reglab/statecodes huggingface dataset:
2023 California Code › Health and Safety Code - HSC › DIVISION 2 - LICENSING PROVISIONS › CHAPTER 4 - Human Whole Blood, Human Whole Blood Derivatives, and Other Biologics › ARTICLE 1 - Definitions › Section 1600.21.

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 components which are to be transported to the blood bank for processing, storing, and distribution.
(Added by Stats. 1991, Ch. 800, Sec. 2.)
2023 California Code › Health and Safety Code - HSC › DIVISION 2 - LICENSING PROVISIONS › CHAPTER 4 - Human Whole Blood, Human Whole Blood Derivatives, and Other Biologics › ARTICLE 1 - Definitions › Section 1600.22.

1600.22. “Stationary” means a nonmobile room or building maintained at a fixed address.
(Added by Stats. 1991, Ch. 800, Sec. 3.)
2023 California Code › Health and Safety Code - HSC › DIVISION 2 - LICENSING PROVISIONS › CHAPTER 4 - Human Whole Blood, Human Whole Blood Derivatives, and Other Biologics › ARTICLE 1 - Definitions › Section 1600.25.

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 bank for processing, storing, and distribution.
(Added by Stats. 1991, Ch. 800, Sec. 4.)
2023 California Code › Health and Safety Code - HSC › DIVISION 2 - LICENSING PROVISIONS › CHAPTER 4 - Human Whole Blood, Human Whole Blood Derivatives, and Other Biologics › ARTICLE 1 - Definitions › Section 1600.3.

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 and held for transfusion. Such blood bank depositories shall be clinical laboratories, licensed in accordance with the provisions of Chapter 3 (commencing with Section 1200), Division 2 of the Business and Professions Code, or such other places where services essentially equivalent are maintained, as determined by the department.
(Added by Stats. 1963, Ch. 1055.)
2023 California Code › Health and Safety Code - HSC › DIVISION 2 - LICENSING PROVISIONS › CHAPTER 4 - Human Whole Blood, Human Whole Blood Derivatives, and Other Biologics › ARTICLE 1 - Definitions › Section 1600.35.

1600.35. “Blood component” or “blood derivative” means any product produced from whole blood.
(Added by Stats. 1991, Ch. 800, Sec. 5.)
2023 California Code › Health and Safety Code - HSC › DIVISION 2 - LICENSING PROVISIONS › CHAPTER 4 - Human Whole Blood, Human Whole Blood Derivatives, and Other Biologics › ARTICLE 1 - Definitions › Section 1600.5.

1600.5. “Production” includes collection, preparation, testing, processing, storage, and distribution of biologics under a license issued by the department.
(Added by Stats. 1963, Ch. 1055.)
2023 California Code › Health and Safety Code - HSC › DIVISION 2 - LICENSING PROVISIONS › CHAPTER 4 - Human Whole Blood, Human Whole Blood Derivatives, and Other Biologics › ARTICLE 1 - Definitions › Section 1600.7.

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 transfusion-associated hepatitis case where there was a single donor, to contain viral hepatitis, or any donor of human whole blood who has twice been determined by the department to be a possible carrier donor.
(Added by Stats. 1974, Ch. 985.)
2023 California Code › Health and Safety Code - HSC › DIVISION 2 - LICENSING PROVISIONS › CHAPTER 4 - Human Whole Blood, Human Whole Blood Derivatives, and Other Biologics › ARTICLE 1 - Definitions › Section 1600.8.

1600.8. “Possible carrier donor” means any donor of human whole blood whose blood donation was administered where multiple transfusions from multiple donors were administered to a recipient and such transfusions result in a case diagnosed by a physician as transfusion-associated hepatitis.
(Added by Stats. 1974, Ch. 985.)
2023 California Code › Health and Safety Code - HSC › DIVISION 2 - LICENSING PROVISIONS › CHAPTER 4 - Human Whole Blood, Human Whole Blood Derivatives, and Other Biologics › ARTICLE 1 - Definitions › Section 1600.9.

