On October 23, 2019, the Drug Enforcement Administration (DEA) announced the launch of its Suspicious Orders Report System (SORS) Online, a portal allowing for the centralized reporting of suspicious orders, as required by the SUPPORT ACT.
According to DEA’s announcement, 12 registrant business activity classes will utilize this reporting system:
- Distributors
- Manufacturers
- Importers
- Pharmacies
- Hospitals/Clinics
- Teaching Institutions
- Practitioners
- Mid-Level Practitioners
- Mid-Level Practitioners – Ambulance Services
- Researchers
- Analytical Labs
- Narcotic Treatment Programs (NTPs)
Reverse distributors and exporters are excluded from the requirement.
DEA notes that all registrants who already report via ARCOS Online and ARCOS EDI should use their ARCOS log on information to access the system. Those who are not currently ARCOS users, however, will have to register on the website to comply with the SORS reporting requirements. The electronic format of the report is similar to the format for reporting ARCOS data.
It is surprising that this new reporting system was not announced via notice and comment rulemaking, which some may argue (including this author) is required by the Administrative Procedure Act. As such, DEA registrants were denied the opportunity to raise questions or concerns about the proposed reporting process and were likewise not given advanced notice of the reporting requirements in order to implement the necessary changes to their IT systems.
Moreover, because DEA chose not to follow traditional rulemaking, there is little guidance in the announcement, such as:
- Are registrants required to use SORS? If so, when must they begin using it?
- What are the requirements and expectations for providing an explanation for the reason an order is reported as suspicious? This is a new requirement created by DEA and not found in the SUPPORT Act.
- If a registrant is not required to use SORS and chooses instead to report suspicious orders to the local DEA office, does the report need to contain all of the same information required for SORS reporting?
With the statutory deadline (October 24, 2019) looming for establishing a centralized database for collecting suspicious order reports, it would not be surprising to learn that this announcement may have been rushed. In fact, a representative for the Diversion Control Division was asked about SORS at a conference on the day of the announcement and was unable to provide additional insight or guidance on the new reporting system.
My expectation is that DEA will eventually clean this up and provide additional guidance on the use of this system and DEA’s expectations of registrants. In the meantime, good luck!