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N <br />The closed chain of distribution under the CSA is designed to ensure that all controlled <br />substances are accounted for as they make their way from the manufacturer to the end user. As <br />would be expected, all who encounter controlled substances within the distribution chain are <br />required to keep meticulous records. For example, pursuant to 21 C.F.R. § 1305.13(d) <br />distributors of controlled substances must forward a copy of every order filled to the DEA. <br />B. Wholesale Distributors Are Required to Monitor for and Report Suspicious <br />Orders of Opioids under North Carolina Law. <br />To further combat diversion of controlled substances, the distributors are legally required <br />under federal law to be on alert for suspicious controlled substance orders by pharmacies — such <br />as orders of unusual size, frequency, or pattern — and to report these unusual orders to the <br />relevant authorities so that they can be investigated. <br />Federal law charges registered wholesale distributors with the non - delegable duty to <br />"design and operate a system to disclose ... suspicious orders of controlled substances. The <br />registrant [distributor] shall inform the Field Division Office of the Administration in his area of <br />suspicious orders when discovered by the registrant. Suspicious orders include orders of unusual <br />size, orders deviating substantially from a normal pattern, and orders of unusual frequency." 21 <br />C.F.R. § 1301.74(b). <br />North Carolina law requires wholesale drug distributors to comply with State and Federal <br />law. N.C. Gen. Stat. Ann. § 106 - 145.10. By distributing opioids while failing to monitor for and <br />report suspicious orders, wholesale distributors violated both North Carolina state law and <br />federal law. <br />C. Wholesale Distributors Have Been Warned of and Have Admitted Their <br />Obligations. <br />The distributors have been on specific notice of their duties with regard to suspicious <br />orders since at least September 2006, when the DEA sent distributors letters referencing the <br />North Carolina County Opioid Litigation - Privileged and Confidential 4 <br />