Chapter 24.15
SECURE MEDICINE RETURN
Sections:
24.15.010 Authority, purpose, and intent.
24.15.050 Collection of covered drugs.
24.15.070 Disposal of covered drugs.
24.15.080 Administrative and operational costs and fees.
24.15.090 Reporting requirements.
24.15.100 Identification of producers of covered drugs.
24.15.110 Review of proposed plans.
24.15.120 Prior approval for plan changes.
24.15.130 Enforcement procedures and penalties.
24.15.140 Regulations, performance standards, and report.
24.15.150 Plan review and annual operating fees.
24.15.010 Authority, purpose, and intent.
A. The Whatcom County board of health (board of health) enacts the regulations set forth in this chapter under the authority of Chapter 70.05 RCW to preserve, promote, and improve the public health and under the general authority of Article 11, Section 11 of the Washington Constitution.
B. The purpose of these regulations is to provide for and promote the health, safety, and welfare of the general public, and not to create or otherwise establish or designate any particular class or group of person who will or should be especially protected or benefited by this chapter. The provisions of this chapter shall be liberally construed for the accomplishment of its purposes.
C. It is the specific intent of this chapter to place the obligation of complying with its requirements upon drug producers, wholesalers and others designated within the scope of this chapter, and no provision nor term used in this title is intended to impose any duty whatsoever upon the board of health, Whatcom County health department (health department), or any of its officers or employees, for whom the implementation or enforcement of this chapter shall be discretionary and not mandatory.
D. Nothing contained in this chapter is intended to be nor shall be construed to create or form the basis for any liability on the part of the board of health, the health department or any of its officers, employees, or agents for any injury or damage resulting from the failure of any person subject to this chapter to comply with this chapter, or by reason or in consequence of any act or omission in connection with the implementation or enforcement of this chapter on the part of the board of health, the health department, or its officers or employees. (Ord. 2017-073 Exh. A).
24.15.020 Definitions.
The following definitions apply throughout this chapter unless the context clearly indicates otherwise:
A. “Authorized collector” means any person authorized as a collector by the United States Drug Enforcement Administration pursuant to 21 CFR 1317, such as manufacturers, distributors, reverse distributors, retail pharmacies, hospitals/clinics with an on-site pharmacy, or narcotic treatment programs that gather unwanted drugs, including controlled substances, from covered entities for the purpose of collection, transportation and disposal. For purposes of this chapter, “authorized collector” shall also include law enforcement agencies.
B. “Covered drug” means a drug sold in any form and used by covered entities, including prescription and nonprescription drugs, brand name and generic drugs, drugs for veterinary use, and drugs in medical devices and combination products, including pre-filled injector products with a retractable or otherwise securely covered needle. “Covered drug” does not include:
1. Vitamins or supplements;
2. Herbal-based remedies and homeopathic drugs, products or remedies;
3. Cosmetics, shampoos, sunscreens, toothpaste, lip balm, antiperspirants or other personal care products that are regulated as both cosmetics and nonprescription drugs under the Federal Food, Drug and Cosmetic Act (Title 21 U.S.C. Chapter 9);
4. Drugs for which producers provide a pharmaceutical product stewardship or take-back program as part of a Federal Food and Drug Administration managed risk evaluation and mitigation strategy (Title 21 U.S.C. Section 355-1);
5. Drugs that are biological products as defined by 21 CFR 600.3(h) as it exists on the effective date of this regulation if the producer already provides a pharmaceutical product stewardship or take-back program;
6. Injector products and medical devices or their component parts or accessories that contain no covered drug or no more than trace residual amounts of covered drug; and
7. Pet pesticide products contained in pet collars, powders, shampoos, topical applications, or other forms.
C. “Covered entities” means residents of Whatcom County, including individuals living in single- and multiple-family residences and other residential settings, and including other nonbusiness sources of prescription and nonprescription drugs that are unused, unwanted, disposed of or abandoned by residents as identified by the health department. “Covered entities” does not include business generators of pharmaceutical waste, such as hospitals, clinics, doctor’s offices, veterinarian clinics, pharmacies, or airport security and law enforcement drug seizures.
D. “Director” means the administrative director of Whatcom County health department or a duly authorized representative.
E. “Drop-off site” means the location of an authorized collector where a secure drop box for all unwanted covered drugs is provided for residents of the county, or the location of a long-term care facility at which a hospital/clinic or retail pharmacy is authorized by the United States Drug Enforcement Administration to maintain a secure drop box for unwanted covered drugs from residents of the long-term care facility.
F. “Drug wholesaler” means a corporation, individual or other entity that buys drugs or devices for resale and distribution to corporations, individuals or entities other than consumers.
G. “Drug” means:
1. Articles recognized in the official United States pharmacopoeia, the official national formulary; the official homeopathic pharmacopoeia of the United States or any supplement of the formulary or those pharmacopoeias as published by the U.S. Pharmacopeial Convention and the Homeopathic Pharmacopoeia Convention of the United States;
2. Substances intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in humans or other animals;
3. Substances, other than food, intended to affect the structure or any function of the body of humans or other animals; or
4. Substances intended for use as a component of any substances specified in subsection (G)(1), (2) or (3) of this section.
