This week, the Food and Drug Administration (FDA) finally released information and guidance on developing cannabis-based CBD drugs with low levels of THC for the American medical market.
This decision was officially cleared a few weeks ago by the White House, and it means that those wishing to start developing cannabis-derived medicines can do so now, as long as they follow these guidelines. The FDA is still working on regulations that would allow CBD to be sold like other food or dietary items, but this is a major first step regarding how things can be tested and developed.
“A range of stakeholders have expressed interest in development of drugs that contain cannabis and compounds found in cannabis. Recent legislative changes have also opened new opportunities for cannabis clinical research,” FDA Principal Deputy Commissioner Amy Abernethy said regarding the new FDA research information in a press release. “As that body of research progresses and grows, the FDA is working to support drug development in this area.”
Much of the guidance is “limited to the development of human drugs and does not cover other FDA-regulated products” and covers the basics of conducting federally authorized research for drug development purposes, such as where researchers are allowed to obtain cannabis and the importance of demonstrating the ability to “consistently manufacture a quality product.”
This also means that researchers can now get their information from their own in-house stores growing hemp products. It is now legal to test the medical properties of any low-THC hemp; manufacturers don’t only have to rely on the federal manufacturers at the University of Mississippi.
“This change gives sponsors and investigators of clinical studies new options that do not involve the [National Institute on Drug Abuse Drug Supply Program],” the FDA wrote in their findings regarding the study.
“Sponsors and investigators proposing drug development activities involving controlled substances should consult with [Drug Enforcement Administration] about the applicable requirements. Sponsors and investigators may find it useful to calculate the level of delta-9 THC in their proposed investigational drug product early in the development process to gain insight into the potential control status of their product. Regardless of whether cannabis or a cannabis-derived compound meets the definition of hemp, sponsors and applicants should work with reliable laboratories for analytical testing.”
How To Proceed
Those who are interested in applying to make an investigational drug in the CBD field should submit information about the data they have reviewed so far, THC content, and testing methods to see if they will be approved and can move forward with their research. They also provided information on how to determine THC content of hemp.
Now, a public comment period opens up for the next 60 days, and interested parties can weigh in on these guidelines. There is also an indefinite comment period open on the safety of CBD.
While this may seem like a small step, this is one of the biggest relaxations on cannabis research the industry has seen. It will no doubt prove pivotal in learning more about the healing properties of CBD.
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