§314.162. Removal of a drug product from the list.
21 C.F.R. § 314.162
FDA will remove a previously approved new drug product from the list for the period stated when:
The agency withdraws or suspends approval of a new drug application or an abbreviated new drug application under § 314.150(a) or § 314.151 or under the imminent hazard authority of section 505(e) of the act, for the same period as the withdrawal or suspension of the application; or
The agency, in accordance with the procedures in § 314.153(b) or § 314.161, issues a final decision stating that the listed drug was withdrawn from sale for safety or effectiveness reasons, or suspended under § 314.153(b), until the agency determines that the withdrawal from the market has ceased or is not for safety or effectiveness reasons.
FDA will publish in the Federal Register a notice announcing the removal of a drug from the list.
At the end of the period specified in paragraph (a)(1) or (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, and revision history
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]