The Food and Drug Administration (FDA) is releasing new draft guidelines that are thought to streamline approvals for generic oral CBD drugs.
In a notice published in the Federal Register on Wednesday, the bureau stated it is soliciting public comments on its advice to researchers that are considering submitting new drug applications (ANDAs) to CBD solutions.
To expedite the approval process, FDA stated applicants could request a waiver of the in vivo bioequivalence study if they meet specific requirements. This advice includes two years after the agency approved the brand name CBD-based epilepsy medicine Epidiolex out of GW Pharmaceuticals.
Moving forward, if a drug company wishes to create generic versions of that 100 mg/mL cannabidiol solution, they can follow certain rules to skip the in vivo bioequivalence study step if the draft guidance is finalized. The medication would need to be derived from Cannabis sativa L, comprise no more than 0.1 percent THC and have”no inactive component or other change in formulation from the [reference listed drug] that may significantly impact systemic accessibility”
Researchers should use”proper analytical approaches” such as macroscopic or microscopic analysis or DNA bar-coding methods to determine the solution has been made from cannabis sativa.
“Because of the many cultivars within the species, identification and authentication of plant species should be run at the cultivar(s) level in the event the possible cultivar(s) will be used as a pure supply of the [botanical raw material],” FDA said.
Further, when amassing that raw cannabis, the agency said applicants should follow”established good agricultural and collection practices (GACP) approaches to minimize variations in BRM and eventually make sure the batch-to-batch consistency of the drug substance.”
FDA also recently closed a comment period on separate draft guidance on creating cannabis-derived drugs . But, three other federal agencies are currently accepting input a range of other proposed cannabis- and – drug-related regulations.
While this latest document is not the different comprehensive CBD guidance that advocates and industry stakeholders are waiting for, it’s another example of how the scientific landscape around cannabis is shifting, with a federal agency helping facilitate the production of cannabidiol-based drugs.
The agency also recently held a meeting to help notify cannabis investigators and cultivators about chances to protect their proprietary information and encourage studies into the plant.
It also recently filed draft guidance on CBD authorities into the White House Office of Management and Budget–a long-anticipated movement that comes after hemp legalization.
The agency has been mandated under appropriations legislation enacted last year to provide an upgrade on its own regulatory approach to CBD, and it did so in March. The upgrade said that”FDA is currently assessing issuance of a risk-based enforcement policy that would provide increased transparency and clarity concerning factors FDA plans to take into account in prioritizing enforcement conclusions .”
FDA was using police discretion for CBD in the years because hemp became lawful.
The agency has continued to issue warnings to cannabis companies in certain cases–such as instances where companies claimed CBD could cure or treat coronavirus–and supply public finds about recalls.
In July, FDA also filed a report to Congress about the condition of the CBD market , and the record outlines studies the agency has performed over the materials and quality of cannabis-derived goods it has examined within the past six decades.
Also that month, a congressional paying invoice for FDA was released that contains a provision providing”funding to create a framework for regulating CBD solutions.”
The agency is also actively seeking to award a contract to help study CBD as the agency develops regulations for products comprising the non-intoxicating cannabinoid.