Part 251 — Section 804 Importation Program
Current through Sep 8, 2026
Authority: 21 U.S.C. 351, 352, 353, 355, 360, 360eee-1, 371, 374, 381, 384.
Source: 85 FR 62126, Oct. 1, 2020, unless otherwise noted.
Sections
- § 251.1 Scope of the part.
- § 251.2 Definitions.
- § 251.3 SIP proposal submission requirements.
- § 251.4 Review and authorization of importation program proposals.
- § 251.5 Pre-Import Request.
- § 251.6 Termination of authorized importation programs.
- § 251.7 Suspension and revocation of authorized importation programs.
- § 251.8 Modification or extension of authorized 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.