Description

Senate Bill (SB) 212 (Jackson, Chapter 1004, Statutes of 2018) was enacted on September 30, 2018 to establish safe and convenient collection and disposal options for covered drugs and home-generated sharps waste (covered products). CalRecycle is required to adopt regulations for the implementation of SB 212 with an effective date of no later than January 1, 2021.

SB 212 requires covered entities, individually or through a stewardship organization, to design, fund, and implement stewardship programs for the proper collection and disposal of covered products. Covered entities, as defined in statute, can be manufacturers, distributors, re-packagers, the owner or licensee of a covered product, or importer of a covered product in or into California.

For covered drugs, a stewardship program must establish secure collection receptacles throughout the state and fulfill specific convenience standards. For home-generated sharps waste, a stewardship program must distribute sharps waste containers and mail-back materials, at no cost to the ultimate user. Additionally, local agencies may request management or reimbursement for home-generated sharps waste collected at local household hazardous waste facilities. 

Finally, the statute requires a certain level of program participation from retail pharmacies and retail pharmacy chains, and imposes certain record-keeping requirements on all retailers of covered products. 

Affected Regulatory Code Sections

California Code of Regulations, Title 14, Division 7, Chapter 11, Article 4, commencing with Section 18972.1.

Formal Rulemaking Documents

The following documents were part of the final rulemaking package submitted to the Office of Administrative Law.  The Office of Administrative Law approved the Pharmaceutical and Sharps Waste Stewardship Regulations(available online) on January 7, 2021 and the regulations were effective immediately.

Rulemaking File Index

  1. Memos to OAL
  2. Sworn Certification of Rulemaking Record
  3. Delegation of Authority for Adoption of Regulation
  4. STD Form 400 and Notice of Proposed Rulemaking
  5. Informal Rulemaking Workshops
  6. Public Meeting for Approval to Formally Notice Proposed Regulation
  7. Text of Regulation as Originally Proposed
  8. Initial Statement of Reasons (ISOR)
  9. 45-Day Public Comment Period (1/3/2020 – 2/19/2020)
  10. Public Hearing to Accept Comments on the Proposed Regulation
  11. Second Draft of Proposed Regulation
  12. Initial 15-Day Public Comment Period for Proposed Revised Regulation (7/15/2020 – 8/3/2020)
  13. Third Draft of Proposed Regulation
  14. Second 15-Day Public Comment Period for Proposed Revised Regulation (8/21/2020 – 9/4/2020)
  15. CalRecycle Adoption of Proposed Regulation
  16. Economic and Fiscal Impact Statement (Form 399)
  17. Final Statement of Reasons (FSOR)
  18. Technical Studies, Reports, or Documents Relied Upon
  19. California Environmental Quality Act (CEQA)
  20. Final Text