Changes to be Implemented by DEA
The opioid epidemic has had widespread social and economic impact, and legislation is finally catching up. The SUPPORT Act was passed in 2018 and, per the OIRA’s twice annual agenda, the DEA has proposed to take final action on the Suspicious Order Monitoring stipulations within the Act in June 2022.
There are 5 specific changes to be implemented:
- Authority citation updates for Part 1300;
Strictly related to citation, not circumstantial.
- Additional definitions within Section 1300.01;
There are four additional definitions as a part of the rule for: Due Diligence, Order, Order Received Under Suspicious Circumstances, and Suspicious Order.
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- Due Diligence: reasonable and documented investigation into persons and orders.
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- Order: any communication proposing or requesting a distribution by a customer, granted it is not a simply inquiry on price/availability.
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- Order Received Under Suspicious Circumstances: an order potentially meeting the definition of suspicious order. This is most likely to address the extensive confusion on “flagged order” versus “suspicious order.”
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- Suspicious Order: The new definition includes, but does not limit it to, the historical definition: an order of unusual size, an order deviating substantially from a normal pattern, or an order of unusual frequency.
- Authority citation updates for Part 1301;
Strictly related to citation, not circumstantial.
- Other security Controls
a. Inclusion of Know Your Customer requirements and market comparisons (i.e. “facts and circumstances”) into a SOM program.
The inclusion of “facts and circumstances” within the definition of a suspicious order broadens what has historically been a relatively statistical analysis – the same term is included in the new definition of “due diligence” which includes what usually constitutes a Know Your Customer questionnaire. With this provision, the DEA is likely seeking to codify how they have defined a suspicious order in cases against Morris & Dickson (dispensing higher than national average, high ratio of hydrocodone versus other controlled substances, patients paying with cash rather than billing insurance, etc.).
b. An SOM requirement for additional business models that distribute;
Whereas the original SOM requirement specifically applied to entities that are registered with the DEA as distributors, the scope of the SOM requirement now shall apply to registrants that authorized to distribute controlled substances including: manufacturers and importers, practitioners (who are permitted to distribute controlled substances pursuant to the five percent rule without obtaining a separate registration as a distributor), and Narcotic Treatment Programs (NTPs) distributing in controlled substances in bulk form to other NTPs.
- Additional procedures for identifying and reporting suspicious orders of controlled substances within Section 1300.78;
a. Two-part regulatory framework for processing suspicious orders.
Pharma Solutions covered the two-part regulatory framework requirement here. Simply, the framework requires that a registrant either (1) deem an order suspicious, decline to ship the order, and report the suspicious order to the DEA; or (2) investigate the order and dispel each suspicious circumstance within seven days; otherwise a registrant must deem the order suspicious, decline to ship the order, and report the order to the DEA.
b. Registrants shall report suspicious orders to the DEA centralized database.
On October 23, 2019, the DEA launched the Suspicious Orders Report System (SORS) Online as required by the SUPPORT Act. This provision codifies the requirement of using of SORS Online.
c. Recordkeeping.
This provision stipulates that records on suspicious orders must be kept for a period of two years. The record must include: what qualified the order as “suspicious” or “received under suspicious circumstances,” the due diligence performed (to be newly defined by CFR 1300.01), and whether the order was shipped to the customer.
For the full language, please see below
Source 1:
https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202110&RIN=1117-AB47
Source 2:
Changes to PART 1300—DEFINITIONS
1.The authority citation for part 1300 is revised to read as follows:
Authority: 21 U.S.C. 802, 821, 822, 823, 829, 832, 871(b), 951, 958(f).
2.In § 1300.01, amend paragraph (b) by adding definitions of “Due diligence,” “Order,” “Order received under suspicious circumstances,” and “Suspicious order” in alphabetical order to read as follows:
Definitions relating to controlled substances.
(b) * * *
Due diligence means a reasonable and documented investigation into persons and orders (coupled with other appropriate investigations, including previous investigations into persons and orders) that includes, but is not limited to, verification that a person (or a person submitting an order) holds the appropriate DEA registration, verification that a person (or a person submitting an order) holds all licenses required by the state(s) in which a person (or a person submitting an order) conducts business with respect to controlled substances, examination of each suspicious circumstance surrounding an order, and examination of all facts and circumstances that may be relevant indicators of diversion in determining whether a person (or a person submitting an order) is engaged in, or is likely to engage in, the diversion of controlled substances.
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Order means any communication by a person to a registrant proposing or requesting a distribution of a controlled substance, regardless of how it is labeled by the person or the registrant, and regardless of whether a distribution is made by the registrant, except that simple price/availability inquiries, standing alone, do not constitute an order.
