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California State Board of Pharmacy

Approved Regulations

Renewal Requirements
Effective Date: 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
Travel Medications
Effective Date: June 8, 2017

Title 16, California Code of Regulations
Sections 1746.5

Chronology and Status

Board Approved Proposed Text for Rulemaking: July 29, 2015

45-Day Comment Period: September 25, 2015 to November 9, 2015

15-Day Comment Period: January 27, 2016 to February 11, 2016

15-Day Comment Period: March 28, 2016 to April 12, 2016

15-Day Comment Period: February 1, 2017 to February 16, 2017

Board Approved Final Text: February 17, 2017

Approved by the Office of Administrative Law on June 8, 2017

Regulatory Action No. 2017-0426-01SR

Effective Date of Regulation: June 8, 2017
Prescription Drug Take-Back Programs
Effective Date: June 6, 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

Delegation of Certain Functions
Effective Date: July 1, 2017

Title 16, California Code of Regulations
Section 1703

Chronology and Status

Board Approved Proposed Text for Rulemaking: February 24, 2016

45-Day Comment Period: April 22, 2016 – June 6, 2016

Board Approved Final Text: July 27, 2016

Approved by the Office of Administrative Law on May 30, 2017

Regulatory Action No. 2017-0417-02

Effective Date of Regulation: July 1, 2017
Board Accredited Continuing Education
Effective Date: 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 Date: 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
Drug Warnings
Effective Date: April 1, 2017

Title 16, California Code of Regulations Sections 1744

Chronology and Status

Board Approved Proposed Text for Rulemaking: April 21, 2015

45-Day Comment Period: September 25, 2015 – November 9, 2015

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

Board Approved Final Text: July 27, 2016

Approved by the Office of Administrative Law on January 31, 2017

Regulatory Action No. 2016-1220-03S

Effective Date of Regulation: April 1, 2017
Advanced Practice Pharmacist
Effective Date: December 13, 2016

Title 16, California Code of Regulations
Sections 1730, 1730.1, 1749

Chronology and Status

Board Approved Proposed Text for Rulemaking: April 21, 2015

45-Day Comment Period: July 31, 2015 – September 14, 2015

15-Day Comment Period: October 9, 2015 – October 23, 2015

15-Day Comment Period: November 20, 2015 to December 5, 2015

OAL Disapproval:  July 18, 2016

15-Day Comment Period:  August 12, 2016 – August 27, 2016

Board Approved Final Text: August 31, 2016

Approved by the Office of Administrative Law on December 13, 2016

Regulatory Action No. 2016-1031-01SR

Effective Date of Regulation: December 13, 2016
Compounded Drug Preparations
Effective Date: January 1, 2017

Title 16, California Code of Regulations
Amend Articles 4.5 & 7
Add Article 7.5

Chronology and Status

Board Approved Proposed Text for Rulemaking: April 21, 2015

Regulation Hearing: June 25, 2015 at 9:15 a.m.

Department of Consumer Affairs
Headquarter Building Two
1747 N. Market Blvd., Ruby Room
Sacramento, CA  95834

45-Day Comment Period: May 8, 2015 to June 22, 2015

15-Day Comment Period: July 31, 2015 to August 15, 2015

15-Day Comment Period: November 20, 2015 to December 5, 2015

Board Adoption Final Text: January 19, 2016

Approved by the Office of Administrative Law on September 13, 2016

Regulatory Action No. 2016-0801-05S

Effective Date of Regulation: January 1, 2017

Vaccinations
Effective Date: August 25, 2016

Title 16, California Code of Regulations
Section 1746.4

Chronology and Status

Board Approved Proposed Text for Rulemaking: June 4, 2015

45-Day Comment Period: July 24, 2015 – September 7, 2015

15-Day Comment Period: October 8, 2015 - October 22, 2015

15-Day Comment Period: November 20, 2015 to December 5, 2015

15-Day Comment Period: June 10, 2016 to June 25, 2016

Board Adoption of Final Text: July 1, 2016

Approved by the Office of Administrative Law on August 25, 2016

Regulatory Action No. 2016-0714-01SR

Effective Date of Regulation: August 25, 2016

Advanced Practice Pharmacist - Certification Program
Effective Date: August 10 2016

Title 16, California Code of Regulations
Section 1730.2

Chronology and Status

Board Approved Proposed Text for Rulemaking: November  11, 2015

45-Day Comment Period: December 25, 2015 to February 8, 2016

Board Adoption of Final Text: February 25, 2016

Approved by the Office of Administrative Law on August 10, 2016

Regulatory Action No. 2016-0629-04S

Effective Date of Regulation: August 10, 2016

Self-Assessment Forms Revisions
Effective Date:  April 20, 2016

Title 16, California Code of Regulations
Section 1715 and 1784

Chronology and Status

Board Approved Proposed Text for Rulemaking: October 28, 2014

45-Day Comment Period: March 20, 2015 to May 6, 2015

Additional 45-Day Comment Period: May 29, 2015 to July 13, 2015

Board Approved Final Text: January 19, 2016

Approved by the Office of Administrative Law on April 20, 2016

Regulatory Action No. 2016-0310-04

Effective Date of Regulation: April 20, 2016

Self-Assessment Forms (proposed changes marked):
Self-Administered Hormonal Contraception
Effective Date:  April 8, 2016

Title 16, California Code of Regulations
Section 1746.1

Chronology and Status

Board Approved Proposed Text for Rulemaking: March 9, 2015

45-Day Comment Period: May 8 – June 22, 2015

15-Day Comment Period: December 30, 2015 to January 14, 2016

15-Day Comment Period: March 9, 2016 to March 24, 2016

Board Approved Final Text: January 19, 2016

Approved by the Office of Administrative Law on April 8, 2016

Regulatory Action No. 2016-0404-01SR

Effective Date of Regulation: April 8, 2016
Naloxone Hydrochloride
Effective Date:  January 27, 2016

