Department of Consumer Affairs Board of Pharmacy

Laws and Regulations

Pending Regulations

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

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

Patient Centered Labels for Prescription Drug Containers

Title 16, California Code of Regulations
Amend Section 1707.5

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

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 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.