{"id":4321,"date":"2023-07-10T10:57:34","date_gmt":"2023-07-10T02:57:34","guid":{"rendered":"https:\/\/regask.com\/?p=4321"},"modified":"2024-09-25T03:59:26","modified_gmt":"2024-09-24T19:59:26","slug":"groshandel-mit-zusammengesetzten-arzneimitteln-der-fda","status":"publish","type":"post","link":"https:\/\/regask.com\/de\/fda-compounded-drugs-wholesaling\/","title":{"rendered":"US-amerikanische FDA gibt Empfehlungen zum gesetzlichen Verbot ab \u2026"},"content":{"rendered":"<div>\n<div class=\"css-xdofzv\">\n<div id=\"alert__details__read__summary\" class=\"css-25930v\">\n<div class=\"css-xdofzv\">\n<div id=\"alert__details__read__summary\" class=\"css-25930v\">\n<p>Laut FDA beschreibt dieser Leitlinienentwurf die Auslegung und Richtlinien der FDA zum Gro\u00dfhandelsverbot gem\u00e4\u00df Abschnitt 503B des FD&amp;C Act (21 USC 353b). Er enth\u00e4lt au\u00dferdem Beispiele daf\u00fcr, wie die FDA Abschnitt 503B der Gro\u00dfhandelsbestimmung des FD&amp;C Act anwenden will.<\/p>\n<p>Es enth\u00e4lt Informationen zu Schl\u00fcsselbegriffen, durch die Gro\u00dfhandelsbestimmung verbotenen Aktivit\u00e4ten, nicht verbotenen Aktivit\u00e4ten, Inspektionen und Regulierungs- oder Durchsetzungsma\u00dfnahmen.<\/p>\n<p>Elektronische oder schriftliche Kommentare zum Leitlinienentwurf sollten bis sp\u00e4testens 28. August 2023 eingereicht werden, um sicherzustellen, dass die Agentur die Kommentare zu diesem Leitlinienentwurf ber\u00fccksichtigt, bevor sie mit der Arbeit an der endg\u00fcltigen Fassung der Leitlinien beginnt.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<div class=\"MuiGrid-root jss1499 MuiGrid-item MuiGrid-grid-md-12\">\n<div class=\"jss1501\">\n<div class=\"jss1521\">\n<div class=\"jss409 jss434 summaryParagraph\">\n<div>\n<div>\n<div>\n<div>\n<div>\n<div>\n<div>\n<div>\n<div>\n<div>\n<div>\n<p><a href=\"https:\/\/regask.com\/de\/kontakt\/\">Kontaktieren Sie RegASK, um mehr \u00fcber regulatorische \u00c4nderungen in den USA zu erfahren.\u00a0<\/a><\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<a href=\"https:\/\/regask.com\/de\/kontakt\/\" class=\"button secondary\" style=\"border-radius:10px;\">\n\t\t<span>Kontaktieren Sie RegASK f\u00fcr weitere Details<\/span>\n\t<\/a>\n\n<a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/prohibition-wholesaling-under-section-503b-federal-food-drug-and-cosmetic-act\" target=\"_blank\" class=\"button secondary is-link\" rel=\"noopener\" >\n\t\t<span>Mehr lesen<\/span>\n\t<\/a>\n\n<div class=\"row\"  id=\"row-934134785\">\n\n\t<div id=\"col-1398742814\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<a href=\"https:\/\/regask.com\/de\/fallstudien\/ressourcen-fallstudien-pharma-biotech\/\" target=\"_blank\" class=\"button secondary is-link\" rel=\"noopener\" >\n\t\t<span>Lesen Sie Fallstudien aus der Pharma- und Biotech-Industrie<\/span>\n\t<\/a>\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n<\/div>\n<div class=\"MuiGrid-root jss1499 MuiGrid-item MuiGrid-grid-xs-12\">\n<div class=\"jss1500\">\n<div class=\"jss409 jss417 dataText\"><\/div>\n<\/div>\n<\/div>","protected":false},"excerpt":{"rendered":"<p>According to FDA, this draft guidance describes the FDA&#8217;s interpretation of, and policies concerning, the prohibition on wholesaling in section 503B of the FD&amp;C Act (21 U.S.C 353b). This draft guidance also describes examples of how the FDA intends to apply section 503B of the FD&amp;C Act&#8217;s wholesaling provision. It contains information on key terms,&#8230;<\/p>","protected":false},"author":39,"featured_media":4047,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[35],"tags":[40],"class_list":["post-4321","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-pharma-biotech-latest-insights","tag-latest-insights"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.4 (Yoast SEO v28.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>FDA Recommendations on Compounded Drug Wholesaling | RegASK<\/title>\n<meta name=\"description\" content=\"The US FDA issues recommendations on the statutory prohibition on wholesaling for certain compounded drugs. 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