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HomeMy WebLinkAboutcal-um-plan-final-updated-plan-resubmisson-2022-08-31-archive A Product Stewardship Plan for Unwanted Medicine from Households Alameda County, California June 29, 2022 ; Revised August 31, 2022 2 Table of Contents I. Contact Information ............................................................................................................ 5 II. Introduction ........................................................................................................................ 6 III. Plan Definitions ................................................................................................................... 7 IV. Unwanted Medicine ............................................................................................................. 9 V. Collection of Unwanted Medicine ...................................................................................... 10 A. Unwanted Medicine Collection Program ................................................................................ 10 1. Outreach ..................................................................................................................... 10 2. Implementation ............................................................................................................ 10 3. Convenience ................................................................................................................ 10 4. Services ....................................................................................................................... 10 B. Kiosk Drop-Off Sites ........................................................................................................... 11 1. Kiosk Drop-Off Site Locations ........................................................................................ 11 2. Drop-Off Site Kiosk Placement and Maintenance Program ................................................ 12 3. Kiosk Specifications ...................................................................................................... 12 4. Kiosk Collection ............................................................................................................ 13 5. Collection Methods ....................................................................................................... 13 6. Kiosk Service ............................................................................................................... 14 7. Frequency of Pick-Up .................................................................................................... 14 8. Procedures if a Kiosk is Full Prior to Scheduled Pick-Up .................................................... 15 C. Rapid Response Support ..................................................................................................... 15 D. Take-Back Events ................................................................................................................ 15 1. Method ........................................................................................................................ 16 2. Procedures .................................................................................................................. 16 E. Disposal of Unwanted Medicine from Kiosk Drop-Off Sites and Take-Back Events ....................... 17 F. Mail-Back Services for Unwanted Medicine ............................................................................. 17 1. Standard Mail-Back Services for Unwanted Medicine ........................................................ 17 2. Inhaler Mail-Back Services for Inhalers ........................................................................... 18 3. Mail-Back Package Availability ....................................................................................... 18 4. Mail-Back Package Collection and Disposal ..................................................................... 18 VI. Goals .................................................................................................................................. 19 VII. Patient Privacy .............................................................................................................. 20 VIII. Call Center .................................................................................................................... 21 IX. Training ............................................................................................................................. 22 X. Vendor, Transporter, and Disposal Facility Information ................................................... 23 A. Vendors............................................................................................................................. 23 B. Reverse Distributors ........................................................................................................... 23 C. Carriers & Transporters ....................................................................................................... 24 D. Disposal Facilities ............................................................................................................... 26 XI. Unwanted Medicine Educational and Outreach Programming.......................................... 28 A. Overview ........................................................................................................................... 28 B. Audiences .......................................................................................................................... 28 C. Messages .......................................................................................................................... 28 D. Tools/Communications Channels ......................................................................................... 28 1. Phone ......................................................................................................................... 29 2. MED-Project Website .................................................................................................... 29 3. Materials ..................................................................................................................... 29 3 4. Social Media ................................................................................................................ 30 5. Broadcast Outreach ...................................................................................................... 30 E. Collaboration with County Officials and Community Organizations .......................................... 30 F. Effectiveness ..................................................................................................................... 30 G. Disclaimer ......................................................................................................................... 30 XII. Compliance with Applicable Laws, Regulations, and other Legal Requirements ......... 31 H. DEA Controlled Substances Act and Implementing Regulations ............................................... 31 1. DEA Registration Modification ........................................................................................ 32 I. United States Department of Transportation (DOT) ............................................................... 32 J. California Board of Pharmacy .............................................................................................. 32 XIII. Annual Report ............................................................................................................... 33 Appendix A .............................................................................................................................. 34 MED-Project Participants ........................................................................................................... 34 Appendix B .............................................................................................................................. 35 Contact List for Outreach and Education to the Community .......................................................... 35 Appendix C .............................................................................................................................. 36 Interested Sites and Participating Kiosk Drop-Off Sites ................................................................ 36 Appendix D .............................................................................................................................. 42 Potential Additional Kiosk Drop-Off Sites .................................................................................... 42 Appendix E .............................................................................................................................. 52 Sample Kiosk Mock-Up ............................................................................................................. 52 Sample Kiosk Signage ............................................................................................................... 53 Sample Kiosk Signage ............................................................................................................... 54 Sample Kiosk Signage ............................................................................................................... 55 Appendix F ............................................................................................................................... 57 Media List ................................................................................................................................ 57 Appendix G .............................................................................................................................. 64 Sample Standard Mail-Back Package .......................................................................................... 64 Sample Inhaler Mail-Back Package ............................................................................................. 65 Appendix H .............................................................................................................................. 66 Clean Harbors Aragonite, LLC Enforcement Action Summary Report ............................................. 66 Covanta Environmental Solutions, LLC Penalty Record ................................................................. 73 Curtis Bay Energy Penalty Record .............................................................................................. 75 Heritage Thermal Services – Ohio Penalty Record ....................................................................... 78 Ross Incineration Services Penalty Record .................................................................................. 82 Stericycle, Inc., Warren, Ohio Facility Penalty Record .................................................................. 86 Veolia – Port Arthur Penalty Record ........................................................................................... 88 Appendix I ............................................................................................................................... 95 Sample Education and Outreach Call Center ............................................................................... 95 Appendix J ............................................................................................................................... 96 Sample MED-Project Website Home Page ................................................................................... 96 Sample MED-Project Website Check The Package Page ............................................................... 97 Sample MED-Project Website Convenient Locations Pages ........................................................... 98 Sample MED-Project Website Mail Back Page ............................................................................ 100 Sample MED-Project Website Take-Back Events Page ................................................................ 