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HomeMy WebLinkAboutalameda-county-plan-resubmission-revised-march-2025 ALAMEDA COUNTY DEPARTMENT OF ENVIRONMENTAL HEALTH SAFE DRUG DISPOSAL DRUG STEWARDSHIP PLAN March 4, 2022 Revised March 1, 2025 INTRODUCTION 01 OVERVIEW 02 DEFINITIONS 03 GENERAL INFORMATION 05 COLLECTION COMPONENTS 06 TRANSPORTATION AND DISPOSAL INFORMATION 11 POLICIES AND PROCEDURES 14 OUTREACH PROGRAM DESIGN 16 ANNUAL REPORTING 18 PATIENT PRIVACY 19 GOALS 20 APPENDICES 21 I. Introduction Inmar submits this Product Stewardship Program Plan (“Plan”) for all Unwanted Product, regardless of who produced them, in compliance with the Alameda County Safe Drug Disposal Ordinance 2016 located at Title 6, Chapter 6.53, (“Ordinance 6.53”) and the Alameda County Safe Drug Disposal Regulations, (“Regulations”), for the management, collection, transportation, and disposal of Unwanted Product from the Residents of the Alameda County. All capitalized terms not otherwise defined shall have the same meaning as in Ordinance 6.53 and the Regulations. Inmar’s Plan will provide a comprehensive safe drug disposal Stewardship Program that will include compliant drug Collection Methods supported by outreach and education programs to increase County Resident awareness and participation. The Plan will provide safe, secure, and convenient access on an ongoing basis for Residents across the County and will be funded by participating covered manufacturers. The Program will also provide reporting on collection metrics and results of County Resident education and outreach campaigns. Internal only do not distribute without Inmar written permission, 2025 1 II. Overview Inmar’s Plan is compliant with Ordinance 6.53 and the Regulations. The Plan provides for safe, secure and convenient access to Unwanted Covered Drug Collection Points on an ongoing basis for Residents across Alameda County and will be funded and paid for in accordance with Ordinance 6.53.040 (B). Inmar’s Plan also meets all requirements specified in Article 9.1 of Title 16 CCR Division 17 for Prescription Drug Take-Back Services (“BOP Article 9.1”). Inmar’s Plan will accept all Unwanted Covered Drugs regardless of who produced them and there will be no point-of-sale or point-of-collection fee charged to residential generators. Pursuant to the Regulation, § 7, Inmar’s Plan includes the following components: ● General Information: Plan Participants, Inmar coordinator information, website and telephone information; ● Collection Components: A description of the collection systems to provide convenient ongoing collection service for all Unwanted Products in accordance with the Regulation § 7 (D); ● Transporter & Disposal Information: A description of the transportation and disposal systems to be used in accordance with the Regulations § 7 (E) & (F) and the Ordinance 6.53.060; ● Policies and Procedures: A description of the policies and procedures to be followed by Persons handling Unwanted Products; ● Patient Privacy: A description of how patient information on Drug packaging will be handled; ● Public Education & Promotion: A description of Inmar’s public education outreach and promotion strategy required in the Regulation § 7 (G) and the Ordinance 6.53.070, including a copy of standardized instructions for Alameda County Residents, signage developed for Collection Points and required promotional materials; ● Plan Goals: A proposal as to Inmar’s short-term and long-term goals under the Plan in accordance with the Regulations § 7 (H); ● Reporting: A description of the annual reporting Inmar will provide pursuant to the Regulation § 15 and the Ordinance 6.53.080; and ● Miscellaneous: Separating Covered Drugs from packaging where possible and recycling of Drug packaging where feasible. Internal only do not distribute without Inmar written permission, 2025 2 III. Definitions The following is a list of definitions for terms used other than those terms defined in the Ordinance and Regulations: ● Auto-injector (or Auto Injector) means an unused or partially used Pre-filled Injector Product with a retractable or otherwise securely covered needle. ● Auto-Injector Mail-Back Package means a pre-paid, pre-addressed, FDA-cleared Sharps Container and outer shipment Package for the collection and disposal of Pre-filled Injector Products. ● Authorized Collector means the operator of a Collection Point. ● Board of Pharmacy means the California State Board of Pharmacy. ● Carrier means the common carrier used to transport Unwanted Covered Drugs. ● Container means the cardboard box which both supports the Inner Liner inside the Kiosk during medicine collection and becomes the outer shipping Package when the Inner Liner is full and/or removed from the Kiosk. ● Collection Point means a location which hosts an Inmar Kiosk for the collection of Unwanted Covered Drugs and is operated by an entity which has registered with the DEA as an Authorized Collector of Controlled substances under 21 CFR §1317. ● Collection System is Inmar’s term for the Collection Method that utilizes permanent Collection Kiosks at fixed locations. ● Collection Method means one of the three Collection types (Kiosk, Mail-Back, or Event) authorized for collection and disposal of home-generated Controlled substances by the DEA under 21 CFR §1317. ● County Residents means human beings residing in the County of Alameda. “County Residents” does not include business generators of pharmaceutical waste, such as hospitals, clinics, doctor’s offices, veterinary clinics, pharmacies, or airport security and law enforcement drug seizures. ● DEA means the U.S. Drug Enforcement Administration. ● DEA Rule means the DEA Final Rule, “Disposal of Controlled Substances,” 79 Fed. Reg. 53520 et seq. adopted on September 9, 