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CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER D—DRUGS FOR HUMAN USE (parts 300 to 370) > PART 314—APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG > SUBPART D—FDA Action on Applications and Abbreviated Applications (§314.100 to §314.170) > 314.162—Removal of a drug product from the list.

CFR

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accordance with the procedures in § 314.153(b) or § 314.161, issues a final decision stating that the listed drug was withdrawn from sale for safety or effectiveness reasons, or suspended under § 314.153(b), until the agency determines that the withdrawal from the market has ceased or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

Code of Federal Regulations

[57 FR 17996, Apr. 28, 1992]
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