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Title 21

Displaying title 21, up to date as of 7/10/2026. Title 21 was last amended 7/09/2026.
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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 316Orphan Drugs316.1 – 316.52
Subpart AGeneral Provisions316.1 – 316.4
§ 316.1Scope of this part.
§ 316.2Purpose.
§ 316.3Definitions.
§ 316.4Address for submissions.
Subpart BWritten Recommendations for Investigations of Orphan Drugs316.10 – 316.14
§ 316.10Content and format of a request for written recommendations.
§ 316.12Providing written recommendations.
§ 316.14Refusal to provide written recommendations.
Subpart CDesignation of an Orphan Drug316.20 – 316.30
Subpart DOrphan-drug Exclusive Approval316.31 – 316.36
§ 316.31Scope of orphan-drug exclusive approval.
§ 316.34FDA recognition of exclusive approval.
§ 316.36Insufficient quantities of orphan drugs.
Subpart EOpen Protocols for Investigations316.40
§ 316.40Treatment use of a designated orphan drug.
Subpart FAvailability of Information316.50 – 316.52
§ 316.50Guidance documents.
§ 316.52Availability for public disclosure of data and information in requests and applications.