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Title 21

Displaying title 21, up to date as of 9/11/2026. Title 21 was last amended 9/11/2026.
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Title 21Food and DrugsPart / Section
Chapter IFood and Drug Administration, Department of Health and Human Services1 – 1299
Subchapter DDrugs for Human Use300 – 499
Part 312Investigational New Drug Application312.1 – 312.320
Subpart AGeneral Provisions312.1 – 312.10
Subpart BInvestigational New Drug Application (IND)312.20 – 312.38
Subpart CAdministrative Actions312.40 – 312.48
Subpart DResponsibilities of Sponsors and Investigators312.50 – 312.70
Subpart EDrugs Intended to Treat Life-threatening and Severely-debilitating Illnesses312.80 – 312.88
Subpart FMiscellaneous312.110 – 312.145
§ 312.110Import and export requirements.
§ 312.120Foreign clinical studies not conducted under an IND.
§ 312.130Availability for public disclosure of data and information in an IND.
§ 312.140Address for correspondence.
§ 312.145Guidance documents.
Subpart GDrugs for Investigational Use in Laboratory Research Animals or In Vitro Tests312.160
§ 312.160Drugs for investigational use in laboratory research animals or in vitro tests.
Subpart H [Reserved]
Subpart IExpanded Access to Investigational Drugs for Treatment Use312.300 – 312.320
§ 312.300General.
§ 312.305Requirements for all expanded access uses.
§ 312.310Individual patients, including for emergency use.
§ 312.315Intermediate-size patient populations.
§ 312.320Treatment IND or treatment protocol.