Title 21

PART 251

Part 251 - Section 804 Importation Program

PART 251 - SECTION 804 IMPORTATION PROGRAM 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.

• 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.

21:4.0.1.1.17.1	SUBPART A	Subpart A - General Provisions
21:4.0.1.1.17.1.1.1	SECTION 251.1	251.1 Scope of the part.
21:4.0.1.1.17.1.1.2	SECTION 251.2	251.2 Definitions.
21:4.0.1.1.17.2	SUBPART B	Subpart B - Section 804 Importation Program Proposals and Pre-Import Requests
21:4.0.1.1.17.2.1.1	SECTION 251.3	251.3 SIP proposal submission requirements.
21:4.0.1.1.17.2.1.2	SECTION 251.4	251.4 Review and authorization of importation program proposals.
21:4.0.1.1.17.2.1.3	SECTION 251.5	251.5 Pre-Import Request.
21:4.0.1.1.17.2.1.4	SECTION 251.6	251.6 Termination of authorized importation programs.
21:4.0.1.1.17.2.1.5	SECTION 251.7	251.7 Suspension and revocation of authorized importation programs.
21:4.0.1.1.17.2.1.6	SECTION 251.8	251.8 Modification or extension of authorized importation programs.
21:4.0.1.1.17.3	SUBPART C	Subpart C - Certain Requirements for Section 804 Importation Programs
21:4.0.1.1.17.3.1.1	SECTION 251.9	251.9 Registration of Foreign Sellers.
21:4.0.1.1.17.3.1.2	SECTION 251.10	251.10 Reviewing and updating registration information for Foreign Sellers.
21:4.0.1.1.17.3.1.3	SECTION 251.11	251.11 Official contact and U.S. agent for Foreign Sellers.
21:4.0.1.1.17.3.1.4	SECTION 251.12	251.12 Importer responsibilities.
21:4.0.1.1.17.3.1.5	SECTION 251.13	251.13 Labeling of eligible prescription drugs.
21:4.0.1.1.17.3.1.6	SECTION 251.14	251.14 Supply chain security requirements for eligible prescription drugs.
21:4.0.1.1.17.3.1.7	SECTION 251.15	251.15 Qualifying laboratory requirements.
21:4.0.1.1.17.3.1.8	SECTION 251.16	251.16 Laboratory testing requirements.
21:4.0.1.1.17.3.1.9	SECTION 251.17	251.17 Importation requirements.
21:4.0.1.1.17.3.1.10	SECTION 251.18	251.18 Post-importation requirements.
21:4.0.1.1.17.3.1.11	SECTION 251.19	251.19 Reports to FDA.
21:4.0.1.1.17.3.1.12	SECTION 251.20	251.20 Severability.
21:4.0.1.1.17.3.1.13	SECTION 251.21	251.21 Consequences for violations.

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