HomeMy WebLinkAboutcopy-of-approved-med-project-for-unwanted-drugs-2025A Product Stewardship Plan for
Unwanted Medicine from Households
Alameda County, California
Date: September 5, 2025
2
Contents
Executive Summary ...................................................................................................... 4
I. Introduction .............................................................................................................. 5
II. Contact Information ................................................................................................. 6
III. Plan Definitions ........................................................................................................ 7
IV. Unwanted Medicine ................................................................................................. 9
V. Collection of Unwanted Medicine ......................................................................... 10
A. Unwanted Medicine Collection Program ............................................................. 10
1. Convenience ................................................................................................. 10
2. Services ........................................................................................................ 10
B. Kiosk Drop-Off Sites ........................................................................................... 10
1. Kiosk Drop-Off Site Locations ....................................................................... 10
2. Drop-Off Site Kiosk Placement and Maintenance Program .......................... 11
3. Kiosk Specifications ...................................................................................... 11
4. Kiosk Collection ............................................................................................. 12
5. Collection Method ......................................................................................... 13
6. Kiosk Service ................................................................................................ 13
C. Disposal of Unwanted Medicine from Kiosk Drop-Off Sites ................................ 14
D. Mail-Back Services for Unwanted Medicine ....................................................... 14
1. Standard Mail-Back Services for Unwanted Medicine ................................... 14
2. Inhaler Mail-Back Services for Inhalers ......................................................... 15
3. Injector Mail-Back Services for Pre-Filled Injector Products .......................... 15
4. Mail-Back Package Availability ...................................................................... 15
5. Mail-Back Package Collection and Disposal ................................................. 15
VI. Goals ....................................................................................................................... 17
VII. Patient Privacy ................................................................................................... 18
VIII. Call Center ......................................................................................................... 19
IX. Kiosk Drop-Off Site Training ................................................................................. 20
X. Vendor, Reverse Distributor, Transporter, Disposal, and Transfer Facility
Information ............................................................................................................. 21
A. Vendors .............................................................................................................. 21
B. Reverse Distributor ............................................................................................. 22
C. Carriers and Transporters .................................................................................. 22
D. Disposal Facilities ............................................................................................... 23
E. Transfer Facility .................................................................................................. 24
XI. Unwanted Medicine Educational and Outreach Programming .......................... 25
A. Overview ............................................................................................................ 25
B. Audiences ........................................................................................................... 25
C. Messages ........................................................................................................... 25
D. Tools/Communications Channels ....................................................................... 26
1. Phone ............................................................................................................ 26
3
2. Materials........................................................................................................ 26
3. Social Media .................................................................................................. 27
E. Survey ................................................................................................................ 27
F. Disclaimer ........................................................................................................... 27
XII. Compliance with Applicable Laws, Regulations, and other Legal
Requirements ......................................................................................................... 28
A. DEA Controlled Substances Act and Implementing Regulations ........................ 28
1. DEA Modification ........................................................................................... 29
B. United States Department of Transportation (DOT) ........................................... 29
C. California Board of Pharmacy ............................................................................. 29
XIII. Annual Report .................................................................................................... 31
Appendix A .................................................................................................................. 32
MED-Project Participating Producers ....................................................................... 32
Appendix B .................................................................................................................. 33
Participating Kiosk Drop-Off Sites ............................................................................ 33
Appendix C .................................................................................................................. 38
Sample Kiosk Mock-Up ............................................................................................ 38
Sample Kiosk Signage ............................................................................................. 39
Appendix D .................................................................................................................. 42
Sample Mail-Back Packages ................................................................................... 42
Appendix E .................................................................................................................. 45
Penalty Records....................................................................................................... 45
Appendix F ................................................................................................................... 55
Sample MED-Project Website Pages ...................................................................... 55
Appendix G .................................................................................................................. 70
Sample Bi-Fold Brochure ......................................................................................... 70
4
Executive Summary
MED-Project LLC (“MED-Project”) develops, implements, and operates stewardship
programs for unwanted medicine from households on behalf of hundreds of participating
Producers. MED-Project has substantial, practical, on-the-ground experience
implementing unwanted medicine takeback programs in jurisdictions across the country,
including the County. MED-Project currently administers an approved Product
Stewardship Plan in the County, which has been in operation since 2015 and has
served Residents by collecting over 430,000 pounds of Unwanted Medicine. Further,
MED-Project’s outreach and education efforts have thus far resulted in over 90 million
impressions to Residents.
5
I. Introduction
MED-Project, on behalf of the participating companies identified in Appendix A, submits
this Product Stewardship Plan (“Plan”) for Unwanted Medicine to the Alameda County
Department of Environmental Health (“Department”) in compliance with the Alameda
County Safe Drug Disposal Ordinance, Title 6 of the Alameda County Health and Safety
Code Sections 6.53.010 through 6.53.120, as amended February 2, 2016 (“Ordinance”)
and the Alameda County Safe Drug Disposal Regulations, as amended October 16,
2013 (“Regulations”). The Ordinance requires pharmaceutical Producers1 to develop a
Product Stewardship Program to finance and manage the collection, transportation, and
disposal of Unwanted Medicine from County households. Upon Department approval,
this Plan will supersede MED-Project’s previously approved plans in their entirety,
including, without limitation, their associated notices of determination or conditions of
approval.
1 All capitalized terms used but not otherwise defined herein shall have their respective meanings set forth in the Ordinance and Regulations.
6
II. Contact Information
The Plan Liaison for MED-Project is:
Dr. Victoria Travis, PharmD, MS, MBA
National Program Director
MED-Project LLC
4096 Piedmont Ave Unit 174
Oakland, CA 94611
Phone: 1 (833) 633-7765
Fax: 1 (866) 633-1812
Email: alamedacounty@med-project.org
7
III. Plan Definitions
Board of Pharmacy is the California State Board of Pharmacy.