H. “Independent stewardship plan” means a plan other than the standard stewardship plan for the collection, transportation and disposal of unwanted covered drugs that:
1. May be proposed by a producer or group of producers; and
2. If approved, is financed, developed and implemented by the participating producer or group of producers, and operated by the participating producer or group of producers or a stewardship organization.
I. “Long-term care facility” means a nursing home, retirement care, mental care or other facility or institution which provides extended health care to resident patients and, for the purposes of this chapter, a facility where covered drugs that may be disposed of in a secure drop box pursuant to 21 CFR 1317.80 are in the lawful possession of the resident.
J. “Mail-back services” means a collection method for the return of unwanted covered drugs from covered entities utilizing prepaid and preaddressed mailing envelopes.
K. “Manufacture” means “manufacture” as defined in RCW 18.64.011 that is the production, preparation, propagation, compounding or processing of a drug or other substance or device or the packaging or repackaging of the substance or device, or the labeling or relabeling of the commercial container of such substance or device, but does not include the activities of a practitioner who, as an incident to his or her administration or dispensing such substance or device in the course of his or her professional practice, prepares, compounds, packages, or labels such substance or device.
L. “Manufacturer” means a person, corporation or other entity engaged in the manufacture of drugs or devices, as defined in RCW 18.64.011.
M. “Nonprescription drug” means a drug that may be lawfully sold without a prescription.
N. “Person” means a firm, sole proprietorship, corporation, limited liability company, general partnership, limited partnership, limited liability partnership, association, cooperative or other entity of any kind or nature.
O. “Pharmacy” means a place licensed by the Washington State Pharmacy Quality Assurance Commission where the practice of pharmacy, as defined in RCW 18.64.011, is conducted.
P. “Potential authorized collector” means any person, such as manufacturers, distributors, reverse distributors, retail pharmacies, hospitals/clinics with an on-site pharmacy, or narcotic treatment programs, that may modify their registration with the United States Drug Enforcement Administration to be authorized for collection of drugs, including controlled substances. For purposes of this chapter, “potential authorized collector” shall also include law enforcement agencies.
Q. “Prescription drug” means any drugs, including controlled substances that are required by an applicable federal or state law or regulation to be dispensed by prescription only or are restricted to use by practitioners only.
R. “Producer” means a manufacturer that is engaged in the manufacture of a covered drug sold in or into Whatcom County, including a brand-name or generic drug. “Producer” does not include:
1. A retailer whose store label appears on a covered drug or the drug’s packaging if the manufacturer from whom the retailer obtains the drug is identified under WCC 24.15.030(C);
2. A pharmacist who compounds a prescribed individual drug product for a consumer; or
3. A drug wholesaler who is not also the manufacturer.
S. “Regulation” means the “Secure Medicine Return” Regulation adopted by Whatcom County board of health.
T. “Retail pharmacy” means a pharmacy licensed by the Washington State Pharmacy Quality Assurance Commission for retail sale and dispensing of drugs.
U. “Standard stewardship plan” means the plan for the collection, transportation and disposal of unwanted covered drugs that is:
1. Financed, developed, implemented and participated in by producers;
2. Operated by the participating producers or a stewardship organization; and
3. Approved as the standard stewardship plan.
V. “Stewardship organization” means an organization designated by a producer or group of producers to act as an agent on behalf of each producer to develop and implement and operate the standard stewardship plan or an independent stewardship plan.
W. “Unwanted covered drug” means any covered drug no longer wanted by its owner, that:
1. Has been abandoned or discarded; or
2. Is intended to be discarded by its owner. (Ord. 2017-073 Exh. A).
24.15.030 Participation.
A. Each producer shall participate in the standard stewardship plan approved by the health department except that a producer may individually, or with a group of producers, form and participate in an independent stewardship plan approved by the health department.
B. The standard stewardship plan and any independent stewardship plan shall be approved by the health department before collecting unwanted covered drugs. Once approved, stewardship plans must have prior written approval of the health department for proposed changes as described under WCC 24.15.120.
C. Within 60 days after the date of adoption of this regulation:
1. A producer shall notify the health department in writing of the producer’s intent to participate in the standard stewardship plan or to form and participate in an independent stewardship plan; and
2. A retailer whose store label appears on a covered drug or the drug’s packaging shall notify the health department of intent to participate or provide written notification that the manufacturer from whom the retailer obtains the drug has provided its notice of intent to participate.
For a covered drug not sold in or into Whatcom County at the date of adoption of this regulation, the producer of the covered drug, and, if applicable, the retailer whose store label appears on a covered drug or the drug’s packaging, shall have 180 days from the date of initiating sales of the covered drug in or into the county to make this notification to the health department.
