Law

Key Elements of Law

Chapter 1004, Statutes of 2018 [Jackson, SB 212] set forth the requirements of the Pharmaceutical and Sharps Waste Stewardship Program.

Purpose

The purpose of the Pharmaceutical and Sharps Waste Stewardship Program is to require safe and convenient disposal options for pharmaceutical and home-generated sharps waste through the establishment of stewardship programs.

Key Definitions (from PRC section 42030)

• (f)(1)(A) “Covered entity” means the manufacturer of covered products that are sold in or into the state.
  • (B) If no entity that meets the definition in subparagraph (A) is in the state, “covered entity” means the distributor of covered products that are sold in or into the state that is licensed as a wholesaler, as defined in Section 4043 of the Business and Professions Code, but does not include a warehouse of a retail pharmacy chain that is licensed as a wholesaler if it engages only in intracompany transfers between any division, affiliate, subsidiary, parent, or other entity under complete common ownership and control.
  • (C) If no entity that meets the definition in subparagraph (A) or (B) is in the state, “covered entity” means a repackager, as defined in Section 4044 of the Business and Professions Code, of covered products that are sold in or into the state.
  • (D) If no entity that meets the definition in subparagraph (A), (B), or (C) is in the state, “covered entity” means the owner or licensee of a trademark or brand under which covered products are sold in or into the state, regardless of whether the trademark is registered.
  • (E) If no entity that meets the definition in subparagraph (A), (B), (C), or (D) is in the state, “covered entity” means the importer of the covered products that are sold in or into the state.
• (g) “Covered product” means a covered drug or home-generated sharps waste.
• (q) “Program operator” means a covered entity, or stewardship organization on behalf of a group of covered entities, that is responsible for operating a stewardship program in accordance with this chapter.
• (w) “Stewardship organization” means an organization exempt from taxation under Section 501(c)(3) of the federal Internal Revenue Code of 1986 (21 U.S.C. 501(c)(3)) that is established by a group of covered entities in accordance with this chapter to develop, implement, and administer a stewardship program established pursuant to this chapter.
• (x) “Stewardship plan,” or “plan” means the plan for collecting and properly managing covered products that is developed by a covered entity or stewardship organization pursuant to this chapter.
• (y) “Stewardship program” means a stewardship program for the collection, transportation, and disposal of covered products.

See the statute and regulations (PRC section 42030 and California Code of Regulations (CCR) section 18972.1) for more definitions.

Key Roles

The covered entity establishes and implements either on its own, or as part of a stewardship organization, a stewardship program for pharmaceuticals or home-generated sharps, as applicable.

The program operator designs and manages its own stewardship program by preparing and implementing a stewardship plan and reports annually to CalRecycle on its progress.

CalRecycle approves plans, annual reports and budgets; checks progress; and provides oversight and enforcement to ensure a level playing field among program participants.

Stewardship Plans

A pharmaceutical and/or home-generated sharps waste stewardship plan, commonly referred to as a stewardship plan, outlines how a program operator intends to fulfill its responsibilities under the law and communicates a course of action to stakeholders and the public.

Plans submitted to CalRecycle will be posted at CalRecycle’s Pharmaceutical and Home-Generated Sharps Waste Stewardship Plans webpages:

Pharmaceutical Waste Stewardship Plan
Sharps Waste Stewardship Plan

Funding

Each covered entity, either individually or through a stewardship organization of which it is a member, must pay all administrative and operational costs associated with establishing and implementing the stewardship program in which it participates. This includes a quarterly administrative fee to cover any regulatory costs incurred by a state agency in administering and enforcing the law.

Program operators are required to submit an initial program budget with their stewardship plan and an annual budget which must be approved by CalRecycle as part of the plan and budget approval.

Budgets submitted to CalRecycle will be posted at CalRecycle’s Pharmaceutical and Home-Generated Sharps Waste Stewardship Budgets webpages:

Pharmaceutical Waste Stewardship Budget
Home-Generated Sharps Waste Stewardship Budget

Compliance and Enforcement

If a program operator or covered entity is found out of compliance, CalRecycle has the ability to enforce the law, including the option to impose administrative penalties. Additionally, the Board of Pharmacy has enforcement authority for the laws under its purview and must notify CalRecycle if any covered entity or stewardship organization is in violation of the law. See CalRecycle’s EPR Compliance webpage for contact information.

Reporting

Program operators are required to submit annual reports to CalRecycle. Among other required elements, annual reports must include:

• A list of covered entities participating in the stewardship organization and covered products that each covered entity subject to the stewardship plan sells or offers for sale;
• How the program operator complied with all elements in its stewardship plan. Annual reports are due to CalRecycle by March 31, 2022 and each year thereafter. CalRecycle reviews annual reports for compliance with statutory, regulatory, and plan requirements.

Regulations

On January 7, 2021, the Office of Administrative Law approved the Pharmaceutical and Sharps Waste Stewardship Regulations. The regulations were effective immediately.

A summary of the rulemaking history is available at the Rulemaking Archive.

Listserv

Click here to sign up for email updates related to CalRecycle’s oversight of the Pharmaceutical and Sharps Waste Stewardship Law. You can review previous messages by visiting the Pharmaceutical and Sharps Waste Stewardship Listserv Archive.

This page provides a brief overview, and is not intended to provide a comprehensive list of legal requirements. Please refer to statute and regulations for a complete list of requirements. Users are encouraged to seek the assistance of legal counsel to comply with applicable state law based on their pertinent facts and circumstances.

For more information contact: Pharmaceutical and Sharps Unit, PharmaSharps@calrecycle.ca.gov