{"id":42954,"date":"2020-03-30T13:06:27","date_gmt":"2020-03-30T13:06:27","guid":{"rendered":"https:\/\/regstaging.wpengine.com\/fda-publishes-temporary-policies-for-alcohol-based-hand-sanitizer-amid-covid-19\/"},"modified":"2022-11-29T07:02:57","modified_gmt":"2022-11-29T12:02:57","slug":"fda-publishes-temporary-policies-for-alcohol-based-hand-sanitizer-amid-covid-19","status":"publish","type":"post","link":"https:\/\/legacy.registrarcorp.com\/fr\/fda-publishes-temporary-policies-for-alcohol-based-hand-sanitizer-amid-covid-19\/","title":{"rendered":"La FDA publie des r\u00e8glements temporaires pour les gels mains hydroalcooliques pendant le COVID-19"},"content":{"rendered":"<div class=\"wpb-content-wrapper\">[vc_row][vc_column][vc_column_text]Afin de r\u00e9pondre \u00e0 l\u2019importante demande de produits de d\u00e9sinfection des mains due \u00e0 l\u2019\u00e9pid\u00e9mie de COVID-19 aux Etats-Unis, La Food and Drug Administration (FDA) a publi\u00e9 deux documents de r\u00e9f\u00e9rence (guidance) pr\u00e9cisant les conditions dans lesquelles les\u00a0pharmacies et les entreprises n\u2019\u00e9tant pas d\u2019ordinaire r\u00e8glement\u00e9es par la FDA sont autoris\u00e9es \u00e0 pr\u00e9parer des gels mains d\u00e9sinfectants en base alcool pour leur utilisation par les consommateurs et les professionnels de sant\u00e9.<\/p>\n<p>L\u2019administration pr\u00e9cise qu\u2019elle ne pr\u00e9voit pas d\u2019exercer des mesures coercitives contre les entreprises qui ne sont pas en pleine conformit\u00e9 avec certaines r\u00e8glementations, notamment les requis de bonne pratiques pour les \u00e9tablissements pharmaceutiques, \u00e0 condition que les soci\u00e9t\u00e9s se conforment aux recommandations sp\u00e9cifi\u00e9es dans ces r\u00e8glements temporaires. Ces r\u00e8gles resteront en vigueur pendant la dur\u00e9e de l\u2019urgence sanitaire d\u00e9clar\u00e9e suite au COVID-19.<\/p>\n<p><strong>Quelles sont les conditions pr\u00e9cis\u00e9es dans le r\u00e8glement temporaire\u00a0?<\/strong><\/p>\n<p>Les documents Guidance de la FDA listent plusieurs conditions auxquelles les produits de d\u00e9sinfection des mains doivent se conformer\u00a0:<\/p>\n<ul>\n<li>Les fabricants doivent pr\u00e9parer les d\u00e9sinfectants mains uniquement \u00e0 partir d\u2019une formulation utilisant des ingr\u00e9dients de grade USP (United States Pharmacopoeia)\u00a0:\n<ul>\n<li>alcool isopropylique (75%, v\/v) en solution aqueuse ou alcool (ethanol) (80%, volume\/volume (v\/v)) en solution aqueuse\n<ul>\n<li>L\u2019alcool (ethanol) doit \u00eatre d\u00e9natur\u00e9 conform\u00e9ment aux r\u00e8glementations de l\u2019Alcohol and Tobacco Tax and Trade Bureau, CFR part 20.<\/li>\n<\/ul>\n<\/li>\n<li>Glycerol (1.45% v\/v)<\/li>\n<li>Hydrogen peroxide (0.125% v\/v)<\/li>\n<li>Eau distill\u00e9e st\u00e9rile ou eau froide bouillie<\/li>\n<\/ul>\n<\/li>\n<li>Les fabricants doivent s\u2019assurer que leurs d\u00e9sinfectants contiennent le montant requis d\u2019\u00e9thanol ou d\u2019alcool isopropylique. Les entreprises doivent utiliser la m\u00e9thode la plus ad\u00e9quate disponible pour v\u00e9rifier le volume d\u2019alcool de leurs produits finis avant de distribuer chaque lot.<\/li>\n<li>Les gels d\u00e9sinfectants doivent \u00eatre pr\u00e9par\u00e9s dans des conditions d\u2019hygi\u00e8ne suffisante avec un \u00e9quipement ad\u00e9quat<\/li>\n<li><a href=\"https:\/\/regstaging.wpengine.com\/fda-drugs\/labeling\/?lead_source=Blog\">L\u2019\u00e9tiquetage des produits<\/a> doit comporter les informations sp\u00e9cifiques et le format d\u00e9finis dans les documents guidance de la FDA.