Which statement about 503B outsourcing facilities is true?

Which statement about 503B outsourcing facilities is true?

• A. They may compound any commercially available product at any time
• B. They may only compound sterile products
• C. They may not compound any commercially available products unless the product is documented as being in short supply
• D. They may compound products without FDA authentication

Answer: (C)

Outsourcing facilities under 503B are designed to produce large‑scale, sterile drug products to address shortages, under FDA oversight. The key limitation is that they may not compound a product that is already commercially available unless there is a documented shortage. This keeps these facilities focused on filling gaps in supply rather than duplicating readily obtainable FDA‑approved products. For example, if a sterile injectable is in shortage, an outsourcing facility may compound an equivalent product to meet demand; if the product isn’t in shortage and is readily available, compounding it would not be allowed. While they do compound sterile products, the defining rule tied to their purpose is the shortage documentation requirement.

Outsourcing facilities under 503B are designed to produce large‑scale, sterile drug products to address shortages, under FDA oversight. The key limitation is that they may not compound a product that is already commercially available unless there is a documented shortage. This keeps these facilities focused on filling gaps in supply rather than duplicating readily obtainable FDA‑approved products. For example, if a sterile injectable is in shortage, an outsourcing facility may compound an equivalent product to meet demand; if the product isn’t in shortage and is readily available, compounding it would not be allowed. While they do compound sterile products, the defining rule tied to their purpose is the shortage documentation requirement.