DEA Considers Tramadol a Schedule IV Controlled Substance
Tramadol manufacturers have approximately 45 days to implement new labeling and security procedures now that the Drug Enforcement Administration has determined the opioid analgesic is a Schedule IV controlled substance.
The DEA decision means the 24 brand and generic drugmakers producing tramadol have until Aug. 18 to update labeling to note the drug’s abuse potential and inform pharmacists on how to handle prescribing the product.
By the mid-August deadline they also must meet new security requirements for the storage of tramadol, including installing hidden cameras and alarm systems in warehouses where the drug is stored. Tramadol must be stored in a cage that has restricted access, according to a final rule published July 2. Finally, drugmakers must conduct an inventory of all tramadol on hand and maintain it so the information is available upon request from the DEA.
Tramadol is used in 51 approved brand and generic products, including branded drugs such as Janssen’s Ultram and Cipher Pharma’s Conzip. It previously was not scheduled by the DEA.
The DEA rebuffed a request from the Healthcare Distribution Management Association to stagger implementation of the scheduling. HDMA had agreed to the 45-day inventory deadline, but suggested manufacturers get 120 days to install the security measures.
The additional time would let drugmakers and distributors make necessary changes to information technology systems that monitor and identify suspicious orders of tramadol, HDMA argued. Such IT systems would likely “need additional time for development, testing, conduct staff training and revision to ensure compliance,” said the trade group, one of 32 commenters.
In rejecting HDMA’s request, the DEA says that staggered implementation could lead to “confusion and inconsistent application of the law.” Moreover, the agency already gave affected companies more time to comply with the rule, as most scheduling actions are effective 30 days after a ruling is published, the rule notes.
Experts say the law could help drugmakers comply with regulations on the drug by replacing a patchwork of state laws with a single standard. Currently, 10 states classify tramadol as Schedule IV under state law, with requirements that meet or exceed federal standards. They are Arkansas, Illinois, Kentucky, Mississippi, New Mexico, New York, Oklahoma, Tennessee, North Dakota and Wyoming, the DEA said.
“Now you will have at least a national floor for the prescribing, physical security, recordkeeping and inventory for tramadol,” Larry Cote, a DEA compliance attorney for Quarles & Brady, said.
It remains unclear how the DEA’s decision will impact international efforts to schedule tramadol. The World Health Organization is considering international restrictions on tramadol and 25 other popular painkillers, such as tapentadol.
However, the fact that an influential country such as the U.S. scheduled the drug “certainly indicates there could eventually be international control,” Linden Barber, head of Quarles & Brady’s DEA compliance group, said. — Robert King
Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.