A Product Stewardship Plan For Unwanted Medicine From Households
King County, Washington July 13, 2015 Table of Contents
I. Introduction ...... 4 II. Stewardship Organization ...... 4 III. Contact Information ...... 4 IV. Plan Definitions ...... 5 V. Plan Goals ...... 6 VI. Unwanted Medicine ...... 8
VII. Unwanted Medicine Collection Description ...... 9 A. Flexible Implementation of Unwanted Medicine Collection ...... 9 1. Flexible Implementation Overview ...... 9 2. King County Demographics ...... 12 3. Initial Implementation Strategy ...... 13 4. Flexible Expansion ...... 15 5. Drop-Off Site Locations ...... 16 6. Drop-Off Site Kiosk Placement and Maintenance Program ...... 16 7. Training ...... 17 8. Service Technicians ...... 17 9. Call Center ...... 17 10. Kiosk Collection ...... 18 11. Procedures for Kiosk Drop-off Site Pick-Up and Disposal ...... 18 12. Frequency of Pick-Up ...... 19 13. Procedures if a Kiosk is Full Prior to Scheduled Pick-Up ...... 19 14. Patient Privacy ...... 20 15. Unplanned Event Preparedness ...... 21 B. Take-Back Events ...... 22 1. Method ...... 22 2. Procedures ...... 23 3. Fees and Costs ...... 23 C. Mail-Back Services ...... 23 1. Mail-Back Package Availability ...... 23 2. Mail-Back Package Collection and Disposal ...... 23
VIII. Transporter and Disposal Facility Information ...... 24 A. Transporter of Unwanted Medicines from Kiosk Drop-Off Sites and Take-Back Events ...... 24 B. Disposal Facility for Unwanted Medicines from Kiosk Drop-Off Sites and Take-Back Events ...... 24 IX. Unwanted Medicine Educational and Outreach Programming...... 25 A. Overview ...... 25 B. Audiences ...... 25 C. Messages ...... 25 D. Tools/Communications Channels ...... 26 1. Phone ...... 26 2. Website ...... 26 3. Materials ...... 27 4. Media Outreach ...... 27 E. Collaboration with the County Officials and Community Organizations ...... 27 F. Disclaimer ...... 28
X. Survey ...... 28 XI. Packaging ...... 28
2 XII. Compliance with Applicable Federal, State and Local Legal and Requirements ...... 29 A. DEA Controlled Substances Act and Implementing Regulations ...... 29 B. Washington State Pharmacy Quality Assurance Commission (WSPQAC) ...... 29 C. State of Washington Waste Management Program ...... 30 D. United States Department of Transportation (USDOT)...... 30
XIII. Annual Report...... 30
Appendix A ...... 31 King County MED-Project Participants
Appendix B ...... 32 Detailed Project Plan For Design and Implementation
Appendix C ...... 33 Interested Kiosk Drop-Off Sites
Appendix D ...... 39 King County Initial Drop-Off Site List
Appendix E ...... 42 Past Community Events That May Serve as Future Take-Back Events
Appendix F ...... 43 Possible Contact List For Outreach and Education to the Community
Appendix G A. Picture of Kiosk Prototype ...... 44 B. Sample Kiosk Signage ...... 45 C. Sample Kiosk Signage ...... 46 D. Sample Kiosk Signage ...... 47
Appendix H ...... 48 Sample Media List
Appendix I ...... 51 Sample Mail-back Package
Appendix J ...... 52 Sample Template: Education and Outreach Call Script [1-800-MED-Proj]
Appendix K ...... 55 King County Med-Project Website
Appendix L Brochure/Flyer Mockup ...... 63 Instruction Brochure/Flyer Mockup ...... 64 PSA Outline ...... 65 FAQ Outline ...... 67
Appendix M ...... 69 Sample Template: Take-Back Event Media Advisory
3 I. Introduction King County MED-Project LLC (“King County MED-Project”), on behalf of the participating companies identified in Appendix A, submits this Product Stewardship Plan (“Plan”) for Unwanted Medicine in compliance with the King County Board of Health Secure Medicine Return Regulations, BOH 11. 50.010 – 11.50.160 (“Regulations”). The Regulations require pharmaceutical Producers1 to develop a Product Stewardship Program to finance and manage the collection, transportation and disposal of Unwanted Medicine from King County households. King County MED- Project is requesting standard plan status under the Regulations.
II. Stewardship Organization The Pharmaceutical Product Stewardship Work Group (“PPSWG”), a group of pharmaceutical Producers, has established a limited liability company, King County MED-Project, as the Stewardship Organization to operate the Plan.
III. Contact Information The primary contact person for the King County MED-Project is:
Carrie Hoffman, Plan Development Director King County MED-Project 1155 15th Street, Suite 500 Washington, DC 20005 202-530-6291 [email protected]
1 All capitalized terms used but not otherwise defined herein shall have their respective meanings set forth in the Regulation.
4 IV. Plan Definitions
Chain Pharmacy is one of a group of pharmacies under common control, operation or ownership with locations inside of and outside King County.
DEA is the U.S. Drug Enforcement Administration.
DEA Rule is the “Disposal of Controlled Substances” rule adopted by the DEA on September 9, 2014 which provides that LEAs can accept controlled substances for disposal. The DEA Rule also provides that pharmacies, reverse distributors, hospitals/clinics with on-site pharmacies, and certain other entities, at their discretion on a voluntary basis, can register with the DEA as “collectors,” and become authorized to accept controlled substances.
Healthcare Pharmacy is a pharmacy that is located inside a medical facility such as a hospital, outpatient surgical facility or senior center.
Independent Pharmacy is a pharmacy that is local to the county and independently owned.
King County MED-Project is a limited liability company established by the PPSWG, a group of pharmaceutical Producers, to serve as the Stewardship Organization for the Plan required under the Regulations.
Kiosk Drop-Off Site Host is the designated contact person, or persons, at the kiosk drop-off site.
Law Enforcement Agency or LEA is a Sheriff’s Office or Police Department.
Mail-Back Services are pre-paid mailing envelopes provided upon request to differentially-abled and home bound residents of King County or persons providing services to such residents.
Maintenance Technicians are service personnel who are trained to provide services related to kiosks that are part of the Program. This includes, but is not limited to, installing and responding to damaged kiosks. Maintenance Technicians will be employed, managed and directed by the King County MED-Project Vendor.
Plan or Product Stewardship Plan is the product stewardship plan presented in this submittal by the King County MED-Project.
Program or Product Stewardship Program is the product stewardship program set forth in this Product Stewardship Plan.
Service Technicians are service personnel trained to remove and transport Unwanted Medicine from the kiosks that are part of the Program. Service Technicians will be employed, managed and directed by the Vendor.
Stewardship Organization is an organization designated by a group of Producers to act as an agent on behalf of each Producer to operate a product stewardship program.
Unwanted Medicine is defined in Section VII of this Plan.
Vendor or Collection Vendor is Stericycle, Inc. (“Stericycle”), the collection and transportation vendor for this Plan.
WSPQAC is the Washington State Pharmacy Quality Assurance Commission.
5 V. Plan Goals The short-term, medium-term and long-term goals of the Plan are described generally as follows. Additional detail on implementation is provided in Section VII below.
Goal Area Short- to Medium-Term Long-Term
Collection Short-Term Goals: Establish at least one kiosk drop-off site in every city, town or unincorporated community service Approximately 30 initial drop-off sites. Three area with an LEA or pharmacy and at least drop-off sites within the first 90 days, assuming one additional drop-off site in each city, town (1) a sufficient number of LEAs agree to host or unincorporated community service area for kiosks and/or a sufficient number of pharmacies each 30,000 residents. register as collectors under the DEA Rule and are approved by the WSPQAC and (2) contracts can King County MED-Project will target an be executed with such entities. See Appendix C aggregate of approximately 92 kiosk for a list of drop-off sites that have expressed drop-off sites in LEAs and pharmacies as interest and Appendix D for a list of potential prescribed in the Regulations, assuming LEA locations. (1) a sufficient number of LEAs agree to host kiosks and/or a sufficient number of pharmacies Hosting of take-back events supervised by register as collectors under the DEA Rule and LEAs in compliance with the DEA Rule. First are approved by the WSPQAC, and (2) contracts take-back event to occur during the first 90 days can be executed with such entities. after plan approval, assuming (1) LEAs agree to supervise such events, and (2) sufficient events Take-back events will continue to take place to are available, and (3) contracts can be executed supplement kiosk drop-off sites in order to meet with supervising LEAs. Take-back events will be the convenience standard as defined in the scheduled to supplement drop-off sites in order to Regulations. best meet underserved areas and to better meet the convenience standard.
Mail-back services available upon request to home bound and differentially-abled residents within the first 90 days.
Medium-Term Goals:
Approximately 65 drop-off sites in LEAs and pharmacies, assuming (1) a sufficient number of LEAs agree to host kiosks and/or a sufficient number of pharmacies register as collectors under the DEA Rule and are approved by the WSPQAC and (2) contracts can be executed with such entities.
Hosting of take-back events supervised by LEAs in compliance with the DEA Rule, assuming (1) LEAs agree to supervise such events, (2) sufficient events are available, and (3) contracts can be executed with supervising LEAs. Take-back events will be scheduled to supplement kiosk drop-off sites in order to best meet underserved areas and to better meet the convenience standard.
6 Goal Area Short- to Medium-Term Long-Term
Education Develop baseline number of website page views or On an ongoing basis, King County MED- & Public unique visitors. Project may revise and/or add communications Outreach materials based on changes to the Plan. Establish a baseline of Law Enforcement Agencies; retail pharmacies; other pharmacies (healthcare, King County MED-Project will evaluate etc.); community groups; and other third parties media and public outreach as well as contacted, and report appropriate statistics as collect feedback by survey in order to make outlined in the Survey and Annual Report sections adjustments and improvements to the Product of this Plan. Stewardship Program. The review will measure percent awareness of the stewardship plan, Establish a baseline number of media outlets assess to what extent kiosk drop-off sites and receiving press advisory, with a minimum of five other collection methods are convenient and outlets. easy to use, and assess knowledge and attitudes about risks of abuse, poisonings and overdoses Establish a baseline percentage of County from prescription and nonprescription medicines community centers reached. used in the home. Results of the review will be published on the King County MED-Project Establish a baseline number of messages to King website. County MED-Project returned within predetermined timeframe.
Collector Contact LEAs and retail pharmacies and invite Outreach them to participate in the Plan. Set targets for LEAs and retail pharmacies.
7 VI. Unwanted Medicine For purposes of the Plan, “Unwanted Medicine” includes all materials identified as “Covered Drugs” under BOH 11.50.030.B. According to this provision of the Regulations, Covered Drugs means “a drug sold in any form and used by covered entities, including prescription, nonprescription, brand name and generic drugs.” Covered entities means “residents of King County, including individuals living in single and multiple family residences and other residential settings, and including other nonbusiness sources of prescription and nonprescription drugs that are unused, unwanted, disposed of or abandoned by residents as identified by the director.” BOH 11.50.030.C. Unwanted Medicine does not include the following:
i. Expired 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. 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); vii. Hard surface and toilet disinfectant cleaners; viii. Physician Administered Drugs - drugs administered in hospitals or other clinical settings whereby a patient never handles drug product; ix. Drugs for which producers provide a pharmaceutical product stewardship or take-back program as part of a federal Food and Drug Administration managed risk evaluation and mitigation strategy (Title 21 U.S.C. Sec. 355-1); x. Drugs that are biological products, meaning any virus, therapeutic serum, toxin, antitoxin, or analogous product applicable to the prevention, treatment or cure of diseases or injuries of man, as these terms are defined by 21 C.F.R. 600.3(h), if the producer already provides a pharmaceutical product stewardship or take-back program; xi. Medical devices, their component parts or accessories, or a covered drug contained in or on medical devices or their component parts or accessories; xii. Pet pesticide products contained in pet collars, powders, shampoos, topical applications, or other forms; xiii. Used, empty containers, vials, and pouches that do not contain a usable quantity of covered drugs; xiv. Pre-loaded products with a sharp attached containing prescription or over the counter medications; xv. Auto injectors; and xvi. Schedule I or other illicit drugs.
8 VII. Unwanted Medicine Collection Description The Plan includes three approaches to collecting Unwanted Medicine in King County: kiosk drop-off sites, take- back events and mail-back services. This section of the Plan discusses how Unwanted Medicine will be collected, how each of the approaches are designed, how Unwanted Medicine will be tracked and handled safely and securely, and how the overall collection footprint and infrastructure will fully comply with all applicable local, state and federal laws and regulations.
A. Flexible Implementation of Unwanted Medicine Collection Kiosk drop-off sites will be strategically placed across King County in order to best meet the convenience standard established by the Regulations, which includes equitable access to a network of drop-off sites. This network will provide the residents of King County a number of different outlets to participate in the Plan. King County MED-Project intends to locate kiosks at sites throughout the County in both the incorporated and unincorporated areas.
1. Flexible Implementation Overview The Plan will be implemented in a flexible manner, offering coverage to the King County residential population through a combination of kiosk drop-off sites and take-back events. Current activities taking place prior to Plan approval include outreach to LEAs and pharmacies regarding their receptivity and ability to participate in the Program as kiosk drop-off sites, and outreach to event hosts regarding potential participation in take- back events. Upon Plan approval, the Program shall initiate the development of contracts directly with law enforcement agency locations that agree to participate in the Plan, as well as with pharmacies that meet participation requirements, including being DEA registered and WSPQAC approved collectors. Over the course of implementation, further drop-off sites will be established to the extent that (1) additional LEAs and/ or a sufficient number of WSPQAC approved pharmacies registered as collectors under the DEA Rule agree to participate, and (2) contracts can be executed with such entities. King County MED-Project will continue to conduct supplemental take-back events for underserved areas. For every engagement with LEAs and pharmacies, including the establishing of drop-off sites or the supervising of events, contracts outlining the responsibilities of all involved parties will be drafted, reviewed by appropriate legal departments and entities, and signed by all parties prior to installation of kiosks at drop-off sites and the scheduling of any take-back events.
King County MED-Project will continuously monitor the collection program to improve service delivery in order to meet the convenience standard established by the Regulations. The current version of the more detailed Project Plan is provided in Appendix B.
9 ! Over time, a mixture of drop-off sites and take-back events will be coordinated and distributed throughout King County. A summary of drop-off sites by County Council District is below. King County MED-Project will initially target approximately 30 drop-off sites, expanding to approximately 65 sites, and ultimately targeting approximately 92 sites to accommodate a drop-off site per every 30,000 residents in King County. Take-back events will be hosted to supplement drop-off sites on an ongoing basis when needed to fulfill the convenience standard defined in the Regulations. For more information regarding take-back event scheduling, coverage, and frequency, see Section VII.B.
King County MED-Project has developed this flexible implementation plan based on anticipated interest from and availability of qualified drop-off sites. If qualified drop-off sites become available more quickly than what is proposed above, King County MED-Project will determine which of these sites to accept into the Plan in a manner that fulfills the convenience standard as efficiently as possible.
! ! 10 Estimated Population Outreach by King County Council District
Total Proposed Initial Expansion of Targeted District Population* Drop-Off Sites Drop-Off Sites Drop-Off Sites Comments**
1 214,883 4 7 10 Cities: Bothell, Kenmore, Kirkland, Lake Forest Park, Seattle, Shoreline, Woodinville
2 214,106 2 8 10 Cities: Seattle
3 214,325 4 7 10 Cities: Carnation, Duvall, Issaquah, North Bend, Redmond, Sammamish, Skykomish, Snoqualmie
4 214,216 2 8 11 Cities: Seattle
5 215,099 3 7 10 Cities: Burien, Des Moines, Kent, Normandy Park, Renton, SeaTac, Tukwila
6 214,567 3 7 10 Cities: Beaux Arts Village, Bellevue, Clyde Hill, Hunts Point, Kirkland, Medina, Mercer Island, Redmond, Woodinville, Yarrow Point
7 214,735 4 7 10 Cities: Algona, Auburn, Federal Way, Kent, Milton, Pacific
8 214,455 4 7 11 Cities: Burien, SeaTac, Seattle, Tukwila
9 214,863 4 7 10 Cities: Bellevue, Black Diamond, Covington, Enumclaw, Kent, Maple Valley, Newcastle, Renton
Totals 1,931,249 30 65 92
* http://your.kingcounty.gov/districting/plans/final/DistrictPlan_20111115_Adopted_New.jpg **http://your.kingcounty.gov/districting/plans/final/Data-profile-adopted_20111115_.pdf
11 2. King County Demographics The map of King County illustrates the wide geographical range covered by the Plan. Each of the 9 County Council Districts houses approximately 215,000 residents. The majority of the population lives in 39 incorporated cities and additional unincorporated urban areas. Drop-off sites will be targeted for every city, town, or unincorporated community service area with an LEA or pharmacy location that is able to participate. Ultimately, the King County MED-Project will establish in every city, town or unincorporated community service area with an LEA or pharmacy one drop-off site and at least one additional drop-off site for each 30,000 residents (approximately 92 targeted drop-off sites), assuming (1) a sufficient number of LEAs agree to host kiosks and/or a sufficient number of WSPQAC approved pharmacies register as collectors under the DEA Rule and (2) contracts can be executed with such entities. Where drop-off sites cannot be established, take-back events will be hosted in order to supplement the disposal of Unwanted Medicine by residents in those areas. Mail-back services will be available upon request for differentially-abled or home bound residents, thereby offering more opportunities to dispose of Unwanted Medicine.
County Council District Map in King County http://your.kingcounty.gov/districting/plans/final/DistrictPlan_20111115_Adopted_New.jpg
12 3. Initial Implementation Strategy As required by the Regulations, King County MED-Project performed outreach through calls, emails, and survey to all retail pharmacies and Law Enforcement Agencies provided on the King County website at http:// kingcountysecuremedicinereturn.org/king-county-pharmacies-and-law-enforcement/. Additional outreach included requests for interest in participating in the program, hours of operation, whether the sites currently host a kiosk or other services for the disposal of residential Unwanted Medicine, whether pharmacies are DEA registered collectors and/or approved by the WSPQCA as collection sites, and whether the sites would like more information regarding the program in the event that the Plan is approved. A list of potential drop-off sites that responded to this outreach survey can be viewed in Appendix C. The latest LEA location list, which includes the proposed initial drop-off sites across King County, can be viewed in Appendix D.
Pharmacies that have expressed interest in participating in the Program, are qualified to participate, and complete contracts with King County MED-Project will also be included in the proposed initial drop-off site implementation. In order to participate in the Program, sites must meet DEA and WSPQAC requirements, must have the space to host a kiosk and have a fully executed contract in place with the King County MED-Project. Of the pharmacies surveyed, nearly 25% stated that they were registered collectors with the DEA, however this data does not match information on the DEA website at https://www.deadiversion.usdoj.gov/pubdispsearch/ spring/main?execution=e1s1. Further research is required in order to confirm whether these pharmacies are actually registered collectors with the DEA. In addition, the WSPQCA evidently takes the position that it must approve the involvement of pharmacies that wish to become part of the Program, and until this process is finalized, pharmacies may not be able to participate in the Plan.
LEAs that currently have drop-off sites in the cities of Auburn, Burien, Bothell, Issaquah, Kenmore, Lake Forest Park, Maple Valley, North Bend, Sammamish, Snoqualmie, and Woodinville may transition into the Program pending compliance with all Program requirements.
The map and distribution of proposed initial LEA drop-off sites for King County follows.
13 LEA Sites Proposed to Implement Initial drop-off sites in King County
14 4. Flexible Expansion Implementation is intended to provide a smooth introduction of the training, infrastructure, messaging, and support of multiple stakeholders, systems, and processes. During initial stages of the program, King County MED-Project will assess performance, gauge feedback, and revise its approach as appropriate. As implementation continues, King County MED-Project shall continue to approach organizations that may be available as future drop-off sites. These organizations are listed in Appendix F. Several non-LEA sites in King County already host drop-off sites, and those will be evaluated for transition to this Program.
King County MED-Project will determine how to address requests to host drop-off sites based on existing geographic distribution near the requesting site.
The take-back events will continue to supplement the kiosk drop-off sites and will taper off as the number of drop-off locations increases. An example of the balance of take-back events and kiosk drop-off sites is presented below, where drop-off sites expand in number as supplemental take-back events taper off. In this schematic, King County MED-Project will implement an initial 30 drop-off sites while hosting supplemental take-back events to provide services to underserved areas in order to best meet the convenience standard. Subsequently, the program will expand to approximately 65 drop-off sites, with supplemental take-back events tapering off as drop-off sites increase. Ultimately the goal is to host approximately 92 drop-off sites in order to best meet the convenience standard. Underserved areas will continue to be serviced by supplemental take- back events as needed.
15 Population Supported Targeted Population Take-Back Population Term By Drop-Off Sites and Drop-Off Sites Supported Events Per Year Supported Take-Back Events
Short-Term 30 900,000 Up to 24 1,150,000 2,050,000
Medium-Term 65 1,500,000 Up to 12 550,000 2,050,000
Long-Term 92 2,050,000 As Needed As Needed 2,050,000
Take-back events will target residential populations where drop-off sites are not yet offered in order to best meet the convenience standard. For more information regarding take-back event scheduling, coverage, and frequency, see Section VII.B.
Mail-back services will be available to differentially-abled and home bound residents upon request and will be reviewed continuously for availability and effectiveness.
5. Drop-Off Site Locations The Plan includes outreach to LEAs and retail pharmacies located in the County to host drop-off sites. The LEA locations are listed and identified on a map in Appendix D and all LEA and retail pharmacy sites expressing interest are listed in Appendix C. King County MED-Project has made initial contact with each of these locations and will initiate contracts with interested LEA locations and qualified retail pharmacies within 30 days of Plan approval.
King County MED-Project will initially approach existing LEA drop-off locations about participating in the Plan. An existing drop-off site can be used if it meets the requirements established by King County MED-Project and as outlined by the DEA.
6. Drop-Off Site Kiosk Placement and Maintenance Program Drop-off site placement shall be the responsibility of King County MED-Project at LEAs and retail pharmacy kiosk drop-off sites once the drop-off site has identified a placement location. Costs associated with placement and maintenance will be paid by King County MED-Project per the contracts with the kiosk drop-off sites.
