Weight Loss Medicines

Ozempic, a well-known medication for type 2 diabetes, has gained popularity for its off-label use in weight loss, leading to increased scrutiny by authorities. Recently, U.S. Customs and Border Protection (CBP) officers in Cincinnati seized several shipments of the drug, underscoring the growing demand and associated risks.

There has never been a more fortunate time for compounding pharmacies looking to capitalize on the "Gold Rush" of Ozempic. Due to the forecasted limited supply of the brand name drug, the FDA has put Ozempic on the shortage list, which will allow for a more accommodating set of rules regarding compounding and distribution of semaglutide-based drugs.

The semaglutide industry is relatively new, and significant regulatory enforcement typically lags by at least two years. Accordingly, all participants involved in the semaglutide supply chain should implement well-designed compliance programs now to reduce the risk and severity of future regulatory action.

Intense semaglutide demand has now drawn the attention of regulators beyond the Food & Drug Administration (FDA) and state boards. Last month, a woman was charged by federal prosecutors with violations of criminal law related to misbranded and adulterated weight loss drugs. This prosecution marks the first of many to come.

As summer approaches, soaring demand for weight-loss drugs like Ozempic, Wegovy, and semaglutide compounded copies, will exacerbate the existing short-supply, raising both consumer prices and pharmacy profits for those positioned to capitalize.

Anthony Mahajan delves into the intricacies of off-label prescribing and dispensing for medications such as Ozempic, Wegovy, and Rybelsus. Mahajan discusses legal nuances applicable to manufacturers, physicians, and pharmacists, offering practical guidance for healthcare providers to manage off-label exposure effectively.

Semaglutide compounding pharmacies face regulatory threats as state boards interpret statutes restrictively; Health Law Alliance, led by Anthony Mahajan, emphasizes broader permissions, countering misinterpretations.