The Story of SB 212 - Bringing Producer Funded Pharmaceutical and Sharps to California
State and local governments in the United States followed the lead of Canada, France, Spain, and others to implement pharmaceutical EPR laws and local ordinances. In 2018, California passed national precedent for an EPR program for pharmaceuticals and sharps. For over ten years prior, CPSC helped pass several local ordinances and shared insight with other states to build momentum that lead to the passage of the statewide program. Each of the local ordinances are described below with chronological history and relevant supporting documents.
SB 212, sponsored by CPSC, was authored by Senator Hannah-Beth Jackson (Santa Barbara) and was signed by Governor Brown in September 2018. The legislation is in the regulatory process as the designated agency, CalRecycle, establishes the regulations to carry out the directives of SB 212. The bill's authors, Senator Hannah-Beth Jackson and Assembly member Phil Ting shared their victory with the press, as did CPSC.​
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To learn more about the problems caused by improper disposal of pharmaceuticals and other health products such as sharps, read CPSC’s “A Prescription for Change” publications below.
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Sacramento County - Spring 2014
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Marin County - Fall/Winter 2014
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San Mateo - Spring/Summer 2015
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Alameda County - Spring 2016
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Santa Clara - Spring 2016
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Butte & Tehama Counties - Fall 2016
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San Joaquin County - Summer 2018
First California County to Pass a Pharmaceutical EPR Program: Alameda County, California
On July 24, 2012, Alameda County adopted the Safe Drug Disposal Ordinance. This ordinance is based on the program in British Columbia, operated by many of the same pharmaceutical companies doing business in the U.S. This precedent setting ordinance was the first in the nation to hold pharmaceutical companies responsible for the safe collection and disposal of unused medications from the public, starting with a challenge by the pharmaceutical industry in December of 2012 and two appeals which resulted in the U.S. Supreme Court denying the request to hear the case on May 26, 2015.
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Alameda Safe Drug Disposal Ordinance Timeline:
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1/26/18: Alameda County adopted proposed revisions to the 7/24/2012 Safe Drug Disposal Ordinance. Key changes in the revisions include:
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Adds Over-the-Counter (OTC) medications to the covered items
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Allows for collection of Controlled Substances at both law enforcement AND DEA registrants (Pharmacies and Hospitals)
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Requires the stewardship organization to provide a kiosk to any DEA Registrant even if they have reached the 110 site goal originally stated
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Minor changes to definitions to clarify ordinance, and make enforcement easier
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5/26/15: U.S. Supreme Court denies petitioners’ Writ of Certiorari (request to hear case)
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4/15/15: Alameda responds to Supreme Court questions
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2/25/15: Director of the Department of Environmental Health approves the two stewardship plans that were submitted.
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2/23/15: Alameda County Safe Drug Disposal Program Public Hearing to review submitted product stewardship plans
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Exelsis Drug Disposal Plan – updated 2/2/2015
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Alameda MED-Project LLC Plan – updated 2/23/2015
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12/29/14: PhRMA and other plaintiff organizations file a Petition For Writ of Certiorari asking the U.S. Supreme Court to consider the case – Petition text
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9/30/14: Ninth Circuit Court of Appeals rules for Alameda County – Court ruling
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7/11/14: Ninth Circuit Court of Appeals hearing video (the hearing starts around the 1:01:50 mark)
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9/12/13: Notice of appeal is filed by PhRMA and other plaintiff organizations in the Federal Court of Appeals
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8/28/13: US District Judge Richard Seeborg finds the ordinance constitutional in the 9th circuit court
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12/7/12: Alameda County is sued by three organizations representing the pharmaceutical industry
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7/24/12: Safe Drug Disposal Ordinance is adopted by unanimous vote by the Alameda County Board of Supervisors
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Other Alameda resources:
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Alameda County Safe Drug Disposal Ordinance Website
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Alameda County Safe Drug Disposal Ordinance Amendment Update Package Slideshow – Bill Pollock, 1/11/16
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US Ninth Circuit Court of Appeals Hearing Video – PhRMA v. County of Alameda, 7/11/2014 - (Alameda hearing begins at 1:01:50)
Pharmaceutical EPR Programs in Local Counties in California
Information below is for each county in California that has an Extended Producer Responsibility (EPR) model ordinance for safe medicine and sharps disposal.
