The FDA has issued a reminder to compounders clarifying the conditions under which compounded drugs qualify for exemptions under sections 503A and 503B of the FD&C Act, as national GLP-1 supply stabilizes. The agency explains when a compounded product is considered an 'essentially a copy' of a commercially available drug, using semaglutide combined with vitamin B12 as an example. Compounded products matching a commercially available drug in API, strength, and route of administration do not qualify for exemptions unless a prescriber documents a significant clinical difference for an individual patient.
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