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California State Board of Pharmacy

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

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
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
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

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
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
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
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

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
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
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

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
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
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

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

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