Call Center is the MED-Project call center for Residents, which can be reached by
callers at the toll-free number of 1-844-MED-PROJECT or 1-844-633-7765.
Carrier is the common carrier used to transport Unwanted Medicine.
County means Alameda County, California.
DEA is the U.S. Drug Enforcement Administration.
DEA Rule is the DEA Final Rule, “Disposal of Controlled Substances,” 79 Fed. Reg.
53,520 et seq., adopted on September 9, 2014.
DOT is the U.S. Department of Transportation.
FDA is the U.S. Food and Drug Administration.
Help Desk is the MED-Project call center and email-in database for Kiosk Drop-Off
Sites and Mail-Back Distribution Locations that can be reached by callers at a toll-free
number and/or by email at alamedacounty@med-project.org.
Inhaler Mail-Back Services is the provision of pre-paid, pre-addressed packages for
the collection and disposal of inhalers (“Inhaler Mail-Back Packages”) by Vendor.
Injector Mail-Back Services is the provision of pre-paid, pre-addressed, FDA-cleared
sharps containers for the collection and disposal of pre-filled injector products (“Injector
Mail-Back Packages”) by Vendor.
Kiosk Drop-Off Site is a location that is accessible to the public, hosting a MED-Project
kiosk for the collection of Unwanted Medicine.
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 federal, state, tribal, or local law enforcement
office or agency.
Mail-Back Distribution Location is a site that is accessible to the public, such as a fire
station or library, which provides Standard Mail-Back Packages to Residents.
Mail-Back Services is the provision of pre-paid, pre-addressed containers, envelopes,
or packages (“Mail-Back Packages”) to Residents for the collection and disposal of
Unwanted Medicine by Vendor.
MED-Project Website is the Internet website located at www.med-project.org or
www.medproject.org.
8
Plan or Product Stewardship Plan is the product stewardship plan presented in this
submittal by MED-Project.
Pre-filled Injector Products are pre-filled injector products with a retractable or
otherwise securely covered needle where medicine cannot be removed from them or
where they contain more than trace amounts of Covered Drugs.
Program or Product Stewardship Program is the product stewardship program set
forth in this Product Stewardship Plan.
Residents means human beings residing in the County. “Residents” does not include
nonresidential generators of pharmaceutical waste, such as businesses, hospitals,
clinics, doctor’s offices, veterinary clinics, pharmacies, or airport security and law
enforcement drug seizures.
Specified Languages are English, Spanish, Chinese, Vietnamese, and Tagalog
(Filipino).
Standard Mail-Back Services is the provision of pre-paid, pre-addressed envelopes for
the collection and disposal of Unwanted Medicine (“Standard Mail-Back Packages”)
by Vendor.
Unwanted Medicine is defined in Section IV of this Plan.
Vendor is any vendor retained by MED-Project to carry out its obligations under the
Program.
9
IV. Unwanted Medicine2
For the purposes of the Plan, “Unwanted Medicine” includes all materials identified as
“Covered Drugs” under Ordinance § 6.53.030(3) that qualify as “Unwanted Products”
under Ordinance § 6.53.030(21). According to the Ordinance, Covered Drugs means “a
Drug sold, offered for sale, or dispensed in Alameda County in any form including
prescription and nonprescription drugs, drugs in medical devices and combination
products, brand name and generic drugs, and drugs for veterinary use.” Unwanted
Medicine does not include the following:
i. Expired and/or undispensed samples direct from physicians’ offices;
ii. Unused or expired drugs from hospitals and institutions;
iii. Bulk animal pharmaceuticals from farms (business use);
iv. Vitamins or supplements;
v. Herbal-based remedies and homeopathic drugs, products, or remedies;
vi. Compressed cylinders and mercury-containing thermometers;
vii. Cosmetics, shampoos, sunscreens, toothpaste, lip balm, antiperspirants,
or other personal care products that are regulated as both cosmetics and
nonprescription drugs under the federal Food, Drug, and Cosmetic Act
(Title 21 U.S.C. Chapter 9);
viii. Hard surface and toilet disinfectant cleaners;
ix. Drugs administered in a healthcare setting;
x. Drugs for which Producers provide a pharmaceutical product stewardship
or take-back program as part of an FDA managed risk evaluation and
mitigation strategy (Title 21 U.S.C. Sec. 355-1);
xi. Drugs that are biological products, as defined by 21 C.F.R. 600.3(h) as it
existed on February 2, 2016, if the Producer already provides a
pharmaceutical product stewardship or take-back program;
xii. Medical devices or their component parts or accessories;
xiii. Used, empty containers, vials, and pouches;
xiv. Sharps (e.g., needles)
xv. Schedule I or other illicit drugs.
See Section XII.A for collection limitations imposed by the DEA Rule.
2 Unwanted Medicine collected at Kiosk Drop-Off Sites does not include Pre-filled Injector Products. Unwanted Medicine collected in Standard Mail-Back Packages does not include inhalers or Pre-filled Injector Products.
10
V. Collection of Unwanted Medicine
The Plan provides services to collect Unwanted Medicine, including controlled
substances. The Program accepts Unwanted Medicine regardless of who produced it
unless excused from this requirement by the Department. The collection methods and
any applicable legal requirements are described below.
A. Unwanted Medicine Collection Program
1. Convenience
MED-Project has established a network of convenient Kiosk Drop-Off Sites that
adequately meets the needs of the Residents in the County. See Appendix B for a list of
participating sites. Mail-Back Services are available upon request for all Residents,
including disabled and/or home-bound Residents or persons providing services to such
Residents, via the Call Center and MED-Project Website, thereby offering more
opportunities to dispose of Unwanted Medicine. If the number of Kiosk Drop-Off Sites
falls below 50 locations, distributed jointly, in combination with all other approved
stewardship organizations, Mail-Back Distribution Locations will be used to supplement
Kiosk Drop-Off Sites on a one-for-one basis.
