{"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":"groshandel-mit-zusammengesetzten-arzneimitteln-der-fda","status":"publish","type":"post","link":"https:\/\/regask.com\/de\/fda-compounded-drugs-wholesaling\/","title":{"rendered":"US-amerikanische FDA gibt Empfehlungen zum gesetzlichen Verbot ab \u2026"},"content":{"rendered":"
\n
\n
\n
\n
\n

Laut FDA beschreibt dieser Leitlinienentwurf die Auslegung und Richtlinien der FDA zum Gro\u00dfhandelsverbot gem\u00e4\u00df Abschnitt 503B des FD&C Act (21 USC 353b). Er enth\u00e4lt au\u00dferdem Beispiele daf\u00fcr, wie die FDA Abschnitt 503B der Gro\u00dfhandelsbestimmung des FD&C Act anwenden will.<\/p>\n

Es enth\u00e4lt Informationen zu Schl\u00fcsselbegriffen, durch die Gro\u00dfhandelsbestimmung verbotenen Aktivit\u00e4ten, nicht verbotenen Aktivit\u00e4ten, Inspektionen und Regulierungs- oder Durchsetzungsma\u00dfnahmen.<\/p>\n

Elektronische oder schriftliche Kommentare zum Leitlinienentwurf sollten bis sp\u00e4testens 28. August 2023 eingereicht werden, um sicherzustellen, dass die Agentur die Kommentare zu diesem Leitlinienentwurf ber\u00fccksichtigt, bevor sie mit der Arbeit an der endg\u00fcltigen Fassung der Leitlinien beginnt.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n

\n
\n
\n
\n
\n
\n
\n
\n
\n
\n
\n
\n
\n
\n
\n

Kontaktieren Sie RegASK, um mehr \u00fcber regulatorische \u00c4nderungen in den USA zu erfahren.\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\n\t\tKontaktieren Sie RegASK f\u00fcr weitere Details<\/span>\n\t<\/a>\n\n\n\t\tMehr lesen<\/span>\n\t<\/a>\n\n

\n\n\t
\n\t\t\t\t
\n\t\t\t\n\t\t\t\n\n\t\tLesen Sie Fallstudien aus der Pharma- und Biotech-Industrie<\/span>\n\t<\/a>\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n<\/div>\n
\n
\n
<\/div>\n<\/div>\n<\/div>","protected":false},"excerpt":{"rendered":"

