{"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":"medicamentos-compuestos-de-la-fda-al-por-mayor","status":"publish","type":"post","link":"https:\/\/regask.com\/es\/fda-compounded-drugs-wholesaling\/","title":{"rendered":"La FDA de EE. UU. ofrece recomendaciones sobre la prohibici\u00f3n legal de\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>Seg\u00fan la FDA, este borrador de gu\u00eda describe la interpretaci\u00f3n de la FDA y las pol\u00edticas relacionadas con la prohibici\u00f3n de venta al por mayor en la secci\u00f3n 503B de la Ley FD&amp;C (21 USC 353b). Este borrador de gu\u00eda tambi\u00e9n describe ejemplos de c\u00f3mo la FDA pretende aplicar la secci\u00f3n 503B de la disposici\u00f3n sobre venta al por mayor de la Ley FD&amp;C.<\/p>\n<p>Contiene informaci\u00f3n sobre t\u00e9rminos clave, actividades prohibidas por la disposici\u00f3n de venta al por mayor, actividades no prohibidas, inspecciones y acciones regulatorias o de cumplimiento.<\/p>\n<p>Los comentarios electr\u00f3nicos o escritos sobre el proyecto de gu\u00eda deben enviarse a m\u00e1s tardar el 28 de agosto de 2023, para garantizar que la Agencia considere los comentarios sobre este proyecto de gu\u00eda antes de comenzar a trabajar en la versi\u00f3n final de la gu\u00eda.<\/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\/es\/contacto\/\">Comun\u00edquese con RegASK para obtener m\u00e1s informaci\u00f3n sobre los cambios regulatorios en los EE. UU.\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\/es\/contacto\/\" class=\"button secondary\" style=\"border-radius:10px;\">\n\t\t<span>Contacte con RegASK para m\u00e1s detalles<\/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>Leer m\u00e1s<\/span>\n\t<\/a>\n\n<div class=\"row\"  id=\"row-1692318784\">\n\n\t<div id=\"col-287004723\" 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\/es\/estudios-de-caso\/recursos-casos-de-estudio-farmacia-biotecnologia\/\" target=\"_blank\" class=\"button secondary is-link\" rel=\"noopener\" >\n\t\t<span>Lea estudios de casos de la industria farmac\u00e9utica y biotecnol\u00f3gica<\/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>Seg\u00fan la FDA, este borrador de gu\u00eda describe la interpretaci\u00f3n de la FDA y las pol\u00edticas relacionadas con la prohibici\u00f3n de venta al por mayor en la secci\u00f3n 503B de la Ley FD&amp;C (21 USC 353b). Este borrador de gu\u00eda tambi\u00e9n describe ejemplos de c\u00f3mo la FDA pretende aplicar la secci\u00f3n 503B de la disposici\u00f3n de venta al por mayor de la Ley FD&amp;C. Contiene informaci\u00f3n sobre t\u00e9rminos clave,\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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