2. Services
MED-Project routinely assesses performance, gauges feedback, and revises its
approach to services and convenience as appropriate.
The Program is implemented in a flexible manner, offering coverage to Residents
through a combination of Kiosk Drop-Off Sites and Mail-Back Services. Agreements
outlining the responsibilities of the involved parties are reviewed by appropriate entities
and signed by the parties before participation in the Program.
Mail-Back Services are available to Residents via the Call Center and MED-Project
Website. See Section V.D. for more information about the availability of Mail-Back
Services.
B. Kiosk Drop-Off Sites
Kiosk Drop-Off Sites are conveniently placed across the County.
1. Kiosk Drop-Off Site Locations
Kiosk Drop-Off Sites that are participating in the Program are identified in Appendix B.
As required under Ordinance § 6.53.070(E), MED-Project will include as a Kiosk Drop-
Off Site eligible LEA or retail pharmacy sites willing to serve voluntarily who submit a
written expression of interest to participate to MED-Project, and who are able to meet all
applicable laws, regulations, and other legal requirements. Locations currently serving
11
as a kiosk drop-off site may participate in the Program by signing agreements with
MED-Project and modifying their DEA registrations, if required.
2. Drop-Off Site Kiosk Placement and Maintenance Program
Kiosk installation shall be the responsibility of MED-Project at LEAs and pharmacy
Kiosk Drop-Off Sites when the Kiosk Drop-Off Site Host has identified a compliant
placement location. All kiosks in the Program must be securely placed and maintained
inside a collector’s registered location or LEA’s physical location in accordance with
DEA Rule §§ 1317.75(d)(1) and 1317.35(a). At pharmacies, kiosks are placed in the
immediate proximity of a designated area where controlled substances are stored and
at which an employee is present (i.e., can be seen from the counter), pursuant to DEA
Rule § 1317.75(d)(2). Kiosk placement will also comply with any applicable Board of
Pharmacy requirements. Costs associated with installation and maintenance are paid
by MED-Project per the agreements with the Kiosk Drop-Off Site Hosts.
The maintenance program addresses items such as:
− Monitoring the kiosk for proper functioning; and
− Reporting issues regarding the kiosk to the MED-Project Help Desk.
All Kiosk Drop-Off Site Hosts are able to notify MED-Project of the need for kiosk
service or maintenance via the Help Desk.
3. Kiosk Specifications
A kiosk is offered to eligible host locations. Pursuant to DEA Rule § 1317.75, MED-
Project kiosks at pharmacies must:
− Be securely fastened to a permanent structure;
− Be securely locked, substantially constructed containers with a permanent outer container and removable inner liner;
− Include a small opening in the outer container that allows contents to be added to
the inner liner, but does not allow removal of the inner liner’s contents;
− Prominently display a sign indicating that only Schedule II-V controlled and non-controlled substances are acceptable to be placed in the kiosk; and
− Have the small opening in the outer container locked or made inaccessible to the public when a Kiosk Drop-Off Site employee is not present.
The design of the pharmacy kiosk and signage (Appendix C) satisfies these
requirements through the use of heavy gauge steel; multiple locking mechanisms,
including a locking mechanism on the drop-slot; a tamper-resistant chute; and
commercial hinges. The design increases the likelihood of consumer participation by
providing easy access to wheelchair users. The locking mechanism on the drop-slot
prevents kiosk overflow once the container has reached its maximum level and is
locked by the Kiosk Drop-Off Site employee. MED-Project pharmacy kiosks come with
appropriate regulatory signage and instructions, including an instruction to remove
personal information from any Unwanted Medicine and packaging before depositing
12
them and language required under the DEA Rule3 and by the Board of Pharmacy. Kiosk
signage provides information about what is and is not accepted in the kiosk.
Additionally, under DEA Rule § 1317.60(a), MED-Project kiosk inner liners will:
− Be waterproof, tamper-evident, and tear-resistant;
− Be removable and sealable immediately upon removal without emptying or touching kiosk contents;
− When sealed, make the contents of the inner liner not viewable from the outside;
− Clearly indicate the size of the inner liner; and
− Bear a permanent, unique identifier for tracking purposes.
MED-Project kiosks and inner liners will also comply with the Board of Pharmacy
requirements.
While the DEA Rule does not require LEA kiosks to meet these same requirements,
MED-Project will offer these kiosks and inner liners to LEAs. See Disposal of Controlled
Substances, 79 Fed. Reg. 53,520, 53,531 (Sept. 9, 2014).
4. Kiosk Collection
Under DEA Rule § 1317.05(c)(2)(iv), pharmacy Kiosk Drop-Off Site Hosts must dispose
of sealed inner liners and their contents either on-site, through common or contract
carrier delivery to, or pick-up by a reverse distributor or distributor, or with DEA
assistance.
DEA Rule § 1317.75(c) prohibits the counting, sorting, inventorying, or individual
handling of any substances deposited into a pharmacy kiosk. Additionally, DEA Rule §
1317.60 limits inner liner access to employees of the collector and requires two
employees to immediately seal the inner liner upon its removal from the pharmacy
kiosk’s permanent outer container. See DEA Rule § 1317.60(b), (c). DEA Rule §
1317.75(g) provides that pharmacy kiosk inner liner installation or removal shall be
performed “by or under the supervision of at least two employees of the authorized
collector.” The pharmacy kiosk sealed inner liner must not be opened, x-rayed,
analyzed, or otherwise penetrated. See DEA Rule § 1317.60(c).