The maintenance program will address items such as: • Periodic inspection of drop-off sites to monitor general wear and tear. • Service Technician access to the drop-off sites during the regularly scheduled pick-ups and notification of a Maintenance Technician if necessary. • Reporting by the LEA of damage to a drop-off site or requested maintenance service.
16 7. Training Operational procedures, including training, are the responsibility of the kiosk drop-off site.
King County MED-Project will support training from the Collection Vendor subject to the conclusion of an acceptable contract with the Collection Site. Additionally, Stericycle will manage a support hotline to answer questions and monitor comments for participating drop-off sites.
8. Service Technicians The Service Technicians servicing the Unwanted Medicine deposited at a kiosk will be independent of the technicians that provide maintenance to the kiosks. This ensures a system of monitored communication and an additional level of security to the management of the Plan. The Service Technicians collecting and transporting the Unwanted Medicine will receive privacy training and will be trained on all necessary standards for waste material including, but not limited to, online trainings provided by the Washington State Department of Labor & Industries. The training standards provide professional management of all Unwanted Medicine along with proper documentation of all services at the collection points.
9. Call Center Questions from residents of King County will be managed by a call center with an interactive voice response (IVR) system and the support of an operator available from 8:00am to 5:00pm PST Monday through Friday. If the operator is busy, a resident can leave a message to which the operator will respond. Calls outside of the available hours will be directed to an answering machine. Calls will be returned when the office is open. All operators will be trained to respond based on the requirements set by King County MED-Project.
The IVR will answer general questions, including questions on the following topics:
1. Items that can be disposed in kiosks 2. Other disposal options 3. Direction to the Program website for additional information
Because the list of kiosk drop-off sites is subject to change, King County residents will be directed to the King County MED-Project website or to an operator for detailed information about kiosk locations and service hours.
17 10. Kiosk Collection A kiosk will be offered to all host locations. Kiosks will come with appropriate regulatory signage and consumer instructions, including an instruction to consumers to remove personal information from any Unwanted Medicine or its packaging before depositing them. The design of the kiosk and proposed signage (Appendix G) recognizes the paramount importance of security through the use of heavy gauge steel, multiple locking mechanisms, including a locking mechanism on drop slot, a tamper-proof slot and commercial hinges. The design will increase the likelihood of consumer participation by providing easy access to wheelchair bound users. Additionally, the locking mechanism on the drop slot will prevent kiosk over-flow once the container has reached its maximum level. Drop-off sites will accept Unwanted Medicine in pill, capsule, or liquid form.
The Unwanted Medicine will be securely removed from the kiosk by a Service Technician working for the Collection Vendor under the supervision of two employees of the kiosk drop-off site. These two employees of the kiosk drop-off site will hold the two keys to unlock the kiosk. Once the kiosk is opened, the Unwanted Medicine will be removed. The liners provided in the kiosk will be opaque to prevent visual recognition of the contents. All liners within the collection container will be immediately and effectively secured via plastic zip-tie or other means to prevent contents from spilling.
The contents will be taken to a secure vehicle for containment. The Unwanted Medicine will then be placed in a container for shipment. This container will be marked with a unique barcode label to track the container to the disposal site. The container will be secured with tamper evident tape to prevent removal of any material during transport.
King County MED-Project will work with the King County local hazardous waste management program to obtain reimbursement for kiosks once the kiosks have been deployed and are in service at the kiosk drop-off sites.
11. Procedures for Kiosk Drop-off Site Pick-Up and Disposal Pick-up of Unwanted Medicine collected in the kiosks will be scheduled for all kiosk drop-off sites based on hours of operations and volume collected.
The Vendor shall manage the Unwanted Medicine from the kiosk in compliance with all applicable legal requirements. Collected materials will be weighed, and their weights recorded at the local transfer facility at the close of each service day. Containers will be inspected to verify that the integrity of the security tape is intact. The shipping container will be bar-coded and secured for shipment to provide safe transport along with unique barcode tracking to the approved disposal facility.
The kiosk will be reviewed by the Service Technician for any damages. If damages are found, the Service Technician will note the need for repair via an electronic reporting log. This electronic report will be transmitted to a Maintenance Technician who will respond to specific repair requests.
All shipments containing the Unwanted Medicine will be transported via permitted ground haulers of waste. The Vendor will utilize leased vehicles to manage the service of the kiosk drop-off sites. All vehicles will be permitted and maintained by the Vendor. Permits will comply with all county, state and federal requirements for shipment of the Unwanted Medicine. See Section VIII for additional details.
18 All haulers are trained to meet all applicable local, state and federal requirements. All haulers will adhere to all applicable security requirements and will be monitored periodically by the Vendor managers to ensure compliance of each hauler.
All waste containers will be destroyed in their intact, closed state at a permitted hazardous waste incineration facility. Following disposal, a Certificate of Disposal (“COD”) will be retained via electronic copy.
12. Frequency of Pick-Up Initially, all drop-off sites will be scheduled for a monthly pick-up from the kiosk. The Collection Vendor will communicate with the kiosk drop-off site in the event the frequency of pick-up needs to be increased or decreased based on the volumes collected over time. It is anticipated that the average site will generate up to 40 pounds of Unwanted Medicine per service, per kiosk drop-off site. The Collection Vendor will monitor the exact volumes per service to ensure that all sites are receiving the appropriate service frequency. All weights will be confirmed on a scale located at the local transfer facility at the close of each service day. The Collection Vendor will manage services as frequently as necessary to prevent overflow of the kiosk without providing unnecessary interruption to the participating kiosk drop-off site. Moreover, the Collection Vendor will monitor the volumes of Unwanted Medicine generated at each participating kiosk drop-off site via an electronic catalog retained at the local transfer facility.
The proposed electronic catalog is Stericycle’s proprietary software system that also allows for tracking of service data not available in the standard required shipping paperwork. This software system will provide the opportunity for Service Technicians to communicate the need for kiosk repairs and other relevant information to ensure the most effective management of the program. This information will be transmitted electronically within 24 hours of a service event to Program Managers. These Managers will direct communications to necessary personnel to provide response and support of the needs of the participating kiosk drop-off sites.
13. Procedures if a Kiosk is Full Prior to Scheduled Pick-Up The kiosk provided to the kiosk drop-off site will contain a visual indicator to notify the kiosk drop-off site host if the kiosk is full. Upon such notification that the kiosk is full, the kiosk drop-off site host shall notify the Collection Vendor of the need for service.
The Collection Vendor shall provide a network of trained Service Technicians within King County. The Collection Vendor will communicate this request to field managers responsible for Service Technicians in King County. The Collection Vendor will direct service to a trained Service Technician who is in closest proximity to the kiosk drop-off site requesting the service. This process provides for a timely response to kiosk drop-off sites requiring service prior to the scheduled date.
Service timelines will be assessed based on the specific characteristics of the kiosk drop-off site’s need. If necessary, the Collection Vendor will be able to respond within hours of the request. If the request does not require an urgent response, the Collection Vendor will plan the response within 2 to 3 business days of the request. The Collection Vendor will not exceed one business week from the initial request.
19 14. Patient Privacy Instructions at each kiosk will inform people who deposit Unwanted Medicine that they should completely cross out, remove or otherwise make unreadable any and all personally identifiable information on the drug containers and packaging before depositing them in the kiosk. In cases where people follow the instructions, there will be no personally identifiable information.
For those people who do not follow the directions on the kiosk, the Collection Vendor has additional protections available for keeping their personally identifiable information safe and secure. Service Technicians are well-trained in managing items containing sensitive patient information. Privacy training is part of a Service Technician’s prerequisite for field services. As added protection, the liners for the kiosk will be opaque rather than clear, in compliance with the DEA Rule. This will prevent anyone, including the Service Technician, from seeing any information on the containers placed in the kiosks. The process for securing the liner will take place at the kiosk drop-off site by a Service Technician.
The Collection Vendor will comply with all applicable local, state and federal requirements. Stericycle’s internal training process will address the following:
• Onboarding & on-truck observation of job functions – five days • DOT Training – two days • Client Service Requirements – one day • DEA Training – one day • EPA Waste Characterization – one day • OSHA Training – one day • Waste Handling Demo – one day • Truck Operation – one day • DEA Handling Demo – one day • Review & Written Test – one day • Perform work under supervision to demonstrate proficiency prior to certification to service client accounts. – ten days
20 15. Unplanned Event Preparedness The Collection Vendor maintains a network of emergency responders that can be called on in the case of an emergency or spill incident. Stericycle ensures compliance of all service providers through a business confidential qualification process. This process reviews the compliance history, management structure, financial stability and other key indicators of a reliable emergency response service provider. This system ensures that all participating vendors in the program will meet the county requirements as outlined in the Regulations. Emergency responders will bring all necessary equipment in order to manage the specific needs of the kiosk drop-off site requiring emergency response. Responders will be trained to access and remove a damaged kiosk. The responders will also be trained to adhere to all security requirements required within the Program.
A major event, such as a flood, earthquake or fire, may require response by a service team. This event can jeopardize the security characteristics of the kiosk as well as the structural integrity of the participating location. The team will assess the safety of the area along with the locations to be serviced. Once it is determined the area is safe for access, the team will work to remove the kiosks within the affected area. Once all repairs are completed at the site, a team will return to install a new kiosk.
Along with major event preparedness, the Collection Vendor provides timely responses to events that may cause an inconvenience to the kiosk drop-off Sites. An example of this kind of event would be if the kiosk is giving off an odor prior to the scheduled service date. The Kiosk Drop-off Site Host will contact the Collection Vendor via the dedicated phone number mentioned below. The Collection Vendor is able to respond within two to three (2-3) hours in most cases when notified of a need for emergency response. If the request is not an emergency that poses an immediate threat to the environment or health, the Collection Vendor will respond to a service location within one to two (1-2) business days of the event.
Personal items that a resident inadvertently drops into the kiosk (i.e. dentistry, watch, keys, wallet, etc.) will not be retrieved.
21 B. Take-Back Events During the implementation of drop-off site locations, take-back events will be scheduled in appropriate geographic locations in order to supplement coverage of the residential population across King County. The locations and dates for take-back events will be identified, and education and outreach leveraging established contacts will commence within the first 30 days of implementation.
In previous years, the DEA offered 20 or more sites for take-back events for the residential population across King County (http://www.kingcounty.gov/depts/health/news/2013/April/24-drug-takeback-day.aspx). Proposed events will support the residential population in areas that require additional coverage in addition to that provided by established drop-off sites, which are intended to support approximately 30,000 residents. Up to 24 take-back events will be offered for areas where kiosk drop-off sites do not meet the convenience standard. Event locations and frequency will be determined based on the level of coverage offered by kiosk drop-off sites, the availability of events, and support of law enforcement. Events may be scheduled to simulate previous coverage by the DEA, with numerous sites hosting take-back events simultaneously, or be distributed throughout the year to best offer coverage to the residential population and in order to meet the convenience standard.
Based upon fully executed contracts with supervising LEAs, King County MED-Project will confirm to the County the locations and dates to conduct take-back events for the first year of the program. Targeted events for take-back can be viewed in Appendix E. Federal, state or local law enforcement shall be in attendance at all take-back events. As stated in the goals, it is the intention of King County MED-Project to conduct take-back events in order to supplement the drop-off sites as they are implemented across the County. King County MED-Project will select the location of the take-back events based upon demographics, current drop-off sites, and other population diversity characteristics to maximize County resident access to the events and best meet the convenience standard. In general, King County MED-Project will work to conduct the take-back events in coordination with other scheduled events (i.e., Earth Day celebrations, King County Fair, Health and Wellness Fairs) to maximize convenience to residents while they are participating in other activities.
King County MED-Project will evaluate existing drop-off sites and scheduled take-back events on an on-going basis to ensure that the convenience collection standard is met. Supplemental take-back events will adapt as drop-off sites are established or closed. Due to the continuously changing schedule of take-back events, the list of take-back dates and locations will be maintained on the King County MED-Project website as events are scheduled.
Information gathered at take-back events will aid in determining the need for any special disposal requirements. Liquids will be collected at drop-off sites and take-back events; modifications to the Plan regarding liquids collection may be proposed as part of annual reports based on collection history.
1. Method King County MED-Project will coordinate, as appropriate, the take-back events with applicable King County offices and personnel, including law enforcement. The events will be promoted to county residents through local communication channels including outreach to local print, broadcast and online media identified in Appendix H and at http://www.kingcounty.gov/about/news/social-media.aspx, and outreach to local community organizations and government agencies, including those identified in Appendix F. This approach is further developed in the section of the Plan devoted to public education and outreach.
The take-back events will be adequately staffed to provide effective monitoring of the event.
22 2. Procedures Stericycle trained personnel will have appropriate training and background to meet all regulatory requirements for the management of material provided by residents at approved take-back events. Take-back events will typically be staffed by two Stericycle employees. Stericycle will work in coordination with King County MED- Project, King County, and local law enforcement to monitor and ensure collection of all material at take-back events is compliant with legal requirements and meets the published expectations of the planned event. Stericycle will work in conjunction with local law enforcement to ensure all material is placed in a compliant collection receptacle and securely shipped to meet applicable legal requirements. Any material that falls outside the approved list agreed upon prior to the take-back event or does not meet legal requirements will be rejected by Stericycle.
Following the completion of each event, containers will be securely packaged, labeled and shipped in compliance with all applicable legal requirements. Containers will be tracked via a unique barcode to a permitted hazardous waste incineration facility, where they shall be incinerated.
3. Fees and Costs King County MED-Project shall pay all administrative and operations costs and fees associated with the take- back events.
C. Mail-Back Services King County MED-Project will provide mail-back services at no cost to differentially-abled and home bound residents of King County. Mail-back packages will be pre-paid and pre-addressed, and mail-back services shall comply with all applicable local, state and federal requirements.
1. Mail-Back Package Availability Differentially-abled or home bound King County residents may request a mail-back package by calling the call center or through a link on the King County MED-Project website. Home healthcare professionals providing services to differentially-abled or home bound residents may also request a mail-back package on behalf of a resident through the call center or through a link on the King County MED-Project website. Upon such request, Stericycle shall provide a mail-back package to the differentially-abled or homebound resident which shall comply with the requirements of the DEA Rule.
Each mail-back package will contain an insert with instructions for use and information about other options for disposing of Unwanted Medicine. See Appendix I for a sample envelope. King County MED-Project will monitor mail-back package requests to prevent fraud and abuse.
2. Mail-Back Package Collection and Disposal Requests to receive mailers will be taken through the call center or a link on the King County MED-Project website. Stericycle will track mailers utilizing First Class Mail through the United States Postal Service. All mailers shall be logged upon shipment, using a unique barcode, to residents as well as upon delivery at the approved disposal facility. Residents will be directed to follow the instructions provided in the mail-back package and to place their Unwanted Medicine in the pre-addressed/pre-paid envelope. The USPS estimates up to three business days for delivery of the First Class Mail. The mail-back package shall be sent to the approved destruction facility, scanned for receipt verification, and incinerated.
23 VIII. Transporter and Disposal Facility Information A. Transporter of Unwanted Medicines from Kiosk Drop-Off Sites and Take-Back Events • Name: Burlington Environmental, LLC (a wholly-owned subsidiary of Stericycle Environmental Solutions, Inc.,) will be the transporter utilized to service all kiosk drop-off sites and take-back events and transport the Unwanted Medicine to a permitted hazardous waste incinerator. • Address: 1629 East Alexander Ave, Tacoma, WA 98421 • Phone: (253) 383-3044 • DOT ID Number: WAR000001743 • US DOT Number: 262568 • Permit Status: All relevant permits are active and in good standing. Available upon request.
B. Disposal Facility for Unwanted Medicines from Kiosk Drop-Off Sites and Take Back Events • Name: Veolia ES Technical Solutions • Address: Hwy 73, 3.5 miles West of Taylors Bayou; PO Box 2563 Port Arthur, TX 77640 • Phone: 409.736.2821 • Website: www.veolia-ts.com • Type: Permitted hazardous waste incinerator, EPA I.D. No. TXD000838896, Texas Permit Number 50212, WDW160, WDW358 • Kiosk drop-off sites and take-back events: This facility will be utilized to incinerate all Unwanted Medicines collected from kiosk drop-off sites and take-back events from the King County MED-Project Product Stewardship Program. • Mail-back: One of King County MED-Project’s goals is to identify and utilize an incinerator to destroy the Unwanted Medicine that is collected through the mail-back services program described in this Plan. Under the Regulations, Unwanted Medicines collected through mail-back services must be disposed of at a permitted hazardous waste incinerator. BOH 11.050.080. In addition, under the DEA Rule, controlled substances collected through mail-back services must be shipped to a collector with on-site destruction (incineration) capability that is registered with the DEA. 21 CFR 1317.70. King County MED-Project is engaged in good-faith discussions with three RCRA permitted hazardous waste incinerators that could potentially accept controlled substances as well as other pharmaceutical products shipped by mail as part of the Program. Currently, each of these three permitted hazardous waste incinerators lacks either (1) a DEA Registration allowing collection of controlled substances, or (2) a RCRA permit allowing disposal of controlled substances without sampling and/or inspection. These regulatory hurdles prevent King County MED-Project from operating a mail-back program at this time that would collect controlled substances. King County MED-Project has also evaluated its ability at this time to operate a mail-back program for Unwanted Medicines that are not controlled substances. However, any such program would face similar regulatory hurdles. The DEA position that inadvertent collection of controlled substances is fully regulated under the DEA Rule, 79 Fed. Reg. 53,529, and the fact that some of these incinerators’ RCRA permits do not allow the disposal of Unwanted Medicines that are not controlled substances without sampling/ inspection, also prevent King County MED-Project from operating a mail-back program at this time for only non-controlled substances. King County MED-Project continues to explore all available options to resolve the identified regulatory issues associated with a mail-back incineration facility. King County MED-Project will provide updates on these issues on an ongoing basis to the King County Board of Health, and hopes to have a mail-back program for controlled and non-controlled substances in place by the time the Plan becomes operational.
24 IX. Unwanted Medicine Educational and Outreach Programming
A. Overview The following communications plan includes a description of the public education and outreach efforts that King County MED-Project will undertake to educate King County residents about the collection and disposal of Unwanted Medicine from households.
B. Audiences To effectively educate the public about the Plan, King County MED-Project has developed a comprehensive communications campaign featuring both broad communications tactics (e.g., Public Service Announcements (“PSAs”), media advisories, etc.) as well as targeted outreach to audiences directly involved in the distribution and use of medicines to residents. These audiences include: • General public • Pharmacies, including education for dispensers of Covered Drugs • Retailers of Covered Drugs • Health care providers and their patients • Veterinary providers and animal owners
This plan details program efforts to reach the varied cultural, language, geographic and age-range demographics, including through outreach to ethnic, community and alternate-language media (Appendix H); outreach to community organizations serving a broad range of audiences (Appendix F); availability of alternate language phone lines (Section IX.D.1); and availability of educational information through a broad range of channels, including toll free telephone lines, broadcast media, and the Internet.
King County demographic information, including race/ethnicity, language, age, and geographic data, will continue to be analyzed in order to appropriately direct outreach and create educational materials to best serve the unique needs of each area. Efforts to ensure that materials are appropriately targeted, translated, and available to these populations will be pursued with associations, agencies, and organizations that can be viewed in Appendix F.
C. Messages King County MED-Project messaging will focus on two main goals: • Educating residents about the appropriate use, storage and disposal of Unwanted Medicine, and • Providing residents with clear steps to properly manage the disposal of their Unwanted Medicine, including following instructions found on the medicine label, use of drop-off sites, participation in take-back events, and, where no disposal instructions are given on the drug labeling and a take-back program is not available, in-home disposal. Key points of emphasis will 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 collection kiosks • How to properly dispose of Unwanted Medicine • Privacy issues (removing personally identifiable information from labeled prescription containers) 25 D. Tools/Communications Channels King County MED-Project will include a number of components designed to reach consumers and provide consistent access to timely and relevant information. Distribution of materials will include audiences such as law enforcement agencies, retail pharmacies, health care providers and systems, health associations, local government agencies, and other community organizations. Tools and communication channels will include:
1. Phone King County MED-Project will include a toll-free telephone number [1-844-MED-Proj] for residents to obtain information about collection kiosks, educational materials and other aspects of the Plan for Unwanted Medicine from households.
The King County MED-Project toll-free telephone line will initially support English and Spanish. The telephone line will also contain an option for callers to be transferred to a staffed call center. A recorded-line script at 1-844-MED-Proj will provide basic information about how the Plan works, where to obtain more information (e.g., the website), and will also include an option to talk with an operator to find a drop-off site or take-back event in the caller’s ZIP code or local area. The recorded call script will include language directing callers with medical emergencies to call 911. Patients with medication-related questions will be directed to contact their health care provider(s). Please see Appendix J for a sample template of the recorded call script.
2. Website Upon Plan approval, King County MED-Project will develop the King County website with capability for mobile devices as well. Information available to users includes locations of collection kiosks, educational materials, frequently asked questions and responses, public outreach events (e.g., take-back events), and results of the most recent survey of awareness of the Plan.
The King County website will be accessible from King County MED-Project (www.med-project.org) and available for public access within 60 days of Plan approval. The Plan currently includes a sample mockup of the King County website and supporting pages from the landing page. Appendix K provides the proof of concept for each page. The King County website will also include access to the public relations toolkit in a downloadable format (see “Materials” section of this plan, Section IX.D.3 below) and contact information for residents. The toolkit available on the website includes a flyer/brochure (Appendix L), a public service announcement available in broadcast and audio versions, and a frequently asked questions (FAQ) document which will be reviewed and updated periodically. Translations of the brochure and FAQ will be available in Spanish, Vietnamese, Mandarin, Russian, and Tagalog. Community and government organizations and other public interest groups seeking materials to promote the Program are encouraged to access these resources.
26 3. Materials Educational materials about the program and on how to properly dispose of Unwanted Medicine will be available through the website, at take-back events, through potential third party partners and community organizations, and at kiosk drop-off sites. King County MED-Project’s approach will depend upon agreement and participation by third party partners and community organizations.
The Plan includes a sample educational brochure and a sample media advisory for promoting take-back events (Appendix M). Educational materials rely on plain language and explanatory images to promote consumer education and use of drop-off sites to residents with limited English proficiency.
