Board Meeting Materials
Agenda Item II. 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 Review of Comments Received During the 15-Day Comment Period to the Third Modified Text
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
Addendum 1 Board Response to Comments Received Specifically Related FDA Category 1 Bulk Drug Substances
Comments Received During the Second 15-Day Comment Period
Comments Vol. 1
Comments Vol. 2
Agenda Item III. Discussion and Possible Action Related to Proposed Amendment to California Code of Regulations, Title 16, Section 1708.2 Related to Discontinuance of Business, Including Review of Comments Received During the 15-Day Comment Period
Agenda Item IV. Discussion and Possible Action Related to Proposed Amendment to California Code of Regulations, Title 16, Section 1711 Related to Quality Assurance Programs, Including Review of Comments Received During the Second 15-Day Comment Period
Agenda Item V. Discussion and Possible Action Related to Proposed Addition of Section 1700 Related to Digital Signatures to California Code of Regulations, Title 16, Including Review of Comments Received During the 45-Day Comment Period
Written Comments 1
Written Comments 2
