Is Compounding FDA Approved?
FDA approval of a drug is extremely expensive and inflexible. Approved drugs must adhere to the formulation approved to retain approval. In other words, if just the flavor of an approved medication is changed, the drug is no longer approved. So, because of the changing nature of compounding, it can’t be FDA approved. However, the Food and Drug Administration considers compounding both legal and ethical, and specifies that a compounded drug must be prescribed by a licensed health care provider for one specific patient and prepared by a licensed pharmacy. While the FDA does not approve or regulate compounding per se, state boards of pharmacy do.