LEA Kiosk Drop-Off Sites, Vendor and/or LEA will maintain any records of removal,
storage, or destruction of the collected Unwanted Medicine in a manner consistent with
the LEAs’ recordkeeping requirements for illicit controlled substances evidence
pursuant to DEA Rule § 1317.35. LEAs will record the unique identifier and size of the
sealed inner liner. See DEA Rule § 1317.35. Additionally, any Unwanted Medicine will
be stored in a manner to prevent the diversion of controlled substances and consistent
3 Specifically, as required under DEA Rule § 1317.75(e)(4), all kiosks will prominently display a sign
stating that: “Only Schedule II-V controlled and non-controlled substances that are lawfully possessed by the ultimate user are acceptable to be placed in the kiosk. Schedule I controlled substances, illicit or dangerous substances, and any controlled substances not lawfully possessed by the ultimate user may not be placed in the kiosk.”
13
with the LEA’s standard procedures for storing illicit controlled substances. Collected
Unwanted Medicine will be transferred to the disposal facility in a manner to prevent the
diversion of Unwanted Medicine and consistent with the LEA’s standard procedures for
transferring illicit controlled substances. See DEA Rule § 1317.35.
MED-Project’s Kiosk Drop-Off Site collection system complies with these DEA
requirements for pharmacy and LEA Kiosk Drop-Off Sites. Vendor, pharmacies, and
LEAs participating in the Program will keep all records required under the DEA Rule,
including those required under DEA Rule §§ 1304 and 1317.35. Pharmacies
participating in the Program will also keep all records required under Board of Pharmacy
requirements. Pharmacy Kiosk Drop-Off Sites and Vendor will be instructed never to
count, sort, inventory, or individually handle kiosk contents. MED-Project’s Kiosk Drop-
Off Site collection system will also comply with all applicable Board of Pharmacy
requirements.
5. Collection Method
MED-Project provides for the collection, transport, and disposal of Unwanted Medicine
at no cost to the Kiosk Drop-Off Site.
Kiosk Drop-Off Site Hosts are provided with instructions for the management of the
Unwanted Medicine collection box and inner liner in accordance with the Kiosk Drop-Off
Site Host agreement. Guidance materials are available to the Kiosk Drop-Off Sites,
including instructions on how to safely pack and seal the inner liner for shipping as soon
as it is full. This method enables the Kiosk Drop-Off Site employees to avoid disruptions
to operations and service the kiosk at the time of their choosing. The Kiosk Drop-Off
Site employees prepare the inner liner for shipment and schedule a Carrier to pick up
the packaged inner liner through MED-Project systems or offer the packaged inner liner
during a regular Carrier pick-up.
6. Kiosk Service
When servicing a kiosk at a Kiosk Drop-Off Site, Kiosk Drop-Off Site employees will:
− Check the kiosk for any damage;
− Remove the inner liner and box from the kiosk and seal them at once, following procedures meeting all DEA requirements;
− Replace the removed inner liner and box with a replenishment inner liner and box provided by Vendor;
− Match the unique identifier of the inner liner to the tracking number on the
shipping label;
− Package the inner liner for transport;
− Prepare the materials for shipment and perform applicable pre-transportation functions following the DOT HMR; and
− Schedule a pick-up from the Carrier to be completed within a few business days or offer the packaging holding the sealed inner liner for pick-up by routine Carrier service at the Kiosk Drop-Off Site.
14
The Kiosk Drop-Off Site employees store the inner liner in compliance with all
applicable laws, regulations, and other legal requirements until Carrier pick-up.
C. Disposal of Unwanted Medicine from Kiosk Drop-Off Sites
Kiosk Drop-Off Site employees, Vendor, and Carrier shall manage the Unwanted
Medicine from Kiosk Drop-Off Sites in compliance with all applicable laws, regulations,
and other legal requirements. Carrier shall deliver Unwanted Medicine collected from
Kiosk Drop-Off Sites to the respective facilities identified in Section X. Each sealed
inner liner and box containing Unwanted Medicine will be weighed at the receiving
facility.
Unwanted Medicine is destroyed in accordance with all applicable laws, regulations,
and other legal requirements at the disposal facilities identified in Section X.
D. Mail-Back Services for Unwanted Medicine
MED-Project will provide three types of Mail-Back Services:
− Standard Mail-Back Services for the collection of Unwanted Medicine as described in Section V.D.1.;
− Inhaler Mail-Back Services for the collection of inhalers as described in Section V.D.2.; and
− Injector Mail-Back Services for the collection of Pre-filled Injector Products as described in Section V.D.3.
Mail-Back Packages will be pre-paid and pre-addressed, and Mail-Back Services shall
comply with all applicable laws, regulations, and other legal requirements.
1. Standard Mail-Back Services for Unwanted Medicine
For Unwanted Medicine, MED-Project offers Standard Mail-Back Services at no cost to
Residents, via the Call Center and MED-Project Website. The pre-paid shipping label
directs the Standard Mail-Back Package to an approved facility identified in Section X.
Standard Mail-Back Packages for Unwanted Medicine shall comply with all applicable
laws, regulations, and other legal requirements.
Pursuant to DEA Rule § 1317.70(c), the Standard Mail-Back Packages are:
− Nondescript and without any markings or information potentially indicating that they contain Unwanted Medicine, including controlled substances;
− Water and spill-proof, tamper-evident, tear-resistant, and sealable;
− Pre-addressed with and delivered to Vendor’s registered address;
− Pre-paid;
− Provided with a unique identifier enabling tracking; and
− Provided with instructions indicating the process for mailing back the packages,
accepted substances, a notice about mailing restrictions, and a notice that only
packages provided by Vendor will be accepted for destruction.
15
Standard Mail-Back Packages will not be opened, x-rayed, analyzed, or otherwise
penetrated upon receipt by Vendor. See DEA Rule § 1317.70(f). Vendor will keep all
records required under the DEA Rule, including those identified in DEA Rule §
1304.22(f).
See Appendix D for a Standard Mail-Back Package image and package specifications.
