The DEA published its final ruling on tramadol earlier this month, deciding that as of August 18 the active pharmaceutical ingredient (API) will be classified as schedule IV, which is a substance with a low potential for abuse and low risk of dependence.
Tramadol - which was previously not a Scheduled substance - has been on the market in various different versions for more than 20 years and the reclassification decision raised some concerns about the proposed timelines and likely impact on industry.
The FDA Law Blog said the “DEA appears to underestimate the modifications that the supply chain will need to make to policies and procedures to comply with tramadol scheduling,” adding in assigning tramadol products a classification manufacturers, distributors, and importers would be subject to “the applicable provisions of the CSA [Controlled Substances Act] and its implementing regulations.”
For a manufacturer, such rules would affect the registration and security of the API and finished products, as well as changes to the packaging and labelling.
J&J subsidiary Janssen has marketed its tramadol hydrochloride product, Ultram, in the US since 1995 and told in-Pharmatechnologist.com it was prepared for next month’s deadline.
“Janssen has been aware of the recommendation to place tramadol into Schedule IV of the Controlled Substances Act for some time,” said spokesperson Craig Stoltz, adding the proposed change was issued on the Federal Register in November last year.
“The security systems are in place to secure the Janssen supply chain for our tramadol products and the new labelling requirements are being addressed so that Janssen will be compliant by the August 18, 2014 deadline,” he confirmed.
The API is supplied to Janssen by Grünenthal which holds the original patent on tramadol, spokesperson for the Germany-headquartered firm Fabia Kehren told us.
“Grünenthal has extensive experience with the production and distribution of controlled substances and will comply with the changes coming into effect on August 18,” she said, adding the classification is due to the rise in prescription opioid abuse in the US over the past decade.
A number of generic drugmakers were contacted by this publication as to the effects of the new scheduling on their product. Only Indian firm Sun Pharma replied, but refused to comment on the upcoming ruling.
The change in status only affects the US, with controlled substances in the EU regulated by individual member states. Tramadol is listed as a controlled substance in Sweden, Kathy Robertson from the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) told us, and as of last month, has received the same status in the UK.