Pending Regulations (Last Updated 5/5/2025)
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:
- Department of Consumer Affairs (DCA) – Legal Office,
- DCA – Legislative and Regulatory Review,
- 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:
- Department of Consumer Affairs (DCA) – Legal Office,
- DCA – Legislative and Regulatory Review,
- Business, Consumer Services and Housing Agency,
- Department of Finance, and
- 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/
| Automated Patient Delivery Systems (APDS) Consultation | Documents |
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Amend section 1713 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: February 21, 2025 to April 7, 2025 Current Status: Comments Undergoing Review |
| Pharmacy/Hospital/Wholesaler/3PL Self-Assessment Forms | Documents |
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Amend section 1715/1784 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: January 10, 2025 to February 24, 2025 Current Status: Rulemaking Withdrawn |
| Discontinuance of Business | Documents |
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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 15-Day Comment Period: February 10, 2025 to February 25, 2025 15-Day Comment Period: March 11, 2025 to March 26, 2025 Current Status: With Board Staff for Completion of the Final Rulemaking File |
| Quality Assurance Programs | Documents |
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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 15-Day Comment Period: January 27, 2025 to February 11, 2025 Current Status: Comments Pending Review by Board |
| Compounded Drug Preparations | Documents |
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Repeal sections 1708.3, 1708.4, 1708.5 of Title 16, Division 17, Article 2 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 Chronology and Status Board Approved Proposed Text for Rulemaking: April 19-20, 2023 45–Day Comment Period: April 19, 2024 to June 3, 2024 Regulation Hearing: June 18, 2024 at 9:00 a.m. Regulation Hearing: https://youtu.be/VDderHcJsEY 30–Day Comment Period: November 8, 2024 to December 9, 2024 15-Day Comment Period: January 10, 2025 to January 27, 2025 15-Day Comment Period: February 6, 2025 to February 21, 2025 15-Day Comment Period: March 6, 2025 to March 21, 2025 Adopted by the Board on March 26, 2025 Current Status: Undergoing Final review by the Department of Consumer Affairs |
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