2014 and codified at 21 CFR §1317. ● DOT means the U.S. Department of Transportation. ● Drop-door means the door on the Kiosk where Unwanted Covered Drugs are deposited by County Residents. ● Inhaler Mail-Back Envelope (Envelopes) means a pre-paid, pre-addressed envelope for the collection and disposal of inhalers. ● Inmar Plan means the Product Stewardship Plan presented in this submittal. ● Inner Liner means the liner placed inside the Container which meets the requirements of 21 CFR §1317.60. ● Kiosk means a metal receptacle into which County Residents deposit Unwanted Covered Drugs and which meets the requirements of 21 CFR §1317. ● Kiosk Drop-off Service means a Collection Method in which County Residents deposit Unwanted Covered Drugs into a Kiosk operated by an Authorized Collector at an Authorized Collection Site. ● Liner Kit is a set of three (3) pre-labeled and pre-paid cardboard box Containers, liquid barriers, and serialized, puncture-resistant Inner Liners. ● Law Enforcement Agency or LEA is a Federal, State, tribal, or local law enforcement office or agency. ● Mail-Back Service means a Collection Method in which County Residents return Unwanted Covered Drugs utilizing prepaid and pre-addressed Mail-Back Envelopes or Packages. Internal only do not distribute without Inmar written permission, 2025 3 ● Mail-Back Kit means Standard Mail-Back Envelopes with a visual reorder trigger, with instructions to Standard Mail-Back Distribution Sites on how to reorder additional Mailers. ● Mailer is Inmar’s generic term used to refer to all pre-paid, pre-addressed Standard and Inhaler Mail-Back Envelopes and Auto-Injector Mail-Back Packages. ● Non-participating means qualified entities not participating in an existing Approved Stewardship Plan as of February 28, 2025. ● Packaged Container means the full Inner Liner used in the Kiosk Drop-off Service after it is removed, secured within the Container, prepared, and sealed for transportation to a DEA Reverse Distributor. ● Pharmacy Employee means the designated contact person or persons at the Collection Point. ● Required Languages means English, Spanish, Chinese, Vietnamese, and Tagalog (Filipino). ● Service Provider means a contracted vendor used to transport, process, and/or dispose of Covered Drugs collected through the Stewardship Program. ● Standard Mail-Back Envelope Distribution Site means a location at which County Residents may obtain one or more standard Mail-Back envelopes at no charge and which is provided by Inmar to meet the Service Convenience Goals established in the Ordinance. ● Standard Mail-Back Envelope (Envelopes) means a prepaid and pre-addressed Mail-Back Envelope for the collection and disposal of all Unwanted Covered Drugs except for those dispensed in an inhaler or auto-injector. Internal only do not distribute without Inmar written permission, 2025 4 IV. General Information a) Plan Participant(s) A list of Plan Participants with contact information will be provided to the Department annually. b) Inmar Plan Liaison Inmar Intelligence Nick Massaro Senior Manager, Consumer Drug Take Back Solutions 1 West Fourth Street, Suite 500 Winston Salem, NC 27101 Email: nicholas.massaro@inmar.com Phone: 336-770-1992 c) Website Inmar’s Plan website: safemedicinedrop.com d) Telephone Number The toll–free number for County Residents: 1-888-371-0717 Internal only do not distribute without Inmar written permission, 2025 5 V. Collection Components A. Convenient and Equitable Access Pursuant to the Regulation § 7 (D) (i) and Ordinance 6.53.060 (A)-(C), and upon Plan approval, Inmar will continue operations of a system of Collection Points that provide convenient and equitable access to Residents across the County as outlined in the Ordinance. Inmar commits to collaboration with the Department to ensure alignment in the proper number and location of Unwanted Product Collection Points. Appendix A-1 includes a list of confirmed Authorized Collector Collection Points. In accordance with the Ordinance 6.53.050 (A) (9), Inmar will correlate the number of Collection Points with the market share of the drugs sold in the County by the Plan Participants in the County. This will result in Inmar placing Kiosks at Collection Points in a proportion equal to or greater than the market share of drugs sold by the Plan Participants. Inmar will review any potential Authorized Collector Site against the California Board of Pharmacy license directory to validate if the location holds an active retail, hospital or clinic license. Additionally, Sites will be required to provide evidence of current DEA registration. Inmar will notify the Department as new Collection Points become operational. To ensure the best possible access for the Residents of the County, Inmar also provides Mail-Back Services and Collection Events which are described in more detail in Section C and Section D. B. Collection Points – Kiosks Pursuant to the Ordinance 6.53.060 (A) and Regulation § 8 (A) (v), Inmar complies with DEA regulation 21 CFR §1317.60 (c) and 1317.70 (f) and BOP Article 9.1 regarding sealed Kiosk Inner Liners and Mail-Back Envelopes. Inner Liners and Envelopes shall not be opened, x-rayed, analyzed, or otherwise penetrated. Accordingly, their contents shall not be sorted or inventoried subsequent to being placed into a Kiosk or Mail-Back Envelope. Patient Privacy is addressed more specifically in Section X. Pursuant to the Ordinance 6.53.050 (A) (11)-(12), Inmar will give preference to Law Enforcement Agencies and retail pharmacies wherever possible to voluntarily serve as Collection Points for Unwanted Covered Drugs. Inmar will work with all Collection Points to validate that the requirements in the Ordinance and the Regulations, including all relevant DEA and BOP Article 9.1 