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Title 21

Displaying title 21, up to date as of 9/23/2021. Title 21 was last amended 9/21/2021.
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Title 21 Food and Drugs Part / Section
Chapter I Food and Drug Administration, Department of Health and Human Services 1 – 1299
Subchapter D Drugs for Human Use 300 – 499
Part 310 New Drugs 310.3 – 310.548
Subpart A General Provisions 310.3 – 310.6
§ 310.3 Definitions and interpretations.
§ 310.4 Biologics; products subject to license control.
§ 310.6 Applicability 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 B Specific Administrative Rulings and Decisions 310.100 – 310.103
§ 310.100 New drug status opinions; statement of policy.
§ 310.103 New drug substances intended for hypersensitivity testing.
Subpart C New Drugs Exempted From Prescription-Dispensing Requirements 310.200 – 310.201
§ 310.200 Prescription-exemption procedure.
§ 310.201 Exemption for certain drugs limited by new-drug applications to prescription sale.
Subpart D Records and Reports 310.305 – 310.306
§ 310.305 Records and reports concerning adverse drug experiences on marketed prescription drugs for human use without approved new drug applications.
§ 310.306 Notification of a permanent discontinuance or an interruption in manufacturing of marketed prescription drugs for human use without approved new drug applications.
Subpart E Requirements for Specific New Drugs or Devices 310.501 – 310.548