4. Media Outreach King County MED-Project will include public outreach, such as traditional and social media outreach, educational signage and community events. Specifically, King County MED-Project will promote the toolkit as well as take-back events using the available channels described in the Plan. Outreach efforts will encourage media outlets and third party groups to download and use the toolkit. King County MED-Project will coordinate outreach for scheduled take-back events to promote participation by residents. The following materials support the Unwanted Medicine educational and outreach programming for King County:
Please see Appendix J for a sample education and outreach call script with the toolkit including flyers in Appendix L and website information included in Appendix K. King County MED-Project’s approach will depend upon agreement and participation by community organizations. Please see Appendix H for a sample media list of key outlets that reach county residents. Please see http://www.kingcounty.gov/about/news/social-media.aspx for sample digital- and hyper-local social media networks/outlets. Successful dissemination of information within these networks will be contingent upon their agreement to post or tweet the content provided. Please see Appendix M for a sample template media advisory announcing take-back events.
E. Collaboration with the County Officials and Community Organizations King County MED-Project will work in collaboration with the King County Board of Health as appropriate to build on existing community outreach resources, such as local organizations, media lists, available public media outlets, etc. Once the Plan is approved, the following activities will be initiated:
• Briefing Materials Provided to Support Coordination with County Officials:
King County MED-Project will provide access to Educational and Outreach Programming materials, including the sample brochure (included as the Appendices), to relevant County Departments and officials.
• Outreach through Community Organizations:
King County MED-Project will further promote the Plan in King County by engaging relevant stakeholders and community organizations. For example, King County MED-Project plans to arm community organizations, including those identified in Appendix F, with the toolkit, including flyers and website information, included in Appendix L. King County MED-Project’s approach will depend upon agreement and participation by community organizations.
27 F. Disclaimer The written and verbal educational materials and public outreach tools required by the Regulations that are disseminated under this Product Stewardship Plan will include a disclaimer similar to the following: “The material has been provided for compliance with the King County Board of Health Secure Medicine Return Regulations and does not necessarily reflect the views of the King County MED-Project or individual producers.”
X. Survey After the first full year of operation of the Plan, King County MED-Project will conduct a survey to determine awareness of the Plan, the convenience of Unwanted Medicine collection options, and community awareness of the risks of abuse, poisonings, and overdoses from pharmaceutical products. The survey will be distributed to residents of King County, pharmacists and health care professionals who interact with members of the community.
Survey questions shall be designed to measure, at a minimum, (1) percent awareness of the Plan, (2) assess to what extent drop-off sites and other collection methods are convenient and easy to use, and (3) assess knowledge and attitudes about risks of abuse, poisonings and overdoses from prescription and nonprescription drugs used in the home. As required by the Regulations, BOH 11.50.070 (A)(5,) a draft of survey questions will be submitted to the Director for review and comment thirty days prior to distribution. Results of the survey will be reported to the Director and made public on the King County MED-Project website.
After the fifth and ninth years of Plan operation, King County MED-Project will conduct the survey again through outreach to the same constituencies.
XI. Packaging The Regulations require that a Plan consider “separating covered drugs from packaging to the extent possible to reduce transportation and disposal costs.” BOH 11.50.050.H.2. King County MED-Project has considered and evaluated this “separation of packaging” option, and has concluded that mandatory separation of inner and/or outer packaging from Unwanted Medicine would 1) potentially expose confidential patient information and possibly result in the disclosure of such confidential patient information, and 2) increase the possibility of potential releases and leakage of Unwanted Medicine. Accordingly, for these reasons, the King County MED-Project Plan does not provide for the separation of packaging from Unwanted Medicine.
28 XII. Compliance with Applicable Federal, State and Local Legal and Requirements The Regulations require that a product stewardship plan describe how all entities participating in the plan will “operate under” all applicable federal and state laws, rules and guidelines. BOH 11.50.050.D. As described in more detail below, the King County MED-Project Plan is designed such that all entities participating in the Plan shall comply with all applicable federal and state laws, rules and other legal requirements.
A. 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.
The DEA Rule provided 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 King County MED-Project Product Stewardship Plan is designed such that all entities that are part of the Plan, including Stericycle, are individually responsible to comply with their respective compliance obligations under the DEA Rule. Stericycle will ensure that the transportation of Unwanted Medicines, including controlled substances, collected from kiosk drop-off sites and take-back events will be constantly moving towards their final location and unnecessary or unrelated stops of an extended duration will not occur.
B. Washington State Pharmacy Quality Assurance Commission (WSPQAC) The Regulations requires that a Plan describe “how any pharmacy collection site will operate under applicable rules and guidelines of the State of Washington Board of Pharmacy.” BOH 11.50.050.D. King County MED- Project has not identified any “rules” or “guidelines” of the WSPQAC (which functions as the State of Washington “Board of Pharmacy”) which would apply to kiosks that would be placed at a pharmacy under the King County MED-Project Product Stewardship Program. King County MED-Project shall coordinate with the King County Board of Health and the WSPQAC regarding any such rules or guidelines.
29 C. State of Washington Waste Management Program Entities participating in the King County MED-Project Product Stewardship Program shall comply with any applicable provisions of the State of Washington’s waste management program including applicable “moderate-risk” waste and product take-back center requirements.
D. United States Department of Transportation (USDOT) When transporting Unwanted Medicine, Stericycle will ensure compliance with all USDOT Hazardous Materials Regulations (HMR). Stericycle anticipates that the Unwanted Medicine will generally be identified with the identification number and shipping name UN 3248 Medicine, Liquid, Flammable, Toxic, N.O.S. 3 (6.1) PG II ERG (131). Shipments of Unwanted Medicine will comply with applicable shipping papers, packaging, placarding and other HMR requirements associated with shipment by ground.
XIII. Annual Report An annual report will be provided to the Director within six months after the end of the first twelve-month period of operation and annually thereafter within six months after the end of each subsequent twelve-month period. BOH 11.50.070.4 and BOH 11.50.100. This report will be provided in the format required by the Regulations.
For the reporting period, the report will include: • A list of producers participating in the Plan; • The total amount, by weight, of Unwanted Medicine collected, including the amount by weight from each collection method used (drop-off sites, take-back events, and mail-back services); • A list of kiosk drop-off sites; • The number of mailers provided for differentially-abled and home bound residents, and the zip codes where mailers were provided; • The dates and locations of take-back events held; • Transporters and disposal facilities used; • A statement whether any safety or security problems occurred during collection, transportation, or disposal of Unwanted Medicine and, if so, what changes have or will be made to alleviate this problem and improve safety and security; • A description of public education, outreach, and evaluation activities implemented, including the capture of survey results from residents, pharmacies, law enforcement agencies, and media outlets in order to analyze statistics related to awareness, participation, understanding, and satisfaction related to the program, and evaluate results for future possible changes to the program activities; • A summary of the Product Stewardship Plan’s goals, the degree of success meeting these goals in the past year, and how these goals will be achieved in the next year if they were not met; and • The Plan’s total expenditures.
30 Appendix A King County MED-Project Participants
The Pharmaceutical Product Stewardship Working Group (“PPSWG”), a group of pharmaceutical Producers, has established a limited liability company, King County MED-Project LLC, as the Stewardship Organization for the Plan. The Participants in King County MED-Project are provided to the County on an on-going basis. List last submitted to the County on July 10, 2015.
31 Appendix B Detailed Project Plan For Design and Implementation
32
Appendix C Interested Kiosk Drop-Off Sites
King County MED-Project, as the Stewardship Organization, will provide to the County on an on-going basis the list of participating drop-off sites.
On November 11, 2014, King County MED-Project contacted all LEA and Pharmacy locations as provided by King County at http://kingcountysecuremedicinereturn.org/king-county-pharmacies-and-law-enforcement/, and copies of all letters were sent to the Director. King County MED-Project performed additional outreach that included requests for interest in participating in the program, hours of operation, whether the sites currently host a kiosk or other services for the disposal of residential Unwanted Medicine, whether pharmacies are DEA registered collectors and/ or approved by the WSPQCA as collection sites, and whether the sites would like more information regarding the program in the event that the Plan is approved.
Below is a list of locations that were contacted about participating in the program and their expressed interest in participating or receiving additional information as a kiosk drop-off site. The pharmacy responses below reflect information provided by the pharmacists surveyed.
33 Appendix C Continued Interested Kiosk Drop-Off Sites Hours of Operation M - F: 9 AM to PM M - F: 8 AM to 6 PM M - F: 9 AM to 7 PM M - F: 8 AM to 7 PM M - F: 9 AM to 7 PM M - F: 9 AM to PM M - F: 9 AM to 7 PM M - F: 9 AM to 7 PM M - F: 8 AM to 7 PM M - F: 8 AM to 6 PM M - F: 9 AM to 7 PM M - F: 9 AM to PM M - F: 9 AM to PM M - F: 9 AM to 7 PM M - F: 9 AM to 7 PM M - F: 8 AM to 7 PM M - F: 8 AM to 6 PM M - F: 9 AM to 7 PM M - F: 8 AM to 7 PM M - F: 9 AM to 7 PM M - F: 9 AM to PM Yes Yes WSPQAC* Approved by DEA Collector* Registered Registered Yes Yes Kiosk Hosting Currently No No No No No No No No Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Program Interested in WA WA WA WA WA WA WA WA WA WA WA WA WA WA WA WA WA WA WA WA WA City State Seattle Seattle Seattle Seattle Renton Renton Renton Renton Renton Renton Renton Renton Renton Redmond Redmond Redmond Redmond Redmond Redmond Sammamish Sammamish Address 17667 NE 76th St 14880 NE 24th St Way 17220 Redmond 17700 NE 76th St 8862 161st Ave NE # 102 8862 161st Ave 3116 NE Sunset Blvd Center Way 365 Renton SW # G # P 601 S Grady Way 16940 166th Pl SE SE 772541 40th Ave SE 17615 140th Ave 4700 NE 4th St NE 526 228th Ave 3066 Issaquah Pine Lake SE Rd 1404 3rd Ave 1628 Fifth Ave 616 Olive Way E # Ave 2324 Eastlake 405 Pharmacy Name Fred Meyer Pharmaca lntegrative Pharmacy Way 15840 Redmond Rite Aid Rite Aid Target - UW MedicinePrescription Pad 400 s 43rd St Bartell Drugs Prescription Pad - UW MedicinePrescription Pad S # 1 Rd 4011 Talbot Rite Aid Fred Meyer Rite Aid Bartell Drugs Bartell Drugs Rite Aid Bartell Drugs Bartell Drugs Rite Aid Bartell Drugs Bartell Drugs Pharmacy Kelley-Ross Pharmacy Ross Kelly *Status as self-reported by pharmacy. *Status
34 Appendix C Continued Interested Kiosk Drop-Off Sites Hours of Operation M - F: 8 AM to 6 PM M - F: 9 AM to PM M - F: 9 AM to 7 PM M - F: 8 AM to 7 PM M - F: 8 AM to 6 PM M - F: 8 AM to 7 PM M - F: 9 AM to 7 PM M - F: 8 AM to 7 PM M - F: 9 AM to 7 PM M - F: 8 AM to 6 PM M - F: 9 AM to 7 PM M - F: 9 AM to PM M - F: 8 AM to 6 PM M - F: 9 AM to 7 PM M - F: 8 AM to 6 PM M - F: 9 AM to 7 PM M - F: 8 AM to 6 PM M - F: 9 AM to PM M - F: 9 AM to 7 PM M - F: 8 AM to 6 PM M - F: 8 AM to 7 PM WSPQAC* Approved by Yes DEA Collector* Registered Registered Kiosk Hosting Currently No No No No No No Yes Yes Yes YesYes Yes YesYes Yes YesYes Yes Yes Yes Yes Yes Yes Yes Program Interested in WA WA WA WA WA WA WA WA WA WA WA WA WA WA WA WA WA WA WA WA WA City State Kent Seattle Seattle Seattle Seattle Issaquah Issaquah Issaquah Issaquah Kenmore Kenmore Enumclaw Enumclaw Enumclaw Covington Des Moines Address 120 N 85th St 1820 N 45th St 17125 SE 272nd St 627 S 227th St Hwy 21615 Pacific Hwy 27055 Pacific S Des Moines S Des Moines 1009 Monroe Ave Ave 232 Roosevelt 33431 13th Place S Federal Way 201 Broadway E 33702 21st Ave SW33702 21st Ave 2131 SW 336th St Federal Way 1065 NW Gilman Blvd Federal Way Sammamish 5700 E Lake Pkwy SE Sammamish 6100 E Lake SE # F 4570 Klahanie Dr SE 6414 NE Bothell Way NE 18022 68th Ave SE # E 25022 104th Ave Pharmacy Name Bartell Drugs Bartell Drugs Pharmacia Integrative Pharmacy # 110 1815 N 45th St Rite Aid Des Moines Drug Store Bartell Drugs Bartell Drugs Plateau Community PharmacyQFC Ave 3021 Griffin Rite Aid Pharmacy Federal Way Rite Aid Fred Meyer Rite Aid Rite Aid Bartell Drugs Fred Meyer QFC Ostroms Drug & Gift Rite Aid Inc. A&H Stores *Status as self-reported by pharmacy. *Status
35 Appendix C Continued Interested Kiosk Drop-Off Sites Hours of Operation M - F: 9 AM to 7 PM M - F: 9 AM to PM M - F: 8 AM to 6 PM M - F: 8 AM to 7 PM M - F: 8 AM to 6 PM M - F: 8 AM to 6 PM M - F: 9 AM to PM M - F: 9 AM to 7 PM M - F: 8 AM to 6 PM M - F: 8 AM to 7 PM M - F: 9 AM to 7 PM M - F: 8 AM to 6 PM M - F: 9 AM to PM M - F: 8 AM to 6 PM M - F: 9 AM to 7 PM M - F: 8 AM to 7 PM M - F: 9 AM to PM M - F: 8 AM to 6 PM M - F: 9 AM to 7 PM M - F: 8 AM to 6 PM M - F: 8 AM to 6 PM WSPQAC* Approved by DEA Collector* Registered Registered Kiosk Hosting Currently No No No Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Program Interested in WA WA WA WA WA WA WA WA WA WA WA WA WA WA WA WA WA WA WA WA WA City State Kent Kent Kent Kent Burien Burien Burien Seattle Seattle Bothell Bothell Auburn Auburn Auburn Auburn Kirkland Bellevue Bellevue Bellevue Bellevue Covington Address 4741 Rainier Ave S Ave 4741 Rainier S Ave 5405 Rainier 12946 SE Kent Kangley Kangley 12946 SE Kent Rd 10407 SE 256th St 10201 SE 240th St SE 20518 108th Ave SE 3902 A St N # F Way 801 Auburn N Way 1231 Auburn S Way 1509 Auburn 10116 NE 8th St NE 653 156th Ave NE 2041 148th Ave 1510 145th Pl SE # A NE 18921 Bothell Way NE 19107 Bothell Way SW # 100 14901 4th Ave 110 SW 148th St S 14300 1st Ave 16735 SE 272nd ST NE 12071 124th Ave Pharmacy Name Columbia Pharmacy Premiere Pharmacy Bartell Drugs Rite Aid Fred Meyer Rite Aid Bartell Drugs Fred Meyer Rite Aid Rite Aid Bartell Drugs Bartell Drugs Fred Meyer QFC QFC Rite Aid Bartell Drugs Rite Aid Fred Meyer Fred Meyer Assured Pharmacy Inc. *Status as self-reported by pharmacy. *Status
36 Appendix C Continued Interested Kiosk Drop-Off Sites Hours of Operation M - F: 8 AM to 5 PM M - F: 8 AM to 5 PM M - F: 8 AM to 5 PM M - F: 8 AM to 5 PM M - F: 8 AM to 5 PM M - F: 8 AM to 5 PM M - F: 8 AM to 5 PM M - F: 8 AM to 5 PM M - F: 8 AM to 5 PM M - F: 8 AM to 5 PM M - F: 8 AM to 5 PM M - F: 8 AM to 5 PM M - F: 8 AM to 5 PM M - F: 8 AM to 5 PM M - F: 8 AM to 5 PM M - F: 8 AM to 5 PM M - F: 8 AM to 5 PM M - F: 8 AM to 5 PM M - F: 8 AM to 5 PM M - F: 8 AM to 5 PM M - F: 8 AM to 5 PM Kiosk Hosting Currently No No No No Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes YesYes Yes Yes Yes Yes Yes Program Interested in WA WA WA WA WA WA WA WA WA WA WA WA WA WA WA WA WA WA WA WA WA State City Duvall Burien Bothell Auburn Auburn Medina Kirkland Bellevue Bellevue Bellevue Issaquah Kenmore Clyde Hill Enumclaw Des Moines Federal Way Federal Way Maple Valley Maple Valley Black Diamond Lake Forest Park Lake Address 22300 SE 231st 17425 Ballinger Way NE 17425 Ballinger Way 4950 S 298th St 26225 NE Stephens St 26225 NE Stephens 39015 172nd Ave SE 39015 172nd Ave Law Enforcement Agency Name Law Medina Police DepartmentMedina Police Road 501 Evergreen Point Beaux Arts Village Maple Valley Police Department Police Maple Valley Suite 100 Road, 22017 SE Wax Lake Forest Park Police Forest Park Lake Kenmore Police Department Police Kenmore DepartmentKirkland Police NE 18120 68th Ave 123 5th Ave Issaquah Police DepartmentIssaquah Police 130 E Sunset Way Federal Way Police Department Police Federal Way S 33325 8th Ave. King County Sheriffs Enumclaw Police DepartmentEnumclaw Police St 1705 Wells Carnation-Duvall Police Carnation-Duvall Police Department Des Moines Police DepartmentDes Moines Police S 21900 11th Ave Burien Police DepartmentBurien Police DepartmentClyde Hill Police SW 14905 6th Ave 9605 NE 24th Street Bothell Police DepartmentBothell Police NE 18410 101st Ave Black Diamond Police DepartmentBlack Diamond Police St 25510 Lawson Muckelshoot Tribe Police Police Tribe Muckelshoot Department DepartmentBellevue Police DepartmentBellevue Police 3915 Factoria Blvd SE DepartmentBellevue Police NE 1336 156th Ave NE 450 110th Ave Auburn Police Department Police Auburn 340 East Main, Suite 201
37 Appendix C Continued Interested Kiosk Drop-Off Sites Hours of Operation M - F: 8 AM to 5 PM M - F: 8 AM to 5 PM M - F: 8 AM to 5 PM M - F: 8 AM to 5 PM M - F: 8 AM to 5 PM M - F: 8 AM to 5 PM M - F: 8 AM to 5 PM M - F: 8 AM to 5 PM M - F: 8 AM to 5 PM M - F: 8 AM to 5 PM M - F: 8 AM to 5 PM M - F: 8 AM to 5 PM M - F: 8 AM to 5 PM M - F: 8 AM to 5 PM M - F: 9 AM to 4 PM M - F: 8 AM to 5 PM M - F: 8 AM to 5 PM M - F: 8 AM to 5 PM M - F: 8 AM to 5 PM Kiosk Hosting Currently No No No No No Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Program Interested in WA WA WA WA WA WA WA WA WA WA WA WA WA WA WA WA WA WA WA State City Milton Pacific Seattle Seattle Seattle Seattle Seattle Seattle SeaTac Renton Tukwila Vashon Shoreline Newcastle Woodinville Snoqualmie Sammamish Mercer Island Normandy Park Address 19021 Vashon Hwy SW 19021 Vashon 9839 8 Ave SW 9839 8 Ave Law Enforcement Agency Name Law Woodinville Police Department Police Woodinville NE 17301 133rd Ave King County Sheriffs Tukwila Police Department Police Tukwila 6200 Southcenter Blvd Snoqualmie Police DepartmentSnoqualmie Police 34825 SE Douglas St Shoreline Police DepartmentShoreline Police 1206 N 18th St Seattle Police DepartmentSeattle Police N 10049 College Way Seattle Police DepartmentSeattle Police 610 Fifth Ave Seattle Police DepartmentSeattle Police 1519 12th Ave King County Sheriffs Seattle Police DepartmentSeattle Police St 2300 SW Webster SeaTac Police Department Police SeaTac DepartmentSeattle Police 4800 S 188 St 810 Virginia St Sammamish Police DepartmentSammamish Police SE 801 228th Ave Milton Police DepartmentMilton Police DepartmentNewcastle Police Department Police Normandy Park St 1000 Laurel Suite 200 12835 Newcastle Way, 801 SW 174th St Police Department Pacific Department Police Renton Ave SE 133 3rd 1055 S Grady Way Mercer Police DepartmentMercer Police 9611 SE 36th St
38 Appendix D King County Initial Drop-Off Site List
The following LEA sites are proposed to be the initial 30 drop-off sites. Existing sites include four District 1 sites, four District 3 sites, and one each in Districts 7, 8, and 9. In addition, a “Yes” in the column titled “Drop-Off Site” indicates that there was a kiosk in this location prior to the submission of this Plan. If retail pharmacies are qualified to participate and are interested in participating, they will be added to the implementation plan upon the full execution of contracts with King County MED-Project.
# Law Enforcement Agency Site County Council Kiosk Currently In District Place?
1 Bothell Police Department 1 Yes 18410 101st Ave NE Bothell WA 98011 2 Kenmore Police Department 1 Yes 18120 68th Ave NE Kenmore WA 98028 3 Lake Forest Park Police 1 Yes 17425 Ballinger Way NE Lake Forest Park WA 98155 4 Woodinville Police Department 1 Yes 17301 133rd Ave NE Woodinville WA 98072
39
Appendix D Continued King County Initial Drop-Off Site List
County Council Kiosk Currently In # Law Enforcement Agency Site District Place?
