Sharps EPR Enforcement
CalRecycle provides enforcement oversight of the Sharps Waste Stewardship Law. Compliance is evaluated through various means, including, but not limited to, site inspections and records review.
The following is not an exhaustive list of requirements under the law. For a complete list, refer to the statutes and regulations.
During an inspection, CalRecycle may ask a site to provide information and records that demonstrate compliance with the following:
Retail Pharmacies/Retail Pharmacy Chains
Sale of Sharps
[PRC 42035(c), 14 CCR 18974.3]
Retail pharmacies and retail pharmacy chains that sell, offer for sale, or distribute sharps products in California must monitor CalRecycle’s Pharmaceutical and Sharps Program Lists webpage to determine which covered entities and stewardship organizations comply with the law.
If it is determined that a covered product from a covered entity is not listed, retail pharmacies and retail pharmacy chains must notify CalRecycle within 30 days following the discovery.
To support the reporting of covered entities and covered products not listed on CalRecycle’s website, reporting can be completed through CalRecycle’s Sharps Referral System.
This law does not prohibit the sale of covered products not listed in on CalRecycle’s Pharmaceutical and Sharps Program Lists.
Retail pharmacies and retail pharmacy chains need to be able to:
- Provide information regarding who at the business monitors CalRecycle’s website.
- Identify the website monitored to verify accuracy.
Retail pharmacies and retail pharmacy chains that sell sharps products, including but not limited to lancets and pen needles, can provide and/or initiate the distribution of a sharps waste container and mail-back materials at no cost to the customer. Contact the program operators (stewardship organizations) for more information on how to provide this service.
Program Operators / Stewardship Organizations must provide and/or initiate the distribution of a sharps waste container and mail-back materials at the point of sale of sharps products, at no cost to the customer.
CalRecycle may request information regarding the monitoring requirements and the sharps products sales and distribution. CalRecycle may ask:
- Provide information regarding who at the business monitors CalRecycle’s website.
- Identify the website monitored to verify accuracy.
- For examples of sharps products provided, sold, or dispensed to customers, including prescription and over-the-counter products.
- Information on whether sharps waste containers are provided and/or initiated for your customers.
- Who provides the sharps waste containers to the pharmacy.
- For an explanation of the process followed to provide and/or initiate providing sharps waste containers.
Records Maintenance
[PRC 42035.6(a) and (b), 14 CCR 18974(c)]
Retail pharmacies and retail pharmacy chains that sell sharps products must maintain records of those covered products for a minimum of 3 years.
Upon request, retail pharmacies and retail pharmacy chains shall provide both of the following:
- Reasonable and timely access to its facilities and operations, to determine compliance with this chapter.
- Relevant records to determine compliance with this chapter.
Product records include:
- Manufacturer of the product
- Date the retailer obtained the product
- Date retailer sold, offered for sale, or dispensed the product
Other Retailers
Sale of Sharps
[PRC 42035(c), 14 CCR 18974.3]
Retailers that sell, offer for sale, or distribute sharps products in California must monitor CalRecycle’s Pharmaceutical and Sharps Program Lists webpage to determine which covered entities and stewardship organizations comply with the law.
If it is determined that a covered product from a covered entity is not listed, retailers must notify CalRecycle within 30 days following the discovery.
To support the reporting of covered entities and covered products not listed on CalRecycle’s website, reporting can be completed through CalRecycle’s Sharps Referral System.
This law does not prohibit the sale of covered products not listed in on CalRecycle’s Pharmaceutical and Sharps Program Lists.
Retailers need to be able to:
- Provide information regarding who at the business monitors CalRecycle’s website.
- Identify the website monitored to verify accuracy.
Retailers of sharps products, including but not limited to lancets and pen needles, can provide and/or initiate distribution of a sharps waste container and mail-back materials at no cost to the customer. Contact the program operators for more information on how to provide this service.
Program Operators / Stewardship Organizations must provide and/or initiate distribution of a sharps waste container and mail-back materials at the point of sale of sharps products, at no cost to the customer.
CalRecycle may request information regarding the monitoring requirements and the sharps products sales and distribution. CalRecycle may ask:
- Provide information regarding who at the business monitors CalRecycle’s website.
- Identify the website monitored to verify accuracy.
- For examples of sharps products provided, sold, or dispensed to customers, including prescription and over-the-counter products.
- Information on whether sharps waste containers are provided and/or initiated for your customers.
- Who provides the sharps waste containers to the pharmacy.
- For an explanation of the process followed to provide and/or initiate providing sharps waste containers.
Manufacturers
Sharps Stewardship Plan Requirement
Manufacturers (which could be ‘covered entities’) of sharps that are sold or offered for sale in or into California must, individually or through a sharps stewardship organization, participate in a stewardship program subject to a Sharps Stewardship Plan that has been approved by CalRecycle. To ensure the obligations of covered entities are met:
- As a covered entity manufacturer, it is recommended that efforts are made to verify that your business and products are part of an approved stewardship plan.
CalRecycle may request information and documentation supporting compliance with the requirements.
Repackagers/Owners or Licensees/Importers
Sharps Stewardship Plan Requirement
Repackagers, Owners or Licensees, and Importers of sharps products sold or offered for sale in or into California may meet the law’s definition of ‘covered entities’. When determined to be a covered entity, the requirements to participate in a stewardship program subject to a Sharps Stewardship Plan approved by CalRecycle must be met.
- Participation in a stewardship program through a Sharps Stewardship Plan can be achieved individually or through a sharps stewardship organization.
- Coordinating with members of your supply chain is important to ensure that a covered entity’s obligations are met.
CalRecycle may request information and documentation supporting compliance with the requirements.
Wholesalers/Distributors
Monitor CalRecycle’s Website
[PRC 42035(c), 14 CCR 18974.3]
Wholesalers and/or distributors of sharps products that are sold or offered for sale in or into California are required to monitor CalRecycle’s Pharmaceutical and Sharps Program Lists webpage to determine which covered entities and stewardship organizations comply with the law.
If it is determined that a covered product from a covered entity is not listed, wholesalers and/or distributors must notify CalRecycle within 30 days following the discovery.
To support the reporting of covered entities and covered products not listed on CalRecycle’s website, reporting can be completed through CalRecycle’s Sharps Referral System.
This law does not prohibit the sale of covered products not listed in on CalRecycle’s Pharmaceutical and Sharps Program Lists.
Wholesalers and/or distributors need to be able to:
- Provide information regarding who at the business monitors CalRecycle’s website.
- Identify the website monitored to verify accuracy.
- Provide a complete list of covered products and covered entities being distributed in or into California.
Sharps Stewardship Plan Requirement
Wholesalers or Distributors of sharps products sold or offered for sale in or into California may meet the law’s definition of ‘covered entities’. When determined to be a covered entity, the requirements to participate in a stewardship program subject to a Sharps Stewardship Plan approved by CalRecycle must be met.
- Participation in a stewardship program through a sharps stewardship plan can be achieved individually or through a sharps stewardship organization.
- Coordinating with members of your supply chain is important to ensure that a covered entity’s obligations are met.
CalRecycle may request information and documentation supporting compliance with the requirements.