{"id":53570,"date":"2021-10-20T15:45:14","date_gmt":"2021-10-20T19:45:14","guid":{"rendered":"https:\/\/regstaging.wpengine.com\/fda-issues-first-otc-monograph-final-orders-includes-updates-to-sunscreen-drug-product-requirements\/"},"modified":"2021-11-09T11:54:16","modified_gmt":"2021-11-09T16:54:16","slug":"fda-issues-first-otc-monograph-final-orders-includes-updates-to-sunscreen-drug-product-requirements","status":"publish","type":"post","link":"https:\/\/legacy.registrarcorp.com\/pt\/fda-issues-first-otc-monograph-final-orders-includes-updates-to-sunscreen-drug-product-requirements\/","title":{"rendered":"A FDA emite primeiros pedidos finais de Monografias OTC; que Incluem atualiza\u00e7\u00f5es para requisitos de prote\u00e7\u00e3o solar"},"content":{"rendered":"<p>Em 20 de setembro de 2021, a Food and Drug Administration (FDA) dos Estados Unidos publicou um lote inicial de ordens administrativas finais para monografias de prateleira (ou OTC), \u00e9 o primeiro lote de ordens administrativas para a reforma do Monografias OTC a serem divulgadas. A FDA estabeleceu a reforma em 7 de mar\u00e7o de 2020, de acordo com a Lei de Aux\u00edlio, Al\u00edvio e Seguran\u00e7a Econ\u00f4mica mediante \u00e0 pandemia do Coronav\u00edrus, de acordo com a Lei (CARES).<\/p>\n<p>A FDA emitiu os seguintes regulamentos administrativos finais:<\/p>\n<ul>\n<li>Medicamentos OTC para dormir para humanos<\/li>\n<li>Medicamentos OTC anti-flatul\u00eancia para uso humano<\/li>\n<li>Medicamentos OTC \u00d3ticos T\u00f3picos para uso Humano<\/li>\n<li>Medicamentos OTC para remover calos e calosidades para uso humano<\/li>\n<\/ul>\n<p>A FDA continuou a emitir v\u00e1rias ordens administrativas finais desde o lote inicial, o que reflete o portal. As adi\u00e7\u00f5es recentes incluem um pedido final de medicamentos de prote\u00e7\u00e3o solar para humanos vendidos sem prescri\u00e7\u00e3o m\u00e9dica.<\/p>\n<p><strong>Instru\u00e7\u00f5es finais para medicamentos de prote\u00e7\u00e3o solar<\/strong><\/p>\n<p>A ag\u00eancia FDA regulamentou os produtos de prote\u00e7\u00e3o solar sob crit\u00e9rio de conformidade por mais de 20 anos, mantendo uma suspens\u00e3o em uma monografia final de 1999. A FDA havia estabelecido anteriormente v\u00e1rias regras propostas para produtos de prote\u00e7\u00e3o solar que suspendiam a isen\u00e7\u00e3o. Em 2011, a FDA publicou uma regra final que codificou a rotulagem de produtos de prote\u00e7\u00e3o solar OTC, incluindo mudan\u00e7as significativas no conte\u00fado do painel de Drugs Facts. Em 2019, a FDA emitiu uma monografia provis\u00f3ria final na forma de uma regra proposta que considerava todos os ingredientes ativos exclu\u00eddos do GRASE, com exce\u00e7\u00e3o do di\u00f3xido de tit\u00e2nio e \u00f3xido de zinco, e inclu\u00eda altera\u00e7\u00f5es dentro dos requisitos do produto rotulado.<\/p>\n<p>A FDA divulgou o <a href=\"https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/omuf\/OTCMonograph_M020-SunscreenDrugProductsforOTCHumanUse09242021.pdf\">pedido final<\/a> em considera\u00e7\u00e3o para produtos de prote\u00e7\u00e3o solar de venda livre para uso humano. Ao mesmo tempo, a FDA emitiu um pedido proposto para alterar a regra final que inclu\u00eda mudan\u00e7as significativas, imitando muito do que havia sido inclu\u00eddo na monografia final provis\u00f3ria de 2019. A FDA est\u00e1 atualmente recebendo coment\u00e1rios p\u00fablicos sobre o pedido proposto.<\/p>\n<p>Compara\u00e7\u00f5es e contrastes not\u00e1veis entre o pedido final e o pedido proposto mais recente incluem:<\/p>\n<ul>\n<li>O pedido final mant\u00e9m os mesmos ingredientes ativos GRASE que foram cobertos pela monografia original final de 1999. O di\u00f3xido de tit\u00e2nio e o \u00f3xido de zinco permanecem classificados e geralmente reconhecidos como seguros e eficazes (GRASE) para uso em protetores. solares em concentra\u00e7\u00f5es de at\u00e9 25 por cento, de acordo com a proposta. No entanto, o pedido proposto excluiria v\u00e1rios outros ingredientes do GRASE, citando dados insuficientes.<\/li>\n<li>Um valor m\u00e1ximo de Fator de Prote\u00e7\u00e3o Solar (&#8220;FPS&#8221;) de 60+ e limites no valor m\u00e1ximo de FPS formulado do produto.<\/li>\n<li>O p\u00f3 como forma de dosagem est\u00e1 listado no pedido final, mas n\u00e3o \u00e9 considerado GRASE dentro do pedido proposto.