Current through Register 2024 Notice Reg. No. 38, September 20, 2024
Within six months of the adoption date of the regulations in this Article by the department, a program operator shall submit a stewardship plan to the department. To be complete, the stewardship plan shall include the following:
(a) Contact information of the corporate officer, or designee, responsible for submitting and overseeing the stewardship plan on behalf of the program operator, including, but not limited to:
(1) Contact name and title
(2) Name of program operator
(3) Mailing and physical address(es)
(4) Phone number
(5) Email address
(6) Internet website address
(b) Contact information for each covered entity participating in the stewardship plan, including, but not limited to:
(1) Contact name and title
(2) Name of covered entity
(3) Mailing and physical address(es)
(4) Covered entity email address
(5) Covered entity internet website address
(6) Covered entity phone number
(c) List of each covered drug sold or offered for sale by each participating covered entity covered by the stewardship plan.
(d) Authorized Collectors.
(1) Contact information for each participating authorized collector operating a collection site where covered drugs are collected, including, but not limited to, the following:
(A) Contact name and title
(B) Name of authorized collector
(C) Mailing and physical address(es)
(D) List of participating authorized collection sites, with name and physical address, by county
(2) Pursuant to Section 42032.2(b)(1) of the Public Resources Code, list of potential authorized collectors, in the counties in which the program will operate, that were notified of the opportunity to serve as an authorized collector for the proposed stewardship program, and the method(s) by which each potential authorized collector was notified. The notification shall occur at least 120 days before the stewardship plan is submitted to the department.
(3) Pursuant to Section 42032.2(b)(1) of the Public Resources Code, description of the process by which good faith negotiations with potential authorized collectors were and, if applicable, continue to be conducted. If a potential authorized collector expresses interest in participating in a stewardship program, the program operator shall commence good faith negotiations with the potential authorized collector within 30 days.
(4) Description of efforts to work with retail pharmacies and retail pharmacy chains to fulfill the requirement in section 42032.2(b)(2) of the Public Resources Code, if applicable.
(5) Description of the process to incorporate potential authorized collectors that submit a written offer to join the stewardship program, in accordance with section 42032.2(b)(3) of the Public Resources Code. A program operator shall include under its stewardship program any entity listed in subdivision (b) of section 42030 of the Public Resources Code that offers to participate in the stewardship program, in writing and without compensation, even if the minimum convenience standards set in clause (i) of subsection (1)(F) of subdivision (a) of section 42032.2 of the Public Resources Code have been achieved. The program operator shall include the offering entity as an authorized collector in the stewardship program within 90 days of receiving the written offer to participate. A program operator shall not be required to respond to offers pursuant to this subsection until the program operator's stewardship plan has been approved by the department.
(6) Description of the reasons for excluding any potential authorized collectors, including those who request joining the program, as applicable.
(7) Description of how the program operator will notify any potential authorized collectors of the reasons they were rejected from inclusion in the stewardship program and what changes the potential authorized collector can make in order to join the stewardship program.
(e) State Agency Determinations and Compliance Certifications.
(1) State agency determinations, pursuant to section 42032.2(a)(1)(C) of the Public Resources Code. If a determination of noncompliance was initially issued, the stewardship plan shall include both the initial determination of noncompliance and the superseding determination of compliance. If any state agency failed to respond to a request for review within 90 days of receipt of the stewardship plan, the program operator shall include documentation of this request along with a written certification, signed by an authorized representative of the program operator, that, at the time of submission to the department, the stewardship plan is consistent with all laws and regulations relevant to that agency's authority, and the applicable state agency failed to respond within 90 days of receipt of the stewardship plan.
(2) Written certification by an authorized representative of the program operator that, at the time of submission to the department, the stewardship plan, including all aspects of the plan related to the collection, transportation, and disposal of covered drugs, is in compliance with all applicable local, state, and federal laws and regulations, including, but not limited to United States Drug Enforcement Administration regulations.
(f) Initial Program Budget and Program Funding. Demonstration of adequate funding for all administrative and operational costs of the stewardship program for the first five calendar years of operation, to be borne by participating covered entities pursuant to section 18973.6.
(g) Collection, Transportation, and Disposal System. Descriptions of the following:
(1) Processes and policies that will be used to safely and securely collect, track, and properly manage covered drugs from collection through final disposal.
(2) How convenience standards pursuant to subsection (1)(F) of subdivision (a) of section 42032.2 of the Public Resources Code will be met for each county, including the following:
(A) How reasonable geographic spread is determined, including all factors applied to develop the determination. Population considerations shall use the most recent publicly available population calculations from the State of California Department of Finance.
(B) How frequently the convenience standards will be re-evaluated to ensure compliance with the convenience standards, including updating population estimates.
(3) Tracking mechanism(s) for collection, transportation, and disposal.
(4) Metrics that will be used to measure the amount, including, but not limited to, weight, of covered drugs collected from ultimate users at each authorized collection site.
(5) Each service provider to be used to transport, process, or dispose of covered drugs collected through the stewardship program, including, but not limited to:
(A) Name of service provider
(B) Mailing and physical address(es)
(6) Mail-back services or an alternative form of collection and disposal system to be provided to ultimate users, pursuant to sections 42032.2(a)(1)(G) and 42032.2(c) of the Public Resources Code. Include, at a minimum, the following information:
(A) List of locations and/or description of mechanisms to provide ultimate users with preaddressed, prepaid mail-back materials or an alternative form of collection and disposal system that would render the covered drug inert, if applicable.
