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California State Board of Pharmacy

Pending Regulations (Last Updated 5/31/2019)

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/

Fee Schedule Documents

Title 16, California Code of Regulations
Section 1749

Chronology and Status

Board Approved Proposed Text for Rulemaking: December 14, 2018

45-Day Comment Period: April 26, 2019 to June 10, 2019

Current Status: Open Comment Period
Naloxone Fact Sheet Documents

Title 16, California Code of Regulations
Section 1746.3

Chronology and Status

Board Approved Proposed Text for Rulemaking: March 27, 2018

45-Day Comment Period: April 26, 2019 to June 17, 2019

Current Status: Open Comment Period
Remote Dispensing Pharmacy Technicians Documents

Title 16, California Code of Regulations
Section 1793.9

Chronology and Status

Board Approved Proposed Text for Rulemaking: July 26, 2017

45-Day Comment Period: April 12, 2019 to May 28, 2019

Current Status: Comments Pending Review by the Board