Safe Drug Disposal Ordinance

Community Development Agency
The Marin County Board of Supervisors passed the Marin County Safe Drug Disposal Ordinance in August 2015. The new ordinance will require any producer of prescription and over-the-counter drugs offered for sale in Marin County to participate in an approved drug stewardship program for collection and disposal of unwanted medications.

The ordinance requires pharmaceutical manufacturers to manage and fund a comprehensive program to collect and dispose of County residents’ unwanted prescription and over-the-counter drugs. The ordinance will make it easier for residents to safely dispose of these medications by providing more collection sites geographically located throughout the county. The proper disposal of medications would help reduce risks to health and the environment.

The ordinance is based on the concept of “extended producer responsibility” (EPR) which makes the product manufacturers financially responsible for the full costs of their products (including disposal). Safe drug disposal ordinances based on the extended producer responsibility model have recently been adopted in Alameda County, the City and County of San Francisco, San Mateo County, and Santa Clara County.

A copy of the revised MED-Project Stewardship Plan can be found here:
MED-Project Stewardship Plan
The revised MED-Project Stewardship Plan was submitted on January 29th, 2017. The Marin County Director approved this plan on March 3, 2017. The MED-Project Stewardship Plan is scheduled to be implemented within 90 days of plan approval.

A copy of the Safe Drug Disposal Ordinance can be found here:
Marin County Safe Drug Disposal Ordinance (see Ordinance No. 3635).

A webinar for producers covered under the Ordinance was held on November 4, 2015 by the California counties of San Francisco, San Mateo, Santa Clara, and Marin. The webinar slide presentation can be found here: Safe Medicine Disposal Ordinance Webinar

Household Sharps and Pharmaceutical FREE Waste Drop-off Locations

Contact Information:  SafeDrugDisposal@marincounty.org (415) 473-6907

 

Background

Pharmaceutical medications by prescription or over-the-counter when taken as directed, allow us to maintain or improve our health. However, medications often are not completely consumed when they are purchased. As a result, most households have leftover, unwanted, or unused medications. Studies show that in the U.S. up to 33% of medications go unused annually.

Unused medications are causing harm to human and environmental health. Easy availability of unused medications leads to inadvertent misuse, and although these hazards can be reduced through removal of unwanted medications from homes, few options for safe and convenient disposal exist in most communities. As a result, the drugs are frequently left in homes, flushed down sinks or toilets or tossed in the garbage. Disposal by flushing or by tossing into the garbage have environmental consequences, particularly related to water quality.

The County in cooperation with the sanitary districts have provided safe drug disposal for county residents by establishing the County pharmaceutical take-back program in 2005. The 16 collection sites are voluntary with most along the Highway 101 corridor. Unfortunately, limited funding has hampered expansion of more collection sites and program promotions.

The Safe Drug Disposal Ordinance will address the above by establishing a greater number of collection sites to a minimum of 25, geographically and conveniently located throughout the county. Additionally, the public will be educated about proper drug disposal, the drug disposal program, and mail-back alternatives for people unable to travel.

Which medicines are included in County of Marin’s Safe Drug Disposal Ordinance?

Marin’s Ordinance includes medicines which meet the definition of a “covered drug”. A “covered drug” means a drug sold in any form and used by County residents, including prescription, nonprescription, brand name, and generic drugs.

“Covered Drug” does not include:
  • Vitamins or supplements
  • Herbal-based remedies and homeopathic drugs, products, or remedies
  • 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)
  • Drugs for which Producers already 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)
  • Drugs that are biological products as defined by 21 C.F.R. 600.3(h) as it exists on the effective date of the Ordinance if the Producer already provides a pharmaceutical product stewardship or take-back program
  • Medical devices or their component parts or accessories

Safe Drug Disposal Ordinance Participants

Program participants are defined as follows:

