As expected, the Drug Enforcement Administration (“DEA”) published its final rule in the Federal Register today (79 Fed. Reg. 37,623 (July 2, 2014) placing tramadol (2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol) into schedule IV of the federal Controlled Substances Act (“CSA”). Tramadol is currently controlled in at least ten states. We wrote a blog here analyzing the eight-factor analyses conducted by Health and Human Services and DEA outlined in the notice of proposed rulemaking on November 4, 2013.
DEA received 27 comments on the proposed rule; 16 supported scheduling and nine opposed the action. The scheduling action is effective August 18, 2014, which means that the regulated industry has only 45 days to ensure compliance with the registration, security, recordkeeping and reporting requirements. One commenter, a national association that represents healthcare distributors, opined that the agency should provide an extended time period for registrants to comply with security, labeling and packaging and reporting requirements. DEA replied that scheduling actions are generally effective 30 days after the date of publication of the final rule in the Federal Register, and asserted that the 45-day effective period “will provide a reasonable time for registrants to comply with the handling requirements for a schedule IV controlled substance and was established upon a full consideration of the totality of circumstances specific to tramadol.”
DEA appears to underestimate the modifications that the supply chain will need to make to policies and procedures to comply with tramadol scheduling, especially for a drug that has been marketed as a non-controlled substance under federal law for almost 20 years. While DEA and FDA cited to concerns about increased abuse of tramadol as a basis for the need to schedule the drug, there was no compelling evidence of diversion from the supply chain to warrant not providing additional time for the industry to conform its compliance systems to the new requirements. DEA’s placement of tramadol in schedule IV subjects manufacturers, distributors, dispensers including pharmacies and physicians, importers, exporters, and anyone in possession of the drug to the applicable provisions of the CSA and its implementing regulations. The CSA and DEA regulations impose specific registration, security, labeling and packaging, inventory, recordkeeping, reporting, prescription, and import and export requirements for schedule IV controlled substances.
It is also worth noting, the World Health Organization Expert Committee on Drug Dependence (“ECDD”) recently met to decide whether tramadol should be scheduled under the international drug control treaties. The results of the ECDD review will not be known for several months.