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The patient demand greatly outweighs the federal government's appetite to enforce, so we are in a unique legal environment.” But again, Holt says, “simply because a peptide is not banned does not make it legal.” A pharmacy can compound a bulk substance if it meets one of three criteria: It has a USP monograph (official, written quality standards for a substance that is approved by the FDA), it is a component of an FDA-approved drug, or it’s on the FDA 503A Positive List

party verification with a published certificate of analysis to ensure concentration levels and identity standards meet strict quality control protocols