requirements, are met. Kiosk Specifications and Design Inmar’s Kiosk is made in the USA and designed to be safe and secure as required. Produced from 16- gauge cold-rolled steel, and with an easy-to-use, Americans with Disabilities Act (ADA)-compliant Drop box design, County Residents can easily drop unused medications through the Drop-door and into the shippable Container and Inner Liner. The Container is a 275lb-rated box with a 6-mil, DEA-compliant Inner Liner. Inner liners are either 18 gallons or 35 gallons dependent upon geographical location and population density of the Kiosk location. This volume rating is printed directly onto our 6-mil DEA-compliant Inner Internal only do not distribute without Inmar written permission, 2025 6 Liners and has passed the tests prescribed in accordance with ASTM D 1922 and ASTM D 1709. The Kiosk design itself exceeds standard security requirements. The top of the Kiosk is sloped, limiting the ability to stack items on top. In addition, the drop slot features an extended metal drop door that lowers into the Container to detect when product capacity is reached. When the drop door encounters resistance within the Kiosk, it is an indication that it is time to change the Container. This manual capacity indicator eliminates the need to change batteries and/or sacrifice the location of the Kiosk to be proximate to an electrical outlet. Lastly, the Container access door is reversible to allow for convenient placement in any appropriate location in the pharmacy. Per DEA requirements, Kiosks will be installed in the line of sight of Pharmacy or DEA registrant employees and bolted to the floor or a permanent fixture. Inmar’s Kiosks have pre-drilled holes in the bottom for easier installation. It also features a 4-point locking system with steel projections in two center locations and the top and bottom of the door that are activated when locked for strengthened security. The Inmar Kiosk will have signage that communicates what is and is not allowed to be placed inside. See Appendix B for examples of signage. Inmar’s Kiosk is sent to the Authorized Collector along with enough supplies for 3 returns. Supplies include: ● Pre-addressed, pre-paid serialized Container ● Serialized Inner Liners to protect against puncture and provide a liquid barrier ● Easy-to-use zip ties to seal Inner Liner compliantly ● Absorbent pad for placement in the bottom of the Inner Liner bag Self-Service Returns For the safe on-site removal of contents from Kiosks, Inmar abides by the DEA regulations in 21 CFR §1300 et al. Inmar will train Authorized Collectors to service the Containers on their own to allow for expedited servicing as they desire. Inmar will provide Authorized Collectors with training materials including step-by-step instructions for tracking, sealing, shipping, and replacing Containers. Training materials also include instructions for the scheduling of Kiosk maintenance as necessary. The process for the Authorized Collector once a Kiosk is installed is as follows: ● The Authorized Collector receives the Liner Kit ● The Authorized Collector team (consisting of 2 Authorized Collector employees) constructs the Container with Inner Liner, inserts and securely locks the Kiosk ● The Authorized Collector team unlocks the Kiosk Drop-door to enable consumer use ● Installation date of Inner Liner is documented and witnessed-by on Tracking Sheet ● Once Kiosk is full, Authorized Collector employees will jointly open Kiosk ● Container and Inner Liner is removed and documented on the Tracking Sheet ● Container is to be packaged (Inner Liner is zip tied, outer box is taped) in compliance with all DOT Regulations ● The sealed Inner Liner is not to be opened, x-rayed, analyzed, or otherwise penetrated ● Replacement Container and Inner Liner is constructed, inserted and secured into Kiosk and documented on the Tracking Sheet ● Authorized Collector employees contact Carrier for pickup of Container to ship to authorized Service Provider for destruction Internal only do not distribute without Inmar written permission, 2025 7 ● If the Container (and Inner Liner) must be shipped at a later time (shipment cannot take place at time of service), storage of the Container must comply with the requirements set forth in 21 CFR §1317.75-§1317.80 ● Inspect Kiosk to ensure proper operation. Should maintenance be necessary, refer to Training Materials provided to request service as required ● Kiosk Containers will be sent via Carrier to the Service Provider As part of the self-service option for Kiosk servicing, the Authorized Collector will be responsible for packaging the Container and Inner Liner for shipment and contacting the Carrier for pickup via the Carrier phone number or website. Auto-Replenishment of Kiosk Supplies Supplies used to collect and transport Unwanted Product are provided in automatically-replenished Liner Kits of three. Each Liner Kit includes: pre-labeled, pre-addressed and prepaid cardboard box Containers, liquid barriers and serialized, puncture-resistant Inner Liners. Auto replenishment reduces the amount of inventory maintained at the Collection Point while maintaining sufficient supplies to keep the Kiosk continuously operable. C. Mail-Back Services Pursuant to the Ordinance 6.53.050 (A) (5), Inmar will provide prepaid and pre-addressed Mailers to County Residents containing written instructions for returning unused or unwanted medication. Standard Mail-Back Envelopes will be provided at Standard Mail-Back Envelope Distribution Sites. All Mailers are available directly from Inmar via the Program website and toll-free telephone number. Once a location has been accepted as a Standard Mail-Back Envelope Distribution Site, Inmar will send a predetermined number of prepaid, pre-addressed Standard