5 King County Sheriffs 12629 2 Renton Ave S Renton WA 98178 6 Seattle Police Department 2 3001 S Myrtle St Seattle WA 98108 7 Issaquah Police Department 3 Yes 130 E Sunset Way Issaquah WA 98027 8 North Bend Police Department 3 Yes 1550 Boalch Ave NW North Bend WA 98045 9 Sammamish Police Department 3 Yes 801 228th Ave SE Sammamish WA 98075 10 Snoqualmie Police Department 3 Yes 34825 SE Douglas St Snoqualmie WA 98065 11 Seattle Police Department 4 810 Virginia St Seattle WA 98101 12 Seattle Police Department 4 10049 College Way N Seattle WA 98133 13 Des Moines Police Department 5 21900 11th Ave S Des Moines WA 98198 14 Kent Police Department 5 232 4th Ave S Kent WA 98030 15 Normandy Park Police Department 5 801 SW 174th St Normandy Park WA 98166 16 Bellevue Police Department 6 1336 156th Ave NE Bellevue WA 98007 17 Bellevue Police Department 6 450 110th Ave NE Bellevue WA 98009 18 Clyde Hill Police Department 6 9605 NE 24th Street Clyde Hill WA 98004
40 Appendix D Continued King County Initial Drop-Off Site List
County Council Kiosk Currently In # Law Enforcement Agency Site District Place?
19 Milton Police Department 7 1000 Laurel St Milton WA 98354 20 Algona Police Department 7 402 Warde Street Algona WA 98001 21 Auburn Police Department 7 Yes 340 East Main, Suite 201 Auburn WA 98008 22 Muckelshoot Tribe Police Department 7 39015 172nd Ave SE Auburn WA 98092 23 Burien Police Department 8 Yes 14905 6th Ave SW Burien WA 98166 24 Seattle Police Department 8 2300 SW Webster St Seattle WA 98106 25 King County Sheriffs 8 9839 8 Ave SW Seattle WA 98106 26 King County Sheriffs 8 9609 16th Ave. SW Seattle WA 98112 27 Bellevue Police Department 9 3915 Factoria Blvd SE Bellevue WA 98006 28 Black Diamond Police Department 9 25510 Lawson St Black Diamond WA 98010 29 Covington Police Department 9 16720 SE 271st St Covington WA 98042 30 Maple Valley Police Department 9 Yes 22017 SE Wax Road Maple Valley WA 98038
41 Appendix E Past Community Events That May Serve as Future Take-Back Events
The following examples of past events that will be targeted for the annual take-back event based on timing and geographic needs:
• Health and Wellness Fair, Medical Dental Building, Seattle, WA • Health and Wellness Fair, Mirabella Emerald Hall, Seattle, WA • Health and Fitness Expo, CenturyLink Field and Event Center, Seattle, WA • Recycling and Collection Event, City of Redmond, WA • Earth Day Events throughout King County, WA • South King County Latino Family Health & Safety Fair, Auburn, WA • King County Fair, Enumclaw Expo Center, Enumclaw, WA • Giant Free Health Clinic, Key Arena at Seattle Center, Seattle, WA • Household Hazardous Waste Collection Events throughout King County, WA • Recycling Fairs and Events throughout King County, WA
42 Appendix F Possible Contact List For Outreach and Education to the Community
The following are Associations, Agencies, and Organizations that will be contacted for assistance with outreach and education to the community. They will also be contacted to participate as potential future drop-off sites or take- back event sponsors. King County Med-Project will also contact existing drop-off sites.
Health Systems: Auburn Regional Medical Center in Auburn Caldwell Health Center in Des Moines Childrens’ Hospital and Regional Medical Center in Seattle North Enumclaw Community Hospital in Enumclaw Evergreen Hospital Medical Center in Kirkland Fairfax Hospital in Kirkland Group Health Medical Center in Mercer Island, Kirkland, Seattle South Harborview Medical Center in Seattle South Healthpoint Auburn Medical and Dental Center in Redmond Highline Medical Center in Des Moines Kindred Hospital Seattle in Seattle North Mason Hospital in Seattle South Northwest Hospital in Seattle North Overlake Hospital Medical Center in Mercer Island, Kirkland Providence Mount Saint Vincent Medical Center in Duwamish Head Riverton General Hospital in Des Moines Saint Francis Hospital in Poverty Bay Shick Shadel Hospital in Des Moines Snoqualmie Valley Hospital in Snoqualmie Swedish Medical Center in Shilshole Bay, Seattle South, Issaquah United States Marina Hospital in Seattle South University of Washington Medical Center in Seattle North Valley Medical Center in Renton Veterans Affairs Medical Center Seattle in Seattle South Virginia Mason Medical Center in Seattle South
Health Associations: Washington State Board of Pharmacy Washington State Pharmacy Association (WSPA) Washington State Department of Health Washington State Medical Commission Washington State Nurses Association (WSNA) King County Nurses Association (KCNA) King County Board of Health King County Medical Society (KCMS)
Organizations, Districts, and Agencies: King County Solid Waste Division Washington State Recycling Association (WSRA) King County Department of Community and Human Services King County Department of Public Health Municipal Utilities Districts Water Quality and Water Agencies School Districts, Campuses, and University Systems King County Council
A list of pharmacies and LEAs that may serve as Drop-Off Sites is available at http://kingcountysecuremedicinereturn.org/king-county-pharmacies-and-law-enforcement/ 43 Sample – Not for Distribution. All text subject to change pending review and approval by King County. Appendix G A. Picture of Kiosk Prototype
LOCKABLE CHUTE DOOR, SLOPED TOP TO EASY TO USE TILT-AND-SLIDE PREVENT STORAGE WITH ANTI-TAMP PROTECTION
HANDLE FULFILLS ADA REQUIREMENTS FULL INDICATOR LIGHT
DUAL LOCKS FOR ADDED SECURITY
ANCHORS TO FLOOR OR WALL
The kiosk is approximately 42”tall x 19”wide x 20 .5”deep (without handle).
The design of the kiosk recognizes the paramount importance of security through the use of heavy gauge steel, multiple locking mechanisms, tamper-proof slot and commercial hinges, meeting the stringent requirements under law. At the same time, the design provides accessibility and ease of use.
44 Sample – Not for Distribution. All text subject to change pending review and approval by King County. Appendix G B. Sample Kiosk Signage
Top of Kiosk Key Art 42” tall x 19” wide x 20.5” deep
45
Sample – Not for Distribution. All text subject to change pending review and approval by King County. Appendix G C. Sample Kiosk Signage
Side Panel of Kiosk 42” tall x 19” wide x 20.5” deep
46
Sample – Not for Distribution. All text subject to change pending review and approval by King County. Appendix G D. Sample Kiosk Signage
Front Panel of Kiosk 42” tall x 19” wide x 20.5” deep
47
Appendix H Sample Media List
The following is a representative list of key media outlets to help educate King County residents about proper disposal of expired or Unwanted Medicines. 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 City/Coverage Area Website
Allied Law Group Seattle www.alliedlawgroup.com
Auburn Reporter Auburn www.auburn-reporter.com
Bellevue Reporter Bellevue www.bellevuereporter.com
Bothell/Kenmore Reporter Kirkland www.bothell-reporter.com
Capitol Hill Times Bellevue www.capitolhilltimes.com
City Living Seattle www.citylivingseattle.com/
Covington/Maple Valley Reporter Maple Valley www.covingtonreporter.com
Daily Journal of Commerce Seattle www.djc.com
Eastern European Echo Seattle www.theecho.us
Enumclaw Courier-Herald Enumclaw www.courierherald.com
Federal Way Mirror Federal Way www.fedwaymirror.com
Issaquah Press Issaquah www.issaquahpress.com
Issaquah/Sammamish Reporter Bellevue www.issaquah-reporter.com
Kent Reporter Kent www.kentreporter.com
Kirkland Reporter Kirkland www.kirklandreporter.com
Mercer Island Reporter Bellevue www.mi-reporter.com
Northwest Asian Weekly Seattle www.nwasianweekly.com
Northwest Vietnamese News Seattle www.nvnorthwest.com
Queen Anne/Magnolia News Seattle www.queenannenews.com
Redmond Reporter Kirkland www.redmond-reporter.com
Russian World Kirkland www.russianworldnewspaper.com
Sammamish Review Issaquah www.sammamishreview.com
Snoqualmie Valley Record Snoqualmie www.valleyrecord.com
SnoValley Star Issaquah www.snovalleystar.com
The Daily, Univ. of Washington Seattle www.thedaily.washington.edu
Vashon-Maury Island Beachcomber Vashon www.vashonbeachcomber.com
Woodinville Weekly Woodinville www.nwnews.com
48 Appendix H Continued Sample Media List
Television Outlets Network
KOMO ABC
KING NBC
KIRO CBS
KCTS PBS
KSTW (licensed to Tacoma, studios in Seattle) The CW
KVOS (licensed to Bellingham) Me-TV
KCPQ (licensed to Tacoma, studios in Seattle) Fox
KONG (licensed to Everett, studios in Seattle) Independent
Radio Outlets City/Coverage Area
KVI Seattle
KIRO Seattle
KTTH Seattle
KGNW Burien
KIXI Mercer Island
KJR Seattle
KOMO Seattle
KBLE Seattle
KFNQ Seattle
KKXA Snohomish
KXPA Bellevue
KLFE Seattle
KYIZ Renton
KNTS Seattle
KNHC Seattle
KEXP Seattle
KBCS Bellevue
KQMV Bellevue
KUBE Seattle
49 Appendix H Continued Sample Media List
Radio Outlets City/Coverage Area
KMPS Seattle
KUOW Seattle
KJR Seattle
KJAQ Seattle
KING Seattle
KLCK Seattle
KISW Seattle
KKWF Seattle
KPLZ Seattle
KZOK Seattle
KMCQ Covington
KNDD Seattle
50 Appendix I Sample Mail-Back Package
Sample Mail-back Package
NO POSTAGE NECESSARY IF MAILED IN THE Street Address: ______UNITED STATES City/State:______ZIP: ______POSTAGE DUE COMPUTED BY DELIVERY UNIT
FIRST CLASS MAIL
MERCHANDISE RETURN LABEL USPS TRACKING # PERMIT NO. XXX INDIANAPOLIS IN 123456 STERICYCLE, INC. 1234 MERCHANT RD POSTAGE DUE UNIT US POSTAL SERVICE 2670 EXECUTIVE DRIVE 9221 6901 0328 7207 2035 85 INDIANAPOLIS, IN 46241-1111
Untitled-1 1 2/25/14 8:32 AM Description: Plastic Envelope with Merchandise Return Label and instructional flyer
Page Size : Envelope: Outer Dimension: 8.063” x 10.5” Inner Dimension: 7.81” x 10.375”, 2” flap (Hot Melt Tape- Tamper Evident) Merchandise Return Label: 3” x 8” Instructional Sheet: 5.5” x 8.5”
Paper Stock : Envelope: 4mil white/ silver poly mailer w/sequential barcode Return Label: 60# uncoated label stock Instructional Sheet: 80# Gloss Text
Color : Envelope: 5/3 Print: Silver, white, white, + 2 PMS on clear web; Silver + 2 PMS on white web Return Label: K/0 no bleeds (personalized barcode) Instructional sheet: K/K
51 Sample – Not for Distribution. All text subject to change pending review and approval by King County. Appendix J Sample Template: Education and Outreach Call Script [1-800-MED-Proj] Residents will also be able to select a Spanish version.
Thank you for calling the information line for the King County Medication Education and Disposal Project, or King County MED-Project.
CALL RECEIVED Option: English or Spanish
General & Emergency Information
press 0 press 1 press 2 Talk to or Repeat Disposal leave message Script d Options
for operator
d d d d d
press 3 press 4 press 5
Convenient Take-back Mail-back Kiosks Events Services d d d
Press 1 for Spanish or remain on the line for English ` If you are experiencing a medical emergency, please hang up and dial 9-1-1. ` If you are experiencing a non-emergency but suspect that you or a family member has ingested something poisonous, please call the Washington Poison Center at 800-222-1222. ` If you have questions about your medication, please hang up and dial your health care provider. ` Be sure to store medications properly to prevent accidental ingestion or misuse by others in your household, especially children. ` King County MED-Project is a consumer education campaign dedicated to proper medication use and consumer disposal. ` King County MED-Project reminds you that taking your medicine as directed by your health care provider is critically important to your health. ` If you have expired or unwanted medications, press 2 to hear disposal options. ` For additional questions about the proper disposal of expired or unwanted medications from households, please go to www.med-project.org/KingCounty or press 0 to talk to an operator or leave a message. ` For information on how to properly dispose of sharps such as needles, please visit http://www.kingcounty.gov/ healthservices/health/communicable/hiv/resources/disposal.aspx. ` To hear this menu again, please press 1 ` Thank you for calling King County MED-Project. 52 Appendix J Continued Sample Template: Education and Outreach Call Script [1-800-MED-Proj]
Script for when 2 is selected for Disposal Options: ` To protect your privacy, remove or black out all personally identifiable information before disposing of your medications. ` If there are any instructions for disposal on your medication’s label or patient information that accompanies the medication, please follow those instructions. ` Kiosks are located throughout the county and provide convenient options for returning expired or unwanted medicines. Press 3 for more information about convenient kiosks. ` Take-back events are scheduled throughout the year and offer residents a free and convenient way to dispose of expired or unwanted medicines. Press 4 for more information. ` Mail-back services are available to King County residents who are home bound or differentially-abled. Press 5 for more information. ` If no disposal instructions are given on the drug labeling and no take-back program is available in your area, throw the drugs in the household trash following these steps: o Remove them from their original containers and mix them with an undesirable substance, such as used coffee grounds or kitty litter (this makes the drug less appealing to children and pets, and unrecognizable to people who may intentionally go through the trash seeking drugs). o Place the mixture in a sealable bag, empty can, or other container to prevent the drug from leaking or breaking out of a garbage bag.1 ` To repeat this information, press 2. ` For additional questions about the proper disposal of expired or unwanted medications from households, please go to www.med-project.org/KingCounty or press 0 to speak to an operator or leave a message. ` To return to the main menu, please press 1. ` Thank you for calling King County MED-Project.
Kiosk Script for when 3 is selected: ` Kiosks to collect expired and unwanted medicine are located conveniently through King County. ` Prescription and non-prescription medicines in pill, capsule or liquid form may be turned in at kiosks. No illicit drugs, medical devices, or needles will be accepted. ` For information on how to properly dispose of sharps such as needles, please see http://www.kingcounty.gov/ healthservices/health/communicable/hiv/resources/disposal.aspx. ` King County MED-Project continuously evaluates kiosk locations to provide maximum convenience to King County residents, and most kiosk sites operate from 9am to 9pm, however opening times may vary. To locate the kiosk site nearest you, or for precise information about kiosk hours of operation, visit http://med-project.org/ kingcounty/convenient-kiosks to search by your zip code, or press 0 to leave a message or talk to the operator. ` To repeat this information, press 3. ` To return to the main menu, please press 1. ` Thank you for calling King County MED-Project.
Take-back Script for when 4 is selected: ` King County MED-Project is working with local law enforcement and other community organizations to offer regular expired and unwanted medicine take-back events throughout the county. For a complete list of take- back events, please visit: http://med-project.org/kingcounty/take-back-events, or press 0 to speak to or leave message for the operator. ` To repeat this information, press 4. ` To return to the main menu, please press 1. ` Thank you for calling King County MED-Project.
1 http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm101653.htm, page last updated May 19, 2014 53 Appendix J Continued Sample Template: Education and Outreach Call Script [1-800-MED-Proj]
Mail-back Package Script for when 5 is selected: ` King County MED-Project has made available pre-paid, pre-addressed mail-back packages to residents of King County who are home bound or differentially-abled. ` Residents may request 1 envelope at a time. Home healthcare professionals may also request an envelope on behalf of a resident. Envelopes will be delivered via the United States Postal Service. ` To request a mail-back package, please visit http://med-project.org/kingcounty/mail-back, or press 0 to talk to or leave message for the operator. ` To repeat this information, press 5. ` To return to the main menu, please press 1. ` Thank you for calling King County MED-Project.
54 Sample – Not for Distribution. All text subject to change pending review and approval. Appendix K King County MED-Project Website
55 Sample – Not for Distribution. All text subject to change pending review and approval. Appendix K King County MED-Project Website
56 Sample – Not for Distribution. All text subject to change pending review and approval. Appendix K King County MED-Project Website
57 Sample – Not for Distribution. All text subject to change pending review and approval. Appendix K King County MED-Project Website
58 Sample – Not for Distribution. All text subject to change pending review and approval. Appendix K King County MED-Project Website
59 Sample – Not for Distribution. All text subject to change pending review and approval. Appendix K King County MED-Project Website
60 Sample – Not for Distribution. All text subject to change pending review and approval. Appendix K King County MED-Project Website
61 Sample – Not for Distribution. All text subject to change pending review and approval. Appendix K King County MED-Project Website
62 Sample – Not for Distribution. All text subject to change pending review and approval. Appendix L
Translations of the brochure and FAQ will be available in Spanish, Vietnamese, Mandarin, Russian, and Tagalog.
Brochure/Flyer Mockup
63 Sample – Not for Distribution. All text subject to change pending review and approval.
Appendix L Continued
Translations of the brochure and FAQ will be available in Spanish, Vietnamese, Mandarin, Russian, and Tagalog.
Instruction Brochure/Flyer Mockup
64 Appendix L Continued PSA Outline
The following is a proposed outline for a public service announcement (PSA) promoting King County MED-Project.
Radio Script (approx. :60 seconds)
The King County Medication Education & Disposal Project wants the public to know the best way to dispose of expired and unwanted medications.
First, check the label. If there are specific disposal instructions on the label, follow those. Do not flush prescription drugs down the toilet, unless the product information instructs you to do so.
Second, local drug take-back events and kiosks offer residents the option to dispose of unwanted or expired medicines.
Third, if no instructions are provided on the label and there’s no take-back program in your area, you can dispose of these drugs at home by following these simple steps.
Remove the expired drugs from their original containers and mix them with an undesirable substance, like coffee grounds or kitty litter (this makes the drug less appealing to children and pets). Next place the mixture in a sealable bag, then place in a trash bag.
For more information on the MED-Project and to hear your disposal options again, visit www.med-project.org or call 1-844-MED-PROJ.
Paid for by King County MED-Project.
###
65 Appendix L Continued PSA Outline
TV Script (approx. :30 seconds)
Sample Visual Sample Audio
VO: Open on a panning shot of several prescription drug vials or a hand removing a vial from a medicine There are several ways to dispose of expired and cabinet. unwanted medications.
Cut to a tight shot of the vial in someone’s hands and First, check the label and follow the specific disposal the finger scans the label. instructions.
Then cut to an over the shoulder shot of a person Or check local drug take-back events and kiosks looking at a laptop and going to the website. We can available in your area. show screenshot of locator on our website. Alt visual, person making a phone call.
Cut to a person at a kitchen counter with several pill Or dispose of expired or unwanted medications by vials. Cut to person dumping the container of one vial removing them from their original container and mixing into a plastic sealable bag with coffee grounds in it. them with an undesirable substance like coffee grounds Cut to hand sealing the bag. Cut to hand placing in a or kitty litter. Then place the mixture in a sealable bag trash can. and place in a trash bag.
Cut to white screen with black text: This message is brought to you by the King County TEXT: MED-Project. For more information on the MED-Project, visit www. med-project.org Or call 1-844-MED-PROJ (1-844-633-7765)
66 Sample – Not for Distribution. All text subject to change pending review and approval.
Appendix L Continued
Translations of the brochure and FAQ will be available in Spanish Vietnamese, Mandarin, Russian, and Tagalog.
FAQ Outline
The following are suggested questions to be addressed by the “Frequently Asked Questions” section of the King County MED-Project website/public relations toolkit. All text is subject to change pending review and approval.
• What is the King County MED-Project? King County MED-Project is the public, non-profit entity implementing the King County Product Stewardship Plan, including the education and outreach programming.
• What should I do if I am having a medical emergency? If you are having a medical emergency, contact emergency medical services immediately by dialing 911.
• What should I do if I think I have ingested something poisonous? If you think you have ingested something poisonous, contact emergency services immediately. Please dial 911 or contact your local poison control center.
• What should I do if my pet has ingested medication? If you believe your pet may have ingested human or animal medication not intended for consumption by your pet, please contact your veterinarian or local animal poison control hotline.
• Whom should I call with a question about my medication? Please direct all questions regarding your medication to your health care provider.
• Where can I find information about the safe storage of medication? You should follow any storage instructions provided by your healthcare provider, and any written instructions provided with your medication or listed on its packaging.
In addition, many government agencies provide information regarding safe storage of medication. Possible sources include the National Institutes of Health’s information page and the CDC’s information page
• Can I flush my medication down the toilet? Do not flush medications down the toilet unless the information on the label, package or package insert specifically instructs you to do so.
• Should I remove my personal information before disposing of my medication? Please remove all personal and identifying information from your medication labels and/or its packaging before disposal.
• Where are the King County MED-Project disposal locations nearest me? King County MED-Project is providing disposal locations throughout the King County. For more information about the location nearest to you, please visit the “Find the Nearest Disposal Location” portion of the King County MED-Project web site, or call the hotline at 1-844-MED-Proj.
• Will it cost me anything to dispose of my expired or unwanted medications? There will be no fee for medication disposal charged at the point of collection.
67 Appendix L Continued FAQ Outline
• What items can I dispose of in the King County MED-Project kiosks? Prescription and non-prescription medicines in pill, capsule or liquid form may be turned in at kiosks. No illicit drugs, medical devices, or needles, herbal remedies, cosmetics or other personal care products, or pet pesticides will be accepted.
• Will there be a take-back event in my area? Please visit the King County MED-Project web site or dial the hotline at 1-844-MED-PROJ to learn about take-back events in your area.
• I am differentially-abled or home bound and unable to go to a kiosk or attend a take-back event. How can I dispose of my expired or unwanted medicine? Please dial the hotline at 1-844-MED-PROJ to request a pre-paid envelope to return your unwanted or expired medicine.
• Where else can I find information about the safe disposal of expired or unwanted medicines? Several government agencies provide information regarding safe disposal of medication. Please refer to the FDA’s website for more information “Consumer Updates: How to Dispose of Unused Medicines”.
• I have a question not answered by this website. Is there someone I can contact with a question about King County MED-Project? For more information, please dial the hotline at 1-844-MED-Proj.