2. Inhaler Mail-Back Services for Inhalers
For inhalers, MED-Project offers Inhaler Mail-Back Services at no cost to Residents via
the Call Center and MED-Project Website. The pre-paid shipping label directs the
Inhaler Mail-Back Packages to an approved facility identified in Section X. An instruction
sheet is included with the Inhaler Mail-Back Package that describes how to properly
dispose of inhalers, explains what materials may be placed in the Inhaler Mail-Back
Package, and how to return the Inhaler Mail-Back Package.
See Appendix D for an Inhaler Mail-Back Package image and package specifications.
3. Injector Mail-Back Services for Pre-Filled Injector Products
For Pre-filled Injector Products, MED-Project offers Injector Mail-Back Services at no
cost to Residents, via the Call Center and MED-Project Website. The pre-paid shipping
label directs the Injector Mail-Back Packages to an approved facility identified in Section
X. An instruction sheet is included with the Injector Mail-Back Package that describes
how to properly dispose of the Pre-filled Injector Products, explains what materials may
be placed in the Injector Mail-Back Package, and how to return the Injector Mail-Back
Package.
See Appendix D for an Injector Mail-Back Package image and package specifications.
4. Mail-Back Package Availability
Residents may request Standard Mail-Back Packages, Inhaler Mail-Back Packages,
and/or Injector Mail-Back Packages by calling the Call Center or through a link on the
MED-Project Website. If the number of Kiosk Drop-Off Sites falls below 50 locations,
distributed jointly, in combination with all other approved stewardship organizations,
Mail-Back Distribution Locations that disseminate Standard Mail-Back Packages will be
used to supplement Kiosk Drop-Off Sites on a one-for-one basis.
Each Mail-Back Package contains an insert with instructions for use and information
about other options for disposing of Unwanted Medicine in the Specified Languages.
See Appendix D for Mail-Back Package images.
5. Mail-Back Package Collection and Disposal
Requests to receive Mail-Back Packages are taken through the Call Center and the
MED-Project Website. Residents are directed to follow the instructions provided in the
Mail-Back Package and to place their Unwanted Medicine in the pre-addressed, pre-
16
paid package. The Mail-Back Package is sent to an approved disposal facility in
compliance with all applicable laws, regulations and other legal requirements. Each
Mail-Back Package has a unique identifier for tracking.
For Standard Mail-Back Packages, upon arriving at the disposal facility, the Mail-Back
Packages are scanned for receipt verification and incinerated at the disposal facilities
listed in Section X. Any storage of filled Standard Mail-Back Packages by Vendor
complies with the applicable security requirements of DEA Rule § 1317, including the
requirement that Unwanted Medicine is securely stored in a manner consistent with the
security requirements for Schedule II Controlled Substances. Unwanted Medicine in
Standard Mail-Back Packages is weighed and destroyed promptly at the receiving
facility. The total amount by weight collected through Mail-Back Services may be
provided using an actual or an average weight per Mail-Back Package, as provided by
Vendor.
17
VI. Goals
The short-term and long-term goals of the Plan are described generally as follows.
Goal Area Short-Term and Long-Term Goals:
Collection reasonably convenient access for Residents as follows:
• If the number of Kiosk Drop-Off Sites falls below 50 locations
(distributed jointly, in combination with all other approved
stewardship organizations), Mail-Back Distribution Locations will be used to supplement Kiosk Drop-Off Sites on a one-for-one basis.
• Additionally, MED-Project may send a letter to potential Kiosk Drop-
Off Site Hosts outlining the opportunity to participate in the Program.
Maintain Mail-Back Services via the MED-Project Website and Call Center.
Education & Public Outreach
Continue media program consistent with Regulations § 8.A.viii via the
following:
• MED-Project Website.
• Call Center.
• Media campaigns (for example, digital display, connected TV, streaming audio, or social media).
18
VII. Patient Privacy
Instructions at each Kiosk Drop-Off Site inform Residents who deposit Unwanted
Medicine that they should completely cross out, remove, or otherwise make unreadable
any and all personally identifiable information on the containers and packaging before
depositing them in the kiosk. In cases where people follow the instructions, there will be
no personally identifiable information.
In addition to kiosk signage, MED-Project promotional and educational materials
encourage Residents to protect their information by removing identifiable information
before depositing containers into kiosks or Mail-Back Packages. As an added
protection, inner liners for the kiosks are opaque rather than clear, in compliance with
DEA Rule.
19
VIII. Call Center
MED-Project has established a toll-free telephone number for Residents to obtain
information about Kiosk Drop-Off Sites, Mail-Back Services, educational materials, and
other aspects of the Program. Callers with medical emergencies are directed to call
911. Patients with medication-related questions are directed to contact their health care
provider(s).
The Call Center provides information about:
− Items that can be disposed of;
− Disposal options;
− Kiosk Drop-Off Sites and disposal options in the caller’s specified ZIP code;
− The MED-Project Website; and
− How to obtain Mail-Back Packages.
To increase access to the Program for Residents, MED-Project has included dialing
options for TTY and 711 services.
20
IX. Kiosk Drop-Off Site Training
At a Kiosk Drop-Off Site, operational procedures, including training, are the
responsibility of the Kiosk Drop-Off Site Host. Included in the training materials are
documents that address:
− Permit requirements;
− Management of kiosks, including cleanliness, monitoring the kiosk for proper
functioning, and how to report issues regarding the kiosk to MED-Project; and
− Proper inner liner setup and closure, preparation of shipment, and timely removal
of the packaged inner liner from the site.
MED-Project provides a system that allows Kiosk Drop-Off Site Hosts to request
resources or support anytime. MED-Project also provides a 24/7 Help Desk to answer
questions, monitor comments, and fulfill requests from participating Kiosk Drop-Off Sites
and Mail-Back Distribution Locations.
21
X. Vendor, Reverse Distributor, Transporter, Disposal,
and Transfer Facility Information
All Vendors, transporters, and disposal facilities utilized by the Program will operate in
accordance with all applicable laws, regulations, and other legal requirements.
A. Vendors
Record
Compliance,
Inc.