  • Drug Wholesaler: a person who buys Drugs for resale and distribution to corporations, individuals, or entities other than consumers.
  • Retail Pharmacy: a Pharmacy licensed by the State of California Board of Pharmacy for retail sale and dispensing of Drugs.
  • Repackager: a person who owns or operates an establishment that repacks and re-labels a product or package for further sale, or for distribution without a further transaction.
  • Producer: a Manufacturer engaged in the Manufacture of a Covered Drug sold in the County, including a brand-name or generic drug. “Producer” does not include: (1) a retailer whose store label appears on a Covered Drug or the drug’s packaging if the Manufacturer from whom the retailer obtains the Drug is identified in Section 7.90.040(E) of the Ordinance; (2) a Repackager if the Manufacturer from whom the Repackager obtains the Drug is identified under Section 7.90.040(E) of the Ordinance; (3) a pharmacist who compounds or repackages a prescribed individual drug product for a consumer; or (4) a wholesaler who is not also the Manufacturer.

Your business may have more than one role under the ordinance. For a full list of the terms, please refer to the Ordinance.

Ordinance Requirements for Wholesalers

Section 7.90.040(C) of the Ordinance requires that each drug wholesaler that sells any covered drug in the County shall provide a list of the producers of those covered drugs to the Director of Environmental Health. The list must be submitted in a form prescribed by the Director, and submitted to the County of Marin Division of Environment Health Services within 60 days of the Ordinance’s effective date (November 10, 2015).

If you meet the definition of a drug wholesaler and sell covered drugs in Marin County, use the Wholesaler Submittal Template to list the producers of covered drugs that you sell or distribute in or into the County. Please submit your list in Microsoft Excel, .xlsx or .xls format. Submit your list of producers by email to SafeDrugDisposal@marincounty.org.

This list was due by November 10, 2015. Wholesalers are required to update and resubmit their list of producers annually by January 15. Wholesalers have no other obligations under the ordinance.

To arrange for another type of electronic media transfer, contact us by email at SafeDrugDisposal@marincounty.org.

Wholesalers Not Covered under the Safe Drug Disposal Ordinance

If you are a drug wholesaler, but do not currently sell or distribute any covered drugs in or into the County, complete this online form. Once a wholesaler has submitted this form, no additional submittals will be required, unless covered drugs are subsequently sold or distributed in Marin County.

Ordinance Requirements for Retailers and Repackagers

Section 7.90.040(E) of the Ordinance requires retailers and Repackagers of covered drugs in the County of Marin to provide information about the manufacturers from which covered drugs are obtained. In order to comply with the Safe Drug Disposal Ordinance, retailers and Repackagers must submit their data and an online form by March 11, 2016.

The neighboring counties of San Francisco, San Mateo, and Santa Clara have each passed a similar local ordinance. Although each county has a separate and independent ordinance, all four ordinances have the same goal and the same requirements for retailers and Repackagers. We are working together to streamline compliance activities for your benefit. Companies are encouraged to make one common submittal to all applicable counties.

If you meet the definition of a retailer and/or Repackager, please visit the website for our partners in San Francisco and use the submittal template found at the links below:

Instructions and submittal template for retailers

Instructions and submittal template for Repackagers

Ordinance Requirements for Producers

A webinar for producers covered under the Ordinance was held by the California counties of San Francisco, San Mateo, Santa Clara, and Marin on November 4, 2015. Materials covered during the webinar included the definitions and requirements common among all four ordinances, and compliance dates and convenience standards on a county-by-county basis. The video recording of the webinar can be found here: Safe Medicine Disposal Ordinance Webinar

If you are a producer and you believe that your business is not covered under this ordinance, please fill out the online form located here: Form for Producers Not Covered Under the Ordinance(s)

Notice of Intent – Due March 11, 2016

Producer means a Manufacturer engaged in the manufacture of a covered drug sold in or into the County of Marin, including prescription, nonprescription, brand-name, and generic drugs. The Ordinance requires each drug Producer that sells any covered drug in the County to notify the Director of Environmental Health of the Producer's intent to participate in a Stewardship Plan or to form a new Stewardship Plan.

