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Title 21

Displaying title 21, up to date as of 7/16/2026. 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 CDrugs: General200 – 299
Part 201Labeling201.1 – 201.328
Subpart AGeneral Labeling Provisions201.1 – 201.26
Subpart BLabeling Requirements for Prescription Drugs and/or Insulin201.50 – 201.58
§ 201.50Statement of identity.
§ 201.51Declaration of net quantity of contents.
§ 201.55Statement of dosage.
§ 201.56Requirements on content and format of labeling for human prescription drug and biological products.
§ 201.57Specific requirements on content and format of labeling for human prescription drug and biological products described in § 201.56(b)(1).
§ 201.58Waiver of labeling requirements.
Subpart CLabeling Requirements for Over-the-Counter Drugs201.60 – 201.80
Subpart DExemptions From Adequate Directions for Use201.100 – 201.130
Subpart EOther Exemptions201.150 – 201.161
§ 201.150Drugs; processing, labeling, or repacking.
§ 201.161Medical gases.
Subpart FLabeling Claims for Drugs in Drug Efficacy Study201.200
§ 201.200Disclosure of drug efficacy study evaluations in labeling and advertising.
Subpart GSpecific Labeling Requirements for Specific Drug Products201.300 – 201.328
Appendix A to Part 201
Examples of Graphic Enhancements Used by FDA