Certain Requirements for Section 804 Importation Programs

  1. Law
  2. CFR 21
  3. Food and Drugs
  4. Food and Drug Administration, Department of Health and Human Services
  5. Drugs: General
  6. Section 804 Importation Program
  7. Certain Requirements for Section 804 Importation Programs

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Section
251.9

Registration of Foreign Sellers.

Section
251.10

Reviewing and updating registration information for Foreign Sellers.

Section
251.11

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

Section
251.12

Importer responsibilities.

Section
251.13

Labeling of eligible prescription drugs.

Section
251.14

Supply chain security requirements for eligible prescription drugs.

Section
251.15

Qualifying laboratory requirements.

Section
251.16

Laboratory testing requirements.

Section
251.17

Importation requirements.

Section
251.18

Post-importation requirements.

Section
251.19

Reports to FDA.

Section
251.20

Severability.

Section
251.21

Consequences for violations.