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 tests or who exhibits symptoms which lead a physician to render a diagnostic opinion that the person has contracted viral hepatitis.
(Added by Stats. 1974, Ch. 985.)
2023 California Code › Health and Safety Code - HSC › DIVISION 2 - LICENSING PROVISIONS › CHAPTER 4 - Human Whole Blood, Human Whole Blood Derivatives, and Other Biologics › ARTICLE 2 - Human Whole Blood and Human Whole Blood Derivatives › Section 1602.6.

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 standards set forth in the latest edition of the “Standards for Blood Banks and Transfusion Services,” as published by the American Association of Blood Banks, or any later published editions or amendments thereto.
(b)  Any later editions of the “Standards for Blood Banks and Transfusion Services,” or amendments thereto, published by the American Association of Blood Banks, shall become effective for purposes at this section 90 days after the effective date of this section, or 90 days after publication by the association, whichever is later, unless the department sends written notice, within the 90-day period, to all persons who import human whole blood or human whole blood derivatives produced outside the state that have requested this notice, stating the portions of those later editions or amendments that shall not become effective.
(c)  The department may determine that no portion of any later editions or amendments shall become effective for purposes of this section. The department shall determine that no portion of a later edition or amendment shall become effective for purposes of this section whenever the department has not received a copy of the later edition or amendment by the date it is published by the American Association of Blood Banks.
(d)  The department shall administer and enforce this section in accordance with this chapter and in a manner that assures, to the greatest degree, consistency with Section 1602.5.
(Added by Stats. 1992, Ch. 760, Sec. 1. Effective January 1, 1993.)
2023 California Code › Health and Safety Code - HSC › DIVISION 2 - LICENSING PROVISIONS › CHAPTER 4 - Human Whole Blood, Human Whole Blood Derivatives, and Other Biologics › ARTICLE 2 - Human Whole Blood and Human Whole Blood Derivatives › Section 1603.2.

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 by the Department of Motor Vehicles, pursuant to Division 6 (commencing with Section 12500) of the Vehicle Code, from all donors of human whole blood or blood components who receive payment in return for the donation of that blood or blood components.
(b)  For the purposes of this section, “payment” means the transfer by a blood bank or plasma center to any person of money or any other valuable consideration that can be converted to money by the recipient, except that payment shall not include any of the following:
(1)  Cancellation or refund of the nonreplacement fees or related blood or blood components transfusion charges.
(2)  Blood assurance benefits to a person as a result of a blood or blood components donation to a donor club or blood assurance program.
(3)  Time away from employment granted by an employer to an employee in order to donate blood or blood components.
(Amended by Stats. 2003, Ch. 419, Sec. 2. Effective January 1, 2004.)
2023 California Code › Health and Safety Code - HSC › DIVISION 2 - LICENSING PROVISIONS › CHAPTER 4 - Human Whole Blood, Human Whole Blood Derivatives, and Other Biologics › ARTICLE 2 - Human Whole Blood and Human Whole Blood Derivatives › Section 1603.4.

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 bank or plasma center shall be liable for an inadvertent, accidental, or otherwise unintentional disclosure of the results of an HIV test.
As used in this section, “public entity” includes, but is not limited to, any publicly owned or operated blood bank or plasma center, local health officer, and the department.
(b)  Neither the department nor any blood bank or plasma center, including a blood bank or plasma center owned or operated by a public entity, or local health officer shall be held liable for any damage resulting from the notification of test results, as set forth in paragraph (2) of subdivision (a) of, or in subdivision (c) of, Section 1603.3.
(Amended by Stats. 2003, Ch. 419, Sec. 4. Effective January 1, 2004.)
2023 California Code › Health and Safety Code - HSC › DIVISION 2 - LICENSING PROVISIONS › CHAPTER 4 - Human Whole Blood, Human Whole Blood Derivatives, and Other Biologics › ARTICLE 2 - Human Whole Blood and Human Whole Blood Derivatives › Section 1603.5.

