---
kind: "section"
citation: "21 C.F.R. § 314.162"
title: "21"
number: "314.162"
heading: "Removal of a drug product from the list."
url: "https://uscodex.org/cfr/21/314.162"
---

# §314.162. Removal of a drug product from the list.

- (a) FDA will remove a previously approved new drug product from the list for the period stated when:
  - (1) The agency withdraws or suspends approval of a new drug application or an abbreviated new drug application under [§ 314.150(a)](/cfr/21/314.150.md?p=a) or [§ 314.151](/cfr/21/314.151.md) or under the imminent hazard authority of [section 505(e)](/cfr/21/505.md?p=e) of the act, for the same period as the withdrawal or suspension of the application; or
  - (2) The agency, in accordance with the procedures in [§ 314.153(b)](/cfr/21/314.153.md?p=b) or [§ 314.161](/cfr/21/314.161.md), issues a final decision stating that the listed drug was withdrawn from sale for safety or effectiveness reasons, or suspended under [§ 314.153(b)](/cfr/21/314.153.md?p=b), until the agency determines that the withdrawal from the market has ceased or is not for safety or effectiveness reasons.
- (b) FDA will publish in the Federal Register a notice announcing the removal of a drug from the list.
- (c) At the end of the period specified in paragraph [(a)(1)](#a-1) or [(a)(2)](#a-2) of this section, FDA will relist a drug that has been removed from the list. The agency will publish in the Federal Register a notice announcing the relisting of the drug.

## Notes

### Amendments

[57 FR 17996, Apr. 28, 1992]

### Source

Source: 50 FR 7493, Feb. 22, 1985, unless otherwise noted. Redesignated at 57 FR 17983, Apr. 28, 1992.

### Authority

Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 355a, 355f, 356, 356a, 356b, 356c, 356e, 360cc, 360ddd, 360ddd-1, 371, 374, 379e, 379k-1.

### Source

Source: 50 FR 7493, Feb. 22, 1985, unless otherwise noted.

### Amendments

[57 FR 17996, Apr. 28, 1992]