Controlled Substances In Clinical Trials: Considerations, Challenges, And Growing Demand

By Rich Nelson, Associate Director of North America Trade Compliance and Logistics, John Hufnagel, Senior Manager of Clinical Supplies, and Rachel Castro, Senior Manager of Clinical Project Management, PCI Pharma Services

Cannabis-derived compounds and other recreational drugs offer significant potential therapeutic value, and a growing number of these compounds are being used in clinical trials. But working with controlled substances in clinical studies presents multiple layers of complexity for planning and implementation. The amount of planning required may be greater by several orders of magnitude, and as more countries become involved in the trials process, the difficulty continues to increase. Regulations concerning the manufacture, packaging, storage, and distribution of controlled substances vary from country to country, requiring developers to understand how the materials involved in a clinical study are scheduled in each country where trials sites are located. This adds to the complexity of the clinical trials and presents hurdles for supply chain operations.

Partnering with a contract development and manufacturing organization (CDMO) that has extensive experience of storing, packaging, and distributing many different types of scheduled materials is a key step for developers to efficiently navigate the complexity of clinical trial design. A manufacturing partner that has the knowledge and resources to handle controlled substances in compliance with DEA regulation in the United States and with varying governing institutions globally is invaluable to developers. PCI Pharma Services is one of the few companies that can handle controlled substances from Schedule I through V and offers suitable manufacturing and storage facilities for scheduled materials. Learn more about the best practices for navigating an evolving regulatory landscape and what to look for in a CDMO partner.