Board of Pharmacy - Regulations

Laws and Regulations

Pending Regulations

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	Notice of Proposed Action Proposed Text Initial Statement of Reasons
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	Notice of Proposed Action Proposed Text Initial Statement of Reasons Notice of Extending Public Comment Period

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	Notice of Proposed Action Proposed Text Document Incorporated by Reference “Guidance for Industry, Standards for Securing the Drug Supply Chain – Standardized Numerical Identification for Prescription Drug Packages (FDA Guidance Document) Initial Statement of Reasons First Notice of Modified Text First Modified Text Notice of Second Modified Text Second Modified Text

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	Notice of Proposed Action Proposed Text Initial Statement of Reasons Notice of Modified Text Modified Text Final Statement of Reasons (revised) Adopted Text

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	Notice of Proposed Action Proposed Text 17M-39 Compounding Self-Assessment (Proposed) Initial Statement of Reasons Notice of Modified Text and to Add Documents to Rulemaking Modified Text Final Statement of Reasons Adopted Text 17M-39 Compounding Self-Assessment (FINAL)

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	Notice Proposed Text Initial Statement of Reasons Final Statement of Reasons Adopted Text

Disciplinary Guidelines
Title 16, California Code of Regulations Section 1760	Notice of Proposed Action Proposed Text Disciplinary Guidelines (Proposed) Initial Statement of Reasons Decision Not to Proceed

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 of Proposed Action Proposed Text Initial Statement of Reasons Notice of 15-Day Comment Period Modified Text for 15-Day Comment Period Final Statement of Reasons Adopted Text

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	Notice of Proposed Action Proposed Text Initial Statement of Reasons Notice of 15-Day Comment Period Modified Text for 15-Day Comment Period Final Statement of Reasons Order of Adoption

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 Initial Statement of Reasons Final Statement of Reasons Adopted Text Self-Assessment Forms(as adopted) 17M-13 Community Pharmacy Self-Assessment / Hospital Outpatient Pharmacy Self-Assessment 17M-14 Hospital Pharmacy Self-Assessment 17M-26 Wholesaler Dangerous Drug and Dangerous Devices Self-Assessment 17M-39 Compounding 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	Notice of Proposed Action Proposed Text Pharmacy Technician Application 17A-5 (proposed) Initial Statement of Reasons Final Statement of Reasons Adopted Text Pharmacy Technician Application 17A-5

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	Notice of Proposed Action Proposed Text Initial Statement of Reasons Notice of 15-Day Comment Period Modified Text for 15-Day Comment Period Notice of 2nd 15-Day Comment Period Modified Text for 2nd 15-Day Comment Period Final Statement of Reasons Supplement to the Final Statement of Reasons Adopted Text
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	Notice of Proposed Action Proposed Language Initial Statement of Reasons Final Statement of Reasons Order of Adoption
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	Notice of Proposed Action Proposed Text Initial Statement of Reasons Final Statement of Reasons Adopted Text
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	Notice of Proposed Action California Regulatory Notice Register 2008, No. 34-Z Proposed Language Draft Self-Assessment Form Initial Statement of Reasons Notice of Public Hearing October 29, 2008 Notice of 1st 15-Day Comment Period Proposed Text Notice of 2nd 15-Day Comment Period Proposed Text Final Statement of Reasons Addendum to Final Statement of Reasons Adopted Text Self-Assessment Form

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	Notice of Proposed Regulatory Action Proposed Text Initial Statement of Reasons Final Statement of Reasons Adopted Text Disciplinary Guidelines (Rev. 10/07)
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	Notice of Proposed Regulatory Action Initial Statement of Reasons Proposed Language Notice of Regulatory Hearing Notice of 15-Day Comment Period Modified Text for 15-Day Comment Period Final Statement of Reasons Adopted Text

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.

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