Compounded Preparation
A medication prepared by a licensed pharmacy by combining or altering ingredients to meet a specific patient or clinical need; not an FDA-approved drug.
A compounded preparation is a medication prepared by a licensed compounding pharmacy by combining, mixing, or altering ingredients to create a specific dosage form for a specific patient (503A) or for office-stock supply (503B). Compounded preparations are not FDA-approved drugs.
Compounding pharmacies operate under FDA oversight of the compounding pharmacy operations themselves, while individual compounded preparations are regulated by state pharmacy boards (503A) or the FDA's outsourcing facility framework (503B). Each batch is prepared per state and federal compounding regulations.
For wholesale procurement, the relevant question is which source pharmacy compounds a given preparation, what documentation accompanies the batch, and what storage and shipping requirements apply.