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Title 21

Displaying title 21, up to date as of 7/13/2026. 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 310New Drugs310.3 – 310.548
Subpart AGeneral Provisions310.3 – 310.6
§ 310.3Definitions and interpretations.
§ 310.4Biologics; products subject to license control.
§ 310.6Applicability of “new drug” or safety or effectiveness findings in drug efficacy study implementation notices and notices of opportunity for hearing to identical, related, and similar drug products.
Subpart BSpecific Administrative Rulings and Decisions310.100 – 310.103
§ 310.100New drug status opinions; statement of policy.
§ 310.103New drug substances intended for hypersensitivity testing.
Subpart CNew Drugs Exempted From Prescription-Dispensing Requirements310.200 – 310.201
§ 310.200Prescription-exemption procedure.
§ 310.201Exemption for certain drugs limited by new-drug applications to prescription sale.
Subpart DRecords and Reports310.305 – 310.306
§ 310.305Records and reports concerning adverse drug experiences on marketed prescription drugs for human use without approved new drug applications.
§ 310.306Notification of a permanent discontinuance or an interruption in manufacturing of marketed prescription drugs for human use without approved new drug applications.
Subpart ERequirements for Specific New Drugs or Devices310.501 – 310.548