Frequently Asked Questions
[expand title=”What research on marijuana does the University of Mississippi (UM) conduct?” tag=”h3″]
Answer:
UM’s research interests include studies of the botanical, pharmacological and chemical properties of the cannabis plant. In addition to supporting the research community through UM’s participation in the National Institute on Drug Abuse (NIDA) Drug Supply Program, UM collaborates with industry partners in support of the development and commercialization of FDA-approved drug products derived from cannabis. UM’s expertise in drug delivery is used to develop optimized formulations for evaluation in animal models and human clinical trials.
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[expand title=”What is Harper Grace’s law?” tag=”h3″]
Answer:
Mississippi Code § 41-29-136 (2017), known as Harper Grace’s Law, was enacted by Mississippi legislators in response to the needs of young patients who suffered from certain epileptic conditions. This law allows physicians to conduct clinical research studies at the University of Mississippi Medical Center (UMMC) using a cannabis extract oral solution enriched in cannabidiol (CBD) and very low tetrahydrocannabinol (THC) content. The concentrated extract is prepared and provided by the National Center for Natural Products Research (NCNPR) at the University of Mississippi, and the oral solution is dispensed by the UMMC Pharmacy for the purpose of these investigational trials. The intention is to evaluate the safety of this treatment in patients eligible for the studies under the guidance of physicians at UMMC. For the study, patients and their families are allowed to use the experimental drug without prosecution for controlled substance violations. The law also allows preparation of the CBD solution by other pharmacies or laboratories under the appropriate federal and state regulations.
Harper Grace’s Law expires on July 1, 2024.
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[expand title=”What is the difference in marijuana and hemp?” tag=”h3″]
Answer:
The scientific name Cannabis sativa L. describes a single species of the cannabis plant that has multiple varieties that may be identified by their physical and chemical characteristics. The terms “marijuana” and “hemp” describe varieties having high and low levels of tetrahydrocannabinol (THC) respectively. While both have medicinal value, marijuana has traditionally been abused for its psychoactive effects, while hemp has traditionally been used for industrial purposes such as seeds and fiber products. Both have been considered DEA Schedule-I controlled substances for decades in the U.S., but the 2018 Farm Bill includes amendments to the Controlled Substance Act (21 U.S.C. 812) which makes the hemp variety (with <0.3% THC content) no longer a controlled substance. Marijuana, however, remains as Schedule-I.
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[expand title=”How has the federal legalization of hemp affected the cannabis work at UM?” tag=”h3″]
Answer:
Hemp legislation under the Farm Bills of 2014 and 2018 were intended to promote research and commercialization of hemp-based products which had previously been curtailed due to hemp’s designation as a DEA Schedule-I controlled substance. The 2018 Farm Bill clarified the definition of hemp based upon the measured level of tetrahydrocannabinol (THC) in the plant and in products derived from the plant. Although hemp is no longer a DEA controlled substance, its cultivation is regulated by USDA. Because NCNPR has a long history of advancing safe and effective utilization of botanicals for health and medicinal applications, we will embrace the prospects afforded by any federal legalization of the cannabis plant.
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[expand title=”Does cannabis have medical benefits?” tag=”h3″]
Answer:
Dronabinol, the active ingredient in FDA approved Marinol® capsules and generic equivalents, is synthetic delta-9-tetrahydrocannabinol (THC). THC is a naturally occurring compound in cannabis. Dronabinol is approved as a prescription drug product in many countries for the treatment of anorexia associated with weight loss in patients with AIDS, as well as for nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments. Sativex®, a standardized cannabis extract containing THC and cannabidiol (CBD), is approved as a pharmaceutical product for the treatment of MS Spasticity in over 25 countries, but not the U.S. The oral solution of purified CBD in sesame seed oil, Epidiolex®, has been approved in the U.S. and other countries for the treatment of certain seizure disorders.
Additional clinical research is needed to better understand the safety and efficacy of cannabis, especially in the smoked form. For a complete listing of all projects funded by the National Institutes of Health (NIH) examining the potential therapeutic benefits of cannabinoids, see the Therapeutic Cannabinoid Research category in the NIH RePORT database.
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[expand title=”Is the University of Mississippi the only legal marijuana grower in the U.S.?” tag=”h3″]
Answer:
Under the 1961 international Single Convention on Narcotic Drugs and the 1970 Controlled Substances Act, the federal government is the single “agent” allowed to provide marijuana for research. For many years the DEA only authorized one grower, the University of Mississippi, which grows marijuana under contract with the National Institute on Drug Abuse. As part of this contract, UM holds a DEA Schedule-I Bulk Manufacturer registration to cultivate plants for this purpose. However, in 2016 DEA announced a new interpretation of the Single Convention to allow other growers to cultivate marijuana, but with DEA as the single agent rather than NIDA. Other growers are now approved to cultivate marijuana for research and for product development.
