Pharmaceutical EPR Enforcement
CalRecycle provides enforcement oversight of the Pharmaceutical 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 Pharmaceuticals
[PRC 42035(c), 14 CCR 18974.3]
Retail pharmacies and pharmacy chains that sell, offer for sale, or distribute pharmaceutical 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 Pharmaceuticals Referral System.
This law does not prohibit the sale of covered products not listed on CalRecycle’s Pharmaceutical and Sharps Program Lists.
CalRecycle may request information regarding the monitoring requirements, including but not limited to:
- Who at the business monitors CalRecycle’s website.
- Identify the website monitored to verify accuracy.
Records Maintenance
[PRC 42035.6(a) and (b), 14 CCR 18974(c)]
Retail pharmacies and retail pharmacy chains that sell pharmaceutical products must maintain records of the over-the-counter and prescription pharmaceutical products sold or offered for sale 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 Pharmaceuticals
[PRC 42035(c), 14 CCR 18974.3]
Retailers that sell, offer for sale, or distribute pharmaceutical 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 Pharmaceuticals Referral System.
This law does not prohibit the sale of covered products not listed on CalRecycle’s Pharmaceutical and Sharps Program Lists.
CalRecycle may ask retailers to:
- Provide information regarding who at the business monitors CalRecycle’s website.
- Identify the website monitored to verify accuracy.
Authorized Collectors
Collection Records Maintenance
[PRC 42032.2(a)(1)(G)(iii)(I))]
Authorized collectors must maintain and provide access to receipts or collection manifests that support the verification of the servicing of the collection receptacle.
CalRecycle may request information and documentation supporting compliance with this requirement.
Manufacturers
Pharmaceutical Stewardship Plan Requirement
Manufacturers (which could be covered entities) of pharmaceutical products that are sold or offered for sale in or into California must, individually or through a pharmaceutical stewardship organization, participate in a stewardship program subject to a Pharmaceutical Stewardship Plan that CalRecycle has approved.
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
Pharmaceutical Stewardship Plan Requirement
Repackagers, Owners or Licensees, and Importers of pharmaceutical products that are 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 Pharmaceutical Stewardship Plan approved by CalRecycle must be met.
- Participation in a stewardship program through a Pharmaceutical Stewardship Plan can be achieved individually or through a pharmaceutical 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 pharmaceutical products sold or offered for sale in or into 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, 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 Pharmaceuticals Referral System.
This law does not prohibit the sale of covered products not listed in on CalRecycle’s Pharmaceutical and Sharps Program Lists.
CalRecycle may request 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.
Pharmaceutical Stewardship Plan Requirement
Wholesalers or Distributors of pharmaceutical products that are sold or offered for sale in or into California may meet the law’s definition of ‘covered entities’. When this is determined, the requirements to participate in a stewardship program subject to a Pharmaceutical Stewardship Plan that has been approved by CalRecycle must be met.
- Participation in a stewardship program through a Pharmaceutical Stewardship Plan can be achieved individually or through a pharmaceutical 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.