White Papers / Tech Papers

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

Released by DPT Laboratories

July 11, 2013

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 2011 there were 36 cases of pharmaceutical cargo theft in the United States at an average value of more than $500,000 per incident. Abundant federal and state regulations, plus 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 contract development and manufacturing organization (CDMO) experienced in supply chain management of controlled substances, from Schedule II and III through to V, can prevent costly delays, steep penalties for regulatory noncompliance, and the potential postponement of a clinical trial.

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