101 4 Sample MED-Project Website MEDfaq Page .............................................................................. 102 Sample MED-Project Website Contact Page .............................................................................. 103 Appendix K ............................................................................................................................ 104 Sample Brochure .................................................................................................................... 104 5 I. Contact Information The primary contact person for MED-Project is: Dr. Victoria Travis, PharmD, MS, MBA National Program Director MED-Project LLC 4096 Piedmont Ave Unit 174 Oakland, CA 94611 Phone: (833) 633-7765 Fax: (866) 633-1812 alamedacounty@med-project.org 6 II. Introduction MED-Project LLC (“MED-Project”), on behalf of the participating companies identified in Appendix A, submits this Product Stewardship Plan (“Plan”) for Unwanted Medicine to the Alameda County Department of Environmental Health (“Department”) in compliance with the Alameda County Safe Drug Disposal Ordinance, Title 6 of the Alameda County Health and Safety Code Sections 6.53.010 through 6.53.120, as amended February 2, 2016 (“Ordinance”) and the Alameda County Safe Drug Disposal Regulations, as amended October 16, 2013 (“Regulations”). The Ordinance requires pharmaceutical Producers1 to develop a Product Stewardship Program to finance and manage the collection, transportation, and disposal of Unwanted Medicine from Alameda County households. 1 All capitalized terms used but not otherwise defined herein shall have their respective meanings set forth in the Ordinance and Regulations. 7 III. Plan Definitions Board of Pharmacy is the California State Board of Pharmacy. Call Center is the MED-Project call center for Residents, which can be reached by callers at the toll-free number of 1-844-MED-PROJECT or 1-844-633-7765. Carrier is the common carrier used to transport Unwanted Medicine from Kiosk Drop-Off Sites and/or Take-Back Events. County means Alameda County, California. DEA is the U.S. Drug Enforcement Administration. DEA Rule is the DEA Final Rule, “Disposal of Controlled Substances,” 79 Fed. Reg. 53,520 et seq., adopted on September 9, 2014. DOT is the U.S. Department of Transportation. FDA is the U.S. Food and Drug Administration. Help Desk is the MED-Project call center and email-in database for Kiosk Drop-Off Sites that can be reached by callers at a toll-free number and/or by email at alamedacounty@med-project.org. Inhaler Mail-Back Services is the provision of pre-paid, pre-addressed packages for the collection and disposal of inhalers (“Inhaler Mail-Back Packages”) by Vendor. Kiosk Drop-Off Site is a location that is accessible to the public, hosting a MED-Project kiosk for the collection of Unwanted Medicine, including On-Demand Collection Service Kiosk Drop-Off Sites and Scheduled Collection Service Kiosk Drop-Off Sites. Kiosk Drop-Off Site Host is the designated contact person or persons at the Kiosk Drop-Off Site, including On-Demand Collection Service Kiosk Drop-Off Site Hosts and Scheduled Collection Service Kiosk Drop-Off Site Hosts. Law Enforcement Agency or LEA is a federal, state, tribal, or local law enforcement office or agency. Mail-Back Services is the provision of pre-paid, pre-addressed containers, envelopes, or packages (“Mail-Back Packages”) to Residents for the collection and disposal of Unwanted Medicine by Vendor. MED-Project Website is the Internet website located at www.med-project.org or www.medproject.org. Plan or Product Stewardship Plan is the product stewardship plan presented in this submittal by MED-Project. Program or Product Stewardship Program is the product stewardship program set forth in this Product Stewardship Plan. On-Demand Collection Service is a service model where Unwanted Medicine Kiosk Drop-Off Site staff manage removal and packaging of full Unwanted Medicine inner liners prior to transfer to a common carrier for transport to a reverse distributor. Residents means human beings residing in the County. “Residents” does not include nonresidential generators of pharmaceutical waste, such as businesses, hospitals, clinics, doctor’s offices, veterinary clinics, pharmacies, or airport security and law enforcement drug seizures. 8 Scheduled Collection Service is a service model where MED-Project provides for a vendor service technician to help prepare Unwanted Medicine inner liners at Unwanted Medicine Kiosk Drop-Off Sites for transfer to a common carrier for transport to a reverse distributor. Unwanted Medicine Service Technicians are personnel trained to service Program kiosks and/or Take-Back Events. Standard Mail-Back Services is the provision of pre-paid, pre-addressed envelopes for the collection and disposal of Unwanted Medicine (“Standard Mail-Back Packages”) by Vendor. Specified Languages are English, Spanish, Chinese, Vietnamese, and Tagalog (Filipino). Take-Back Event is a one-day event at a location accessible to the public, conducted by MED-Project, with oversight by law enforcement, for the collection of Unwanted Medicine from Residents. Unwanted Medicine is defined in Section IV of this Plan. Vendor is any vendor retained by MED-Project to carry out its obligations under the Program. 9 IV. Unwanted Medicine For the purposes of the Plan, “Unwanted Medicine” includes all materials identified as “Covered Drugs” under Ordinance § 6.53.030(3) that qualify as “Unwanted Products” under Ordinance § 6.53.030(21). According to the Ordinance, Covered Drugs means “a Drug sold, offered for sale, or dispensed in Alameda County in any form including prescription and nonprescription drugs, drugs in medical devices and combination products, brand name and generic drugs, and drugs for veterinary use.” Unwanted Medicine does not include the following: i. Expired and/or undispensed samples direct from physicians’ offices; ii. Unused or expired drugs from hospitals and institutions; iii. Bulk animal pharmaceuticals from farms (business use); iv. Vitamins or supplements; v. Herbal-based remedies and homeopathic drugs, products, or remedies; vi. Compressed cylinders and mercury-containing thermometers; vii. 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); viii. Hard surface and toilet disinfectant cleaners; ix. Drugs administered in a healthcare setting; x. Drugs for which Producers provide a pharmaceutical product stewardship or take-back program as part of an FDA managed risk evaluation and mitigation strategy (Title 21 U.S.C. Sec. 355-1); xi. Drugs that are biological products, as defined by 21 C.F.R. 600.3(h) as it existed on February 2, 2016, if the Producer already provides a pharmaceutical product stewardship or take-back program; xii. Medical devices or their component parts or accessories; xiii. Used, empty containers, vials, and pouches; xiv. Sharps (e.g., needles, auto-injectors); and xv. Schedule I or other illicit drugs. See Section XII.A for collection limitations imposed by the DEA Rule. 10 V. Collection of Unwanted Medicine The Plan provides services to collect Unwanted Medicine, including controlled substances. The Program accepts Unwanted Medicine regardless of who produced it unless excused from this requirement by the Department. The collection methods and any applicable legal requirements are described below. A. Unwanted Medicine Collection Program 1. Outreach MED-Project continues to periodically perform outreach to potential collection sites through calls, emails, and/or site visits with the goal of establishing Kiosk Drop-Off Sites distributed throughout the County. LEAs and Pharmacies that currently host kiosks in the County may transition into the Program upon entering into an agreement with MED-Project. 2. Implementation MED-Project continues to implement the Program through executed agreements with Kiosk Drop-Off Site Hosts. Take-Back Events will also be conducted in coordination with scheduled Alameda County Department of Environmental Health Household Hazardous Waste (“HHW”)2 events throughout the County. Collection of Unwanted Medicine begins at Kiosk Drop-Off Sites once agreements have been executed with each location, kiosks have been installed, sites have been trained, and, in the case of pharmacies, all requirements of the DEA and Board of Pharmacy have been met. 3. Convenience Mail-Back Services are available upon request by disabled and home-bound Residents, or persons providing services to such Residents, via the Call Center and MED-Project Website, thereby offering more opportunities to dispose of Unwanted Medicine. 4. Services MED-Project routinely assesses performance, gauges feedback, and revises its approach to services and convenience as appropriate. As implementation proceeds, MED-Project shall continue to approach organizations that may be available as future Kiosk Drop-Off Sites on a periodic basis, such as those listed in Appendix B. The Program is implemented in a flexible manner, offering coverage to Residents through a combination of Kiosk Drop-Off Sites, Mail-Back Services, and/or Take-Back Events. Over the course of implementation, additional Kiosk Drop-Off Sites have been established to the extent that (1) additional eligible LEAs and/or DEA-registered collector pharmacies agree to participate, and (2) contracts can be executed with such entities. For every engagement with LEAs and pharmacies, including the establishment of Kiosk Drop-Off Sites and/or the conducting of Take-Back Events, contracts outlining the responsibilities of all involved parties are drafted, reviewed by appropriate entities, and signed by all parties before MED- Project installs kiosks and/or schedules Take-Back Events. For more information regarding Take-Back Event scheduling, coverage, and frequency, see Section V.C. 2 http://stopwaste.org/recycling/residents/household-hazardous-waste/one-day-event 11 Mail-Back Services are available to disabled and home-bound Residents, or to persons providing services to such Residents, via the Call Center and MED-Project Website. See Section V.F for more information about the availability of Mail-Back Services. B. Kiosk Drop-Off Sites Kiosk Drop-Off Sites will continue to be strategically placed across the County in order to best serve Residents. All Kiosk Drop-Off Site Hosts shall provide Residents with access to Program kiosks during regular business hours. 1. Kiosk Drop-Off Site Locations Kiosk Drop-Off Sites that are currently interested in and participating in the Program are identified in Appendix C. MED-Project continues outreach to potential Kiosk Drop-Off Site Hosts that are not interested in or participating in the Program, such as sites listed in Appendix D. As required under Ordinance § 6.53.070(E), the Plan includes as a Kiosk Drop-Off Site any eligible site willing to serve voluntarily as a Kiosk Drop-Off Site for Unwanted Medicine and able to meet all applicable laws, regulations, and other legal requirements. Locations currently serving as a drop-off site may participate in the MED-Project Program by signing agreements with MED-Project and modifying their DEA registrations if required. MED-Project will work with the Kiosk Drop-Off Site Host to transition to the Program and Vendor. A map of existing Kiosk Drop-Off Sites is below. 