April 28, 2023

FDA clarifies position on compounding semaglutide sodium

In a letter sent this week to NABP, FDA clarified its position on the compounding of semaglutide sodium.

FDA stated that it is aware that some compounders may be using salt forms of semaglutide, including semaglutide sodium and semaglutide acetate. However, the FDA emphasized that it is not aware of any basis for compounding a drug using these semaglutide salts that would meet federal law requirements that limit the types of active ingredients that can be used in compounding.

Compounded drugs can be made and distributed with fewer restrictions when the drug appears on the FDA’s drug shortages list. However, the FDA has clarified that the listing of Wegovy and Ozempic on the Drug Shortage website does not authorize the compounding of semaglutide sodium or any other salt form of semaglutide.