DEPARTMENT OF HEALTH
[Filed July 1, 2019, 12:07 p.m., effective August 1, 2019]
Effective Date of Rule: Thirty-one days after filing.
Purpose: Chapter 246-480 WAC, Drug take-back program, the department of health (department) is adopting a new chapter of rules to implement a single uniform, statewide system of regulation for the safe and secure collection of medicines through a drug take-back system. The enabling legislation (chapter 69.48
RCW) is very descriptive of how the drug take-back program is to be established and executed, including the functions that the department must perform. The purpose of the rule is to clarify parts of RCW needing more detail.
The rules primarily address administrative and oversight details to include:
A process to identify covered manufacturers who must pay into the drug take-back program.
The type of budget information required in the program operator's proposal submitted to the program for approval, as well as budget information submitted by the program operator with each annual report.
The process to appeal department decisions.
How to determine areas in the state being underserved by the drug take-back program.
Citation of Rules Affected by this Order: New WAC 246-480-010, 246-480-020, 246-480-030, 246-480-040, 246-480-050, 246-480-060, 246-480-070, 246-480-080, 246-480-090, and 246-480-990.
Adopted under notice filed as WSR 19-08-085 on April 3, 2019.
Changes other than editing from proposed to adopted version: WAC 246-480-040(5), added language to clarify that the program costs to be considered when submitting a program proposal to the department for approval must include each item listed in this WAC subsection as a minimum, but the department will also accept any information beyond that if provided.
WAC 246-480-040 (5)(b)(iii), corrected a citation as follows "… personnel costs in (a)(i)(A) of this subsection."
WAC 246-480-060 (2)(c), "driving distances and times" was changed to "travel distances and times" to clarify the department's original intent that a variety of distance calculations will be included when determining "underserved areas."
WAC 246-480-070, "sites" was changed to "collection sites" for clarity.
WAC 246-480-080, disposal of covered drugs, was removed from the proposed rule and the remaining sections renumbered accordingly. The department has determined that the notification mechanism in RCW 69.48.050
(5)(a) for program operators to notify the department about the disposal sites it intends to use after the program has begun operating, along with the department's ability to require information about disposal site type and permit number [is] sufficient for the department to implement the statute.
A final cost-benefit analysis is available by contacting Carly Bartz-Overman, Department of Health, P.O. Box 47850 Olympia, WA 98504-7850, phone 360-236-4698, fax 360-236-2901, TTY 360-833-6388 or 711, email email@example.com, web site https://www.doh.wa.gov/ForPublicHealthandHealthcareProviders/HealthcareProfessionsandFacilities/SafeMedicationReturnProgram/.
Number of Sections Adopted in Order to Comply with Federal Statute: New 0, Amended 0, Repealed 0; Federal Rules or Standards: New 0, Amended 0, Repealed 0; or Recently Enacted State Statutes: New 10, Amended 0, Repealed 0.
Number of Sections Adopted at the Request of a Nongovernmental Entity: New 0, Amended 0, Repealed 0.
Number of Sections Adopted on the Agency's own Initiative: New 0, Amended 0, Repealed 0.
Number of Sections Adopted in Order to Clarify, Streamline, or Reform Agency Procedures: New 0, Amended 0, Repealed 0.
Number of Sections Adopted using Negotiated Rule Making: New 0, Amended 0, Repealed 0; Pilot Rule Making: New 0, Amended 0, Repealed 0; or Other Alternative Rule Making: New 10, Amended 0, Repealed 0.
Date Adopted: June 27, 2019.
John Weisman, DrPH, MPH
Chapter 246-480 WAC
DRUG TAKE-BACK PROGRAM
WAC 246-480-010Purpose and scope.
The purpose of this chapter is to:
(1) Establish a single uniform, statewide system of regulation for safe and secure collection and disposal of medicines through a uniform drug take-back program, operated and funded by drug manufacturers, and regulated by the department of health consistent with chapter 69.48
(2) Establish criteria and an approval process for program operators to operate a drug take-back program under chapter 69.48
(3) Ensure every covered manufacturer whose drugs are sold in or into Washington complies with chapter 69.48
RCW and this chapter.
The definitions in RCW 69.48.020
apply to this chapter unless the context clearly indicates otherwise.
WAC 246-480-030Identification of covered manufacturers.
(1) Upon review of an inquiry response letter described in RCW 69.48.040
(3), the department shall notify the person or entity in writing whether or not the person or entity is considered a covered manufacturer. If the department determines that the person or entity is a covered manufacturer, the written notice will include a warning regarding the penalties for violation of this chapter, as authorized in RCW 69.48.110
(2)(a) Within thirty days after the first full year of a drug take-back program's implementation, and annually thereafter, the department may provide a list of covered manufacturers potentially not participating in a drug take-back program to each approved program operator.
(b) Within thirty days of receiving such a list, approved program operators may provide any comments on the list to the department.
(c) Within thirty days of receiving and considering any approved program operator comments, the department may publish on its web site a list of all covered manufacturers not participating in a drug take-back program.
(3) The department shall remove any covered manufacturer identified in the published list if the covered manufacturer participates in an approved drug take-back program.
WAC 246-480-040Drug take-back program proposal components.
