{"id":68,"date":"2014-12-09T11:48:18","date_gmt":"2014-12-09T15:48:18","guid":{"rendered":"http:\/\/blogs.duanemorris.com\/lifescienceslaw\/?p=68"},"modified":"2017-05-22T11:38:52","modified_gmt":"2017-05-22T15:38:52","slug":"duane-morris-llp-fda-issues-guidance-on-registration-fees-and-reporting-requirements-for-drug-compounding-outsourcing-facilities","status":"publish","type":"post","link":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/2014\/12\/09\/duane-morris-llp-fda-issues-guidance-on-registration-fees-and-reporting-requirements-for-drug-compounding-outsourcing-facilities\/","title":{"rendered":"FDA Issues Guidance on Registration, Fees and Reporting Requirements for Drug Compounding Outsourcing Facilities"},"content":{"rendered":"<p>On November 21, 2014, the U.S. Food and Drug Administration (FDA) <a href=\"http:\/\/www.fda.gov\/NewsEvents\/Newsroom\/PressAnnouncements\/ucm424214.htm?source=govdelivery&amp;utm_medium=email&amp;utm_source=govdelivery\" target=\"_blank\">announced the release<\/a> of three new guidance documents related to drug compounding outsourcing facilities.\u00a0These documents include:<\/p>\n<div id=\"fixedwidth\">\n<div id=\"content\">\n<div id=\"sidebar\">\n<div id=\"main\">\n<ul>\n<li><a href=\"http:\/\/www.fda.gov\/downloads\/Drugs\/GuidanceComplianceRegulatoryInformation\/Guidances\/UCM377051.pdf\" target=\"_blank\">Final Guidance<\/a> on registration of human drug compounding outsourcing facilities<\/li>\n<li><a href=\"http:\/\/www.fda.gov\/downloads\/Drugs\/GuidanceComplianceRegulatoryInformation\/Guidances\/UCM391102.pdf\" target=\"_blank\">Final Guidance<\/a> on registration fees for such outsourcing facilities<\/li>\n<li><a href=\"http:\/\/www.fda.gov\/downloads\/Drugs\/NewsEvents\/UCM424303.pdf\" target=\"_blank\">Revised Draft Guidance<\/a> on electronic drug product reporting requirements for compounding outsourcing facilities<\/li>\n<\/ul>\n<p>As detailed in an earlier <a href=\"http:\/\/www.duanemorris.com\/alerts\/compounding_pharmacies_now_subject_to_federal_oversight_5076.html\"><i>Duane Morris Alert<\/i><\/a>, the 2013 Drug Quality and Securities Act (DQSA) added Section 503B to the Food, Drug, and Cosmetic Act (FDCA), which established federal oversight for human drug compounding outsourcing pharmacies (outsourcing facilities).<\/p>\n<p>To read the full text of this <em>Alert<\/em>, please visit the <a href=\"http:\/\/www.duanemorris.com\/alerts\/fda_guidance_registration_fee_reporting_requirements_drug_compounding_outsourcing_5392.html\">Duane Morris website<\/a>.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>On November 21, 2014, the U.S. Food and Drug Administration (FDA) announced the release of three new guidance documents related to drug compounding outsourcing facilities.\u00a0These documents include: Final Guidance on registration of human drug compounding outsourcing facilities Final Guidance on registration fees for such outsourcing facilities Revised Draft Guidance on electronic drug product reporting requirements &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/2014\/12\/09\/duane-morris-llp-fda-issues-guidance-on-registration-fees-and-reporting-requirements-for-drug-compounding-outsourcing-facilities\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;FDA Issues Guidance on Registration, Fees and Reporting Requirements for Drug Compounding Outsourcing Facilities&#8221;<\/span><\/a><\/p>\n","protected":false},"author":6,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[2],"tags":[208,201,207,70,29,203,205,202,204,206],"ppma_author":[521],"class_list":["post-68","post","type-post","status-publish","format-standard","hentry","category-general","tag-alison-rosenblum","tag-compounding","tag-dispute-resolution","tag-drug","tag-fda","tag-fdca","tag-fee","tag-outsourcing-facilities","tag-pharmacies","tag-reinspection"],"authors":[{"term_id":521,"user_id":6,"is_guest":0,"slug":"duanemorris3","display_name":"Duane Morris","avatar_url":"https:\/\/secure.gravatar.com\/avatar\/843ff6e7a8fe5fc92109b47a45f34b6cf0ea499e6e788db23456c838b0ae6747?s=96&d=blank&r=g","0":null,"1":"","2":"","3":"","4":"","5":"","6":"","7":"","8":""}],"_links":{"self":[{"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/posts\/68","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/users\/6"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/comments?post=68"}],"version-history":[{"count":0,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/posts\/68\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/media?parent=68"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/categories?post=68"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/tags?post=68"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/ppma_author?post=68"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}