“DEA Finalizes Rule to Schedule Tramadol”
DEA Chronicles 04/01/14 By Susan B. Trujillo
Possibly in the hopes of catching everyone before they leave for their 4th of July holiday, the DEA published its Final Rule in the Federal Register on July 2nd placing tramadol into Schedule IV effective August 18, 2014. (Tramadol is a centrally acting opioid analgesic first approved for use in the U.S. in 1995 under the name “Ultram”. Since then, the FDA has approved for marketing generic, combination and extended release versions.) The DEA follows in the path of a number of states that have already taken this step such as Arkansas, Mississippi, and New York. 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 “reasonable time for registrants to comply with handling requirements for a schedule IV” drug, such as moving tramadol products into a warehouse cage or adjusting suspicious monitoring systems to include tramadol orders. Though 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 “C-IV” onto every bottle and it is unlawful for commercial containers of tramadol to be distributed without that designation. The DEA believes that the 45 day window between July 2nd and August 18th will “provide a reasonable time for distributors to sell existing stock” without the designation and to stock inventory with the proper designation. Also, 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. § 1304.11(d). Anyone who doesn’t want to handle controlled substances, but that currently stocks tramadol, must surrender the stock according to § 1307.21 or must transfer the stock to a DEA registrant before August 18th.