City & County of San Francisco, California
In 2010, San Francisco introduced a Safe Drug Disposal Ordinance. However, in 2012 the city chose to instead accept $110,000 from PhRMA and Genentech to fund a pilot project to collect data on the issue. In August 2013 the same two organizations provided another payment of $125,000 to fund the pilot project an additional year. A separate Safe Drug Disposal Information Ordinance was passed in May 2011 to supplement the PhRMA-funded pilot program by requiring pharmacies that won’t host a bin to advertise those that do.
The Safe Medicine Disposal Pilot program has been well-utilized, with over 37,000 pounds collected in the first 26 months.
Following the U.S. 9th Circuit Court of Appeals ruling upholding Alameda’s ordinance, San Francisco Board President David Chiu reintroduced the Ordinance on October 21, 2014. Board President Chiu was elected to the California State Assembly in November 2014 and Supervisor London Breed became the author of the ordinance and was elected President of the Board of Supervisors. The ordinance was heard in committee on February 26th with a 3 – 0 vote to move the ordinance to the full Board. The ordinance was heard before the full Board twice – once on March 10, 2015 where it received an 11 – 0 vote to adopt and again on March 17, 2015 where it received a second and final unanimous vote to adopt. San Francisco Mayor Edwin Lee signed the legislation on March 26, 2015 and the ordinance’s date of enactment is 30 days after signing.
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CPSC Fact Sheet on San Francisco City and County Pharmaceutical EPR Ordinance- revised 8/16/18
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Safe Drug Disposal Stewardship Ordinance – signed 3/26/2015
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Resources:
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SF Environment Safe Drug Disposal Stewardship Ordinance Information
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San Francisco Board of Supervisors Meeting 3/10/2015 – Meeting video, San Francisco Government TV, 3/10/2015 (Ordinance discussion begins 00:16:20)
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Government Audit and Oversight Committee Public Hearing – Hearing video, San Francisco Government TV, 2/26/2015
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Creating Safe Medicine Disposal Options – Op Ed by London Breed, San Francisco Examiner, 2/25/2015
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San Francisco May Be First Major U.S. City With a Drug Take-Back Program – Ed Silverman, Wall Street Journal, 3/25/2015
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Contra Costa County, California
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12/20/16 – Final Safe Drug Disposal ordinance adopted on consent. Ordinance is effective 30 days from passage. County staff will return to the Board with an update before July 2017 and work to address multiple additional items including the makeup of the Stewardship Organization that implements the program to be listed as a 501-c3 and adding specificity to the method of medication disposal.
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12/13/16 – Motion to waive the ordinance reading and fix 12/20/16 as the adoption date of the revised ordinance passes unanimously by 5-0 vote.​
San Mateo County, California
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CPSC Fact Sheet on San Mateo’s Pharmaceutical EPR Ordinance – revised 8/2/2018
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4/28/15 – Ordinance adopted on consent
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Resources:
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San Mateo County Health System Safe Medicine Disposal Ordinance Information
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County of San Mateo Board of Supervisors Meeting 4/14/15 – Meeting video, San Mateo County YouTube Channel, 4/14/15 (Ordinance discussion begins 1:39:31)
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Summary of Medication Disposal Consumer Survey Results – San Mateo County [PDF]
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Santa Barbara County, California
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CPSC Fact sheet on Santa Barbra’s Pharmaceutical EPR Ordinance– Revised 8-2-18
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6/7/16 – Board of Supervisors heard staff presentation and public comment on their proposed pharmaceutical EPR ordinance and passed by a 3-1 vote, with one Supervisor abstaining. The ordinance can become law after a final vote in two weeks.
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5/19/15 – Board of Supervisors Hearing held on unused pharmaceuticals; Board directed staff to begin stakeholder process. 10/6/15 – agenda item 15-00784 passed by a 5-0 vote and directs staff to draft an EPR ordinance for pharmaceuticals and return to the Board in early 2016.
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6/7/16 – Board of Supervisors hearing held on proposed pharmaceutical EPR ordinance; ordinance passed by a 3-1 vote with one Supervisor abstaining.
