The FDA and the Alliance for Pharmacy Compounding (APC) are cautioning patients against purchasing compounded semaglutide from online pharmacies utilizing semaglutide salts. The APC asserts that its compounders have the right to produce legitimate compounded semaglutide, in contrast to the stance of some state boards of pharmacies, Novo Nordisk, and certain media reports.

Last year, the high demand for diabetes and weight loss drugs, including Ozempic and Wegovy, led to these medications being added to the FDA’s Drug Shortages list. In response, the FDA permitted compounded forms of semaglutide. However, as of May 2023, both Ozempic and Wegovy remain on the Drug Shortages list.

The APC states that FDA-approved semaglutide drugs are still considered “currently in shortage.” This designation doesn’t necessarily mean complete unavailability but indicates a potential insufficient supply to meet demand.

Novo Nordisk, the sole company in the U.S. with FDA-approved products containing semaglutide, including Wegovy, Ozempic, and Rybelsus, has asserted its patent rights, sending cease-and-desist letters to some compounding pharmacies. The company is actively monitoring and taking action against entities engaged in the unlawful sale of compounded semaglutide, false advertising, and trademark infringement.

Novo Nordisk emphasizes the safety, quality, and effectiveness assurances of its FDA-approved drugs compared to compounded products, which may pose health risks. The company does not endorse the safety or effectiveness of products claiming to contain semaglutide that are not their branded products.

The APC argues that the FDA’s guidance on compounding during drug shortages doesn’t distinguish for patented drugs, and compounded versions are not viewed as “essentially a copy” of the FDA-approved drug.

The organization advises pharmacy compounders to seek legal counsel regarding patent issues and compounding semaglutide medications. The FDA also warns patients about the potential for products sold as “semaglutide” to contain different active ingredients, such as salt formulations, which have not been proven safe and effective.

In conclusion, the situation involves a complex interplay between the pharmaceutical company’s patent, compounding regulations during shortages, and concerns about the safety and legitimacy of compounded semaglutide.

Credited Source: DRUGTOPICS