodium and semaglutide acetate.

These salt forms of semaglutide are different active ingredients than the approved drugs, “which contain the base form of semaglutide,” the statement explained.

“Products containing these salts, such as semaglutide sodium and semaglutide acetate, have not been shown to be safe and effective,” the FDA said. “Healthcare professionals who are considering working with compounders to obtain semaglutide products should be aware that compounders may be using salt forms of semaglutide. FDA is not aware of any basis for compounding a drug using semaglutide salts that would meet federal requirements.”

No generic form of semaglutide exists, but compounded forms — a process that involves combining, mixing, or altering ingredients to create the medication — can be made for individual patients during a shortage. Ongoing demand has landed Ozempic and Wegovy on the FDA’s national drug shortage list for the past several months, where they still sit as of May 2023.

The Alliance for Pharmacy Compounding (APC) also recently weighed in on the topic, noting in a statement that semaglutide sodium “does not appear to meet the criteria for compounding,” given that it’s not the active pharmaceutical ingredient (API) listed on the reference products’ labeling, it does not appear on FDA’s bulk compounding list, and it does not have a U.S. Pharmacopeia monograph.

“Until more is known about whether or not semaglutide sodium is an API used in either of the FDA-approved drug products, it is APC’s current position that compounding with semaglutide sodium technically is not eligible to be used in a compounded medication,” the organization stated.

FDA emphasized that patients with a semaglutide prescription from a licensed medical provider should only obtain the drug “from state-licensed pharmacies or outsourcing facilities registered with FDA.”

“Purchasing medicine online from unregulated, unlicensed sources can expose patients to potentially unsafe products that have not undergone appropriate evaluation or approval, or do not meet quality standards,” the FDA said. “If you choose to use an online pharmacy, FDA’s BeSafeRx campaign resources and tools can assist in making safer, more informed decisions when purchasing prescription medicine online.”

The agency asked that any adverse events associated with these compounded drugs be submitted to the MedWatch Adverse Event Reporting program.