{"id":176,"date":"2023-02-24T21:02:02","date_gmt":"2023-02-24T21:02:02","guid":{"rendered":"https:\/\/www.libertymanagement.us\/fda-news\/?p=176"},"modified":"2023-02-24T21:02:02","modified_gmt":"2023-02-24T21:02:02","slug":"drug-reporting","status":"publish","type":"post","link":"https:\/\/www.libertymanagement.us\/fda-news\/2023\/02\/24\/drug-reporting\/","title":{"rendered":"DRUG REPORTING"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">To address drug shortages, the FDA has issued a new guidance\non <a href=\"https:\/\/www.fdahelp.us\/fda-drug-reporting.html\">drug reporting<\/a>\nunder which drug establishments are required to submit reports on the amount of\neach listed drug manufactured, prepared, propagated, compounded, or processed\nfor commercial distribution, as required by section 510(j)(3) of FD&amp;C act.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">As per the guidance, drug manufacturers are required to\nsubmit a list of all drugs they manufacture, prepare, propagate, compound, or\nprocess for commercial distribution annually. This list must include the name\nand <a href=\"https:\/\/www.fdahelp.us\/fda-labeler-code.html\">National Drug Code<\/a>\n(NDC) of each drug, as well as other information such as the dosage form,\nstrength, route of administration, and package size.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The FDA uses this information to maintain a comprehensive\ndatabase of all marketed drugs in the United States. This database is known as\nthe National Drug Code Directory and is used by healthcare providers,\npharmacists, and others to identify and track drugs in the supply chain.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">FDA requires all drug manufacturers which includes prescription drugs, <a href=\"https:\/\/www.fdahelp.us\/otc-drug-products.html\">over the counter (OTC) drugs<\/a>, and biologic products , re-packers and re-labelers, &nbsp;<a href=\"https:\/\/www.fdahelp.us\/api-listing.html\">active pharmaceutical ingredient (API)<\/a>, and other types of listed drugs, medical gases, <a href=\"https:\/\/www.fdahelp.us\/homeopathic-drug-listing.html\">homeopathic products<\/a>, animal drug products, and distributors to submit <a href=\"https:\/\/www.fdahelp.us\/fda-drug-reporting.html\">drug reporting<\/a> to the agency.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">For private label distributors, the data should be submitted\nseparately by the NDC associated with the registrant\u2019s labeler code and the NDC\nassociated with the private label distributor\u2019s labeler code.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Reports on the amount of each registrant\u2019s listed drugs must\nbe submitted yearly. Such reports should include information regarding the\namount of drug released for the respective calendar year (January 1 \u2013 December\n31) and should be submitted no later than February 15 of the following fiscal\nyear.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Liberty Management Group, as a leading FDA consulting firm, can help you in submitting the drug reports to FDA on time.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Sudha S<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Regulatory Consultant<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Mail: <a href=\"mailto:Office@libertymanagment.us\">Office@libertymanagment.us<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><a href=\"http:\/\/www.fdahelp.us\">www.fdahelp.us<\/a> <\/p>\n","protected":false},"excerpt":{"rendered":"<p>To address drug shortages, the FDA has issued a new guidance on drug reporting under which drug establishments are required to submit reports on the amount of each listed drug manufactured, prepared, propagated, compounded, or processed for commercial distribution, as required by section 510(j)(3) of FD&amp;C act. As per the guidance, drug manufacturers are required &hellip; <a href=\"https:\/\/www.libertymanagement.us\/fda-news\/2023\/02\/24\/drug-reporting\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;DRUG REPORTING&#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":[26],"tags":[33],"class_list":["post-176","post","type-post","status-publish","format-standard","hentry","category-fda-registration-drug","tag-fda-drug-reporting"],"_links":{"self":[{"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/posts\/176","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/comments?post=176"}],"version-history":[{"count":2,"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/posts\/176\/revisions"}],"predecessor-version":[{"id":178,"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/posts\/176\/revisions\/178"}],"wp:attachment":[{"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/media?parent=176"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/categories?post=176"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/tags?post=176"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}