Mail-Back Envelopes to that location as part of their Mail-Back Starter Kit. Standard Mail-Back Envelopes will accept all Unwanted Covered Drugs. Inmar will track the unique identifier for all Standard Mail-Back Envelopes sent to each location and will include instructions for Standard Mail-Back Envelope Distribution Sites to order additional envelopes when needed. Requesting Standard Mail-Back Envelopes and Inhaler Envelopes County Residents are able to request up to three (3) Standard and/or Inhaler Envelopes at a time via the Program website or toll-free number. Both the Standard and Inhaler Envelopes will meet DEA rule requirements under 21 CFR §1317.70(c): ● Pre-addressed, postage paid ● Nondescript, and do not indicate what may be inside ● Waterproof, tamper-evident, tear-resistant, and sealable ● Contain a unique ID number that allows for tracking ● Include instructions for the County Resident that indicates the process for mailing the Envelope and Unwanted Products that can be returned ● No personally-identifiable information will be required Internal only do not distribute without Inmar written permission, 2025 8 Requesting Auto-Injector Mail-Back Packages County Residents are able request up to three (3) Auto-Injector Mail-Back Packages at a time via the Program website or toll-free number. See below for specifications: ● Specifications: Access Petals ● Dimensions (in.): approx. 7.5 x 3.6 x 3.6 in. ● Color: Red ● Lid Type:Hinge Cap ● Liquid Absorbing Pad ● Universal Biohaz Symbol included Mailer Instructions Mailer instructions to County Residents for all types of Mailers are provided in Appendix B. Mailer Tracking All Mailers (Standard Envelopes, Inhaler Envelopes and Auto-Injector Mail-Back Packages) will have a unique, serialized identification number. Once the Mailer arrives at the destruction facility, the serial number, among other information, will be noted before final disposition. Please see the Disposal Section VI for additional information as to what information is retained for reporting purposes. Mailers distributed directly to County Residents via the Program website or via toll-free phone number requests will be tracked by Inmar when sent to Residents and tracked at the destruction facility when they are returned. Appendix A provides lists of where Inmar has established Collection Points and Standard Mail-Back Envelope Distribution Sites. D. Collection Events Inmar will work with the Department and local Law Enforcement Agencies to determine a feasible number of Collection Events and regional locations. Events may include the monthly one-day Collection Events coordinated with the Alameda County Household Hazardous Waste Department. Event Staffing and Oversight In compliance with 21 CFR §1317.65(a)(b), Inmar will ensure that at least one Law Enforcement Agency Personnel is present at each Collection Event. Inmar will provide personnel to be present to assist LEAs with logistics, coordination and/or other needs during the event. It will be Inmar’s responsibility to coordinate with the County and LEAs to ensure compliance with all applicable laws and regulations. Execution Procedures As required by 21 CFR §1317.65(b), law enforcement officers employed will maintain control and custody of the collected substances from the time the substances are collected from the ultimate user or person authorized to dispose of the County Resident's property until secure transfer, storage, or destruction of the controlled substances has occurred. At the conclusion of Collection Events, Inmar will work with LEAs to ensure that the collected materials Internal only do not distribute without Inmar written permission, 2025 9 are properly weighed, packaged and shipped to Inmar’s designated Service Provider (see Section VI) in compliance with all applicable laws. Inner Liners will be tracked via their unique identifiers from shipment location to the designated destruction facility. Internal only do not distribute without Inmar written permission, 2025 10 VI. Transportation and Disposal Information Pursuant to Ordinance 6.53.060 (A) Inmar complies with all local, State, and Federal laws and regulations applicable to disposal of medical waste and Controlled substances. Kiosk Containers will be sent, from the Authorized Collector via Carrier to Inmar’s Service Provider. All Mailers will be sent from the County Resident via Carrier to Inmar’s Service Provider. The Service Provider will record the following information upon receipt of every individual Container and Mailer: ● Date received ● Serialized barcode label information ● Carrier Tracking information ● Weight ● Manifest number (if applicable) A record of Inmar’s Service Provider’s penalties, violations, and regulatory orders in the last five years are provided in the supplemental attachment titled: Service Provide Compliance Reports. Company Name Contact Information Registration Information Service Provided 123 Compliant Logistics, LLC 2626 N 29th Ave Phoenix, AZ 85009 602-612-4140 DEA Reverse Distributor- Collector: R90571264 DEA Reverse Distributor Chesapeake Waste Solutions 190 Shellyland Road Manheim, PA 17545-8679 717-653-8882 DEA Reverse Distributor Collector: RC0322595 EPA ID: PAR00533521 USPS-040A19 DEA Reverse Distributor Covanta Environmental Solutions, LLC 2515 S. Holt Road, Suite 200 Indianapolis, IN 46241 317-719-6397 DEA Reverse Distributor RC0561628 USPS-040A19 DEA Reverse Distributor Clean Harbors Aragonite 11600N. Aptus Rd. Aragonite, UT94029 435-884-8100 EPA ID: UTD981552177 Hazardous Waste Incinerator Clean Harbors El Dorado, LLC 309 American Circle El Dorado, AR 71730 870-863-7173 EPA ID: ARD069748192 Hazardous Waste Incinerator Veolia ES Technical Solutions, L.L.C 7665 Highway 73 Port Arthur, TX 77640 281-216-9618 EPA ID: TXD000838896 