Title 21

PART 4 SUBPART A

Subpart A - Current Good Manufacturing Practice Requirements for Combination Products

• 21 U.S.C. 321, 331, 351, 352, 353, 355, 360, 360b-360f, 360h-360j, 360l, 360hh-360ss, 360aaa-360bbb, 371(a), 372-374, 379e, 381, 383, 394; 42 U.S.C. 216, 262, 263a, 264, 271.
• 78 FR 4321, Jan. 22, 2013, unless otherwise noted.

21:1.0.1.1.4.1.63.1	SECTION 4.1	4.1 What is the scope of this subpart
21:1.0.1.1.4.1.63.2	SECTION 4.2	4.2 How does FDA define key terms and phrases in this subpart
21:1.0.1.1.4.1.63.3	SECTION 4.3	4.3 What current good manufacturing practice requirements apply to my combination product
21:1.0.1.1.4.1.63.4	SECTION 4.4	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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