Approved Regulations

Approved regulations are posted online for two years.

Ownership, Management & Control of Business Entities	Effective April 1, 2022
Title 16, California Code of Regulations Section 1709 Chronology and Status Board Approved Proposed Text for Rulemaking: October 26, 2016 45-Day Comment Period: July 23, 2021 to September 7, 2021 Regulatory Action No. 2021-1130-03S Filed with the Secretary of State on January 11, 2022 Effective Date of Regulation: April 1, 2022	Notice of Proposed Action Initial Statement of Reasons Proposed Text Final Statement of Reasons Order of Adoption (Approved Regulation Text)

Automatic Refill Programs	Effective July 1, 2022
Title 16, California Code of Regulations Sections 1717.5 Chronology and Status Board Approved Proposed Text for Rulemaking: May 3, 2017 15-Day Comment Period: September 25, 2020 to October 10, 2020 Second 15-Day Comment Period: May 28, 2021 to June 12, 2021 Regulatory Action No. 2021-0330-01S Filed with the Secretary of State on June 22, 2021 Effective Date of Regulation: July 1, 2022	Notice of Proposed Action Initial Statement of Reasons Proposed Text Notice of Modified Text Modified Text Notice of Second Modified Text Second Modified Text Final Statement of Reasons Order of Adoption (Approved Regulation Text)

HIV Preexposure and Postexposure Prophylaxis Furnishing	Effective June 8, 2021
Title 16, California Code of Regulations Sections 1747 Chronology and Status Board Approved Proposed Text for Rulemaking: January 29, 2020 45-Day Comment Period: January 29, 2021 to March 15, 2021 Regulatory Action No. 2021-0427-01C Filed with the Secretary of State on June 8, 2021 Effective Date of Regulation: June 8, 2021	Notice of Proposed Action Initial Statement of Reasons Proposed Text Final Statement of Reasons Order of Adoption (Approved Regulation Text)

Automated Drug Delivery Systems	Effective July 1, 2021
Title 16, California Code of Regulations Sections 1711, 1713, and 1715.1 Chronology and Status Board Approved Proposed Text for Rulemaking: January 30, 2019 45-Day Comment Period: July 3, 2020 to August 17, 2020 15-Day Comment Period: September 25, 2020 to October 10, 2020 Approved by the Office of Administrative Law on May 20, 2021 Regulatory Action No. 2021-0407-01S Filed with the Secretary of State on May 20, 2021 Effective Date of Regulation: July 1, 2021	Notice of Proposed Action Initial Statement of Reasons Proposed Text Self-Assessment Form (17M-112) Notice of Modified Text Modified Text Modified Self-Assessment Form (17M-112) Final Statement of Reasons Order of Adoption (Approved Regulation Text) Final Self-Assessment Form (17M-112) (pending)

Off-site Storage	Effective July 1, 2021
Title 16, California Code of Regulations Section 1707 Chronology and Status Board Approved Proposed Text for Rulemaking: January 27, 2017 45-Day Comment Period: February 7, 2020 to March 23, 2020 15-Day Comment Period: May 19, 2020 to June 3, 2020 Approved by the Office of Administrative Law on May 20, 2021 Regulatory Action No. 2020-1210-02S Filed with the Secretary of State on May 20, 2021 Effective Date of Regulation: July 1, 2021	Notice of Proposed Action Initial Statement of Reasons Proposed Text Notice of Modified Text Modified Text Final Statement of Reasons Order of Adoption (Approved Regulation Text)

Dangerous Drug Distributors	Effective April 1, 2021
Title 16, California Code of Regulations Sections 1780, 1781, 1782, and 1783 Chronology and Status Board Approved Proposed Text for Rulemaking: October 26, 2016 45-Day Comment Period: May 29, 2020 to July 13, 2020 Board Approved Final Text: July 27, 2020 Approved by the Office of Administrative Law on February 22, 2021 Regulatory Action No. 2021-0112-02S Filed with the Secretary of State on February 22, 2021 Effective Date of Regulation: April 1, 2021	Notice of Proposed Action Initial Statement of Reasons Proposed Text Final Statement of Reasons Order of Adoption (Approved Regulation Text)

Renewal Requirements	Effective July 1, 2021
Title 16, California Code of Regulations Section 1702, 1702.1, 1702.2, 1702.5 Chronology and Status Board Approved Proposed Text for Rulemaking: May 2, 2018 45-Day Comment Period: February 7, 2020 to March 23, 2020 Board Approved Final Text: May 7, 2020 Approved by the Office of Administrative Law on March 1, 2021 Regulatory Action No. 2020-0921-03S Filed with the Secretary of State on March 1, 2021 Effective Date of Regulation: July 1, 2021	Notice of Proposed Action Initial Statement of Reasons Proposed Text Final Statement of Reasons Order of Adoption (Approved Regulation Text)

Emergency Regulation – HIV Preexposure and Postexposure Prophylaxis Furnishing	Effective April 30, 2020
Title 16, California Code of Regulations Section 1747 Chronology and Status Board Approved Proposed Text for Rulemaking: January 29, 2020 5-Working Day Notice Period: April 10, 2020 – April 17, 2020 5- Day Public Comment Period: April 20, 2020 – April 24, 2020 Emergency Regulation effective April 30, 2020 5-Working Day Notice Period of Readoption: February 5, 2021 – February 12, 2021 5-Day Public Comment Period: February 16, 2021 – February 20, 2021	Notice of Intent to File Emergency Regulation Finding of Emergency Approved Emergency Text Notice of Approval Notice of Intent to Readopt Emergency Regulation Readopt Finding of Emergency Notice of Readoption Approval

