{"id":307,"date":"2026-01-22T20:31:13","date_gmt":"2026-01-22T20:31:13","guid":{"rendered":"https:\/\/www.libertymanagement.us\/fda-news\/?p=307"},"modified":"2026-01-22T20:31:13","modified_gmt":"2026-01-22T20:31:13","slug":"drug-de-listings-2","status":"publish","type":"post","link":"https:\/\/www.libertymanagement.us\/fda-news\/2026\/01\/22\/drug-de-listings-2\/","title":{"rendered":"DRUG DE-LISTINGS"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\"><strong>DRUG DE-LISTINGS <\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">All drug\nmanufacturers must de-list the drugs with marketing end date from FDA <a href=\"https:\/\/www.fdahelp.us\/ndc-labeler-code.html\">NDC drug<\/a> code directory\nif they no longer market the drug for commercial distribution.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Regulatory Requirements<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>As per 21 CFR 2027, manufacturers or\nregistrants must de-list the drug when they are not going to market it in the\nUnited States.<ul><li>Registrants must notify FDA if there are\nany de-listings every June and December.<\/li><\/ul><ul><li>Registrants must submit the\nde-listings with marketing end date which is date of last lot manufacture. <\/li><\/ul><\/li><\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>De-listing vs. Inactivation <\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The key\ndifference between de-listing and Inactivation is as follows.<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>De-listing: It is action taken by the\ncompany to notify FDA that the drug is no longer be marketed in the United\nStates.<ul><li>Inactivation: It is the action taken\nby FDA when the company fails to renew the <a href=\"https:\/\/www.fdahelp.us\/fda-drug-registration.html\">establishment\nregistration<\/a> and drug listing between yearly renewal period October 1<sup>st<\/sup>\nand December 31<sup>st<\/sup> every year. FDA will remove all the drugs listings\nfrom its database and the drugs sold after that will be considered as\nmisbranded.<\/li><\/ul><\/li><\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Databases to track down withdrawn drugs.<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Withdrawn or Removed list: Drugs which\nare unsafe or not effective will be removed and these drugs cannot be used by\ncompounders.<ul><li>Orange Book: This is database of\napproved drugs, drugs whose safety or efficacy approval has been withdrawn are\nexcluded from this list.<\/li><\/ul><ul><li>NDC Directory: It is a database to\nfind the status of a drug with its <a href=\"https:\/\/www.fdahelp.us\/fda-labeler-code.html\">NDC number.<\/a><\/li><\/ul><\/li><\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Implications of inactivation<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Drugs will be considered as misbranded\nand cannot be legally marketed.<ul><li>Selling misbranded drugs can lead to\nFDA warning letters, product discontinuation, and penalties.<\/li><\/ul><ul><li>For foreign manufacturers, FDA will\nput them on import alert and detain the drugs at the border.<\/li><\/ul><ul><li>Insurance will decline the claims if\nthere is no valid <a href=\"https:\/\/www.fdahelp.us\/fda-labeler-code.html\">NDC\nnumber<\/a> which can lead to loss of reimbursement.<\/li><\/ul><\/li><\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">To rectify\nthis, manufacturers can reactivate the drug listings by resubmitting SPL files\nwith correct establishment registration information.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><a href=\"http:\/\/www.fdahelp.us\">Liberty Management Group<\/a>\nprovides assistance with <a href=\"https:\/\/www.fdahelp.us\/fda-drug-registration.html\">drug establishment\nregistration<\/a>, <a href=\"https:\/\/www.fdahelp.us\/otc-drug-products.html\">drug listing<\/a> and <a href=\"https:\/\/www.fdahelp.us\/drug-establishment-registration-renewal.html\">drug listing renewals<\/a>, and de-listings.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Sudha S<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Regulatory Consultant<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Email: office@libertymanagement.us<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><a href=\"http:\/\/www.fdahelp.us\">www.fdahelp.us<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n","protected":false},"excerpt":{"rendered":"<p>DRUG DE-LISTINGS All drug manufacturers must de-list the drugs with marketing end date from FDA NDC drug code directory if they no longer market the drug for commercial distribution. Regulatory Requirements As per 21 CFR 2027, manufacturers or registrants must de-list the drug when they are not going to market it in the United States. &hellip; <a href=\"https:\/\/www.libertymanagement.us\/fda-news\/2026\/01\/22\/drug-de-listings-2\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;DRUG DE-LISTINGS&#8221;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[26],"tags":[48],"class_list":["post-307","post","type-post","status-publish","format-standard","hentry","category-fda-registration-drug","tag-fda-drug-de-listings"],"_links":{"self":[{"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/posts\/307","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/comments?post=307"}],"version-history":[{"count":1,"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/posts\/307\/revisions"}],"predecessor-version":[{"id":308,"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/posts\/307\/revisions\/308"}],"wp:attachment":[{"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/media?parent=307"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/categories?post=307"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/tags?post=307"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}