Covered Entities
Pharmaceutical and Sharps Waste Stewardship
California law requires a covered entity, or a stewardship organization established on behalf of a group of covered entities, to develop and submit a stewardship plan(s) to CalRecycle. See Public Resources Code (PRC) section 42030(f) for the definition of “covered entity.”
Covered Entity Requirements
Covered entities are subject to statutory and regulatory requirements, including, but not limited to:
- Submittal of product lists to the California State Board of Pharmacy (see PRC section 42031(a)(1)).
- Submittal of updated lists to the California State Board of Pharmacy on or before January 15 of each year (see PRC section 42031(a)(2)).
- Respond to the California State Board of Pharmacy’s letters of inquiry pursuant to PRC section 42031(d), if necessary.
- Please contact BOPstewardship@dca.ca.gov for questions.
- Submittal of a stewardship plan to the California State Board of Pharmacy prior to submitting to CalRecycle. Covered product(s) must be subject to an approved stewardship plan (see PRC section 42031.4(a)).
- Either individually or through membership in a stewardship organization exempt from taxation under section 501(c)(3) of the federal Internal Revenue Code of 1986 (21 U.S.C. Sec. 501(c)(3)), to establish and implement a stewardship program that complies with the requirements of the Law (PRC sections 42030-42036.4 and California Code of Regulations sections 18972.1-18975.2).
- This includes the following:
- Paying all administrative and operational costs associated with establishing and implementing the stewardship program in which it participates, including the cost of collecting, transporting, and disposing of covered products and the department’s administrative fee pursuant to PRC sections 42034 and 42034.2.
- Submittal of annual reports and annual program budgets to CalRecycle, either individually or through a stewardship organization, on or before March 31 each year.
- This includes the following:
- For more information, including key definitions, please see the Law.
Approved Stewardship Organizations
The list is not an endorsement or recommendation by CalRecycle. Per statute, a covered entity may submit a stewardship plan independently, or a group of covered entities may establish a stewardship organization and submit a stewardship plan to CalRecycle (see PRC section 42030(w)).
The stewardship organization listed below operates stewardship programs for covered drugs and home-generated sharps waste based on stewardship plans approved by CalRecycle.
MED-Project, Pharmaceutical Product Stewardship Work Group
https://ppswg.org/
1800 M Street, NW Suite 400 South
Washington, DC 20036
CONTACT:
Christina McGrath, Vice-President, Membership and Communications
cmcgrath@ppswg.org
1 (202) 868-4436
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.