• What is recommended for safe disposal of expired or unwanted medicine in King County? The following disposal options and sequence should be considered when disposing of unwanted medicine:
Check the Package: If there are any specific instructions for disposal on the label, package or package insert, please follow those instructions. 1. Do not flush drugs down the toilet unless the information on the package specifically instructs you to do so. Take-Back Events: Local take-back events may be sponsored in your area and offer residents a free and convenient way to dispose of expired or unwanted medicines. Local law enforcement authorities may sponsor local drug take-back days in your area.
Convenient Kiosks: Community drug take-back locations at local law enforcement agencies allow residents to bring expired or unwanted medicines to a convenient, centralized location for proper disposal.
In-Home Disposal: If no disposal instructions are given on the drug labeling and no take-back program is available in your area, throw the drugs in the household trash following these steps. 1. Remove them from their original containers and mix them with an undesirable substance, such as used coffee grounds or kitty litter (this makes the drug less appealing to children and pets, and unrecognizable to people who may intentionally go through the trash seeking drugs).
2. Place the mixture in a sealable bag, empty can, or other container to prevent the drug from leaking or breaking out of a garbage bag.1
1 http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm101653.htm, page last updated May 19, 2014 68 Sample – Not for Distribution. All text subject to change pending review and approval. Appendix M Sample Temple: Take-Back Event Media Advisory
ADVISORY * * * ADVISORY * * * ADVISORY * * * ADVISORY
King County MED-Project to Support King Take-Back Event on [Date, 2016]
King County residents are invited to bring expired or unwanted medications to [Location] from [x time] to [y time] for disposal
King County, Washington, [Date] – The King County Medication Education & Disposal Project (King County MED- Project), a consumer education campaign dedicated to responsible medication use and disposal, announced today that it will be supporting a medication take-back event supervised by a local law enforcement agency for consumers in [town] on [date]. All King County residents are invited to bring their expired or unwanted medications for disposal. The service is free. [Insert information for residents about what can be collected]. To protect privacy, consumers are reminded to remove all personally identifiable information on prescription labels or materials which are brought to this take-back event.
What: King County MED-Project Medication Take-Back Event – bring your expired or unwanted medicines for disposal When: [Date], [Time] Where: [Location]
For more information about disposal options for expired or Unwanted Medicine, visit www.med-project.org.
###
Contact: King County MED-Project Public Affairs 202-xxx-xxxx
69
King County MED-Project Participant List
Key: Parent Company Participating in Program Parent Company NOT Participating in Program Affiliated Company Participating in Program Notes Company Parent Company Full Address Full Name Title Work Phone Email
1 North Waukegan Road North AbbVie Inc. AbbVie Inc. Chicago, IL 60064 UNITED STATES Floreine Kahn Director, State Government Affairs (916) 206-6640 [email protected] 1009 Slater Road Suite 210-B Durham, Accord Healthcare Inc. Accord Healthcare Inc. NC 27703 UNITED STATES Shail Shah Associate-Regulatory Affairs (919) 941-7878 [email protected]
Acorda Therapeutics, 420 Saw Mill River Road Ardsley, NY Acorda Therapeutics, Inc. Inc. 10502 Mark DellaPorta Director, Legal R & D (914) 326-5780 [email protected]
Acorda Therapeutics, 420 Saw Mill River Road Ardsley, NY Civitas Therapeutics Inc. 10502 Mark DellaPorta Director, Legal R & D (914) 326-5780 [email protected] 9001 Aerial Center Parkway Aerial Acorda Therapeutics, Center Executive Park Morrisville, NC Neuronex, Inc. Inc. 27560-9731 Mark DellaPorta Director, Legal R & D (914) 326-5780 [email protected] 400 Interpace Parkway Parsippany, NJ [email protected] Actavis plc Actavis plc 07054 Loredana Cromarty Executive Director, Government Affairs (973) 216-4568 m 200 Elmora Avenue Elizabeth, NJ Actavis Elizabeth LLC Actavis plc 07207 Loredana Cromarty Executive Director, Government Affairs (973) 216-4568 [email protected] 60 Columbia Road Bldg. B Morristown, Actavis Inc. Actavis plc NJ 07960 Loredana Cromarty Executive Director, Government Affairs (973) 216-4568 [email protected] Via L. Pasteur, 10 20014 NERVIANO MI Actavis Italy SpA [or] Made in Italy Actavis plc ITALY Loredana Cromarty Executive Director, Government Affairs (973) 216-4568 [email protected]
Actavis Mid Atlantic LLC Actavis plc 1877 Kawai Road Lincolnton, NC 28092 Loredana Cromarty Executive Director, Government Affairs (973) 216-4568 [email protected] No 101, 102, 106, 107 Sidco Pharm. Compl 1st Fl., Alathur Near Sipcot Actavis Pharma Manufacturing Pvt. Ltd. Indus. Est. Old Mahabalipuram Road (India) Actavis plc TIRUPORUR 603110 INDIA Loredana Cromarty Executive Director, Government Affairs (973) 216-4568 [email protected] Actavis Pharma UT, Inc. (f/k/a Watson 132 Business Center Drive Corona, CA Laboratories Inc.) Actavis plc 92880-1724 Loredana Cromarty Executive Director, Government Affairs (973) 216-4568 [email protected] Corporate Center III 400 Interpace Actavis Pharma, Inc. Actavis plc Parkway Parsippany, NJ 07054 Loredana Cromarty Executive Director, Government Affairs (973) 216-4568 [email protected] 13800 N.W. 2nd Street Suite 190 Actavis South Atlantic LLC Actavis plc Sunrise, FL 33325 Loredana Cromarty Executive Director, Government Affairs (973) 216-4568 [email protected] 100 Somerset Corporate Blvd Aptalis Pharma US, Inc. Actavis plc Bridgewater, NJ 08807 Loredana Cromarty Executive Director, Government Affairs (973) 216-4568 [email protected] HF62 Hal Far Industrial Estate Arrow Pharma (Malta) Limited Actavis plc Birzebbuga BBG3000 MALTA Loredana Cromarty Executive Director, Government Affairs (973) 216-4568 [email protected] 6500 Kitimat Rd MISSISSAUGA, Ontario Cobalt Pharmaceutical, Inc. (Canada) Actavis plc L5N 2B8 CANADA Loredana Cromarty Executive Director, Government Affairs (973) 216-4568 [email protected]
Forest Laboratories LLC Actavis plc 909 Third Ave. New York, NY 10022 Loredana Cromarty Executive Director, Government Affairs (973) 216-4568 [email protected] 13600 Shoreline Drive St. Louis, MO Forest Pharmaceuticals Inc. Actavis plc 63045 UNITED STATES Loredana Cromarty Executive Director, Government Affairs (973) 216-4568 [email protected]
Inwood Laboratories, Inc. Actavis plc 321 Prospect Street Inwood, NY 11096 Loredana Cromarty Executive Director, Government Affairs (973) 216-4568 [email protected] S.C. SINDAN - PHARMA S.R.L. [or] Made in 11 Ion Mihalache Blvd 011171 Romania Actavis plc BUCHAREST 1 ROMANIA Loredana Cromarty Executive Director, Government Affairs (973) 216-4568 [email protected]
Warner Chilcott (US), LLC Actavis plc 100 Enterprise Dr Rockaway, NJ 07866 Loredana Cromarty Executive Director, Government Affairs (973) 216-4568 [email protected] 320 WOODS CORS NORWICH, NY Warner Chilcott Pharmaceuticals, Inc. Actavis plc 13815 Loredana Cromarty Executive Director, Government Affairs (973) 216-4568 [email protected]
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Key: Parent Company Participating in Program Parent Company NOT Participating in Program Affiliated Company Participating in Program Notes Company Parent Company Full Address Full Name Title Work Phone Email Corporate Center III 400 Interpace Watson Pharma Inc. (Distributor only) Actavis plc Parkway Parsippany, NJ 07054 Loredana Cromarty Executive Director, Government Affairs (973) 216-4568 [email protected] Plot No. N-15 MIDC, Additional Ambernath Anand Nagar THANE Watson Pharma Private LTD. (India) Actavis plc 421506 INDIA Loredana Cromarty Executive Director, Government Affairs (973) 216-4568 [email protected]
Aegerion 101 Main St. Ste. 1850 Cambridge, MA Aegerion Pharmaceuticals, Inc. Pharmaceuticals, Inc. 02142 Gerald S. Abernathy Director, Supply Chain (857) 242-5046 [email protected]
Participant Added Since 1925 West Field Court, Suite 300 Lake Last Plan Submission Akorn, Inc. Akorn, Inc. Forest, IL 60045, UNITED STATES April Polikoff Associate Counsel 631.789.8228 x4702 [email protected]
Participant Added Since Akrimax 11 Commerce Drive, 1st Floor Last Plan Submission Akrimax Pharmaceuticals, LLC Pharmaceuticals, LLC Cranford, NJ 07016 UNITED STATES Keith S. Rotenberg Corp. VP, Chief Scientific Officer (908) 372-1209 [email protected] 2525 DuPont Drive Irvine, CA 92612 [email protected] Allergan, Inc. Allergan, Inc. UNITED STATES Sulaiman Hamidi Director, Sustainability (714) 246-4433 m 2525 Dupont Drive 14th Irvine, CA Allergan Sales LLC Allergan, Inc. 92612-1531 Sulaiman Hamidi Director, Sustainability (714) 246-4433 [email protected] 2525 DuPont Drive Irvine, CA 92612 Allergan USA, Inc. Allergan, Inc. UNITED STATES Sulaiman Hamidi Director, Sustainability (714) 246-4433 [email protected] 18600 Von Karman Ave. Irvine, CA Pacific Pharma, Inc. Allergan, Inc. 92612 Sulaiman Hamidi Director, Sustainability (714) 246-4433 [email protected]
Alva-Amco Pharmacal 7711 Merrimac Avenue Niles, IL 60714- VP, Quality Assurance and Product Alva-Amco Pharmacal Companies, Inc. Companies, Inc. 3423 UNITED STATES Tom Clark Development 847-663-0700 x532 [email protected] 1430 Rt. 206 #200 Bedminster, NJ natasha.nelson- Amarin Corp PLC Amarin Corp PLC 07921 Natasha Nelson Compliance Officer (908) 326-2568 [email protected] 1430 Rt. 206 #200 Bedminster, NJ natasha.nelson- Amarin Pharma Inc. Amarin Corp PLC 07921 Natasha Nelson Compliance Officer (908) 326-2568 [email protected] First Floor, Block 3 The Oval, Shelbourne Road BALLSBRIDGE 4 natasha.nelson- Amarin Pharmaceuticals Ireland Ltd. Amarin Corp PLC IRELAND Natasha Nelson Compliance Officer (908) 326-2568 [email protected] 530 Industrial Park Boulevard natasha.nelson- Kowa Pharmaceuticals America Amarin Corp PLC Montgomery, AL 36117 Natasha Nelson Compliance Officer (908) 326-2568 [email protected]
Amerisource Health Services Corporation Amerisource Health Services Corporation DBA: DBA: American Health 2550-A John Glenn Avenue Columbus, sford@americanhealthpackagin American Health Packaging Packaging OH 43217 UNITED STATES Stephanie M. Ford Packaging Compliance Manager 614-492-8177 g.com One Amgen Center Drive Thousand Director Customer Service, Trade Amgen Inc. Amgen Inc. Oaks, CA 91320 UNITED STATES David Popowitz Operations (805) 447-3033 [email protected] 1201 Amgen Court West Seattle, WA Director Customer Service, Trade Immunex Corporation Amgen Inc. 98119-3105 David Popowitz Operations (805) 447-3033 [email protected] Rua Raphael de Marco N° 43 Jardim Laboratorio Quimico Farmaceutico Bergamo das Oliveiras MUNICIPIO DE TABOAO Director Customer Service, Trade Ltd Amgen Inc. DA SERRA Sao Paulo BRAZIL David Popowitz Operations (805) 447-3033 [email protected]
Ayazaga Mahallesi Meydan Sokak No 1 Director Customer Service, Trade Mustafa Nevzat Amgen Inc. ISTANBUL, Maslak Beybi Gi ISTANBUL David Popowitz Operations (805) 447-3033 [email protected]
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Key: Parent Company Participating in Program Parent Company NOT Participating in Program Affiliated Company Participating in Program Notes Company Parent Company Full Address Full Name Title Work Phone Email 249 E. Grand Avenue South San Director Customer Service, Trade Onyx Pharmaceuticals Amgen Inc. Francisco, CA 94080 David Popowitz Operations (805) 447-3033 [email protected]
Amneal 400 Crossing Boulevard Third Floor Amneal Pharmaceuticals LLC Pharmaceuticals LLC Bridgewater, NJ 08807 Beth Kaufman, Esq. Assistant General Counsel (908) 947-3139 [email protected]
2400 N. Commerce Parkway Suite 400 Director of Government Affairs & Apotex Holdings, Inc. Apotex Holdings, Inc. Weston, FL 33326 Steve Giuli Industry Relations (954) 349-4239 [email protected] 200 Barmac Drive Toronto, Ontario Director of Government Affairs & ApoPharma USA, Inc. Apotex Holdings, Inc. M9L 2Z7 CANADA Steve Giuli Industry Relations (954) 349-4239 [email protected] 2400 North Commerce Parkway, Suite Director of Government Affairs & Apotex Corp. Apotex Holdings, Inc. 400 Weston, FL 33326 Steve Giuli Industry Relations (954) 349-4239 [email protected] 3250 Commerce Pkwy Miramar, FL Director of Government Affairs & Aveva Drug Delivery Systems, Inc. Apotex Holdings, Inc. 33025 Steve Giuli Industry Relations (954) 349-4239 [email protected]
Participant Added Since Arbor Pharmaceuticals, 6 Concourse Parkway Suite 1800 Last Plan Submission Arbor Pharmaceuticals, Inc. Inc. Atlanta, GA 30328 UNITED STATES Scott Silverman Manager, Compliance (678) 334-2422 [email protected]
Participant Affiliate Added Arbor Unit 7, The Mall, Clare Road ENNIS Since Last Plan Submission Arbor Pharmaceuticals Ireland Ltd. Pharmaceuticals, Inc. IRELAND Scott Silverman Manager, Compliance (678) 334-2422 [email protected]
Participant Affiliate Added Arbor 6 Concourse Parkway Suite 1800 Since Last Plan Submission Arbor Pharmaceuticals Sales, LLC Pharmaceuticals, Inc. Atlanta, GA 30328 UNITED STATES Scott Silverman Manager, Compliance (678) 334-2422 [email protected]
Participant Affiliate Added Arbor 6 Concourse Parkway Suite 1800 Since Last Plan Submission Arbor Pharmaceuticals, LLC Pharmaceuticals, Inc. Atlanta, GA 30328 UNITED STATES Scott Silverman Manager, Compliance (678) 334-2422 [email protected]
Participant Affiliate Added Arbor 6 Concourse Parkway Suite 1800 Since Last Plan Submission Wilshire Pharmaceuticals Pharmaceuticals, Inc. Atlanta, GA 30328 UNITED STATES Scott Silverman Manager, Compliance (678) 334-2422 [email protected]
Participant Added Since Ascend Laboratories, 180 Summit Avenue, Suite 200 [email protected] Last Plan Submission Ascend Laboratories, LLC LLC Montvale, NJ 07645 UNITED STATES Hindy Schiff Director of Regulatory Affairs (201) 326-9010 m
Astellas Pharma US, Inc. Astellas Pharma US, Inc. 1 Astellas Way Northbrook, IL 60062 Brian Eckman Assistant General Counsel, Regulatory (224) 205-8917 [email protected]
701 Pennsylvania Avenue, NW Suite AstraZeneca 500 Washington, DC 20004 UNITED Director, Policy and Executive Branch [email protected] AstraZeneca Pharmaceuticals LP Pharmaceuticals LP STATES Carrie Harney Advocacy 202.350.5546 m AstraZeneca 1800 Concord Pike Wilmington, DE Director, Policy and Executive Branch AstraZeneca LP Pharmaceuticals LP 15437 UNITED STATES Carrie Harney Advocacy 202.350.5546 [email protected]
AstraZeneca 1 MedImmune Way Gaithersburg, MD Director, Policy and Executive Branch MedImmune Biologics Inc. Pharmaceuticals LP 20878 Carrie Harney Advocacy 202.350.5546 [email protected]
AstraZeneca 1800 Concord Pike Wilmington, DE Director, Policy and Executive Branch MedImmune LLC Pharmaceuticals LP 15437 UNITED STATES Carrie Harney Advocacy 202.350.5546 [email protected]
Participant Added Since Aurobindo Pharma USA, 6 Wheeling Road Dayton, NJ 08810 Last Plan Submission Aurobindo Pharma USA, Inc Inc UNITED STATES Jefferey Jackowski VP Quality Assurance and Compliance (732) 839-9417 [email protected]
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Key: Parent Company Participating in Program Parent Company NOT Participating in Program Affiliated Company Participating in Program Notes Company Parent Company Full Address Full Name Title Work Phone Email
Participant Affiliate Added Aurobindo Pharma 6 Wheeling Road Dayton, NJ 08810 Since Last Plan Submission Aurobindo Pharma Limited USA, Inc UNITED STATES Jefferey Jackowski VP Quality Assurance and Compliance (732) 839-9417 [email protected]
Participant Affiliate Added Aurobindo Pharma 6 Wheeling Road Dayton, NJ 08810 Since Last Plan Submission Aurobindo Pharma USA USA, Inc UNITED STATES Jefferey Jackowski VP Quality Assurance and Compliance (732) 839-9417 [email protected]
Participant Affiliate Added Aurobindo Pharma 6 Wheeling Road Dayton, NJ 08810 Since Last Plan Submission AuroHealth, LLC USA, Inc UNITED STATES Jefferey Jackowski VP Quality Assurance and Compliance (732) 839-9417 [email protected]
Participant Affiliate Added Aurobindo Pharma 6 Wheeling Road Dayton, NJ 08810 Since Last Plan Submission AuroLife Pharma USA, Inc UNITED STATES Jefferey Jackowski VP Quality Assurance and Compliance (732) 839-9417 [email protected]
Participant Affiliate Added Aurobindo Pharma 6 Wheeling Road Dayton, NJ 08810 Since Last Plan Submission AuroMedics, LLC USA, Inc UNITED STATES Jefferey Jackowski VP Quality Assurance and Compliance (732) 839-9417 [email protected]
30 Enterprise Suite 400 Aliso Viejo, CA Avanir Pharmaceuticals Avanir Pharmaceuticals 92656 UNITED STATES Elmer Nazareno Associate Director Quality Assurance (949) 599-6309 [email protected] 15501 W. 109th St. Lenexa, KS 66219 B.F. Ascher & Co., Inc. B.F. Ascher & Co., Inc. UNITED STATES Marc Elton Director, Scientific and Legal Affairs (913) 888-1880 [email protected] Baxter Healthcare One Baxter Parkway Deerfield, IL Baxter Healthcare Corporation Corporation 60015-4625 Carla Pittman Sr. Counsel (805) 372-3554 [email protected] Baxter Healthcare One Baxter Parkway Deerfield, IL Baxter International, Inc. Corporation 60015-4625 Carla Pittman Sr. Counsel (805) 372-3554 [email protected] 100 Bayer Boulevard Whippany, NJ Director, Public Policy & Government Bayer HealthCare LLC Bayer HealthCare LLC 07981-0915 UNITED STATES Chris Piazza Affairs (862) 404-6179 [email protected] 100 Bayer Boulevard Whippany, NJ Director, Public Policy & Government Bayer HealthCare Animal Health Inc. Bayer HealthCare LLC 07981-0915 UNITED STATES Chris Piazza Affairs (862) 404-6179 [email protected] 1191 Second Avenue, Suite 1000 Director, Public Policy & Government Bayer HealthCare Pharmaceuticals Inc. Bayer HealthCare LLC Seattle, WA 98101-2933 Chris Piazza Affairs (862) 404-6179 [email protected] 100 Bayer Boulevard Whippany, NJ Director, Public Policy & Government MSD Consumer Care Inc. Bayer HealthCare LLC 07981-0915 UNITED STATES Chris Piazza Affairs (862) 404-6179 [email protected] 90 North Broadway Irvington, NY Bedrock Brands Bedrock Brands 10533 UNITED STATES Bernie Kropfelder Chief Operating Officer (410)350-9791 [email protected] Participant's Name Changed Since Last Plan 225 Binney Street Cambridge, MA Submission Biogen Inc. Biogen Inc. 02142-1031 UNITED STATES Harry Carey Operations Counsel (781) 464-1995 [email protected]
BioMarin Senior Director, Supply Chain Planning BioMarin Pharmaceutical Inc. Pharmaceutical Inc. 105 Digital Drive Novato, CA 94949 Kevin Webb & Logistics (415) 506-6185 [email protected] 1800 Swift Drive Oak Brook, IL 60523 Blistex Inc. Blistex Inc. UNITED STATES Scott D. Halliday Vice President, Operations (630) 571-3491 [email protected]
Participant Added Since Blu Pharmaceuticals, 301 Robey St. Franklin, KY 42134 Last Plan Submission Blu Pharmaceuticals, LLC LLC UNITED STATES Sharon B. Luster Vice President (270) 586-6386 [email protected]
Participant Affiliate Added Blu Pharmaceuticals, Carr 698 km 0.8, Bo Mameyal Dorado, Since Last Plan Submission Blu Caribe LLC Puerto Rico 00646 Sharon B. Luster Vice President (270) 586-6386 [email protected]