12 2. Drop-Off Site Kiosk Placement and Maintenance Program Kiosk installation shall be the responsibility of MED-Project at LEAs and pharmacy Kiosk Drop-Off Sites when the Kiosk Drop-Off Site Host has identified a compliant placement location. All kiosks in the Program must be securely placed and maintained inside a collector’s registered location or LEA’s physical location in accordance with DEA Rule §§ 1317.75(d)(1) and 1317.35(a). At pharmacies, kiosks are placed in the immediate proximity of a designated area where controlled substances are stored and at which an employee is present (i.e., can be seen from the counter), pursuant to DEA Rule § 1317.75(d)(2). Kiosk placement will also comply with any applicable Board of Pharmacy requirements. Costs associated with installation and maintenance are paid by MED-Project per the contracts with the Kiosk Drop-Off Site Hosts. The maintenance program addresses items such as: − Periodic inspection of kiosks to monitor general wear and tear; − Unwanted Medicine Service Technician access to the kiosks at Scheduled Collection Service Kiosk Drop-Off Sites during the regularly scheduled Collection Service; − Reporting by the Kiosk Drop-Off Site Host of damage to a kiosk or requested maintenance service. All Kiosk Drop-Off Site Hosts are able to notify MED-Project of the need for kiosk service or maintenance via the Help Desk. 3. Kiosk Specifications A blue kiosk is offered to eligible host locations. Pursuant to DEA Rule § 1317.75, MED-Project kiosks at pharmacies must: − Be securely fastened to a permanent structure; − Be securely locked, substantially constructed containers with a permanent outer container and removable inner liner; − Include a small opening in the outer container that allows contents to be added to the inner liner, but does not allow removal of the inner liner’s contents; − Prominently display a sign indicating that only Schedule II-V controlled and non-controlled substances are acceptable to be placed in the kiosk; and − Have the small opening in the outer container locked or made inaccessible to the public when a Kiosk Drop-Off Site employee is not present. The design of the pharmacy kiosk and signage (Appendix E) satisfies these requirements through the use of heavy gauge steel; multiple locking mechanisms, including a locking mechanism on the drop-slot; a tamper-resistant slot; and commercial hinges. The design increases the likelihood of consumer participation by providing easy access to wheelchair users. The locking mechanism on the drop-slot prevents kiosk overflow once the container has reached its maximum level and is locked by the Kiosk Drop-Off Site employee. MED-Project pharmacy kiosks come with appropriate regulatory signage and instructions, including an instruction to remove personal information from any Unwanted Medicine and packaging before depositing them and language required under the DEA Rule3 and by the Board of Pharmacy. Kiosk signage provides information about what is and is not accepted in the kiosk. Additionally, under DEA Rule § 1317.60(a), MED-Project kiosk inner liners will: 3 Specifically, as required under DEA Rule § 1317.75(e)(4), all kiosks will prominently display a sign stating that: “Only Schedule II-V controlled and non-controlled substances that are lawfully possessed by the ultimate user are acceptable to be placed in the kiosk. Schedule I controlled substances, illicit or dangerous substances, and any controlled substances not lawfully possessed by the ultimate user may not be placed in the kiosk.” 13 − Be waterproof, tamper-evident, and tear-resistant; − Be removable and sealable immediately upon removal without emptying or touching kiosk contents; − When sealed, make the contents of the inner liner not viewable from the outside; − Clearly indicate the size of the inner liner; and − Bear a permanent, unique identifier for tracking purposes. MED-Project kiosks and inner liners will also comply with the Board of Pharmacy requirements. While the DEA Rule does not require LEA kiosks to meet these same requirements, MED-Project will offer these kiosks and inner liners to LEAs. See Disposal of Controlled Substances, 79 Fed. Reg. 53,520, 53,531 (Sept. 9, 2014). 4. Kiosk Collection Under DEA Rule § 1317.05(c)(2)(iv), pharmacy Kiosk Drop-Off Site Hosts must dispose of sealed inner liners and their contents either on-site, through common or contract carrier delivery to, or pick-up by a reverse distributor or distributor, or with DEA assistance. DEA Rule § 1317.75(c) prohibits the counting, sorting, inventorying, or individual handling of any substances deposited into a pharmacy kiosk. Additionally, DEA Rule § 1317.60 limits inner liner access to employees of the collector and requires two employees to immediately seal the inner liner upon its removal from the pharmacy kiosk’s permanent outer container. See DEA Rule § 1317.60(b), (c). DEA Rule § 1317.75(g) provides that pharmacy kiosk inner liner installation or removal shall be performed “by or under the supervision of at least two employees of the authorized collector.” The pharmacy kiosk sealed inner liner must not be opened, x-rayed, analyzed, or otherwise penetrated. See DEA Rule § 1317.60(c). At LEA Kiosk Drop-Off Sites, Vendor and/or LEA will maintain any records of removal, storage, or destruction of the collected Unwanted Medicine in a manner consistent with the LEAs’ recordkeeping requirements for illicit controlled substances evidence pursuant to DEA Rule § 1317.35. LEAs will record the unique identifier and size of the sealed inner liner transferred to Vendor. See DEA Rule § 1317.35. Additionally, any Unwanted Medicine will be stored in a manner to prevent the diversion of controlled substances and consistent with the LEA’s standard procedures for storing illicit controlled substances. Collected Unwanted Medicine will be transferred to the disposal facility in a manner to prevent the diversion of Unwanted Medicine and consistent with the LEA’s standard procedures for transferring illicit controlled substances. See DEA Rule § 1317.35. MED-Project’s Kiosk Drop-Off Site collection system complies with these DEA requirements for pharmacy and LEA Kiosk Drop-Off Sites. Vendor, pharmacies, and LEAs participating in the Program will keep all records required under the DEA Rule, including those required under DEA Rule §§ 1304 and 1317.35. Pharmacies participating in the Program will also keep all records required under Board of Pharmacy requirements. Pharmacy Kiosk Drop-Off Sites and Vendor will be instructed never to count, sort, inventory, or individually handle kiosk contents. MED-Project’s Kiosk Drop-Off Site collection system will also comply with all applicable Board of Pharmacy requirements. 5. Collection Methods A Kiosk Drop-Off Site Host may choose to participate in the program via either the Scheduled Collection Service method or On-Demand Collection Services method, the latter of which is dependent upon the Department’s approval of a Petition for Exception. For both methods, MED-Project provides for the collection, transport, and disposal of Unwanted Medicine at no cost to the Kiosk Drop-Off Site. If a Kiosk Drop-Off Site Host elects to participate via the On-Demand Collection Services method and receives Departmental approval of a Petition for Exception, the Kiosk Drop-Off Site employees shall 14 prepare the inner liner for shipment. On-Demand Collection Services enables a Kiosk Drop-Off Site Host to directly control the timing for servicing the kiosk and are able to seal the liner for packaging and transport at a time of their choosing. The Kiosk Drop-Off Site employees can schedule a common carrier to pick up the packaged inner liner or can offer the packaged inner liner during a regular common carrier pick up. This method enables the Kiosk Drop-Off Site to avoid disruptions to operations that may result from Vendor-scheduled visits or storage limitations. If a Kiosk Drop-Off Site Host elects to participate via the Scheduled Collection Service method, an Unwanted Medicine Service Technician will regularly come to the Kiosk Drop-Off Site to help prepare the inner liner for shipment and disposal. Kiosk Drop-Off Sites that are taking part in the Scheduled Collection Service pick-up method will have regular year-round scheduled time for pick up by a common carrier based on the specific location’s business hours and weight of collected medications. 6. Kiosk Service When servicing a kiosk at a Kiosk Drop-Off Site, two On-Demand Collection Services Kiosk Drop-Off Site employees or an Unwanted Medicine Service Technician under the supervision of two Scheduled Collection Service Kiosk Drop-Off Site employees following instructions provided by Vendor will: − Check the kiosk for any damage. − Remove the inner liner and box from the kiosk and seal them at once following procedures meeting all DEA requirements. − Replace the removed inner liner and box with a replenishment inner liner and box provided by Vendor. − Match the unique identifier of the inner liner to the tracking number on the shipping label, − Package the inner liner for transport. − Prepare the materials for shipment and perform applicable pre-transportation functions to following the DOT HMR. − Schedule a pick-up from the Carrier to be completed within a few business days or offer the packaging holding the sealed inner liner for pick-up by routine Carrier service at the Kiosk Drop- Off Site. If the package with the sealed inner liner is prepared before pick-up, the Kiosk Drop-Off Site Host store the inner liner in compliance with all applicable laws, regulations, and other legal requirements until Carrier pick-up. 7. Frequency of Pick-Up Initially, all Scheduled Collection Kiosk Drop-Off Sites will be scheduled for a monthly pick-up from the kiosk. The Vendor will communicate with MED-Project in the event that the frequency of pick-up needs to be changed based on the volumes collected over time. As needed, MED-Project will communicate with the Scheduled Collection Kiosk Drop-Off Site Host in the event the frequency of pick-up needs to be changed. Vendor will monitor the volumes per service to ensure that all sites are receiving the appropriate service frequency. Vendor will manage pick-up services as frequently as necessary to prevent overflow of the kiosk without providing unnecessary interruption to the participating Scheduled Collection Kiosk Drop-Off Site. On-Demand Collection Kiosk Drop-Off Sites will be instructed to service the kiosk and request a pick-up by Carrier, as needed. Vendor will monitor the weight of Unwanted Medicine generated at each participating Kiosk Drop-Off Site. 15 8. Procedures if a Kiosk is Full Prior to Scheduled Pick-Up The Scheduled Collection Service Kiosk Drop Off Site Host shall be instructed to lock the drop slot of the kiosk and notify MED-Project of the need for service prior to the scheduled date. Vendor shall provide a network of trained Unwanted Medicine Service Technicians. Vendor will communicate service requests to field managers responsible for Unwanted Medicine Service Technicians. Vendor will direct service to the trained Service Technician who is in closest proximity to the Scheduled Collection Service Kiosk Drop Off Site requesting the service. This process provides for a timely response to Scheduled Collection Service Kiosk Drop Of Sites requiring service prior to the scheduled date. Service timelines will be assessed based on the specific characteristics of the Scheduled Collection Kiosk Drop-Off Site’s need. If necessary, Vendor will be able to respond within hours of the request. If the request does not require an urgent response, Vendor will respond within two business days of the request. In the interim, pharmacy Scheduled Collection Kiosk Drop-Off Site Hosts shall be instructed to secure the kiosk and its contents in accordance with DEA requirements. On-Demand Collection Kiosk Drop-Off Sites will be instructed to service the kiosk and request a pick-up by Carrier, as needed. C. Rapid Response Support An unplanned event may necessitate a service at a Kiosk Drop-Off Site. A major event, such as a flood, earthquake, or fire, may jeopardize the security characteristics of the kiosk as well as the structural integrity of the Kiosk Drop-Off Site. Such events may require the involvement of law enforcement, fire, or other emergency service personnel. Kiosk Drop-Off Site employees will be directed to call 911 in situations posing an immediate threat to the environment or health. Once the area is safe for access, if needed, Vendor will dispatch Rapid Responders to secure the kiosk and remove its contents. Vendor maintains a network of Rapid Responders that can be contacted in the case of an incident or other event requiring a Rapid