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On March 10 th , the FDA issued guidance clarifying that 503A and 503B drug compounders must soon cease compounding semaglutide injection products[i] or risk enforcement action.[ii] This has a significant impact on compounding pharmacies as, under the Federal Food, Drug, and Cosmetic Act (the FD&C ), drug compounders are permitted to compound their own copies of a patented drug if the FDA determines it is in shortage
Costs can fluctuate but its around $1,200 for a monthly supply of the drugs, after the patient pays for cold storage, shipping, customs and tax, he said
For most patients, gastrointestinal side effects like nausea significantly improve or resolve completely within 23 months as tolerance develops
