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. 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.