(B) Pursuant to section 42032.2(a)(1)(G)(i) of the Public Resources Code, mechanism to provide preaddressed, prepaid mail-back materials or an alternative form of collection and disposal system requested by ultimate users who are homeless, homebound, or disabled through the program operator's internet website and toll-free telephone number.
(C) Pursuant to section 42032.2(c)(2) of the Public Resources Code, description of any mail-back program or alternative form of collection and disposal system that complies with applicable local, state, and federal laws and regulations including, but not limited to, United States Drug Enforcement Administration regulations that will be used as a supplemental service for any county that does not have the minimum number of authorized collection sites due to circumstances beyond the program operator's control.
(D) Pursuant to section 42032.2(a)(1)(G)(ii) of the Public Resources Code, any alternative methods of collection for covered drugs, other than controlled substances, that cannot be accepted or commingled with other covered drugs in secure collection receptacles or through a mail-back program, to the extent technically feasible and permissible under applicable state and federal law, including, but not limited to, United States Drug Enforcement Administration regulations.
(E) Metrics that will be used to measure the amount of preaddressed, prepaid mail-back materials distributed or alternative form of collection and disposal system provided, and the metrics used to measure the amount of material returned.
(7) Description of a service schedule that meets the needs of each authorized collection site. Process by which collection receptacles will be monitored, explanation of how service schedules are determined to ensure that collection receptacles do not reach capacity, and procedures to be followed if capacity is reached. The service schedule must meet the needs of each authorized collection site to ensure that collected covered drugs are transported to final disposal in a timely manner.
(8) What corrective actions will be taken if a program operator discovers critical instances of noncompliance with stewardship plan policies and procedures.
(9) How each participating collection site will be funded or reimbursed, if applicable.
(10) Standard operating procedures that will address incidents related to safety and security, including processes to ensure that the department and applicable local, state, and federal agencies are notified of the incident. This description shall also explain the actions that will be taken to change policies, procedures, and tracking mechanisms to alleviate the problems with safety and security and improve safety and security.
(h) Collection, Transportation, and Disposal System Records. Description of how and where the records generated during the collection, transportation, and disposal of collected covered drugs will be maintained. These records include, but are not limited to: collection manifests, mailer distributions, receipts of returned covered drugs, return mailings, and final disposal of covered drugs, as applicable.
(i) Ordinance Repeals. Pursuant to subdivision (e) of section 42032.2 of the Public Resources Code, description of processes, logistics, and timing of implementation that will be necessary for the stewardship program to expand into jurisdictions not previously included in the stewardship plan, in the event of the repeal of a local stewardship program ordinance. The description shall include an explanation of how the stewardship program will meet the convenience standards, pursuant to subsection (1)(F) of subdivision (a) of section 42032.2 of the Public Resources Code.
(j) Education and Outreach. Description of a comprehensive education and outreach program that shall include, but is not limited to, the following:
(1) Any activities to promote awareness and maximize ultimate user participation in the stewardship program, including, but not limited to, provision of educational and outreach materials for persons authorized to prescribe drugs, pharmacies, pharmacists, ultimate users, and others, as necessary.
(2) Materials to be utilized that are distributed in languages suited to local demographics, consistent with section 7295 of the Government Code. These materials shall include, but are not limited to, signage for hospitals, pharmacies, and other locations, as necessary. Signage or labeling for secure collection receptacles shall be designed with explanatory graphics which are readily understandable by all ultimate users.
(3) Establishment of an internet website designed with functionality for mobile platforms, provided with language options suited to local demographics, consistent with section 7295 of the Government Code, and maintained to ensure all information is up to date and accurate. The internet website's digital content and navigability must be accessible to disabled individuals. The internet website shall include, but is not limited to, the following:
(A) Authorized collection site physical addresses
(B) Authorized collection site contact telephone numbers
(C) Authorized collection site days and hours of operation
(D) Mechanism to accept requests for mail-back materials from ultimate users who are homeless, homebound, or disabled
(E) Information to promote the stewardship program, including, but not limited to, instructions for safe handling and proper disposal of covered drugs and information on collection options
(4) Establishment of a toll-free telephone number to accept requests for mail-back materials from ultimate users who are homeless, homebound, or disabled, and to provide disposal options and other program information to ultimate users without access to the internet. The toll-free telephone number shall offer language options suited to local demographics, accept calls via human representative, and provide services for hearing-impaired and speech-impaired individuals.
(5) Metrics to evaluate performance of the comprehensive education and outreach program, including, but not limited to, ultimate user awareness, program usage, and accessibility.
(6) How ultimate users will be encouraged to separate products that are not covered products from covered products, when appropriate, before submitting the covered products to an authorized collection site or mail-back program.
(7) How the program operator will comply with the requirement in section 42031.6(b) of the Public Resources Code.
(k) Coordination Efforts. Description of how the program operator will coordinate with other program operators to avoid confusion to the public and all program participants in the event that multiple stewardship programs for covered drugs are in operation concurrently or new stewardship programs begin operating.
(l) Process for providing grants, loans, sponsorships, reimbursements, or other incentives, if applicable.
(m) Process for selecting service providers, including a description of any competitive procedure used, if applicable.
1. New section filed 1-7-2021; operative 1-7-2021 (Register 2021, No. 2). Filing deadline specified in Government Code section 11349.3(a) extended 60 calendar days pursuant to Executive Order N-40-20 and an additional 60 calendar days pursuant to Executive Order N-71-20.
Note: Authority cited: Sections 40401, 42031.2 and 40502, Public Resources Code. Reference: Sections 42030, 42031, 42031.6, 42032, 42032.2, 42033, 42035.8, 42036.2 and 42036.4, Public Resources Code; and Section 17041, California Code of Regulations.
