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e-CFR data is current as of February 25, 2021

Title 21Chapter ISubchapter APart 4Subpart A → §4.1


Title 21: Food and Drugs
PART 4—REGULATION OF COMBINATION PRODUCTS
Subpart A—Current Good Manufacturing Practice Requirements for Combination Products


§4.1   What is the scope of this subpart?

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.

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