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Regulations last checked for updates: May 14, 2025

Title 21 - Food and Drugs last revised: May 12, 2025
All TitlesTitle 21Chapter IPart 201 - PART 201—LABELING
  • Subpart A [§ 201.1 - § 201.26] - Subpart A—General Labeling Provisions
  • Subpart B [§ 201.50 - § 201.58] - Subpart B—Labeling Requirements for Prescription Drugs and/or Insulin
  • Subpart C [§ 201.60 - § 201.80] - Subpart C—Labeling Requirements for Over-the-Counter Drugs
  • Subpart D [§ 201.100 - § 201.130] - Subpart D—Exemptions From Adequate Directions for Use
  • Subpart E [§ 201.150 - § 201.161] - Subpart E—Other Exemptions
  • Subpart F [§ 201.200 - § 201.200] - Subpart F—Labeling Claims for Drugs in Drug Efficacy Study
  • Subpart G [§ 201.300 - § 201.328] - Subpart G—Specific Labeling Requirements for Specific Drug Products
authority: 21 U.S.C. 321,331,343,351,352,353,355,358,360,360b,360ccc,360ccc-1,360ee,360gg-360ss,371,374,379e; 42 U.S.C. 216,241,262,264
source: 40 FR 13998, Mar. 27, 1975, unless otherwise noted.
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