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 container of blood which the person produces with a label, upon which the following designations shall be printed in letters the size of which shall be no less prominent than the proper name of the product.
(1)  If the person giving the blood received no payment for the blood, the designation shall be “volunteer donor.”
(2)  If the person giving the blood received payment for the blood, the designation shall be “paid donor.”
(b)  As used in this section:
(1)  “Blood” means human whole blood or components of human blood, including plasma, which are prepared from human whole blood by physical, rather than chemical processes, but does not include blood derivatives manufactured or processed by industrial use.
(2)  “Industrial use” means a use of blood in which the blood is modified by physical or chemical means to produce derivatives for therapeutic or pharmaceutic biologics, laboratory reagents, or in vitro diagnostics.
(3)  “Payment” means the transfer by a blood bank, or any other party, to any person of money or any other valuable consideration which can be converted to money by the recipient, except that “payment” shall not include any of the following:
(i)  Cancellation or refund of the nonreplacement fees or related blood transfusion charges.
(ii)  Blood assurance benefits to a person as a result of a blood donation to a donor club or blood assurance program.
(iii)  Time away from employment granted by an employer to an employee in order to donate blood.
(c)  Any blood bank receiving blood from a blood bank outside of California shall comply with the labeling requirements of this chapter. Any blood bank receiving this blood may label the blood as “volunteer donor” blood only if the blood bank receives with the blood a certificate from the out-of-state blood bank which states either that the particular shipment of blood was acquired from volunteer donors not receiving payment or that all blood processed by the out-of-state blood bank is acquired from volunteer donors not receiving payment. If the blood bank receiving such blood receives no such certificate with the blood, the blood shall be labeled as “paid donor” blood.
(d)  No warranty shall be implied from the fact that any blood is labeled in accordance with the requirements of this section.
(Amended by Stats. 1989, Ch. 513, Sec. 1.)
2023 California Code › Health and Safety Code - HSC › DIVISION 2 - LICENSING PROVISIONS › CHAPTER 4 - Human Whole Blood, Human Whole Blood Derivatives, and Other Biologics › ARTICLE 2 - Human Whole Blood and Human Whole Blood Derivatives › Section 1604.

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 only to blood bank depositories or to other licensed blood banks.
(Repealed and added by Stats. 1963, Ch. 1055.)
2023 California Code › Health and Safety Code - HSC › DIVISION 2 - LICENSING PROVISIONS › CHAPTER 4 - Human Whole Blood, Human Whole Blood Derivatives, and Other Biologics › ARTICLE 2 - Human Whole Blood and Human Whole Blood Derivatives › Section 1604.6.

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 this chapter. Any additional standards for blood banks to store umbilical cord blood may be implemented by the department through the adoption of regulations.
(b) (1) The department may adopt emergency regulations to implement and make specific subdivision (a) in accordance with Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code. For purposes of the Administrative Procedure Act, the adoption of regulations shall be deemed an emergency and necessary for the immediate preservation of the public peace, health and safety, or general welfare.
(2) (A) Notwithstanding Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code, these emergency regulations shall not be subject to the review and approval of the Office of Administrative Law. Notwithstanding Sections 11346.1 and 11349.6 of the Government Code, the department shall submit these regulations directly to the Secretary of State for filing.
(B) Emergency regulations adopted pursuant to this section shall become effective immediately upon filing by the Secretary of State, shall be subject to public hearing within 120 days of filing with the Secretary of State, and shall comply with Sections 11346.8 and 11346.9 of the Government Code, or shall be repealed by the department.
(3) The Office of Administrative Law shall provide for the printing and publication of emergency regulations adopted pursuant to this section in the California Code of Regulations.
(4) Notwithstanding Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code, and subject to subparagraph (B) of paragraph (2), the emergency regulations adopted pursuant to this subdivision shall not be repealed by the Office of Administrative Law and shall remain in effect until revised or repealed by the department.
(Amended by Stats. 2007, Ch. 130, Sec. 160. Effective January 1, 2008.)
2023 California Code › Health and Safety Code - HSC › DIVISION 2 - LICENSING PROVISIONS › CHAPTER 4 - Human Whole Blood, Human Whole Blood Derivatives, and Other Biologics › ARTICLE 2 - Human Whole Blood and Human Whole Blood Derivatives › Section 1605.

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 chapter shall be considered as blood bank depositories. Laboratory tests and other procedures with respect to the preparation of blood for transfusion shall be the sole responsibility of the blood bank depository.
(Repealed and added by Stats. 1963, Ch. 1055.)
2023 California Code › Health and Safety Code - HSC › DIVISION 2 - LICENSING PROVISIONS › CHAPTER 4 - Human Whole Blood, Human Whole Blood Derivatives, and Other Biologics › ARTICLE 2 - Human Whole Blood and Human Whole Blood Derivatives › Section 1606.

