WSR 05-19-113

PROPOSED RULES

DEPARTMENT OF HEALTH


(Board of Pharmacy)

[ Filed September 20, 2005, 3:51 p.m. ]

Original Notice.

Exempt from preproposal statement of inquiry under RCW 34.05.310(4).

Title of Rule and Other Identifying Information: WAC 246-889-070, 246-889-075, 246-889-080, 246-889-085, 246-889-090, 246-889-095, 246-889-100, 246-889-105, and 246-889-110, retail transaction logs for ephedrine, pseudoephedrine, and phenylpropanolamine products. Precursor substance control. The proposed rule sets the standards for recording retail transactions (sales) of ephedrine, pseudoephedrine, and phenylpropanolamine products.

Hearing Location(s): Department of Health, Point Plaza East, Room 152, 310 Israel Road S.E., Tumwater, WA 98501, on November 2, 2005, at 9:00 a.m.

Date of Intended Adoption: November 2, 2005.

Submit Written Comments to: Lisa Salmi, Department of Health, P.O. Box 47863, Olympia, WA 98504-7863, e-mail www3.doh.wa.gov/policyreview/default.asp, fax (360) 586-4359, by October 20, 2005.

Assistance for Persons with Disabilities: Contact Lisa Salmi by October 15, 2005, TTY (800) 833-6388 or (711) for relay.

Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: The proposed rule will add new sections to chapter 246-889 WAC, Precursor substance control. The proposed rule is intended to protect the health and welfare of persons in Washington state by eliminating or reducing methamphetamine labs in Washington state. The proposed rule requires retailers to record the transaction or sale of ephedrine, pseudoephedrine, and phenylpropanolamine products. It is expected that the recording of the sale of these products in transaction log will deter the illegal purchases of products used to manufacture methamphetamine.

Reasons Supporting Proposal: ESHB 2266 directs the Board of Pharmacy to adopt rules to set standards for the collection and maintenance of logs to record the retail transactions of ephedrine, pseudoephedrine, and phenylpropanolamine products.

Statutory Authority for Adoption: Chapter 69.43 RCW, RCW 18.64.005.

Statute Being Implemented: Chapter 69.43 RCW, chapter 388, Laws of 2005.

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, Implementation and Enforcement: Steven M. Saxe, 310 Israel Road S.E., P.O. Box 47863, Olympia, WA 98504-7863, (360) 236-4825.

No small business economic impact statement has been prepared under chapter 19.85 RCW. Under RCW 19.85.025 the agency is not required to complete an analysis if the rule is adopted under RCW 34.05.310(4). Consistent with RCW 34.05.310 (4)(c), this rule adopts, without material change, Washington state statute.

A cost-benefit analysis is not required under RCW 34.05.328. A cost benefit analysis is not required under RCW 34.05.328 (5)(b)(iii), because the rule adopts without material change, Washington state statute.

September 7, 2005

Steven Saxe

Executive Director

OTS-8220.4


NEW SECTION
WAC 246-889-070   Retail sales logs for ephedrine, pseudoephedrine, and phenylpropanolamine products.   Purpose.

The legislature has recognized that restricting access to ephedrine, pseudoephedrine, and phenylpropanolamine products, or their salts or isomers, is a valid method to reduce the availability of these products for the illegal manufacture of methamphetamine. To reduce the illegal use of these products in the manufacture of methamphetamine, while continuing access for legitimate medical purposes, the legislature directed the board to adopt rules for the recording of retail sales involving ephedrine, pseudoephedrine or phenylpropanolamine products. The record of sales must be collected and maintained in a written or electronic log or other alternative means. Data from this log will be used to determine if the log is an effective law enforcement tool and if the information received is an effective deterrent to criminal activity. The following rules describe the requirements for the transaction logs.

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NEW SECTION
WAC 246-889-075   Definitions.   (1) "Ephedrine, pseudoephedrine, and phenylpropanolamine products" means any product containing any detectable quantity of ephedrine, pseudoephedrine or phenylpropanolamine.

