21 CFR Part 251 — Section 804 Importation Program
Subpart A — General Provisions
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.