A pharmacy is interested in compounding an FDA-approved prod…
A pharmacy is interested in compounding an FDA-approved product which is commercially available and is not on the FDA’s shortage list. The pharmacy manager has discussed the product with local physicians and determined that the physicians would write prescriptions for about 200 patients each month. The pharmacy manager believes they can offer this product at a much lower price than the commercial option without any significant changes to the product. The pharmacy is compliant with USP , , and . How is the compounding pharmacy violated 503A regulations?