Hazardous Waste Incinerator Ross Incineration Services 36790 Giles Road Grafton, OH 4044 440-748-5800 EPA ID: OHD048415665 Title V Permit #: P0108010 Hazardous Waste Incinerator Internal only do not distribute without Inmar written permission, 2025 11 Curtis Bay Medical Waste Services 3200 Hawkins Point Road Baltimore City, MD 21226 855-228-1715 EPA ID: MDD985404318 Refuse Disposal Permit #: 2017-WMI-0036 Medical Waste Incinerator Covanta Huntsville, Inc. 5251 Triana Boulevard SW Huntsville, AL 35805 256-882-1019 EPA ID: AL0000266726 Title V Permit #: AL0000000108900104 Medical Waste Incinerator City of Spokane WTW & Recycling Disposal Site 2900 S. Geiger Blvd Spokane, WA, 99224 509-625-6514 EPA ID: WAR000000463 Title V Permit #: AOP-3 Municipal Waste Combustor Barron County Waste to Energy & Recycling Facility 585 10 1/2 Avenue Almena, WI 54805 715-637-6890 EPA ID: Title V Permit #: 60304904A-P21 Municipal Waste Combustor Reworld Marion (Formerly Covanta) 4850 Brooklane Rd NE Salem, OR 97305 800-950-8749 EPA ID: 11000165343 Title V Permit #: 24-5398-TV01 Incinerator Biologic Environmental Services & Waste Solutions (Formerly Reworld, formerly Covanta) 23490 CONNECTICUT STREET HAYWARD, CA 94545 510-265-1900 EPA ID: CAR000226894 Medical Waste Treatment Facility Permit (CDPH): TS/OST - 127 Autoclave TransChem Environmental 542 East 27th Street Tucson, AZ 85713 520-829-5651 EPA ID – AZD982484578 USDOT ID Number – 1341480 HazMat Reg #: 052322550137E Transporter FedEx 847-346-6292 FedEx Express DOT ID # - 86876 FedEx Ground DOT ID # - 265752 Transporter USPS 919-501-9394 N/A Transporter Schneider National Trucking 3101 SOUTH PACKERLAND DRIVE GREEN BAY, WI 54313 800-333-7400 US DOT ID: 121058 Hazmat Reg #: 052421550207DF Transporter Internal only do not distribute without Inmar written permission, 2025 12 Saia Freight 11465 Johns Creek Parkway Suite 400, Johns Creek, GA 30097 800-558-6767 US DOT ID: 264184 Hazmat Reg #: 060922550094EG Transporter Internal only do not distribute without Inmar written permission, 2025 13 VII. Policies and Procedures Inmar will ensure that it acts in compliance with all applicable laws, rules, and regulations as specified by the Program requirements and require by contract where applicable that Service Providers and Collection Points are also compliant with all laws, regulations, and legal requirements. Inmar, Collection Points, and Service Providers will specifically be required to comply with The Controlled Substances Act, 21 USC SS 801-971 and 21 CFR §1317; United States Department of Transportation Hazardous Materials Regulation, 49 CFR parts 100-185; California Board of Pharmacy, title 16, Article 9.1 and all applicable Alameda County Ordinances and Regulations. The DEA Rule defines Authorized Collectors as Law Enforcement Agencies and additionally as retail pharmacies, reverse distributors, hospitals, or clinics with onsite pharmacies, and certain other entities that are registered with DEA as an Authorized Collector. Inmar has established standard operating procedures that require Authorized Collectors to adhere to these standards. Any Authorized Collector agreements specifically require their compliance ensuring their commitment to compliant operation of the Collection Points and shipping of contents in compliance with the DEA regulations. A refusal to sign the agreement or comply with the DEA regulations would be a reason why an Authorized Collector would be excluded from the Inmar Stewardship Plan. Documentation and Tracking Pursuant to the Ordinance 6.54.050 (A) (7) and the Regulation § 8 (A) (iii – iv), the below section outlines the Plan’s management practices, policies, and procedures. Collection Containers and Inner Liners will have a serialized identification number to enable tracking at all stages of the return process. Tracking is documented as evidenced by the Inmar serialization tracking form. This form must be completed and witnessed by two employees of the Authorized Collector. The purpose of this form is to document the use of the serialized Inner Liner throughout the collection process and to help the Authorized Collector meet DEA and Board of Pharmacy record-keeping requirements. Inmar will require each Authorized Collector to understand and comply with all Federal, State, and local regulatory requirements pertaining to Unwanted Covered Drugs applicable at the authorized Collection Point. The serial numbers, date acquired, and signature of an employee of the Authorized Collector must be completed upon receipt of the Container and Inner Liner. The date installed is to be completed by two employees of the Authorized Collector with their names and signatures. The date the Container and Inner Liner are removed from the Kiosk is also to be noted with names and signatures. Finally, the date the Container and Inner Liner are shipped is noted with authorized names and signatures. Authorized Collectors must maintain a copy of the completed form, a copy of the Carrier tracking information, and other records as applicable, on file at the Collection Point for at least two years. Transport The Authorized Collector will properly seal, store securely, and arrange for pickup of the sealed Inner Liner and its contents from the registered location in a manner consistent with DEA regulations. The Container Internal only do not distribute without Inmar written permission, 2025 14 will include a pre-addressed and prepaid shipping label. The Carrier representative will take possession of the Container and deliver the Container to Inmar’s Service Provider. Disposal Once the Container and Inner Liner arrives at the destruction facility, the serial number will be noted before final disposition, which will allow Inmar to report the number of Containers and Inner Liners distributed