Marinol: Encyclopedia II - Marinol - Regulatory history

Marinol - Regulatory history

Since at least 1986, the trend has been for THC in general, and especially the Marinol preparation, to be downgraded to less and less stringently-controlled Schedules of controlled substances, in the U.S. and internationally.

On July 13, 1986, the Drug Enforcement Administration issued a Final Rule and Statement of Policy authorizing the "Rescheduling of Synthetic Dronabinol in Sesame Oil and Encapsulated in Soft Gelatin Capsules From Schedule I to Schedule II"(DEA 51 FR 17476-78). This permitted medical use of Marinol, albeit with the severe restrictions associated with Schedule II status. For instance, refills of Marinol prescriptions were not permitted. At its 1045th meeting, on April 29, 1991, the Commission on Narcotic Drugs, in accordance with article 2, paragraphs 5 and 6, of the Convention on Psychotropic Substances, decided that delta-9-tetrahydrocannabinol (also referred to as delta-9-THC) and its stereochemical variants should be transferred from Schedule I to Schedule II of that Convention. This released Marinol from the restrictions imposed by Article 7 of the Convention[1].

An abstract published in the April-June 1998 issue of the Journal of Psychoactive Drugs found that "Healthcare professionals have detected no indication of scrip-chasing or doctor-shopping among the patients for whom they have prescribed dronabinol"[2]. The authors suggested that Marinol had a low potential for abuse.

In 1999, Marinol was rescheduled from Schedule II to III of the Controlled Substances Act, reflecting a finding that THC had a potential for abuse less than that of LSD, cocaine, and heroin. This rescheduling comprised part of the argument for a 2002 petition for cannabis rescheduling in the United States, in which petitioner Jon Gettman noted, "Cannabis is a natural source of dronabinol (THC), the ingredient of Marinol™, a Schedule III drug. There are no grounds to schedule cannabis in a more restrictive schedule than Marinol™"[3].

At its 33rd meeting, the World Health Organization Expert Committee on Drug Dependence recommended transferring tetrahydrocannabinol to Schedule IV of the Convention, citing its medical uses and low abuse potential. This would put THC in the Convention's least stringently-controlled Schedule.

Adapted from the Wikipedia article "Regulatory history", under the G.N U Free Docmentation License. Please also see http://en.wikipedia.org/wiki