According to FDA, this draft guidance describes the FDA’s interpretation of, and policies concerning, the prohibition on wholesaling in section 503B of the FD&C Act (21 U.S.C 353b). This draft guidance also describes examples of how the FDA intends to apply section 503B of the FD&C Act’s wholesaling provision. It contains information on key terms,…<\/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":"\nFDA 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. Learn more with RegASK.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/regask.com\/de\/groshandel-mit-zusammengesetzten-arzneimitteln-der-fda\/\" \/>\n<meta property=\"og:locale\" content=\"de_DE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"US FDA Provides Recommendations on the Statutory Prohibition on Wholesaling for Certain Compounded Drugs\" \/>\n<meta property=\"og:description\" content=\"The US FDA issues recommendations on the statutory prohibition on wholesaling for certain compounded drugs. Learn more with RegASK.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/regask.com\/de\/groshandel-mit-zusammengesetzten-arzneimitteln-der-fda\/\" \/>\n<meta property=\"og:site_name\" content=\"RegASK\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/\" \/>\n<meta property=\"article:published_time\" content=\"2023-07-10T02:57:34+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-09-24T19:59:26+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/regask.com\/wp-content\/uploads\/2022\/12\/Amendment-to-the-Clinical-Trials-Regulation-CTR-on-Investigational-Medicinal-Products-IMPs-Labelling.png\" \/>\n\t<meta property=\"og:image:width\" content=\"331\" \/>\n\t<meta property=\"og:image:height\" content=\"301\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Benoit Trouwaert\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@ASKRegASK\" \/>\n<meta name=\"twitter:site\" content=\"@ASKRegASK\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Benoit Trouwaert\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"1\u00a0Minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/regask.com\\\/fda-compounded-drugs-wholesaling\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/fda-compounded-drugs-wholesaling\\\/\"},\"author\":{\"name\":\"Benoit Trouwaert\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/person\\\/c1d261e8dcf7b1c30b2c4f2c119df42d\"},\"headline\":\"US FDA Provides Recommendations on the Statutory Prohib…\",\"datePublished\":\"2023-07-10T02:57:34+00:00\",\"dateModified\":\"2024-09-24T19:59:26+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/fda-compounded-drugs-wholesaling\\\/\"},\"wordCount\":207,\"publisher\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/fda-compounded-drugs-wholesaling\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2022\\\/12\\\/Amendment-to-the-Clinical-Trials-Regulation-CTR-on-Investigational-Medicinal-Products-IMPs-Labelling.png\",\"keywords\":[\"Latest Insights\"],\"articleSection\":[\"Pharma and Biotech\"],\"inLanguage\":\"de\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/regask.com\\\/fda-compounded-drugs-wholesaling\\\/\",\"url\":\"https:\\\/\\\/regask.com\\\/fda-compounded-drugs-wholesaling\\\/\",\"name\":\"FDA Recommendations on Compounded Drug Wholesaling | RegASK\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/fda-compounded-drugs-wholesaling\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/fda-compounded-drugs-wholesaling\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2022\\\/12\\\/Amendment-to-the-Clinical-Trials-Regulation-CTR-on-Investigational-Medicinal-Products-IMPs-Labelling.png\",\"datePublished\":\"2023-07-10T02:57:34+00:00\",\"dateModified\":\"2024-09-24T19:59:26+00:00\",\"description\":\"The US FDA issues recommendations on the statutory prohibition on wholesaling for certain compounded drugs. Learn more with RegASK.\",\"inLanguage\":\"de\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/regask.com\\\/fda-compounded-drugs-wholesaling\\\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"de\",\"@id\":\"https:\\\/\\\/regask.com\\\/fda-compounded-drugs-wholesaling\\\/#primaryimage\",\"url\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2022\\\/12\\\/Amendment-to-the-Clinical-Trials-Regulation-CTR-on-Investigational-Medicinal-Products-IMPs-Labelling.png\",\"contentUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2022\\\/12\\\/Amendment-to-the-Clinical-Trials-Regulation-CTR-on-Investigational-Medicinal-Products-IMPs-Labelling.png\",\"width\":331,\"height\":301,\"caption\":\"Amendment To The Clinical Trials Regulation (ctr) On Investigational Medicinal Products (imps) Labelling\"},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/regask.com\\\/#website\",\"url\":\"https:\\\/\\\/regask.com\\\/\",\"name\":\"RegASK\",\"description\":\"Empowering Smarter Regulatory Decisions\",\"publisher\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/regask.com\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"de\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\",\"name\":\"RegASK\",\"url\":\"https:\\\/\\\/regask.com\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"de\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/logo\\\/image\\\/\",\"url\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2024\\\/10\\\/RegASK-Logo-Dark-Round.png\",\"contentUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2024\\\/10\\\/RegASK-Logo-Dark-Round.png\",\"width\":401,\"height\":401,\"caption\":\"RegASK\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/logo\\\/image\\\/\"},\"sameAs\":[\"https:\\\/\\\/www.facebook.com\\\/RegASKRegulatoryAffairs\\\/\",\"https:\\\/\\\/x.com\\\/ASKRegASK\",\"https:\\\/\\\/www.linkedin.com\\\/company\\\/RegASK\\\/\",\"https:\\\/\\\/www.youtube.com\\\/playlist?list=PL6yPC6gFqelkHbOeyUVKjtHOZXZ2LQbJd\"]},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/person\\\/c1d261e8dcf7b1c30b2c4f2c119df42d\",\"name\":\"Benoit Trouwaert\"}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"Empfehlungen der FDA zum Gro\u00dfhandel mit zusammengesetzten Arzneimitteln | RegASK","description":"Die US-amerikanische FDA ver\u00f6ffentlicht Empfehlungen zum gesetzlichen Gro\u00dfhandelsverbot f\u00fcr bestimmte Rezepturarzneimittel. Erfahren Sie mehr mit RegASK.