On July 2, 2014, the DEA published in the Federal Register the final rule placing Tramadol into Schedule IV of the Controlled Substances Act. This rule will become effective on August 18, 2014. All regulatory requirements applicable to Schedule IV controlled substances will apply to Tramadol beginning August 18, 2014. The final rule is available online at www.regulations.gov.
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.
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).
Drug Enforcement Administration (DEA) will make all Tramadol-containing products Schedule IV CS on August 18, 2014. Pharmacist should be aware:
- An inventory is required to be taken on this day of all affected products. The inventory should be kept with the most recent CS inventory.
- Schedule IV physical security requirements will apply.
- The six-month/five refill limits will apply.
- According to the BNDD, existing prescriptions and refills from mid-level practitioners who do not have CS authority and DEA/BNDD registrations will become void.
*Source: Drug Enforcement Administration, Office of Diversion Control, Drug & Chemical Evaluation Section