part_subject: "APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG"
subpart_code: "D"
subpart_subject: "FDA Action on Applications and Abbreviated Applications"
section_number: "314.162"
section_subject: "Removal of a drug product from the list."
cfr_reference: "21 CFR 314.162"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 300 to 499"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
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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accordance with the procedures in § 314.153(b) or § 314.161, issues a final decision stating that the listed drug was withdrawn from sale for safety or effectiveness reasons, or suspended under § 314.153(b), until the agency determines that the withdrawal from the market has ceased or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.