{"id":239,"date":"2023-11-02T19:50:03","date_gmt":"2023-11-02T19:50:03","guid":{"rendered":"https:\/\/www.libertymanagement.us\/fda-support\/?p=239"},"modified":"2023-11-02T19:50:03","modified_gmt":"2023-11-02T19:50:03","slug":"what-is-spl","status":"publish","type":"post","link":"https:\/\/www.libertymanagement.us\/fda-support\/2023\/11\/02\/what-is-spl\/","title":{"rendered":"What is SPL?"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">SPL stands for Structured Product Labeling. SPL is an\nXML-based document markup standard that provides a consistent way to format and\norganize information about a drug or cosmetic product, including its\ningredients, labels and other details. <\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><a href=\"https:\/\/www.fdahelp.us\/drugs.html\">Drug<\/a> &amp; <a href=\"https:\/\/www.fdahelp.us\/cosmetics.html\">Cosmetic<\/a> companies are\nrequired to submit product information to the FDA in SPL format. SPL is used\nfor various FDA submissions related to FDA regulated products. It is designed\nto improve the accuracy and consistency of product information and make it\neasier for healthcare professionals, regulators, and the public to access and\nunderstand this information. Some of the key FDA submissions that utilize SPL\ninclude:<\/p>\n\n\n\n<ol class=\"wp-block-list\"><li><a href=\"https:\/\/www.fdahelp.us\/fda-drug-registration.html\">Drug Establishment\nRegistration<\/a> &#8211; Manufacturers of drug products must register their\nfacilities with the FDA, and SPL is used for this purpose.<\/li><li>Drug Listing &#8211; Manufacturers and distributors of\ndrug products are required to list their products with the FDA. SPL is used to\nprovide comprehensive product information for the FDA&#8217;s <a href=\"https:\/\/www.fdahelp.us\/ndc-labeler-code.html\">NDC<\/a> Directory.<\/li><li>Drug Renewals &amp; Listing updates \u2013 Annual\nDrug renewals &amp; any changes to a drug product&#8217;s label or listing info, must\nbe submitted to the FDA using SPL.<\/li><li><a href=\"https:\/\/www.fdahelp.us\/fda-cosmetic-registration.html\">Cosmetic Facility\nRegistration<\/a> &#8211; Manufacturers &amp; processors of cosmetic products must\nregister their facilities with the FDA, and SPL is used for this purpose.<\/li><li>Cosmetic Product Listing \u2013 A responsible person\nmust list the cosmetic products with FDA by way of SPL submissions.<\/li><li>Cosmetic Renewals &amp; Listing updates \u2013 Annual\nCosmetic renewals &amp; any changes to a cosmetic product&#8217;s label or listing\ninfo, must be submitted to the FDA using SPL.<\/li><\/ol>\n\n\n\n<p class=\"wp-block-paragraph\">Liberty Management Group Ltd can help with SPL preparation\n&amp; submissions to FDA. <\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><em>Namrata <\/em><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><em>Regulatory Consultant<\/em><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><em>support@libertymanagement.us<\/em><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><a href=\"http:\/\/www.fdahelp.us\">http:\/\/www.fdahelp.us<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>SPL stands for Structured Product Labeling. SPL is an XML-based document markup standard that provides a consistent way to format and organize information about a drug or cosmetic product, including its ingredients, labels and other details. Drug &amp; Cosmetic companies are required to submit product information to the FDA in SPL format. SPL is used &hellip; <a href=\"https:\/\/www.libertymanagement.us\/fda-support\/2023\/11\/02\/what-is-spl\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;What is SPL?&#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":[13,38],"tags":[80,10,82,81,83],"class_list":["post-239","post","type-post","status-publish","format-standard","hentry","category-cosmetics-regulations","category-us-fda-registration","tag-cosmetic-listing","tag-cosmetic-registration","tag-drug-listing","tag-drug-registration","tag-drug-renewal"],"_links":{"self":[{"href":"https:\/\/www.libertymanagement.us\/fda-support\/wp-json\/wp\/v2\/posts\/239","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.libertymanagement.us\/fda-support\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.libertymanagement.us\/fda-support\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.libertymanagement.us\/fda-support\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.libertymanagement.us\/fda-support\/wp-json\/wp\/v2\/comments?post=239"}],"version-history":[{"count":1,"href":"https:\/\/www.libertymanagement.us\/fda-support\/wp-json\/wp\/v2\/posts\/239\/revisions"}],"predecessor-version":[{"id":240,"href":"https:\/\/www.libertymanagement.us\/fda-support\/wp-json\/wp\/v2\/posts\/239\/revisions\/240"}],"wp:attachment":[{"href":"https:\/\/www.libertymanagement.us\/fda-support\/wp-json\/wp\/v2\/media?parent=239"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.libertymanagement.us\/fda-support\/wp-json\/wp\/v2\/categories?post=239"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.libertymanagement.us\/fda-support\/wp-json\/wp\/v2\/tags?post=239"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}