This subpart applies to combination products. It establishes which current good manufacturing practice requirements apply to these products. This subpart 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.
21 CFR Part 4 · Regulation of Combination Products
§ 4.1 What is the scope of this subpart?
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Amendment history
Federal Register documents that created or amended this section.
- 78 FR 4321 22 Jan 2013