DEA Publishes Final Rules Rescheduling Tramadol to Schedule IV
Effective August 18, 2014
The US Drug Enforcement Administration has published its Final Rule in the Federal Register placing tramadol into Schedule IV effective August 18, 2014.
A number of states in the country including Arkansas, Mississippi and New York have already placed tramadol as a controlled substance.
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.
Effective August 18, 2014 all manufacturers will be required to print the designation "C-IV" on every bottle and it is unlawful for commercial containers of tramadol to be distributed without that designation. In addition, all DEA registrants will be required to take an inventory of all tramadol stock in compliance with 21 C.F.R. § 1304.11(d).