1606. The procurement, processing, distribution, or use of whole blood, plasma, blood products, and blood derivatives for the purpose of injecting or transfusing the same, or any of them, into the human body shall be construed to be, and is declared to be, for all purposes whatsoever, the rendition of a service by each and every person, firm, or corporation participating therein, and shall not be construed to be, and is declared not to be, a sale of such whole blood, plasma, blood products, or blood derivatives, for any purpose or purposes whatsoever.
(Repealed and added by Stats. 1963, Ch. 1055.)
2023 California Code › Health and Safety Code - HSC › DIVISION 2 - LICENSING PROVISIONS › CHAPTER 4 - Human Whole Blood, Human Whole Blood Derivatives, and Other Biologics › ARTICLE 2 - Human Whole Blood and Human Whole Blood Derivatives › Section 1607.5.

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 of tissue which is necessary to accomplish such donation, and a blood bank may accept such donation.
(b)  Notwithstanding any other provision of law, a person who has attained the age of 15 may consent to the donation of his or her blood and to the penetration of tissue which is necessary to accomplish such donation, and a blood bank may accept such donation, if he or she has the written consent of his or her parents or a guardian, and the written authorization of a physician and surgeon.
(c)  As used in this section “donation of blood” means a giving of blood in which the donor of the blood receives no payment therefor.
(Amended by Stats. 1981, Ch. 23.)
2023 California Code › Health and Safety Code - HSC › DIVISION 2 - LICENSING PROVISIONS › CHAPTER 4 - Human Whole Blood, Human Whole Blood Derivatives, and Other Biologics › ARTICLE 2 - Human Whole Blood and Human Whole Blood Derivatives › Section 1608.

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.
(Repealed and added by Stats. 1963, Ch. 1055.)
2023 California Code › Health and Safety Code - HSC › DIVISION 2 - LICENSING PROVISIONS › CHAPTER 4 - Human Whole Blood, Human Whole Blood Derivatives, and Other Biologics › ARTICLE 3 - Biologics Other Than Human Whole Blood and Human Whole Blood Derivatives › Section 1609.

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 the Public Health Service, United States Department of Health, Education and Welfare.
(b) In a laboratory licensed by the Animal Inspection and Quarantine Branch, Agricultural Research Service, United States Department of Agriculture.
(c) In a clinical trial site storing or preparing for patient administration biologics, other than human whole blood and human whole blood derivatives, intended solely for investigational use by experts qualified by scientific training and experience to investigate the safety and effectiveness of drugs or devices if the investigation is conducted in accordance with the requirements of Section 505(i) of the federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 355(i)) or Section 520(g) thereof (21 U.S.C. Sec. 360j(g)) and the regulations adopted pursuant to the federal act.
(d) Under the provisions of this chapter.
(Amended by Stats. 2022, Ch. 955, Sec. 2. (SB 1500) Effective January 1, 2023.)
2023 California Code › Health and Safety Code - HSC › DIVISION 2 - LICENSING PROVISIONS › CHAPTER 4 - Human Whole Blood, Human Whole Blood Derivatives, and Other Biologics › ARTICLE 3 - Biologics Other Than Human Whole Blood and Human Whole Blood Derivatives › Section 1610.

1610. The department shall make rules and regulations governing the production of all biologics produced in establishments under subdivision (c) of Section 1609.
(Repealed and added by Stats. 1963, Ch. 1055.)
2023 California Code › Health and Safety Code - HSC › DIVISION 2 - LICENSING PROVISIONS › CHAPTER 4 - Human Whole Blood, Human Whole Blood Derivatives, and Other Biologics › ARTICLE 3 - Biologics Other Than Human Whole Blood and Human Whole Blood Derivatives › Section 1611.

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 animals.
(Repealed and added by Stats. 1963, Ch. 1055.)
2023 California Code › Health and Safety Code - HSC › DIVISION 2 - LICENSING PROVISIONS › CHAPTER 4 - Human Whole Blood, Human Whole Blood Derivatives, and Other Biologics › ARTICLE 4 - Licenses › Section 1613.

