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Code of Federal Regulations (Last Updated: July 5, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter D - Drugs for Human Use |
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Part 314 - Applications for FDA Approval to Market a New Drug |
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Subpart D - FDA Action on Applications and Abbreviated Applications |
§ 314.162 - Removal of a drug product from the list.
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§ 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) 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
(2) 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accordance with the procedures in § 314.153(b) or § 314.161, issues a final decision stating that the listed drug was withdrawn from sale for safety or effectiveness reasons, or suspended under § 314.153(b), until the agency determines that the withdrawal from the market has ceased or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.
(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) 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.
[57 FR 17996, Apr. 28, 1992]