In addition to this section, the drug take-back proposal must comply with chapter 69.48
RCW. Each proposal must be on a form provided by the department and must:
(1) Contain a table of contents clearly denoting, at a minimum, where each component specified in RCW 69.48.050
is located within the program proposal;
(2) Provide a description of a drug collection system that includes:
(a) A list of participating authorized collectors;
(b) A list of drop-off (kiosk) locations; and
(c) A detailed description of how mail-back distribution locations or periodic collection events will be used.
(3) Demonstrate that the policies and procedures to be followed by persons handling unwanted covered drugs collected under the drug take-back program as required in RCW 69.48.050
(a) How all entities participating in the drug take-back program will operate under all applicable federal and state laws and rules including, but not limited to, United States Drug Enforcement Administration rules; and
(b) How any pharmacy collection sites will operate under applicable rules from the Washington state pharmacy quality assurance commission.
(4) Include a detailed description of the geographical distribution of collection sites that will provide equitable and reasonably convenient access to all residents consistent with RCW 69.48.060
(5) Include a budget estimate for providing the statewide program. Estimates must show total costs for each of the categories described in this subsection and a sum total of all program costs representing the totals for each category:
(a) Category 1: Administrative costs. A total for all administrative costs must include, but is not limited to:
(i) Contracted and employed personnel overhead costs;
(ii) Legal fees;
(iii) Local and state business licensing fees;
(iv) Local, state, and federal taxes;
(v) Property costs, including rentals;
(vi) Utilities, phone, and internet; and
(vii) General equipment and supplies.
(b) Category 2: Collection and disposal costs. A total for all collection and disposal costs must include, but is not limited to:
(i) Collection, transportation, and disposal of drugs;
(ii) Purchase, maintenance, and replacement of collection receptacles;
(iii) Compensation of authorized collectors, if separate from personnel costs in (a)(i) of this subsection; and
(iv) Production, distribution, and postage of mailers.
(c) Category 3: Communication costs. A total for all communication costs must include, but is not limited to:
(iii) Web site creation and maintenance; and
(iv) Operation of a toll-free phone number.
(6) Describe how the program operator will work with Washington state counties and the department to incorporate local programs into their proposed statewide plan consistent with RCW 69.48.160
(7) Include an implementation plan and schedule for initiating operation of the approved drug take-back program.
WAC 246-480-050Program application.
(1) A drug take-back program operator must submit its program proposal and substantial changes to an approved program on forms provided by the department.
(2) If the department takes enforcement action as provided in RCW 69.48.050
(3)(c)(iv), the applicant through its authorized representative may request an adjudicative proceeding under chapter 246-10 WAC. A request for an adjudicative proceeding must be in writing, state the basis for contesting the adverse action, include a copy of the adverse notice and be served on and received by the department within twenty-eight days of the program operator's receipt of the adverse notice. If a request for adjudicative proceeding is not received by the department within twenty-eight days of the date of the program operator's receipt of the adverse notice, the secretary's decision is final.
WAC 246-480-060Collection of covered drugs—Underserved areas.
(1) To assist the program operators in complying with RCW 69.48.060
(3)(c) and (d), the department will determine and locate each population center consistent with RCW 69.48.060
and this chapter using geographical information systems (GIS) mapping technology, and will publish updated population data to the department's web site annually.
(2) The department, in consultation with the local health jurisdiction, will determine underserved areas described in RCW 69.48.060
(3) using the following criteria:
(a) Population density of counties;
(b) Estimated number of participating collection sites;
(c) Travel distances and times;
(d) Accessible public facilities such as libraries, town halls, and police and fire departments; and
(e) Geographic features that may inhibit access to collection locations such as mountains and islands.
Approved program operators must update their list of authorized collectors, collection sites, locations to receive mailers, and locations for drug take-back events at least quarterly on their web site.
WAC 246-480-080Program operator annual report.
(1) To comply with RCW 69.48.100
(1), each program operator shall submit an annual report to the department by July 1st on a form developed by the department.
(2) In addition to the elements identified and described in RCW 69.48.100
, the report must include a summary of the program's annual expenditures organized using the same criteria as described in WAC 246-480-040(5).
WAC 246-480-090Proprietary information.
(1) Consistent with RCW 69.48.170
, chapter 42.56
RCW, and other applicable laws, proprietary information submitted to the department under chapter 69.48
RCW is exempt from public disclosure. The manufacturer or drug take-back organization must identify in writing the information it considers proprietary when submitting information to the department. Information automatically disclosable under law may not be marked proprietary. Information not deemed automatically disclosable cannot be marked as proprietary in their entirety.
(2) If the department receives a request for disclosure under chapter 42.56
RCW which includes information identified by the manufacturer or drug take-back organization as proprietary, the department will notify the manufacturer or drug take-back organization of the status of such documents prior to their release. The manufacturer or drug take-back organization may seek to enjoin the release of the information as provided under RCW 42.56.540
This section establishes the initial and annual fees for a program operator implementing a drug take-back program under chapter 69.48
RCW and this chapter.
(1) Initial fee. By no later than October 1, 2019, a program operator shall submit to the department an initial fee of seven hundred thousand dollars.
(2) Renewal fee.
(a) By August 1, 2020, and each August 1st thereafter, the department shall notify a program operator the amount of its annual renewal fee as determined according to RCW 69.48.120
. Renewal fees will reflect the department's actual administrative, oversight, enforcement, and contractual costs for that fiscal year, or not more than ten percent of the program operator's annual expenses as reported on July 1st of each year, whichever amount is smaller.
(b) By October 1, 2020, and each October 1st thereafter, a program operator shall submit to the department the renewal fee.