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:
(a)  The name and address of the person owning the place, establishment, or institution in which biologics production is planned.
(b)  The name and address of the person to be in charge of biologics production.
(c)  The types of biologics to be produced.
(d)  A full description of the building, its location, facilities, equipment, and apparatus to be used in biologics production.
(e)  The name and address of each blood collection center operated by the applicant and whether the applicant operates any mobile units.
(f)  Any additional information as the department may require.
(Amended by Stats. 1991, Ch. 800, Sec. 12.)
2023 California Code › Health and Safety Code - HSC › DIVISION 2 - LICENSING PROVISIONS › CHAPTER 4 - Human Whole Blood, Human Whole Blood Derivatives, and Other Biologics › ARTICLE 4 - Licenses › Section 1614.

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 writing, serving a copy upon the applicant.
The notice may be served by registered mail addressed to the applicant at his last known address.
(Amended by Stats. 1991, Ch. 800, Sec. 13.)
2023 California Code › Health and Safety Code - HSC › DIVISION 2 - LICENSING PROVISIONS › CHAPTER 4 - Human Whole Blood, Human Whole Blood Derivatives, and Other Biologics › ARTICLE 4 - Licenses › Section 1615.

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 may be secured for the new location, owner, or person in charge prior to the actual change if the contemplated change is in compliance with all the provisions of this chapter and regulations pertaining thereto.
(b)  Proceedings for denial of license shall be conducted in accordance with Section 100171.
(Amended by Stats. 1997, Ch. 220, Sec. 18. Effective August 4, 1997.)
2023 California Code › Health and Safety Code - HSC › DIVISION 2 - LICENSING PROVISIONS › CHAPTER 4 - Human Whole Blood, Human Whole Blood Derivatives, and Other Biologics › ARTICLE 5 - Revenue › Section 1616.

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 amount sufficient to cover the cost of administering this chapter but not to exceed those costs, as specified pursuant to Section 1616.5.
(b)  The state department shall receive and account for all moneys received pursuant to this chapter and shall deposit them with the Treasurer for deposit in the Clinical Laboratory Improvement Fund established pursuant to Section 1302 of the Business and Professions Code. All funds received pursuant to this chapter shall, upon appropriation, be expended to administer this chapter.
(c)  Each license issued under this chapter shall expire 12 months from the date of its issuance. Application for renewal of license accompanied by the fee shall be filed with the department not less than 10 days prior to the expiration each year. Failure to make a timely renewal shall result in expiration of the license.
(Amended by Stats. 1994, Ch. 492, Sec. 5. Effective January 1, 1995.)
2023 California Code › Health and Safety Code - HSC › DIVISION 2 - LICENSING PROVISIONS › CHAPTER 4 - Human Whole Blood, Human Whole Blood Derivatives, and Other Biologics › ARTICLE 5 - Revenue › Section 1616.5.

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 subdivision (b), shall not exceed the following:
One thousand five hundred dollars ($1,500) for a blood bank and no more than one blood collection center operated at the same location as the blood bank. In addition and irrespective of the location of the blood collection center, a fee of five hundred dollars ($500) for each additional blood collection center operated by the blood bank up to a maximum of one thousand five hundred dollars ($1,500) for three or more blood collection centers.
(b)  The maximum application and renewal fees for blood bank licenses pursuant to subdivision (a) shall be adjusted annually in the manner specified in Section 100450. The adjustments shall be rounded off to the nearest whole dollar.
(c)  This chapter shall not be interpreted to exempt the state, a district, city, county, or city and county, from payment of fees or from meeting the requirements established pursuant to this chapter or regulations adopted thereunder.
(Amended by Stats. 1996, Ch. 1023, Sec. 169. Effective September 29, 1996.)
2023 California Code › Health and Safety Code - HSC › DIVISION 2 - LICENSING PROVISIONS › CHAPTER 4 - Human Whole Blood, Human Whole Blood Derivatives, and Other Biologics › ARTICLE 6 - Enforcement › Section 1617.

