WSR 07-10-123

PROPOSED RULES

DEPARTMENT OF HEALTH


(Board of Pharmacy)

[ Filed May 2, 2007, 9:45 a.m. ]

Original Notice.

Preproposal statement of inquiry was filed as WSR 04-18-091.

Title of Rule and Other Identifying Information: WAC 246-889-050 Suspicious transactions and reporting requirements, the proposed rule revises criteria for reporting sales of ephedrine, pseudoephedrine, and phenylpropanolamine products by wholesalers and manufacturers to retailers.

Hearing Location(s): Department of Health, Marketing Center Creekside Three at CenterPoint, 20435 72nd Avenue South, Room 1, Kent, WA 98032, on July 26, 2007, at 9:15 a.m.

Date of Intended Adoption: July 26, 2007.

Submit Written Comments to: Manet Wade, Department of Health, P.O. Box 47863, Olympia, WA 98504-7863, web site http://www3.doh.wa.gov/policyreview/, fax (360) 586-4359, by July 13, 2007.

Assistance for Persons with Disabilities: Contact Manet Wade by July 10, 2007, TTY (800) 833-6388 or 711.

Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: The rule will implement 2004 legislation (ESHB [ESSB] 6478) chapter 52, Laws of 2004 codified as RCW 69.43.035 by amending WAC 246-889-050. The proposed rule requires wholesalers and manufacturers to report suspicious transactions of the sale of ephedrine, pseudoephedrine, and phenylpropanolamine products. It is expected that the reporting of suspicious transactions will deter the purchase of products used to manufacture methamphetamine.

Reasons Supporting Proposal: ESSB 6478 directs the board of pharmacy to adopt rules for reporting the suspicious transaction sales of ephedrine, pseudoephedrine, and phenylpropanolamine products.

Statutory Authority for Adoption: RCW 18.64.005.

Statute Being Implemented: RCW 69.43.035.

Rule is not necessitated by federal law, federal or state court decision.

Name of Proponent: Washington state department of health, board of pharmacy, governmental.

Name of Agency Personnel Responsible for Drafting: Jim Doll, 310 Israel Road S.E., Tumwater, WA, (360) 236-4833; Implementation and Enforcement: Lisa Salmi, 310 Israel Road S.E., Tumwater, WA, (360) 236-4828.

No small business economic impact statement has been prepared under chapter 19.85 RCW. The proposed rule does not impose more than minor costs to businesses within the industry per RCW 19.85.030.

A cost-benefit analysis is required under RCW 34.05.328. A preliminary cost-benefit analysis may be obtained by contacting Manet Wade, Washington State Department of Health, Board of Pharmacy, P.O. Box 47863, Olympia, WA 98504, phone (360) 236-4838, fax (360) 586-4359, e-mail manet.wade@doh.wa.gov.

April 18, 2007

Lisa Salmi

Acting Executive Director

OTS-9528.3


AMENDATORY SECTION(Amending WSR 03-13-027, filed 6/10/03, effective 7/11/03)

WAC 246-889-050   Suspicious transactions and reporting requirements.   ((Any)) (1) A manufacturer or wholesaler who sells, transfers, or furnishes ((any substance specified in RCW 69.43.010(1) or WAC 246-889-020)) a regulated product to any ((person)) 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:

(((1))) (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:

(((a))) (i) The amount of the substance involved;

(((b))) (ii) The method of payment;

(((c))) (iii) The method of delivery; or

(((d))) (iv) Any past dealings with any participant in the transaction.

(((2) The transaction involves)) (b) Any sale or transfer involving payment for ((any substance specified in RCW 69.43.010(1) or WAC 246-889-020)) a regulated product in cash or money orders in a total amount of more than two hundred dollars.

(((3))) (c) Any sale or transfer of ((any substance specified in RCW 69.43.010(1) or WAC 246-889-020)) a regulated product that meets the criteria identifying suspicious orders in ((Appendix A of)) 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 ((state)) board of pharmacy.

(((4) In addition to the above suspicious transaction criteria, the following requirements shall apply to over-the-counter wholesalers and full-line wholesalers:

(a) An over-the-counter wholesaler shall also use the following formula to identify a suspicious transaction:

(i) Any wholesaler whose individual sale or transfer of any product specified in RCW 69.43.010(1) or WAC 246-889-020 exceeds ten percent of the seller's distribution, during the same calendar month, shall be considered a suspicious transaction (e.g., if a wholesaler sells one thousand dollars' worth of pseudoephedrine tablets during a month in which less than ten thousand dollars of other goods are sold to its customers). In this case, the sales to each of the customers must be reported to the board.

(ii) Any time the value of a sale to a single customer of any product listed in RCW 69.43.010(1) or WAC 246-889-020 exceeds ten percent of the value of the full order shipped to the customer (e.g., if a wholesaler sells an order to a customer which contains one hundred dollars' worth of the pseudoephedrine tablets either alone or along with twenty-five dollars' worth of aspirin tablets).

(b) A full-line wholesaler shall also use the formula listed in Appendix E-3 of the U.S. Department of Justice, Drug Enforcement Administration, Diversion Control Program Report of the Suspicious Orders Task Force to identify a suspicious transaction.)) (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:

(a) Cosmetics;

(b) Food, dietary, and vitamin supplements;

(c) Herbs;

(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 ((and)), address and phone number of the ((person or firm receiving)) recipient of the suspicious transaction;

(((c))) (g) Quantity of substance purchased, transferred, or furnished, by number of units and doses per unit;

(((d))) (h) Date of purchase((,)) or transfer((, or furnish; and));

(((e))) (i) Method of payment of the substance;

(j) Lot number if available; and

(k) National Drug Code Number if available.

[Statutory Authority: RCW 69.43.035 and 18.64.005(7). 03-13-027, 246-889-050, filed 6/10/03, effective 7/11/03.]

Washington State Code Reviser's Office