D. A producer or group of producers participating in the standard stewardship plan or an independent stewardship plan shall:
1. Within 120 days after this regulation is adopted, identify in writing to the health department a plan operator, including the plan operator’s telephone, mailing address and email contact information, who is authorized to be the official point of contact for the stewardship plan;
2. Within 120 days after this regulation is adopted, notify all potential authorized collectors in the county of the opportunity to participate as a drop-off site in accordance with WCC 24.15.050(A), (E), and (F), and provide a process for forming an agreement between the plan and interested potential authorized collectors; and
a. Annually thereafter, make the same notification to any nonparticipating potential authorized collectors in the county; and
b. Commence good faith negotiations with each potential authorized collector expressing an interest in participating as a drop-off site within 30 calendar days of the expression of such interest;
3. Within 180 days after this regulation is adopted, submit a proposed stewardship plan as described in WCC 24.15.040 to the health department for review and approval;
4. Within 90 days after the health department’s approval of the stewardship plan:
a. Provide documentation to the health department confirming that all potential authorized collectors participating in the approved stewardship plan, not including law enforcement, have amended their registrations with the United States Drug Enforcement Administration; and
b. Begin operation of the approved stewardship plan and provide the collection system for unwanted covered drugs required under this chapter;
5. At least every four years after each plan initiates operations, submit an updated plan to the health department explaining any substantive changes to components of the stewardship plan required in WCC 24.15.040, and accompanied by the review fee in accordance with WCC 24.15.150. The health department shall review updated stewardship plans using the process described in WCC 24.15.110;
6. Pay all administrative and operational costs and fees associated with their stewardship plan as required under WCC 24.15.080 and 24.15.150.
E. A producer or group of producers participating in the standard stewardship plan or an independent stewardship plan may:
1. Enter into contracts and agreements with stewardship organizations, service providers, or other entities as necessary, useful or convenient to provide all or portions of their stewardship plan;
2. Notify the health department of any producer selling covered drugs in or into the county that is failing to participate in a stewardship plan; or
3. Perform any other functions as may be necessary or proper to provide the stewardship plan and to fulfill any or all of the purposes for which the plan is organized.
F. After the first full year of operation of the approved standard stewardship plan, a producer or group of producers participating in the standard stewardship plan may notify the health department in writing of intent to form an independent stewardship plan, and identify a plan operator, including the plan operator’s telephone, mailing address and email contact information, who is authorized to be the official point of contact for the proposed independent stewardship plan. Within 90 days of such notification, the producer or group of producers may submit a proposed independent stewardship plan as described under WCC 24.15.040 to the health department for review and approval.
G. The health department may approve in writing extensions to later dates for the submission dates and deadlines in this section.
H. The health department may upon request provide consultation and technical assistance about the requirements of this chapter to assist a producer, group of producers or stewardship organization in developing its proposed plan. (Ord. 2017-073 Exh. A).
24.15.040 Plan components.
The standard stewardship plan or any independent stewardship plan, which must be submitted and reviewed according to WCC 24.15.110, shall include:
A. Contact information for all drug producers participating in the stewardship plan;
B. A description of the proposed collection system to provide convenient ongoing collection service for all unwanted covered drugs from covered entities in compliance with the provisions and requirements in WCC 24.15.050, including:
1. A list of all collection methods and participating potential authorized collectors;
2. A list of drop-off sites with addresses;
3. A description of how periodic collection events will be scheduled and located, if applicable;
4. A description of how mail-back services will be provided and an example of the prepaid, preaddressed mailers to be utilized;
5. A list of potential authorized collectors contacted by the plan under WCC 24.15.030(D)(2), and a list of all potential authorized collectors who offered to participate, and, if any potential authorized collector who offered to participate was not included in the plan, an explanation for the reasons for such decision;
6. A description of proposed alternative collection methods for any covered drugs that may not be acceptable in secure drop boxes, collection events or mailers; and
7. An example of the agreement that the stewardship plan provides to a potential authorized collector to arrange services at a drop-off site;
C. A description of the handling and disposal system, including identification of and contact information for potential authorized collectors, transporters and waste disposal facilities to be used by the stewardship plan in accordance with WCC 24.15.050 and 24.15.070;
D. A description of the policies and procedures to be followed by persons handling unwanted covered drugs collected under the stewardship plan, including:
1. A description of how all authorized collectors, transporters and waste disposal facilities utilized will ensure the collected, unwanted covered drugs are safely and securely tracked from collection through final disposal;
2. How all entities participating in the stewardship plan will operate under all applicable federal and state laws, regulations and guidelines, including those of the United States Drug Enforcement Administration; and
3. How any pharmacy drop-off site will operate under applicable regulations and guidance of the Washington State Pharmacy Quality Assurance Commission;
E. A description of how patient information on drug packaging will be kept secure during: collection; transportation; and recycling or disposal;
F. A description of the public education effort and promotion strategy required in WCC 24.15.060, including a copy of standardized instructions for covered entities, signage developed for authorized collectors and required promotional materials;
G. A proposal on the short-term and long-term goals of the stewardship plan for collection amounts and public awareness; and
H. A description of how the stewardship plan will consider:
1. Use of existing providers of waste pharmaceutical services;
2. Separating covered drugs from packaging to the extent possible to reduce transportation and disposal costs; and
3. Recycling of drug packaging to the extent feasible. (Ord. 2017-073 Exh. A).
24.15.050 Collection of covered drugs.
A. This chapter does not require any person to serve as an authorized collector in a stewardship plan. A person may offer to participate as an authorized collector voluntarily, or may agree to participate as an authorized collector in exchange for compensation offered by a producer, group of producers or stewardship organization. Retail pharmacies, hospitals/clinics with an on-site pharmacy, law enforcement agencies, and any other entities participating as authorized collectors in a stewardship plan, shall operate in accordance with state and federal laws and regulations for the handling of unwanted covered drugs, including those of the United States Drug Enforcement Administration, and in compliance with this chapter. A pharmacy drop-off site shall operate under applicable regulations and guidance of the Washington State Pharmacy Quality Assurance Commission.
