US states warn compounding pharmacies of legal action for producing/selling unauthorized weight-loss drugs containing semaglutide, an unapproved FDA ingredient.
Several U.S. states are threatening legal action against compounding pharmacies that are manufacturing or dispensing unauthorized versions of the weight-loss drugs Ozempic and Wegovy. State regulators are concerned about the safety of some compounding pharmacies that are using semaglutide, an active ingredient that is not approved by the FDA. Compounding pharmacies are allowed to create medications tailored to specific patient needs, but they must comply with FDA guidelines. Regulators are particularly concerned about medications made using semaglutide sodium salt, which is a cheaper and modified version of the compound used for scientific research but not intended for use in humans. Compounding pharmacists making unauthorized versions of Ozempic and Wegovy may face fines, probation, or lose their license to dispense medications. The warning from state regulators means compounding pharmacists across the nation, including Nevada, could face legal action.
AUTHOR: Ayesha Mehdi is a partner in the healthcare group at Spencer Fane, LLP, and provides legal counsel to healthcare practitioners and closely-held healthcare businesses in the Las Vegas Greater Area. With expertise in corporate, transactional, regulatory, and licensure matters, Ayesha offers comprehensive support to clients in the Nevada healthcare industry. Ayesha has authored multiple publications on healthcare law and is also a sought-after speaker at regional and national seminars and conferences organized by legal and healthcare associations. If you require legal assistance for your healthcare business or practice, Ayesha is available to help. You can reach her at firstname.lastname@example.org or 702.408.3416.
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