FDA Cracking Down on Compounded GLP-1 Drugs

The U.S. Food and Drug Administration (FDA) says it plans to take formal action against Hims & Hers, a telehealth company that has prescribed and shipped compounded versions of GLP-1 weight-loss medications.

According to Reuters, the agency intends to block the company’s access to certain drug ingredients and may refer the case to the U.S. Department of Justice for further investigation.

Compounded medications are custom-mixed versions of drugs created by pharmacies, often used when approved medications are in short supply or when patients need specific formulations. However, regulators have raised concerns that some compounded versions of popular GLP-1 weight-loss drugs may bypass important safety and manufacturing standards.

The scrutiny comes as demand for medications such as Wegovy and other GLP-1 treatments has surged nationwide.

Hims & Hers recently abandoned plans to sell a compounded tablet version of Novo Nordisk’s Wegovy for about $49 per month, amid growing regulatory pressure.