On October 5th, the U.S. Food and Drug Administration (FDA) issued a request for comments regarding the abuse potential, actual abuse, medical usefulness, trafficking and impact of scheduling changes on the availability for medical use of 10 drug substances, including ketamine.
ASPET has submitted comments articulating the Society’s objection to object to any adoption of an international regulation of ketamine that might result in more restrictive regulation in the US, which would interfere with the use of the drug by licensed professionals for authorized and appropriate use. The response outlines the myriad uses for ketamine that are essential to clinical trials and biomedical research.
The World Health Organization (WHO) is considering a change to the international scheduling of ketamine, proposed by China and the comments will be considered as FDA prepares a response to the WHO regarding the abuse liability and diversion of these drugs and will be provided to the 36th Expert Committee on Drug Dependence (ECDD), which will meet in Geneva November 16-20th.
View ASPET’s response here.
Last updated: October 19, 2015