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FDAs Authority For 503A pharmacies: FDA can inspect but doesnt routinely Takes action when problems are identified Provides guidance on compounding standards Can take enforcement action against unsafe practices For 503B facilities: FDA registration required Regular FDA inspections Must report adverse events Subject to enforcement for cGMP violations The Drug Shortage Connection Why shortage status matters: Normally, compounders cant make essentially copies of approved drugs Drug shortage status provides an exception FDA maintains the drug shortage list Semaglutides presence on this list enables legal compounding Current status: Wegovy and Ozempic have been on the shortage list This permits compounding of semaglutide Status can change as supply improves Compounders must monitor shortage status FDA Enforcement Actions Types of action: Warning letters for violations Import alerts for foreign suppliers Injunctions to stop operations Criminal prosecution in severe cases Product recalls Recent concerns: FDA has warned about some semaglutide products Concerns include products containing salts (semaglutide sodium) not approved in branded products Some products have failed testing FDA has issued safety communications What this means for consumers: Not all compounded semaglutide is equivalent Working with reputable providers matters FDA oversight provides some protection Vigilance is still important How to Evaluate a Compounding Pharmacy Not all compounding pharmacies are equal

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