{"id":7953,"date":"2025-10-21T06:11:06","date_gmt":"2025-10-21T06:11:06","guid":{"rendered":"https:\/\/pharmamachinecn.com\/?page_id=7953"},"modified":"2025-10-21T06:16:31","modified_gmt":"2025-10-21T06:16:31","slug":"dea-registration-for-tablet-press-machine","status":"publish","type":"page","link":"https:\/\/pharmamachinecn.com\/tr\/dea-registration-for-tablet-press-machine\/","title":{"rendered":"Tablet Pres Makinesi i\u00e7in DEA Kayd\u0131"},"content":{"rendered":"<h3 class=\"wp-block-heading\"><strong>Tablet Bask\u0131 Makineleri i\u00e7in DEA Kayd\u0131n\u0131n Anla\u015f\u0131lmas\u0131<\/strong><\/h3>\n\n\n\n<p>&quot;Bir&quot; i\u00e7in ba\u015fvuruda bulunmak<a href=\"https:\/\/deadiversion.usdoj.gov\/drugreg\/registration.html\" target=\"_blank\" rel=\"noopener\">DEA lisans\u0131<\/a>&quot;Bir tablet bask\u0131 makinesi i\u00e7in belirli bir s\u00fcre\u00e7 s\u00f6z konusudur \u00e7\u00fcnk\u00fc DEA makinenin kendisini &quot;lisanslamaz&quot;. Bunun yerine,\u00a0<strong>\u015firket ve konum<\/strong>\u00a0Kontroll\u00fc maddeleri \u00fcretecek, da\u011f\u0131tacak veya ithal edecek ve daha sonra bu kay\u0131tl\u0131 faaliyetin bir par\u00e7as\u0131 olarak tablet presi gibi belirli ekipmanlar\u0131n kullan\u0131m\u0131n\u0131 onaylayacak.<\/p>\n\n\n\n<p>Temel fark, bir lisans ba\u015fvurusunda bulunmuyor olman\u0131zd\u0131r&nbsp;<em>makine i\u00e7in<\/em>, ancak bunun yerine makineyi DEA kayd\u0131 gerektiren kontroll\u00fc madde \u00fcretim veya i\u015fleme operasyonunuzun bir par\u00e7as\u0131 olarak dahil etmek.<\/p>\n\n\n\n<p>\u0130\u015fte ad\u0131m ad\u0131m s\u00fcre\u00e7 ve kritik gereksinimler:<\/p>\n\n\n\n<h4 class=\"wp-block-heading\"><strong>Ad\u0131m 1: \u0130\u015fletme Faaliyetinizi Belirleyin ve Do\u011fru DEA Kayd\u0131n\u0131 Al\u0131n<\/strong><\/h4>\n\n\n\n<p>\u00d6ncelikle, DEA \u00dcretici Kayd\u0131 (DEA Form 225) ba\u015fvurusunda bulunmal\u0131 ve bunu almal\u0131s\u0131n\u0131z. Bu, bir tesisin tabletleme s\u00fcrecini de i\u00e7eren kontroll\u00fc maddelerin &quot;\u00fcretimine&quot; izin veren temel lisanst\u0131r.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>\u00d6n ko\u015ful:<\/strong>\u00a0DEA ba\u015fvurunuzu onaylamadan \u00f6nce gerekli t\u00fcm eyalet ve yerel i\u015fletme lisanslar\u0131na sahip olman\u0131z gerekir.<\/li>\n\n\n\n<li><strong>Ba\u015fvuru:<\/strong>\u00a0Ba\u015fvuru, DEA&#039;n\u0131n Tahliye Kontrol B\u00f6l\u00fcm\u00fc portal\u0131 arac\u0131l\u0131\u011f\u0131yla \u00e7evrimi\u00e7i olarak yap\u0131l\u0131r.\u00a0<strong><a href=\"https:\/\/ehs.oregonstate.edu\/sites\/ehs.oregonstate.edu\/files\/pdf\/dea_form_225_instructions.pdf\" target=\"_blank\" rel=\"noopener\">DEA Formu 225<\/a><\/strong>.<\/li>\n\n\n\n<li><strong>\u00dccret:<\/strong>\u00a0Bu uygulama ile ili\u015fkili \u00f6nemli bir kay\u0131t \u00fccreti vard\u0131r (genellikle<strong> $3,000<\/strong> (\u00dc\u00e7 y\u0131ll\u0131k kay\u0131t i\u00e7in ge\u00e7erlidir, ancak g\u00fcncel tutar\u0131 DEA web sitesinden teyit edin).<\/li>\n<\/ul>\n\n\n\n<h4 class=\"wp-block-heading\"><strong>Ad\u0131m 2: S\u0131k\u0131 G\u00fcvenlik \u00d6nlemlerini Uygulay\u0131n<\/strong><\/h4>\n\n\n\n<p>Tablet presi sipari\u015f etmeden veya kontroll\u00fc maddeler i\u00e7in kullanmadan \u00f6nce, tesisinizin DEA g\u00fcvenlik gerekliliklerini kar\u015f\u0131lamas\u0131 gerekir. Bu, ba\u015fvurunun ve m\u00fcteakip denetimin kritik bir par\u00e7as\u0131d\u0131r.