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Key: Parent Company Participating in Program Parent Company NOT Participating in Program Affiliated Company Participating in Program Notes Company Parent Company Full Address Full Name Title Work Phone Email
2550-A John Glenn Avenue Columbus, sford@americanhealthpackagin BluePoint Laboratories BluePoint Laboratories OH 43217 UNITED STATES Stephanie M. Ford Packaging Compliance Manager 614-492-8177 g.com Mary.mcconnell- Boehringer Ingelheim 900 Ridgebury Road Ridgefield, CT Mary McConnell- Executive Director, Environmental meachen@boehringer- Boehringer Ingelheim USA, Inc. USA, Inc. 06877 UNITED STATES Meachen Health & Safety (203) 798-5075 ingelheim.com Mary.mcconnell- Boehringer Ingelheim 300 Northfield Road Bedford, OH Mary McConnell- Executive Director, Environmental Health meachen@boehringer- Bedford Laboratories, Inc. USA, Inc. 44146 Meachen & Safety (203) 798-5075 ingelheim.com Mary.mcconnell- Boehringer Ingelheim 300 Northfield Road Bedford, OH Mary McConnell- Executive Director, Environmental Health meachen@boehringer- BenVenue Laboratories, Inc. USA, Inc. 44146 Meachen & Safety (203) 798-5075 ingelheim.com Mary.mcconnell- Boehringer Ingelheim 6701 Kaiser Drive Fremont, CA 94555 Mary McConnell- Executive Director, Environmental Health meachen@boehringer- Boehringer Ingelheim Fremont, Inc. USA, Inc. UNITED STATES Meachen & Safety (203) 798-5075 ingelheim.com Mary.mcconnell- Boehringer Ingelheim 900 Ridgebury Road Ridgefield, CT Mary McConnell- Executive Director, Environmental Health meachen@boehringer- Boehringer Ingelheim Pharmaceuticals, Inc. USA, Inc. 06877 UNITED STATES Meachen & Safety (203) 798-5075 ingelheim.com Mary.mcconnell- Boehringer Ingelheim 1809 Wilson Road Columbus, OH Mary McConnell- Executive Director, Environmental Health meachen@boehringer- Boehringer Ingelheim Roxane, Inc. USA, Inc. 43216 UNITED STATES Meachen & Safety (203) 798-5075 ingelheim.com Mary.mcconnell- Boehringer Ingelheim 2612 Belt Highway St. Joseph, MO Mary McConnell- Executive Director, Environmental Health meachen@boehringer- Boehringer Ingelheim Vetmedica, Inc. USA, Inc. 64506 UNITED STATES Meachen & Safety (203) 798-5075 ingelheim.com Mary.mcconnell- Boehringer Ingelheim 1809 Wilson Road Columbus, OH Mary McConnell- Executive Director, Environmental Health meachen@boehringer- Roxane Laboratories, Inc. USA, Inc. 43216 UNITED STATES Meachen & Safety (203) 798-5075 ingelheim.com Global Head & Vice President - Bristol-Myers Squibb P.O. Box 4500 Princeton, NJ 08543 Environment, Health, Safety & Bristol-Myers Squibb Company Company UNITED STATES Carol R. Powell Sustainability (609) 897-5082 [email protected] Global Head & Vice President - Bristol-Myers Squibb Sanofi Pharmaceuticals Bristol-Myers Squibb 777 Scudders Mill Road Plainsboro, NJ Environment, Health, Safety & Partnership Company 08536 Carol R. Powell Sustainability (609) 897-5082 [email protected] Global Head & Vice President - Bristol-Myers Squibb 777 Scudders Mill Road Plainsboro, NJ Environment, Health, Safety & E.R. Squibb & Sons, LLC Company 08536 Carol R. Powell Sustainability (609) 897-5082 [email protected] Global Head & Vice President - Bristol-Myers Squibb 777 Scudders Mill Road Plainsboro, NJ Environment, Health, Safety & ZymoGenetics, Inc. Company 08536 Carol R. Powell Sustainability (609) 897-5082 [email protected]
86 Morris Avenue H-222E Summit, NJ Director, US Health Policy & Celgene Corporation Celgene Corporation 07901-3915 UNITED STATES Francesca Tedesco Reimbursement (908) 673-9622 [email protected]
1255 Crescent Green Ste 250 Cary, NC Chiesi USA, Inc. Chiesi USA, Inc. 27518 UNITED STATES Noel Barnard Assistant Counsel (919) 678-6668 [email protected]
1255 Crescent Green Ste 250 Cary, NC Aristos Pharmaceuticals, Inc. Chiesi USA, Inc. 27518 UNITED STATES Noel Barnard Assistant Counsel (919) 678-6668 [email protected]
Chiesi USA (Formerly Cornerstone 1255 Crescent Green Ste 250 Cary, NC Therapeutics Inc.) Chiesi USA, Inc. 27518 UNITED STATES Noel Barnard Assistant Counsel (919) 678-6668 [email protected]
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Key: Parent Company Participating in Program Parent Company NOT Participating in Program Affiliated Company Participating in Program Notes Company Parent Company Full Address Full Name Title Work Phone Email
Colgate-Palmolive 300 Park Avenue New York, NY 10022 General Manager, Professional Oral Colgate-Palmolive Company Company UNITED STATES Julie Dillon Care, North America 212-310-2038 [email protected]
Colgate-Palmolive 300 Park Avenue New York, NY 10022 General Manager, Professional Oral Care, Colgate Oral Pharmaceuticals, Inc. Company UNITED STATES Julie Dillon North America 212-310-2038 [email protected]
1101 Westchester Avenue White Combe Incorporated Combe Incorporated Plains, NY 10604 UNITED STATES Laura Quintano VP, Associate General Counsel 914-461-4466 [email protected]
Participant Added Since County Line 13890 Bishop's Drive Suite 410 tgraverson@countylinepharma. Last Plan Submission County Line Pharmaceuticals, LLC Pharmaceuticals, LLC Brookfield, WI 53005 UNITED STATES Todd Graverson Regional VP, Sales (262) 439-8109 X120 com 900 Broken Sound Parkway NW Suite Participant Added Since 400 Boca Raton, FL 33487 UNITED [email protected] Last Plan Submission CSL Behring, LLC CSL Behring, LLC STATES Janice Campbell Director, Logistics Americas (561) 912-3061 m
Cubist Pharmaceuticals, 65 Hayden Avenue Lexington, MA Cubist Pharmaceuticals, Inc. Inc. 02421 Joseph L. Farmer Chief Corporate Counsel (781) 860-1068 [email protected] Cubist Cubist Pharmaceuticals U.S. Pharmaceuticals, Inc. 65 Hayden Ave Lexington, MA 02421 Joseph L. Farmer Chief Corporate Counsel (781) 860-1068 [email protected]
Affiliate Removed: Ohm Laboratories Inc., Ranbaxy Assistant General Counsel, Commercial Laboratories Inc., Ranbaxy Daiichi Sankyo, Inc. 2 Hilton Court Administration, Legal Affairs Pharmaceuticals Inc. Daiichi Sankyo, Inc. Daiichi Sankyo, Inc. Parsippany, NJ 07054 Albert McCormick Department (973) 944-2731 [email protected]
Participant Affiliate Added Assistant General Counsel, Commercial Since Last Plan Submission American Regent, Inc. Daiichi Sankyo, Inc. One Luitpold Drive Shirley, NY 11967 Albert McCormick Administration, Legal Affairs Department (973) 944-2731 [email protected]
Assistant General Counsel, Commercial Luitpold Pharmaceuticals, Inc. Daiichi Sankyo, Inc. 5 Ramsey Rd Shirley, NY 11967 Albert McCormick Administration, Legal Affairs Department (973) 944-2731 [email protected] Participant Added Since 7999 Gateway Blvd Suite 300 Newark, Last Plan Submission Depomed, Inc. Depomed, Inc. CA 94560 UNITED STATES Paul Mcgoff Controlled Substance Officer (510) 744-8694 [email protected]
Dr. Reddy's 107 College Road East Princeton, NJ Dr. Reddy's Laboratories, Inc. Laboratories, Inc. 08540 Joy Kainer AD Lead Medical Affairs, North America (609) 375-9882 [email protected] Dr. Reddy's Dr. Reddy's Laboratories Louisiana, LLC Laboratories, Inc. 8800 Line Ave Shreveport, LA 71106 Joy Kainer AD Lead Medical Affairs, North America (609) 375-9882 [email protected] Dr. Reddy's Dr. Reddy's Laboratories Tennessee, LLC Laboratories, Inc. 201 Industrial Drive Bristol, TN 37620 Joy Kainer AD Lead Medical Affairs, North America (609) 375-9882 [email protected] 200 Somerset Corporate Boulevard Dr. Reddy's Building II, 7 Floor Bridgewater, NJ Promius Pharma, LLC Laboratories, Inc. 08807 Joy Kainer AD Lead Medical Affairs, North America (609) 375-9882 [email protected]
Participant Added Since 919 Conestoga Road, Building I, Suite Last Plan Submission Duchesnay USA, Inc. Duchesnay USA, Inc. 20 Rosemont, PA 19010 Joseph Ebling Controller (484) 380-2641 [email protected]
Participant Affiliate Added 950 Boulevard Michele-Bohec, Since Last Plan Submission Duchesnay Inc. Duchesnay USA, Inc. Blainville, Quebec J7C 5E2 CANADA Joseph Ebling Controller (484) 380-2641 [email protected] 1250 Capital of Texas Hwy, Participant Added Since Edgemont South/Building 3 Ste 400, Austin, TX Head Formulation Development & CMC [email protected] Last Plan Submission Edgemont Pharmaceuticals LLC Pharmaceuticals LLC 78746 Mike Vachon Advisor (514) 989-8184 om
7/9/2015 1155 15th Street NW, Suite 500, Washington, DC 20005 Page 6 of 17 King County MED-Project Participant List
Key: Parent Company Participating in Program Parent Company NOT Participating in Program Affiliated Company Participating in Program Notes Company Parent Company Full Address Full Name Title Work Phone Email
100 Tice Blvd Wood Cliff Lake, NJ Eisai, Inc. Eisai, Inc. 07677 Jack Geisser Sr. Manager, Western United States (916) 397-4734 [email protected]
Lilly Corporate Center Indianapolis, IN Eli Lilly Eli Lilly 46285 UNITED STATES Adam Phipps Assistant General Counsel 317-655-0862 [email protected]
One Technology Place Rockland, MA Richard A. Feldman, Vice President, Trade and Product [email protected] EMD Serono, Inc. EMD Serono, Inc. 02370 UNITED STATES R.Ph. Security (781) 681-2838 om Participant's Name Changed Since Last Plan 1400 Atwater Drive Malvern, PA Submission Endo US Inc. Endo US Inc. 19335 UNITED STATES Margaret Richardson Vice President, Legal (256) 799-7175 [email protected] Participant is Now Under 1400 Atwater Drive Malvern, PA 19335 a New Parent Entity Auxilium Pharmaceuticals, Inc. Endo US Inc. UNITED STATES Margaret Richardson Vice President, Legal (256) 799-7175 [email protected] 130 Vintage Drive Huntsville, AL 35811 BOCA Pharmacals, Inc. Endo US Inc. UNITED STATES Margaret Richardson Vice President, Legal (256) 799-7175 [email protected] 130 Vintage Drive Huntsville, AL 35811 DAVA Pharmaceuticals, Inc. Endo US Inc. UNITED STATES Margaret Richardson Vice President, Legal (256) 799-7175 [email protected] 1400 Atwater Drive Malvern, PA 19355 Endo Pharmaceuticals Inc. Endo US Inc. UNITED STATES Margaret Richardson Vice President, Legal (256) 799-7175 [email protected] Generics Bidco I, LLC d/b/a Qualitest 130 Vintage Drive Huntsville, AL 35811 Pharmaceuticals Endo US Inc. UNITED STATES Margaret Richardson Vice President, Legal (256) 799-7175 [email protected]
Participant Affiliate Added 1400 Atwater Drive Malvern, PA 19355 Since Last Plan Submission Quartz Specialty Pharmaceuticals, LLC Endo US Inc. UNITED STATES Margaret Richardson Vice President, Legal (256) 799-7175 [email protected]
Participant Affiliate Added Vintage Pharmaceuticals, Inc. d/b/a Qualitest 130 Vintage Ave Huntsville, AL 35811 Since Last Plan Submission Pharmaceuticals Endo US Inc. UNITED STATES Margaret Richardson Vice President, Legal (256) 799-7175 [email protected] Participant Added Since Ferring Pharmaceuticals 100 Interpace Parkway, Parsippany, Director, Compliance Reporting and Last Plan Submission Ferring Pharmaceuticals Inc. Inc. NJ 07054 Rhonda S. O'toole Systems (973) 796-1772 [email protected] Three Corporate Drive Lake Zurich, IL Fresenius Kabi USA, LLC Fresenius Kabi USA, LLC 60047 UNITED STATES Ken Kucera VP Supply Chain - North America (847) 550-2761 [email protected]
Participant Added Since 111 Coolidge Street South Plainfield, Vice President, Corporate Quality & Last Plan Submission G&W Laboratories, Inc. G&W Laboratories, Inc. NJ 07080 UNITED STATES Joseph Greer Compliance (908) 753-2000 [email protected]
Participant Affiliate Added G&W Laboratories, 111 Coolidge Street South Plainfield, NJ Vice President, Corporate Quality & Since Last Plan Submission G&W NC Laboratories LLC Inc. 07080 UNITED STATES Joseph Greer Compliance (908) 753-2000 [email protected]
Participant Affiliate Added G&W Laboratories, 111 Coolidge Street South Plainfield, NJ Vice President, Corporate Quality & Since Last Plan Submission G&W PA Laboratories LLC Inc. 07080 UNITED STATES Joseph Greer Compliance (908) 753-2000 [email protected]
Participant Added Since Galderma Laboratories, 14501 North Freeway Fort Worth, TX Last Plan Submission Galderma Laboratories, L.P. L.P. 76177 UNITED STATES Steven B. Midgley Associate General Counsel (817) 961-5076 [email protected]
Participant Affiliate Added Galderma 14501 North Freeway Fort Worth, TX Since Last Plan Submission Owen Laboratories, Inc. Laboratories, L.P. 76177 UNITED STATES Steven B. Midgley Associate General Counsel (817) 961-5076 [email protected]
Participant Added Since GAVIS Pharmaceuticals 400 Campus Drive Somerset, NJ 08873 Last Plan Submission GAVIS Pharmaceuticals LLC LLC UNITED STATES Anand Natarajan Associate General Counsel 908-603-6000 ext 1002 [email protected]
7/9/2015 1155 15th Street NW, Suite 500, Washington, DC 20005 Page 7 of 17 King County MED-Project Participant List
Key: Parent Company Participating in Program Parent Company NOT Participating in Program Affiliated Company Participating in Program Notes Company Parent Company Full Address Full Name Title Work Phone Email
Participant Affiliate Added GAVIS 400 Campus Drive Somerset, NJ 08873 Since Last Plan Submission Edison Therapeutics LLC Pharmaceuticals LLC UNITED STATES Anand Natarajan Associate General Counsel 908-603-6000 ext 1002 [email protected]
Participant Affiliate Added GAVIS 400 Campus Drive Somerset, NJ 08873 Since Last Plan Submission GAVIS Pharma LLC Pharmaceuticals LLC UNITED STATES Anand Natarajan Associate General Counsel 908-603-6000 ext 1002 [email protected]
Participant Affiliate Added GAVIS 400 Campus Drive Somerset, NJ 08873 Since Last Plan Submission Novel Laboratories Inc. Pharmaceuticals LLC UNITED STATES Anand Natarajan Associate General Counsel 908-603-6000 ext 1002 [email protected] 333 Lakeside Drive Foster City, CA Gilead Sciences, Inc. Gilead Sciences, Inc. 94404 Kacy Hutchison Vice President, Government Affairs 650-522-1831 [email protected] 333 Lakeside Drive Foster City, CA Bristol-Myers Squibb & Gilead Sciences, LLC Gilead Sciences, Inc. 94404 Kacy Hutchison Vice President, Government Affairs 650-522-1831 [email protected] Granta Park Abington Cambridge CB21 Gilead Sciences Limited Gilead Sciences, Inc. 6GT UNITED KINGDOM Kacy Hutchison Vice President, Government Affairs 650-522-1831 [email protected] 5 Moore Drive RTP, NC 27709 UNITED US, Latam, UK and Ireland EHS Shared GlaxoSmithKline, LLC GlaxoSmithKline, LLC STATES Dan Sullivan Service (919) 414-1213 [email protected] 1000 Gsk Drive Moon Township US, Latam, UK and Ireland EHS Shared GlaxoSmithKline Consumer Healthcare L.P. GlaxoSmithKline, LLC Pittsburgh, PA 15108 Dan Sullivan Service (919) 414-1213 [email protected] Five Moore Drive Research Triangle US, Latam, UK and Ireland EHS Shared Stiefel GlaxoSmithKline, LLC Park, NC 27709 UNITED STATES Dan Sullivan Service (919) 414-1213 [email protected] Five Moore Drive Research Triangle US, Latam, UK and Ireland EHS Shared ViiV Healthcare Company GlaxoSmithKline, LLC Park, NC 27709-3398 Dan Sullivan Service (919) 414-1213 [email protected] Glenmark Pharmaceuticals Inc., 750 Corporate Drive Mahwah, NJ jessicac@glenmark- Participant Name Changed Glenmark Pharmaceuticals Inc., USA USA 07430 Jessica Cangemi Director, Marketing (201) 684-8015 generics.com
Grifols Shared Services Grifols Shared Services North America Inc. North America Inc. 2410 Lillyvale Avenue Los Angeles, CA (Formerly Grifols Inc.) (Formerly Grifols Inc.) 90032 UNITED STATES George Baumbach Associate Director, Regulatory Affairs (919) 359-7280 [email protected]
Grifols Shared Services North America Inc. 2410 Lillyvale Avenue Los Angeles, CA Grifols Biologicals Inc. (Formerly Grifols Inc.) 90032 UNITED STATES George Baumbach Associate Director, Regulatory Affairs (919) 359-7280 [email protected]
Grifols Shared Services North America Inc. 2410 Lillyvale Avenue Los Angeles, CA Grifols S.A. (Formerly Grifols Inc.) 90032 UNITED STATES George Baumbach Associate Director, Regulatory Affairs (919) 359-7280 [email protected]
Grifols Shared Services North America Inc. 2410 Lillyvale Avenue Los Angeles, CA Grifols Therapeutics Inc. (Formerly Grifols Inc.) 90032 UNITED STATES George Baumbach Associate Director, Regulatory Affairs (919) 359-7280 [email protected]
Grifols Shared Services North America Inc. 2410 Lillyvale Avenue Los Angeles, CA Grifols USA, LLC (Formerly Grifols Inc.) 90032 UNITED STATES George Baumbach Associate Director, Regulatory Affairs (919) 359-7280 [email protected]
Grifols Shared Services North America Inc. 2410 Lillyvale Avenue Los Angeles, CA Grifols Worldwide Operations USA (Formerly Grifols Inc.) 90032 UNITED STATES George Baumbach Associate Director, Regulatory Affairs (919) 359-7280 [email protected]
7/9/2015 1155 15th Street NW, Suite 500, Washington, DC 20005 Page 8 of 17 King County MED-Project Participant List
Key: Parent Company Participating in Program Parent Company NOT Participating in Program Affiliated Company Participating in Program Notes Company Parent Company Full Address Full Name Title Work Phone Email
Grifols Shared Services North America Inc. 2410 Lillyvale Avenue Los Angeles, CA Instituto Grifols S.A. (Formerly Grifols Inc.) 90032 UNITED STATES George Baumbach Associate Director, Regulatory Affairs (919) 359-7280 [email protected]
Grifols Shared Services North America Inc. 2410 Lillyvale Avenue Los Angeles, CA Talecris Biotherapeutics, Inc. (Formerly Grifols Inc.) 90032 UNITED STATES George Baumbach Associate Director, Regulatory Affairs (919) 359-7280 [email protected] Participant Added Since Harris Pharmaceuticals, 9090 Park Royal Drive Ft. Myers, FL kcollias@harrispharmaceutical. Last Plan Submission Harris Pharmaceuticals, Inc. Inc. 33908 Kerry Collias Director of Business Development (239) 278-4749 ext 221 com
Participant Added Since Heritage 12 Christopher Way Suite 300 Last Plan Submission Heritage Pharmaceuticals Inc. Pharmaceuticals Inc. Eatontown, NJ 07724 UNITED STATES Pablo Dávila-Zavala Senior Director, Scientific Affairs (732) 429-1000 x101 [email protected] 1 DNA Way South San Francisco, CA Hoffman La Roche, Inc. Hoffman La Roche, Inc. 94080-4990 Candice Lo Program Manager, Channel Operations (650) 225-6932 [email protected] Hoffman La Roche, 1 DNA Way South San Francisco, CA Genentech USA, Inc. Inc. 94080-4990 Candice Lo Program Manager, Channel Operations (650) 225-6932 [email protected] Hoffman La Roche, 1 DNA Way South San Francisco, CA Genentech, Inc. Inc. 94080-4990 Candice Lo Program Manager, Channel Operations (650) 225-6932 [email protected] 520 Lake Cook Road Suite 520 Sr. Director, Government & Public Horizon Pharma plc Horizon Pharma plc Deerfield, IL 60015 Marilyn Vetter Affairs 224.383.3298 [email protected]
Participant Affiliate Added 520 Lake Cook Road Suite 520 Since Last Plan Submission Horizon Pharma USA, Inc. Horizon Pharma plc Deerfield, IL 60015 Marilyn Vetter Sr. Director, Government & Public Affairs 224.383.3298 [email protected]
Participant Affiliate Added 520 Lake Cook Road Suite 520 Since Last Plan Submission Horizon Therapeutics Inc. Horizon Pharma plc Deerfield, IL 60015 Marilyn Vetter Sr. Director, Government & Public Affairs 224.383.3298 [email protected]