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6/21/16 – Proposed ordinance passes with 4-1 vote to adopt. Ordinance becomes effective 7/21/16
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Resources:
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County Board of Supervisors Meeting 6/7/16 – Item #7, Stewardship for Safe Drug Disposal
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County Board of Supervisors Meeting 6/21/16, Stewardship for Safe Drug Disposal
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County of Santa Barbara Press Release – Santa Barbara County Board of Supervisors Adopt Safe Drug Collection Program Ordinance, 6/21/16
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Santa Clara County, California
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CPSC Fact Sheet on Santa Clara’s Pharmaceutical and Sharps EPR Ordinance– Revised 8/27/18
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3/7/18- The County of Santa Clara Board of Supervisors has passed a law (Ordinance No., NS-517.92) requiring sharps manufacturers and pharmaceutical companies who produce and distribute medicines that require home injection to submit and implement a comprehensive plan for safe disposal of consumer-generated sharps waste.
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3/14/17 – Ordinance to amend the existing Safe Drug Disposal Ordinance in order to clarify and strengthen ordinance requirements prior to implementation of MED-Project’s proposed stewardship passed by a 3-0 vote with two Supervisors recusing themselves.
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5/19/15 – Ordinance introduced at Board of Supervisors Meeting and passed by a 3-0 vote with two Supervisors recusing themselves due to pharmaceutical investments. 6/23/15 – Ordinance second reading before Board and received a unanimous 3 – 0 vote to adopt, with two Supervisors recusing themselves due to pharmaceutical investments. 7/23/15 – ordinance went into effect.
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Resources:
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County of Santa Clara Safe Drug Disposal Ordinance Information
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County of Santa Clara Board of Supervisors Meeting 5/19/15 – Meeting video, County of Santa Clara Board of Supervisors, 5/19/15 (Ordinance discussion begins at 3:47:20)
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Marin County, California
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7/28/15 – Ordinance first reading at Board of Supervisors Hearing and received a 4-0 vote to approve, with one Supervisor recusing themselves due to pharmaceutical investments. 8/11/15 – Ordinance read the second time and received a 4-0 vote to adopt, with one Supervisor recusing themselves due to pharmaceutical investments. 9/11/15 – ordinance went into effect.
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County of Marin Safe Drug Disposal Ordinance – Adopted, 8/11/15
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Press and Resources
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County of Marin Safe Drug Disposal Ordinance Information
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Marin Joins List of County Drug Takeback Ordinances As Local EPR Goes Nationwide – California Life Sciences Association, 8/10/15
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Marin: Drug Firms Must Pay for Disposal of Their Medications, Nels Johnson, Marin Independent Journal, 8/12/15
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Los Angeles County, California
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8/11/15 – agenda item #4 passed by a 4-0 vote with one Supervisor abstaining; directed staff to initiate the stakeholder process for development of a pharmaceutical and medical sharps EPR ordinance. 11/13-15 – public stakeholder meeting held at the Kenneth Hahn Hall of Administration.
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5/17/16 – After three previous postponed votes, the LA County Board of Supervisors postponed voting on their proposed pharmaceutical and sharps EPR ordinance. The item will be rescheduled for the next Board public meeting held June 14, 2016. The Board heard public comment and asked a few questions.
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Coverage of 5/17/16 vote to postpone:
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Video of EPR ordinance public comment and Board discussion
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Vote on LA County drug take-back proposal delayed again – Stephanie O’Neill, Southern California Public Radio, 5/16/16
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LA Times Column Covers LA County Proposed EPR Ordinance – California Inc., David Lazarus, 5/16/2016
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Dangerous prescription drug battle plan for LA County: Let’s put it off, Hoa Quach, MyNewsLA.com, 5/17/16
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6/14/16 – The Board of Supervisors voted 3-0 with two supervisor’s abstaining in favor of a motion that will have industry contribute funding towards quarterly take back events, study the results of Walgreen’s voluntary medication collection program in LA County, and create an education campaign on existing take back locations and disposal in the trash. The EPR ordinance may be reconsidered in November 2016.
