The Drug Enforcement Administration (DEA) issued its final rule for the scheduling of fospropofol, which is effective November 5, 2009. In the final rule, the DEA placed fospropofol into schedule IV of the Controlled Substances Act, which means that the regulatory controls and criminal sanctions of Schedule IV will be applicable to the manufacture, distribution, dispensing, importation, and exportation of fospropofol and products containing fospropofol. Such scheduling will allow fospropofol to remain readily available for use by responsible clinicians in urgent and emergent situations, but will require that it be reasonably stored in a restricted and secure environment with access limited to qualified clinicians.
The ASA applauds this effort by the DEA and has fully supported the scheduling of fospropofol as a Schedule IV controlled substance. The DEA acknowledged the comments from ASA in its final rule stating that ASA “is in agreement with the findings of scientific and medical evaluation that formed the basis for the present rule controlling fospropofol as a schedule IV substant and [ASA] fully supported this control action.”