Department of Consumer Affairs Board of Pharmacy

Laws and Regulations (Last Updated 2/12/2016)

To promulgate a regulation, the board must follow the rulemaking procedures specified in the Administrative Procedures Act and regulations adopted by the Office of Administrative Law (OAL). The general process is summarized below (note: the board may stop pursuing a regulation at any point in the process):

  1. Once the board approves the initial proposed text, a “notice of proposed action” is published and disseminated by OAL and the board. This begins a 45-day comment period to allow the public time to submit written comments. At the close of the 45-day comment period, a regulation hearing may be held to allow for oral comments to be submitted.
  2. After the comment period has ended and any testimony taken, the board will review the comments and determine if changes are necessary in the text in response to the comments.
  3. If changes are made, the modified text must be noticed for a 15-day comment period, followed by a board review of the comments, and possible modification of the proposed regulation again (no additional regulation hearing is scheduled).  If significant changes are made, the board may start a new rulemaking process with a new 45-day comment period. 

    Whenever changes are made following a 15-day comment period, the process repeats until no additional changes are made by the board.

  4. After any comment period, when the board declines to modify the regulation, the board adopts the regulation and directs staff to compile the rulemaking file.

Once the Board adopts the final regulation text, board staff prepare a final rulemaking package that is submitted for review and approval by the following agencies, a process that may take six months:

  1. Department of Consumer Affairs (DCA) – Legal Office,
  2. DCA – Legislative and Regulatory Review,
  3. Business, Consumer Services and Housing Agency,
  4. Department of Finance, and
  5. the Office of Administrative Law.
Once approved by OAL, the regulation becomes effective on the first day of the following quarter, unless the board requests and is granted an earlier effective date by OAL. Additional information can be found on OAL’s website at the follow link: http://www.oal.ca.gov/Regular_Rulemaking_Process.htm.

Pending Regulations

Prescription Drug Take-Back Programs

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

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

Board Approval of Proposed Text: January 19, 2016

Current Status: Active Comment Period
Advanced Practice Pharmacist - Certification Program

Title 16, California Code of Regulations
Section 1730.2

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

Board Approval of Proposed Text: November 11, 2015

Current Status: Active Comment Period
Board Accredited Continuing Education

Title 16, California Code of Regulations
Sections 1732.02, 1732.2, and 1732.5

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

Board Approval of Proposed Text: October 29, 2015

Current Status: Comments Awaiting Review by Board
Patient-Centered Labels for Prescription Drug Containers: Requirements

Title 16, California Code of Regulations Section 1707.5

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

Board Approval of Proposed Text: January 28, 2015

Current Status: Comments Awaiting Review by Board
Reconciliation and Inventory Report of Controlled Substances

Title 16, California Code of Regulations Sections 1715.65

45-Day Comment Period: October 16, 2015 to November 30, 2015

Regulation Hearing: February 2, 2016 at 10:45am – 2:45pm.

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

Board Approval of Proposed Text: July 29, 2015

Current Status: Comments Awaiting Review by Board
Travel Medications

Title 16, California Code of Regulations Sections 1746.5

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

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

Board Approval of Modified Text: January 19, 2016

Current Status: Active Comment Period
Drug Warnings

Title 16, California Code of Regulations Sections 1744

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

Board Approval of Proposed Text: April 21, 2015

Current Status: Comments Awaiting Review by Board
Disciplinary Guidelines

Title 16, California Code of Regulations Sections 1760

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

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

Board Approval of Proposed Text: July 29, 2015

Current Status: Comments Awaiting Review by Board
Advanced Practice Pharmacist

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

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

Board Adoption of Final Text: January 19, 2016

Current Status: Board Staff Drafting Final Rulemaking Documents
Vaccinations

Title 16, California Code of Regulations Section 1746.4

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

Board Adoption of Final Text: January 19, 2016

Current Status: Undergoing Review by the Department of Consumer Affairs
Self-Administered Hormonal Contraception

Title 16, California Code of Regulations
Section 1746.1

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

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

Board Adoption of Final Text: September 30, 2015

Current Status: Undergoing Review by the Office of Administrative Law
Compounded Drug Preparations

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

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 of Final Text: January 19, 2016

Current Status: Board Staff Drafting Final Rulemaking Documents
Self-Assessment Forms Revisions

Title 16, California Code of Regulations
Section 1715 and 1784

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

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

Board Adoption of Final Text: January 19, 2016

Current Status: Undergoing Review by the Department of Consumer Affairs

 

Compounded Drug Preparations

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

Regulation Hearing: November 4, 2014 at 10:30 a.m.

