Title 21

PART 212 SUBPART H

Subpart H - Finished Drug Product Controls and Acceptance

• 21 U.S.C. 321, 351, 352, 355, 371, 374; Sec. 121, Pub. L. 105-115, 111 Stat. 2296.
• 74 FR 65431, Dec. 10, 2009, unless otherwise noted.

21:4.0.1.1.12.8.1.1	SECTION 212.70	212.70 What controls and acceptance criteria must I have for my finished PET drug products
21:4.0.1.1.12.8.1.2	SECTION 212.71	212.71 What actions must I take if a batch of PET drug product does not conform to specifications

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