Subpart I—Expanded Access to Investigational Drugs for Treatment Use

1. CFR
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3. Title 21
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5. Chapter I
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7. Part 312
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9. Subpart I

Sections

Section numbering in the official eCFR can be non-consecutive. Omitted section numbers are not treated here as reserved unless the source explicitly labels them that way.

• 312.300
  § 312.300 General.
• 312.305
  § 312.305 Requirements for all expanded access uses.
• 312.310
  § 312.310 Individual patients, including for emergency use.
• 312.315
  § 312.315 Intermediate-size patient populations.
• 312.320
  § 312.320 Treatment IND or treatment protocol.