Substantial Relationship and Rehabilitation Criteria	Effective December 28, 2020
Title 16, California Code of Regulations Sections 1769 and 1770 Chronology and Status Board Approved Proposed Text for Rulemaking: May 6, 2019 45-Day Comment Period: March 13, 2020 to April 27, 2020 Approved by the Office of Administrative Law on December 28, 2020 Regulatory Action No. 2020-0717-01S Filed with the Secretary of State on December 28, 2020 Effective Date of Regulation: December 28, 2020	Notice of Proposed Action Initial Statement of Reasons Proposed Text Final Statement of Reasons Order of Adoption (Approved Regulation Text)

Community Pharmacy Staffing	Effective September 15, 2020
Title 16, California Code of Regulations Section 1714.3 Chronology and Status Board Approved Proposed Text for Rulemaking: July 25, 2019 45-Day Comment Period: February 28, 2020 to April 30, 2020 Approved by the Office of Administrative Law on September 15, 2020 Regulatory Action No. 2020-0605-03S Filed with the Secretary of State on September 15, 2020 Effective Date of Regulation: September 15, 2020	Notice of Proposed Action Initial Statement of Reasons Proposed Text Extension of Comment Period Final Statement of Reasons Order of Adoption (Approved Regulation Text)

Duty to Consult	Effective October 1, 2020
Title 16, California Code of Regulations Section 1707.2 Chronology and Status Board Approved Proposed Text for Rulemaking: May 2, 2018 45-Day Comment Period: August 16, 2019 to September 30, 2019 Board Approved Final Text: November 6, 2019 Approved by the Office of Administrative Law on June 19, 2020 Regulatory Action No. 2020-0306-01S Filed with the Secretary of State on June 19, 2020 Effective Date of Regulation: October 1, 2020	Notice of Proposed Action Initial Statement of Reasons Proposed Text Final Statement of Reasons Order of Adoption (Approved Regulation Text)

Abandonment of Applications	Effective October 1, 2020
Title 16, California Code of Regulations Section 1706.2 Chronology and Status Board Approved Proposed Text for Rulemaking: February 6, 2018 45-Day Comment Period: August 30, 2019 to October 14, 2019 Board Approved Final Text: November 6, 2019 Approved by the Office of Administrative Law on June 15, 2020 Regulatory Action No. 2020-0303-03S Filed with the Secretary of State on June 15, 2020 Effective Date of Regulation: October 1, 2020	Notice of Proposed Action Initial Statement of Reasons Proposed Text Final Statement of Reasons Order of Adoption (Approved Regulation Text)

Emergency Regulation – HIV Preexposure and Postexposure Prophylaxis Furnishing	Effective April 30, 2020
Title 16, California Code of Regulations Section 1747 Chronology and Status Board Approved Proposed Text for Rulemaking: January 29, 2020 5-Working Day Notice Period: April 10, 2020 – April 17, 2020 5- Day Public Comment Period: April 20, 2020 – April 24, 2020 Emergency Regulation effective April 30, 2020	Notice of Intent to File Emergency Regulation Finding of Emergency Approved Emergency Text Notice of Approval

Naloxone Fact Sheet	Effective April 1, 2020
Title 16, California Code of Regulations Section 1746.3 Chronology and Status Board Approved Proposed Text for Rulemaking: March 27, 2018 45-Day Comment Period: April 26, 2019 to June 17, 2019 Board Approved Final Text: July 21, 2019 Approved by the Office of Administrative Law on January 27, 2020 Regulatory Action No. 2019-1211-01S Filed with the Secretary of State on January 27, 2020 Effective Date of Regulation: April 1, 2020	Notice of Proposed Action Initial Statement of Reasons Proposed Text Final Statement of Reasons Order of Adoption (Approved Regulation Text)

Fee Schedule	Effective April 1, 2020
Title 16, California Code of Regulations Section 1749 Chronology and Status Board Approved Proposed Text for Rulemaking: December 14, 2018 45-Day Comment Period: April 26, 2019 to June 10, 2019 Board Approved Final Text: June 21, 2019 Approved by the Office of Administrative Law on November 12, 2019 Regulatory Action No. 2019-0930-02S Filed with the Secretary of State on November 12, 2019 Effective Date of Regulation: April 1, 2020	Notice of Proposed Action Initial Statement of Reasons Proposed Text Final Statement of Reasons Order of Adoption (Approved Regulation Text)

Compounded Drug Preparations	Effective January 30, 2019
Title 16, California Code of Regulations Sections 1735.1, 1735.2, 1735.6, 1751.1, 1751.4 Chronology and Status Board Approved Proposed Text for Rulemaking: July 26, 2017 45-Day Comment Period: August 3, 2018 to September 17, 2018 15-Day Comment Period: September 26, 2018 to October 11, 2018 Board Approved Final Text: October Approved by the Office of Administrative Law on January 30, 2019 Regulatory Action No. 2018-1214-01C Effective Date of Regulation: January 30, 2019	Notice of Proposed Action Initial Statement of Reasons Proposed Text Notice of Modified Text Modified Text Notice of Documents Added to Rulemaking File OAL Notice of Approval of Regulatory Action Form 400 Final Statement of Reasons Order of Adoption (Approved Regulation Text)