DEA removes Epidiolex from its controlled substance list
Until in Ukraine the possibility of using leaves and inflorescences of technical hemp of therapeutic orientation for industrial purposes is regulated at the level of departmental orders in Ukraine , our patients will not use food products (for example, therapeutic hemp varieties of therapeutic orientation grown legally grown in their own home garden ), cosmetic preparations or dietary supplements having from uschestvennym therapeutic effect greater than the one that gives Epidiolex, and will be forced smuggled avozit for their own use, pharmacological preparations of dubious quality that can be used for treatment .
The United States Drug Enforcement Administration (DEA) has removed the pharmaceutical drug Epidiolex from the national list of controlled substances, which should simplify patient access to the drug . Epidiolex - the only preparation obtained directly from the hemp plant , which has been approved by the FDA for the quality of food products and medicines (Food and Drug Administration, FDA) of the USA for use on the territory of the country . The drug is a flavored oral solution with cannabidiol (CBD), which reduces seizures in children with epilepsy . The drug is not psychoactive, since it also contains less than 0.1 percent tetrahydrocannabinol (THC).
After Epidiolex received FDA approval in June 2018, the pharmacological drug was included in the "List V" « the Controlled Substances Act » ( Controlled Substances Act , the CSA). On April 6, 2020, the relevant US government agencies provided an official clarification according to which Epidiolex is no longer subject to the criteria according to which it should be controlled as a drug on the “List V” CSA.
According to the CEO of the manufacturing company, Justin Gover, “The DEA official notice fully confirms that Epidiolex is the only CBD drug approved by the US FDA that is no longer a controlled substance under the federal“ Controlled Substances Act ”. It is important to note that the removal of restrictions in respect of the preparation of sales opportunities in the United States can greatly facilitate patient access to cannabis therapy , suffering from Lennox-Gastaut and Dravet - two of the most debilitating forms of epilepsy. "
Analysts at the American hemp market claim that removing Epidiolex from CSA will not only make the drug more accessible to patients . Doctors will not need to go through a drug monitoring program to make sure their patients are not addicted to drugs. In addition, the patient can freely purchase hemp medicine in any pharmacy, and not “be tied” to a single doctor who can prescribe medicine in a particular pharmacy.
Commentary experts of the Association "Ukrainian industrial hemp "
Epidiolex is manufactured by the English pharmaceutical company GW Pharmaceutical . The above company is already seeking FDA approval for the use of Epidiolex for the treatment of diseases other than Lennox-Gastaut and Drava syndromes . In 2018, GW Pharmaceutical management announced that the average annual cost of using Epidiolex would be about $ 32,500 a year.
A good example of the sane approach of US government officials to the problem of using various kinds of goods made on the basis of hemp raw materials is the fact that even a pharmacological preparation that contains less than 0.1% tetrahydrocannabinol is not considered socially dangerous in the USA . In our country , even if a trace amount of THC is found even in a cosmetic product , dietary supplement or food product (within the sensitivity of the device - 0.0001%), law enforcement agencies will institute criminal proceedings , as this kind of case allows them to “significantly increase their own welfare. ” Until in Ukraine the possibility of using leaves and inflorescences of technical hemp of therapeutic orientation for industrial purposes is regulated at the level of departmental orders in Ukraine , our patients will not use food products (for example, therapeutic hemp varieties of therapeutic orientation grown legally grown in their own home garden ), cosmetic preparations or dietary supplements having from uschestvennym therapeutic effect greater than the one that gives Epidiolex, and will be forced smuggled avozit for their own use pharmacological drugs of questionable quality, which can be used for treatment .