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 the following:
(1)  Enter or inspect on an announced or unannounced basis any building, premise, equipment, materials, records, or information at any reasonable time to secure compliance with, or prevent a violation of, this chapter or the regulations adopted pursuant thereto.
(2)  Inspect, photograph, or copy any records, reports, test results, test specimens, or other information related to the requirements of this chapter or the regulations adopted pursuant thereto.
(3)  Secure any sample, photograph, or other evidence from any building or premise for the purpose of enforcing this chapter or the regulations adopted pursuant thereto.
(Amended by Stats. 1991, Ch. 800, Sec. 16.)
2023 California Code › Health and Safety Code - HSC › DIVISION 2 - LICENSING PROVISIONS › CHAPTER 4 - Human Whole Blood, Human Whole Blood Derivatives, and Other Biologics › ARTICLE 6 - Enforcement › Section 1618.

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 department under authority conferred by this chapter. The proceedings shall be conducted in accordance with Section 100171.
(b)  Licenses may be denied for any reason applicable to revocation and suspension of licenses.
(c)  District and city attorneys shall prosecute violations of this chapter upon evidence of violations within their respective jurisdictions submitted by the department.
(Amended by Stats. 1997, Ch. 220, Sec. 19. Effective August 4, 1997.)
2023 California Code › Health and Safety Code - HSC › DIVISION 2 - LICENSING PROVISIONS › CHAPTER 4 - Human Whole Blood, Human Whole Blood Derivatives, and Other Biologics › ARTICLE 6 - Enforcement › Section 1619.

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 that division shall apply to biologics within the meaning of this chapter, except that this chapter shall not apply to products of:
(a)  A laboratory licensed by the Public Health Service, United States Department of Health, Education and Welfare.
(b)  A laboratory licensed by the Animal Inspection and Quarantine Branch, Agricultural Research Service, United States Department of Agriculture.
(Amended by Stats. 1996, Ch. 1023, Sec. 170. Effective September 29, 1996.)
2023 California Code › Health and Safety Code - HSC › DIVISION 2 - LICENSING PROVISIONS › CHAPTER 4 - Human Whole Blood, Human Whole Blood Derivatives, and Other Biologics › ARTICLE 6 - Enforcement › Section 1620.

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 dollars ($1,000), or by imprisonment for not more than 30 days, or by both.
(Amended by Stats. 1983, Ch. 1092, Sec. 148. Effective September 27, 1983. Operative January 1, 1984, by Sec. 427 of Ch. 1092.)
2023 California Code › Health and Safety Code - HSC › DIVISION 2 - LICENSING PROVISIONS › CHAPTER 4 - Human Whole Blood, Human Whole Blood Derivatives, and Other Biologics › ARTICLE 7 - Blood Donations › Section 1625.

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 physical, rather than chemical processes, but does not include blood derivatives manufactured or processed for industrial use.
(b)  “Cytapheresis” means the separation and collection of blood cells by hemapheresis.
(c)  “Hemapheresis” means the removal of whole blood from a donor, separation of the blood into components, retention of the desired components, and return of the recombined remaining elements to the donor.
(d)  “Industrial use” means a use of blood in which the blood is modified by physical or chemical means to produce derivatives for therapeutic or pharmaceutic biologics, laboratory reagents, or in vitro diagnostics.
(e)  “Paid donor” means a person who donates blood and who receives payment in return for the donation of such blood.
(f)  “Payment” means the transfer by a blood bank to any person of money or any other valuable consideration which can be converted to money by the recipient, except that payment shall not include any of the following:
(1)  Cancellation or refund of the nonreplacement fees or related blood transfusion charges.
(2)  Blood assurance benefits to a person as a result of a blood donation to a donor club or blood assurance program.
(3)  Time away from employment, with or without pay, granted by an employer to an employee in order to donate blood.
(g)  “Person” means any individual, blood bank, hospital, firm, corporation, or any other entity.
(h)  “Transfusion” means a use of blood in which the blood is administered to a human being for treatment of sickness or injury.
(Amended by Stats. 1986, Ch. 1007, Sec. 2.)
2023 California Code › Health and Safety Code - HSC › DIVISION 2 - LICENSING PROVISIONS › CHAPTER 4 - Human Whole Blood, Human Whole Blood Derivatives, and Other Biologics › ARTICLE 7 - Blood Donations › Section 1625.1.

