Title 21

PART 312 SUBPART I

Subpart I - Expanded Access to Investigational Drugs for Treatment Use Source:74 FR 40942, Aug. 13, 2009, unless otherwise noted.

• 21 U.S.C. 321, 331, 351, 352, 353, 355, 360bbb, 371; 42 U.S.C. 262.
• Source: 52 FR 8831, Mar. 19, 1987, unless otherwise noted.

21:5.0.1.1.3.9.1.1	SECTION 312.300	312.300 General.
21:5.0.1.1.3.9.1.2	SECTION 312.305	312.305 Requirements for all expanded access uses.
21:5.0.1.1.3.9.1.3	SECTION 312.310	312.310 Individual patients, including for emergency use.
21:5.0.1.1.3.9.1.4	SECTION 312.315	312.315 Intermediate-size patient populations.
21:5.0.1.1.3.9.1.5	SECTION 312.320	312.320 Treatment IND or treatment protocol.

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