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Regulations last checked for updates: Aug 22, 2025

Title 21 - Food and Drugs last revised: Aug 15, 2025
All TitlesTitle 21Chapter IPart 201Subpart A - Subpart A—General Labeling Provisions
  • § 201.1 - Drugs; name and place of business of manufacturer, packer, or distributor.
  • § 201.2 - Drugs and devices; National Drug Code numbers.
  • § 201.5 - Drugs; adequate directions for use.
  • § 201.6 - Drugs; misleading statements.
  • § 201.10 - Drugs; statement of ingredients.
  • § 201.15 - Drugs; prominence of required label statements.
  • § 201.16 - Drugs; Spanish-language version of certain required statements.
  • § 201.17 - Drugs; location of expiration date.
  • § 201.18 - Drugs; significance of control numbers.
  • § 201.19 - Drugs; use of term “infant”.
  • § 201.20 - Declaration of presence of FD&C Yellow No. 5 and/or FD&C Yellow No. 6 in certain drugs for human use.
  • § 201.21 - Declaration of presence of phenylalanine as a component of aspartame in over-the-counter and prescription drugs for human use.
  • § 201.22 -
  • § 201.23 - Required pediatric studies.
  • § 201.24 - Labeling for systemic antibacterial drug products.
  • § 201.25 - Bar code label requirements.
  • § 201.26 - Exceptions or alternatives to labeling requirements for human drug products held by the Strategic National Stockpile.
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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