Response. Vendor is able to respond within two to three hours in most cases when notified of a need for a Rapid Response. Rapid Responders will bring all necessary equipment to manage the specific needs of the Kiosk Drop-Off Site requiring a Rapid Response. Along with major event preparedness, Vendor provides timely responses to events that may cause an inconvenience to the Kiosk Drop-Of Site. In situations requiring Rapid Response that do not require the involvement of emergency service personnel, the Kiosk Drop-Off Site Host will place a service request through the Help Desk. If the request does not require a Rapid Response, Vendor will typically respond within two to three business days of the event. An event may occur, such as a site requiring an emergency response or an LEA that is unwilling or unable to securely store inner liners prepared for shipment, that necessitates a direct transport of a sealed inner liner from a Kiosk Drop-Off Site to a disposal facility listed in Section X. In such cases, a Service Technician will seal the kiosk inner liner for packaging and transport according to the process outlined in Section V.B.4.a. The packaged inner liner will then be transported to one of the disposal facilities listed in Section X. D. Take-Back Events MED-Project will conduct Take-Back Events in coordination with HHW events throughout the County. MED-Project may also conduct Take-Back Events upon request by LEAs. LEA employees shall oversee all 16 Take-Back Events. MED-Project will confirm and/or finalize the locations and dates to conduct Take-Back Events once contracts with overseeing LEAs have been executed. Due to the changing schedule of Take-Back Events, the list of dates and locations will be maintained on the MED-Project Website as events are scheduled and confirmed. Annually, MED-Project will review the gaps in coverage and convenience that may exist, as well as progress being made against set collection goals to determine the need for Take-Back Events. 1. Method The conducting of Take-Back Events by MED-Project is contingent upon participation and oversight by LEAs. MED-Project will work with participating LEAs to ensure Take-Back Events are compliant and successful. Events will be promoted and communicated to the public through local communication channels as outlined in Appendix F. MED-Project Take-Back Events will meet all applicable laws, regulations, and other legal requirements. MED-Project will contract with LEAs to oversee Take-Back Events. MED-Project will work with LEAs to accommodate any reasonable requirements. 2. Procedures MED-Project will partner with LEAs to ensure that at least one law enforcement officer oversees collection at all Take-Back Events pursuant to DEA Rule § 1317.65(a), (b). The law enforcement officers will maintain control and custody of all Unwanted Medicine collected at Take-Back Events from collection until secure transfer, storage, or destruction of the Unwanted Medicine, as required by DEA Rule § 1317.65(b). Only ultimate users and persons authorized to dispose of an ultimate user decedent’s property in lawful possession of controlled substances in Schedules II-V may transfer these substances to the LEA during the event. No other person will handle controlled substances at Take-Back Events under DEA Rule § 1317.65(e); however, Vendor may assist LEAs in the collection of Unwanted Medicine at Take-Back Events. See Disposal of Controlled Substances, 79 Fed. Reg. 53,520, 53,539 (Sept. 9, 2014). Take-Back Events will typically be staffed by at least two Vendor employees. Vendor will work in coordination with MED-Project, the County, and LEAs to monitor and ensure collection of all material at Take-Back Events is compliant with all applicable laws, regulations, and other legal requirements and meets the published expectations of the planned event. Vendor will work in conjunction with law enforcement to ensure all material is placed in a compliant collection receptacle and securely shipped to meet all applicable laws, regulations, and other legal requirements. Any material that is not Unwanted Medicine or does not meet legal requirements will be rejected. Vendor and the LEA will maintain all records of collection, storage, or destruction of the collected Unwanted Medicine in a manner consistent with the LEA’s recordkeeping requirements for illicit controlled substances evidence pursuant to DEA Rule § 1317.35. Any collected Unwanted Medicine will be stored to prevent the diversion of controlled substances and consistent with the LEA’s standard procedures for storing illicit controlled substances. Any storage of Unwanted Medicine by Vendor will also comply with the applicable security requirements of DEA Rule §§ 1301 and 1317, including the requirement that Unwanted Medicine is securely stored in a manner consistent with the security requirements for Schedule II controlled substances. Following the completion of each event, containers will be weighed, securely packaged, labeled, transported from the event site to the LEA site, and shipped in compliance with all applicable laws, regulations, and other legal requirements. Law enforcement officers will maintain control and custody of all Unwanted Medicine collected at Take-Back Events while it is transported to the point of secure transfer, storage or destruction. Containers and inner liners will be tracked via unique identifiers to a 17 facility identified in Section X, where they shall be incinerated. Vendor will ship the containers (and inner liners) in accordance with the requirements outlined in Section XII.B. E. Disposal of Unwanted Medicine from Kiosk Drop-Off Sites and Take- Back Events Kiosk Drop-Off Site Host Employees, (or the LEA for Take-Back Events), Vendor, and Carrier shall manage the Unwanted Medicine from Kiosk Drop-Off Sites and Take-Back Events in compliance with all applicable laws, regulations, and other legal requirements. Carrier shall deliver Unwanted Medicine collected from Kiosk Drop-Off Sites and/or Take-Back Events to the respective facilities identified in Section X. Unwanted Medicine is destroyed in accordance with all applicable laws, regulations, and other legal requirements at the disposal facilities identified in Section X. F. Mail-Back Services for Unwanted Medicine MED-Project will provide two types of Mail-Back Services: − Standard Mail-Back Services for disabled and home-bound Residents or persons providing services to such Residents as described in Section V.F.1; − Inhaler Mail-Back Services for the collection of inhalers for disabled and home-bound Residents or persons providing services to such Residents as described in Section V.F.2. Mail-Back Packages will be pre-paid and pre-addressed, and Mail-Back Services shall comply with all applicable laws, regulations, and other legal requirements. 1. Standard Mail-Back Services for Unwanted Medicine For Unwanted Medicine, MED-Project offers Standard Mail-Back Services at no cost to disabled and home-bound Residents, or to persons providing services to such Residents, via the Call Center and MED- Project Website. Standard Mail-Back Packages will also be available to Residents in underserved areas of the County until MED-Project has met its long-term kiosk installation goals. The pre-paid shipping label directs the Standard Mail-Back Package to the facility identified in Section X. Standard Mail-Back Packages for Unwanted Medicine shall comply with all applicable laws, regulations, and other legal requirements. Pursuant to DEA Rule § 1317.70(c), the Standard Mail-Back Packages are: − Nondescript and without any markings or information potentially indicating that they contain Unwanted Medicine, including controlled substances; − Water and spill-proof, tamper-evident, tear-resistant, and sealable; − Pre-addressed with and delivered to Vendor’s registered address; − Pre-paid; − Provided with a unique identifier enabling tracking; and − Provided with instructions indicating the process for mailing back the packages, accepted substances, a notice about mailing restrictions, and a notice that only packages provided by Vendor will be accepted for destruction. Ultimate users and persons lawfully entitled to dispose of an ultimate user decedent’s property will not be required to provide any personally identifiable information when using Standard Mail-Back Services to dispose of Unwanted Medicine. See DEA Rule § 1317.70(d). As required under DEA Rule § 1317.70(e), Vendor will only accept Standard Mail-Back Packages it made available (or packages lawfully forwarded under DEA requirements). Within three business days of receipt, Vendor will notify the DEA if it receives Standard Mail-Back Packages likely containing controlled substances that Vendor did not make available or did not agree to receive pursuant to DEA requirements. In accordance with DEA Rule § 1317.70(f), 18 when Standard Mail-Back Packages are received, only employees of Vendor will handle the Standard Mail- Back Packages. Standard Mail-Back Packages will not be opened, x-rayed, analyzed, or otherwise penetrated upon receipt by Vendor. See DEA Rule § 1317.70(f). Vendor will keep all records required under the DEA Rule, including those identified in DEA Rule § 1304.22(f). See Appendix G for Standard Mail-Back Package image and package specifications. 2. Inhaler Mail-Back Services for Inhalers For inhalers, MED-Project offers Inhaler Mail-Back Services at no cost to disabled and home-bound Residents, or persons providing services to such Residents, via the Call Center and MED-Project Website. The pre-paid shipping label directs the Inhaler Mail-Back Packages to an approved facility identified in Section X. An instruction sheet is included with the Inhaler Mail-Back Package that describes how to properly dispose of inhalers, explains what materials may be placed in the Inhaler Mail-Back Package, and how to return the Inhaler Mail-Back Package. See Appendix G for an Inhaler Mail-Back Package image and package specifications. 3. Mail-Back Package Availability Disabled and home-bound Residents or persons providing services to such Residents may request Standard Mail-Back Packages and/or Inhaler Mail-Back Packages by calling the Call Center or through a link on the MED-Project Website. Upon request, such Residents are provided Mail-Back Packages. Standard Mail-Back Packages will also be available to Residents in underserved areas of the County until MED-Project has met its long-term kiosk installation goals. Each Mail-Back Package contains an insert with instructions for use and information about other options for disposing of Unwanted Medicine in the Specified Languages. See Appendix G for Mail-Back Package images. 4. Mail-Back Package Collection and Disposal Requests to receive Mail-Back Packages are taken through the Call Center and the MED-Project Website. Residents are directed to follow the instructions provided in the Mail-Back Package and to place their Unwanted Medicine in the pre-addressed, pre-paid package. The Mail-Back Package shall be sent to an approved disposal facility in compliance with all applicable laws, regulations and other legal requirements. Each Mail-Back Package has a unique identifier for tracking. For Standard Mail-Back Packages, upon arriving at the disposal facility, the Mail-Back Packages are scanned for receipt verification and incinerated at the disposal facilities listed in Section X. Any storage of filled Standard Mail-Back Packages by Vendor complies with the applicable security requirements of DEA Rule § 1317, including the requirement that Unwanted Medicine is securely stored in a manner consistent with the security requirements for Schedule II controlled substances. All Unwanted Medicine in Standard Mail-Back Packages are destroyed promptly. 