Pending Regulations (Last Updated 12/20/2024)

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/

Digital Signatures Documents

Add section 1700 of Title 16, Division 17, Article 1 of the California Code of Regulations

Chronology and Status

Board Approved Proposed Text for Rulemaking: April 24, 2024

45–Day Comment Period: December 20, 2024 to February 3, 2025

Current Status: Open Comment Period
Discontinuance of Business Documents

Amend section 1708.2 of Title 16, Division 17, Article 2 of the California Code of Regulations

Chronology and Status

Board Approved Proposed Text for Rulemaking: April 24, 2024

45–Day Comment Period: November 15, 2024 to December 30, 2024

Current Status: Open Comment Period
Independent HIV Preexposure Prophylaxis Furnishing - Permanent Documents

Amend section 1747 of Title 16, Division 17, Article 5 of the California Code of Regulations

Chronology and Status

Board Approved Proposed Text for Rulemaking: April 24, 2024

45–Day Comment Period: September 20, 2024 to November 4, 2024

Current Status: Undergoing Final Review by the Department of Consumer Affairs

Pharmacy Technician Certification Programs Documents Documents

Amend section 1793.65 of Title 16, Division 17, Article 11 of the California Code of Regulations

Chronology and Status

Board Approved Proposed Text for Rulemaking: February 8, 2024

45–Day Comment Period: August 23, 2024 to October 7, 2024

Current Status: Undergoing Final Review by the Office of Administrative Law

Quality Assurance Programs Documents

Amend section 1711 of Title 16, Division 17, Article 2 of the California Code of Regulations

Chronology and Status

Board Approved Proposed Text for Rulemaking: February 7, 2024

45–Day Comment Period: August 9, 2024 to September 23, 2024

15-Day Comment Period: November 15, 2024 to December 2, 2024

Current Status: Comments Pending Review by Board

Compounded Drug Preparations Documents

Repeal sections 1708.3, 1708.4, 1708.5 of Title 16, Division 17, Article 2 of the California Code of Regulations
Repeal 1735 et seq of Title 16, Division 17, Article 4.5 of the California Code of Regulations
Repeal 1751 et seq of Title 16, Division 17, Article 7 of the California Code of Regulations

Add new sections 1735 et seq of Title 16, Division 17, Article 4.5 of the California Code of Regulations
Add new sections/Article 1736 et seq of Title 16, Division 17, Article 4.6 of the California Code of Regulations
Add new sections/Article 1737 et seq of Title 16, Division 17, Article 4.7 of the California Code of Regulations
Add new sections/Article 1738 et seq of Title 16, Division 17, Article 4.8 of the California Code of Regulations

Chronology and Status

Board Approved Proposed Text for Rulemaking: January 28, 2022

45–Day Comment Period: April 19, 2024 to June 3, 2024

Regulation Hearing: June 18, 2024 at 9:00 a.m.
Department of Consumer Affairs, Board of Pharmacy
First Floor Hearing Room
2720 Gateway Oaks Dr., Ste 100
Sacramento, CA 95833

Regulation Hearing: https://youtu.be/VDderHcJsEY

30–Day Comment Period: November 8, 2024 to December 9, 2024

Current Status: Comments Pending Review by Board
Designation of Pharmacist-in-Charge Documents

Amend section 1709.1 of Title 16, Division 17, Article 2 of the California Code of Regulations

Chronology and Status

Board Approved Proposed Text for Rulemaking: January 28, 2022

45–Day Comment Period: November 17, 2023 to January 2, 2024

15–Day Comment Period: April 29, 2024 to May 14, 2024

15-Day Comment Period: October 17, 2024 to November 1, 2024

Current Status: Undergoing Final Review by the Office of Administrative Law