{"id":42948,"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":"2022-11-29T01:37:59","modified_gmt":"2022-11-29T06:37:59","slug":"fda-publishes-temporary-policies-for-alcohol-based-hand-sanitizer-amid-covid-19","status":"publish","type":"post","link":"https:\/\/legacy.registrarcorp.com\/es\/fda-publishes-temporary-policies-for-alcohol-based-hand-sanitizer-amid-covid-19\/","title":{"rendered":"En Medio de COVID-19, la FDA Publica Pol\u00edticas Temporales Para Desinfectantes de Manos a Base de Alcohol"},"content":{"rendered":"<div class=\"wpb-content-wrapper\">[vc_row][vc_column][vc_column_text]En respuesta a la gran demanda de productos desinfectantes de manos asociados con el brote de COVID-19 en los Estados Unidos, la Administraci\u00f3n de Alimentos y Medicamentos de los Estados Unidos (FDA) public\u00f3 dos documentos de orientaci\u00f3n que describen las condiciones bajo las cuales farmacias de composici\u00f3n y otras empresas que no son reguladas por FDA usualmente pueden preparar alcohol desinfectante para manos a base de agua para el uso de los consumidores y profesionales de la salud.<\/p>\n<p>La Agencia declara que no tiene la intenci\u00f3n de tomar medidas contra las empresas que no cumplan con ciertas regulaciones, tales como los requisitos actuales de buenas pr\u00e1cticas de manufactura, siempre que las empresas se adhieran a las recomendaciones de las pol\u00edticas temporales de la FDA. \u00c9stas seguir\u00e1n vigentes mientras dure la emergencia de salud p\u00fablica provocada por COVID-19.<\/p>\n<p><strong>\u00bfCu\u00e1les son las condiciones de estas pol\u00edticas?<\/strong><\/p>\n<p>Los documentos de la FDA describen varias pautas claves a las que deben ajustarse los productos desinfectantes\/sanitizantes para manos bajo estas pol\u00edticas. Estos son:<\/p>\n<ul>\n<li>Los fabricantes deben preparar desinfectante para manos solo a partir de una formulaci\u00f3n espec\u00edfica que utilice ingredientes de grado USP (Farmacopea de los Estados Unidos):<br \/>\n&#8211; Alcohol isoprop\u00edlico (75%, v\/v) o alcohol (etanol) (80%, v\/v) en una soluci\u00f3n acuosa.<br \/>\n&#8211; El alcohol (etanol) debe desnaturalizarse de acuerdo con los reglamentos de la Oficina de Comercio e Impuestos sobre Alcohol y Tabaco detallados en CFR parte 20.<br \/>\n&#8211; Glicerol (1.45% v\/v)<br \/>\n&#8211; Per\u00f3xido de hidr\u00f3geno (0.125% v\/v)<br \/>\n&#8211; Agua destilada est\u00e9ril o agua hervida y enfriada.<\/li>\n<\/ul>\n<ul>\n<li>Los fabricantes deben asegurarse de que sus desinfectantes\/sanitizantes contengan la cantidad adecuada de etanol o alcohol isoprop\u00edlico. Las empresas deben utilizar el m\u00e9todo m\u00e1s preciso disponible para analizar el contenido de alcohol de sus productos terminados antes de distribuir cada lote.<\/li>\n<li>Los desinfectantes deben prepararse en condiciones sanitarias y con el equipo apropiado.<\/li>\n<li>El <a href=\"https:\/\/regstaging.wpengine.com\/fda-drugs\/labeling\/?lead_source=Blog\">etiquetado del producto<\/a> debe ser coherente con el contenido y formato espec\u00edficos descritos en los documentos de orientaci\u00f3n de la FDA.<\/li>\n<li>Las empresas que no sean farmacias de composici\u00f3n <a href=\"https:\/\/regstaging.wpengine.com\/fda-drugs\/registration\/?lead_source=Blog\">deben registrarse con la FDA<\/a> y listar sus sanitizantes antes de comercializarlos en los EEUU.<\/li>\n<li>Las empresas deben tener un espacio en su etiqueta que incluya una direcci\u00f3n o n\u00famero de tel\u00e9fono con sede en EEUU <a href=\"https:\/\/regstaging.wpengine.com\/fda-drugs\/adverse-event\/?lead_source=Blog\">para recibir informes de eventos adversos<\/a>, as\u00ed como un m\u00e9todo para enviar dichos informes a la FDA.<\/li>\n<\/ul>\n<p>Es posible que los productos que no cumplan con estas condiciones deban cumplir con los requisitos est\u00e1ndar de medicamentos de la FDA, tales como conformidad con una monograf\u00eda de la FDA o la aprobaci\u00f3n mediante una nueva aplicaci\u00f3n de medicamentos (NDA). La comercializaci\u00f3n de otros tipos de desinfectantes o sanitizantes de manos que no cumplan con los requisitos aplicables de la FDA puede dar lugar a medidas de cumplimiento, incluyendo detenciones, rechazos, cartas de advertencia, y m\u00e1s.<\/p>\n<p>Registrar Corp asiste con el cumplimiento de las regulaciones de la FDA. Nuestros especialistas en regulaciones pueden ayudarlo a <a href=\"https:\/\/regstaging.wpengine.com\/fda-drugs\/registration\/?lead_source=Blog\">registrar y listar<\/a> sus productos desinfectantes y otros productos farmac\u00e9uticos con la FDA, a <a href=\"https:\/\/regstaging.wpengine.com\/fda-drugs\/labeling\/?lead_source=Blog\">revisar su etiquetado<\/a><u>,<\/u> o a cumplir con otros requisitos. Para recibir asistencia, ll\u00e1menos al + 1-757-224-0177 o converse con un <a href=\"https:\/\/regstaging.wpengine.com\/livechat\">Asesor Regulatorio las 24hs, los 7 d\u00edas de la semana<\/a>.[\/vc_column_text][\/vc_column][\/vc_row]\n<\/div>","protected":false},"excerpt":{"rendered":"<p>[vc_row][vc_column][vc_column_text]En respuesta a la gran demanda de productos desinfectantes de manos asociados con el brote de COVID-19 en los Estados Unidos, la Administraci\u00f3n de Alimentos y Medicamentos de los Estados Unidos (FDA) public\u00f3 dos documentos de orientaci\u00f3n que describen las condiciones bajo las cuales farmacias de composici\u00f3n y otras empresas que no son reguladas por<\/p>\n","protected":false},"author":30,"featured_media":42944,"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":[60],"tags":[],"class_list":{"0":"post-42948","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-drugs-es","8":"entry"},"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v20.9 (Yoast SEO v25.5) - 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