Order received under suspicious circumstances means an order potentially meeting the definition of suspicious order.
Suspicious order includes, but is not limited to, an order of unusual size, an order deviating substantially from a normal pattern, or an order of unusual frequency.
Changes to PART 1301—REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS OF CONTROLLED SUBSTANCES
3.The authority citation for part 1301 is revised to read as follows:
Authority: 21 U.S.C. 821, 822, 823, 824, 831, 832, 871(b), 875, 877, 886a, 951, 952, 953, 956, 957, 958, 965.
4.In § 1301.74, revise the section heading and paragraph (b) to read as follows:
Other security controls for non-practitioners; non-practitioners and practitioners for orders received under suspicious circumstances; narcotic treatment programs and compounders for narcotic treatment programs.
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(b)
(1) Each registrant shall design and operate a system to identify suspicious orders of controlled substances for the registrant that complies with applicable Federal and State privacy laws. The system shall be designed and operated to identify orders of unusual size, orders deviating substantially from a normal pattern, and orders of unusual frequency. In addition, the system shall be designed and operated to identify suspicious orders based on facts and circumstances that may be relevant indicators of diversion in determining whether a person (or a person submitting an order) is engaged in, or is likely to engage in, the diversion of controlled substances.
(2) Registrants in receipt of an order received under suspicious circumstances shall follow the procedures set forth in § 1301.78(a).
(3) In addition to entities that are registered as distributors, the requirements in this paragraph (b) shall also apply to registrants authorized to distribute controlled substances. However, controlled substances dispensed or administered within the normal course of professional practice of a practitioner, to include prescriptions filled by a pharmacy, and orders placed by registrants to DEA registered reverse distributors requesting the return or destruction of controlled substances, are not distributions subject to the provisions of this part.
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5.Add § 1301.78 to read as follows:
Procedures for identifying and reporting suspicious orders of controlled substances.
(a) Upon receipt of an order received under suspicious circumstances, the registrant shall proceed under one of the following two options:
(1) The registrant shall decline to distribute pursuant to the suspicious order, immediately file a suspicious order report through the DEA centralized database (which includes the information described in paragraph (b) of this section), and maintain a record of the suspicious order and any due diligence related to the suspicious order (which includes at least the information described in paragraph (c) of this section); or
(2) The registrant, before distributing pursuant to the order received under suspicious circumstances, shall conduct due diligence to investigate each suspicious circumstance surrounding the order.
(i) If, through its due diligence, the registrant is able to dispel each suspicious circumstance surrounding the order received under suspicious circumstances within seven calendar days after receiving the order, it is not a suspicious order; the registrant may then distribute pursuant to the order, and the order need not be reported to the DEA as a suspicious order, but the registrant must maintain a record of its due diligence which includes at least the information described in paragraph (c) of this section.
(ii) If the registrant, through its due diligence, is unable to dispel each suspicious circumstance surrounding the order received under suspicious circumstances within seven calendar days after receiving the order, it is a suspicious order; the registrant shall file a suspicious order report through the DEA centralized database, which includes the information described in paragraph (b) of this section, decline to distribute pursuant to the suspicious order, and maintain a record of its due diligence which includes at least the information described in paragraph (c) of this section.
(b)
(1) Registrants shall report suspicious orders to the DEA centralized database. The report, identifying each suspicious order, must include the following information:
(i) The DEA registration number of the registrant placing the order for controlled substances;
(ii) The date the order was received;
(iii) The DEA registration number of the registrant reporting the suspicious order;
(iv) The National Drug Code number, unit, dosage strength, and quantity of the controlled substances ordered;
(v) The order form number for schedule I and schedule II controlled substances;
(vi) The unique transaction identification number for the suspicious order; and
(vii) What information and circumstances rendered the order actually suspicious.
(2) Upon notification from the DEA that a suspicious order report or reports contain inaccurate or incomplete information, the registrant shall have seven calendar days to correct the inaccurate or incomplete information.
(c) Registrants shall maintain a record of every suspicious order and every order received under suspicious circumstances for at least two years from the date of such record in accordance with 21 CFR 1304.04(a), and how the registrant handled such orders. The record must be prepared no later than seven calendar days after the suspicious order or order received under suspicious circumstances was received and must include the following information:
(1) What information and circumstances rendered the order actually or potentially suspicious;
(2) What steps, if any, the registrant took to conduct due diligence;
(3) If the registrant conducted due diligence, what information it obtained during its investigation, and where the registrant concludes that each suspicious circumstance has been dispelled, the specific basis for each such conclusion; and
(4) Whether or not the registrant distributed controlled substances pursuant to the order.
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