{"id":71,"date":"2014-12-24T10:46:10","date_gmt":"2014-12-24T14:46:10","guid":{"rendered":"http:\/\/blogs.duanemorris.com\/lifescienceslaw\/?p=71"},"modified":"2014-12-24T10:46:10","modified_gmt":"2014-12-24T14:46:10","slug":"fdas-final-guidance-on-the-circumstances-that-constitute-interference-with-a-drug-inspection","status":"publish","type":"post","link":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/2014\/12\/24\/fdas-final-guidance-on-the-circumstances-that-constitute-interference-with-a-drug-inspection\/","title":{"rendered":"FDA&#8217;s Final Guidance on the Circumstances That Constitute Interference with a Drug Inspection"},"content":{"rendered":"<p>The U.S. Food and Drug Administration (FDA) recently published its final <a href=\"http:\/\/www.fda.gov\/downloads\/RegulatoryInformation\/Guidances\/UCM360484.pdf\">Guidance for Industry<\/a> detailing circumstances that would constitute interference with a drug inspection under the Food and Drug Administration Safety and Innovation Act (FDASIA), signed into law on July 9, 2012.<\/p>\n<p>Prior to the passage of the FDASIA, sections 301(e) and 301(f) of the Food, Drug, and Cosmetic Act (FD&amp;C Act) prohibited drug facilities from denying FDA: (1) entry or the opportunity for inspection or; (2) refusing access to or the opportunity to copy specific records. Section 707 of the FDASIA extends this prohibition, through section 501(j) of the FD&amp;C Act, by deeming a drug adulterated if &#8221; \u2026 it has been manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection.&#8221; This provision extends to &#8220;any factory, warehouse, or establishment in which \u2026 drugs \u2026 are manufactured, processed, packed, or held, for introduction into interstate commerce or after such introduction, or to enter any vehicle being used to transport or hold such \u2026 drugs \u2026 in interstate commerce.&#8221; FDASIA also adds section 704(a)(4) to the FD&amp;C Act, allowing FDA to &#8220;request, in advance of or in lieu of an inspection, within a reasonable timeframe, within reasonable limits, and in a reasonable manner, records or information that FDA may inspect under section 704(a).&#8221;<\/p>\n<p>To read the full text of this <em>Alert<\/em>, please visit the <a href=\"http:\/\/www.duanemorris.com\/alerts\/fda_final_guidance_on_circumstances_that_constitute_interference_drug_inspection_5411.html\">Duane Morris website<\/a>. <\/p>\n","protected":false},"excerpt":{"rendered":"<p>The U.S. Food and Drug Administration (FDA) recently published its final Guidance for Industry detailing circumstances that would constitute interference with a drug inspection under the Food and Drug Administration Safety and Innovation Act (FDASIA), signed into law on July 9, 2012. Prior to the passage of the FDASIA, sections 301(e) and 301(f) of the &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/2014\/12\/24\/fdas-final-guidance-on-the-circumstances-that-constitute-interference-with-a-drug-inspection\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;FDA&#8217;s Final Guidance on the Circumstances That Constitute Interference with a Drug Inspection&#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":[210,29,65,209,204],"ppma_author":[521],"class_list":["post-71","post","type-post","status-publish","format-standard","hentry","category-general","tag-drug-inspection","tag-fda","tag-final-guidance","tag-frederick-ball","tag-pharmacies"],"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\/71","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=71"}],"version-history":[{"count":0,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/posts\/71\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/media?parent=71"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/categories?post=71"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/tags?post=71"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/ppma_author?post=71"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}