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California State Board of Pharmacy

Pending Regulations (Last Updated 10/16/2020)

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):

Once the Board approves the initial proposed text, board staff prepare the initial rulemaking package that is submitted for pre-review and approval by the following agencies, a process that may take six months or longer:

  1. Department of Consumer Affairs (DCA) – Legal Office,
  2. DCA – Legislative and Regulatory Review,
  3. Business, Consumer Services and Housing Agency,

Once the initial rulemaking package is approved, 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. 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.

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.

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 final review and approval by the following agencies, a process that may take six months or longer:

  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/rulemaking_process/regular_rulemaking_process/

Automatic Refill Programs Documents

Title 16, California Code of Regulations
Sections 1717.5

Chronology and Status

Board Approved Proposed Text for Rulemaking: May 3, 2017

15-Day Comment Period: September 25, 2020 to October 10, 2020

Current Status: Comments Pending Review by Board
Dangerous Drug Distributors Documents

Title 16, California Code of Regulations
Sections 1780, 1781, 1782, and 1783

Chronology and Status

Board Approved Proposed Text for Rulemaking: October 26, 2016

45-Day Comment Period: May 29, 2020 to July 13, 2020

Current Status: Board Staff Drafting Final Rulemaking Documents
Automated Drug Delivery Systems Documents

Title 16, California Code of Regulations
Sections 1711, 1713, and 1715.1

Chronology and Status

Board Approved Proposed Text for Rulemaking: January 30, 2019

15-Day Comment Period: September 25, 2020 to October 10, 2020

Current Status: Comments Pending Review by Board
Substantial Relationship and Rehabilitation Criteria Documents

Title 16, California Code of Regulations
Sections 1769 and 1770

Chronology and Status

Board Approved Proposed Text for Rulemaking: May 6, 2019

45-Day Comment Period: March 13, 2020 to April 27, 2020

Current Status: Undergoing Review by the Office of Administrative Law
Renewal Requirements Documents

Title 16, California Code of Regulations
Section 1702, 1702.1, 1702.2, 1702.5

Chronology and Status

Board Approved Proposed Text for Rulemaking: May 2, 2018

45-Day Comment Period: February 7, 2020 to March 23, 2020

Current Status: Undergoing Review by the Office of Administrative Law
Off-site Storage Documents

Title 16, California Code of Regulations
Section 1707

Chronology and Status

Board Approved Proposed Text for Rulemaking: January 27, 2017

45-Day Comment Period: February 7, 2020 to March 23, 2020

15-Day Comment Period: May 19, 2020 to June 3, 2020

Current Status: Undergoing Review by the Department of Consumer Affairs