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e-CFR data is current as of January 15, 2021

Title 21Chapter ISubchapter CPart 251


TITLE 21—Food and Drugs

CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)

SUBCHAPTER C—DRUGS: GENERAL

PART 251—SECTION 804 IMPORTATION PROGRAM

rule

Subpart A—GENERAL PROVISIONS

§251.1
Scope of the part.
§251.2
Definitions.
rule

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.
rule

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.

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