The neighboring counties of San Francisco, San Mateo, and Santa Clara have each passed a similar local ordinance. Although each county has a separate and independent ordinance, all four ordinances have the same goal and the same requirements for Producers. Producers can submit their Notice of Intent for Marin County using the form located here: Producer Notice of Intent Form

Notification of Plan Operator – Due June 11, 2016

Producers covered by the Ordinance are required to identify a Stewardship Plan Operator that will be submitting and operating the Stewardship Plan on their behalf. If your company intends to submit its own individual Stewardship Plan, your company is the Plan Operator. If your company chooses to join or form a Stewardship Organization, the Organization is the Plan Operator.

Producers can download and complete the Notification of Plan Operator Form located here: Notification of Plan Operator Form (PDF). Please designate your company’s intended Stewardship Plan Operator and provide their contact information. Scan the completed form with an authorized signature and email it to: SafeDrugDisposal@marincounty.org.

Proposed Stewardship Plans – Due September 12, 2016

Producers covered by the Ordinance are required to participate in a Stewardship Plan, either by operating a Plan (individually or jointly with other Producers) or by entering into an agreement with a Stewardship Organization that will operate a Plan on the Producer’s behalf. Please note that the California counties of San Francisco, San Mateo, Santa Clara, and Marin are NOT able to accept a single Plan submittal for all four counties. Proposed Stewardship Plans need to be submitted individually and separately to each County.

Proposed Stewardship Plans for Marin County should be submitted in both electronic and paper hard copy form. Please email the electronic form to SafeDrugDisposal@marincounty.org. Two (2) paper hard copies should be sent to the address below:

ATTN: Whitney King
County of Marin Environmental Health Services
3501 Civic Center Drive, Suite 236
San Rafael, CA 94903

Approved Fee Schedule

Ordinance Fee Schedule

On July 19, 2016, the Marin County Board of Supervisors approved an hourly Plan Review Fee and a per-Plan Annual Operating Fee to recover Environmental Health Services Division’s costs of administering and enforcing the Marin County Safe Drug Disposal Ordinance. A Plan Operator or a Stewardship Organization may remit the fees on behalf of the Producers participating in their Plan.

Approved Fee Schedule (PDF)effective September 19, 2016.

Ordinance Timeline for Implementation

Each producer shall participate in a Stewardship Plan. Each Producer must: (1) Operate, individually or jointly with other Producers, a Stewardship Plan approved by the Director; or (2) Enter into an agreement with a Stewardship Organization to operate, on the Producer’s behalf, a Stewardship Plan approved by the Director.

  • By November 10, 2015, each Drug Wholesaler that sells any Covered Drugs in the County must provide a list of the Producers of those Covered Drugs to the Director in a form prescribed by the Director. Wholesalers must update and resubmit the list by January 15 each year.
  • By March 11, 2016, if a Producer is not already participating in a Stewardship Plan - within six months after a Producer starts the sale of a Covered Drug in the County, a Producer must notify the Director in writing of the Producer’s intent to participate in an existing Stewardship Plan or to form a new Stewardship plan.
  • By March 11, 2016, Retailers and Repackagers notify the Director, of Producers.

A Producer, either individually or jointly with other Producers, shall:

  • By June 11, 2016, or within nine months after starting sale of a Covered Drug in the County, identify in writing to the Director, a Stewardship Plan Operator that is authorized to be the official point of contact for the Stewardship Plan.
  • By June 11, 2016, or within nine months after starting sale of a Covered Drug in the County, notify all Retail Pharmacies and law enforcement agencies in the County of the opportunity to participate as a drop-off site and provide a process for forming an agreement between the Stewardship Plan and interested Collectors; and annually thereafter, make the same notification to any nonparticipating or new Retail Pharmacies in the County.
  • By September 12, 2016, or within one year after starting sale of a Covered Drug in the County, submit a proposed Stewardship Plan to the Director for review.
  • Within three months after the Director's approval of the Stewardship Plan, operate or participate in the Stewardship Plan in accordance with this ordinance.
  • Pay all costs and fees associated with its Stewardship Plan, as described in Sections 7.90.120 and 7.90.130 of the Ordinance.

 

Proposed Ordinance Implementation Timeline