and returned by each Collection Point in the Reporting provided to Alameda County, as required. Internal only do not distribute without Inmar written permission, 2025 15 VIII. Outreach Program Design Inmar will execute a comprehensive and measurable public outreach strategy to drive awareness of the Plan and maximize participation pursuant to the Ordinances 6.53.050 (A) (8) and 6.53.070, and the Regulations §7 (G) and § 8 (A) (vi-vii). In addition to preventative education, Inmar’s strategy is designed to ensure that where and how to return Unwanted Products is widely understood by County Residents, pharmacists, retail pharmacies, health care facilities and providers, veterinarians, and veterinary hospitals. Pursuant to the Ordinance 6.53.070, the individual components of Inmar’s public outreach strategy are detailed below. Across all tactics, key messages will include, but not be limited to, the following: ● Promote safe storage of all drugs, wanted or unwanted, by County Residents in their homes; ● Discourage stockpiling and storage of Unwanted Products in the home ● Describe where and how to return Unwanted Products ● Discourage improper disposal of drugs (e.g., flushing or solid waste collection) A. Outreach Materials Inmar will provide educational materials for dissemination to interested parties including County Residents, pharmacists, retailers, and health care practitioners upon request and at no charge. Materials will be available in English, Spanish, Chinese, Vietnamese and Tagalog. These materials will: ● Provide instruction on how to safely store Covered Drugs at home ● Inform of the risks of disposing of Unwanted Products in inappropriate waste streams (e.g., solid waste collection, sewer, or septic systems) ● Outline how to participate in the Plan for safe disposal of Unwanted Covered Drugs. Please see Appendix C for example materials. B. Standardized Instructions Collection Kiosk Signage The Collection Kiosks themselves will be readily-recognizable. Each Kiosk is adorned with clear graphical instructions for proper use, which will be provided in English and Spanish. Please see Appendix B for an image of the Collection Kiosk and disposal instructions. C. Website and Toll-Free Number Website Inmar will provide a mobile-optimized website, appropriately translated into the Required Languages, which will publicize collection options and educate interested parties. Specifically, the website will: Internal only do not distribute without Inmar written permission, 2025 16 ● Allow County Residents to find the nearest Collection Point or Mail-Back Distribution Site via a list of locations and a map. The website will be updated routinely to ensure accuracy. ● Allow interested parties to request prepaid Mailers. ● Include educational and outreach materials promoting safe storage of Covered Drugs Retailers or pharmacies interested in participating in the Plan will be able to request more information through the website. Please see Appendix C for images of the website interface and functionality. Toll-Free Number Inmar will operate a multi-lingual, live operator (English, Spanish, Chinese, Vietnamese and Tagalog) toll-free call center that interested parties can call to learn more about the Program, Collection Events, and best practices for disposal of Unwanted Covered Drugs. Callers will be validated by zip code for applicable County Program offerings. County Residents will also be able to request information about the nearest Collection Point or Standard Mail-Back Envelope Distribution Site, or request that a prepaid Mailer is sent to them. The call center is operated with live operators and will be staffed with a third party service to assist with live translation in the required languages. All operators are trained to assist and answer questions related to any and all questions related to the Stewardship Plan operation including but not limited to Authorized Collector Kiosk support and service requests. D. Traditional & Digital Media Inmar will utilize a combination of traditional and digital media tactics to educate County Residents on safe disposal of Unwanted Products. Traditional media tactics can include, but are not limited to, radio, newspaper ads, and direct mail. Digital media tactics can include, but are not limited to, influencer marketing and programmatic advertising. Media promotion will be scheduled throughout the Program year. E. Additional Promotional Considerations Authorized Collector Marketing Support To drive awareness and participation at a local level, Inmar will provide individual Authorized Collectors with a variety of marketing assets including in-store signage, social media content kits, press release templates, a radio ad script, and scripts for Pharmacy Employees to let County Residents know that they can safely dispose of their Unwanted Product at that location. Authorized Collectors will be able to request additional marketing materials through the toll-free number. Biennial Survey To measure the effectiveness of the comprehensive and measurable public outreach strategy, Inmar will conduct a biennial survey of County Residents as well as pharmacists, veterinarians, and health professionals separately who interact with patients on use of medicines after the first full year of operation of the Stewardship Plan. The aim of the survey questions will be to measure the percent awareness of the Stewardship Plan, assess to what extent Kiosks 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 non-prescription drugs used in the home. Internal only do not distribute without Inmar written permission, 2025 17 IX. Annual Reporting Pursuant to the Ordinance 6.53.080 and the Regulation §15 as the Department advises and annually thereafter, Inmar will submit a report describing