19 VI. Goals The short- and long-term goals of the Plan are described generally as follows. Additional detail on implementation is provided in Section V.A.2. Goal Area Short-Term Goals (12 to 18 months Post Approval) (19 to 36 months Post Approval) MED-Project’s goal is to achieve 100 Kiosk Drop-Off Sites, distributed jointly, in combination with other approved product stewardship programs, across the County to provide equitable and reasonably convenient access to Residents. Accept any additional potential Kiosk Drop- Off Sites that are eligible and request participation in the Program. Reduce collection via Take-Back Events and/or Mail-Back Services by establishing additional Kiosk Drop-Off Sites throughout the County. Education & Public Outreach Continue media Program consistent with Regulations § 8.A.viii via the following: • Website • Call Center • Media campaigns (for example, digital television, radio, and social media) Continue media Program consistent with Regulations § 8.A.viii via the following: • Website • Call Center • Media campaigns (for example digital television, radio, and social media) MED-Project continues to implement Kiosk Drop-Off Sites in eligible locations that best serve the demographics and distribution of Residents. See Section V.B for more information about Kiosk Drop-Off Site collection. MED-Project Mail-Back Packages will be made available to disabled and home-bound Residents, persons providing services to such Residents, and Residents in underserved areas of the County by request through the Call Center and MED-Project Website 20 VII. Patient Privacy Instructions at each Kiosk Drop-Off Site informs Residents who deposit Unwanted Medicine that they should completely cross out, remove, or otherwise make unreadable any and all personally identifiable information on the containers and packaging before depositing them in the kiosk. In cases where people follow the instructions, there will be no personally identifiable information. In addition to kiosk signage, MED-Project promotional and educational materials encourage Residents to protect their information by ensuring that identifiable information is not present before depositing containers into kiosks or Mail-Back Packages. Materials to help Residents cross out any personally identifiable information will also be available at Take- Back Events. This will ensure any patient information on drug packaging will be unreadable. Vendor has additional protections available for keeping Residents’ personally identifiable information safe and secure. Unwanted Medicine Service Technicians are trained in managing items containing sensitive patient information. Privacy training is part of an Unwanted Medicine Service Technician’s prerequisite for field services. As an added protection, inner liners for the kiosks are opaque rather than clear, in compliance with DEA Rule. 21 VIII. Call Center MED-Project has established a toll-free telephone number for Residents to obtain information about Kiosk Drop-Off Sites, Mail-Back Services, educational materials, and other aspects of the Program. Callers with medical emergencies are directed to call 911. Patients with medication-related questions are directed to contact their health care provider(s). The Call Center provides information about: − Items that can be disposed of; − Disposal options; − Unwanted Medications Kiosk Drop-Off Sites and disposal options in the caller’s specified zip code; − The MED-Project website; and − How to obtain Mail-Back Packages. To increase access to the Program for Residents, MED-Project has included dialing options for TTY and 711 services. A sample Call Center outline is included in Appendix I. 22 IX. Training Vendor certifies training of Unwanted Medicine Service Technicians on the following: − DOT HMR training to meet the requirements of 49 CFR Part 172.704(a). − DEA controlled substances handling protocols. − Emergency Spill Response and Contingency Plan − Health Insurance Portability and Accountability Act (HIPAA) requirements. − OSHA Blood Borne Pathogens Standards. − Safety Training − Security awareness Training − Communication Devices − PPE Utilization − Alarm Systems − General Awareness/Familiarization − In-Depth Security Training (if applicable) − Function Specific Training At a Kiosk Drop-Off Site, operational procedures, including annual training, are the responsibility of the Kiosk Drop-Off Site Host. MED-Project provides a Help Desk to answer questions and monitor comments for participating Kiosk Drop-Off Sites. 23 X. Vendor, Transporter, and Disposal Facility Information All Vendors, transporters, and disposal facilities utilized by the Program will operate in accordance with all applicable laws, regulations, and other legal requirements.4 A. Vendors Name Address Phone Website Type Penalty Record (5 years) Solutions, LLC 190 Shellyland Road, Manheim, PA 17545 (717) 653- 8882 www.cova nta.com Vendor None PureWay Compliance, Inc. Freeway, Suite 206, Katy, TX 77450 3030 way.com Stericycle, Inc. Waukegan Road, Bannockbu rn, IL 60015 5910 ycle.com B. Reverse Distributors Name Address Phone Website Type Issued Permits Penalty Record (5 years) Environmental Solutions, LLC 2515 S Holt Rd, Indianapolis, IN 46241 (317) 719- 6397 https://ww w.covanta. com/Our- Facilities/C ES-Indy DEA Registered Collector and Reverse Distributor DEA Registratio n No: RC0561628 See Appendix H 4 Two witnesses of the registrant will witness destruction at the disposal facilities. 24 Name Address Phone Website Type Issued Permits Record (5 years) Covanta Manheim, Pennsylvania Facility 190 Shellyland Road, Manheim, PA 17545 (717) 653- 8882 www.cova ntaes.com DEA Registered Collector and Reverse Distributor DEA Registratio n No: RC0322595 None Stericycle, Inc. Warren, Ohio Facility 1901 Pine Avenue, SE, Warren, OH 44483 (330) 393- 0370 www.steric ycle.com/s ervice- locations/o hio/warren DEA Registered Collector and Reverse Distributor DEA Registratio n No: RS0498130 See Appendix H Sedgwick Claims Management Services, Inc 2670 Executive Drive, Suite A, Indianapolis, IN 46241 317- 250- 4353 Sedgwick.c om Registered Reverse Distributor Registratio n No: RS0629874 Appendix H C. Carriers & Transporters Record (5 years) Covanta Environment al Solutions dba Chesapeake Waste Solutions, LLC 190 Shellyland Road, Manheim, PA 17545 (336) 683-0809 www.cova ntaes.com Carrier PADEP Registration PA-HC0283 None 25 Name Address Phone Website Type Issued Permits Penalty Record (5 years) Covanta Environment al Solutions Carriers II, LLC 5300 N 33rd St, Milwaukee, WI 53209 (336) 683-0809 www.cova ntaes.com Hazardous Waste Transporter DOT No: 508337 None Doncin Transport, Inc. 3478 Sunnyside Rd, Manheim, PA 17545 (602) 344-4536 None provided Contract Carrier DOT No: 1625457 None EMS Dispatch, Inc. 316 W Mt Vernon St, Lansdale, PA 19446 689-5129 ww.facebo ok.com/pa ges/Ems- Dispatch/1 37953629 908858 Carrier 000743959 Heritage Transport 1626 Research Way, Indianapoli s, IN 46231 (317) 486-2973 http://ww w.heritage - enviro.co m/ Hazardous Waste Transporter DOT No: 314460 None Stericycle Inc. 2850 100th Court NE, Blaine, MN 55449 (612) 285-9865 www.steri cycleenvir onmental. com Hazardous Waste Transporter DOT No: 1348411 None Tri-State Motor Transit Co. 8141 E 7th St, Joplin, MO 64801 860-1600 tatesecure d.com/ Waste Transporter 1007292 26 Name Address Phone Website Type Issued Permits Penalty Record (5 years) United Parcel Service, Inc. 55 Glenlake Parkway NE, Atlanta, GA 30328 (800) PICK-UPS www.UPS. com/ Common Carrier DOT No: 121058 Closed Case 9/18/201 9 VA- 2019- 0057- US1436 United States Postal Service 475 L’Enfant Plaza SW, Washington , DC 20260 (202) 268-2000 www.USP S.com/ Common Carrier N/A See USPS SEC filings D. Disposal Facilities Permits Record (5 years) Harbors Aragonite, LLC 11600 North Aptus Rd, Grantsville, UT 84029 884-8900 nharbors. com/locat ion/arago nite- incinerati on-facility Waste Incinerator UTD98155217 7 Title V Operating Permit No: 4500048003 H Curtis Bay Energy, LP 3200 Hawkins Point Road, Baltimore, MD 21226 (855) 228-1715 www.curti sbaymws. com Medical Waste Incinerator EPA ID No: MDD98540431 8 Refuse Disposal Permit No: 2017-WMI- 0036 See Appendix H 27 Name Address Phone Website Type Issued Permits Record (5 years) Heritage Thermal Services – Ohio 1250 Saint George Street, East Liverpool, OH 43920 (800) 545-7655 http://ww w.heritag e- thermal.c om/ Hazardous Waste Incinerator EPA ID No: OHD98061354 1 Title V Operating Permit No: OH000000021 5020233 See Appendix H Ross Incineration Services, Inc. 36790 Giles Road, Grafton, OH 44044 (440)- 748-5800 http://ww w.rossenv ironmenta l.com/ Hazardous Waste Incinerator EPA ID No: OHD04841566 5 Title V Operating Permit No: OH000000024 7050278 See Appendix H Stericycle, Inc., Warren, Ohio Facility 1901 Pine Avenue SE, Warren, OH 44483 393-0370 ww.steric ycle.com/ service- locations/ ohio/warr en Waste Incinerator OHD98079528 0 Title V Operating Permit No: OH000000027 8080634 H Veolia – Port Arthur 7665 Highway 73, Beaumont, TX 77705 (409) 736-2821 www.veol ianortham erica.com Hazardous Waste Incinerator EPA ID No: TXR00003625 1 Title V Operating Permit No: TX0000004824 500118 See Appendix H 28 XI. Unwanted Medicine Educational and Outreach Programming A. Overview MED-Project will perform public education and outreach to educate Residents about the collection and disposal of Unwanted Medicine from households. B. Audiences To effectively educate the public about the Program, MED-Project will continue to implement a comprehensive communications campaign featuring both broad communications tactics as well as targeted outreach to audiences directly involved in the distribution and use of medicines to Residents. These audiences may include: • General public. • Pharmacies, including education for dispensers of Unwanted Medicine. • Retailers of Unwanted Medicine. • Health care providers and their patients. • Veterinary providers and animal owners. • Public health facilities; and/or • LEAs. The Program will include efforts to reach the varied cultural, linguistic, geographic, and age demographics, including through outreach to ethnic, community, and alternate-language media; outreach to community organizations serving a broad range of audiences; availability of alternate language phone lines (Section XI.D.1); and availability of educational information through a broad range of media platforms. Survey results will be utilized in order to inform improvements to the design of the outreach program and educational materials where necessary (see Section XI.F). C. Messages MED-Project anticipates that messaging will: • Educate Residents about the appropriate use, storage, and disposal of Unwanted Medicine. • Educate Residents about available Mail-Back Services; and • Provide Residents with information about available locations and events in their area that offer disposal of Unwanted Medicine. Key points of emphasis might include: • The importance of taking medicines as prescribed by your health care provider. • The importance of adhering to and completing your provider-prescribed therapy. • The importance of properly and securely storing medicines. • The importance of promptly and properly disposing of Unwanted Medicine. • How to find and use Kiosk Drop-Off Sites. • How to properly dispose of Unwanted Medicine; and • Privacy issues (removing personally identifiable information from labeled prescription containers). D. Tools/Communications Channels The MED-Project Program will include a number of components designed to reach consumers and provide consistent access to timely and relevant information. Distribution of materials will likely include audiences 29 such as LEAs, retail pharmacies, health care providers and systems, health associations, local government agencies, and other community organizations. MED-Project will design and execute a measurable public education and outreach strategy aimed at driving awareness of take-back of Unwanted Medicine and in line with Ordinance §§ 6.53.050 (A) (8) and 6.53.070. MED-Project will evaluate and Plan media tactics based on the needs of the campaign and media usage within the target audience, and these may include a combination of digital media campaigns, print ads, out-of-home ads, digital video, and traditional broadcast