Tramadol Moved to Schedule 4

by Ashley Builta, Pharm.D., MPA fellow of association management and business development

A success for pharmacists noting the abuses of tramadol by their patients!

On July 2, 2014, the Drug Enforcement Administration (DEA) issued a final rule that moved all salts, isomers and salts of isomers of tramadol (first marketed as ULTRAM®) into Schedule 4 of the Controlled Substances Act. This scheduling becomes effective Aug. 18, 2014. All regulatory requirements of Schedule 4 substances (records, inventory, etc.) will apply to tramadol as of Aug. 18, 2014. The Aug. 18 date is 45 days, rather than the usual 30 days, after the ruling to allow for everyone to comply with the new scheduling of tramadol.

As with other Schedule 4 controlled substances, a prescription for tramadol as of Aug. 18 will only be valid for six months after it is written and may be refilled up to five times within that six-month period. Commercial containers of tramadol distributed to pharmacies after Aug. 18 shall have “C-IV” printed on the container.

Pharmacies and other DEA registrants will need to take an inventory of their tramadol stock on hand on Aug. 18. After that, tramadol stock will be included in the inventory of all controlled substances on hand taken every two years. Records for tramadol will also need to be maintained in the same manner as other Schedule 4 controlled substances.

This move is in response to four petitions to the U.S. Food and Drug Administration to have tramadol scheduled as a controlled substance, supported by a recommendation from the Department of Health and Human Services and an investigation by the DEA that found tramadol to have an abuse potential equivalent to other Schedule 4 controlled substances. The DEA published the notice to schedule tramadol in the Federal Register in November 2013. 

The DEA ruling can be found online.