B. The collection system shall be convenient on an ongoing, year-round basis to adequately serve the needs of covered entities and shall be designed in consideration of equitable opportunities for all Whatcom County residents for the safe and convenient return of unwanted covered drugs, in accordance with this section.
C. The collection system for all unwanted covered drugs shall be safe and secure, including protection of patient information on drug packaging.
D. The service convenience goal for the standard stewardship plan and any independent stewardship plan is a system of drop-off sites distributed to provide reasonably convenient and equitable access for all residents in incorporated and unincorporated areas of the county, and meeting the requirements of this subsection.
1. In establishing and operating a stewardship plan, a producer, group of producers or stewardship organization shall give preference to having drop-off sites located at retail pharmacies, hospitals/clinics with an on-site pharmacy, and law enforcement agencies. A stewardship plan shall include, within 90 days of their offer to participate, any retail pharmacy, any hospital/clinic with an on-site pharmacy or any law enforcement agency willing voluntarily to participate as a drop-off site for unwanted covered drugs and able to meet the requirements of this chapter, unless the collector requests a longer time frame. A producer or group of producers establishing and operating a stewardship plan may also accept any potential authorized collector, narcotic treatment program, or long-term care facility willing to participate as a drop-off site for unwanted covered drugs and able to meet the requirements of this chapter.
2. In every city and town with a potential authorized collector and in the unincorporated county, the system of drop-off sites shall provide one drop-off site and a minimum of at least one additional drop-off site for every 20,000 residents at the locations of retail pharmacies, hospitals/clinics with an on-site pharmacy, or law enforcement agencies, geographically distributed to provide reasonably convenient and equitable access.
3. If the minimum number of drop-off sites in subsection (D)(2) of this section cannot be achieved by the standard stewardship plan or any independent stewardship plan due to a lack of potential drop-off sites in specific areas of the county, then service to those areas shall be supplemented by periodic collection events and mail-back services.
4. In the following communities in unincorporated areas of the county, a stewardship plan shall provide these services:
a. In Acme, Birch Bay-Lynden, Deming, Glacier, Kendall, Lummi Island, Maple Falls, Newhalem, Point Roberts, and Sudden Valley, if no drop-off site can be arranged, mail-back services shall be provided to residents through distribution of prepaid, preaddressed mailers at libraries and fire stations serving each community. Pre-paid, preaddressed mailers shall also be provided upon request to grocery stores located in these communities.
b. In Birch Bay and Columbia Valley, if no drop-off site can be arranged, at least one collection event shall be provided to residents annually.
5. In determining the collection services required under this subsection, the annual population estimate provided by the Washington State Office of Financial Management shall be utilized to define the population of cities, towns and unincorporated areas of Whatcom County. The current Whatcom County Comprehensive Plan shall be utilized to define communities in unincorporated areas of the county.
E. Drop-off sites shall accept all covered drugs from covered entities during all hours that the authorized collector is normally open for business with the public. Drop-off sites at long-term care facilities shall only accept covered drugs from individuals who reside, or have resided, at the long-term care facility, pursuant to 21 CFR 1317.80.
F. Drop-off sites shall utilize secure drop boxes in compliance with all applicable federal and state laws, including requirements of the United States Drug Enforcement Administration. A producer, group of producers, or stewardship organization shall provide a service schedule that meets the needs of each drop-off site to ensure that each secure drop box is serviced as often as necessary to avoid reaching capacity and that collected covered drugs are transported to final disposal in a timely manner, including a process for additional prompt collection service upon notification from the drop-off site. Secure drop box signage shall include a prominently displayed 24 hour, toll-free telephone number and website for the stewardship plan, by which any resident can provide feedback on collection activities, including but not limited to the need to empty the receptacle.
G. Mail-back services shall be free of charge, and shall be made available to differentially-abled and home bound residents upon request through the stewardship plan’s toll-free telephone number and web site. An adequate and ongoing supply of prepaid, preaddressed mailers shall be:
1. Provided upon request to persons providing services to differentially-abled and home bound residents, including hospice service providers;
2. Provided to each long-term care facility in the county; and
3. Provided to libraries, fire stations, and any other mailer distribution locations according to subsection D of this section.
H. Periodic collection events, if utilized as a collection method according to subsection D of this section, must be arranged with law enforcement personnel through voluntary agreements, and shall be conducted in compliance with United States Drug Enforcement Administration protocols, any additional requirements of participating law enforcement agencies, and in compliance with this chapter.
