The US Food and Drug Administration recently issued its draft guidance on clinical research for the development of drugs that contain cannabis or cannabis-derived compounds of botanical origin (as opposed to synthetic). The guidance provides some clarity on the use of cannabis in clinical research in light of the changes made by the Agriculture Improvement Act 2018, which federally legalised hemp and derivatives that contain no more than 0.3% by dry weight of THC.
The consequences of supply chain interruptions from a compliance perspective vary slightly, depending on the type of product and its indication. Human drug products and medical device products have different requirements for reporting supply chain disruptions and the impact of COVID-19 has cast a bright light on this inequity. Compliance with reporting requirements is therefore paramount during the ongoing pandemic.