Participant Affiliate Added 520 Lake Cook Road Suite 520 Since Last Plan Submission HZNP USA , Inc. Horizon Pharma plc Deerfield, IL 60015 Marilyn Vetter Sr. Director, Government & Public Affairs 224.383.3298 [email protected] Participant Added Since Last Plan Submission Hospira Hospira 275 N. Fields Drive Lake Forest, IL John Robbins Environemental Manager (224) 212-4999 [email protected] Participant Added Since Humco Holding Group, 7400 Alumax Dr. Texarkana, TX 75501 Last Plan Submission Humco Holding Group, Inc. Inc. UNITED STATES Francisco J. Lozano VP Quality and Regulatory (903) 334-6233 [email protected] 30831 Huntwood Ave. Hayward, CA Impax Laboratories, Inc. Impax Laboratories, Inc. 94544 Bill Haish Vice President Global Engineering (510) 240-6204 [email protected] 1801 Augustine Cut-Off ATT: Accounts Payable Wilmington, DE 19803 Senior Director, Compliance Auditing & Incyte Corporation Incyte Corporation UNITED STATES Justin A. Dillon Monitoring (302) 498-6721 [email protected] Participant Added Since Ingenus Last Plan Submission Ingenus Pharmaceuticals, LLC Pharmaceuticals, LLC 4190 Millenia Blvd. Orlando, FL 32839 Matthew Baumgartner CFO/General Counsel 407-354-5740 [email protected] One Kew Place, ISO Rouse Boulevard Participant Added Since Iroko Pharmaceuticals, Philadelphia, PA 19112 UNITED Last Plan Submission Iroko Pharmaceuticals, LLC LLC STATES Gary Budney Vice President, Quality (267) 546-1659 [email protected]
Participant Added Since Jacobus Pharmaceutical 37 Cleveland Lane P.O. Box 5290 laura.jacobus@jacobus- Last Plan Submission Jacobus Pharmaceutical Company, Inc. Company, Inc. Princeton, NJ 08540 UNITED STATES Laura R. Jacobus Vice President (609) 921-7447 x207 pharmaceutical.com Jazz Pharmaceuticals Senior Director & Senior Compliance Jazz Pharmaceuticals PLC PLC 3180 Porter Drive Palo Alto, CA 94304 Kari Loeser Counsel 650-496-3002 [email protected] Jazz Pharmaceuticals Senior Director & Senior Compliance Jazz Pharmaceuticals, Inc. PLC 3180 Porter Drive Palo Alto, CA 94304 Kari Loeser Counsel 650-496-3002 [email protected]
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Key: Parent Company Participating in Program Parent Company NOT Participating in Program Affiliated Company Participating in Program Notes Company Parent Company Full Address Full Name Title Work Phone Email One Johnson & Johnson Plaza, WH- Director, Sustainability Janssen Johnson & Johnson Johnson & Johnson 4110, New Brunswick, NJ 08933 Phil Dahlin Pharmaceuticals (609) 730-2329 [email protected] 325 Paramount Dr Raynham, MA Director, Sustainability Janssen DePuy Mitek, Inc. Johnson & Johnson 02767 Phil Dahlin Pharmaceuticals (609) 730-2329 [email protected] 1125 Trenton-Harbourton Road Director, Sustainability Janssen Janssen Pharmaceuticals, Inc. Johnson & Johnson Titusville, NY 08560 Phil Dahlin Pharmaceuticals (609) 730-2329 [email protected] Director, Sustainability Janssen Janssen Products, LP Johnson & Johnson 800 Ridgeview Dr. Horsham, PA 19044 Phil Dahlin Pharmaceuticals (609) 730-2329 [email protected] Johnson & Johnson Consumer Companies, One Johnson & Johnson Plaza, WH- Director, Sustainability Janssen Inc. Johnson & Johnson 4110, New Brunswick, NJ 08933 Phil Dahlin Pharmaceuticals (609) 730-2329 [email protected] McNeil Consumer Healthcare Latin America One Johnson & Johnson Plaza, WH- Director, Sustainability Janssen LLC Johnson & Johnson 4110, New Brunswick, NJ 08933 Phil Dahlin Pharmaceuticals (609) 730-2329 [email protected] One Johnson & Johnson Plaza, WH- Director, Sustainability Janssen McNeil Consumer Pharmaceuticals Co. Johnson & Johnson 4110, New Brunswick, NJ 08933 Phil Dahlin Pharmaceuticals (609) 730-2329 [email protected] One Johnson & Johnson Plaza, WH- Director, Sustainability Janssen McNeil Healthcare LLC Johnson & Johnson 4110, New Brunswick, NJ 08933 Phil Dahlin Pharmaceuticals (609) 730-2329 [email protected] One Johnson & Johnson Plaza, WH- Director, Sustainability Janssen McNeil MMP, LLC Johnson & Johnson 4110, New Brunswick, NJ 08933 Phil Dahlin Pharmaceuticals (609) 730-2329 [email protected] One Johnson & Johnson Plaza, WH- Director, Sustainability Janssen McNeil Nutritionals LLC Johnson & Johnson 4110, New Brunswick, NJ 08933 Phil Dahlin Pharmaceuticals (609) 730-2329 [email protected] One Johnson & Johnson Plaza, WH- Director, Sustainability Janssen McNeil-PPC, Inc. Johnson & Johnson 4110, New Brunswick, NJ 08933 Phil Dahlin Pharmaceuticals (609) 730-2329 [email protected] One Johnson & Johnson Plaza, WH- Director, Sustainability Janssen Neutrogena Corporation Johnson & Johnson 4110, New Brunswick, NJ 08933 Phil Dahlin Pharmaceuticals (609) 730-2329 [email protected] 1000 U.S. Route 202 South Raritan, NJ Director, Sustainability Janssen Ortho-McNeil Finance LLC Johnson & Johnson 08869 Phil Dahlin Pharmaceuticals (609) 730-2329 [email protected] 820 West Maude Avenue Sunnyvale, Director, Sustainability Janssen Scios, Inc. Johnson & Johnson CA 94085 Phil Dahlin Pharmaceuticals (609) 730-2329 [email protected] 7500 Centurion Parkway, Suite 100 Director, Sustainability Janssen Vistakon Pharmaceuticals, Inc. Johnson & Johnson Jacksonville, FL 32256 Phil Dahlin Pharmaceuticals (609) 730-2329 [email protected] Jubilant Cadista Jubilant Cadista Pharmaceuticals Inc. Pharmaceuticals Inc. 207 Kiley Drive Salisbury, MD 21801 Kamal Mandan Chief Financial Officer (410) 912-3736 [email protected] Kadmon Corporation, 450 East 29th Street, 5th Floor New Kadmon Corporation, LLC LLC York, NY 10016 UNITED STATES Amy Holben Associate Director Customer Service (724) 778-6100 [email protected] Kadmon Corporation, 119 Commonwealth Drive Warrendale, Kadmon Pharmaceuticals, LLC LLC PA 15086 Amy Holben Associate Director Customer Service (724) 778-6100 [email protected] Participant's Name Changed Since Last Plan Global Environmental Health and Safety Submission L. Perrigo Co. L. Perrigo Co. 515 Eastern Ave. Allegan, MI 49010 Rob Somers Director (269) 686-7923 [email protected] Global Environmental Health and Safety Athena Neurosciences, LLC L. Perrigo Co. Treasury Building DUBLIN 2 IRELAND Rob Somers Director (269) 686-7923 [email protected] 3315 Algonquin Road, Suite 310 Rolling Global Environmental Health and Safety Cobrek Pharmaceuticals, Inc. L. Perrigo Co. Meadows, IL 60008 Rob Somers Director (269) 686-7923 [email protected] Clarendon House 2 Church Street Global Environmental Health and Safety Elan Corporation Limited L. Perrigo Co. Hamilton HM 11 BERMUDA Rob Somers Director (269) 686-7923 [email protected] Treasury Building Lower Grand Canal Global Environmental Health and Safety Elan Pharma International Limited L. Perrigo Co. Street DUBLIN 2 IRELAND Rob Somers Director (269) 686-7923 [email protected] 300 Technology Square Third Floor Global Environmental Health and Safety Elan Pharmaceuticals, LLC L. Perrigo Co. Cambridge, MA 02139 Rob Somers Director (269) 686-7923 [email protected] Global Environmental Health and Safety L. Perrigo Company L. Perrigo Co. 515 Eastern Ave Allegan, MI 49010 Rob Somers Director (269) 686-7923 [email protected] 3940 Quebec Ave N Minneapolis, MN Global Environmental Health and Safety Paddock Laboratories, Inc. L. Perrigo Co. 55427 Rob Somers Director (269) 686-7923 [email protected]
7/9/2015 1155 15th Street NW, Suite 500, Washington, DC 20005 Page 10 of 17 King County MED-Project Participant List
Key: Parent Company Participating in Program Parent Company NOT Participating in Program Affiliated Company Participating in Program Notes Company Parent Company Full Address Full Name Title Work Phone Email Global Environmental Health and Safety PBM Holdings, LLC L. Perrigo Co. 515 Eastern Ave Allegan, MI 49010 Rob Somers Director (269) 686-7923 [email protected] Global Environmental Health and Safety PBM Nutritionals, LLC L. Perrigo Co. 515 Eastern Ave Allegan, MI 49010 Rob Somers Director (269) 686-7923 [email protected] Global Environmental Health and Safety Perrigo Company of South Carolina, Inc. L. Perrigo Co. 515 Eastern Ave Allegan, MI 49010 Rob Somers Director (269) 686-7923 [email protected] 515 Eastern Avenue Allegan, MI 49010- Global Environmental Health and Safety Perrigo Company of Tennessee L. Perrigo Co. 9070 Rob Somers Director (269) 686-7923 [email protected] 3780 Mansell Rd T50 Alpharetta, GA Global Environmental Health and Safety Perrigo Diabetes Care LLC L. Perrigo Co. 30022 Rob Somers Director (269) 686-7923 [email protected] Global Environmental Health and Safety Perrigo Florida, Inc. L. Perrigo Co. 515 Eastern Ave Allegan, MI 49010 Rob Somers Director (269) 686-7923 [email protected] Treasury Building Lower Grand Canal Global Environmental Health and Safety Perrigo LLC L. Perrigo Co. St. DUBLIN 2 IRELAND Rob Somers Director (269) 686-7923 [email protected] Global Environmental Health and Safety Perrigo New York, Inc. L. Perrigo Co. 1700 Bathgate Ave Bronx, NY 10457 Rob Somers Director (269) 686-7923 [email protected] Global Environmental Health and Safety Perrigo Pharmaceuticals Company L. Perrigo Co. 515 Eastern Ave Allegan, MI 49010 Rob Somers Director (269) 686-7923 [email protected] Participant Added Since 13200 Townsend Rd Philadelphia, PA Last Plan Submission Lannett Company, Inc. Lannett Company, Inc. 19154 James D. Gatto EHS Manager 215-333-9000 x2122 [email protected]
Participant Affiliate Added Lannett Company, 601 Yellowstone Avenue, Cody, WY Since Last Plan Submission Cody Laboratories Inc. 82414 James D. Gatto EHS Manager 215-333-9000 x2122 [email protected]
Participant Affiliate Added Lannett Company, 1033 Stoneleigh Avenue, Carmel, NY Since Last Plan Submission Silarx Pharmaceuticals Inc. 10512 James D. Gatto EHS Manager 215-333-9000 x2122 [email protected] Participant Added Since Lehigh Valley 514 North 12th Street Allentown, PA Last Plan Submission Lehigh Valley Technologies, Inc. Technologies, Inc. 18102 UNITED STATES Larry Dalesandro Chief Financial Officer 610-782-9780 X 15 [email protected] 1 Sylvan Way Parsippany, NJ 07054 deborah.eickhoff@leo- LEO Pharma A/S LEO Pharma A/S UNITED STATES Deborah Eickhoff Senior Manager, Regulatory Affairs 973-637-1657 pharma.com Lil' Drug Store Products, 1201 Continental Pl. NE Cedar Rapids, Lil' Drug Store Products, Inc. Inc. IA 52402 UNITED STATES Neil Dow Director of QA & RA (319) 294-3733 [email protected]
175 Cooper Avenue Tonawanda, NY Director, Quality Assurance & Lornamead Inc. Lornamead Inc. 14150-6656 UNITED STATES Del Liotta Regulatory Affairs 716-874-7190 Ext.1847 [email protected] Four Parkway North Deerfield, IL Lundbeck LLC Lundbeck LLC 60015 Erik Eglite V.P. Chief Compliance Officer (847) 282-1108 [email protected] Lupin Pharmaceuticals, Harborplace Tower 21st. Fl 111 S. Lupin Pharmaceuticals, Inc. Inc. Calvert St. Baltimore, MD 21202 Sean Moriarty V.P. Legal Affairs (410) 576-5043 [email protected] Mallinckrodt 601 Pennsylvania Ave. NW Suite 650 Mallinckrodt Pharmaceuticals Pharmaceuticals North Bldg Washington, DC 20004 Derek Naten Sr. Director- Government Affairs 2023830090x73703 [email protected] 440 Rt. 22 E Suite 130 Bridgewater, NJ Matrixx Initiatives, Inc. Matrixx Initiatives, Inc. 08807 UNITED STATES Christopher Naughton Controller 908-344-3481 [email protected] Participant Added Since 1240 Sugg Parkway Greenville, NC [email protected] Last Plan Submission Mayne Pharma Mayne Pharma 27834 UNITED STATES Kyle Clifton Distribution Manager (252) 758-8522 m
Participant Affiliate Added 1240 Sugg Parkway Greenville, NC Since Last Plan Submission Libertas Pharma Inc Mayne Pharma 27834 UNITED STATES Kyle Clifton Distribution Manager (252) 758-8522 [email protected]
Participant Affiliate Added 1240 Sugg Parkway Greenville, NC Since Last Plan Submission Metrics Inc Mayne Pharma 27834 UNITED STATES Kyle Clifton Distribution Manager (252) 758-8522 [email protected] One Post Street, San Francisco, CA McKesson Corporation McKesson Corporation 94104 Thomas Steed Senior Regulatory Specialist (404) 338-2331 [email protected]
7/9/2015 1155 15th Street NW, Suite 500, Washington, DC 20005 Page 11 of 17 King County MED-Project Participant List
Key: Parent Company Participating in Program Parent Company NOT Participating in Program Affiliated Company Participating in Program Notes Company Parent Company Full Address Full Name Title Work Phone Email 1400 South Wolfe Road Suite 200 McKesson Wheeling Cook, IL 60090 UNITED Cypress Medical Products LLC Corporation STATES Thomas Steed Senior Regulatory Specialist (404) 338-2331 [email protected]
McKesson 4345 Southpoint Boulevard Gulf South Medical Supply, Inc. Corporation Jacksonville, FL 32216 UNITED STATES Thomas Steed Senior Regulatory Specialist (404) 338-2331 [email protected] McKesson 8741 Landmark Road Richmond, VA McKesson Medical-Surgical Inc. Corporation 23228 UNITED STATES Thomas Steed Senior Regulatory Specialist (404) 338-2331 [email protected] McKesson 1690 New Britain Avenue Farmington, Moore Medical LLC Corporation CT 06032 UNITED STATES Thomas Steed Senior Regulatory Specialist (404) 338-2331 [email protected] McKesson 4971 Southridge Blvd #101 Memphis, Northstar Rx LLC Corporation TN 38141 Thomas Steed Senior Regulatory Specialist (404) 338-2331 [email protected]
McKesson 4345 Southpoint Boulevard PSS World Medical, Inc. Corporation Jacksonville, FL 32216 UNITED STATES Thomas Steed Senior Regulatory Specialist (404) 338-2331 [email protected] McKesson 22 Corporate Park Irvine, CA 92606 Zee Medical, Inc. Corporation UNITED STATES Thomas Steed Senior Regulatory Specialist (404) 338-2331 [email protected] Participant Added Since Meda Pharmaceuticals, 265 Davidson Avenue Somerset, NJ Last Plan Submission Meda Pharmaceuticals, Inc. Inc. 08873 Brian Hill Director of Compliance (732) 564-2427 [email protected]
Participant Affiliate Added Meda 265 Davidson Avenue Somerset, NJ Since Last Plan Submission Meda Consumer Health Pharmaceuticals, Inc. 08873 Brian Hill Director of Compliance (732) 564-2427 [email protected]
Participant Affiliate Added Meda 265 Davidson Avenue Somerset, NJ Since Last Plan Submission Wallace Pharmaceuticals Pharmaceuticals, Inc. 08873 Brian Hill Director of Compliance (732) 564-2427 [email protected]
2000 Galloping Hill Road Kenilworth, Executive Director, Federal Government Merck & Co., Inc. Merck & Co., Inc. NJ 07033 UNITED STATES Jennifer Bland Relations & Counsel (404) 702-6007 [email protected]
2031 Route 130, Unit B Monmouth Executive Director, Federal Government Cherokee Pharmaceutical LLC Merck & Co., Inc. Junction, NJ 08852 Jennifer Bland Relations & Counsel (404) 702-6007 [email protected]
Executive Director, Federal Government Intervet, Inc. Merck & Co., Inc. 556 Morris Avenue Summit, NJ 07901 Jennifer Bland Relations & Counsel (404) 702-6007 [email protected]
1 Merck Dr Whitehouse Station, NJ Executive Director, Federal Government Merck Sharp & Dohme Corp. Merck & Co., Inc. 08889 Jennifer Bland Relations & Counsel (404) 702-6007 [email protected]
100 Rodolphe Street Building 1300 Executive Director, Federal Government Organon Teknika LLC Merck & Co., Inc. Durham, NC 27712 Jennifer Bland Relations & Counsel (404) 702-6007 [email protected] Merz North America, 6501 Six Forks Road Raleigh, NC 27615 Merz North America, Inc. Inc. UNITED STATES David Dobrowski Vice President, Regulatory Affairs 336-217-2616 [email protected] Merz North America, 4215 Tudor Lane Greensboro, NC Merz Pharmaceuticals, LLC Inc. 27401 UNITED STATES David Dobrowski Vice President, Regulatory Affairs 336-217-2616 [email protected] Participant Added Since Mission Pharmacal 38505 IH-10 West Boerne, TX 78006 (830) 249-9822 ext. [email protected] Last Plan Submission Mission Pharmacal Company Company UNITED STATES Eric J. White Senior Vice President, Regulatory Affairs 4317 om
Participant Affiliate Added Mission Pharmacal P.O. Box 786099 San Antonio, TX (830) 249-9822 ext. [email protected] Since Last Plan Submission BioComp Pharma Company 78278-6099 UNITED STATES Eric J. White Senior Vice President, Regulatory Affairs 4317 om Participant Added Since Mist Pharmaceuticals, 11 Commerce Drive, 1st Floor Last Plan Submission Mist Pharmaceuticals, LLC LLC Cranford, NJ 07016 UNITED STATES Keith S. Rotenberg Corp. VP, Chief Scientific Officer (908) 372-1209 [email protected] 700 6th Street NW Suite 525 Vice President, Federal Government Mylan Inc. Mylan Inc. Washington, DC 20001 Nimish Shah Relations (202) 507-5317 [email protected]
7/9/2015 1155 15th Street NW, Suite 500, Washington, DC 20005 Page 12 of 17 King County MED-Project Participant List
Key: Parent Company Participating in Program Parent Company NOT Participating in Program Affiliated Company Participating in Program Notes Company Parent Company Full Address Full Name Title Work Phone Email Mylan Institutional Inc (formerly known as 1718 Northrock Court Rockford, IL Vice President, Federal Government UDL Laboratories, Inc.) Mylan Inc. 61103 Nimish Shah Relations (202) 507-5317 [email protected] Mylan Institutional LLC (formerly known as 272 East Deerpath Rd., Suite 304 Lake Vice President, Federal Government Bioniche Pharma USA) Mylan Inc. Forest, IL 60045 Nimish Shah Relations (202) 507-5317 [email protected]
700 6th Street NW Suite 525 Vice President, Federal Government Mylan Pharmaceuticals, Inc. Mylan Inc. Washington, DC 20001 UNITED STATES Nimish Shah Relations (202) 507-5317 [email protected] Mylan Specialty LP (formerly known as Dey 110 Allen Road, 4th Floor Basking Vice President, Federal Government Pharma LP) Mylan Inc. Ridge, NJ 07920 Nimish Shah Relations (202) 507-5317 [email protected] 2202 N West Shore Blvd # 450 Tampa, Vice President, Federal Government Somerset Pharmaceuticals, Inc Mylan Inc. FL 33607 Nimish Shah Relations (202) 507-5317 [email protected] Affiliate removed: Novartis Novartis Animal Health Pharmaceuticals One Health Plaza Building 310-4130E US, Inc. Novartis Pharmaceuticals Corporation Corporation East Hanover, NJ 07936 Greg King Head, US Region HSE (862) 778-0495 [email protected] Novartis Pharmaceuticals 6201 South Freeway Fort Worth, TX Alcon Laboratories, Inc. Corporation 76134 Greg King Head, US Region HSE (862) 778-0495 [email protected] Novartis Pharmaceuticals 1999 Marcus Ave Ste 300 New Hyde Eon Labs, Inc. Corporation Park, NY 11042-102 Greg King Head, US Region HSE (862) 778-0495 [email protected] Novartis Pharmaceuticals Fougera Pharmaceuticals Inc. Corporation 60 Baylis Road Melville, NY 11747 Greg King Head, US Region HSE (862) 778-0495 [email protected] Novartis Pharmaceuticals 200 Kimball Drive Parsippany, NY Novartis Consumer Health, Inc. Corporation 07054-062 Greg King Head, US Region HSE (862) 778-0495 [email protected] Novartis Pharmaceuticals One Health Plaza 200/444 East Novartis Pharmaceuticals Corporation Corporation Hanover, NJ 07936 Greg King Head, US Region HSE (862) 778-0495 [email protected] Novartis Pharmaceuticals 506 Carnegie Center Dr. Princeton, NJ Sandoz Inc. Corporation 08540 Greg King Head, US Region HSE (862) 778-0495 [email protected] Noven Pharmaceuticals, Noven Pharmaceuticals, Inc. Inc. 11960 SW 144th St Miami, FL 33186 David B. Vance Sr. Dir., Compliance Counsel (305) 964-3210 [email protected] Noven 100 Campus Drive Suite 117 Florham Hisamitsu America, Inc. Pharmaceuticals, Inc. Park, NJ 07932 UNITED STATES David B. Vance Sr. Dir., Compliance Counsel (305) 964-3210 [email protected] Noven Noven Therapeutics, LLC Pharmaceuticals, Inc. 350 5th Ave #37 New York, NY 10118 David B. Vance Sr. Dir., Compliance Counsel (305) 964-3210 [email protected] 800 Scudders Mill Road Plainsboro, NJ Novo Nordisk Inc. Novo Nordisk Inc. 08536 John Sullivan Director, Supply Chain (609) 514-8074 [email protected] Otsuka America 1 University Square Drive Princeton, Senior Manager Supply Chain and Otsuka America Pharmaceutical, Inc. Pharmaceutical, Inc. NJ 08540 Kevin Friel Distribution (609) 524-6774 [email protected] Par Pharmaceutical 1 Ram Ridge Rd Spring Valley, NY Par Pharmaceutical Companies, Inc. Companies, Inc. 10977 Angela Feniger Dir., DEA Comp. & QA Documentation (845) 573-5749 [email protected] Par Pharmaceutical 9601 Jeronimo Road Irvine, CA 92618- Anchen Pharmaceuticals, Inc. Companies, Inc. 2025 Angela Feniger Dir., DEA Comp. & QA Documentation (845) 573-5749 [email protected] Par Pharmaceutical 300 Tice Boulevard Woodcliff Lake Par Pharmaceutical, Inc. Companies, Inc. 07677 Angela Feniger Dir., DEA Comp. & QA Documentation (845) 573-5749 [email protected] Par Sterile Products, LLC (Formerly known as Par Pharmaceutical 870 Parkdale Road Rochester, MI JHP Pharmaceuticals, LLC) Companies, Inc. 48307 Angela Feniger Dir., DEA Comp. & QA Documentation (845) 573-5749 [email protected]
