“California Biologics Laws: Stem Cells, IVF, Transplantation, and Blood Banks” is a comprehensive and reliable source of the current laws regulating biologics laboratories in California. “Biologics” includes stem cells, cadaveric transplant tissue, gametes and embryos used in assisted reproduction technologies and blood and blood components used in transfusions. California laws addressing stem cells and research involving stem cells and human subjects is emphasized, as research in this complex field is increasing rapidly in the search to understand and apply these cells to curing disease.
204 pages
ISBN-10: 1479291994
Table of Contents
Foreword to the First Edition
PART 1: RESEARCH STATUTES, REGULATIONS, GUIDANCE
Protection of Human subjects in Medical Experimentation California Health and Safety Code
State Guidelines for Research Involving Human Embryonic Stem Cells in California, California Health and Safety Code
California Department of Public Health Guidelines for Human stem Cell Research, Revised December 5, 2011
Human Embryonic Stem Cell Research Regulations, California Code of Regulations Title 17
Oocyte Retrieval for Fertility Treatment, California Health and Safety Code
Procuring of Oocytes for Research, California Health and Safety Code
Registry of Anonymous Embryos Available for Research, California Health and Safety Code
The Health Research Fairness Act, California Health and Safety Code
The Inclusion of Women and Minorities in Clinical Research Act, California Health and Safety Code
Human Cloning Prohibition, California Health and Safety Code
PART 2: CALIFORNIA INSTITUTE FOR REGENERATIVE MEDICINE
California Constitution Article XXXV: Medical Research
California Stem Cell Research and Cures Bond Act, California Health and Safety Code
California Stem Cell Research and Cures Bond Act of 2004, California Health and Safety Code
California Stem Cell Research and Cures Bond Act – Definitions, California Health and Safety Code
Conflicts of Interest Code: California Institute for Regenerative Medicine, California Code of Regulations Title 17
Appendix A: Assigned Disclosure
Appendix B: Disclosure Categories
Revenue Sharing: For-Profit Organizations, California Code of Regulations Title 17
Intellectual Property and Revenue Sharing: Non-Profit and For-Profit Grantees, California Code of Regulations Title 17
CIRM Loan Policies, California Code of Regulations Title 17
PART 3: TISSUE BANKS
Tissue Banks, California Health and Safety Code
ARTICLE 1. Definitions, Licensure, and Exceptions
ARTICLE 2. Regulation of Tissue Banks
ARTICLE 3. Suspension or Revocation of License
ARTICLE 4. Organ, Tissue or Body Fluid Donation
ARTICLE 5. Genetic Depositories
ARTICLE 6. The Paul Gann Blood Safety Act
ARTICLE 7. Human Milk
Tissue Bank Regulations (Inoperative), California Code of Regulations, Title 17
Uniform Anatomical Gift Act, California Health and Safety Code
PART 4: BLOOD BANKS
Blood and Blood Products, California Health and Safety Code
ARTICLE 1. Definitions
ARTICLE 2. Human Whole Blood and Human Whole Blood Derivatives
ARTICLE 3. Biologics Other Than Human Whole Blood and Human Whole Blood Derivatives
ARTICLE 4. Licenses
ARTICLE 5. Revenue
ARTICLE 6. Enforcement
ARTICLE 7. Blood Donations
ARTICLE 8. Umbilical Cord Blood Program
Production and Distribution of Biologics, California Code of Regulations, Title 17
ARTICLE 1. Licenses
ARTICLE2. Exemptions
ARTICLE 3. Inspection and Records
ARTICLE 4. Storage
ARTICLE 5. Containers and Labeling
ARTICLE 7. Samples
ARTICLE 8. Vaccine Culture
ARTICLE 9. Preparation and Distribution of Whole Blood (Human)
ARTICLE 10. Preparation and Distribution of Normal Human Plasma
ARTICLE 11. Preparation of Other Blood Derivatives
ARTICLE 12. Transportation of Etiologic Agents
INDEX
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