Title 16, California Code of Regulations Section 1746.3

45-Day Comment Period: May 22, 2015 – July 13, 2015

15-Day Comment Period: September 5, 2015 - September 19, 2015

Board Adoption of Final Text: September 30, 2015

Approved by the Office of Administrative Law on January 27, 2016

Regulatory Action No. 2015-1215-01

Effective Date of Regulation: January 27, 2016

Naloxone Emergency Regulation
Effective Date:  January 27, 2016

Title 16, California Code of Regulations
Section 1746.3

5-Day Comment Period: April 3, 2015 to April 9, 2015

Emergency Regulation effective April 9, 2015 and Extended October 8, 2015.

The current expiration date of Emergency Regulation is April 6, 2016.

Permanent Regulation Effective: January 27, 2016

Nicotine Replacement Products
Effective Date:  January 25, 2016

Title 16, California Code of Regulations Section 1746.2

45-Day Comment Period: May 8 – June 22, 2015

Board Adoption of Final Text: September 30, 2015

Approved by the Office of Administrative Law on January 25, 2016

Regulatory Action No. 2015-1215-03

Effective Date of Regulation: January 25, 2016

Pharmacy Technician Application
Effective Date:  January 1, 2016

Title 16, California Code of Regulations
Section 1793.5

45-Day Comment Period: February 20 – April 6, 2015

15-Day Comment Period: May 26, 2015 – June 15, 2015

Approved by the Office of Administrative Law on November 19, 2015

Regulatory Action No. 2015-1008-03

Effective Date of Regulation and New Application: January 1, 2016

Patient Centered Labels for Prescription Drug Containers
Effective Date:  April 1, 2015

Title 16, California Code of Regulations
Amend Section 1707.5

Regulation Hearing: May 27, 2014 at 9:30 a.m.

45-Day Comment Period: April 11, 2014 to May 26, 2014

Approved by the Office of Administrative Law on January 8, 2015
Regulatory Action No. 2014-1124-01S

Effective Date:  April 1, 2015


Fee Schedule
Effective Date: July 1, 2014

Title 16, California Code of Regulations
Amend Section 1749

Regulation Hearing: July 30, 2013 at 1:00 p.m.

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

45-Day Comment Period: June 14, 2013 – July 29, 2013

15-Day Comment Period: Nov 15-30, 2013

Approved by the Office of Administrative Law on April 14, 2014

Regulation Action No. 2014-0313-01 S

Effective Date: July 1, 2014

Partial Filling of Schedule II Prescriptions; Unprofessional Conduct Defined; Criteria for Rehabilitation
Effective Date: April 1, 2014

Title 16, California Code of Regulations
Amend Section 1745
Add Section 1762
Amend Section 1769

45-Day Comment Period:  October 19 – December 10, 2012

15-Day Comment Period: July 29 – August 13, 2013

Approved by the Office of Administrative Law on February 24, 2014
Regulatory Action No. 2014-0110-06S

Effective Date: April 1, 2014
Emergency Contraception
Operative Date: July 1, 2013

Title 16, California Code of Regulations
Section 1746

45-Day Comment Period: Jan. 6, 2012 – Feb. 20, 2012

15-Day Comment Period: Oct. 30, 2012 – Nov. 14, 2012

Approved by the Office of Administrative Law on March 13, 2013
Regulatory Action No. 2013-0129-04S

Operative Date: July 1, 2013
Compounding Drug Products
Effective Date: April 1, 2013

Title 16, California Code of Regulations
Beginning with Section 1735.1

45-Day Comment Period:  March 9 – April 23, 2012

Regulation Hearing: May 1, 2012

15-Day Comment Period: July 5-20, 2012

Approved by the Office of Administrative Law

Effective Date:  April 1, 2013
Intern Pharmacist Applicants; Pharmacist Exam Applicants; Requirements
Effective Date: July 18, 2012

Title 16, California Code of Regulations
Starting with Section 1727.2

45-Day Comment Period: May 6 – June 20, 2011

Approved by the Office of Administrative Law on June 18, 2012

Effective Date: July 18, 2012
Notice to Consumers
Effective Date: February 16, 2012

Title 16, California Code of Regulations
Amend Section 1707.2 and Add 1707.6

45-Day Comment Period: May 27 – July 11, 2011

Regulation Hearing: July 27, 2011

15-Day Comment Period: July 28-August 12, 2011

Approved by the Office of Administrative Law on January 17, 2012

Effective Date:  February 16, 2012

Pharmacies and Wholesalers; Self-Assessments
Effective Date: October 19, 2011

Title 16, California Code of Regulations
Beginning with Section 1715

45-Day Comment Period: Mar. 11 – Apr. 25, 2011

Approved by the Office of Administrative Law on
September 19, 2011

Effective Date: October 19, 2011


  • Notice of Proposed Action
  • Proposed Text
  • Self-Assessment Forms(proposed):

    • 17M-13Community Pharmacy Self‑Assessment / Hospital Outpatient Pharmacy Self‑Assessment
    • 17M-14Hospital Pharmacy Self‑Assessment
    • 17M-26Wholesaler Dangerous Drug & Dangerous Devices Self-Assessment
    • 17M-39Compounding Self-Assessment
Pharmacy Technician Application
Effective Date of Regulation and New Application: October 1, 2011

Title 16, California Code of Regulations
Section 1793.5

45-Day Comment Period: April 8 – May 23, 2011

Approved by the Office of Administrative Law on
September 1, 2011

Effective Date of Regulation and New Application: October 1, 2011