<\/li>\n<\/ul>\n<p><strong>Como a FDA est\u00e1 avan\u00e7ando no manuseio de monografias OTC<\/strong><\/p>\n<p>A FDA declarou que ir\u00e1 liberar os pedidos restantes em lotes em fases. A Ag\u00eancia tamb\u00e9m publicar\u00e1 todos os pedidos em seu novo portal na web, <a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cder\/omuf\/index.cfm\">Monografia dos OTC @FDA<\/a>. A FDA declarou que, \u00e0 medida que as ordens administrativas finais adicionam, excluem ou alteram as condi\u00e7\u00f5es de uma monografia OTC existente, o portal refletir\u00e1 essas altera\u00e7\u00f5es. As ordens administrativas finais n\u00e3o ser\u00e3o anunciadas no Federal Register, que era pr\u00e1tica comum publicar as regras propostas e finais antes da reforma da monografia OTC.<\/p>\n<p>Antes da Reforma da Monografia OTC, a Lei de Procedimentos Administrativos determinava o processo para estabelecer, revisar e modificar uma monografia. Se a FDA determinasse que um medicamento era geralmente reconhecido como seguro e eficaz (GRASE) para uma categoria terap\u00eautica, a FDA colocaria o medicamento em um est\u00e1gio de regulamenta\u00e7\u00e3o proposta e a Monografia Final seria provis\u00f3ria. A cria\u00e7\u00e3o de regras \u00e9 um processo demorado que requer uma proposta, per\u00edodos de coment\u00e1rios p\u00fablicos e finaliza\u00e7\u00e3o.<\/p>\n<p>A Reforma da Monografia OTC substituiu o amplo est\u00e1gio de cria\u00e7\u00e3o de regras para monografias por um processo de pedido administrativo mais simplificado. Esse processo indica que um medicamento que atende a determinados requisitos \u00e9 GRASE, n\u00e3o \u00e9 um medicamento novo e n\u00e3o est\u00e1 sujeito a determinados requisitos. As ordens administrativas podem ser aplicadas a medicamentos que, entre outras regras, atendam aos requisitos espec\u00edficos de conformidade com as monografias provis\u00f3rias ou finais atuais e representam a vers\u00e3o mais recente dos termos de uso do medicamento.<\/p>\n<div class=\"callout-row text-center margin-bottom\">\n<h3>Perguntas Sobre os Requerimentos da FDA?<\/h3>\n<p>A Registrar Corp \u00e9 uma empresa privada que auxilia empresas no cumprimento das regulamenta\u00e7\u00f5es da FDA. Podemos ajud\u00e1-lo com atualiza\u00e7\u00f5es para as Revis\u00f5es de Monografias de Produtos OTC. Para mais informa\u00e7\u00f5es, ligue para + 1-757-224-0177, escreva para nosso e-mail <a href=\"mailto:info@registrarcorp.com\">info@registrarcorp.com<\/a> ou converse por chat com um especialista em regulamenta\u00e7\u00e3o 24 horas por dia acessando: <a href=\"https:\/\/regstaging.wpengine.com\/livechat\">regstaging.wpengine.com\/livechat<\/a>.<\/p>\n<p class=\"btn-row\"><a class=\"btn btn-red-white\" href=\"https:\/\/regstaging.wpengine.com\/pt\/fda-food\/registration\/?lead_source=blog\">Acesse nosso Chat<\/a><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Em 20 de setembro de 2021, a Food and Drug Administration (FDA) dos Estados Unidos publicou um lote inicial de ordens administrativas finais para monografias de prateleira (ou OTC), \u00e9 o primeiro lote de ordens administrativas para a reforma do Monografias OTC a serem divulgadas. A FDA estabeleceu a reforma em 7 de mar\u00e7o de<\/p>\n","protected":false},"author":30,"featured_media":53059,"comment_status":"closed","ping_status":"closed","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-53570","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) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>A FDA emite primeiros pedidos finais de Monografias OTC; que Incluem atualiza\u00e7\u00f5es para requisitos de prote\u00e7\u00e3o solar - Registrar<\/title>\n<meta name=\"robots\" content=\"noindex, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<meta property=\"og:locale\" content=\"pt_PT\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"A FDA emite primeiros pedidos finais de Monografias OTC; que Incluem atualiza\u00e7\u00f5es para requisitos de prote\u00e7\u00e3o solar\" \/>\n<meta property=\"og:description\" content=\"Em 20 de setembro de 2021, a Food and Drug Administration (FDA) dos Estados Unidos publicou um lote inicial de ordens administrativas finais para monografias de prateleira (ou OTC), \u00e9 o primeiro lote de ordens administrativas para a reforma do Monografias OTC a serem divulgadas. 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