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Regulatory News | 16 June 2015 | By Alexander Gaffney, RAC
The US Drug Enforcement Administration (DEA) has proposed a massive increase in the amount of marijuana it will allow to be produced this year in the hopes of meeting the demand of researchers studying new medicinal uses for the drug, it has announced.
In the US, the manufacture and production of marijuana is controlled by the DEA, whose authority to do so stems from the Controlled Substances Act (CSA)—a law which categorizes drugs in accordance with their risk of abuse and medical benefit.
For example, drugs regulated by DEA under Schedule II of the CSA may have a recognized benefit, but also a substantial risk of misuse or abuse. A Schedule V drug, meanwhile, may have a recognized medical benefit and a very small risk of misuse or abuse.
And then there are Schedule I drugs like cocaine and marijuana—drugs which DEA claims have no recognized medicinal purpose as well as a high risk of misuse or abuse.
But while these drugs might not have the approval of the US Food and Drug Administration (FDA) or DEA, that doesn't mean they are totally banned in the US. Under the CSA, DEA controls the production of schedule I and II drugs, including for research purposes.
As a result, even drugs like cocaine are allowed to be manufactured and distributed under DEA's Aggregate Production Quotas (APQs). Such quotas determine the exact amount of each drug that is permitted to (legally) be produced in the US each year for research or other official purposes.
In September 2014, DEA released its Established Aggregate Production Quotas for Schedule I and II Controlled Substancesin the Federal Register. The document details the exact amount of each schedule I and II drug that can be produced in the US during 2015.
Among the drug substances included in DEA's initial 2015 APQ is marijuana—spelled marihuana in the document—which is set at a production quota of 125,000 grams.
Then, in April 2015, DEA proposed a further and substantial increase for the APQ for marijuana, which it said should be increased to 400,000 grams.
The increase, DEA said, was in response to an elevated demand for cannabidiol, an active ingredient in marijuana, for research purposes.
"Since the establishment of the initial 2015 aggregate production quotas, the DEA has received notification from DEA registered manufacturers that research and product development involving cannabidiol, is increasing beyond that previously anticipated for 2015," DEA explained in its notice. "The associated product development activities are related to process validation and commercialization activities, including qualification activities related to potential FDA submission support."
In plain terms, several companies have been trying to obtain supplies of cannabidiol to test its medicinal properties. For example, two companies, Insys Therapeutics and GW Pharma, are seeking FDA approval for drugs to treat different types of epilepsy. Dozens of other studies are hoping to determine if the ingredient is helpful in treating schizophrenia, graft versus host disease, Dravet syndrome and more.
The boost in demand is also due, in part, to increased interest from the government. DEA said the National Institute on Drug Abuse (NIDA) has requested "Additional supplies of marijuana to be manufactured in 2015 to provide for ongoing and anticipated research efforts involving marijuana."
But even a three-fold increase in the APQ is apparently not enough. DEA is now proposing to increase its production quota for marijuana even further.
In a Federal Register posting on 16 June 2015, the agency said upon further review of the quota, and in consideration of comments received from the public, it will increase the production quota for marijuana to 658,000 grams—more than five times the amount permitted previously.
The new quota amount applies to all of fiscal year 2015, DEA said.
DEA: Controlled Substances: Difenoxin, Diphenoxylate (for conversion), and Marijuana; Aggregate Production Quotas
Tags: DEA, Marijuana, Cannabidiol, Marihuana