Effective Controlled Substances Supply Chain Management: What You Need to Know to Ensure Compliance and Optimize Efficiency


At a time when supply chain management has become increasingly complex, managing the unique challenges of the controlled substance supply chain can seem daunting for companies lacking in‐house capabilities and resources.

Controlled substances are highly regulated and must be vigilantly monitored from the laboratory to the marketplace to prevent theft and illicit sale in the black market, a growing trend. In addition to abundant federal and state regulations, increased globalization – with its stringent import and export restrictions, permits and declarations required for controlled substances – has made compliance even more challenging.

Effective management of the controlled substance supply chain and navigation of the regulatory process with minimal costs and delays requires considerable time, effort and expertise. For a drug company and/or its contract development and manufacturing organization (CDMO), management calls for rigorous attention to compliance, thorough planning, robust risk‐management capabilities and the skills for effective implementation. Understanding and complying with federal, local and, if applicable, global regulatory requirements of your supply chain destinations is critical to prevent delays and penalties.

With supply chains growing faster than resources today, many companies producing controlled substances are outsourcing to gain the needed expertise, efficiency and flexibility. Partnering with a CDMO experienced in supply chain management of controlled substances can prevent costly delays, steep penalties for noncompliance, and the potential postponement of a clinical trial.