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Fiziksel G\u00fcvenlik:<\/strong>\u00a0Tablet bask\u0131 makinesi, yetkisiz eri\u015fimi ve h\u0131rs\u0131zl\u0131\u011f\u0131 \u00f6nleyecek \u015fekilde tasarlanm\u0131\u015f, g\u00fcvenli bir \u015fekilde kilitlenmi\u015f bir alanda (\u00f6rne\u011fin bir kafes veya kasa) muhafaza edilmelidir. Tesisin tamam\u0131nda alarmlar, izleme sistemleri ve kontroll\u00fc eri\u015fim noktalar\u0131 bulunmal\u0131d\u0131r.<\/li>\n\n\n\n<li><strong>Arka Plan Kontrolleri:<\/strong>\u00a0Kontroll\u00fc maddelere veya tabletleme alan\u0131na eri\u015fimi olacak t\u00fcm \u00e7al\u0131\u015fanlar\u0131n kapsaml\u0131 ge\u00e7mi\u015f kontrollerinden ge\u00e7mesi gerekmektedir.<\/li>\n<\/ul>\n\n\n\n<h4 class=\"wp-block-heading\"><strong>Ad\u0131m 3: Tablet Pres Makinesinin Sat\u0131n Al\u0131nd\u0131\u011f\u0131n\u0131 Bildirin<\/strong><\/h4>\n\n\n\n<p>Bu, sorunuza \u00f6zel en \u00f6nemli ad\u0131md\u0131r. Tablet presi, Kontroll\u00fc Maddeler Yasas\u0131 kapsam\u0131nda &quot;d\u00fczenlenmi\u015f makine&quot; olarak kabul edilir.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Gereklilik:<\/strong>\u00a0Bir dosyalama yapmal\u0131s\u0131n\u0131z\u00a0<strong>D\u00fczenlenmi\u015f \u0130\u015flem Raporu (<a href=\"https:\/\/deadiversion.usdoj.gov\/21cfr_reports\/reg_machines\/reg-machines.html\" target=\"_blank\" rel=\"noopener\">DEA Formu 452<\/a>)<\/strong>\u00a0DEA&#039;n\u0131n Uyu\u015fturucuyla M\u00fccadele Kontrol Ofisi ile.<\/li>\n\n\n\n<li><strong>Zaman \u00c7izelgesi:<\/strong>\u00a0Bu rapor dosyalanmal\u0131d\u0131r\u00a0<strong>en az 15 g\u00fcn \u00f6nce<\/strong>\u00a0Makinenin m\u00fclkiyetinin al\u0131nmas\u0131 (yani, tesisinize g\u00f6nderilmesinden \u00f6nce).<\/li>\n\n\n\n<li><strong>\u0130stenen Bilgiler:<\/strong>\u00a0Formda makine hakk\u0131nda detayl\u0131 bilgiler (marka, model, seri numaras\u0131) ve makineyi sat\u0131n ald\u0131\u011f\u0131n\u0131z tedarik\u00e7inin bilgileri istenecektir.<\/li>\n\n\n\n<li><strong>Devam Eden Sorumluluk:<\/strong>\u00a0Tablet bask\u0131 makinenizi satman\u0131z, devretmeniz veya elden \u00e7\u0131karman\u0131z durumunda da benzer bir rapor sunman\u0131z gerekir.<\/li>\n<\/ul>\n\n\n\n<h4 class=\"wp-block-heading\"><strong>4. Ad\u0131m: \u00d6n Kay\u0131t Denetimine Haz\u0131rl\u0131k Yap\u0131n<\/strong><\/h4>\n\n\n\n<p>DEA Form 225 ba\u015fvurunuz incelendikten sonra, DEA muhtemelen tesisinizde yerinde bir inceleme ger\u00e7ekle\u015ftirecektir. Bu incelemede \u015funlar do\u011frulanacakt\u0131r:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Tesisin tamam\u0131nda al\u0131nan g\u00fcvenlik \u00f6nlemleri ve tablet presinin yap\u0131laca\u011f\u0131 \u00f6zel lokasyon.<\/li>\n\n\n\n<li>Kontroll\u00fc madde hammaddelerinin (\u00f6rne\u011fin, API&#039;ler \u2013 Aktif \u0130la\u00e7 \u0130\u00e7erikleri) sipari\u015f edilmesi ve i\u015flenmesi i\u00e7in kay\u0131t tutma sistemleriniz.<\/li>\n\n\n\n<li>At\u0131k bertaraf\u0131 ve kay\u0131p \u00f6nleme prosed\u00fcrleriniz.<\/li>\n\n\n\n<li>Kilit personelinizin nitelikleri.<\/li>\n<\/ul>\n\n\n\n<p><strong>Bu denetimi ge\u00e7ene kadar kayd\u0131n\u0131z onaylanmayacakt\u0131r.<\/strong><\/p>\n\n\n\n<h4 class=\"wp-block-heading\"><strong>\u00d6nemli Noktalar\u0131n \u00d6zeti<\/strong><\/h4>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>\u201cMakine i\u00e7in lisans\u201d alamazs\u0131n\u0131z.