[{"@context":"https:\/\/schema.org\/","@type":"BlogPosting","@id":"https:\/\/www.brppharma.com\/dea-finalizes-rule-to-schedule-tramadol#BlogPosting","mainEntityOfPage":"https:\/\/www.brppharma.com\/dea-finalizes-rule-to-schedule-tramadol","headline":"DEA Finalizes Rule to Schedule Tramadol","name":"DEA Finalizes Rule to Schedule Tramadol","description":"By Susan Trujillo on\u00a0July 1, 2014 Posted in\u00a0DEA Compliance,\u00a0Drug Policy,\u00a0Scheduling Actions Possibly in the hopes of catching everyone before they leave for their 4th of July holiday, the\u00a0DEA published its Final Rule in the Federal Register on July 2nd\u00a0placing tramadol into Schedule IV effective August 18, 2014.\u00a0 (Tramadol is a centrally acting opioid analgesic first […]","datePublished":"2014-07-02","dateModified":"2014-07-02","author":{"@type":"Person","@id":"https:\/\/www.brppharma.com\/author\/bhmedia#Person","name":"Louie","url":"https:\/\/www.brppharma.com\/author\/bhmedia","identifier":2,"image":{"@type":"ImageObject","@id":"https:\/\/secure.gravatar.com\/avatar\/06b658cd4be5303f1f8f8a9317a41aaf784e175e3e7f6da9db18f4821c64ff09?s=96&d=mm&r=g","url":"https:\/\/secure.gravatar.com\/avatar\/06b658cd4be5303f1f8f8a9317a41aaf784e175e3e7f6da9db18f4821c64ff09?s=96&d=mm&r=g","height":96,"width":96}},"publisher":{"@type":"Organization","name":"BRP Pharmaceuticals","logo":{"@type":"ImageObject","@id":"https:\/\/www.brppharma.com\/wp-content\/uploads\/2017\/10\/brp-logo.png","url":"https:\/\/www.brppharma.com\/wp-content\/uploads\/2017\/10\/brp-logo.png","width":340,"height":100}},"image":{"@type":"ImageObject","@id":"https:\/\/www.brppharma.com\/wp-content\/uploads\/2018\/08\/brp-Landing-logo.png","url":"https:\/\/www.brppharma.com\/wp-content\/uploads\/2018\/08\/brp-Landing-logo.png","width":133,"height":55},"url":"https:\/\/www.brppharma.com\/dea-finalizes-rule-to-schedule-tramadol","about":["News"],"wordCount":371,"articleBody":"By Susan Trujillo on\u00a0July 1, 2014Posted in\u00a0DEA Compliance,\u00a0Drug Policy,\u00a0Scheduling ActionsPossibly in the hopes of catching everyone before they leave for their 4th of July holiday, the\u00a0DEA published its Final Rule in the Federal Register on July 2nd\u00a0placing tramadol into Schedule IV effective August 18, 2014.\u00a0 (Tramadol is a centrally acting opioid analgesic first approved for use in the U.S. in 1995 under the name \u201cUltram\u201d.\u00a0 Since then, the FDA has approved for marketing generic, combination and extended release versions.)\u00a0 The DEA follows in the path of a number of states that have already taken this step such as Arkansas, Mississippi, and New York.\u00a0 By making tramadol a Schedule IV controlled substance, the DEA makes it easier for the pharmaceutical industry to develop consistent policies and procedures nationwide for how this drug is handled.Acknowledging that changes such as these take time to implement, the DEA extended the usual effective date for this type of change from 30 to 45 days to provide what it considers to be \u201creasonable time for registrants to comply with handling requirements for a schedule IV\u201d drug, such as moving tramadol products into a warehouse cage or adjusting suspicious monitoring systems to include tramadol orders. \u00a0Though in the past the DEA has allowed for additional time for compliance or staggered the implementation process, it specifically chose to forgo staggered dates here to avoid confusion and inconsistent application of the new requirement.It is important to note that as of August 18, 2014, manufacturers are required to print the designation \u201cC-IV\u201d onto every bottle and it is unlawful for commercial containers of tramadol to be distributed without that designation.\u00a0 The DEA believes that the 45 day window between July 2nd and August 18th will \u201cprovide a reasonable time for distributors to sell existing stock\u201d without the designation and to stock inventory with the proper designation. \u00a0Also, August 18th will be a busy day, as on August 18th every DEA registrant possessing tramadol must take an inventory of all tramadol stock in compliance with 21 C.F.R. \u00a7 \u00a01304.11(d).\u00a0 Anyone who doesn\u2019t want to handle controlled substances, but that currently stocks tramadol, must surrender the stock according to \u00a7 1307.21 or must transfer the stock to a DEA registrant before August 18th."},{"@context":"https:\/\/schema.org\/","@type":"BreadcrumbList","itemListElement":[{"@type":"ListItem","position":1,"name":"DEA Finalizes Rule to Schedule Tramadol","item":"https:\/\/www.brppharma.com\/dea-finalizes-rule-to-schedule-tramadol#breadcrumbitem"}]}]