media based on budget. The quantity and frequency will be confirmed as activities are completed. MED-Project expects that the tools and communication channels will include: 1. Phone The Program will provide a toll-free telephone number for Residents to obtain information about Kiosk Drop-Off Sites, Take-Back Events, Mail-Back Services, educational materials, and other aspects of the Program for the take-back of Unwanted Medicine from households. The toll-free number will provide: • Call Center in the Specified Languages. The telephone line will also provide an option for callers to be transferred to a staffed Call Center. Live operators will be available in English and Spanish. If a caller requires assistance in Chinese, Vietnamese or Tagalog, an operator will be available to provide additional assistance. Operators providing services in over 200 languages are available 24 hours a day, seven days a week. • Basic information about the Program, such as where to obtain more information (e.g., the MED- Project Website) and an option to talk with an agent to find or utilize Kiosk Drop-Off Sites, Mail- Back Services, and/or Take-Back Events, if applicable, in the caller’s zip code or local area. • A recorded call script directing callers with medical emergencies to call 911 and directing callers with medication-related questions to contact their health care provider(s). Please see Appendix I for the Call Center IVR flow. 2. MED-Project Website MED-Project will update the mobile-friendly MED-Project Website with translations in the Specified Languages. MED-Project expects information available to users will include pages to help Residents find locations of Kiosk Drop-Off Sites, Mail-Back Services, as well as educational materials, frequently asked questions and responses, and Take-Back Event dates and locations. • The Plan currently includes a mockup of the types of information a MED-Project Website and its supporting pages might contain. Appendix J provides proof of concept samples for a possible MED-Project Website with subpages. • The MED-Project Website may also include access to a public relations toolkit in a printable format (see Section XI.D.3) and contact information for Residents. A toolkit could include items such as a flyer/brochure (See Appendix K for an example) and a frequently asked questions (FAQ) document. Translations of the brochure and FAQ will be available in the Specified Languages. • Community and government organizations and other public interest groups seeking materials to promote the Program will be encouraged to access these resources. 3. Materials Educational materials about the Program and how to properly dispose of Unwanted Medicine will be available through the MED-Project Website, through potential third-party partners, community organizations, and at Kiosk Drop-Off Sites. 30 The Plan includes the information and educational brochure (Appendix K). Educational materials will use plain language and explanatory images to promote consumer education and collection options to Residents with limited English proficiency. 4. Social Media MED-Project has established social media accounts to communicate outreach information. Outreach is based on the establishment of Kiosk Drop-Off Sites, Mail-Back Services, and the scheduling of Take-Back Events. Posts will be utilized as needed to reflect the most up-to-date information. 5. Broadcast Outreach Outreach through local print, online, radio, and television outlets, including through outlets specifically targeting the diverse demographic communities within the County, will continue upon Plan approval. Please see Appendix F for a media list of key outlets. Broadcast outreach will be scheduled to reflect the learnings and needs of the campaign based on the biennial survey outcomes and budget. E. Collaboration with County Officials and Community Organizations MED-Project expects that the Program will work in collaboration with the County as appropriate to build on existing community outreach resources, such as local organizations, media lists, available public media outlets, etc. Activities like the following will continue upon Plan approval: • Briefing Materials Provided to Support Coordination with County Officials: o The Program will provide access to updated educational and outreach materials, including the brochure (see Appendix K), to relevant departments and officials. • Outreach through Community Organizations: o The Program will engage relevant stakeholders and community organizations by providing selected community organizations identified in Appendix B with the updated brochure included in Appendix K. F. Effectiveness MED-Project will conduct a biennial survey of Residents and pharmacists, veterinarians, and health professionals in the County who interact with patients to measure awareness of the take-back of Unwanted Medicine from households and to evaluate the effectiveness of its education and outreach activities. The survey will be conducted in conjunction with the biennial survey conducted under MED- Project’s stewardship program for the collection of sharps from households. The first survey was conducted after the first full year of operation of MED-Project’s program for sharps. G. Disclaimer The written and verbal educational materials and public outreach tools that are required by the Ordinance and disseminated under this Product Stewardship Plan will include a disclaimer similar to the following: “This material has been provided for the purpose of compliance with legislation and does not necessarily reflect the views of MED-Project or the Producers participating in the MED-Project Product Stewardship Plan.” 31 XII. Compliance with Applicable Laws, Regulations, and other Legal Requirements As described in more detail below, the Plan is designed such that all entities participating in the Program shall comply with all applicable laws, regulations, and other legal requirements. H. DEA Controlled Substances Act and Implementing Regulations On October 12, 2010, the United States Congress enacted the Secure and Responsible Drug Disposal Act of 2010 (“Disposal Act”) as amendments to the Controlled Substances Act (“CSA”). The Disposal Act amended the CSA to allow for the expansion of entities to which users can deliver pharmaceutical controlled substances for disposal, subject to regulations to be promulgated. On September 9, 2014, the DEA adopted a rule entitled “Disposal of Controlled Substances” (referred to herein as the “DEA Rule”) to implement the Disposal Act. Under the DEA Rule, collection of controlled substances is limited to Schedule II, III, IV, or V controlled substances that are lawfully possessed by an ultimate user or person entitled to dispose of an ultimate user decedent’s property. See DEA Rule §§ 1317.75(b) (Kiosk Drop-Off Sites)5; 1317.65(d) (Take-Back Events); 1317.70(b) (Mail-Back Services). Schedule I controlled substances, controlled substances that are not lawfully possessed as described above, and other illicit or dangerous substances will not be collected. Additionally, as these provisions of the DEA Rule limit collection of controlled substances to those lawfully possessed by an ultimate user or certain other persons, pharmacies are prohibited from disposing their own inventory or stock through the MED-Project Program. See also DEA Rule § 1317.05. The DEA Rule provides that LEAs can continue to accept controlled substances for disposal. However, the DEA Rule also provides that pharmacies, reverse distributors, hospitals/clinics with on-site pharmacies, and certain other entities, can register with the DEA as “collectors” and become authorized at their discretion on a voluntary basis to accept controlled substances. The DEA Rule: • Provides for the collection of controlled substances at Kiosk Drop-Off Sites at LEAs, pharmacies, and hospitals with on-site pharmacies; • Provides for collection of controlled substances at Take-Back Events; • Provides for the use of mail-back programs to collect controlled substances; • Allows for the commingling of controlled and non-controlled substances; • Establishes detailed collection, recordkeeping, security, and other measures for all approved collection methods; and • Provides that all collected pharmaceutical products be destroyed so that the products are rendered non-retrievable. The Plan is designed such that all entities that are part of the Program, including Vendor, are individually responsible to comply with their respective compliance obligations under the DEA Rule. Vendor will ensure that the collection, transportation, and disposal of Unwanted Medicine collected from Kiosk Drop- Off Sites, Mail-Back Services, and Take-Back Events, including controlled substances, complies with all DEA requirements, including those in DEA Rule § 1317. Controlled substances collected pursuant to the Plan may be commingled with non-controlled substances at Kiosk Drop-Off Sites, Take-Back Events, and through Mail-Back Services per the DEA Rule. See DEA 5 For Kiosk Drop-Off Site collection, only certain substances “that are lawfully possessed by an ultimate user or other authorized non-registrant person may be collected.” DEA Rule § 1317.75(b). This language is similar to, but slightly different than, provisions limiting collection at Take-Back Events and through Mail-Back Services to ultimate users or other persons (lawfully) entitled to dispose of an ultimate user decedent’s property. See DEA Rule §§ 1317.65(d); 1317.70(b). 32 Rule §§ 1317.75(b) (Kiosk Drop-Off Sites); 1317.65(d) (Take-Back Events); 1317.70(b) (Mail-Back Services). 1. DEA Registration Modification Pursuant to DEA Rule § 1301.51(b), pharmacies may modify their registrations to become authorized collectors by submitting a written request to the DEA or online at www.DEAdiversion.usdoj.gov. This request must contain: • The registrant’s name, address, and registration number (as printed on the registration certificate); • The collection methods the registrant intends to conduct; and • A signature in accordance with 21 C.F.R. § 1301.13(j). See DEA Rule § 1301.51(b). MED-Project will consult with participating pharmacies, as requested, regarding how to modify DEA registrations to become authorized collectors. I. United States Department of Transportation (DOT) When transporting Unwanted Medicine, Vendor will ensure compliance with the U.S. DOT HMR and other applicable DOT requirements. J. California Board of Pharmacy On June 8, 2017, the Board of Pharmacy adopted the Board of Pharmacy Regulations, Article 9.1 of Division 17 of Title 16 of the California Code of Regulations. Largely based on the DEA Rule, the Board of Pharmacy Regulations establish requirements applicable to pharmacies, hospitals/clinics with on-site pharmacies, distributors, and reverse distributors conducting certain drug take-back services. Among other things, the Board of Pharmacy Regulations provide: • That California-licensed pharmacies and hospitals/clinics with on-site pharmacies must be in good standing with, and notify, the Board of Pharmacy to host a drug kiosk. See 16 CCR §§ 1776, 1776.1(i). • That pharmacies must “know and adhere” to all applicable “federal, state, and local requirements governing the collection and destruction of dangerous drugs” when operating a drug take-back program. See 16 CCR § 1776.1(b). • Drug kiosk placement and monitoring requirements. See 16 CCR §§ 1776.3(b)–(d). • Drug kiosk inner liner, container, and signage requirements. See 16 CCR §§ 1776.3(f), (h), (m). • Inner liner handling, storage, and destruction requirements for drug kiosks. See, e.g., 16 CCR §§ 1776.3(h)–(j), 1776.5(a)–(c). • Pharmacy and reverse distributor recordkeeping requirements. See 16 CCR §§ 1776.5(e)–(f), 1776.6. • Pharmacy drug mail-back program requirements. See 16 CCR § 1776.2. The Plan is designed such that all entities that are part of the Program, including Vendor, are individually responsible for complying with their respective compliance obligations under the Board of Pharmacy Regulations. 