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Video of 6/14/16 Board of Supervisors meeting staff report, public comment, and Board discussion
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LA County Supervisors set — again — to vote on drug take-back ordinance, Stephanie O’Neill, Southern California Public Radio, 6/13/16
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L.A. County supervisors roll back plans for a drug take-back program, Abby Sewell, Los Angeles Times, 6/14/16
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Pharma loses one batter over drug take-back programs, but wins another, Ed Silverman, STAT News, 6/16/16
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8/26/16 – County of Los Angeles disapproves the revised plan submitted on 8/12/16 in a letter to industry and identifies areas where the plan needs improvement
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Resources:
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Letter of Support from CPSC and 11 other signatories and List of Key Elements of a Properly Constructed Ordinance, 11/9/15
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County of Los Angeles Department of Public Health Pharmaceutical Take-Back website
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Santa Cruz County, California
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CPSC Fact Sheet on Santa Cruz’ Pharmaceutical and Sharps EPR Ordinance – revised 8/7/18
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9/1/15 – agenda item #27 passed and directed staff to initiate the stakeholder process for development of a pharmaceutical and medical sharps EPR ordinance. 10/8/15 – a public stakeholder meeting was held at the Santa Cruz County Board of Supervisors Chambers. 11/10/15 – Ordinance read for the first time at the Santa Cruz County Board of Supervisors Hearing and received a 5-0 vote to approve the first reading and then approved again at the second reading 12/8/15 with a 5-0 vote. 1/8/16 – Ordinance goes into effect.
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8/9/16 – City of Santa Cruz proposed Safe Drug and Sharps Disposal Ordinance passes by a 7-0 vote. Ordinance goes into effect 9/9/2016
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City of Santa Cruz and National Stewardship Action Council press release, Updated 10/21/16
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8/25/16 – City of Capitola proposed Safe Drug and Sharps Disposal Ordinance passes by a 5-0 vote. Ordinance goes into effect the 31st day after passage.
Sonoma County, California
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8/10/18- Safe Medicine Disposal Ordinance posted for public comment before County Supervisors vote on 9/11/18
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9/22/17 – Sonoma County Board of Supervisors announce Safe Medicine Disposal Ordinance in press release
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10/4/16 – Sonoma County Board of Supervisors held a Safe Medicine Disposal – EPR Study Session (Agenda Item #21) at their public Board Meeting and directed staff to continue working cooperatively with the existing Safe Medicine Ordinance Collaborative, cities, and other stakeholders and return to the Board with a pharmaceutical EPR ordinance proposal that includes a deeper analysis and recommendations regarding the ordinance options and a program implementation plan.
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Sonoma County Press Release – Sonoma County to Develop Safe Medicine Disposal Ordinance, 10/4/16
San Luis Obispo County, California
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3/11/15 – Ordinance passed by the the San Luis Obispo County Integrated Waste Authority (IWMA) Board of Directors by an 11-0 vote with two Directors absent. Ordinance is “Transitional to EPR” policy since a different group in the product chain – in this case retailers – is having to pay for the program but not producers. 4/11/15 – Ordinance takes effect. Effective 9/11/15, retail pharmacies in the IWMA region are required to provide a mail back program and/or collection receptacle program to dispose of unwanted prescription drugs as required under the Ordinance
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1/10/2018 – Full EPR Ordinance passed by the IWMA shifts the cost burden of the program to the producers.
Tehama County, California
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7/3/18 – Ordinance passed by the Tehama County Board of Supervisors by a 4-1 vote. The ordinance covers both medications and sharps and is the first to require the stewardship organization to be an IRS c3 to promote public benefit and be transparent as a non profit. This is the first rural county to pass an ordinance with both medications and sharps collection paid for by producers.
Pharmaceutical EPR Programs Around the Country​​​​​​​​​​​​​​
New York State
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7/11/18 – Drug Take Back Act Take Back Act passes. Key points from the act include that ALL pharmacies must participate and the collection of sharps are not included.
Washington State
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1/10/18- Washington Association of Sheriffs and Police Chiefs release letter of support for secure drug take-back legislation
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2/9/18- Washington state passes, with an 86-12 bipartisan vote, new secure medicine return legislation.
King County
On June 20, 2013 the King County Board of Health in Washington passed the Secure Medication Return Rule & Regulation to create a drug take-back program for King County residents. The program promotes the safe disposal of unused prescription and over-the-counter drugs, and will be funded and operated by the drug manufacturers. On November 27, 2013 four groups of major drug manufacturers sued the County. The suit was dismissed following the U.S. Supreme Court’s 5/26/2015 decision not to hear industry’s legal challenge to the Alameda County Safe Drug Disposal Ordinance.
Status – On October 16, 2015, King County approved the Return Meds LLC stewardship plan and rejected the King County MED-Project LLC stewardship plan. The MED-Project submitted a revised proposed stewardship plan for review in accordance with the December 14, 2015 deadline. The compliance deadline for the approved stewardship plan to be fully implemented is no later than April 13, 2016.