the Plan’s activities during the previous Reporting Period. The report will include: a. Report Narrative with the following subsections: i. Executive summary to include a brief description of collection and disposal efforts during the reporting period ii. A Summary of the Plan goals to include degree of success and opportunities of unmet goals iii. Proposed Goals to be accomplished in the upcoming year iv. A description of the collection efforts of the past year v. A description of education and public outreach efforts of the past year vi. Safety and Security report including any known security and safety incidents at Collection Points along with any corrective or other action taken in response to the incident, law enforcement involved or any litigation arbitrations or other legal proceedings arising out of or involving the incident. b. Report Data containing the following: i. All Producers participating in the Plan ii. Each Collection Point location: Collection Point name and address, weight of collected Unwanted Products over the past year and number of times Unwanted Products were picked up for transportation iii. Mail-Back Program to include number of Mail-Back Envelopes distributed, returned and total weight of collected Unwanted Products iv. For each Disposal Facility: name address and telephone number, total weight of collected Unwanted Products disposed. Internal only do not distribute without Inmar written permission, 2025 18 X. Patient Privacy Inmar provides training to our participating Authorized Collectors and strictly follows the DEA guidelines for the proper handling of the Kiosks and Inner Liners. This begins with the proper training of the Authorized Collector in the compliant operation of the Kiosks and proper preparation, removal, and packaging of the Container. It also involves the training of the Inmar staff that may come into contact with the full Container to ensure proper handling. Inmar strictly complies with State and Federal statutes and regulations including, but not limited to, the DEA guidelines cited below. According to the DEA - As provided in §§ 1317.60(c) and 1317.70(f), Inner Liners shall be sealed immediately upon removal from the permanent outer Container; sealed Inner Liners and returned Mailers shall not be opened, x-rayed, analyzed, or otherwise penetrated. Accordingly, their contents shall not be sorted or inventoried subsequent to being placed into Kiosks or Mailers. To clarify this, § 1317.75(c) was modified to add the prohibition against individually handling substances after they have been deposited into Collection Kiosks. Internal only do not distribute without Inmar written permission, 2025 19 XI. Goals PROGRAM COLLECTION GOALS Short-Term Goals (12-18 Months After Approval) Long-Term Goals (19+ Months After Approval) Continue partnership with Alameda County Department of Environmental Health to participate in household hazardous waste events. Inmar’s goal is to achieve 100 Kiosks distributed jointly, in combination with other Plan Owners, across the County to provide equitable and reasonably convenient access to Residents. PROGRAM PROMOTION GOALS Short-Term Goals (12-18 Months After Approval) Long-Term Goals (19+ Months After Approval) Website functionality updates: o Collection Point and Mail-Back Envelope Distribution Site list updated (ongoing) In Process as new locations are acquired. Continue digital media tactics throughout the year which can include, but are not limited to, influencer marketing and programmatic advertising. Explore additional promotional avenues based on feedback from the biennial survey. Continue traditional media tactics throughout the year which can include, but are not limited to, radio, newspaper ads, and direct mail. Internal only do not distribute without Inmar written permission, 2025 20 APPENDICES A: Authorized Collector Collection Points & Mailer Sites A-1: Confirmed Collection Points 22 A-2: Confirmed Standard Mail-Back Envelope Distribution Sites 23 B: Kiosk Signage & Mailer Instructions 25 C: Sample Promotional Materials 36 D: Participating Producers 52 Internal only do not distribute without Inmar written permission, 2025 21 Appendix A-1: Confirmed Collection Points Collection Point Name Street City Zip District Safeway Pharmacy #0691 1444 Shattuck Place Berkeley 94709 5 Safeway Pharmacy #0951 867 Island Drive Alameda 94502 3 Safeway Pharmacy #0971 22280 Foothill Boulevard Hayward 94541 2 Safeway Pharmacy #0993 3902 Washington Blvd Fremont 94538 1 Safeway Pharmacy #1197 1790 Decoto Road Union City 94587 2 Safeway Pharmacy #1257 4495 First St Livermore 94551 1 Safeway Pharmacy #1931 46848 Mission Blvd Fremont 94539 1 Safeway Pharmacy #2708 2227 South Shore Center Alameda 94501 3 Safeway Pharmacy #2856 6790 Bernal Ave Pleasanton 94566 4 Safeway Pharmacy #2870 6310 College Ave Oakland 94618 5 Safeway Pharmacy #3132 5100 Broadway Oakland 94611 5 Safeway Pharmacy #3281 2600 5Th St. Alameda 94501 3 TIB Pharmacy 7999 Gateway Blvd., Suite 110 Newark 94560 2 University of California at Berkeley 222 Bancroft Way Berkeley 94720 5 Internal only do not distribute without Inmar written permission, 2025 22 Appendix A-2: Confirmed Standard Mail-Back Envelope Distribution Sites Site Name Street City Zip District Aids Healthcare Foundation - Oakland 400 30th Street, Suite 300 Oakland 94609 5 Albany Police Department 1000 San Pablo Ave Albany 94706 5 Albany Police Department 1000 San Pablo Avenue Albany 94706 5 Alegre Home Care - East Bay 5767 Broadway, Suite 201 Oakland 94618 5 Alta Bates Outpatient Pharmacy 2001 Dwight Way Berkeley 94704 5 Bonita House Inc. 6333 Telegraph Avenue, Suite 102 Oakland 94609 5 California Sinus Center 5924 Soneridge Drive Suite 207 Pleasanton 94588 4 Costco Pharmacy #1061 28505 Hesperian Blvd Hayward 94545 