33 XIII. Annual Report An annual report will be provided to the Director on or before the date set by the Department and annually thereafter. Ordinance § 6.53.080. This report will be provided in the format required by the Ordinance § 6.53.080 and Regulations § 15. The total amount by weight collected by a Mail-Back Program will be provided using an average weight per Mail-Back Package, as provided by Vendor. 34 Appendix A MED-Project Participants The list of participating Producers in MED-Project’s Program in the County is provided to the County on a periodic basis to satisfy Ordinance requirements. 35 Appendix B Contact List for Outreach and Education to the Community The following is a representative list of Associations, Agencies, and Organizations that may be contacted for assistance with outreach and education to the community. Health Systems: Alameda County Medical Center Children’s Hospital and Research Center Fremont Hospital Kaiser Foundation Hospital St. Rose Hospital Sutter Health Stanford Health Washington Hospital Health Associations and Societies: California State Board of Pharmacy California Pharmacists Association The Medical Board of California California Nurses Association National Association of Social Workers California Chapter California Board of Registered Nursing California Board of Vocational Nursing California Department of Health Care Services California Health and Human Services Agency Organizations, Districts, and Agencies: Alameda County Public Health Department Alameda County Department of Environmental Health Alameda County Public Works Agency Alameda County Board of Supervisors Alameda County Fire Department American Medical Response Alameda County CalRecycle 36 Appendix C Interested Sites and Participating Kiosk Drop-Off Sites as of June 29, 2022 MED-Project will provide the County with a list of participating Kiosk Drop-Off Sites on a periodic basis, as requested by the County. Kiosk Drop-Off Sites marked with an asterisk have received an exception from Alameda County Department of Environment Health to operate as an On-Demand Collection Service Kiosk Drop-Off Site. Site Name Address City Zip Code 2693 FRUITVALE AVENUE OAKLAND 94601 ACTIVE SITE* ALAMEDA COUNTY SHERIFF’S OFFICE 15001 FOOTHILL BLVD. SAN LEANDRO 94578 INTERESTED ALAMEDA HOSPITAL 2070 CLINTON AVENUE ALAMEDA 94501 ACTIVE SITE ALAMEDA POLICE DEPARTMENT 1555 OAK ST. ALAMEDA 94501 ACTIVE SITE* DEPARTMENT 101 8TH ST. OAKLAND 94607 ACTIVE SITE BERKELEY POLICE DEPARTMENT (1st kiosk) 2100 MARTIN LUTHER KING JR. WAY BERKELEY 94704 ACTIVE SITE BERKELEY POLICE DEPARTMENT (2nd kiosk) 2100 MARTIN LUTHER KING JR. WAY BERKELEY 94704 ACTIVE SITE California State University, East Bay 25800 Carlos Bee Boulevard Hayward 94542 ACTIVE SITE* PANSMART, INC. 2557 MOWRY AVE. FREMONT 94538 ACTIVE SITE CLOVER PHARMACY 6170 THORNTON AVE. NEWARK 94560 ACTIVE SITE* CVS/PHARMACY #0331 CVS/PHARMACY #0816 22501 FOOTHILL BLVD. HAYWARD 94541 ACTIVE SITE* CVS/PHARMACY #09397 4405 1ST ST. LIVERMORE 94551 ACTIVE SITE* 37 Site Name Address City Zip Code CVS/PHARMACY #09494 35080 NEWARK BLVD. NEWARK 94560 ACTIVE SITE* CVS/PHARMACY #09553 4349 SAN PABLO AVENUE EMERYVILLE 94608 ACTIVE SITE* CVS/PHARMACY #09600 35720 FREMONT BLVD. FREMONT 94536 ACTIVE SITE* CVS/PHARMACY #09622 243 W JACKSON ST. HAYWARD 94544 ACTIVE SITE* CVS/PHARMACY #09635 1550 E 14TH STREET SAN LEANDRO 94577 ACTIVE SITE* CVS/PHARMACY #09678 1500 1ST ST. LIVERMORE 94550 ACTIVE SITE* CVS/PHARMACY #09876 699 LEWELLING BLVD. SAN LEANDRO 94579 ACTIVE SITE* CVS/PHARMACY #09904 3667 CASTRO VALLEY BLVD. CASTRO VALLEY 94546 ACTIVE SITE* CVS/PHARMACY #09941 1451 SHATTUCK AVE. BERKELEY 94709 ACTIVE SITE* #09942 1401 WASHINGTON AVE. SAN LEANDRO 94577 ACTIVE SITE* CVS/PHARMACY #10119 6750 BERNAL AVE. PLEASANTON 94566 ACTIVE SITE* CVS/PHARMACY #10121 2655 TELEGRAPH AVE. BERKELEY 94704 ACTIVE SITE* CVS/PHARMACY #10199 26059 MISSION BLVD. HAYWARD 94544 ACTIVE SITE * CVS/PHARMACY #10475 2964 BROADWAY OAKLAND 94611 ACTIVE SITE* CVS/PHARMACY #10924 3010 BERNAL AVE. PLEASANTON 94566 ACTIVE SITE* 38 Site Name Address City Zip Code CVS/PHARMACY #3024 7201 REGIONAL ST. DUBLIN 94568 ACTIVE SITE* CVS/PHARMACY #3026 2300 SHATTUCK AVE. BERKELEY 94704 ACTIVE SITE* CVS/PHARMACY #8431 CVS/PHARMACY #9099 4020 FREMONT HUB FREMONT 94538 ACTIVE SITE* CVS/PHARMACY #9128 2314 SANTA CLARA AVE. ALAMEDA 94501 ACTIVE SITE* CVS/PHARMACY #9130 CVS/PHARMACY #9226 CVS/PHARMACY #9234 46445 MISSION BLVD. FREMONT 94539 ACTIVE SITE* CVS/PHARMACY #9250 885 ISLAND DR. STE. A ALAMEDA 94502 ACTIVE SITE* CVS/PHARMACY #9251 CVS/PHARMACY #9255 931 MARINA VILLAGE PKWY ALAMEDA 94501 ACTIVE SITE * CVS/PHARMACY #9378 4100 REDWOOD RD. OAKLAND 94619 ACTIVE SITE * DUBLIN POLICE SERVICES 100 CIVIC PLAZA DUBLIN 94568 ACTIVE SITE Dublin Police Services 6361 Clark Avenue DUBLIN 94568 ACTIVE SITE* SUTTER HEALTH EDEN MEDICAL CENTER (1ST KIOSK) 20103 LAKE CHABOT ROAD CASTRO VALLEY 94546 ACTIVE SITE EDEN HOSPITAL (2ND KIOSK) 20103 LAKE CHABOT ROAD CASTRO VALLEY EMERYVILLE POLICE DEPARTMENT 2449 POWELL ST. EMERYVILLE 94608 ACTIVE SITE* AND MEDICAL SUPPLY 37323 FREMONT BLVD. FREMONT 94536 ACTIVE SITE * HIGHLAND HOSPITAL OUTPATIENT 1411 E 31ST ST. OAKLAND 94602 ACTIVE SITE 39 Site Name Address City Zip Code PHARMACY (1ST KIOSK) 34460 FREMONT BLVD., SUITE B FREMONT 94555 ACTIVE SITE KAISER HEALTH PLAN OHLONE PHY 162 (1st kiosk) 39400 PASEO PADRE PKWAY FREMONT 94538 ACTIVE SITE* KAISER HEALTH PLAN OHLONE PHY 162 (2nd kiosk) 39400 PASEO PADRE PKWAY FREMONT 94538 ACTIVE SITE* KAISER DUBLIN MOB PHARMACY 061 3100 DUBLIN BLVD., FL. 1 DUBLIN 94568 ACTIVE SITE* KAISER HEALTH PLAN SOUTH 1 PHY 471 7601 STONERIDGE PLEASANTON 94588 ACTIVE SITE* KAISER PERMANENTE PHARMACY #102 3701 BROADWAY OAKLAND 94611 ACTIVE SITE* KAISER PERMANENTE PHARMACY #105 3600 BROADWAY OAKLAND 94611 ACTIVE SITE * KAISER PERMANENTE PHARMACY #241 3000 LOS POSITAS LIVERMORE 94551 ACTIVE SITE KAISER PERMANENTE PHARMACY NO 101 2417 CENTRAL AVE. ALAMEDA 94501 ACTIVE SITE* KAISER UNION CITY MAIN MOB 2 PHY #132 (1st kiosk) 3553 WHIPPLE RD. UNION CITY 94587 ACTIVE SITE* KAISER UNION CITY MAIN MOB 2 PHY #132 (2nd kiosk) 3553 WHIPPLE RD. UNION CITY 94587 ACTIVE SITE* KAISER PERMANENTE PHARMACY #923 (1st kiosk) 2500 MERCED ST., BLDG H, FL 1, ROOM 1436 40 Site Name Address City Zip Code KAISER PERMANENTE PHARMACY #923 (2nd kiosk) 2500 MERCED ST., BLDG H, FL 1, ROOM 1436 SAN LEANDRO 94577 ACTIVE SITE* Kaiser Berkeley #910 OP Pharmacy 2621 Tenth Street, FL 2 Room 2505 MISSION PHARMACY MOWRY MEDICAL PHARMACY 1999 MOWRY AVE., STE A FREMONT 94538 ACTIVE SITE* NEW OAKLAND PHARMACY - LAKE MERRITT 250 E. 18TH ST. OAKLAND 94606 ACTIVE SITE NEW OAKLAND PHARMACY #2 388 9TH ST. OAKLAND 94607 ACTIVE SITE NEW OAKLAND PHARMACY #1 333 9TH ST. OAKLAND 94607 ACTIVE SITE PIEDMONT POLICE DEPARTMENT 403 HIGHLAND AVE. PIEDMONT 94611 ACTIVE SITE PLEASANTON / BART POLICE SERVICES CENTER 6050 STONERIDGE MALL ROAD PLEASANTON 94588 ACTIVE SITE PLEASANTON POLICE DEPARTMENT 4833 BERNAL AVE. PLEASANTON 94566 ACTIVE SITE RITE AID 05918 3744 MOWRY AVENUE FREMONT 94538 INTERESTED RITE AID 05920 31091 MISSION BOULEVARD HAYWARD 94544 ACTIVE SITE* RITE AID 05922 BOULEVARD VALLEY RITE AID 05925 968 MURRIETA BOULEVARD LIVERMORE 94550 ACTIVE SITE* RITE AID 05937 1355 MACARTHUR BOULEVARD SAN LEANDRO 94577 ACTIVE SITE* 41 Site Name Address City Zip Code RITE AID 05942 31836 ALVARADO BOULEVARD UNION CITY 94587 ACTIVE SITE* RITE AID 05943 1650 DECOTO ROAD UNION CITY 94587 ACTIVE SITE* RITE AID 05944 RITE AID 05952 1991 MOUNTAIN BOULEVARD OAKLAND 94611 ACTIVE SITE* RITE AID 06456 1350 NORTH VASCO ROAD LIVERMORE 94551 ACTIVE SITE* SAN LEANDRO HOSPITAL 13855 EAST 14TH ST. SAN LEANDRO 94578 ACTIVE SITE TEDS DRUGS 27453 HESPERIAN HAYWARD 94545 ACTIVE SITE* TENNYSON PHARMACY 589 W. TENNYSON HAYWARD 94544 ACTIVE SITE* UNITED PHARMACY WASHINGTON HOSPITAL PHARMACY 2000 MOWRY AVE. FREMONT 94538 ACTIVE SITE WELLSPRING PHARMACY 4184 C PIEDMONT AVE. OAKLAND 94611 ACTIVE SITE* 42 Appendix D Potential Additional Kiosk Drop-Off Sites Site Name Address City Zip 400 THIRTIETH ST. STE 300 OAKLAND 94609 AIRPORT POLICE SERVICES ALAMEDA PHARMACY LLC ALBANY POLICE DEPARMTNET 1000 SAN PABLO AVE. ALBANY 94706 ALTA BATES SUMMIT MED CTR- HERRICK CAMPUS 2001 DWIGHT WY. BERKELEY 94704 ALTA BATES SUMMIT MEDICAL CENTER - ALTA BATES CAMPUS 2450 ASHBY AVE. BERKELEY 94705 ALTA BATES SUMMIT MEDICAL CENTER 350 HAWTHORNE AVE. OAKLAND 94609 ALTA BATE@S SUMMIT OUTPATIENT PHARMACY 2001 DWIGHT WAY STE. 2182 BERKELEY 94704 BART POLICE DEPARTMENT BRADFORD PHARMACY INC. 445 8TH STREET OAKLAND 94607 CALIFORNIA DEPARTMENT OF TOXIC SUBSTANCES CONTROL 700 HEINZ AVE., #200 BERKELEY 94710 CALIFORNIA STATE UNIVERSITY, EAST BAY 25800 CARLOS BEE BLVD. HAYWARD 94542 CENTRAL ADMIXTURE PHARMACY 48006 FREMONT BLVD. FREMONT 94538 CHILDREN'S HOSPITAL & RESEARCH 747 52ND ST. OAKLAND 94609 CHILDREN'S HSP MED CTR AMBULATORY CARE 744 52ND ST. OAKLAND 94609 CHILDRENS CLINIC PHARMACY 747 52ND STREET OAKLAND 94609 CLEAR CHOICE PHARMACY 3059 HOPYARD RD. STE. C PLEASANTON 94588 COMMUNITY A WALGREENS PHARMACY #16477 3009 BROADWAY OAKLAND 94611 43 CORAM CVS/SPECIALTY INFUSION SERVICES 3160 CORPORATE PLACE HAYWARD 94545 COSTCO PHARMACY #1061 28505 HESPERIAN BLVD. HAYWARD 94545 COSTCO PHARMACY #146 2800 INDEPENDENCE DRIVE LIVERMORE 94550 COSTCO PHARMACY #778 43621 PACIFIC COMMONS BLVD. FREMONT 94538 COSTCO PHARMACY 118 1900 DAVIS STREET SAN LEANDRO 94577 CPP PET CARE 3157 CORPORATE PL. HAYWARD 94545 CRESCENT HEALTHCARE 2547 BARRINGTON CT. HAYWARD 94545 7200 AMADOR PLAZA RD. DUBLIN 94568 4300 LAS POSITAS RD. LIVERMORE 94551 CVS/PHARMACY # 16764 15555 E 14TH ST STE 400 SAN LEANDRO 94578 CVS/PHARMACY # 16804 2499 WHIPPLE RD. HAYWARD 94544 CVS/PHARMACY # 17044 1057 ESTSHORE HWY. ALBANY 94710 CVS/PHARMACY # 17265 19661 HESPERIAN BLVD HAYWARD 94541 CVS/PHARMACY # 17592 43950 PACIFIC COMMONS BLVD FREMONT 94538 CVS/PHARMACY # 17624 1555 40TH STREET EMERYVILLE 94608 CVS/PHARMACY # 17628 2800 DUBLIN BLVD DUBLIN 94568 CVS/PHARMACY # 17657 2700 5TH ST. ALAMEDA 94501 CVS/PHARMACY # 17673 2187 SHATTUCK AVE. BERKELEY 94704 CVS/PHARMACY # 17781 2650 BROADWAY OAKLAND 94612 CVS/PHARMACY # 09595 CVS/PHARMACY # 09929 DAYSMAN PHARMACY LLC 3760 MOWRY AVE. FREMONT 94538 DELIVERCARERX PHARMACY LLC 3095 INDEPENDENCE DR., STE LIVERMORE 94551 44 EAST BAY AIDS CENTER OUTPATIENT 3100 SUMMIT ST. OAKLAND 94609 EAST BAY REGIONAL PARK POLICE 17930 LAKE CHABOT ROAD CASTRO 94546 EAST OAKLAND HEALTH PHARMACY ENTIRELYPETS PHARMACY 34571 SEVENTH ST. UNION CITY 94587 FAIRMONT HOSPITAL PHARMACY 15400 FOOTHILL BOULEVARD SAN LEANDRO 94578 FOODMAXX PHARMACY #484 3100 EAST 9TH ST. OAKLAND 94601 15400 FOOTHILL BLVD. SAN LEANDRO 94578 39001 SUNDALE DR. FREMONT 94538 FREMONT POLICE DEPARTMENT 94538 GARFIELD BEACH CVS LLC D/B/A CVS/PHARMACY # 17712 1414 UNIVERSITY AVE. BERKELEY 94702 HALLER'S LTC PHARMACY 4067 PERALTA BLVD. FREMONT 94536 HAYWARD POLICE DEPARTMENT 300 WEST WINTON AVE. HAYWARD 94544 HAYWARD SISTERS HOSPITAL DBA ST ROSE HOSPITAL 27200 CALAROGA AVE. RM A1- 108 HAYWARD 94545 HERRICK CAMPUS PHARMACY 2100 DWIGHT WAY RM 2113 BERKELEY 94704 HIGHLAND HOSPITAL POLICE SERVICES 1411 E 31ST ST. OAKLAND 94606 HIGH STREET PHARMACY 4248 MACARTHUR BLVD. OAKLAND 94619 10500 MACARTHUR BLVD. #103 OAKLAND 94605 2060 FAIRMONT DRIVE SAN LEANDRO 94578 KABAFUSION LLC KAISER FDN HSP INP PHY 16A 39400 PASEO PADRE PARKWAY FREMONT 94538 45 KAISER FDN HLT PLAN FABIOLA 1 PHY 115 KAISER FOUNDATION CPP PHARMACY 300 G PULLMAN STREET LIVERMORE 94550 KAISER FOUNDATION HOSPITAL PHARMACY #10A 275 W MACARTHUR BLVD. OAKLAND 94611 KAISER FOUNDATION HOSPITAL PHARMACY #92A 2500 MERCED ST HOSPITAL BLDG SAN LEANDRO 94577 KAISER FOUNDATION HOSPITAL PHY 7601 STONERIDGE DR. RM PLEASANTON 94588 KAISER HEALTH PLAN NILES 3 PHY 164 39400 PASEO PADRE FREMONT 94538 KAISER HEALTH PLAN NILES PHY 161 39400 PASEO PADRE PARKWAY FREMONT 94538 39400 PASEO PADRE PKWY., NILES BLDG FL 2, RM. 7210 FREMONT 94538 5600 STONERIDGE MALL PLEASANTON 94588 KAISER HLTH PLAN SLEEPY HOLLOW PHY 143 27303 SLEEPY HOLLOW AVENUE SOUTH HAYWARD 94545 3701 BROADWAY FLR 3 OAKLAND 