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 any other requirements identified by the State Department of Health Services, hemapheresis donors shall provide a medical history questionnaire completed by a trained interviewer who questions and verifies the accuracy of responses before every donation.
The department may require testing or examinations to reflect changing technology and to increase the safety of blood products.
(Added by Stats. 1986, Ch. 1007, Sec. 3.)
2023 California Code › Health and Safety Code - HSC › DIVISION 2 - LICENSING PROVISIONS › CHAPTER 4 - Human Whole Blood, Human Whole Blood Derivatives, and Other Biologics › ARTICLE 7 - Blood Donations › Section 1626.

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.
(b)  Subdivision (a) shall not be applicable to any transfusion of blood that was obtained from a paid donor if the physician and surgeon performing the transfusion has determined, taking into consideration the condition of the patient who is the recipient of the transfusion, that other blood of a type compatible with the blood type of the patient cannot reasonably be obtained for the transfusion.
(c)  Subdivision (a) shall not apply to blood platelets secured from paid donors through the hemapheresis process if all of the following requirements are satisfied:
(1)  The blood platelets are ordered by a doctor holding a valid California physician’s and surgeon’s certificate.
(2)  The blood platelets are secured from a single donor and are sufficient to constitute a complete platelet transfusion.
(3)  The donor’s identification number is recorded on the platelet label and is kept in the records of the entity providing the blood platelets for a minimum of five years.
(4)  The donor has been examined by a doctor holding a valid California physician’s and surgeon’s certificate, and a repeat donor is reexamined at least annually.
(5)  The transfusion is performed in a general acute care hospital.
(6)  The blood platelets are processed according to standards issued by the American Association of Blood Banks, pursuant to Section 1602.1.
(7)  The donor and blood are tested in accordance with regulations issued by the State Department of Health Services.
(8)  The entity providing the blood platelets is licensed by the State Department of Health Services.
(9)  The information that the donor of the blood platelets was compensated is printed on the label in accordance with Section 1603.5.
(10)  In all instances, a potential donor shall provide a blood sample, which shall be tested with the standard panel of blood tests required by the State Department of Health Services for all blood donations. The results of the testing shall be obtained, evaluated, and determined to be acceptable prior to allowing the potential donor to provide his or her first donation of platelets. In addition, all donors shall be required to schedule an appointment for platelet donation.
(11)  Any entity that is not collecting blood platelets from paid donors on August 1, 2000, shall obtain written permission from the director prior to compensating any donor for blood platelets.
(d)  Subdivision (c) shall become inoperative on January 1, 2003.
(Amended by Stats. 2012, Ch. 728, Sec. 83. (SB 71) Effective January 1, 2013.)
2023 California Code › Health and Safety Code - HSC › DIVISION 2 - LICENSING PROVISIONS › CHAPTER 4 - Human Whole Blood, Human Whole Blood Derivatives, and Other Biologics › ARTICLE 8 - Umbilical Cord Blood Program › Section 1628.

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 Program Fund is hereby created in the State Treasury. Any fees collected pursuant to Section 103625 shall be deposited into the fund. Moneys in the fund shall be available, upon appropriation by the Legislature, for purposes of this article.
(c) The fund may include additional federal, state, and private funds made available for purposes of the program, including, but not limited to, the fees collected for the fund pursuant to Section 103625, and, notwithstanding Section 16305.7 of the Government Code, any interest earned on moneys in the fund.
(d) (1) Funds shall be appropriated for the purposes of this article to the extent the plan the University of California is requested to develop pursuant to subdivision (a) of Section 1627 and the implementation of the plan are consistent with the goals and intent of this article.
(2) In the event that funds are not appropriated for the program as described in this article, it is the intent of the Legislature that the University of California shall not implement the program.
(Amended by Stats. 2010, Ch. 529, Sec. 3. (AB 52) Effective September 29, 2010. Repealed as of January 1, 2027, pursuant to Section 1630.)
2023 California Code › Health and Safety Code - HSC › DIVISION 2 - LICENSING PROVISIONS › CHAPTER 4 - Human Whole Blood, Human Whole Blood Derivatives, and Other Biologics › ARTICLE 8 - Umbilical Cord Blood Program › Section 1629.