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[expand title=”How does a grower apply for a DEA registration?” tag=”h3″]
Answer:
To be registered as a “marijuana grower” under a DEA Bulk Manufacturer registration:
- An applicant must submit an online registration request to DEA, using the DEA Form 225 link.
- DEA will review the application and ask the applicant to provide additional information, such as the type of materials to be manufactured (bulk marijuana, marijuana extract, or purified cannabinoids).
- DEA will publish in the Federal Register the application information for comments.
- During or after the comment period the DEA will arrange for a site visit to inspect the applicant’s provisions for security and storage.
- If the applicant meets all requirements for a registration (2, 3 & 4) the DEA sends the applicant a draft Memorandum of Agreement (MOA) for the applicant to sign to serve as a legal agreement between the registrant and DEA for production of marijuana.
- Once a MOA is in place, the DEA will issue the registration.
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[expand title=”How much marijuana does the facility grow?” tag=”h3″]
Answer:
UM grows various amounts of different varieties of cannabis to meet the anticipated needs of researchers under the National Institute on Drug Abuse contract. A typical outdoor growing season yields over 500kg of plant material, while an indoor season yields about 10kg.
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[expand title=”Why does marijuana grown at the facility look different from marijuana in dispensaries?” tag=”h3″]
Answer:
Marijuana produced at UM is manicured to a uniform particle size because it is required to be standardized in various research protocols.
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[expand title=”How can researchers request other forms of marijuana?” tag=”h3″]
Answer:
Researchers should send requests to the project officers of the National Institute on Drug Abuse Drug Supply Program: Robert Walsh, (301) 443-9825, or Rik Kline, (301) 827-5243.
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[expand title=”What is CBD oil?” tag=”h3″]
Answer:
For the purpose of the University of Mississippi’s R&D program, “CBD oil” is referred to as “CBD extract oral solution.” It is prepared from the plant extract, which is formulated for pharmaceutical use, and is suitable for oral administration. The current product version contains 50 mg/ml CBD, or cannabidiol, and not more than 2.5 mg/ml of THC.
UM’s CBD oil product is prepared from a concentrated extract of Cannabis [CBD-enriched Cannabis extract] with a high ratio of CBD to THC, or tetrahydrocannabinol.
Note that the term “CBD oil” is used fairly indiscriminately by marketers and users, and may refer either to concentrated oily residues of the plant, or to many derived products with different oils added. These products may vary highly in CBD content, quality, purity and in the content of other cannabinoids.
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[expand title=”Is your marijuana free of microbial and heavy metal contamination?” tag=”h3″]
Answer:
UM performs quality control testing to ensure that the products meet quality standards for botanical products. Certain bacteria, such as E. coli and Salmonella, cannot be tolerated in products intended for human ingestion. The natural flora of yeasts and molds that occur on plants of every species also occur on marijuana plants. The level of yeast and mold expected in normal flora are of little concern, but higher levels, such as visible mold, are not allowed. As cannabis plants grow, any heavy metals in the surrounding soil will be concentrated in the tissues of the plants. Although the risk of metal contamination in plants grown under controlled conditions is very low, UM tests representative samples for heavy metal contamination.
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[expand title=”Since many states now have laws to allow medical marijuana, is the UM program still necessary?” tag=”h3″]
Answer:
Yes. Purchasing or possessing marijuana products available in state dispensaries remains illegal at the federal level, although a number of states are working to facilitate research on the therapeutic benefits of marijuana and its constituent cannabinoids, and some have allocated funding from tax revenue for research. UM’s program provides materials for research that meet the legal and safety requirements of both DEA and FDA. Marijuana intended for scientific research must be standardized and meet certain quality requirements, which UM can guarantee based on its growing processes and adherence to the FDA’s Good Manufacturing Processes.
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[expand title=”Can UM analyze an external researcher’s marijuana samples?” tag=”h3″]
Answer:
Yes, but only if the researcher maintains a DEA Schedule-I registration that allows transfer of materials between registrants.
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[expand title=”How does FDA regulate products containing cannabis and/or cannabis-derived ingredients?” tag=”h3″]
Answer:
Please see: https://www.fda.gov/newsevents/publichealthfocus/ucm421168.htm#legal
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