Board Meeting Materials

Agenda Item III. 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, and Review of Comments Received During the 30-Day Comment Period

• Recommended Second Modified Text Dated 1/8/25 (updated 1/2/25)

Staff Recommended Responses

Section 1735 et seq (Nonsterile)

Section 1736 et seq (Sterile)

Section 1737 et seq (Hazardous)

Section 1738 et seq (Radiopharmaceuticals)

General Comments

Comments Received During the 30-Day Comment Period

Comments 1 of 2

Comments 2 of 2

• Original Proposed Text Dated 3/25/24
• Modified Text Dated 8/29/24
• Letter from Medical Board of California

Agenda Item IV Discussion and Possible Action Related to Proposed Amendment to California Code of Regulations, Title 16, Section 1708.2 Related to Discontinuance of Business and Review of Comments Received During the 45-Day Comment Period

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

• Staff Recommended Responses
• Comments Received During the 15-Day Comment Period
• Modified Text Dated 10/31/24

Agenda Item VI. Report on Appointment to Research Advisory Panel of California pursuant to Health and Safety Code Section 11480

Written Comments Received 1
Written Comments Received 2