I. Alternative collection methods shall be provided for any covered drugs that cannot be accepted or commingled with other covered drugs in secure drop boxes, in mailers, or at collection events. Such collection methods shall be reviewed and approved by the health department and shall operate in compliance with applicable regulations. (Ord. 2017-073 Exh. A).
24.15.060 Promotion.
A. A producer or group of producers participating in the standard stewardship plan or an independent stewardship plan must develop and provide a system of promotion, education, and public outreach about safe storage and secure collection of covered drugs. Each stewardship plan shall include and have a plan for performing the following activities:
1. Promote the use of their stewardship plan so that where and how to return unwanted covered drugs to drop-off sites and how to use other collection options for unwanted covered drugs are widely understood by residents, pharmacists, retailers of covered drugs, health care practitioners including doctors, dentists, and other prescribers, veterinarians, and veterinary hospitals;
2. Discourage the disposal of unwanted covered drugs in the garbage;
3. Promote the safe storage of prescription and nonprescription drugs by residents before secure disposal through their stewardship plan;
4. Work with authorized collectors participating in their stewardship plan to develop clear, standardized instructions for residents on the use of drop boxes and a readily recognizable, consistent design of drop boxes. Whatcom County health department may provide guidance to producers and authorized collectors on the development of the instructions and design;
5. Establish a toll-free telephone number and website where collection options and current locations of drop-off sites will be publicized and prepare educational and outreach materials promoting safe storage of prescription and nonprescription drugs and describing where and how to return unwanted covered drugs to the stewardship plan. These materials must be provided to pharmacies, health care facilities, county agencies, and other interested parties for dissemination to residents. Plain language and explanatory images should be utilized to make use of medicine collection services readily understandable by all residents, including individuals with limited English proficiency. The website and all materials shall discourage disposal of unused, expired, or contaminated pharmaceutical wastes in the solid waste system in Whatcom County;
6. Conduct a survey of residents of Whatcom County and a survey of pharmacists, health professionals, and veterinarians in the county who interact with residents on use of prescription and nonprescription drugs and law enforcement, prior to the start of operation of the approved plan, after the first full year of operation of the plan, and again biennially thereafter until such time as the health department designates a less frequent schedule. Survey questions shall measure percent awareness of drop-off sites in the county for unwanted covered drugs, assess to what extent drop-off sites, mail-back services, and other collection methods are convenient and easy to use, and assess knowledge and attitudes about risks of abuse, poisonings and overdoses from prescription and nonprescription drugs used in the home. Draft survey questions shall be submitted to the health department for review and comment at least 30 days prior to initiation of the survey. All survey data and results shall be reported to the health department and made available to the public on the stewardship plan’s website within 90 days of the end of the survey period;
7. Annually evaluate the effectiveness of its promotion, outreach, and public education, and include this evaluation in its annual report; and
8. All educational and outreach materials and surveys required in this section shall be provided in English, Russian, Spanish, Punjabi, Mandarin and Vietnamese, and any additional languages that may be designated by the health department on an annual basis.
B. If more than one stewardship plan is approved then all approved stewardship plans shall coordinate their promotional activities to ensure that all residents can easily identify, understand and access the collection services provided by any stewardship plan, including providing residents with a single toll-free telephone number and a single web site to access information about collection services for every approved plan.
C. Pharmacies and other entities selling prescription and nonprescription drugs in or into Whatcom County are encouraged to promote secure disposal of covered drugs by covered entities through the use of an approved stewardship plan or plans. Pharmacies must provide materials explaining the use of approved stewardship plans to customers upon request.
D. Whatcom County health department and government agencies throughout the county responsible for health, solid waste management, and wastewater treatment shall promote safe storage of prescription and nonprescription drugs by residents, secure disposal of covered drugs by residents through the use of the stewardship plans, and the toll-free telephone number and web site for approved stewardship plans through their standard educational methods. (Ord. 2017-073 Exh. A).
24.15.070 Disposal of covered drugs.
A. Covered drugs collected under a stewardship plan must be disposed of at a permitted hazardous waste disposal facility as defined by the United States Environmental Protection Agency under 40 CFR Parts 264 and 265.
B. The health department may grant approval for a producer or group of producers participating in the standard stewardship plan or an independent stewardship plan to dispose of some or all collected covered drugs at a permitted large municipal waste combustor, as defined by the United States Environmental Protection Agency under 40 CFR Parts 60 and 62, if use of a hazardous waste disposal facility described under subsection A of this section is deemed not feasible for the stewardship plan based on cost, logistics or other considerations.
