Suspicious transactions and reporting requirements.
(1) A manufacturer or wholesaler who sells, transfers, or furnishes a regulated product to any licensee shall report any suspicious transaction in writing to the state board of pharmacy.
(2) For the purpose of this rule, a regulated product is defined as a product specified in RCW 69.43.010
(1) or WAC 246-889-020
(3) For the purposes of this rule, a "suspicious transaction" is defined as any sale or transfer that meets any of the following criteria:
(a) Any sale or transfer that would lead a reasonable person to believe that the substance is likely to be used for the purpose of unlawfully manufacturing a controlled substance under chapter 69.50
RCW, based on such factors as:
(i) The amount of the substance involved;
(ii) The method of payment;
(iii) The method of delivery; or
(iv) Any past dealings with any participant in the transaction.
(b) Any sale or transfer involving payment for a regulated product in cash or money orders in a total amount of more than two hundred dollars.
(c) Any sale or transfer of a regulated product that meets the criteria identifying suspicious orders in the U.S. Department of Justice, Drug Enforcement Administration, Diversion Control Program Report of the Suspicious Orders Task Force. Copies of the publication are available upon request from the board of pharmacy.
(d) Any individual sale or transfer of a regulated product that exceeds ten percent of the nonprescription drugs contained in the order. (Example: If a wholesaler sells three thousand dollars worth of products to a shopkeeper and that order contains one thousand dollars worth of nonprescription drugs, the wholesaler must submit a suspicious transaction report if the order contains over one hundred dollars worth of regulated products.)
(e) Any order which contains regulated products and has no additional nonprescription drugs is considered a suspicious transaction.
(4) For the purposes of this rule, nonprescription drugs are defined as those drugs which may be sold at retail without a prescription for the diagnosis, treatment, cure or prevention of any disease that has been approved by the FDA and bears an appropriate label. An over-the-counter (OTC) drug is the same as a nonprescription drug.
The following are examples of products sold at retail which are not defined as OTC drugs:
(b) Food, dietary, and vitamin supplements;
(d) Products that carry the statements "this product is not intended to diagnose, treat, cure or prevent any disease" or "not evaluated by FDA."
(5) The written report of a suspicious transaction shall contain, at a minimum, the following information:
(a) Name, address and phone number of the manufacturer and/or wholesaler making the report;
(b) Washington state license number of the wholesaler;
(c) Washington state Unified Business Identifier (UBI) number of the recipient of the suspicious transaction;
(d) Trade/brand name of regulated product;
(e) Generic name of regulated product’s active ingredients;
(f) Name, address and phone number of the recipient of the suspicious transaction;
(g) Quantity of substance purchased, transferred, or furnished, by number of units and doses per unit;
(h) Date of purchase or transfer;
(i) Method of payment of the substance;
(j) Lot number if available; and
(k) National Drug Code Number if available.
[Statutory Authority: RCW 18.64.005
and 69.43.035. WSR 07-23-018, § 246-889-050, filed 11/9/07, effective 12/10/07. Statutory Authority: RCW 69.43.035
and 18.64.005(7). WSR 03-13-027, § 246-889-050, filed 6/10/03, effective 7/11/03.]