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California State Board of Pharmacy

Approved Regulations

Approved regulations are posted online for two years.

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
Fee Schedule Effective April 20, 2018

Title 16, California Code of Regulations
Sections 1749

Chronology and Status

Board Approved Proposed Text for Rulemaking: October 27, 2016

45-Day Comment Period: April 14, 2017 – May 30, 2017

Board Approved Final Text: July 26, 2017

Approved by the Office of Administrative Law on April 20, 2018

Regulatory Action No. 2018-1309-02

Effective Date of Regulation: April 20, 2018
Inventory Reconciliation Report of Controlled Substances Effective April 1, 2018

Title 16, California Code of Regulations
Sections 1715.65

Chronology and Status

Board Approved Proposed Text for Rulemaking: October 27, 2016

45-Day Comment Period: April 14, 2017 – May 30, 2017

Board Approved Final Text: July 26, 2017

Approved by the Office of Administrative Law on April 20, 2018

Regulatory Action No. 2018-1309-02

Effective Date of Regulation: April 20, 2018
Disciplinary Guidelines Effective April 1, 2018

Title 16, California Code of Regulations
Sections 1760

Chronology and Status

Board Approved Proposed Text for Rulemaking: July 29, 2015

45-Day Comment Period: September 4, 2015 to October 19, 2015

15-Day Comment Period: December 22, 2015 to January 6, 2016

15-Day Comment Period: April 6, 2016 to April 21, 2016

15-Day Comment Period: March 15, 2017 to March 29, 2017

Board Approved Final Text: March 30, 2017

Approved by the Office of Administrative Law on January 17, 2018

Regulatory Action No. 2017-1201-03SR

Effective Date of Regulation: April 1, 2018
Renewal Requirements Effective January 1, 2018

Title 16, California Code of Regulations
Sections 1702, 1702.1, 1702.2, and 1702.5

Chronology and Status

Board Approved Proposed Text for Rulemaking: July 30, 2013

45-Day Comment Period: August 12, 2016 – September 26, 2016

15-Day Comment Period: October 27, 2016 - November 11,2016

Board Approved Final Text: December 14, 2016

Approved by the Office of Administrative Law on September 19, 2017

Regulatory Action No. 2017-0807-01S

Effective Date of Regulation: January 1, 2018
Compounding Emergency Regulation Effective December 19, 2017

Title 16, California Code of Regulations
Section 1735.2

Chronology and Status

Board Approved Proposed Text for Rulemaking: July 25, 2017

5-Working Day Notice Period: December 1, 2017 – December 8, 2017

Emergency Regulation effective December 19, 2017.

5-Working Day Notice of Re-Adoption: May 31, 2018 – June 6, 2018

5-Working Day Notice of Re-Adoption: August 30, 2018 – September 6, 2018

The current expiration date of the Emergency Regulation is January 30, 2019.
Delegation of Certain Functions Effective July 1, 2017

Title 16, California Code of Regulations
Add Article 9.1, Sections 1776 – 1776.6

Chronology and Status

Board Approved Proposed Text for Rulemaking: January 19, 2016

45-Day Comment Period: February 12, 2016 to March 28, 2016

Regulation Hearing: April 13, 2016 at 10:00 a.m.

University of Southern California
Orange County Center
2300 Michelson Drive
Irvine, CA 92612

Regulation Hearing: April 13, 2016 at 1:00 p.m.

Department of Consumer Affairs
1625 N. Market Blvd.
1st Floor Hearing Room
Sacramento, CA 95834

15-Day Comment Period: May 3, 2016 to May 18, 2016

Second 15-Day Comment Period: August 4, 2016 to August 19, 2016

Third 15-Day Comment Period: September 29, 2016 to October 14, 2016

Board Approved Final Text: October 26, 2016

Approved by the Office of Administrative Law on June 6, 2017

Regulatory Action No. 2017-0424-01S

Effective Date of Regulation: June 6, 2017

Board Accredited Continuing Education Effective July 1, 2017

Title 16, California Code of Regulations
Sections 1732.05, 1732.2, and 1732.5

Chronology and Status

Board Approved Proposed Text for Rulemaking: October 29, 2015

45-Day Comment Period: November 13, 2015 to December 28, 2015

Regulation Hearing: February 2, 2016 from 9:00am – 10:30am.

Department of Consumer Affairs
1625 N. Market Blvd.
1st Floor Hearing Room
Sacramento, CA 95834

15-Day Comment Period: August 3, 2016 to August 18, 2016

Board Approved Final Text: September 22, 2016

Approved by the Office of Administrative Law on March 20, 2017

Regulatory Action No. 2017-0203-01S

Effective Date of Regulation: July 1, 2017
Patient-Centered Labels for Prescription Drug Containers: Requirements Effective July 1, 2017

Title 16, California Code of Regulations
Section 1707.5

Chronology and Status

Board Approved Proposed Text for Rulemaking: January 28, 2015

45-Day Comment Period: October 23, 2015 to December 7, 2015

15-Day Comment Period: May 11, 2016 to May 26, 2016

15-Day Comment Period: August 3, 2016 to August 18, 2016

Board Approved Final Text: August 31, 2016

Approved by the Office of Administrative Law on March 2, 2017

Regulatory Action No. 2017-0119-02S

Effective Date of Regulation: July 1, 2017