21 CFR Part 251
PART 251—SECTION 804 IMPORTATION PROGRAM
- PART 251—SECTION 804 IMPORTATION PROGRAM
- Chapter I—Food and Drug Administration, Department of Health and Human Services › Subchapter C—Drugs: General
- Subpart A—General Provisions
- § 251.1 Scope of the part.
- § 251.2 Definitions.
- Subpart B—Section 804 Importation Program Proposals and Pre-Import Requests
- § 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.
- 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.
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