(2) "Retailer" means a pharmacy licensed by, or shopkeeper or itinerant vendor registered with, the department of health under chapter 18.64 RCW, or an employee, a practitioner as defined in RCW 18.64.011, or a traditional Chinese herbal practitioner as defined in chapter 69.43 RCW.

(3) "Sale" means the sale, transfer, or otherwise furnishing of any ephedrine, pseudoephedrine, or phenylpropanolamine product to any person.

(4) "Law enforcement" means any general or limited authority Washington peace officer.

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NEW SECTION
WAC 246-889-080   Records of sale.   You must keep a record of a sale except when:

(1) The sale of any product containing ephedrine, pseudoephedrine or phenylpropanolamine that is in liquid, liquid capsule, or in a gel capsule form and is combined with another active ingredient.

(2) The sale of any ephedrine, pseudoephedrine or phenylpropanolamine product that is sold via a prescription written by an authorized practitioner.

(3) The sale of any ephedrine, pseudoephedrine, or phenylpropanolamine product is recorded in a pharmacy profile and the profile is maintained by the pharmacy. The profile must be the individualized record for the purchaser, containing identifying information, including, but not limited to, name, address, date of purchase, purchaser's date of birth, and product description.

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NEW SECTION
WAC 246-889-085   Requirements for the sale of an ephedrine, pseudoephedrine, or phenylpropanolamine product.   A retailer must:

(1) Review the purchaser's photo identification. The photo identification must include the date of birth of the purchaser. The purchaser must be eighteen years of age or older.

(2) Record the information detailed in WAC 246-889-095 for the record of transaction.

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NEW SECTION
WAC 246-889-090   Acceptable forms of photo identification.   To be an acceptable form of identification, the identification must be issued by a government agency and include the person's photograph, date of birth, and signature. The following are acceptable forms of identification:

(1) A driver's license or instruction permit issued by any U.S. state or province of Canada. If the customer's driver's license has expired, he/she must also show a valid temporary driver's license with the expired card.

(2) A United States armed forces identification card issued to active duty, reserve, and retired personnel and the personnel's dependents.

(3) A merchant marine identification card issued by the United States Coast Guard.

(4) A state liquor control identification card. An official age identification card issued by the liquor control authority of any U.S. state or Canadian province.

(5) A state identification card issued by any U.S. state or province of Canada.

(6) An official passport issued by any nation.

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NEW SECTION
WAC 246-889-095   Record of sale.   Information required. The retailer must record:

(1) Date of purchase;

(2) Name of the purchaser;

(3) Date of birth of the purchaser;

(4) Address of purchaser;

(5) Signature of the purchaser;

(6) Type of identification, agency issuing the identification, and the identification number if applicable; and

(7) Number of packages and the number of tablets per package.

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NEW SECTION
WAC 246-889-100   Methods for collecting, recording, and storing records of sales data.   Sales records must be maintained on a written or electronic log and must be readily retrievable and contain all information required in WAC 246-889-095. Methods other than electronic or written must be approved in advance by the board of pharmacy and must contain all the information required for a written or electronic log and be retained for the same period of time as a written or electronic log.

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NEW SECTION
WAC 246-889-105   Record retention and destruction.   The retailer must maintain transaction records for two years. Sales records may be destroyed after the retention period of two years. When records are destroyed, the records must be destroyed in a manner that leaves the record unidentifiable and nonretrievable.

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NEW SECTION
WAC 246-889-110   Access to retail records of sales.   Records of sales are confidential and are only open to inspection by the board of pharmacy and law enforcement agencies. The retailer does not have to transmit records to law enforcement or the board of pharmacy. Law enforcement and/or the board of pharmacy will request and obtain records if they are needed. Retailers shall also produce the records in a court whenever lawfully required to do so.

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Washington State Code Reviser's Office