{"id":321,"date":"2022-04-21T09:38:54","date_gmt":"2022-04-21T13:38:54","guid":{"rendered":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/?p=321"},"modified":"2022-04-21T09:38:54","modified_gmt":"2022-04-21T13:38:54","slug":"fdas-guidance-creates-administrative-burden-for-animal-drug-compounding-documentation","status":"publish","type":"post","link":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/2022\/04\/21\/fdas-guidance-creates-administrative-burden-for-animal-drug-compounding-documentation\/","title":{"rendered":"FDA&#8217;s Guidance Creates Administrative Burden for Animal Drug Compounding Documentation"},"content":{"rendered":"<p>On April 13, 2022, the FDA issued\u00a0<a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/cvm-gfi-256-compounding-animal-drugs-bulk-drug-substances\" target=\"_blank\" rel=\"noopener\">Guidance for Industry #256<\/a>\u00a0about the enforcement policy regarding the compounding of animal drugs from bulk drug substances by or under the direct supervision of veterinarians or pharmacists in either state-licensed pharmacies or federal facilities. FDA has spent several years and gone through multiple iterations trying to develop new industry guidance on compounding animal medications. While changes have been made from previous iterations, FDA has implemented significant administrative burdens for documentation of clinical need and limitations on drug substances that can be compounded for office use.<\/p>\n<p>FDA has taken the current position that drugs compounded from bulk substances violate the Federal Food, Drug and Cosmetic Act (FD&amp;C Act) because they are not approved or indexed, are not made according to current good manufacturing practice and cannot satisfy the FD&amp;C Act\u2019s adequate directions for use provision. However, FDA has generally refrained from taking enforcement action against animal drugs compounded from bulk drug substances under certain circumstances when no other medically appropriate treatment options exist. Especially for animal drugs, compounding plays a crucial role in providing medically appropriate treatments for a wide variety of species of all different shapes and sizes\u2015specifically, those for whom a single dosage form or level will not be medically appropriate.<\/p>\n<p>To read the full text of this Duane Morris Alert, please <a href=\"https:\/\/www.duanemorris.com\/alerts\/fda_issues_guidance_compounding_animal_drugs_bulk_drug_substances_0422.html\">visit the firm website<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>On April 13, 2022, the FDA issued\u00a0Guidance for Industry #256\u00a0about the enforcement policy regarding the compounding of animal drugs from bulk drug substances by or under the direct supervision of veterinarians or pharmacists in either state-licensed pharmacies or federal facilities. FDA has spent several years and gone through multiple iterations trying to develop new industry &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/2022\/04\/21\/fdas-guidance-creates-administrative-burden-for-animal-drug-compounding-documentation\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;FDA&#8217;s Guidance Creates Administrative Burden for Animal Drug Compounding Documentation&#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":[415,416,29,209,64,607,298,418],"ppma_author":[521],"class_list":["post-321","post","type-post","status-publish","format-standard","hentry","category-general","tag-animals","tag-drug-compounding","tag-fda","tag-frederick-ball","tag-guidance","tag-irfan-malani","tag-patrick-gallagher","tag-vet-pharma"],"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","author_category":"1","last_name":"Sullivan","first_name":"Margaret","job_title":"","user_url":"http:\/\/www.duanemorris.com","description":"<a href=\"http:\/\/www.duanemorris.com\">Visit the Duane Morris website.<\/a>"}],"_links":{"self":[{"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/posts\/321","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=321"}],"version-history":[{"count":0,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/posts\/321\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/media?parent=321"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/categories?post=321"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/tags?post=321"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/ppma_author?post=321"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}