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Part 251
FEDERAL · 21 CFR
Part 251 — Section 804 Importation Program
21 sections · Title 21: Food and Drugs
§ 251.1
Scope of the part.
§ 251.2
Definitions.
§ 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.
§ 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.