16225 Park Ten Place, Suite
830, Houston,
3030 com
Stericycle, Inc.
Waukegan
Road, Bannockburn,
5910 e.com
22
B. Reverse Distributor
Permits Record (5 years)
Inc. Warren, Ohio Facility
1901 Pine
Avenue,
SE,
44483
0370 cle.com/ Registered
Collector and Reverse
No: RS0498130
See
Appendix E
C. Carriers and Transporters
Permits Record (5
Harbors Environme
ntal Services
1021 Berryessa Road, San
Jose, CA
95113
0962 arbors.com Waste Transporter 180743 Appendix E
Sharps Solutions, LLC
23575
Cabot Blvd., Ste 205, Hayward,
8449 s-solutions.com/contact/
Carrier 2810784
Stericycle Inc. 2355 Waukegan Road,
Bannockbur
5910 cle.com Waste Transporter 397962
United
Parcel Service,
55 Glenlake
Parkway UPS om/ 21800
23
Name Address Phone Website Type Issued Permits Record (5
States Postal Service
475 L’Enfant Plaza SW, Washington
2000 .com/ See SEC filings
D. Disposal Facilities
Permits Record (5
Harbors Aragonite, LLC
11600
North Aptus
Rd, Grantsville, UT 84029
8900 arbors.com/ Waste
Incinerator
UTD981552
177 Title V Operating Permit No:
450004800
See
Appendix E
Curtis Bay Energy, LP 3200 Hawkins
Point Road,
Baltimore, MD 21226
1715 aymws.com Waste
Incinerator
MDD98540
4318
Refuse Disposal Permit No: 2017-WMI-
SeeAppendix E
Arcwood Environmental – East
Liverpool, Inc. (Formerly Heritage Thermal
Services –
1250 Saint George Street, East
Liverpool,
OH 43920
7655 arcwoodenviro.com/ Waste Incinerator OHD980613541
Title V
Operating Permit No: OH0000000215020233
See Appendix E
24
Name Address Phone Website Type Issued Permits Record (5
Inc., Warren, Ohio Facility
1901 Pine Avenue SE,
44483
6275 .stericycle.com Waste Incinerator OHD980795280 Title V
Operating Permit No:
See Appendix E
E. Transfer Facility
Permits Record (5
Harbors Environmental
1021 Berryessa Rd. San Jose, CA
3379 arbors.com Medical Waste Transfer
Waste Permit TS-51
Appendix E
25
XI. Unwanted Medicine Educational and Outreach
Programming
A. Overview
MED-Project will perform public education and outreach to educate Residents about the
collection and disposal of Unwanted Medicine from households.
B. Audiences
A comprehensive communications campaign featuring both general awareness
strategies and targeted outreach to audiences directly involved in the distribution and
use of medicines to Residents will educate the public about the Program. These
audiences may include:
− General public;
− Pharmacies, including education for dispensers of Covered Drugs;
− Retailers of Covered Drugs;
− Health care providers and their patients; and
− Veterinary providers and animal owners.
The Program will include efforts designed to reach a broad range of diverse audiences.
The Program will make available a multilingual Call Center (Section XI.D.1.) and will
make available educational information through a range of media platforms.
C. Messages
MED-Project’s messaging will:
− Educate Residents about the appropriate use, storage, and disposal of
Unwanted Medicine;
− Educate Residents about available Mail-Back Services; and
− Provide Residents with information about available Kiosk Drop-Off Sites and Mail-Back Distribution Locations in their area that offer disposal of Unwanted Medicine.
Key points of emphasis might include:
− The importance of properly and securely storing medicines;
− The importance of promptly and properly disposing of Unwanted Medicine;
− How to find and use Kiosk Drop-Off Sites;
− How to properly dispose of Unwanted Medicine; and
− Privacy information (removing personally identifiable information from labeled prescription containers).
26
D. Tools/Communications Channels
The Program will include a number of components designed to reach consumers and
provide consistent access to timely and relevant information.
MED-Project will execute a measurable public education and outreach strategy aimed
at driving awareness of take-back of Unwanted Medicine and in accordance with
Ordinance §§ 6.53.050 (A) (8) and 6.53.070.
MED-Project will use a combination of the following tools and communication channels:
1. Phone
The Program provides a Call Center for Residents to obtain information about Kiosk
Drop-Off Sites, Mail-Back Services, Mail-Back Distribution Locations, educational
materials, and other aspects of the Program for the take back of Unwanted Medicine
from households. The Call Center provides:
− Assistance in the Specified Languages;
− Information about how the Program works, and how to obtain more information (e.g., the MED-Project Website);
− An option to speak with an agent to locate Kiosk Drop-Off Sites and/or Mail-Back Distribution Locations, if applicable, in the Resident’s ZIP code or local area; and
− Information about Mail-Back Services, including how to request a pre-paid and
pre-addressed Mail-Back Package.
The Call Center also provides a recorded call script directing callers with medical emergencies to call 911 and directing callers with medication-related questions to contact their health care provider(s).
MED-Project will provide a mobile-friendly MED-Project Website with translations
available in the Specified Languages. The MED-Project Website allows Residents to
request Mail-Back Packages, provides information on locations of Kiosk Drop-Off Sites
and, if applicable, Mail-Back Distribution Locations, and provides access to educational
materials and answers to frequently asked questions. Promotional and educational
materials will be provided on the MED-Project Website, including brochures and Mail-
Back Package inserts, with translations available in the Specified Languages. Public
interest groups will be encouraged to use these resources to promote the Program.
Appendix F contains a sample mockup of the MED-Project Website and supporting
pages.
2. Materials
Educational materials about the Program and how to properly dispose of Unwanted
Medicine are provided for dissemination, upon request, through the MED-Project
Website and the Call Center, to interested parties, including healthcare facilities,
27
pharmacies, and Kiosk Drop-Off Sites. The educational brochure is provided in
Appendix G.