<\/strong>\u00a0\u0130\u015fletme faaliyetiniz (\u00dcretim) i\u00e7in bir kay\u0131t al\u0131rs\u0131n\u0131z ve ard\u0131ndan belirli makineyi DEA&#039;ya bildirirsiniz.<\/li>\n\n\n\n<li>\u0130\u015flem s\u0131ral\u0131d\u0131r:\n<ol start=\"1\" class=\"wp-block-list\">\n<li>T\u00fcm eyalet\/yerel lisanslar\u0131 edinin.<\/li>\n\n\n\n<li>DEA \u00dcretici Kayd\u0131 i\u00e7in ba\u015fvuruda bulunun (Form 225).<\/li>\n\n\n\n<li>Ayn\u0131 zamanda tablet presine ili\u015fkin D\u00fczenlenmi\u015f \u0130\u015flem Raporu&#039;nu (Form 452) sat\u0131n almadan en az 15 g\u00fcn \u00f6nce dosyalay\u0131n.<\/li>\n\n\n\n<li>DEA&#039;n\u0131n \u00f6n kay\u0131t denetiminden ge\u00e7in.<\/li>\n<\/ol>\n<\/li>\n\n\n\n<li>G\u00fcvenlik ve kay\u0131t tutma tart\u0131\u015fmaya a\u00e7\u0131k de\u011fildir ve s\u0131k\u0131 bir \u015fekilde denetlenecektir.<\/li>\n<\/ul>\n\n\n\n<h4 class=\"wp-block-heading\"><strong>\u00d6nemli Uyar\u0131<\/strong><\/h4>\n\n\n\n<p>DEA, yasad\u0131\u015f\u0131 uyu\u015fturucu (fentanil i\u00e7eren sahte re\u00e7eteli haplar gibi) \u00fcretimine y\u00f6nlendirilme potansiyelleri y\u00fcksek oldu\u011fundan, tablet bask\u0131 makinelerini ve di\u011fer kaps\u00fclleme makinelerini yak\u0131ndan takip etmektedir. Ba\u015fvuru s\u00fcrecinde, g\u00fcvenlik protokol\u00fcnde veya kay\u0131t tutmada herhangi bir yanl\u0131\u015f ad\u0131m, ba\u015fvurunuzun derhal reddedilmesine, mevcut bir kayd\u0131n iptal edilmesine veya a\u011f\u0131r yasal cezalara yol a\u00e7abilir.<\/p>\n\n\n\n<p><strong>Yasal Uyar\u0131:<\/strong>\u00a0<em>Bu bilgiler yaln\u0131zca rehberlik ama\u00e7l\u0131d\u0131r ve hukuki tavsiye te\u015fkil etmez. DEA d\u00fczenleme s\u00fcreci karma\u015f\u0131kt\u0131r ve de\u011fi\u015fikli\u011fe tabidir. Do\u011frudan \u015fu ki\u015fiyle g\u00f6r\u00fc\u015fmelisiniz:<a href=\"https:\/\/www.dea.gov\/operational-division\/diversion\" target=\"_blank\" rel=\"noopener\"> ABD Uyu\u015fturucuyla M\u00fccadele Dairesi Uyu\u015fturucuyla M\u00fccadele Kontrol Birimi<\/a> ve tam uyumlulu\u011fu sa\u011flamak i\u00e7in nitelikli bir hukuk dan\u0131\u015fmanl\u0131\u011f\u0131 al\u0131n.<\/em><\/p>","protected":false},"excerpt":{"rendered":"<p>Understanding DEA Registration for Tablet Press Machines Applying for a &#8220;DEA license&#8221; for a tablet press machine involves a specific [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"class_list":["post-7953","page","type-page","status-publish","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/pharmamachinecn.com\/tr\/wp-json\/wp\/v2\/pages\/7953","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pharmamachinecn.com\/tr\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/pharmamachinecn.com\/tr\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/pharmamachinecn.com\/tr\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/pharmamachinecn.com\/tr\/wp-json\/wp\/v2\/comments?post=7953"}],"version-history":[{"count":2,"href":"https:\/\/pharmamachinecn.com\/tr\/wp-json\/wp\/v2\/pages\/7953\/revisions"}],"predecessor-version":[{"id":7955,"href":"https:\/\/pharmamachinecn.com\/tr\/wp-json\/wp\/v2\/pages\/7953\/revisions\/7955"}],"wp:attachment":[{"href":"https:\/\/pharmamachinecn.com\/tr\/wp-json\/wp\/v2\/media?parent=7953"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}