1. (1) For the purposes of this section and WAC 246-945-590, "suspicious order" means an order(s) of a controlled substance or drug of concern that, relative to the customer's order history and the history of similarly situated customer, may include:

   1. (a) Unusual size;
   2. (b) Substantial deviation from a normal pattern; or
   3. (c) Unusual frequency.

2. (2) Wholesalers shall design and operate a system to identify and report suspicious orders to the commission that resulted in customer termination.

   1. (a) Suspicious orders that resulted in customer termination shall be submitted electronically to the commission within five business days of the customer termination, and must include, but not necessarily be limited to:

      1. (i) Customer name;
      2. (ii) Customer address;
      3. (iii) Customer DEA registration number, if applicable;
      4. (iv) Washington state license number(s);
      5. (v) Order date;
      6. (vi) Drug name;
      7. (vii) NDC number;
      8. (viii) Quantity ordered; and
      9. (ix) The factual basis for the identification of the order as suspicious and customer termination.
   2. (b) Wholesalers may apply to the commission for an exemption from the reporting requirements if they do not distribute controlled substances or drugs of concern.

3. (3) Except as provided in subsection (4) of this section, a wholesaler shall conduct due diligence on customers ordering or seeking to order controlled substances or drugs of concern, and establish the normal and expected transactions conducted by those customers, in order to identify and prevent the sale of controlled substances or drugs of concern that are likely to be diverted from legitimate channels. Such due diligence measures shall include, but are not limited to, the following, which shall be conducted prior to an initial sale and as necessary:

   1. (a) Questionnaires and affirmative steps by the wholesaler to confirm the accuracy and validity of the information provided, it shall be considered illegal for a customer to provide false or misleading information;
   2. (b) For a customer who is a prescriber, confirmation of prescriber type, specialty practice area, and if the prescriber personally furnishes controlled substances or drugs of concern, the quantity furnished;
   3. (c) Review of drug utilization reports; and

   4. (d) Obtaining and conducting a review of the following:

      1. (i) Methods of payment accepted and in what ratios;
      2. (ii) The ratio of controlled versus noncontrolled prescriptions and overall sales;
      3. (iii) Orders for controlled substances or drugs of concern from other wholesalers U.S. DEA's Automation of Reports and Consolidated Orders System (ARCOS); and
      4. (iv) The ratio of out-of-state patients served compared to in-state patients.

4. (4) A wholesaler receiving a request for an initial sale of a controlled substance or drugs of concern may conduct the sale before complying with subsection (3) of this section if all of the following apply:

   1. (a) The sale is to a new customer;
   2. (b) The wholesaler documents that the order is to meet an emergent need;
   3. (c) The wholesaler completes the requirements of subsection (3) of this section no later than sixty business days from the date of sale.

5. (5) Any potential customer that the wholesaler refuses to onboard due to a possible diversion risk shall be electronically reported to the commission within five business days of the wholesaler's refusal to onboard. Such reports shall include:

   1. (a) Name of potential customer;
   2. (b) Address of potential customer;
   3. (c) Potential customer's DEA number, if applicable;
   4. (d) Washington state license number(s); and
   5. (e) A detailed explanation of why the wholesaler identified the potential customer as a possible diversion risk.
6. (6) All information submitted under this section must be readable and accessible to the commission.

[Statutory Authority: RCW 18.64.005 and 18.64.046. WSR 25-21-014, s 246-945-585, filed 10/3/25, effective 11/3/25. Statutory Authority: RCW 18.64.005, 18.64.080, 18.130.075, 18.64.043, 18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310, 18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253, 18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-585, filed 6/1/20, effective 7/1/20.]