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e-CFR data is current as of March 5, 2021

Title 21Chapter ISubchapter CPart 251Subpart C → §251.12


Title 21: Food and Drugs
PART 251—SECTION 804 IMPORTATION PROGRAM
Subpart C—Certain Requirements for Section 804 Importation Programs


§251.12   Importer responsibilities.

(a) The Importer is responsible for:

(1) In accordance with the procedures set forth in §207.33 of this chapter, proposing an NDC for assignment for each eligible prescription drug imported pursuant to this part;

(2) Examining the Canadian labeling of a sample of each shipment of eligible prescription drugs to verify that the labeling is that of the HPFB-approved drug, and attesting that such examination has been conducted through reports to FDA required under this part;

(3) Screening eligible prescription drugs for evidence that they are adulterated, counterfeit, damaged, tampered with, expired, suspect foreign product, or illegitimate foreign product;

(4) Ensuring the eligible prescription drug is relabeled with the required U.S. labeling, including the container and carton labeling; Prescribing Information; and patient labeling, such as Medication Guides, Instruction for Use documents, and patient package inserts, in accordance with §§251.13 and 251.14(d);

(5) Arranging for an entry to be submitted in accordance with §251.17;

(6) Collecting and submitting the information and documentation to FDA about the imported drug(s) pursuant to section 804(d) of the Federal Food, Drug, and Cosmetic Act, in addition to information about the Foreign Seller, as set forth in §251.19; and

(7) Submitting the adverse event, field alert, and other reports, and complying with drug recalls, in accordance with §251.18.

(b) If the Importer is also relabeling the eligible prescription drug, the Importer must also:

(1) Register with FDA as a repackager or relabeler under section 510(b) of the Federal Food, Drug, and Cosmetic Act, in accordance with §207.25 of this chapter;

(2) Obtain a labeler code from FDA and propose an NDC for each eligible prescription drug pursuant to §207.33 of this chapter; and

(3) List each eligible prescription drug pursuant to §207.53 of this chapter.

(c) If the Importer is not itself relabeling the eligible prescription drug, the Importer must:

(1) Obtain its own labeler code from FDA under §207.33(c) of this chapter;

(2) Ensure that the eligible prescription drug incorporates the NDC the Importer proposed for assignment, which must include the Importer's labeler code; and

(3) Ensure that the entity relabeling an eligible prescription drug on its behalf proposes an NDC pursuant to §207.33 of this chapter and lists each eligible prescription drug pursuant to §207.53 of this chapter.

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