C. A producer or group of producers participating in the standard stewardship plan or an independent stewardship plan may petition the health department for approval to use final disposal technologies that provide superior environmental and human health protection than provided by the disposal technologies in subsections A and B of this section, or equivalent protection at lesser cost. The proposed technology must provide equivalent or superior protection in each of the following areas:
1. Monitoring of any emissions or waste;
2. Worker health and safety;
3. Air, water or land emissions contributing to persistent, bioaccumulative, and toxic pollution; and
4. Overall impact to the environment and human health. (Ord. 2017-073 Exh. A).
24.15.080 Administrative and operational costs and fees.
A. A producer or group of producers participating in the standard stewardship plan or an independent stewardship plan shall pay all administrative and operational costs related to their stewardship plan, except as provided under this section. Administrative and operational costs related to the stewardship plan include:
1. Collection and transportation supplies for each drop-off site;
2. Purchase of secure drop boxes for each drop-off site;
3. Ongoing maintenance or replacement of secure drop boxes, as requested by authorized collectors;
4. Providing mail-back services and providing prepaid, preaddressed mailers to differentially-abled and home bound residents and their service providers, to long-term care facilities, and to libraries, fire stations, and other mailer distribution locations in specific areas of the county under WCC 24.15.050;
5. Operating periodic collection events, including costs of law enforcement staff time if necessary;
6. Transportation of all collected drugs to final disposal;
7. Environmentally sound disposal of all collected drugs under WCC 24.15.070; and
8. Program promotion, surveys, and evaluation under WCC 24.15.060, including costs of providing materials to pharmacies to fulfill customer requests.
B. No person or producer may charge a specific point-of-sale fee to consumers to recoup the costs of their stewardship plan, nor may they charge a specific point-of-collection fee at the time the covered drugs are collected from covered entities.
C. Producers are not required to pay for costs of staff time at drop-off sites provided by authorized collectors volunteering for a stewardship plan, but may offer compensation to authorized collectors for their participation. (Ord. 2017-073 Exh. A).
24.15.090 Reporting requirements.
A. Quarterly Report. Within 30 days after each 90-day period of operation, the plan operator of the standard stewardship plan and of any independent stewardship plan shall submit a quarterly report to the health department on behalf of participating producers that provides the total amount, by weight, of unwanted covered drugs collected during the previous 90-day period. After the first two years of operation of an approved stewardship plan, the health department may determine that quarterly reporting of the collection amount is no longer required and shall notify the plan operator of any change in the reporting schedule.
B. Annual Report. Within 180 days after the end of the first one-year period of operation, and annually thereafter, the plan operator of the standard stewardship plan and of any independent stewardship plan shall submit an annual report to the health department on behalf of participating producers describing their plan’s activities during the previous annual reporting period to comply with this chapter. The annual report must include:
1. A list of producers participating in the stewardship plan;
2. The total amount, by weight, of unwanted covered drugs collected during the annual reporting period, and the amount by weight from each collection method during each 90-day period of the annual reporting period;
3. A list of drop-off sites with addresses, and the amount by weight of unwanted covered drugs collected at each drop-off site during each 90-day period of the annual reporting period;
4. The number of mailers provided for differentially-abled and home bound residents, a list of locations where mailers were provided, and the number of mailers received by the plan during each 90-day period of the annual reporting period;
5. A list of dates and locations of any collection events held and the total amount, by weight, of unwanted covered drugs collected at each event;
6. A list of transporters used, and the disposal facility or facilities used;
7. Whether any safety or security problems occurred during collection, transportation or disposal of unwanted covered drugs during the annual reporting period and, if so, what changes have or will be made to policies, procedures or tracking mechanisms to alleviate the problem and to improve safety and security in the future;
8. A description of the public education, outreach, survey, and evaluation activities implemented during the reporting period;
9. A description of how collected packaging was recycled to the extent feasible, including the recycling facility or facilities used;
10. A summary of the stewardship plan’s goals for collection amounts and public awareness, the degree of success in meeting those goals during the previous annual reporting period and, if any goals have not been met, what effort will be made to achieve the goals in the next year; and
11. The total expenditure of the stewardship plan during the annual reporting period.
C. The health department may specify a report format or form that plan operators shall use for quarterly or annual reports. The health department shall make reports submitted under this section available to the public.
D. For the purposes of this section, “annual reporting period” means the period from January 1st through December 31st of the same calendar year, unless otherwise specified to the plan operator by the health department. (Ord. 2017-073 Exh. A).
24.15.100 Identification of producers of covered drugs.
A. Within 60 days of a request from the health department, any drug wholesaler that sells any covered drug in or into the county must provide a list of producers of covered drugs to Whatcom County health department in a form agreed upon with the health department. Wholesalers must update the list, no more than annually, if requested by the health department.
B. Any person receiving a letter of inquiry from the health department regarding whether or not it is a producer under this chapter must respond in writing within 60 days. If such person does not believe it is a producer under this chapter, it must state the basis for such belief and provide a list of any covered drugs it sells, distributes, repackages, or otherwise offers for sale within the county, and identify the name and contact information of the manufacturer of the covered drug. (Ord. 2017-073 Exh. A).
24.15.110 Review of proposed plans.
A. Within 180 days after the date of adoption of this regulation, a producer, group of producers or stewardship organization shall submit its proposed stewardship plan to the health department for review, accompanied by the plan review fee in accordance with WCC 24.15.150 and indicating whether the plan is proposed as the standard stewardship plan or an independent stewardship plan. If multiple proposals are submitted for the standard stewardship plan, the health department shall designate the standard stewardship plan at time of plan approval.
