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California State Board of Pharmacy

Pending Regulations (Last Updated 6/4/2024)

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/

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

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Current Status: Open Comment Period

Disciplinary Guidelines Documents

Amend section 1760 of Title 16, Division 17, Article 8 of the California Code of Regulations

Chronology and Status

Board Approved Proposed Text for Rulemaking: January 28, 2022

45-Day Comment Period: February 23, 2024 to April 12, 2024

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

Current Status: Pending with Board Staff
Opioid Antagonist Protocol Documents

Amend section 1746.3 of Title 16, Division 17, Article 5 of the California Code of Regulations

Chronology and Status

Board Approved Proposed Text for Rulemaking: February 7, 2023

45-Day Comment Period: December 15, 2023 to January 29, 2024

15-Day Comment Period: March 1, 2024 to March 16, 2024

Current Status: Pending with Board Staff
Continuing Education Documents

Amend section 1732.5 and Add section 1732.8 of Title 16, Division 17, Article 2 of the California Code of Regulations

Chronology and Status

Board Approved Proposed Text for Rulemaking: February 7, 2023

45-Day Comment Period: December 15, 2023 to January 29, 2024

Current Status: Undergoing Final Review by Department of Consumer Affairs
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

Current Status: Pending with Board Staff