{"id":42950,"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":"2022-11-29T08:22:43","modified_gmt":"2022-11-29T13:22:43","slug":"fda-publishes-temporary-policies-for-alcohol-based-hand-sanitizer-amid-covid-19","status":"publish","type":"post","link":"https:\/\/legacy.registrarcorp.com\/pt\/fda-publishes-temporary-policies-for-alcohol-based-hand-sanitizer-amid-covid-19\/","title":{"rendered":"Em Meio do COVID-19, a FDA Lan\u00e7a Pol\u00edticas Tempor\u00e1rias Para Desinfetantes Para M\u00e3os \u00e0 Base de \u00c1lcool"},"content":{"rendered":"<p>Em resposta \u00e0 alta demanda por desinfetantes para m\u00e3os associados ao surto de COVID-19 nos Estados Unidos, a Administra\u00e7\u00e3o de Alimentos e Medicamentos dos Estados Unidos (FDA) divulgou dois documentos de orienta\u00e7\u00e3o descrevendo as condi\u00e7\u00f5es sob as quais as farm\u00e1cias de composi\u00e7\u00e3o e outras empresas que n\u00e3o s\u00e3o regulamentadas pela FDA geralmente podem preparar desinfetante para m\u00e3os \u00e0 base de \u00e1gua para uso por consumidores e profissionais de sa\u00fade.<\/p>\n<p>A Ag\u00eancia declara que n\u00e3o pretende tomar medidas de conformidade contra empresas que n\u00e3o cumpram determinadas regulamenta\u00e7\u00f5es, como os requisitos atuais de boas pr\u00e1ticas de fabrica\u00e7\u00e3o, sempre que as empresas sigam as recomenda\u00e7\u00f5es das pol\u00edticas tempor\u00e1rias da FDA. Estas continuar\u00e3o em vigor durante toda a emerg\u00eancia de sa\u00fade p\u00fablica causada pelo COVID-19.<\/p>\n<p><strong>Quais s\u00e3o as condi\u00e7\u00f5es destas pol\u00edticas?<\/strong><\/p>\n<p>Os documentos da FDA descrevem v\u00e1rias diretrizes importantes que os desinfetantes para m\u00e3os devem seguir de acordo com essas pol\u00edticas. Estes s\u00e3o:<\/p>\n<ul>\n<li>Os fabricantes devem preparar o desinfetante para m\u00e3os somente a partir de uma formula\u00e7\u00e3o espec\u00edfica usando ingredientes de grau USP (Farmacopeia dos Estados Unidos):<br \/>\n&#8211; \u00c1lcool isoprop\u00edlico (75%, v\/v) ou \u00e1lcool (etanol) (80%, v\/v) em uma solu\u00e7\u00e3o aquosa.<br \/>\n&#8211; O \u00e1lcool (etanol) deve ser desnaturado de acordo com os regulamentos do Escrit\u00f3rio de Com\u00e9rcio e Impostos sobre \u00c1lcool e Tabaco, detalhados no CFR parte 20.<br \/>\n&#8211; Glicerol (1.45% v\/v)<br \/>\n&#8211; Per\u00f3xido de hidrog\u00eanio (0.125% v\/v)<br \/>\n&#8211; \u00c1gua destilada est\u00e9ril ou \u00e1gua fervida e resfriada.<\/li>\n<li>Os fabricantes devem garantir que seus desinfetantes contenham a quantidade adequada de etanol ou \u00e1lcool isoprop\u00edlico. As empresas devem usar o m\u00e9todo mais preciso dispon\u00edvel para analisar o teor de \u00e1lcool de seus produtos acabados antes de distribuir cada lote.<\/li>\n<li>Os desinfetantes devem ser preparados em condi\u00e7\u00f5es sanit\u00e1rias e com o equipamento apropriado.<\/li>\n<li>A <a href=\"https:\/\/regstaging.wpengine.com\/fda-drugs\/labeling\/?lead_source=Blog\">rotulagem do produto<\/a> deve ser consistente com o conte\u00fado e o formato espec\u00edficos descritos nos documentos de orienta\u00e7\u00e3o da FDA.<\/li>\n<li>As empresas que n\u00e3o sejam farm\u00e1cias de composi\u00e7\u00e3o <a href=\"https:\/\/regstaging.wpengine.com\/fda-drugs\/registration\/?lead_source=Blog\">devem se registrar na FDA<\/a> e listar seus desinfetantes antes de serem comercializados nos EUA.<\/li>\n<li>As empresas devem ter um espa\u00e7o no r\u00f3tulo que inclua um endere\u00e7o ou n\u00famero de telefone nos EUA <a href=\"https:\/\/regstaging.wpengine.com\/fda-drugs\/adverse-event\/?lead_source=Blog\">para receber relat\u00f3rios de eventos adversos<\/a>, bem como um m\u00e9todo para enviar esses relat\u00f3rios \u00e0 FDA.<\/li>\n<\/ul>\n<p>Os produtos que n\u00e3o atendem a essas condi\u00e7\u00f5es podem precisar atender aos requisitos normais para medicamentos da FDA, como conformidade com uma monografia da FDA ou aprova\u00e7\u00e3o meante a Nova Aplica\u00e7\u00e3o de Medicamentos (NDA). A comercializa\u00e7\u00e3o de outros tipos de desinfetantes ou produtos similares para m\u00e3os que n\u00e3o atendam aos requisitos aplic\u00e1veis da FDA pode levar a medidas de conformidade, incluindo deten\u00e7\u00f5es, rejei\u00e7\u00f5es, cartas de aviso, e mais.<\/p>\n<p>Registrar Corp ajuda na conformidade com os regulamentos da FDA. Nossos especialistas em regulamenta\u00e7\u00e3o podem ajud\u00e1-lo a <a href=\"https:\/\/regstaging.wpengine.com\/fda-drugs\/registration\/?lead_source=Blog\">registrar e listar<\/a> seu desinfetante e outros produtos farmac\u00eauticos junto \u00e0 FDA, <a href=\"https:\/\/regstaging.wpengine.com\/fda-drugs\/labeling\/?lead_source=Blog\">revisar sua rotulagem<\/a> ou cumprir outros requisitos. Para obter assist\u00eancia, ligue para o + 1-757-224-0177 ou fale com um <u>Assessor Regulat\u00f3rio 24hs por dia, 7 dias por semana<\/u>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Em resposta \u00e0 alta demanda por desinfetantes para m\u00e3os associados ao surto de COVID-19 nos Estados Unidos, a Administra\u00e7\u00e3o de Alimentos e Medicamentos dos Estados Unidos (FDA) divulgou dois documentos de orienta\u00e7\u00e3o descrevendo as condi\u00e7\u00f5es sob as quais as farm\u00e1cias de composi\u00e7\u00e3o e outras empresas que n\u00e3o s\u00e3o regulamentadas pela FDA geralmente podem preparar desinfetante<\/p>\n","protected":false},"author":30,"featured_media":42943,"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":[96],"tags":[],"class_list":{"0":"post-42950","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-drugs-pt","8":"entry"},"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v20.9 (Yoast SEO v25.5) - 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