3. Social Media
MED-Project uses social media to communicate outreach information about Kiosk Drop-
Off Sites and Mail-Back Services. Posts are made as needed to reflect the most up-to-
date information.
E. Survey
MED-Project will conduct a biennial survey of Residents in the County to measure
awareness of the take-back of Unwanted Medicine from households.
F. Disclaimer
The written and verbal educational materials and public outreach tools that are required
by the Ordinance and disseminated under this Product Stewardship Plan may include a
disclaimer similar to the following: “This material has been provided for the purpose of
compliance with legislation and does not necessarily reflect the views of MED-Project or
the Producers participating in the MED-Project Product Stewardship Plan.”
28
XII. Compliance with Applicable Laws, Regulations, and
other Legal Requirements
As described in more detail below, the Plan is designed such that all entities
participating in the Program shall comply with all applicable laws, regulations, and other
legal requirements.
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.
Under the DEA Rule, collection of controlled substances is limited to Schedule II, III, IV,
or V controlled substances that are lawfully possessed by an ultimate user or person
entitled to dispose of an ultimate user decedent’s property. See DEA Rule §§
1317.75(b) (Kiosk Drop-Off Sites),41317.70(b) (Mail-Back Services). Schedule I
controlled substances, controlled substances that are not lawfully possessed as
described above, and other illicit or dangerous substances will not be collected.
Additionally, as these provisions of the DEA Rule limit collection of controlled
substances to those lawfully possessed by an ultimate user or certain other persons,
pharmacies are prohibited from disposing their own inventory or stock through the
Program. See also DEA Rule § 1317.05.
The DEA Rule provides that LEAs can continue to accept controlled substances for
disposal. However, the DEA Rule also provides that pharmacies, reverse distributors,
hospitals/clinics with on-site pharmacies, and certain other entities, can register with the
DEA as “collectors” and become authorized at their discretion on a voluntary basis to
accept controlled substances. The DEA Rule:
− Provides for the collection of controlled substances at Kiosk Drop-Off Sites at LEAs, pharmacies, and hospitals with on-site pharmacies;
− Provides for the use of mail-back programs to collect controlled substances;
− Allows for the commingling of controlled and non-controlled substances;
4 For Kiosk Drop-Off Site collection, only certain substances “that are lawfully possessed by an ultimate
user or other authorized non-registrant person may be collected.” DEA Rule § 1317.75(b). This language is similar to, but slightly different than, provisions limiting collection through Mail-Back Services to ultimate users or other persons (lawfully) entitled to dispose of an ultimate user decedent’s property. See DEA Rule §§ 1317.65(d); 1317.70(b).
29
− Establishes detailed collection, recordkeeping, security, and other measures for all approved collection methods; and
− Provides that all collected pharmaceutical products be destroyed so that the products are rendered non-retrievable.
The Plan is designed such that all entities that are part of the Program, including
Vendor, are individually responsible to comply with their respective compliance
obligations under the DEA Rule. The collection, transportation, and disposal of
Unwanted Medicine collected from Kiosk Drop-Off Sites and Mail-Back Services,
including controlled substances, will comply with applicable DEA requirements.
Controlled substances collected pursuant to the Plan may be commingled with non-
controlled substances at Kiosk Drop-Off Sites and through Mail-Back Services per the
DEA Rule. See DEA Rule §§ 1317.75(b) (Kiosk Drop-Off Sites); 1317.70(b) (Mail-Back
Services).
1. DEA Modification
Pursuant to DEA Rule § 1301.51(b), pharmacies may modify their registrations to
become authorized collectors by submitting a written request to the DEA or online at
www.DEAdiversion.usdoj.gov. This request must contain:
− The registrant’s name, address, and registration number (as printed on the
registration certificate);
− The collection methods the registrant intends to conduct; and
− A signature in accordance with 21 C.F.R. § 1301.13(j).
See DEA Rule § 1301.51(b). MED-Project will consult with participating pharmacies, as
requested, regarding how to modify DEA registrations to become authorized collectors.
B. United States Department of Transportation (DOT)
The transporting of Unwanted Medicine will comply with the U.S. DOT HMR and other
applicable DOT requirements.
C. California Board of Pharmacy
On June 8, 2017, the Board of Pharmacy adopted the Board of Pharmacy Regulations,
Article 9.1 of Division 17 of Title 16 of the California Code of Regulations. Largely based
on the DEA Rule, the Board of Pharmacy Regulations establish requirements applicable
to pharmacies, hospitals/clinics with on-site pharmacies, distributors, and reverse
distributors conducting certain drug take-back services. Among other things, the Board
of Pharmacy Regulations provide:
− That California-licensed pharmacies and hospitals/clinics with on-site pharmacies
must be in good standing with, and notify, the Board of Pharmacy to host a drug
kiosk. See 16 CCR §§ 1776, 1776.1(i);
30
− That pharmacies must “know and adhere” to all applicable “federal, state, and local requirements governing the collection and destruction of dangerous drugs”
when operating a drug take-back program. See 16 CCR § 1776.1(b);
− Drug kiosk placement and monitoring requirements. See 16 CCR §§ 1776.3(b)–(d).
− Drug kiosk inner liner, container, and signage requirements. See 16 CCR §§ 1776.3(f), (h), (m);
− Inner liner handling, storage, and destruction requirements for drug kiosks. See, e.g., 16 CCR §§ 1776.3(h)–(j), 1776.5(a)–(c);
− Pharmacy and reverse distributor recordkeeping requirements. See 16 CCR §§ 1776.5(e)–(f), 1776.6; and
− Pharmacy drug mail-back program requirements. See 16 CCR § 1776.2.
The Plan is designed such that all entities that are part of the Program, including
Vendor, are individually responsible for complying with their respective compliance
obligations under the Board of Pharmacy Regulations.