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National Press Release – King County and Alameda County Secure Medication Return 6/26/13
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Washington County
Additional Washington Counties with EPR medicine disposal ordinances: Kitsap (2016), Pierce (2016), Snohmish (2016), Whatcom (2017), Clallam (2017)​
This video describes the drug manufacturers’ MED-Project program that is working in Snohomish and King counties under their Secure Medicine Return ordinances. The WA Secure Drug Take-Back Act (SHB 1047) is modeled on these successful local laws.
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Pharmaceutical EPR Programs Around the World​​​​​​​​​​​​​​​
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Europe
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Belgium – Bonusage
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First implemented in the Brussels region in 2002, Bonusage is organized through a partnership of pharmaceutical wholesalers, manufacturers, and pharmacies. The program is funded by wholesalers, who pay for collection, storage and transportation, and manufacturers, who pay for incineration of the collected materials based on market share. Medicines managed through the program increased 33% from 2000 to 2011.
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France – Cyclamed
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The Cyclamed program started in 1993 as a voluntary program before becoming mandated by law in 2007. Funding is fully provided by the pharmaceutical industry and all pharmacies are mandated to take back medicines.
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CPSC International Pharmaceutical EPR Fact sheet France Cyclamed
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In 2012 Dastri, a non-profit organization, was approved to collect and dispose of hazardous sharps waste. This program is funded entirely by drug manufacturers.
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Hungary – Recyclomed
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The Recyclomed program began collecting medicines in 2005 after legislation mandated a national program. Funding is provided by drug manufacturers and all pharmacies are mandated to host take-back. In 2011 there were over 4,000 locations nationally.
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Portugal – Sistema Integrado de Gestão de Resíduous de Embalagens de Medicamentos (SIGREM)
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Administered by the nonprofit VALORMED, SIGREM was implemented in 2001 with funding provided by pharmaceutical manufacturers and distributors as well as the national pharmacy association. Although participation is voluntary, over 99% of pharmacies acted as take-back locations in 2011.
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Spain – SIGRE Medicines and the Environment
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Administered by the nonprofit SIGRE, this program has been in operation since 2003 with manufacturers funding and operating the take-back program. Collection is located exclusively at pharmacies, with over 21,000 participating take-back locations in 2014. Results indicate that over 70% of households utilize the system.
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Sweden – Sveriges Farmaceuter
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Sweden passed legislation in 2009 mandating a producer responsibility take-back program for medications. The Swedish Pharmacy Association is the managing non-profit, consisting of nine member companies that operate the program. 85% of Swedes are aware they can take-back medications to a pharmacy.
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North America
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Canada – Medications Return Programs
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This producer funded and operated program started voluntarily in British Columbia (B.C.) over 15 years ago and since has become mandated. The program has expanded beyond B.C. and now operates in most provinces.
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Nova Scotia Medication Disposal Program and Safe Sharps Bring-Back Program Fact Sheet
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CPSC International Fact Sheet Pharmaceutical EPR – Ontario
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2014 Annual Report on the Ontario Medications and Sharps Collection Program, Health Products Stewardship Association, 2015
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2013 Annual Report on the Ontario Medications and Sharps Collection Program, Health Products Stewardship Association, 2014
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Prince Edward Island Medication Return Program and Sharps Collection Program Fact Sheet
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Saskatchewan Pharmaceutical Waste Disposal Program Fact Sheet – “transitional” EPR program
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Mexico – Sistema Nacional De Gestión De Residuous De Envases Y Medicamentos (SINGREM)
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Administered by Mexico’s National Chamber of the Pharmaceutical Industry (CANIFARMA), the SINGREM program began collecting medicines in 2010 in several Mexican states with funding supplied by CANIFARMA. In 2014 the program underwent a major national expansion to implement the program in all cities with 100,000 or more inhabitants. As of 2014, there were 4,000 collection locations in 22 states.
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South America
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Brazil – Descarte Consciente
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Administered by Brazil Health Service, Descarte Consciente was implemented in 2010 with funding provided by the pharmaceutical industry. Collection is located at pharmacies but is not mandatory. In 2013 the program collected 22 tons.
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CPSC Program Fact Sheet
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Colombia – Punto Azul
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Administered by Colombia’s National Association of Entrepreneurs (ANDI), the Punto Azul program began collecting medicines in 2010 with funding supplied by pharmaceutical manufacturers and importers. Collection is located at pharmacies and large supermarkets but is not mandatory. In 2014 there were over 685 locations nationally covering 43% of the population.