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/regask.com\/de\/groshandel-mit-zusammengesetzten-arzneimitteln-der-fda\/","og_locale":"de_DE","og_type":"article","og_title":"US FDA Provides Recommendations on the Statutory Prohibition on Wholesaling for Certain Compounded Drugs","og_description":"The US FDA issues recommendations on the statutory prohibition on wholesaling for certain compounded drugs. Learn more with RegASK.","og_url":"https:\/\/regask.com\/de\/groshandel-mit-zusammengesetzten-arzneimitteln-der-fda\/","og_site_name":"RegASK","article_publisher":"https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/","article_published_time":"2023-07-10T02:57:34+00:00","article_modified_time":"2024-09-24T19:59:26+00:00","og_image":[{"width":331,"height":301,"url":"https:\/\/regask.com\/wp-content\/uploads\/2022\/12\/Amendment-to-the-Clinical-Trials-Regulation-CTR-on-Investigational-Medicinal-Products-IMPs-Labelling.png","type":"image\/png"}],"author":"Benoit Trouwaert","twitter_card":"summary_large_image","twitter_creator":"@ASKRegASK","twitter_site":"@ASKRegASK","twitter_misc":{"Written by":"Benoit Trouwaert","Est. reading time":"1\u00a0Minute"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/regask.com\/fda-compounded-drugs-wholesaling\/#article","isPartOf":{"@id":"https:\/\/regask.com\/fda-compounded-drugs-wholesaling\/"},"author":{"name":"Benoit Trouwaert","@id":"https:\/\/regask.com\/#\/schema\/person\/c1d261e8dcf7b1c30b2c4f2c119df42d"},"headline":"US FDA Provides Recommendations on the Statutory Prohib…","datePublished":"2023-07-10T02:57:34+00:00","dateModified":"2024-09-24T19:59:26+00:00","mainEntityOfPage":{"@id":"https:\/\/regask.com\/fda-compounded-drugs-wholesaling\/"},"wordCount":207,"publisher":{"@id":"https:\/\/regask.com\/#organization"},"image":{"@id":"https:\/\/regask.com\/fda-compounded-drugs-wholesaling\/#primaryimage"},"thumbnailUrl":"https:\/\/regask.com\/wp-content\/uploads\/2022\/12\/Amendment-to-the-Clinical-Trials-Regulation-CTR-on-Investigational-Medicinal-Products-IMPs-Labelling.png","keywords":["Latest Insights"],"articleSection":["Pharma and Biotech"],"inLanguage":"de"},{"@type":"WebPage","@id":"https:\/\/regask.com\/fda-compounded-drugs-wholesaling\/","url":"https:\/\/regask.com\/fda-compounded-drugs-wholesaling\/","name":"Empfehlungen der FDA zum Gro\u00dfhandel mit zusammengesetzten Arzneimitteln | RegASK","isPartOf":{"@id":"https:\/\/regask.com\/#website"},"primaryImageOfPage":{"@id":"https:\/\/regask.com\/fda-compounded-drugs-wholesaling\/#primaryimage"},"image":{"@id":"https:\/\/regask.com\/fda-compounded-drugs-wholesaling\/#primaryimage"},"thumbnailUrl":"https:\/\/regask.com\/wp-content\/uploads\/2022\/12\/Amendment-to-the-Clinical-Trials-Regulation-CTR-on-Investigational-Medicinal-Products-IMPs-Labelling.png","datePublished":"2023-07-10T02:57:34+00:00","dateModified":"2024-09-24T19:59:26+00:00","description":"Die US-amerikanische FDA ver\u00f6ffentlicht Empfehlungen zum gesetzlichen Gro\u00dfhandelsverbot f\u00fcr bestimmte Rezepturarzneimittel. Erfahren Sie mehr mit RegASK.","inLanguage":"de","potentialAction":[{"@type":"ReadAction","target":["https:\/\/regask.com\/fda-compounded-drugs-wholesaling\/"]}]},{"@type":"ImageObject","inLanguage":"de","@id":"https:\/\/regask.com\/fda-compounded-drugs-wholesaling\/#primaryimage","url":"https:\/\/regask.com\/wp-content\/uploads\/2022\/12\/Amendment-to-the-Clinical-Trials-Regulation-CTR-on-Investigational-Medicinal-Products-IMPs-Labelling.png","contentUrl":"https:\/\/regask.com\/wp-content\/uploads\/2022\/12\/Amendment-to-the-Clinical-Trials-Regulation-CTR-on-Investigational-Medicinal-Products-IMPs-Labelling.png","width":331,"height":301,"caption":"Amendment To The Clinical Trials Regulation (ctr) On Investigational Medicinal Products (imps) Labelling"},{"@type":"WebSite","@id":"https:\/\/regask.com\/#website","url":"https:\/\/regask.com\/","name":"RegASK","description":"Intelligentere Regulierungsentscheidungen erm\u00f6glichen","publisher":{"@id":"https:\/\/regask.com\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/regask.com\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"de"},{"@type":"Organization","@id":"https:\/\/regask.com\/#organization","name":"RegASK","url":"https:\/\/regask.com\/","logo":{"@type":"ImageObject","inLanguage":"de","@id":"https:\/\/regask.com\/#\/schema\/logo\/image\/","url":"https:\/\/regask.com\/wp-content\/uploads\/2024\/10\/RegASK-Logo-Dark-Round.png","contentUrl":"https:\/\/regask.com\/wp-content\/uploads\/2024\/10\/RegASK-Logo-Dark-Round.png","width":401,"height":401,"caption":"RegASK"},"image":{"@id":"https:\/\/regask.com\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/","https:\/\/x.com\/ASKRegASK","https:\/\/www.linkedin.com\/company\/RegASK\/","https:\/\/www.youtube.com\/playlist?list=PL6yPC6gFqelkHbOeyUVKjtHOZXZ2LQbJd"]},{"@type":"Person","@id":"https:\/\/regask.com\/#\/schema\/person\/c1d261e8dcf7b1c30b2c4f2c119df42d","name":"Benoit Trouwaert"}]}},"_links":{"self":[{"href":"https:\/\/regask.com\/de\/wp-json\/wp\/v2\/posts\/4321","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/regask.com\/de\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/regask.com\/de\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/regask.com\/de\/wp-json\/wp\/v2\/users\/39"}],"replies":[{"embeddable":true,"href":"https:\/\/regask.com\/de\/wp-json\/wp\/v2\/comments?post=4321"}],"version-history":[{"count":0,"href":"https:\/\/regask.com\/de\/wp-json\/wp\/v2\/posts\/4321\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/regask.com\/de\/wp-json\/wp\/v2\/media\/4047"}],"wp:attachment":[{"href":"https:\/\/regask.com\/de\/wp-json\/wp\/v2\/media?parent=4321"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/regask.com\/de\/wp-json\/wp\/v2\/categories?post=4321"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/regask.com\/de\/wp-json\/wp\/v2\/tags?post=4321"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}