31
XIII. Annual Report
An annual report will be provided to the Director on or before the date set by the
Department and annually thereafter (Ordinance § 6.53.080). This report will be provided
in the format required by the Ordinance § 6.53.080 and Regulations §15.
32
Appendix A
MED-Project Participating Producers
The list of participating Producers in the Program in the County is provided to the
County on a periodic basis to satisfy Ordinance requirements. The County was provided
with an updated list on July 14, 2025.
33
Appendix B
Participating Kiosk Drop-Off Sites
2693 Fruitvale Ave Oakland 94601
System - San 13855 East 14th Street
Alameda Hospital
BART Police Department
Berkeley Police
Department
California State University, East 25800 Carlos Bee Boulevard
Capsmart Pharmacy
Clover Pharmacy
Community a
Walgreens
3009 Broadway Oakland 94611
7201 Regional Street Dublin 94568
7200 Bancroft Avenue Oakland 94605
4020 Fremont Hub Fremont 94538
2314 Santa Clara
Avenue
Alameda 94501
175 41st Street Oakland 94611
3320 Fruitvale Avenue Oakland 94602
34
Site Name Address City Zip Code
CVS Pharmacy 09234
CVS Pharmacy 09251
CVS Pharmacy 09378
CVS Pharmacy 09397
CVS Pharmacy 09494
CVS Pharmacy 09600
CVS Pharmacy 09622
CVS Pharmacy
09635
CVS Pharmacy 09678
CVS Pharmacy 09876
CVS Pharmacy
09904
CVS Pharmacy 09941
CVS Pharmacy 09942
CVS Pharmacy 10119
CVS Pharmacy
10121
CVS Pharmacy 10199
CVS Pharmacy 10924
35
Site Name Address City Zip Code
Dublin Police Services
Emeryville Police Department
Haller's Pharmacy and 37323 Fremont Boulevard
Highland Hospital Outpatient
1411 East 31st Street
Jade Pharmacy
Kaiser Alameda MOB OP 2417 Central Ave. Alameda 94501
OP Pharmacy 2621 Tenth Street Berkeley 94710
MOB Pharmacy
3100 Dublin Blvd
Fl 1
Kaiser Fremont
Ohlone OP
39400 Paseo
Padre Pkway
Kaiser Livermore OP Pharmacy 3000 Las Positas Road
Kaiser Oak Broadway 1Fl OP 3701 Broadway Fl 1
Kaiser Oak Fabiola A 1Fl OP 3801 Howe Street Oakland 94611
Main Pharmacy 3600 Broadway Fl 1
36
Site Name Address City Zip Code
Kaiser Pleasanton South 1
7601 Stoneridge Pleasanton 94588
Leandro Discharge
2500 Merced
Street, Bldg. H, FL 1, Room 1436
Kaiser Union City Main MOB 2 3553 Whipple Rd. Union City 94587
22138 Mission
Boulevard
Hayward 94541
1999 Mowry Avenue, Suite A-2 Fremont 94538
Pharmacy - Lake 250 East 18th Street, 3rd Floor
New Oakland Pharmacy 1
New Oakland Pharmacy 2
Piedmont Police
Department
Pleasanton Police 4833 Bernal Avenue
Teds Drugs
Tennyson Pharmacy
Walgreens 00101
Walgreens 01537
37
Site Name Address City Zip Code
Walgreens 02150
Walgreens 02306
Walgreens 02314
Walgreens 02366
Walgreens 02426
Walgreens 02660
Walgreens 04050
Walgreens 04517
Walgreens 04614
Walgreens 06502
Walgreens 09248
Walgreens 10526
Walgreens 13595
Walgreens 15163
Wellspring Pharmacy
38
Appendix C
Sample Kiosk Mock-Up
39
Sample Kiosk Signage
Kiosk Drop-Slot Panel 11” x 5”
Kiosk Drop-Slot Panel 6” x 2”
40
Kiosk Front Door Panel 15” x 16.5”
41
Kiosk Side Panel 19” x 24”
42
Appendix D
Sample Mail-Back Packages
Sample Standard Mail-Back Package
Description:
Plastic envelope with return label, instructional flyer, and unique identifier enabling
tracking from collection through disposal.
Package Size:
Outer Dimensions: 8.25” x 12”
Inner Dimensions: 7.375” x 10.375”
MED-Project may choose to change its Vendor for Mail-Back Services at any time,
subject to requirements in the Ordinance and Regulations.
43
Sample Inhaler Mail-Back Package
Description:
Inhaler Mail-Back Package including container with mail-back packaging, return label,
instructional flyer and unique identifier enabling tracking from collection through
disposal.
Package Size:
Outer dimensions: 5” x 5” x 9”
Inhaler Mail-Back Services are an example of complete, turnkey systems to provide for
the safe return of inhaler waste through Carrier.
MED-Project may choose to change its Vendor for Mail-Back Services at any time,
subject to the requirements of the Ordinance and Regulations.
44
Sample Injector Mail-Back Package
Description:
Injector Mail-Back Package includes an FDA-cleared sharps container with mail-back
packaging, return label, instructional flyer, and unique identifier enabling tracking from
collection through disposal.
Package Size:
1.4-quart mail-back system
MED-Project may choose to change its Vendor for Injector Mail-Back Services at any
time, subject to requirements in the Ordinance and Regulations
45
Appendix E
Penalty Records
Arcwood Environmental – East Liverpool, Inc. (Formerly Heritage Thermal
Services – Ohio)
46
47
48
Clean Harbors Aragonite, LLC
49
50
51
Clean Harbors Environmental Services, Inc.
1 reported case closed on 7/16/2024
Case# MA-2024-0054-US1624
52
Curtis Bay Energy, LP
53
54
Stericycle Inc. Warren Ohio Facility
55
Appendix F
Sample MED-Project Website Pages
56
57
58
59
60
61
62
63
64
65
66
67
68
69
70
Appendix G
Sample Bi-Fold Brochure
71