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Larry Cote quoted in article “DEA Classifies Tramadol as Schedule IV, Creating New Requirements for Drugmakers”

Drug Industry Daily

Following is an excerpt:

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.

"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, told DID Thursday.

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 (DID, Jan. 2).

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, told DID.

Originally published in Drug Industry Daily, July 7, 2014