Purisys has announced that the U.S. Drug Enforcement Agency (DEA) has removed its Cannabidiol (CBD) from Schedule I of the Controlled Substances Act. In addition to CBD, more than 30 other cannabinoids have also been descheduled. Purisys currently produces all major cannabinoids relevant to pharmaceutical and consumer products (>50), as well as degradants, metabolites and analytical reference standards.
Distinguished Cannabinoids from Purisys
Purisys has been manufacturing ultra-high purity CBD (<0.001 percent THC) via a patented process since 2016, and its products fall far below the 0.3 percent THC (Tetrahydrocannabinol) limits set in the 2018 Farm Bill for use in consumer products.
The cannabinoids produced by Purisys are distinguished by their ultra-low THC concentration, purity, world-scale capacity, exacting quality control, ease of formulation compared to hemp-derived isolates and strong regulatory support.
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At Purisys, we are excited about the findings of the DEA with respect to our cannabinoid ingredients. We look at this descheduling as recognition of the consistent purity and quality we can achieve,” said Jim Mish, CEO of Purisys.
Descheduling- Eases the Regulatory Activities
Purisys cannabinoids are no longer subject to U.S. DEA controls that affect quotas, aggregates, secure vault storage and more, due to DEA descheduling. The customers will no longer need DEA registrations to work with Purisys materials.
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Now that our products no longer are subject to DEA Schedule I status, our customers in the pharmaceutical, personal care and food and beverage spaces are able to more easily conduct the research that will be important to the use of cannabinoids in a wide range of products,” commented Tim Jones, Vice President of Global API and OTC for Purisys.
Advanced Cannabinoids Ingredients: A Key Focus
Purisys will now focus exclusively as a broad-range ingredient and solutions provider to pharmaceutical and consumer products companies looking to use CBD and other cannabinoid-based ingredients. These solutions are targeted toward personal care, pharmaceutical, OTC, food and beverage and nutritional supplement markets as regulations allow.
An equally important part of the Purisys offering to customers in the pharmaceutical and consumer products spaces is the range of support services the company can provide for product development. For consumer products, Purisys has been and will continue to invest in applications development capabilities – including equipment and personnel. These capabilities will range across personal care, OTC, food, beverage and nutritional supplement markets. The company currently has several projects under development in the consumer space that feature its ultra-pure CBD.
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At Purisys, we stand ready to back this research, with our applications support, analytical reference standards and small-scale cGMP manufacturing. Of course, this is backed by our world-scale supply capability for commercial production,” added Mish.
Source: Purisys