Board Meeting Materials

Agenda Item IV. Approval of Board Meeting Minutes

Agenda Item V. Discussion and Consideration of Waiver Related to Temporary Provision for Compounding Certain Parenteral Drug Prodcuts Consistent with BPC Section 4062

Agenda Item VII. Enforcement and Compounding Committee

Agenda Item VIII. Licensing Committee

Agenda Item IX. Discussion of Proposed Issues to Raise as Part of Sunset Report

Agenda Item X. Discussion and Consideration of the Board’s Strategic Plan

Agenda Item XI. Discussion and Possible Action Related to Proposed Amendment to California Code of Regulations, Title 16, Section 1709.1 Related to Designation of Pharmacist-in-Charge, Including Review of Comments Received During the 15-Day Comment Period Initiated to Address Issues Raised by the Office of Administrative Law

Agenda Item XII. Discussion and Possible Action Related to Proposed Amendment to California Code of Regulations, Title 16, Section 1711 Related to Quality Assurance Programs, Including Comments Received During the 15-Day Comment Period

Agenda Item XIII. Organizational Development Committee

Agenda Item XIV. Executive Officer Report

Agenda Item XVII. Discussion and Possible Action Related to Proposed Regulations, Title 16, California Code of Regulations, Repeal of Sections 1708.3, 1708.4, 1735 et seq and 1751 et seq and Addition of Sections 1735 et seq, 1736 et seq, 1737 et seq, and 1738 et seq Related to Compounded Drug Preparations, Hazardous Drugs and Radiopharmaceuticals, Including Educational Presentations by Board Counsel and Staff on Federal Law and Background Information, and Consideration of Comments Received During the 45-Day Comment Period and Regulation Hearing

Compounding Cover Memo
Compounded Drug Preparation Memo

Attachment 1 - Updated Recommended Modified Text Dated 8/29/24
Updated Recommended Modified Text, Including the Changes Recommended By Member Serpa, PharmD and Member Barker, PharmD Consistent With the Delegated Authority. (dated 8/29/24)

Attachment 2 - Updated Recommended Modified Text With Highlight Dated 8/29/24
Updated Recommended Modified Text With Changes Highlighted in Yellow to Illustrate the Changes After July 31-Aug 1 Board Meeting.

Attachment 3 - Supplemental Board Staff Prepared Summarized Comments Dated 8/30/24
Supplemental Staff Recommended Responses Article 4.5 Final

Supplemental Staff Recommended Responses Article 4.6 Final

Supplemental Staff Recommended Responses Article 4.7 Final

Supplemental Staff Recommended Responses Article 4.8 Final

Attachment 4 - Initial Staff Prepared Summarized Comments With Recommendations as Presented During July 2024 Board Meeting
Section 1735 et seq (Non–Sterile) as Presented During July 2024 Board Meeting

Section 1736 et seq (Sterile) as Presented During July 2024 Board Meeting

Section 1737 et seq (Hazardous) as Presented During July 2024 Board Meeting

Section 1738 et seq (Radiopharmaceuticals) as Presented During July 2024 Board Meeting

General Comments as Presented During July 2024 Board Meeting

Attachment 5 - Previously Recommended Modified Text Dated 7/19/24
Board Staff Recommended Modified Text (Dated 7/19/24) Following the 45-day Comment Period and Hearing as Presented During July 2024 Board Meeting

Attachment 6 - Comments Received
Comments Received During the 45-day Comment Period. Comments From the Regulation Hearing are Available to Hear at the Following website: https://youtu.be/VDderHcJsEY

Attachment 7 - Text as Originally Noticed
The Original Proposed Text (Dated 3/24/24) Released for the 45-day Public Comment Period.

Written Comments Received

Written Comments Received 1

Written Comments Received 2

Written Comments Received 3

Written Comments Received 4

Written Comments Received 5

Written Comments Received 6

Presentations

Federal and California Requirements for Human Drug Compounding: An Overview

Compounding