Department of Consumer Affairs
Headquarter Building Two
1747 N. Market Blvd., Room 186
Sacramento, CA  95834

45-Day Comment Period: September 5, 2014 to October 20, 2014

First 15-Day Comment Period: February 06, 2015 – February 20, 2015

Second 15-Day Comment Period: March 11, 2015 – March 25, 2015

Decision Not to Proceed Published May 8, 2015

 

Regulations Approved in 2016

Nicotine Replacement Products

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

Naloxone Hydrochloride

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

 

Regulations Approved in 2015

Naloxone Emergency Regulation

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

Pharmacy Technician Application

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

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


 

Regulations Approved in 2014

Fee Schedule

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

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

 

Regulations Withdrawn or Expired in 2014

Compounding Drug Products

Title 16, California Code of Regulations
To Amend Articles 4.5 and 7

Regulation Hearing: January 16, 2014 at 10:30 a.m.

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

45-Day Comment Period: November 29, 2013 to January 13, 2014
Pedigree Requirements Drop Shipment

Title 16, California Code of Regulations
Add Section 1747.2

Regulation Hearing: October 29, 2013 at 4:00 p.m.

Sheraton Garden Grove
12221 Harbor Blvd.
Garden Grove, CA 92840

45-Day Comment Period: September 13, 2013 October 28, 2013

Decision Not To Proceed Published March 28, 2013

Pedigree Requirements – Unique Identification Number; Grandfathering

Title 16, California Code of Regulations
Add New Article 5.5 “Pedigree Requirements”
Beginning with Section 1747

45-Day Comment Period:  September 21 – November 5, 2012

First Modified Text
15-Day Comment Period: December 21, 2012 to January 7, 2013

Second Modified Text
15-Day Comment Period: January 11 – January 28, 2013

OAL Disapproval Decision
OAL File No. 2013-0913-06S
October 31, 2013

 

Regulations Approved in 2013

Emergency Contraception

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

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

Regulations Approved in 2012

Intern Pharmacist Applicants; Pharmacist Exam Applicants; Requirements

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
Disciplinary Guidelines

Title 16, California Code of Regulations
Section 1760

Board Accredited Continuing Education

Title 16, California Code of Regulations
Beginning with Section 1732.2

45-Day Comment Period:  Oct. 8 – Nov. 22, 2010

15-Day Comment Period:  Feb. 4 – 21, 2011

Rulemaking Withdrawn January 31, 2012

Notice to Consumers

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

Regulations Approved in 2011

Pharmacies and Wholesalers; Self-Assessments

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

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

Regulations Approved in 2010

Patient-Centered Labels for Prescription Drug Containers; Requirements

Title 16, California Code of Regulations
Beginning with Section 1707.5

45-Day Comment Period: Nov. 20, 2009 - Jan. 4, 2010

Regulation Hearing: January 20, 2010

1st 15-Day Comment Period: Feb. 22 - Mar. 10, 2010

2nd 15-Day Comment Period: Apr. 28 - May 13, 2010

Approved by the Office of Administrative Law on
November 17, 2010

Effective Date of Regulation: January 1, 2011

Dishonest Conduct During Examination; Confidentiality of Exam Questions

Title 16, California Code of Regulations
Beginning with Section 1721

45-Day Comment Period: Oct. 30 - Dec. 14, 2009

Office of Administrative Law
Notice of Approval
Filed With the Secretary of State:  August 18, 2010

Effective Date of Regulation:  September 17, 2010

Pharmacists: Mandatory Submission of Fingerprints

Title 16, California Code of Regulations
Beginning with Section 1702

45-Day Comment Period: Dec 25, 2009 - Feb. 8, 2010

Office of Administrative Law
Notice of Approval
Filed With the Secretary of State:  June 7, 2010

Effective Date of Regulation:  December 7, 2010

Requirements for Pharmacies that Compound Medications

Title 16, California Code of Regulations
Beginning with Section 1716

Office of Administrative Law
Notice of Approval
Filed with Secretary of State: 1/6/2010

Effective Date of Regulation: 7/6/2010

Regulations Approved in 2009

Disciplinary Guidelines - Amended

Title 16, California Code of Regulations
Amend Section 1760

Office of Administrative Law Notice of Approval
Filed With the Secretary of State: April 27, 2009

Effective Date of Regulation: May 27, 2009

Ethics Course

Title 16, California Code of Regulations
Amend Section 1773 and Adopt Section 1773.5

Office of Administrative Law Notice of Approval
Filed With the Secrtary of State: August 4, 2009

Effective Date of Regulation: September 3, 2009

Withdrawn Regulations

 
   

Disclaimer: The Board of Pharmacy encourages public comments on pending regulations or regulation changes. If you are interested in submitting comments on a regulation at any time, please mail, fax or e-mail your comments to the board.

In addition, the board is required to respond to all comments submitted during the formal comment periods (that are prescribed in law) in its rulemaking file to adopt, change or repeal any regulation. You can identify regulations that are currently undergoing a formal comment period by reviewing this Legislation and Regulation webpage.

During formal comment periods, the board accepts e-mail or faxed comments if the comments contain the name and mailing address of the individual submitting the comments.

A business or person who has provided comments on proposed regulations, or a member of the public, is entitled to a copy of the final statement of reasons for any proposed regulations, once this document is complete.