94611 KAISER ONCOLOGY PHARMACY #165 39400 PASEO PADRE PKWY ND FREMONT 94538 KAISER PERMANENTE PHARMACY #181 1795 SECOND ST., SUITE B BERKELEY 94710 KAISER PERMANENTE PHARMACY #470 KAISER PERMANENTE PHARMACY #921 2500 MERCED ST. FL 1 SAN LEANDRO 94577 KAISER PERMANENTE PHARMACY #922 2500 MERCED ST. 2ND FL RM SAN LEANDRO 94577 KINDRED HSP-SAN FRANCISCO BAY 2800 BENEDICT DR. SAN LEANDRO 94577 3451 E 12TH ST. OAKLAND 94601 LA CLINICA DE LA RAZA, INC. 1030 INTERNATIONAL BLVD. OAKLAND 94606 LIFESCRIPT PHARMACY 7700 EDGEWATER DR. #220 OAKLAND 94621 46 LIVERMORE POLICE DEPARTMENT LUCKY PHARMACY #711 40055 MISSION BLVD. FREMONT 94539 LUCKY PHARMACY #712 34101 FREMONT BLVD. FREMONT 94555 LUCKY PHARMACY #714 5000 MOWRY AVE. FREMONT 94538 LUCKY PHARMACY #715 22555 MISSION BLVD. HAYWARD 94541 LUCKY PHARMACY #716 25151 SANTA CLARA ST. HAYWARD 94544 LUCKY PHARMACY #721 2000 PORTOLA AVE. LIVERMORE 94550 LUCKY PHARMACY #722 1951 HOLMES ST. LIVERMORE 94550 LUCKY PHARMACY #736 247 E 18TH ST. OAKLAND 94606 LUCKY PHARMACY #744 6155 W LAS POSITAS BLVD. PLEASANTON 94588 1300 FAIRMONT DR. SAN LEANDRO 94578 LUCKY PHARMACY #768 15840 HESPERIAN BLVD. SAN LORENZO 94580 LUCKY PHARMACY #782 32300 DYER ST. UNION CITY 94587 MASONIC HOME PHARMACY 34400 MISSION BLVD. UNION CITY 94587 MAXOR CORRECTIONAL PHARMACY C/O SANTA RITA JAIL DUBLIN 94568 MEDICAL ARTS PHARMACY 13847 E 14TH ST., STE. 103 SAN LEANDRO 94578 MED-PLUS PHARMACY INC. MIDTOWN PHARMACY PROFESSIONAL CORPORATION MOWRY PLAZA PHARMACY 668 MOWRY AVE. FREMONT 94536 NEWARK POLICE DEPARTMENT 94560 NEW CHINA TOWN PHARMACY 719 EAST 12TH STREET OAKLAND 94606 NEW TIBURCIO VASQUEZ HEALTH 33255 9TH STREET UNION CITY 94587 NICHOLS HILL PRESCRIPTION PHARMACY 2844 SUMMIT STREET OAKLAND 94609 47 NOWRX INC NOWRX INC 7067 COMMERCE CIRCLE PLEASANTON 94588 OAKLAND CLINIC PHARMACY 5220 CLAREMONT AVE. OAKLAND 94618 OAKLAND CITY HOUSING AUTHORITY POLICE DEPARTMENT OAKLAND POLICE DEPARTMENT 455 7TH STREET OAKLAND 94607 OAKLAND UNIFIED SCHOOL DISTRICT POLICE DEPARTMENT 1000 BROADWAY, SUITE 680 OAKLAND 94607 OHLONE COMMUNITY COLLEGE DISTRICT POLICE DEPARTMENT OMNICARE OF HAYWARD 20967 CABOT BLVD. HAYWARD 94545 ONEPOINT PATIENT CARE 1599 FACTOR AVE. STE. B SAN LEANDRO 94577 PACIFIC PHARMACY 650 INTERNATIONAL BLVD. OAKLAND 94606 3300 WEBSTER ST., GROUND FL OAKLAND 94609 PETNET PHARMACEUTICAL 26563 CORPORATE AVE., STE HAYWARD 94545 PHARMACA INTEGRATIVE PHARMACY INC 5729 COLLEGE AVE. OAKLAND 94618 PHARMACA INTEGRATIVE PHARMACY INC 1744 SOLANO AVE. BERKELEY 94707 PHARMERICA 32980 ALVARADO NILES RD. UNION CITY 94587 PLEASANT CARE PHARMACY 1652 B ST. HAYWARD 94541 RALEYS PHARMACY #316 5420 SUNOL BLVD. PLEASANTON 94566 1500 SOLANO AVE. ALBANY 94706 1444 SHATTUCK PLACE BERKELEY 94709 SAFEWAY PHARMACY #0768 20629 REDWOOD RD. CASTRO VALLEY 94546 SAFEWAY PHARMACY #0908 3550 FRUITVALE AVE. OAKLAND 94602 48 SAFEWAY PHARMACY #0951 867 ISLAND DR. ALAMEDA 94502 SAFEWAY PHARMACY #0971 22280 FOOTHILLS BLVD. HAYWARD 94541 SAFEWAY PHARMACY #0993 3902 WASHINGTON BLVD. FREMONT 94538 SAFEWAY PHARMACY #1197 1790 DECOTO RD. UNION CITY 94587 SAFEWAY PHARMACY #1257 4495 FIRST ST. LIVERMORE 94551 SAFEWAY PHARMACY #1931 46848 MISSION BLVD. FREMONT 94539 SAFEWAY PHARMACY #1932 4440 TASSAJARA RD. DUBLIN 94568 SAFEWAY PHARMACY #1953 7499 DUBLIN BLVD. DUBLIN 94568 SAFEWAY PHARMACY #2708 2227 S SHORE CENTER ALAMEDA 94501 SAFEWAY PHARMACY #2856 6790 BERNAL AVE. PLEASANTON 94566 6310 COLLEGE AVE. OAKLAND 94618 SAFEWAY PHARMACY #3125 3889 SAN PABLO AVE. EMERYVILLE 94608 SAFEWAY PHARMACY #3132 5100 BROADWAY OAKLAND 94611 SAFEWAY PHARMACY #3281 2600 5TH ST. ALAMEDA 94501 SAN LENADRO POLICE DEPARTMENT 835 EAST 14TH ST. SAN LEANDRO 94577 SAVE MART SUPERMARKETS #73 105 W HANFORD-ARMONA RD LIVERMORE 93245 SKILLED NURSING PHARMACY 21150 CABOT BLVD. HAYWARD 94545 SOLEO HEALTH INC 1324 W WINTON AVE. HAYWARD 94545 STANFORD EMERYVILLE HEALTH CENTER PHARMACY 5800 HOLLIS ST., RM 2325 EMERYVILLE 94608 SUTTER INFUSION & PHARMACY SERVICES 1105 ATLANTIC AVE. STE 102 ALAMEDA 94501 THE MEDICINE SHOPPE 5860 OWENS DRIVE, STE. 130 PLEASANTON 94588 TIB PHARMACY LLC 5886 MOWRY SCHOOL RD. NEWARK 94560 49 TRUEPILL UC BERKELEY POLICE DEPARTMENT 1 SPROUL HALL (BASEMENT) BERKELEY 94720 UNION CITY POLICE DEPARTMENT 34009 ALVARADO NILES RD. UNION CITY 94587 UNIVERSAL COMPOUNDING PHARMACY UNIVERSITY HEALTH SERVICE 2222 BANCROFT AVE RM. 1115 BERKELEY 94702 VALLEY MEMORIAL HOSPITAL PHARMACY 1111 EAST STANLEY LIVERMORE 94550 VALLEYCARE MEDICAL CENTER PHARMACY 5555 W LAS POSITAS BLVD. 1ST FL PLEASANTON 94588 VALOR COMPOUNDING PHARMACY 2461 SHATTUCK AVENUE BERKELEY 94720 VERSAILLES PHARMACY 2801 ENCINAL ALAMEDA 94501 VIBRANT CARE PHARMACY INC 7400 MACARTHUR BLVD STE. OAKLAND 94605 WAL MART PHARMACY 10 2031 30600 DYER STREET UNION CITY 94587 WAL-MART PHARMACY 10-1972 2700 LAS POSITAS RD. LIVERMORE 94551 WAL-MART PHARMACY 10-5434 15555 HESPERIAN BLVD. SAN LEANDRO 94579 WAL-MART PHARMACY 10-5611 3112 SANTA RITA RD. PLEASANTON 94566 WALGREEN CO D/B/A WALGREENS 5809 FOOTHILL BLVD. OAKLAND 94605 WALGREENS #00101 3382 CASTRO VALLEY BLVD. CASTRO 94546 WALGREENS #01536 3434 HIGH STREET OAKLAND 94619 WALGREENS #01537 3232 FOOTHILL BLVD. OAKLAND 94601 WALGREENS #01625 5055 TELEGRAPH AVE. OAKLAND 94609 WALGREENS #02150 1763 SANTA RITA RD. PLEASANTON 94566 WALGREENS #02306 1138 W TENNYSON_RD. HAYWARD 94544 WALGREENS #02314 1050 GILMAN ST. BERKELEY 94710 50 WALGREENS #02366 3860 DECOTO ROAD FREMONT 94555 WALGREENS #02401 21463 FOOTHILL BLVD. HAYWARD 94541 WALGREENS #02426 15500 WASHINGTON AVE. SAN LEANDRO 94579 WALGREENS #02609 2995 SAN PABLO AVE. BERKELEY 94702 WALGREENS #02660 41400 BLACOW RD. FREMONT 94538 WALGREENS #03170 3400 TELEGRAPH AVE. OAKLAND 94609 WALGREENS #04050 1916 WEBSTER ST. ALAMEDA 94501 WALGREENS #04517 2600 MOWRY AVE. FREMONT 94538 WALGREENS #04614 2801 ADELINE ST. BERKELEY 94703 WALGREENS #04659 164 W JACKSON ST. HAYWARD 94544 23958 HESPERIAN BLVD. HAYWARD 94541 WALGREENS #07274 1456 136TH AVE. SAN LEANDRO 94578 WALGREENS #09248 2300 OTIS DRIVE ALAMEDA 94501 WALGREENS #10045 2310 TELEGRAPH AVE. BERKELEY 94704 WALGREENS #10526 3250 LAKESHORE AVE. SUITE OAKLAND 94610 WALGREENS #11706 301 EAST 18TH STREET OAKLAND 94606 WALGREENS #13595 1333 BROADWAY OAKLAND 94612 2190 SHATTUCK AVE. BERKELEY 94704 WALGREENS #15163 1620 FIRST STREET LIVERMORE 94550 WALMART PHARMACY #10-2989 44009 OSGOOD RD. FREMONT 94539 WALMART PHARMACY #10-5426 40580 ALBRAE ST. FREMONT 94538 WALMART PHARMACY 10 2161 4501 ROSEWOOD DRIVE PLEASANTON 94588 WALMART PHARMACY NO 10 2648 1919 DAVIS STREET SAN LEANDRO 94577 51 WEST OAKLAND HEALTH CENTER PHARM 700 ADELINE ST. OAKLAND 94607 52 Appendix E Sample Kiosk Mock-Up 53 Sample Kiosk Signage1 Drop-Slot Panel Kiosk Art 1 Household Hazardous Waste facilities do not accept illicit drugs. 54 Sample Kiosk Signage Front Door Panel Kiosk Art 55 Sample Kiosk Signage Side Panel Kiosk Art 56 57 Appendix F Media List The following is a representative list of key media outlets to help educate Residents about proper disposal of expired or Unwanted Medicine. The list includes local print, online, television, and radio outlets, as well as outlets specifically targeting the diverse demographic communities within the County. Print Outlets Coverage Area Website Alameda Sun Alameda County http://alamedasun.com/ Berkeley Daily Planet Berkeley Voice Berkeleyside Berkeley http://www.berkeleyside.com California Magazine Berkeley https://alumni.berkeley.edu/california-magazine Castro Valley Times Center for Investigative Reporting Berkeley https://revealnews.org/ Contra Costa Times Alameda County http://www.eastbaytimes.com/ Dublin Tri Valley Herald E'ville Eye Community News Alameda County http://www.evilleeye.com/ Nichi Bei Times (Japanese/English) Alameda County https://www.nichibei.org East Bay Express East Bay Times Fremont Bulletin Alameda County http://www.mercurynews.com/fremont Fremont Tribune Alameda County http://www.fremonttribune.com/ The Independent Pleasanton Inter-City Express Oakland www.intercityexpress.news 58 Print Outlets Coverage Area Website La Opinion (Spanish) Alameda County http://www.laopinion.com/ Pleasanton Weekly Alameda County https://www.pleasantonweekly.com San Francisco Chronicle The Argus Alameda County argus/ The Daily Californian (UC Berkeley) Alameda County http://www.dailycal.org The Montclarion Oakland http://themontclarion.org Tri-Valley Times Tri-City Voice Alameda County http://www.tricityvoice.com/ Vision Hispana Oakland, Hayward http://www.visionhispanausa.com Your Town Monthly 59 Television Outlets Network BAVC Public Access KDTV Univision KEMO KGO ABC KNTV NBC KPIX KQED PBS KRON Media General KSTS KTVU 60 Radio Outlets City/County/Coverage Area KALW FM 91.7 San Francisco KCBS AM 740 San Francisco KCSF (College app radio) KGO AM 810 San Francisco KQED FM 88.5 San Francisco KSFO AM 560 KUSF (College online radio) San Francisco KPFB FM 89.3 Berkeley KALX FM 90.7 KNGY FM 92.7 KPFA FM 94.1 Berkeley KKIQ FM 101.7 Livermore KBLX FM 102.9 KNEW AM 910 Oakland KMKY AM 1310 Oakland KVTO AM 1400 KPIG AM 1510 Piedmont KACR FM 96.1 Alameda KCRH FM 89.9 KPOO 89.5 KSMC 89.5 Moraga KCSM 91.1 San Mateo KKDV 92.1 61 Radio Outlets City/County/Coverage Area KRZZ 93.3 San Francisco KYLD 94.9 San Francisco KBWF 95.7 KOIT 96.5 San Francisco KLLC 97.3 San Francisco KISQ 98.1 KSOL 98.9 San Francisco KMVQ 99.7 San Francisco KBRG 100.3 KVVZ 100.7 KIOI 101.3 San Francisco KDFC 190.3 San Francisco KKSF 103.7 KFOG 104.5 San Francisco KITS 105.3 San Francisco KVVF 105.7 KMEL 106.1 San Francisco KFRC 106.9 San Francisco KSTN 107.3 KSAN 107.7 KSFO 560 AM San Francisco KEAR 610 AM San Francisco KSTE 650 AM 62 Radio Outlets City/County/Coverage Area KNBR 680 AM San Francisco KFIA 710 AM Carmichael KCBC 770 AM KTRB 860 AM San Francisco KATD 990 AM Pittsburg KIQI 1010 AM KTCT 1050 AM San Mateo KFAX 1100 AM San Francisco KHTK 1140 AM KLOK 1170 AM KDYA 1190 AM Vallejo KNTS 1220 AM Palo Alto KSRO 1350 AM KZSF 1370 AM San Jose KEST 1450 AM San Francisco KFBK 1530 AM KLIV 1590 AM San Jose KDIA 1640 AM Vallejo KEBR 88.1 KECG 88.1 KXPR 88.9 Sacramento KOHL 89.3 Fremont KREV 92.7 63 Radio Outlets City/County/Coverage Area KSFN 1510 AM Piedmont 64 Appendix G Sample Standard Mail-Back Package Description: Plastic envelope with return label and instructional flyer. Package Size: Outer dimensions: 8.25” x 12” Inner dimensions: 7.375” x 10.375” MED-Project may choose to change its Vendor for Mail-Back Services at any time. Any proposed changes to Vendor will be submitted in writing to the Department and approved by the Department in writing prior to implementation of any change. 65 Sample Inhaler Mail-Back Package Description: Inhaler Mail-Back Package including container with mail-back packaging, return label, and instructional flyer. Package Size: Outer dimensions: 9”x 11.5”x 4.5” Inhaler Mail-Back Services are an example of complete, turnkey systems to provide for the safe return of inhaler waste through Carrier. MED-Project may choose to change its Vendor for Mail-Back Services at any time. Any proposed changes to Vendor will be submitted in writing to the Department and approved by the Department in writing prior to implementation of any change. 66 Appendix H Clean Harbors Aragonite, LLC Enforcement Action Summary Report 67 68 69 70 71 72 73 Covanta Environmental Solutions, LLC Penalty Record 74 75 Curtis Bay Energy Penalty Record 76 77 78 Heritage Thermal Services – Ohio Penalty Record 79 80 81 82 Ross Incineration Services Penalty Record 83 84 85 86 Stericycle, Inc., Warren, Ohio Facility Penalty Record 87 88 Veolia – Port Arthur Penalty Record 89 90 91 92 93 94 95 Appendix I Sample Education and Outreach Call Center 96 Appendix J Sample MED-Project Website Home Page 97 Sample MED-Project Website Check The Package Page 98 Sample MED-Project Website Convenient Locations Pages 99 100 Sample MED-Project Website Mail Back Page 101 Sample MED-Project Website Take-Back Events Page 102 Sample MED-Project Website MEDfaq Page 103 Sample MED-Project Website Contact Page 104 Appendix K Sample Brochure 105 106 This page is intentionally left blank.