A facility qualifies as an outsourcing facility if it engages in anticipatory compounding of sterile drugs and complies with which regulatory provision?

• A. FDA section 504A of the FDC Act
• B. FDA Drug Supply Chain Security Act
• C. FDA section 503B of the FDC Act
• D. FDA 2020 Compounding Guidelines

Answer: (C)

Outsourcing facilities are defined by the provision that created Section 503B of the Federal Food, Drug, and Cosmetic Act. This rule establishes a pathway for compounding sterile drugs in anticipation of demand and governs these facilities with current good manufacturing practices, FDA registration, and FDA inspections. In other words, to qualify as an outsourcing facility, a site must operate under the Section 503B framework, which distinguishes it from traditional, patient-specific compounding regulated under Section 503A.

The Drug Supply Chain Security Act is about tracking and tracing drug products through the supply chain, not about designating outsourcing facilities. The 2020 Compounding Guidelines are guidance rather than a binding regulatory provision. So the specific regulatory basis for an outsourcing facility is Section 503B of the FDC Act.