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California State Board of Pharmacy

Pending Regulations (Last Updated 1/25/2022)

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/

Notification of Temporary Closure Documents

Title 16, California Code of Regulations
Section 1708.1

Chronology and Status

Board Approved Proposed Text for Rulemaking: July 29, 2020

45-Day Comment Period: October 29, 2021 to December 13, 2021

Current Status: Comments Pending Review by Board
Pharmacy Technicians Documents

Title 16, California Code of Regulations
Section 1793.5, 1793.6, 1793.65

Chronology and Status

Board Approved Proposed Text for Rulemaking: March 18, 2021

45-Day Comment Period: October 22, 2021 to December 6, 2021

Current Status: Comments Pending Review by Board
Reporting Drug Loss Documents

Title 16, California Code of Regulations
Section 1715.6

Chronology and Status

Board Approved Proposed Text for Rulemaking: January 30, 2020

45-Day Comment Period: June 4, 2021 to July 19, 2021

15-Day Comment Period: December 3, 2021 to December 18, 2021

Current Status: Undergoing Review by the Office of Administrative Law
Wholesaler/3PL Self-Assessment Form Documents

Title 16, California Code of Regulations
Section 1784

Chronology and Status

Board Approved Proposed Text for Rulemaking: November 9, 2017

45-Day Comment Period: September 17, 2021 to November 1, 2021

Current Status: Comments Pending Review by Board
Inventory Reconciliation Documents

Title 16, California Code of Regulations
Section 1715.65

Chronology and Status

Board Approved Proposed Text for Rulemaking: January 29, 2020

45-Day Comment Period: September 17, 2021 to November 1, 2021

15-Day Comment Period: December 3, 2021 to December 18, 2021

Current Status: Comments Pending Review by Board

Pharmacy/Hospital Self-Assessment Forms Documents

Title 16, California Code of Regulations
Section 1715

Chronology and Status

Board Approved Proposed Text for Rulemaking: November 9, 2017

45-Day Comment Period: November 12, 2021 to December 27, 2021

Current Status: Comments Pending Review by Board