B. The health department shall review each proposed stewardship plan and determine whether the proposed plan meets the requirements of WCC 24.15.040 and other applicable sections of this regulation. In reviewing a proposed stewardship plan, the health department shall provide opportunity for written public comment and consider any comments received.
C. After the review under subsection B of this section and within 90 days after receipt of the proposed stewardship plan, the health department shall either (1) approve as submitted, (2) approve subject to conditions, or (3) reject the proposed stewardship plan in writing to a producer, group of producers or stewardship organization and, if approved subject to conditions or rejected, provide reasons for the decision.
D. Plan Rejection. If the proposed stewardship plan is rejected, a producer, group of producers or stewardship organization must submit a revised stewardship plan to the health department within 60 days after receiving written notice of the rejection. The health department shall review and approve or reject a revised stewardship plan as provided under subsections B and C of this section.
E. Conditional Plan Approval. If the proposed stewardship plan is approved subject to conditions, the health department shall provide a written notice to the plan operator that lists the conditions that must be addressed by the producer or group of producers participating in the stewardship plan or their stewardship organization. The health department shall define the time frame, which shall not be less than 30 days, of each required action that must be taken or each revision to the stewardship plan that shall be made by the producer, group of producers or stewardship organization. The health department will identify any conditions that must be addressed prior to operation of the stewardship plan as required under WCC 24.15.030(D)(4).
F. Revised Plan Rejection. If the health department rejects a revised stewardship plan, or any subsequently revised plan, the health department may deem the producer or group of producers out of compliance with this chapter and subject to the enforcement provisions in this chapter.
1. If a revised proposal for the standard stewardship plan is rejected, the health department may require the submission of a further revised standard stewardship plan or develop and impose changes to some or all components of the rejected plan to constitute an approved standard stewardship plan. If the health department imposes some or all of the approved plan, the health department may not deem the producers participating in and complying with the approved standard stewardship plan in accordance with this chapter out of compliance with this chapter.
2. If a revised independent stewardship plan is rejected, the producer or group of producers submitting the independent stewardship plan shall participate in the standard stewardship plan and are not eligible to propose an independent stewardship plan for 180 days after the rejection. The health department may not deem out of compliance with this chapter a producer whose revised independent stewardship plan is rejected if the producer participates in and complies with the standard stewardship plan.
G. In approving a proposed stewardship plan, the health department may exercise reasonable discretion to waive strict compliance with the requirements of this chapter that apply to producers in order to achieve the objectives of this chapter.
H. The health department shall make all stewardship plans submitted under this section available to the public and shall provide an opportunity for written public comment on each plan as described in subsection B of this section. (Ord. 2017-073 Exh. A).
24.15.120 Prior approval for plan changes.
A. Proposed changes to an approved stewardship plan that substantively alter plan operations, including, but not limited to, changes to participating producers, collection methods, achievement of the service convenience goal, policies and procedures for handling covered drugs, education and promotion methods or disposal facilities, must have prior written approval of the health department.
B. A producer or group of producers participating in an approved stewardship plan shall submit to the health department any proposed change to a stewardship plan as described under subsection A of this section in writing at least 30 days before the change is scheduled to occur and accompanied by the review fee in accordance with WCC 24.15.150.
C. The plan operator of an approved stewardship plan shall notify the health department at least 15 days before implementing any changes to drop-off site locations, methods for scheduling and locating periodic collection events, methods for distributing prepaid, preaddressed mailers, or significant changes to agreements with authorized collectors for services at drop-off sites that do not substantively alter achievement of the service convenience goal under WCC 24.15.050(D), or other changes that do not substantively alter plan operations under subsection A of this section.
D. The producer or group of producers participating in an approved stewardship plan shall notify the health department of any changes to the plan operator who is the official point of contact for the stewardship plan within 15 days of the change. The plan operator shall notify the health department of any changes in ownership or contact information for participating producers within 30 days of such change. (Ord. 2017-073 Exh. A).
24.15.130 Enforcement procedures and penalties.
The director is authorized to enforce this chapter in accordance with the provisions of Chapter 24.07 WCC and consistent with the following subsections. When or if the enforcement provisions in this chapter and Chapter 24.07 WCC conflict, the more stringent shall apply.
A. After presenting official credentials and providing notice of an audit or inspection to determine compliance with this chapter or to investigate a complaint, the director or his/her duly authorized inspector may audit a producer’s, group of producers’ or stewardship organization’s records related to a stewardship plan or request that the producer, group of producers or stewardship organization arrange for the health departments to inspect at reasonable times a stewardship plan’s or an authorized collector’s facilities, vehicles and equipment used in carrying out the stewardship plan.
B. The director may enforce the requirements and restrictions of this chapter by one or a combination of the following by written order:
1. Requiring an informal administrative conference;
2. Prohibiting certain conduct or directing certain conduct;
3. Issuing a warning notice; and
4. Imposing a civil penalty of up to $1,000 that may be assessed against a producer or group of producers or drug wholesalers. Each day upon which a violation occurs or is permitted to continue constitutes a separate violation. In determining the appropriate penalty, the health department shall consider the extent of harm caused by the violation, the nature and persistence of the violation, the frequency of past violations, any action taken to mitigate the violation, the financial burden to the violator and the size of the violator’s business.
