{"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":"vente-en-gros-de-medicaments-composes-de-la-fda","status":"publish","type":"post","link":"https:\/\/regask.com\/fr\/fda-compounded-drugs-wholesaling\/","title":{"rendered":"La FDA am\u00e9ricaine fournit des recommandations sur les interdictions l\u00e9gales\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>Selon la FDA, ce projet de directives d\u00e9crit l&#039;interpr\u00e9tation de la FDA et ses politiques concernant l&#039;interdiction de la vente en gros pr\u00e9vue \u00e0 l&#039;article 503B de la FD&amp;C Act (21 USC 353b). Ce projet de directives d\u00e9crit \u00e9galement des exemples de la mani\u00e8re dont la FDA entend appliquer la disposition relative \u00e0 la vente en gros pr\u00e9vue \u00e0 l&#039;article 503B de la FD&amp;C Act.<\/p>\n<p>Il contient des informations sur les termes cl\u00e9s, les activit\u00e9s interdites par la disposition relative \u00e0 la vente en gros, les activit\u00e9s non interdites, les inspections et les mesures r\u00e9glementaires ou d&#039;application.<\/p>\n<p>Les commentaires \u00e9lectroniques ou \u00e9crits sur le projet d\u2019orientation doivent \u00eatre soumis au plus tard le 28 ao\u00fbt 2023, afin de garantir que l\u2019Agence prenne en compte les commentaires sur ce projet d\u2019orientation avant de commencer \u00e0 travailler sur la version finale de l\u2019orientation.<\/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\/fr\/contact-2\/\">Contactez RegASK pour en savoir plus sur les changements de r\u00e9glementation aux \u00c9tats-Unis.\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\/fr\/contact-2\/\" class=\"button secondary\" style=\"border-radius:10px;\">\n\t\t<span>Contactez RegASK pour plus de d\u00e9tails<\/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>En savoir plus<\/span>\n\t<\/a>\n\n<div class=\"row\"  id=\"row-539927853\">\n\n\t<div id=\"col-322616775\" 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\/fr\/etudes-de-cas\/ressources-etudes-de-cas-pharma-biotech\/\" target=\"_blank\" class=\"button secondary is-link\" rel=\"noopener\" >\n\t\t<span>Lisez les \u00e9tudes de cas sur l&#039;industrie pharmaceutique et biotechnologique<\/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>Selon la FDA, ce projet de lignes directrices d\u00e9crit l&#039;interpr\u00e9tation de la FDA et les politiques concernant l&#039;interdiction de la vente en gros pr\u00e9vue \u00e0 l&#039;article 503B de la FD&amp;C Act (21 USC 353b). Ce projet de lignes directrices d\u00e9crit \u00e9galement des exemples de la mani\u00e8re dont la FDA entend appliquer la disposition relative \u00e0 la vente en gros de l&#039;article 503B de la FD&amp;C Act. Il contient des informations sur les termes cl\u00e9s,\u2026<\/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 v27.7 (Yoast SEO v27.7) - 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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