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Other Resources
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Unused Pharmaceuticals – Where Do They End Up? A Snapshot of European Collection Schemes – Health Care Without Harm
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Sharps EPR in the United States
Alameda County
The County of Alameda passed an EPR ordinance for sharps on 11/15/15. The ordinance requires producers that sell sharps in Alameda County to participate in a product stewardship plan for the collection and disposal of sharps. The ordinance went into effect on 12/18/15.
By June 18, 2016 sharps producers must notify the County of their intent to participate in a product stewardship plan. Proposed product stewardship plans must be submitted to the County by December 18, 2016. More information is available on Alameda County Environmental Health’s Safe Drug and Consumer-Generated Sharps Disposal webpage.
Santa Cruz County
The County of Santa Cruz passed an EPR ordinance for pharmaceuticals and sharps on 12/8/15. The ordinance requires producers that sell sharps in Santa Cruz County to participate in a product stewardship plan for the collection and disposal of sharps. The ordinance went into effect on 1/8/16.
By March 1, 2016 sharps producers must submit proposed product stewardship plans to the County for review and approval.
San Luis Obispo County
In 2008 the County of San Luis Obispo adopted a “transitional EPR” sharps management ordinance, setting up a program for the public to conveniently and safely take back used sharps to a retailer, free of charge. The ordinance places the responsibility for providing sharps take back on the retailers with no funding from industry or other members of the product chain. In January, 2018, San Luis Opispo passed a full EPR ordinance, requiring manufactures to pay and manage the pharmaceutical and sharps waste in the county.
Santa Clara County
In 2018, the County of Santa Clara Board of Supervisors has passed an ordinance (No. NS-517.92) requiring sharps manufacturers and pharmaceutical companies who produce and distribute medicines that require home injection to submit and implement a comprehensive plan for safe disposal of consumer-generated sharps waste. This ordinance builds upon the County’s success of the existing Safe Drug Disposal Ordinance, first passed in 2015 and revised in 2017, which provides safe, free and convenient drop-off of unwanted or expired medications. See the County Press Release for more information.
Transitional EPR Local Programs for Sharps
A “Transitional” EPR legislation/policy requires that other members of the product chain but not the producers themselves take responsibility for end-of-life management of the product. In California transitional EPR policy has typically impacted retailers but in other countries different members of the product chain have been included.
City of Sacramento
In 2010, Sacramento adopted a sharps take-back ordinance that required all retail stores, hospitals, and other points of sale or distributors of sharps for home use in the City to take back sharps at no additional cost to the customer at the time of return.
Tulare County
In 2014 the Tulare County JPA and eight other cities in the county adopted sharps take-back Ordinance, modeled after the 2008 San Luis Obispo ordinance, which provide no-cost sharps take-back to Tulare residents. The ordinances require pharmacies and pet stores, among other retailers of sharps in Tulare County, to establish a system for collection of home-generated sharps waste in their retail outlet.
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Tulare County Cities Mandate ‘Sharps’ Drop-off Boxes – Lewis Griswold, Fresno Bee, 7/5/14
Santa Cruz County
In August 2014 the Santa Cruz County Board of Supervisors adopted a sharps take-back ordinance, which requires every retailer and provider of sharps in the unicorporated area of the county to provide at no-cost a sharps take-back program to residents. The ordinance requires pharmacies and pet stores, medical or veterinary offices, clinics, hospitals and approved needle exchange programs located in the unincorporated area of the county to establish a system for collection of home-generated sharps waste on site during normal hours of operation. The ordinance provides several options for compliance. The ordinance takes effect September 5, 2014 with businesses required to establish collection programs by October, 1, 2014.
City of Galt
On October 20, 2015 the Galt City Council adopted a sharps take-back Ordinance which requires retailers selling needles within the City to provide safe disposal for their customers. The ordinance takes effect November, 20, 2015 with businesses required to establish collection programs by January 20, 2015.
Del Norte County
CPSC partnered with the Del Norte Solid Waste Management Authority (DNSWMA) on a grant to foster more product take-back programs. CPSC and DNSWMA developed outreach materials to educate the citizens of the County on proper sharps disposal and to help them to protect their neighbors and community from needlestick injuries.