CHAPTER 4. Human Whole Blood, Human Whole Blood Derivatives, and Other Biologics [1600. - 1630.]

Chapter 4 repealed and added by Stats. 1963, Ch. 1055.

§§ 1600–1630 · 48 sections

1. ARTICLE 1. Definitions §§ 1600–1600.9 · 14 sections

   • § 1600 Unless the context otherwise requires, the definitions in this article govern the construction of this chapter.
   • § 1600.1 “Biologics” includes the following products which are offered for sale or distribution for the prevention or treatment of disease, except biologics which are…
   • § 1600.2 “Blood bank” means any place where human whole blood, and human whole blood derivatives specified by regulation, are collected, prepared, tested, processed, or…
   • § 1600.21 “Blood collection center” means a stationary auxiliary to a blood bank which is designed, equipped, and staffed to procure human whole blood or blood…
   • § 1600.22 “Stationary” means a nonmobile room or building maintained at a fixed address.
   • § 1600.25 “Mobile unit” means a transportable auxiliary to a blood bank designed, equipped, and staffed to procure human whole blood and to transport this blood to the…
   • § 1600.3 “Blood bank depository” means any place other than a blood bank where human whole blood and human whole blood derivatives specified by regulation are stored…
   • § 1600.35 “Blood component” or “blood derivative” means any product produced from whole blood.
   • § 1600.4 “Distribution” includes sale and exchange.
   • § 1600.5 “Production” includes collection, preparation, testing, processing, storage, and distribution of biologics under a license issued by the department.
   • § 1600.6 “Department” means the State Department of Health Services.
   • § 1600.7 “Carrier donor” means any donor of human whole blood whose blood donation has been found, either by laboratory tests or by the tracing of a…
   • § 1600.8 “Possible carrier donor” means any donor of human whole blood whose blood donation was administered where multiple transfusions from multiple donors were…
   • § 1600.9 “Carrier of viral hepatitis” means a person under treatment by a physician who has contracted viral hepatitis which has been confirmed by voluntary laboratory…
2. ARTICLE 2. Human Whole Blood and Human Whole Blood Derivatives §§ 1602.5–1608 · 14 sections

   • § 1602.5 (a) No person shall engage in the production of human whole blood or human whole blood derivatives unless the person is licensed under this chapter and the…
   • § 1602.6 (a) No person shall import any human whole blood or human whole blood derivative produced outside the state unless that blood or blood product meets the…
   • § 1603.1 (a) Except as provided in this subdivision, no blood or blood components shall be used in vivo for humans in this state, unless the blood or blood components…
   • § 1603.2 (a) Each blood bank or plasma center shall require as identification either a photographic driver’s license or other photographic identification that is issued…
   • § 1603.3 (a) Before donation of blood or blood components, a donor shall be notified in writing of, and shall have signed a written statement confirming the…
   • § 1603.4 (a) Notwithstanding Chapter 7 (commencing with Section 120975) of Part 4 of Division 105, or any other provision of law, no public entity or any private blood…
   • § 1603.5 (a) Notwithstanding any other provision of law, every person engaged in the production of blood shall, if the product is intended for transfusion, label each…
   • § 1604 The distribution or release for distribution by blood banks of human whole blood, or those human whole blood derivatives specified by regulation, shall be made…
   • § 1604.6 (a) Notwithstanding any other provision of law, in order to provide umbilical cord blood banking storage services, a blood bank shall be licensed pursuant to…
   • § 1605 Establishments which receive human whole blood and human whole blood derivatives specified by regulation and are not subject to license in accordance with this…
   • § 1606 The procurement, processing, distribution, or use of whole blood, plasma, blood products, and blood derivatives for the purpose of injecting or transfusing the…
   • § 1607 (a) Notwithstanding any other law, licensed clinical laboratory bioanalysts, licensed clinical laboratory technologists, registered clinical laboratory…
   • § 1607.5 (a) Notwithstanding any other provision of law, a person who has attained the age of 17 may consent to the donation of his or her blood and to the penetration…
   • § 1608 This chapter does not repeal or in any manner affect any provision of the Business and Professions Code relating to the practice of medicine.
3. ARTICLE 3. Biologics Other Than Human Whole Blood and Human Whole Blood Derivatives §§ 1609–1611 · 3 sections

   • § 1609 No person shall engage in the production of biologics other than human whole blood and human whole blood derivatives unless: (a) In a laboratory licensed by…
   • § 1610 The department shall make rules and regulations governing the production of all biologics produced in establishments under subdivision (c) of Section 1609.
   • § 1611 The department may make rules and regulations governing the transportation or distribution of cultures of micro-organisms which may produce disease in man or…
4. ARTICLE 4. Licenses §§ 1613–1615 · 3 sections

   • § 1613 Applications for licenses issued under this chapter shall be made upon forms issued by the department. The applications shall contain at least the following:…
   • § 1614 If the department does not within 60 days after the filing of the application issue a license, it shall state the grounds and reasons for its refusal in…
   • § 1615 (a) A license shall be automatically revoked when there is a change of address, ownership, or person in charge of biologics production. However, a new license…
5. ARTICLE 5. Revenue §§ 1616–1616.5 · 2 sections

   • § 1616 (a) Each application for a license or license renewal under this chapter shall be accompanied by a fee determined by the director by regulations and in an…
   • § 1616.5 (a) The fee required pursuant to Section 1616 for the calendar year commencing January 1, 1992, and for each fiscal year thereafter unless adjusted pursuant to…
6. ARTICLE 6. Enforcement §§ 1617–1620 · 4 sections

   • § 1617 (a) The department shall administer this chapter. (b) In order to carry out this chapter, any duly authorized representative of the department may do any of…
   • § 1618 (a) Licenses shall be suspended or revoked by the department for the violation of any provision of this chapter, or of any rule or regulation made by the…
   • § 1619 Nothing in this chapter shall be considered to be in conflict with Part 5 (commencing with Section 109875) of Division 104 of this code and all provisions of…
   • § 1620 The violation of any provision of this chapter is a misdemeanor punishable by a fine of not less than one hundred dollars ($100) nor more than one thousand…
7. ARTICLE 7. Blood Donations §§ 1625–1626 · 3 sections

   • § 1625 As used in this article: (a) “Blood” means human whole blood or components of human blood, including plasma, which are prepared from human whole blood by…
   • § 1625.1 In addition to the requirements of Section 1602.1, subdivisions (a) to (c), inclusive, of Section 1002 of Title 17 of the California Administrative Code, and…
   • § 1626 (a) Except as provided in subdivisions (b) and (c), it shall be unlawful, in any transfusion of blood, to use any blood that was obtained from a paid donor.…
8. ARTICLE 8. Umbilical Cord Blood Program §§ 1627–1630 · 5 sections

   • § 1627 (a) (1) The University of California is requested to develop a plan to establish and administer the Umbilical Cord Blood Collection Program for the purpose of…
   • § 1628 (a) The University of California may accept public and private funds for the purpose of implementing this article. (b) The Umbilical Cord Blood Collection…
   • § 1629 In implementing the program, the department shall make every effort to avoid duplication or conflicts with existing and ongoing programs and to leverage…
   • § 1629.5 (a) On or before January 1, 2026, if it elects to administer the Umbilical Cord Blood Collection Program, the University of California shall provide a report…
   • § 1630 This article shall remain in effect only until January 1, 2027, and as of that date is repealed.