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 home-generated pharmaceutical drug and sharps waste. CalRecycle is required to adopt regulations for the implementation of SB 212 by January 1, 2021.

SB 212 requires covered entities, individually or through a stewardship organization, to design, submit, fund, and implement stewardship plans to achieve the statute’s goals. Covered entities, through a tiered definition in the statute, can be manufacturers, distributors, re-packagers, or the owner or licensee of a covered product. The statute requires retail pharmacy chains to make a reasonable effort to participate as a collector of covered drugs, and, if there are not at least five collection locations in a county, that 15% of each retail pharmacy chain’s store locations must be a collection location. SB 212 also requires the creation of a mail-back program for home generated sharps waste.

CalRecycle will promulgate regulations in consultation with the California State Board of Pharmacy and other interested agencies and stakeholders.

Current Status and Documents

• A Request for Approval to Initiate Formal Rulemaking for Pharmaceutical and Sharps Stewardship Program will be presented at the CalRecycle Monthly Meeting on October 15, 2019 .

Stakeholder Input

• Comments (PDF) received in response to CalRecycle’s SB 212 January 30, 2019 and February 27, 2019 informal rulemaking workshops. 
• Comments (PDF) received in response to CalRecycle’s SB 212 May 17, 2019 and June 17, 2019 informal rulemaking workshops.  

Rulemaking Documents

• Request for Approval to Initiate Formal Rulemaking for Pharmaceutical and Sharps Stewardship Program
• Proposed Regulations (PDF)
• Pharmaceutical and Sharps Waste Stewardship Program, Informal Draft Regulatory Text, dated May 6, 2019
• CalRecycle’s SB 212 June 17, 2019 informal rulemaking workshop presentation document
• CalRecycle’s SB 212 May 17, 2019 informal rulemaking workshop presentation document 
  
• CalRecycle’s SB 212 February 27, 2019 informal rulemaking workshop discussion document.
  
• CalRecycle’s SB 212 January 30, 2019 informal rulemaking workshop discussion document. 

Additional Documents

This section lists additional documents relied upon by CalRecycle in developing the regulations.

• Senate Bill (SB) 212 (Jackson, Chapter 1004, Statutes of 2018).
  
• Title 21 Code of Federal Regulations, Part 1317.
  
• 16 California Code of Regulations Sections 1776-1776.6.

Rulemaking History

• June 17, 2019: CalRecycle held an informal rulemaking workshop to solicit stakeholder feedback on informal draft regulatory text.
• May 17, 2019: CalRecycle held an informal rulemaking workshop to solicit stakeholder feedback on informal draft regulatory text 
• February 27, 2019: CalRecycle held an informal rulemaking workshop to present draft regulatory concepts and solicit stakeholder feedback on Articles 4-7.
  
• January 30, 2019: CalRecycle held an informal rulemaking workshop to present draft regulatory concepts and solicit stakeholder feedback on Articles 1-3.

Contact

For more information, contact the pharmaceutical and sharps team at pharmasharps@calrecycle.ca.gov.