New FDA Guidelines Make It Easier to Greenlight CBD Products
Patients and fans of CBD oil, pills and other products will appreciate the newly updated guidelines recently rolled out by the US Food & Drug Administration. The new guidance will make it easier to approve CBD-based medicines — including CBD oil, CBD pills, and other CBD products.
In a notice published last September in the Federal Register, the agency announced it was soliciting public feedback on its guidance to researchers who are interested in submitting abbreviated new drug applications (ANDAs) for CBD solutions.
New Guidelines Outline CBD Oil Submission Process
“To expedite the approval process, FDA said applicants can request a waiver of an in vivo bioequivalence study if they meet certain requirements. This guidance comes two years after the agency approved the brand-name CBD-based epilepsy medication Epidiolex from GW Pharmaceuticals.
“Going forward, if a drug company wants to produce generic versions of that 100 mg/mL cannabidiol solution, they could follow specific rules to skip the in vivo bioequivalence study step if the draft guidance is finalized. The drug would have to be derived from Cannabis sativa L, contain no more than 0.1 percent THC and have ‘no inactive ingredient or other change in formulation from the [reference listed drug] that may significantly affect systemic availability.’
“Researchers must use ‘appropriate analytical methods’ such as macroscopic or microscopic analysis or DNA bar-coding methods to determine that the solution is being made from cannabis sativa.”
CBD Oil & Tinctures: Natural Products Encouraged
The FDA is strongly encouraging natural productions of CBD oil that are derived from the hemp plant.
“Due to the many cultivars within this species, identification and authentication of plant species should be conducted at the cultivar(s) level if the potential cultivar(s) will be used as a natural source of the [botanical raw material],” FDA said.
Applicants must follow “established good agricultural and collection practices (GACP) procedures to minimize variations in BRM and eventually ensure the batch-to-batch consistency of the drug substance.”
A More Legitimized Approach to Regulating CBD Oil
The FDA was mandated by law last year to provide an update on its regulatory approach to CBD. Its update in March stated that “FDA is currently evaluating issuance of a risk-based enforcement policy that would provide greater transparency and clarity regarding factors FDA intends to take into account in prioritizing enforcement decisions.”
As any Ohio medical marijuana doctor will tell you, it is good news and a sign of progress that federal guidelines are legitimizing CBD oils and tinctures as recognized drug therapies. Cannabis remains illegal under Federal law, though it is recognized under Ohio state law as being legitimate for medical purposes. To obtain medical marijuana legally from a dispensary, you must obtain a recommendation from an Ohio medical marijuana doctor and have an Ohio medical marijuana card.
