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U.S. Code of Federal Regulations
Regulations most recently checked for updates: Aug 27, 2025
All Titles
Title 21
Chapter I
Part 312
Subpart I - Subpart I—Expanded Access to Investigational Drugs for Treatment Use
§ 312.300 - General.
§ 312.305 - Requirements for all expanded access uses.
§ 312.310 - Individual patients, including for emergency use.
§ 312.315 - Intermediate-size patient populations.
§ 312.320 - Treatment IND or treatment protocol.
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