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The Drug Enforcement Administration (DEA) is proposing to adjust the established 2015 aggregate production quota for marijuana. While marijuana is a scheduled I drug and the laws around it are enforced by the DEA, they do allow several government agencies and registered manufacturers to produce it for research and product development.
Registered manufacturers and the National Institute on Drug Abuse (NIDA) have requested a higher quota for production and supply of marijuana for 2015. The previous 2015 established quote for marijuana was 125,000 g, and the new adjusted quota for 2015 is 400,000 g.
The DEA established the initial 2015 aggregate production quotas and assessments of annual need on September 8, 2014 (79 FR 53216). That notice stipulated that, as provided for in 21 CFR 1303.13, all aggregate production quotas and assessments of annual need are subject to adjustment.
Based on unanticipated medical, scientific, research, and industrial needs of the United States the DEA proposes to adjust the established 2015 aggregate production quotas for the schedule I and II controlled substances difenoxin, diphenoxylate (for conversion), and marijuana to be manufactured in the United States in 2015. The adjustment is necessary to provide for the estimated medical, scientific, research, and industrial needs of the United States, lawful export requirements, and the establishment and maintenance of reserve stocks.
In proposing the adjustment, the Administrator has taken into account the following criteria in accordance with 21 CFR 1303.13: (1) Changes in demand for the basic class, changes in the national rate of net disposal for the class, and changes in the rate of net disposal by the registrants holding individual manufacturing quotas for the class; (2) whether any increased demand or changes in the national and/or individual rates of net disposal are temporary, short term, or long term; (3) whether any increased demand for that class can be met through existing inventories, increased individual manufacturing quotas, or increased importation, without increasing the aggregate production quota; (4) whether any decreased demand will result in excessive inventory accumulation by all persons registered to handle the class; and (5) other factors affecting the medical, scientific, research, and industrial needs of the United States and lawful export requirements, as the Administrator finds relevant.
Analysis for Adjusting the Established 2015 Aggregate Production Quota for Marijuana:
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. The associated product development activities are related to process validation and commercialization activities, including qualification activities related to potential U.S. Food and Drug Administration submission support.
Additionally, the DEA has also received notification from the National Institute on Drug Abuse (NIDA) that it required additional supplies of marijuana to be manufactured in 2015 to provide for ongoing and anticipated research efforts involving marijuana. NIDA is a component of the National Institutes of Health and the U.S. Department of Health and Human Services which oversees the cultivation, production and distribution of research-grade marijuana on behalf of the United States Government, pursuant to the Single Convention on Narcotic Drugs (March 30, 1961, 18 UST 1407).
The Administrator Michele M. Leonhart, therefore, proposes to adjust the 2015 aggregate production quotas for difenoxin, diphenoxylate (for conversion), and marijuana, expressed in grams of anhydrous acid or base.
You can read the full Notice by the DEA and provide your opinion as they are requesting comments.
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