---
kind: "section"
citation: "21 C.F.R. § 251.12"
title: "21"
number: "251.12"
heading: "Importer responsibilities."
url: "https://uscodex.org/cfr/21/251.12"
---

# §251.12. Importer responsibilities.

- (a) **The Importer is responsible for—**
  - (1) In accordance with the procedures set forth in [§ 207.33](/cfr/21/207.33.md) 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](/cfr/21/251.13.md) and [251.14(d)](/cfr/21/251.14.md?p=d);
  - (5) Arranging for an entry to be submitted in accordance with [§ 251.17](/cfr/21/251.17.md);
  - (6) Collecting and submitting the information and documentation to FDA about the imported drug(s) pursuant to [section 804(d)](/cfr/21/804.md?p=d) of the Federal Food, Drug, and Cosmetic Act, in addition to information about the Foreign Seller, as set forth in [§ 251.19](/cfr/21/251.19.md); and
  - (7) Submitting the adverse event, field alert, and other reports, and complying with drug recalls, in accordance with [§ 251.18](/cfr/21/251.18.md).
- (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)](/cfr/21/510.md?p=b) of the Federal Food, Drug, and Cosmetic Act, in accordance with [§ 207.25](/cfr/21/207.25.md) of this chapter;
  - (2) Obtain a labeler code from FDA and propose an NDC for each eligible prescription drug pursuant to [§ 207.33](/cfr/21/207.33.md) of this chapter; and
  - (3) List each eligible prescription drug pursuant to [§ 207.53](/cfr/21/207.53.md) 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)](/cfr/21/207.33.md?p=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](/cfr/21/207.33.md) of this chapter and lists each eligible prescription drug pursuant to [§ 207.53](/cfr/21/207.53.md) of this chapter.

## Notes

### Authority

Authority: 21 U.S.C. 351, 352, 353, 355, 360, 360eee-1, 371, 374, 381, 384.

### Source

Source: 85 FR 62126, Oct. 1, 2020, unless otherwise noted.