2 Costco Pharmacy #118 1900 Davis St. San Leandro 94577 3 Costco Pharmacy #1341 7200 Johnson Drive Pleasanton 94588 4 Costco Pharmacy #146 2800 Independence Drive Livermore 94550 1 Costco Pharmacy #1660 350 Newpark Mall Newark 46070 2 Costco Pharmacy #778 43621 Pacific Commons Blvd Fremont 94538 2 Crossroads Home Health - Oakland 333 Hegnberger Road, Suite 710 Oakland 94621 4 Haller's LTC Pharmacy 4067 Peralta Boulevard Fremont 94536 1 Healthflex Home Health & Hospc 7677Oakport Dr. Oakland 94621 4 Home Care Assistance - Oakland 5275 Broadway Oakland 94618 5 Lifelong Medical Care 2031 6th Street Berkeley 94710 5 Lifescript Pharmacy 39039 Paseo Padre Parkway Suite 201 Fremont 94538 1 Medical Arts Pharmacy 13847 East 14th St Suite 103 San Leandro 94578 3 Mindful Health Solutions - Oakland 3300 Webster Street, Suite 402 Oakland 94609 5 New Chinatown Pharmacy 719 East 12th Street Oakland 94606 3 Pak 'N Save-3125 3889 San Pablo Ave Emeryville 94608 5 Prescript Pharmaceuticals 39 California Avenue Pleasanton 94566 4 Raley's Pharmacy #316 5420 Sunol Blvd. Pleasanton 94566 4 Safeway Pharmacy #691 1444 Shattuck Pl Berkeley 94709 5 Safeway Pharmacy #1932 4440 Tassajara Rd Dublin 94568 1 Safeway Pharmacy #1953 7499 Dublin Blvd Dublin 94568 1 Safeway Pharmacy #676 1500 Solano Ave Albany 94706 5 Internal only do not distribute without Inmar written permission, 2025 23 Safeway Pharmacy #768 20629 Redwood Rd Castro Valley 94546 4 Safeway Pharmacy #908 3550 Fruitvale Ave Oakland 94602 4 Specialty Mental Health - Oakland 310 8th Street, Suite 210 Oakland 94607 3 Specialty Mental Health - San Leandro 433 Callan Avenue, Suite 301 San Leandro 94577 3 Sutter Care at Home - Hospice 1025 Atlantic Avenue, Suite 350B Alameda 94501 3 Wild Smiles 4200 East Avenue Livermore 94550 1 Internal only do not distribute without Inmar written permission, 2025 24 Appendix B: Kiosk Signage & Mailer Instructions Figure 1 - Image of Kiosk Internal only do not distribute without Inmar written permission, 2025 25 Figure 2 - Kiosk Top-Sticker Signage Figure 3 - Kiosk Signage - Drop-Door Internal only do not distribute without Inmar written permission, 2025 26 Figure 4 - Sample Kiosk Signage Internal only do not distribute without Inmar written permission, 2025 27 Figure 5 - Instructions for Standard Mail-Back Envelope Distribution Sites Internal only do not distribute without Inmar written permission, 2025 28 Figure 6 - Educational Insert Instructions for Standard Mail-Back Envelope Internal only do not distribute without Inmar written permission, 2025 29 Figure 7 - Educational Insert for Inhaler Envelopes Internal only do not distribute without Inmar written permission, 2025 30 Figure 9 - Educational Insert for Auto-Injector Mail-Back Packages Internal only do not distribute without Inmar written permission, 2025 31 Figure(s) 10 - Kiosk Disposal Instructions Internal only do not distribute without Inmar written permission, 2025 32 Figure(s) 10 - Kiosk Disposal Instructions Internal only do not distribute without Inmar written permission, 2025 33 Figure(s) 10 - Kiosk Disposal Instructions Internal only do not distribute without Inmar written permission, 2025 34 Figure(s) 10 - Kiosk Disposal Instructions Internal only do not distribute without Inmar written permission, 2025 35 Appendix C: Sample Promotional Materials Figure 1 - Sample Promotional Signage Internal only do not distribute without Inmar written permission, 2025 36 Internal only do not distribute without Inmar written permission, 2025 37 Figure(s) 2 - Sample Mail-Back Site Promotional Signage Internal only do not distribute without Inmar written permission, 2025 38 Figure(s) 3- Educational Materials Front (All educational materials are available in Required Languages) Internal only do not distribute without Inmar written permission, 2025 39 Figure(s) 3 - Educational Materials Back (All educational materials are available in Required Languages) Internal only do not distribute without Inmar written permission, 2025 40 Figure(s) 4 - Sample Direct Mailer Front Internal only do not distribute without Inmar written permission, 2025 41 Figure(s) 4 - Sample Direct Mailer Back Internal only do not distribute without Inmar written permission, 2025 42 Figure 5 - Sample Newspaper Advertisement Internal only do not distribute without Inmar written permission, 2025 43 Figure 6 - www.SafeMedicineDrop.com Landing Page with Alameda County zip code entered Figure 7- www.SafeMedicineDrop.com Alameda County Landing Page Internal only do not distribute without Inmar written permission, 2025 44 Figure 8 - www.safemedicinedrop.com Disposal Options Nearby - Alameda County Figure 9 - www.safemedicinedrop.com Mail-Back Request - Alameda County Internal only do not distribute without Inmar written permission, 2025 45 Internal only do not distribute without Inmar written permission, 2025 46 Figure(s) 10 - Frequently Asked Questions (FAQ) Page on www.safemedicinedrop.com Internal only do not distribute without Inmar written permission, 2025 47 Figure 11 - Contact Information on www.safemedicinedrop.com Internal only do not distribute without Inmar written permission, 2025 48 Figure 12- Educational Materials Location on www.safemedicinedrop.com Internal only do not distribute without Inmar written permission, 2025 49 Figure 13 - FAQ Page Figure 14 - Safety Info Page on www.safemedicinedrop.com Internal only do not distribute without Inmar written permission, 2025 50 Figure 15 - Collector Resources Page on www.safemedicinedrop.com Internal only do not distribute without Inmar written permission, 2025 51 Appendix D: Participating Producers Inmar provides a list of Participating Producers to the County annually to satisfy Ordinance requirements. Internal only do not distribute without Inmar written permission, 2025 52