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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 251Subpart C - Subpart C—Certain Requirements for Section 804 Importation Programs
  • § 251.9 - Registration of Foreign Sellers.
  • § 251.10 - Reviewing and updating registration information for Foreign Sellers.
  • § 251.11 - Official contact and U.S. agent for Foreign Sellers.
  • § 251.12 - Importer responsibilities.
  • § 251.13 - Labeling of eligible prescription drugs.
  • § 251.14 - Supply chain security requirements for eligible prescription drugs.
  • § 251.15 - Qualifying laboratory requirements.
  • § 251.16 - Laboratory testing requirements.
  • § 251.17 - Importation requirements.
  • § 251.18 - Post-importation requirements.
  • § 251.19 - Reports to FDA.
  • § 251.20 - Severability.
  • § 251.21 - Consequences for violations.
authority: 21 U.S.C. 351,352,353,355,360,360eee-1,371,374,381,384
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