5. Assessing all costs of enforcement in accordance with Chapter 24.07 WCC.
C. The director shall send a written order and a copy of this chapter and any regulations adopted to implement this chapter to a producer who is not participating in the standard stewardship plan or an independent stewardship plan as required under this chapter. The director shall state that participation in a plan is required and warn of penalties for noncompliance, including all costs incurred for enforcement as provided in Chapter 24.07 WCC.
D. A producer not participating in the standard stewardship plan or an independent stewardship plan and whose covered drug continues to be sold in or into the county 60 days after receiving a written violation order may be assessed a penalty.
E. Failure to begin operation of an approved stewardship plan and provide the collection system for unwanted covered drugs required under this chapter within 90 days of health department approval of the stewardship plan may result in a fine. Each day of delayed implementation of the stewardship plan will constitute a new and separate offense.
F. If the director determines that a stewardship plan is not in compliance with this chapter or its plan approved or conditionally approved under WCC 24.15.110, the health department may send the producer or group of producers participating in the plan a notice of violation stating the plan is in noncompliance, providing notice of the compliance requirements and warning of penalties for noncompliance, including all costs incurred for enforcement of that violation, as provided in Chapter 24.07 WCC.
G. The producer or group of producers has 30 days after receipt of the notice to achieve compliance. This subsection does not preclude the health department from suspending an approved plan, in addition to other penalties, if a violation of this chapter or an approved plan creates a condition that, in the health department’s judgment, constitutes an immediate hazard.
H. The director is authorized to enforce the restrictions or requirements of this chapter against any person or entity, whether it be a producer, group of producers, or drug wholesaler who is not in compliance; assess all costs of enforcement against the person or entity, whether it be a producer, group of producers or drug wholesaler, who is in noncompliance in accordance with Chapter 24.07 WCC; and otherwise pursue compliance with this chapter.
I. The director is authorized to pursue civil penalties and costs including attorney fees by commencement of civil action in the name of Whatcom County health department independent of and/or as a means of enforcing the violations referenced above. (Ord. 2017-073 Exh. A).
24.15.140 Regulations, performance standards, and report.
A. The board of health may adopt regulations necessary to implement, administer and enforce this chapter.
B. The health department may work with the plan operator to define goals for collection amounts and public awareness for a stewardship plan.
1. Upon review of collection amounts in annual reports, the health department may direct a producer or group of producers participating in an approved stewardship plan to change the frequency of collection events or the provision of mail-back services to improve the plan’s performance in providing adequate and reasonably convenient service to all Whatcom County residents as required under WCC 24.15.050.
2. Upon review of annual reports or results of public awareness surveys, the health department may direct a producer or group of producers participating in an approved stewardship program to modify the plan’s promotion and outreach activities to better achieve widespread awareness and understanding among Whatcom County residents and healthcare providers about how to use collection options for unwanted covered drugs as required under WCC 24.15.060.
C. The director shall report annually to Whatcom County board of health concerning the status of the standard and independent stewardship plans and recommendations for changes to this chapter. The annual report shall include an evaluation of the secure medicine return system, a summary of available data on indicators and trends of abuse, poisonings and overdoses from prescription and nonprescription drugs and a review of comprehensive prevention strategies to reduce risks of drug abuse, overdoses and preventable poisonings. (Ord. 2017-073 Exh. A).
24.15.150 Plan review and annual operating fees.
A. A producer or group of producers participating in the standard stewardship plan or an independent stewardship plan shall pay to the health department plan review fees to be established under subsection D of this section for:
1. Review of a proposed stewardship plan;
2. Re-submittal of a proposed stewardship plan;
3. Submittal of revisions to a stewardship plan approved subject to conditions;
4. Review of changes to an approved stewardship plan;
5. Submittal of an updated stewardship plan at least every four years under WCC 24.15.030(D)(5) of this regulation; and
6. Review of any petition for approval to use alternative final disposal technologies under WCC 24.15.070(C).
B. In addition to plan review fees, a producer or group of producers participating in the standard stewardship plan or an independent stewardship plan shall pay to the health department annual operating fees and an evaluation fee to be established in accordance with subsection D of this section.
C. A plan operator or a stewardship organization may remit the fee on behalf of participating producers.
D. Fees shall be set by Whatcom County board of health and shall be subject to revision commensurate with the costs of delivering the service and to administering and enforcing this chapter. All fees collected under the provision of this chapter shall be payable to Whatcom County health department. (Ord. 2017-073 Exh. A).
24.15.160 Appeals.
Any person aggrieved by a decision or final order of the director shall have the right to appeal such decision or order in accordance with the appeal procedures set forth in WCC 24.07.090. (Ord. 2017-073 Exh. A).
24.15.170 Severability.
The provisions of this chapter are hereby declared to be separate and severable. If any section, sentence, clause or phrase of this chapter should be held to be invalid or unconstitutional by a court of competent jurisdiction, such invalidity or unconstitutionality shall not affect the validity of constitutionality of any other section, sentence, clause, or phrase of this regulation. (Ord. 2017-073 Exh. A).