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

193 words·~1 min read·/us/cfr/t21/s§ 314.162·

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(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accordance with the procedures in § 314.153(b) or § 314.161, issues a final decision stating that the listed drug was withdrawn from sale for safety or effectiveness reasons, or suspended under § 314.153(b), until the agency determines that the withdrawal from the market has ceased or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]

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§ 314.162

Removal of a drug product from the list.

Fed. Reg.×408

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