Title 21

PART 212 SUBPART G

Subpart G - Laboratory Controls

• 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.

21:4.0.1.1.12.7.1.1	SECTION 212.60	212.60 What requirements apply to the laboratories where I test components, in-process materials, and finished PET drug products
21:4.0.1.1.12.7.1.2	SECTION 212.61	212.61 What must I do to ensure the stability of my PET drug products through expiry

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