Colorado Research Firm MedPharm Clears DEA Hurdle for Federal Research License
Leading cannabis research and formulation development company MedPharm Research announced today that they have been notified by the Drug Enforcement Administration (DEA) that it had been selected to move forward as one of the first applicants to be granted a license to grow federally legal cannabis under the terms of a new policy statement issued today in the Federal Register.
MedPharm Holdings has a 15,000-square-foot manufacturing, research and development laboratory and cannabis processing facility in Denver, Colorado. Since beginning operations in 2016, MedPharm has grown to a staff of 22 people, including a PhD in Chemistry and Extraction, Dr. Tyrell Towle. Additionally, Scott Karolchyk, the Director of Formulation Development at MedPharm, is a member of the Colorado Department of Public Health and Environment, Marijuana Enforcement Division, Science and Policy Work Group.
The goal of MedPharm is to provide a reliable clinical effect through the use of well-crafted and well-researched oil analytics and dosage forms. The company provides cannabis pharmaceutical-type products using Good Manufacturing Practices (GMP) that include pre-formulation, formulation development, small scale commercial manufacturing, analytical method development and validation, routine quality control analysis and stability studies. MedPharm works to create pharmaceutical dosage forms and produce ingredients utilizing pharmaceutical technology to be used in the delivery of cannabis extracts.
MedPharm CEO Albert Gutierrez was thrilled about the potential magnitude of this announcement. “This is something we have been waiting for since we first sent in our application in September, 2016, as one of the first medical grow facilities to apply for a license,” He continued, “Now, finally, the DEA has seen the importance of allowing federally legal grows to get more active in medical cannabis research, and do the work that we really need to do for patients across the country. It is a real game-changer for the whole medical cannabis industry.”
In a letter to Gutierrez, the DEA stated that MedPharm will be issued a Notice of Proposed Rulemaking, where the company will be asked to comment on regulations about growing cannabis for medical research. However, the DEA has not provided a timetable for when those regulations will be completed. “We at MedPharm stand ready to assist the DEA in any way we can to help expedite this process, and bring to patients the best quality, FDA-approved cannabis that they need for research and treatment as quickly as possible,” said Gutierrez.
According to the University of Mississippi News, in 1968, the Research Institute of Pharmaceutical Sciences at the University of Mississippi School of Pharmacywas awarded a competitive contract from the government to grow marijuana that could be standardized for research. For over 50 years, it has remained the only cultivation facility licensed by the DEA to provide federally legal cannabis for medical researchers, who have reported that cannabis from the university is of such poor quality that it is essentially useless in conducting the lab work and human trials necessary for a reliable FDA-approved medical research.
As more medical cannabis research ramped up, a growing group of medical cannabis researchers pressured the DEA to open up licensing to other facilities. Then, in August, 2016, the DEA stated that they would begin accepting applications for companies wanting licenses for legal grows, but nothing more happened until this June, when one of the applicants sued the DEA for unreasonable delays, prompting today’s response.
MedPharm is well-positioned to work with the DEA and be among the first providers of federally legal cannabis for medical research. The application for the license included outlining research objectives and creating areas where medical research cannabis is grown specifically for research purposes.
You can view a 360 Virtual Tour of the MedPharm facilities here: http://www.medpharmholdings.com/View360