{"data":{"id":"us/21-cfr-314.162","jurisdiction":"us","citation":"21 CFR 314.162","heading":"Removal of a drug product from the list.","body":"(a) FDA will remove a previously approved new drug product from the list for the period stated when:\n(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\n(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accordance with the procedures in § 314.153(b) or § 314.161, issues a final decision stating that the listed drug was withdrawn from sale for safety or effectiveness reasons, or suspended under § 314.153(b), until the agency determines that the withdrawal from the market has ceased or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.\n(b) FDA will publish in the Federal Register a notice announcing the removal of a drug from the list.\n(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.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER D—DRUGS FOR HUMAN USE","PART 314—APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG","Subpart D—FDA Action on Applications and Abbreviated Applications"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"5ad290faab36d62021b9180bc48e2da590e3b228a6d14141b637ec83c9c60192","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-314.161","next":"us/21-cfr-314.170"},"notice":"GroundRules: Original legal text. Not legal advice."}