235 East 42nd Street MS 219-5 New Senior Director, Product Stewardship Pfizer Inc. Pfizer Inc. York, NY 10017 Tom Polton and Global EHS (212) 573-7356 [email protected]
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Key: Parent Company Participating in Program Parent Company NOT Participating in Program Affiliated Company Participating in Program Notes Company Parent Company Full Address Full Name Title Work Phone Email Senior Director, Product Stewardship and Greenstone LLC Pfizer Inc. 100 U.S. 206 Peapack, NJ 07977 Tom Polton Global EHS (212) 573-7356 [email protected] 6350 Stevens Forest Rd #301 Columbia, Senior Director, Product Stewardship and Meridian Medical Technologies, Inc. Pfizer Inc. MD 21046 Tom Polton Global EHS (212) 573-7356 [email protected]
Prestige Brands 660 White Plains Road Suite 205 General Counsel and Vice President of Prestige Brands Holdings, Inc. Holdings, Inc. Tarrytown, NY 10591 Samuel Cowley Business Development (914) 524-6878 [email protected]
Prestige Brands 660 White Plains Road Suite 205 General Counsel and Vice President of Insight Pharmaceuticals Corporation Holdings, Inc. Tarrytown, NY 10591 Samuel Cowley Business Development (914) 524-6878 [email protected]
Prestige Brands 660 White Plains Road Suite 205 General Counsel and Vice President of Medtech Products Inc. Holdings, Inc. Tarrytown, NY 10591 Samuel Cowley Business Development (914) 524-6878 [email protected]
Prestige Brands 660 White Plains Road Suite 205 General Counsel and Vice President of Prestige Brands, Inc. Holdings, Inc. Tarrytown, NY 10591 Samuel Cowley Business Development (914) 524-6878 [email protected]
Participant Added Since 7373 N Scottsdale Rd. B-200, Last Plan Submission Primus Pharmaceuticals Primus Pharmaceuticals Scottsdale, AZ 85253, UNITED STATES Calvin M. Mitchell Senior Vice President (480) 410-1410 [email protected] Prometheus 9410 Carroll Park Drive San Diego, CA Prometheus Laboratories Inc. Laboratories Inc. 92121 Paul Skoczelas Sr. Manager, Trade Relations (858) 587-4171 [email protected] 201 Tresser Blvd One Stamford Forum Purdue Pharma L.P. Purdue Pharma L.P. Stamford, CT 06901 LaDonna L. Steiner Associate General Counsel (203) 588-7018 [email protected] Purdue Pharmaceuticals L.P. Purdue Pharma L.P. 4701 Purdue Drive Wilson, NC 27893 LaDonna L. Steiner Associate General Counsel (203) 588-7018 [email protected] 498 Washington Street Coventry, RI Rhodes Pharmaceuticals LP Purdue Pharma L.P. 02816 LaDonna L. Steiner Associate General Counsel (203) 588-7018 [email protected] The P.F. Laboratories, Inc. Purdue Pharma L.P. 700 Union Blvd. Totowa, NJ 07512 LaDonna L. Steiner Associate General Counsel (203) 588-7018 [email protected] One Monument Square Suite 400 Putney, Inc. Putney, Inc. Portland, ME 04101 Kevin Woods Director, Supply Chain (207) 553-4480 [email protected] 399 Interpace Parkway Parsippany, NJ Reckitt Benckiser LLC Reckitt Benckiser LLC 07054 UNITED STATES David Campbell VP, Regulatory and Government Affairs 973-404-5754 [email protected] Participant Added Since Renaissance Pharma, 411 South State Street Suite E-100 Last Plan Submission Renaissance Pharma, Inc. Inc. Newtown, PA 18940 UNITED STATES John W. Denman General Manager (267) 685-0340 [email protected]
Participant Affiliate Added Renaissance Pharma, 411 South State Street Suite E-100 Since Last Plan Submission Prestium Pharma, Inc. Inc. Newtown, PA 18940 UNITED STATES John W. Denman General Manager (267) 685-0340 [email protected] Participant Added Since Rouses Point 11 Commerce Drive, 1st Floor Last Plan Submission Rouses Point Pharmaceuticals, LLC Pharmaceuticals, LLC Cranford, NJ 07016 UNITED STATES Keith S. Rotenberg Corp. VP, Chief Scientific Officer (908) 372-1209 [email protected] 55 Corporate Drive Bridgewater, NJ Sanofi Group Sanofi Group 08807 UNITED STATES John O'Reilly Associate General Counsel (908) 981-4938 John.O'[email protected] 1715 Wast 38th St. Chattanooga, TN Chattem, Inc. Sanofi Group 37409 John O'Reilly Associate General Counsel (908) 981-4938 John.O'[email protected] 1850 K St NW # 650 Washington, DC Genzyme Corporation Sanofi Group 20006 John O'Reilly Associate General Counsel (908) 981-4938 John.O'[email protected] 3239 Satellite Blvd NW Duluth, GA Merial Limited Sanofi Group 30096 John O'Reilly Associate General Counsel (908) 981-4938 John.O'[email protected] 9920 Medical Center Dr Rockville, MD Sanofi Pasteur, Inc. Sanofi Group 20850 John O'Reilly Associate General Counsel (908) 981-4938 John.O'[email protected] 55 Corporate Drive Bridgewater, NJ Sanofi-Aventis U.S. LLC Sanofi Group 08807 John O'Reilly Associate General Counsel (908) 981-4938 John.O'[email protected] Participant Added Since Sebela Pharmaceuticals, 645 Hembree Pkwy Suite I Roswell, lindsey.hannah@sebelapharma Last Plan Submission Sebela Pharmaceuticals, Inc. Inc. GA 30076 UNITED STATES Lindsey Hannah Senior Director RA/QA (678) 736-5209 .com
7/9/2015 1155 15th Street NW, Suite 500, Washington, DC 20005 Page 14 of 17 King County MED-Project Participant List
Key: Parent Company Participating in Program Parent Company NOT Participating in Program Affiliated Company Participating in Program Notes Company Parent Company Full Address Full Name Title Work Phone Email Shook, Hardy & Bacon 1155 F. St. NW, Participant Added Since Suite 200 Washington, DC 20004 Last Plan Submission Shionogi Inc. Shionogi Inc. UNITED STATES Jesse E. Weisshaar Of Counsel (202) 662-4856 [email protected] Shire Pharmaceuticals 725 Chesterbrook Boulevard Wayne, Shire Pharmaceuticals LLC LLC PA 19087 Aaron P. Buda Senior Legal Director (484) 595-8965 [email protected] Participant is Now Under Shire 725 Chesterbrook Blvd. Wayne, PA a New Parent Entity NPS Pharmaceuticals, Inc. Pharmaceuticals LLC 19087 Aaron P. Buda Senior Legal Director (484) 595-8965 [email protected] Shire Shire HGT, Inc. Pharmaceuticals LLC 700 Main Street Cambridge, MA 02139 Aaron P. Buda Senior Legal Director (484) 595-8965 [email protected] Shire Shire LLC Pharmaceuticals LLC 9200 Brookfield Ct Florence, KY 41042 Aaron P. Buda Senior Legal Director (484) 595-8965 [email protected] Shire Shire Orphan Therapies Inc. Pharmaceuticals LLC 300 Shire Way Lexington, MA 02421 Aaron P. Buda Senior Legal Director (484) 595-8965 [email protected] Shire 7900 Tanners Gate Lane, Suite 200 Shire US Inc. Pharmaceuticals LLC Florence, KY 41042 Aaron P. Buda Senior Legal Director (484) 595-8965 [email protected] Shire 725 Chesterbrook Boulevard Shire US Manufacturing Inc. Pharmaceuticals LLC Chesterbrook, MD 19087 Aaron P. Buda Senior Legal Director (484) 595-8965 [email protected] Shire Shire ViroPharma, Inc. Pharmaceuticals LLC 300 Shire Way Lexington, MA 02421 Aaron P. Buda Senior Legal Director (484) 595-8965 [email protected]
Participant Affiliate Added Shire Since Last Plan Submission ViroPharma Biologics Inc. Pharmaceuticals LLC 300 Shire Way Lexington, MA 02421 Aaron P. Buda Senior Legal Director (484) 595-8965 [email protected] Participant Added Since SigmaPharm 3375 Progress Drive Bensalem, PA Last Plan Submission SigmaPharm Laboratories LLC Laboratories LLC 19020 UNITED STATES Peter Moutis, ESQ Legal Counsel 215-352-6655 ext. 216 [email protected] 9841 Washingtonian Blvd. Suite 500 Sigma-Tau Gaithersburg, MD 20878 UNITED Sigma-Tau Pharmaceuticals, Inc. Pharmaceuticals, Inc. STATES Lester Ricardo Sr. Director, Supply Chain 301-670-1503 [email protected] 7300 W. 110th Street Suite 950 Participant Added Since Silvergate Overland Park, KS 66210 UNITED michael.beckloff@silvergateph Last Plan Submission Silvergate Pharmaceuticals, Inc. Pharmaceuticals, Inc. STATES Michael Beckloff Chief Development Officer (913) 707-3955 arma.com Smith & Nephew Gerry.keith@smith- Smith & Nephew Biotherapeutics Biotherapeutics 3909 Hulen Street Ft. Worth, TX 76107 Gerald P. Keith Senior Counsel, Commercial 817-900-4010 nephew.com
Sun Pharmaceutical 1 Commerce Drive Cranbury, NJ 08512 Sun Pharmaceutical Industries, Inc. Industries, Inc. UNITED STATES Fred Mariash Sr Manager, Sales accounting (609) 819-8220 [email protected] Sun Pharmaceutical 1100 Orthodox St. Philadelphia, PA AR Scientific, Inc. Industries, Inc. 19124 UNITED STATES Fred Mariash Sr Manager, Sales accounting (609) 819-8220 [email protected] Sun Pharmaceutical 270 Prospect Plains Road Cranbury, NJ Caraco Pharma, Inc. Industries, Inc. 08512 UNITED STATES Fred Mariash Sr Manager, Sales accounting (609) 819-8220 [email protected] Sun Pharmaceutical 3708 St. Elmo Avenue Chattanooga, TN Chattem Chemicals, Inc. Industries, Inc. 37409 UNITED STATES Fred Mariash Sr Manager, Sales accounting (609) 819-8220 [email protected] Sun Pharmaceutical 1100 Orthodox St. Philadelphia, PA Dungan Mutual Associates, LLC Industries, Inc. 19124 UNITED STATES Fred Mariash Sr Manager, Sales accounting (609) 819-8220 [email protected] Sun Pharmaceutical 25 Upton Drive Wilmington, MA 01887 DUSA Pharmaceuticals New York, Inc. Industries, Inc. UNITED STATES Fred Mariash Sr Manager, Sales accounting (609) 819-8220 [email protected] Sun Pharmaceutical 25 Upton Drive Wilmington, MA 01887 DUSA Pharmaceuticals, Inc. Industries, Inc. UNITED STATES Fred Mariash Sr Manager, Sales accounting (609) 819-8220 [email protected] Sun Pharmaceutical 1100 Orthodox St. Philadelphia, PA Mutual Pharmaceutical Company, Inc. Industries, Inc. 19124 UNITED STATES Fred Mariash Sr Manager, Sales accounting (609) 819-8220 [email protected] Sun Pharmaceutical 29 Dunham Road Billerica, MA 01821 Pharmalucence, Inc. Industries, Inc. UNITED STATES Fred Mariash Sr Manager, Sales accounting (609) 819-8220 [email protected] Sun Pharmaceutical 25 Upton Drive Wilmington, MA 01887 Sirius Laboratories, Inc. Industries, Inc. UNITED STATES Fred Mariash Sr Manager, Sales accounting (609) 819-8220 [email protected]
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Key: Parent Company Participating in Program Parent Company NOT Participating in Program Affiliated Company Participating in Program Notes Company Parent Company Full Address Full Name Title Work Phone Email Sun Pharmaceutical 3 Skyline Drive Hawthorne, NY 10532 Taro Pharmaceuticals U.S.A., Inc. Industries, Inc. UNITED STATES Fred Mariash Sr Manager, Sales accounting (609) 819-8220 [email protected] Sun Pharmaceutical 1100 Orthodox St. Philadelphia, PA United Research Laboratories, Inc. Industries, Inc. 19124 UNITED STATES Fred Mariash Sr Manager, Sales accounting (609) 819-8220 [email protected] Sun Pharmaceutical 1100 Orthodox St. Philadelphia, PA URL Pharma, Inc. Industries, Inc. 19124 UNITED STATES Fred Mariash Sr Manager, Sales accounting (609) 819-8220 [email protected] Sun Pharmaceutical 1100 Orthodox St. Philadelphia, PA URL PharmPro, LLC Industries, Inc. 19124 UNITED STATES Fred Mariash Sr Manager, Sales accounting (609) 819-8220 [email protected]
Sunovion 6387 Dwane Ave San Diego, CA 92120 Director, State Government Affairs Sunovion Pharmaceuticals Inc. Pharmaceuticals Inc. UNITED STATES April Grant (Western Region) (619) 517-8250 [email protected]
Takeda Pharmaceuticals One Takeda Parkway Deerfield, IL Takeda Pharmaceuticals America, Inc. America, Inc. 60015 UNITED STATES Jason Maxwell Assistant General Counsel- Litigation 224-554-2408 [email protected] Takeda Pharmaceuticals 40 Landsdowne Street Cambridge, MA Millennium Pharmaceuticals, Inc. America, Inc. 02139 Jason Maxwell Assistant General Counsel- Litigation 224-554-2408 [email protected] Takeda Pharmaceuticals One Takeda Parkway Deerfield, IL Takeda Pharmaceuticals U.S.A., Inc. America, Inc. 60015 Jason Maxwell Assistant General Counsel- Litigation 224-554-2408 [email protected] Teva Pharmaceuticals 400 Chestnut Ridge Rd Woodcliff, NJ VP, Global Environment and elizabeth.girardi- Teva Pharmaceuticals USA, Inc. USA, Inc. 07677 UNITED STATES Liz Girardi-Schoen Sustainability (201) 930-2142 [email protected] Participant Added Since The Mentholatum 707 Sterling Drive Orchard Park, NY Last Plan Submission The Mentholatum Company Company 14127 UNITED STATES Jeanine Sortisio Paralegal (716) 558-1409 [email protected]
Personal Health Care Mason Business The Procter & Gamble Ctr 8700 Mason-Montgomery Road Patrick Lockwood- The Procter & Gamble Company Company Mason, OH 45040 UNITED STATES Taylor Vice President, NA Personal Care 513-622-3355 [email protected] Participant Added Since 2500 Main Street Extension, Suite 6 Vice President, Regulatory (732) 721-3415 ext. [email protected] Last Plan Submission Trigen Laboratories, LLC Trigen Laboratories, LLC Sayreville, NJ 08872 UNITED STATES Richard Buecheler Affairs/Quality Assurance 206 m 1950 Lake Park Drive Smyrna, GA UCB Inc. UCB Inc. 30080 Martha Kliss Supply Chain Operations (770) 970-8714 [email protected] Kremers Urban Pharma Inc. UCB Inc. 1101 C Ave W Seymour, IN 47274 Martha Kliss Supply Chain Operations (770) 970-8714 [email protected] 1950 Lake Park Drive Smyrna, GA Upstate Pharma LLC UCB Inc. 30080 Martha Kliss Supply Chain Operations (770) 970-8714 [email protected] Unichem Pharmaceuticals (USA), 201 West Passaic Street Ste. 403 Unichem Pharmaceuticals (USA), Inc. Inc. Rochelle Park, NJ 07662 Milon Roy Associate Director, Regulatory Affairs (201) 226-0240 [email protected] Upsher-Smith 6701 Evenstad Dr. Maple Grove, MN Brent.Eilefson@upsher- Upsher-Smith Laboratories, Inc. Laboratories, Inc. 55369 UNITED STATES Brent G. Eilefson Deputy General Counsel 763.315.2310 smith.com Valeant Participant Added Since Pharmaceuticals 1400 Goodman Street, North Vice President, Global Environment, Last Plan Submission Valeant Pharmaceuticals International International Rochester, NY 14609 UNITED STATES Amy Butler Health, Safety + Sustainability (585) 338-5699 [email protected] Valeant Participant Affiliate Added Pharmaceuticals 1400 N. Goodman St. Rochester, NY Vice President, Global Environment, Since Last Plan Submission Bausch + Lomb International 14609 UNITED STATES Amy Butler Health, Safety + Sustainability (585) 338-5699 [email protected] Valeant Participant Affiliate Added Pharmaceuticals 5 Technology Drive Irvine, CA 92618 Vice President, Global Environment, Since Last Plan Submission Obagi International UNITED STATES Amy Butler Health, Safety + Sustainability (585) 338-5699 [email protected] Valeant Participant Affiliate Added Pharmaceuticals 400 Somerset Corporate Blvd Vice President, Global Environment, Since Last Plan Submission Salix International Bridgewater, NJ 08807 UNITED STATES Amy Butler Health, Safety + Sustainability (585) 338-5699 [email protected]
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Key: Parent Company Participating in Program Parent Company NOT Participating in Program Affiliated Company Participating in Program Notes Company Parent Company Full Address Full Name Title Work Phone Email
Vertex Pharmaceuticals 50 Northern Avenue Boston, MA Vertex Pharmaceuticals Incorporated Incorporated 02210 Phyllis Kidder Sr. Director, Trade & Distribution (617) 961-0524 [email protected] Participant Added Since Virtus Pharmaceuticals, 2649 Causeway Center Drive Tampa, (813) 283-1344 ext. Last Plan Submission Virtus Pharmaceuticals, LLC LLC FL 33619 UNITED STATES Shane Bailey Director, Regulatory Affairs 233 [email protected]
Participant Added Since 351 E. Evelyn Avenue Mountain View, Vice President, Medical & Regulatory Last Plan Submission VIVUS, Inc. VIVUS, Inc. CA 94041 UNITED STATES Santosh T. Varghese Affairs, PV & QA (650) 934-5352 [email protected]
Participant Affiliate Added Intertrust Prins Bernhardplein 200 Vice President, Medical & Regulatory Since Last Plan Submission VIVUS BV (Netherlands) VIVUS, Inc. 1097 JB AMSTERDAM NETHERLANDS Santosh T. Varghese Affairs, PV & QA (650) 934-5352 [email protected] Goodbody Secretarial Limited International Financial Services Centre Participant Affiliate Added 25-28 North Wall Quay DUBLIN 1 Vice President, Medical & Regulatory Since Last Plan Submission Vivus International Limited (Ireland) VIVUS, Inc. IRELAND Santosh T. Varghese Affairs, PV & QA (650) 934-5352 [email protected]
Participant Affiliate Added Clarendon House 2 Church Street Vice President, Medical & Regulatory Since Last Plan Submission Vivus International, L.P. (Bermuda) VIVUS, Inc. Hamilton HM 11 BERMUDA Santosh T. Varghese Affairs, PV & QA (650) 934-5352 [email protected]
Participant Affiliate Added Clarendon House 2 Church Street Vice President, Medical & Regulatory Since Last Plan Submission Vivus Limited (Bermuda) VIVUS, Inc. Hamilton HM 11 BERMUDA Santosh T. Varghese Affairs, PV & QA (650) 934-5352 [email protected] Tenon Limited, Amberley Place 107- Participant Affiliate Added 111 Peascod Street Windsor, Berkshire Vice President, Medical & Regulatory Since Last Plan Submission VIVUS UK Limited (United Kingdom) VIVUS, Inc. SL4 1TE UNITED KINGDOM Santosh T. Varghese Affairs, PV & QA (650) 934-5352 [email protected] WellSpring Pharmaceutical 5911 N. Honore Avenue Suite 211 dcoppenhaver@wellspringphar WellSpring Pharmaceutical Corporation Corporation Sarasota, FL 34243 UNITED STATES Donna Coppenhaver Manager, Regulatory & Compliance 941-312-4727 ext 101 m.com
Participant Added Since 20 Waterview Blvd, 3rd Floor Last Plan Submission Wockhardt USA LLC Wockhardt USA LLC Parsippany, NJ 07054 UNITED STATES Antonia Giuliana General Counsel (973) 257-4980 [email protected]
Participant Affiliate Added 6451 Main Street Morton Grove, IL Since Last Plan Submission Morton Grove Pharmaceuticals, Inc. Wockhardt USA LLC 60053 UNITED STATES Antonia Giuliana General Counsel (973) 257-4980 [email protected]
Participant Affiliate Added Wockhardt Towers Bandra Kurla Since Last Plan Submission Wockhardt Limited Wockhardt USA LLC Complex BANDRA (E) 400051 INDIA Antonia Giuliana General Counsel (973) 257-4980 [email protected] 3410 Central Expressway Santa Clara, Xenoport, Inc. Xenoport, Inc. CA 95051 UNITED STATES Gregory Bates SVP, Regulatory Affairs and Quality 408-616-7398 [email protected]
Participant Added Since Xttrium Laboratories, 1200 E. Business Center Dr Mount Director of Quality Last Plan Submission Xttrium Laboratories, Inc. Inc. Prospect, IL 60056 Joe Scalise Assurance/Regulatory Affairs 7732685800 ext. 130 [email protected]
Zydus Pharmaceuticals 73 Route 31 North Pennington, NJ Zydus Pharmaceuticals USA Inc USA Inc 08534 UNITED STATES Louis Pastor Sr. Director, Trade Operations 6097301900x104 [email protected]
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