Last week, the U.S. Drug Enforcement Administration (DEA) released its long-awaited proposed rule on Suspicious Orders Monitoring System (SOMS) obligations under the federal Controlled Substances Act. The proposed rule will be published on Monday, November 2, with a 60 day comment period. The proposed rule addresses the procedures registrants must follow for identifying, reporting, and refusing to distribute certain orders of controlled substances.

DEA sets forth a “two option framework” for registrants when they receive an “order received under suspicious circumstances,” referred to as an ORUSC. The registrant may either:

• Decline to ship the ORUSC, immediately file a suspicious order report through the DEA centralized database, and maintain a record of the ORUSC and any related due diligence; or
• Conduct due diligence into the ORUSC. If the registrant’s due diligence dispels the suspicious circumstances within seven calendar days of receiving the order, the order may be shipped and need not be reported to DEA. The registrant must retain records of the ORUSC and its due diligence for at least two years. If the due diligence does not dispel suspicion, the ORUSC is deemed a suspicious order and must be reported to the DEA centralized database.

DEA has proposed that this SOMS reporting framework applies not only to distributors, but also to manufacturers and importers who distribute controlled substances, certain practitioners such as pharmacies (who are permitted to distribute controlled substances under the five percent rule), and Narcotic Treatment Programs (NTPs) distributing controlled substances in bulk form to other NTPs.

Notably, the preamble to the proposed rule includes a lengthy discussion emphasizing that “identifying and reporting suspicious orders of controlled substances (and refusing to distribute based on such orders), has always been, and remains the responsibility of the DEA registrant.” It further describes numerous scenarios and enforcement actions to exemplify instances where “some registrants have failed to fulfill their obligations” in detecting and preventing diversion. Also noteworthy is DEA's conclusion that the proposed rule is consistent with and merely codifies recordkeeping and other existing business practices, and thus is expected to have a cost savings to regulated industry.

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