A pharmacy compounds a drug that matches a commercially avai…
A pharmacy compounds a drug that matches a commercially available drug’s active pharmaceutical ingredient and strength and is administered by the same route. The only difference between the two drugs is that the commercially available drug includes a dye that makes the patient itchy, and the compounded drug does not include this dye. A patient has received a prescription for the compounded product for many years, so the pharmacy regularly compounds it in advance and dispenses it when the patient brings in their prescription. The prescription states that the compounded version provides a medical benefit for this patient. Based on the information above, is this compounded drug compliant with FDCA 503A?