{"id":50,"date":"2014-06-24T15:33:45","date_gmt":"2014-06-24T19:33:45","guid":{"rendered":"http:\/\/blogs.duanemorris.com\/lifescienceslaw\/?p=50"},"modified":"2014-09-10T15:15:15","modified_gmt":"2014-09-10T19:15:15","slug":"fda-issues-draft-guidance-for-identification-and-notification-of-suspect-products","status":"publish","type":"post","link":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/2014\/06\/24\/fda-issues-draft-guidance-for-identification-and-notification-of-suspect-products\/","title":{"rendered":"FDA Issues Draft Guidance for Identification and Notification of Suspect Products"},"content":{"rendered":"<p>As discussed in our <a href=\"http:\/\/www.duanemorris.com\/alerts\/fda_seeks_information_for_implementation_of_drug_supply_chain_security_act_5183.html\" target=\"_blank\">April 11, 2014 <em>Alert<\/em><\/a>, the Drug Supply Chain Security Act (DSCSA) was enacted &#8220;to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed within the United States.&#8221; Recently, the U.S. Food and Drug Administration (FDA) has issued a draft <a href=\"http:\/\/www.fda.gov\/downloads\/Drugs\/GuidanceComplianceRegulatoryInformation\/Guidances\/UCM400470.pdf\" target=\"_blank\">Guidance for Industry<\/a> for implementing the DSCSA with respect to identification of suspect products and notification thereof.<\/p>\n<p>Starting January 1, 2015, trading partners and manufacturers are required to &#8220;notify FDA and immediate trading partners (that they have reason to believe may have received [or possess] the illegitimate product) not later than 24 hours after making the determination.&#8221;<\/p>\n<p><a href=\"http:\/\/www.duanemorris.com\/alerts\/FDA_issues_draft_guidance_for_identification_and_notification_of_suspect_products_5237.html\" target=\"_blank\">Click here<\/a> to read the full <em>Alert<\/em>, written by Duane Morris partner <a href=\"http:\/\/www.duanemorris.com\/attorneys\/frederickrball.html\" target=\"_blank\">Rick Ball<\/a> and associate <a href=\"http:\/\/www.duanemorris.com\/attorneys\/carolynaalenci.html\" target=\"_blank\">Carolyn Alenci<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>As discussed in our April 11, 2014 Alert, the Drug Supply Chain Security Act (DSCSA) was enacted &#8220;to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed within the United States.&#8221; Recently, the U.S. Food and Drug Administration (FDA) has issued a draft Guidance for Industry for implementing &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/2014\/06\/24\/fda-issues-draft-guidance-for-identification-and-notification-of-suspect-products\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;FDA Issues Draft Guidance for Identification and Notification of Suspect Products&#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":[139,29,64,119],"ppma_author":[521],"class_list":["post-50","post","type-post","status-publish","format-standard","hentry","category-general","tag-dscsa","tag-fda","tag-guidance","tag-rick-ball"],"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\/50","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=50"}],"version-history":[{"count":0,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/posts\/50\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/media?parent=50"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/categories?post=50"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/tags?post=50"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/ppma_author?post=50"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}