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U.S. Code of Federal Regulations
Regulations most recently checked for updates: Aug 28, 2025
All Titles
Title 21
Chapter I
Part 4
Subpart A - Subpart A—Current Good Manufacturing Practice Requirements for Combination Products
§ 4.1 - What is the scope of this subpart?
§ 4.2 - How does FDA define key terms and phrases in this subpart?
§ 4.3 - What current good manufacturing practice requirements apply to my combination product?
§ 4.4 - How can I comply with these current good manufacturing practice requirements for a co-packaged or single-entity combination product?
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