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Code of Federal Regulations (Last Updated: November 8, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter C - Drugs: General |
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Part 251 - Section 804 Importation Program |
| 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. |