The government agency is advancing rules for the creation of marijuana-based medicine
After receiving strong criticism from regulators, the Food and Drug Administration (FDA) seems to be giving more importance to cannabis-related issues. The agency has now shared its complete guidance on the creation of marijuana-based medicines, including the special factors and different procedures that researchers should keep in mind when dealing with cannabis and hemp.
“Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research” will be the title of the recommendations document to be published today in the Federal Register. According to the FDA’s recommendations, the development of cannabis and cannabis-derived human medicines should focus primarily on clinical research sources.
Through this guidance, the FDA intends to ensure that clinical research has solid steps for the creation of cannabis and cannabis-derived therapeutic products. The FDA also issued a series of non-binding guidelines for researchers interested in creating marijuana-based drugs that can be sold. According to the council, the suggestions “are intended to address legal definitions and regulatory restrictions related to cannabis, as well as address specific questions raised about cannabis-containing medications.”
The draft version has received certain updates to the advisories. For example, clarity is added on which sources of cannabis are federally permitted for use in drug development. As long as it has less than 0.3% THC by dry weight and meets the federal classification of hemp, cannabis will not be classified as a controlled substance like marijuana, which is still regulated by the Drug Enforcement Administration (DEA). This opens up more opportunities when it comes to locating hemp than the federal government allows.