Title 21, Part 251 — Section 804 Importation Program

Scope of the part.

Definitions.

SIP proposal submission requirements.

Review and authorization of importation program proposals.

Pre-Import Request.

Termination of authorized importation programs.

Suspension and revocation of authorized importation programs.

Modification or extension of authorized importation programs.

Registration of Foreign Sellers.

Reviewing and updating registration information for Foreign Sellers.

Official contact and U.S. agent for Foreign Sellers.

Importer responsibilities.

Labeling of eligible prescription drugs.

Supply chain security requirements for eligible prescription drugs.

Qualifying laboratory requirements.

Laboratory testing requirements.

Importation requirements.

Post-importation requirements.

Reports to FDA.

Severability.

Consequences for violations.