Regulation of combination products (21 CFR 4.1-4.4).

Part 4 of Title 21 of the Federal Code of Regulations defines the current good manufacturing practice requirements for combination products (in terms of food safety: drug, device, or biological product that is part of a combination product).
This Regulation clarifies the application of current good manufacturing practice regulations to combination products, and provides a regulatory framework for designing and implementing the current good manufacturing practice operating system at facilities that manufacture co-packaged or single-entity combination products.