<\/li>\n<li>Les entreprises qui ne sont pas des officines de pharmacie doivent\u00a0<a href=\"https:\/\/regstaging.wpengine.com\/fda-drugs\/registration\/?lead_source=Blog\">s\u2019enregistrer \u00e0 la FDA<\/a> et lister leurs gels d\u00e9sinfectants (enregistrement de chaque produit) avant de les mettre sur le march\u00e9 U.S.<\/li>\n<li>Les entreprises doivent inclure dans leur \u00e9tiquetage un espace comportant une adresse aux Etats Unis ou un num\u00e9ro de t\u00e9l\u00e9phone aux US pour recevoir\u00a0<a href=\"https:\/\/regstaging.wpengine.com\/fda-drugs\/adverse-event\/?lead_source=Blog\">des signalements d\u2019effets ind\u00e9sirables<\/a>, ainsi que disposer d\u2019une proc\u00e9dure pour soumettre ces rapports \u00e0 la FDA.<\/li>\n<\/ul>\n<p>Les produits qui ne satisfont pas l\u2019ensemble de ces exigences devraient avoir \u00e0 se conformer aux exigences standard de la FDA pour les produits pharmaceutiques tels que la conformit\u00e9 \u00e0 une monographie de la FDA ou l\u2019obtention d\u2019une approbation FDA pour nouveau produit pharmaceutique (New Drug Approval \u2013 NDA). Mettre sur le march\u00e9 d\u2019autres types de d\u00e9sinfectants des mains qui ne seraient pas en conformit\u00e9 avec les requis de la FDA peut entrainer mesures coercitives, tels que la d\u00e9tention des produits, refus d\u2019entr\u00e9e, lettres d\u2019avertissement, et plus.<\/p>\n<p>Registrar Corp aide les entreprises \u00e0 se conformer \u00e0 la r\u00e8glementation de l\u2019U.S. FDA. Nos sp\u00e9cialistes r\u00e8glementaires peuvent vous aider \u00e0\u00a0<a href=\"https:\/\/regstaging.wpengine.com\/fda-drugs\/registration\/?lead_source=Blog\">vous enregistrer et lister<\/a> les gels d\u00e9sinfectants ainsi que d\u2019autres produits pharmaceutiques \u00e0 la FDA, <a href=\"https:\/\/regstaging.wpengine.com\/fda-drugs\/labeling\/?lead_source=Blog\">v\u00e9rifier et mettre en conformit\u00e9 votre \u00e9tiquetage<\/a>, et plus encore. Pour une assistance imm\u00e9diate, n\u2019h\u00e9sitez pas \u00e0 nous appeler au +1-757-224-0177 ou chattez avec un de nos <a href=\"https:\/\/regstaging.wpengine.com\/livechat\">Sp\u00e9cialistes R\u00e8glementaires 24h\/7.<\/a>[\/vc_column_text][\/vc_column][\/vc_row]\n<\/div>","protected":false},"excerpt":{"rendered":"<p>[vc_row][vc_column][vc_column_text]Afin de r\u00e9pondre \u00e0 l\u2019importante demande de produits de d\u00e9sinfection des mains due \u00e0 l\u2019\u00e9pid\u00e9mie de COVID-19 aux Etats-Unis, La Food and Drug Administration (FDA) a publi\u00e9 deux documents de r\u00e9f\u00e9rence (guidance) pr\u00e9cisant les conditions dans lesquelles les\u00a0pharmacies et les entreprises n\u2019\u00e9tant pas d\u2019ordinaire r\u00e8glement\u00e9es par la FDA sont autoris\u00e9es \u00e0 pr\u00e9parer des gels mains<\/p>\n","protected":false},"author":30,"featured_media":42940,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"content-type":"","om_disable_all_campaigns":false,"inline_featured_image":false,"_genesis_hide_title":false,"_genesis_hide_breadcrumbs":false,"_genesis_hide_singular_image":false,"_genesis_hide_footer_widgets":false,"_genesis_custom_body_class":"","_genesis_custom_post_class":"","_genesis_layout":"","footnotes":""},"categories":[93],"tags":[],"class_list":{"0":"post-42954","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-drugs-fr","8":"entry"},"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v20.9 (Yoast SEO v25.5) - 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