1629. In implementing the program, the department shall make every effort to avoid duplication or conflicts with existing and ongoing programs and to leverage existing resources.
(Added by Stats. 2007, Ch. 516, Sec. 2. Effective January 1, 2008. Repealed as of January 1, 2027, pursuant to Section 1630.)
2023 California Code › Health and Safety Code - HSC › DIVISION 2 - LICENSING PROVISIONS › CHAPTER 4 - Human Whole Blood, Human Whole Blood Derivatives, and Other Biologics › ARTICLE 8 - Umbilical Cord Blood Program › Section 1629.5.

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 to the Assembly and Senate Committees on Health that addresses, at a minimum, all of the following:
(1) The number of cord blood units collected and registered under the program, disaggregated by race and ethnicity.
(2) The number of registered units transplanted as a result of the program, disaggregated by race and ethnicity.
(3) The number of California residents receiving a transplant as a result of the program.
(4) The number of units made available for research and a summary of key research findings as a result of the program.
(5) Annual budget information on the program, including revenues, spending, and beginning- and end-of-year balances.
(6) Budget information for each participating cord blood bank, including collection and storage costs and available revenues to cover those costs.
(7) Fees charged by participating cord blood banks for collecting, storing, handling, and providing units, and a summary of how these fees were determined.
(8) Nationwide data on cord blood units collected, registered, and transplanted, disaggregated by race and ethnicity.
(9) A summary of available cell sources for a hematopoietic stem cell transplant and research on the ability of underrepresented groups to find a suitable match for a transplant.
(10) Any other outcomes or data regarding the impact of the program.
(b) The requirement for submitting a report imposed under subdivision (a) is inoperative on December 31, 2026, pursuant to Section 10231.5 of the Government Code.
(Amended by Stats. 2022, Ch. 604, Sec. 2. (SB 883) Effective January 1, 2023. Repealed as of January 1, 2027, pursuant to Section 1630.)
2023 California Code › Health and Safety Code - HSC › DIVISION 2 - LICENSING PROVISIONS › CHAPTER 4 - Human Whole Blood, Human Whole Blood Derivatives, and Other Biologics › ARTICLE 8 - Umbilical Cord Blood Program › Section 1630.

1630. This article shall remain in effect only until January 1, 2027, and as of that date is repealed.
(Repealed and added by Stats. 2022, Ch. 604, Sec. 4. (SB 883) Effective January 1, 2023. Repealed as of January 1, 2027, by its own provisions. Note: Repeal affects Article 8, commencing with Section 1627.)
2023 California Code › Health and Safety Code - HSC › DIVISION 2 - LICENSING PROVISIONS › CHAPTER 4.1 - Tissue Banks › ARTICLE 1 - Definitions, Licensure, and Exceptions › Section 1635.

1635. (a) “Department” means the State Department of Public Health.
(b) “Donor” means an individual, living or deceased, from whom tissue is removed.
(c) “Gamete bank” means a tissue bank that collects, processes, stores, or distributes sperm, oocytes, or embryos, including a facility that provides professional reproductive services, other than those facilities exempt from tissue bank licensure.
(d) “Person” means an individual, corporation, business trust, estate trust, partnership, association, state or local government, or subdivision or agency thereof, or any other legal entity.
(e) (1) “Tissue” means a human cell, group of cells, including the cornea, sclera, or vitreous humor and other segments of, or the whole eye, bones, skin, arteries, sperm, oocytes, embryos, blood, other fluids, and any other portion of a human body, but shall not include an organ when recovered for transplantation or research purposes.
(2) For purposes of paragraph (1), “organ” means a human kidney, liver, heart, lung, pancreas, intestine (including the esophagus, stomach, small or large intestine, or any portion of the gastrointestinal tract), or vascularized composite allograft, and associated blood vessels recovered from an organ donor during the recovery of the organ.
(f) “Tissue bank” means a place, establishment, or institution that collects, processes, stores, or distributes tissue for transplantation into human beings.
(g) “Transplantation” means the act or process of transferring tissue, including by ingestion, from a donor to the body of the donor or another human being.
(Amended by Stats. 2019, Ch. 539, Sec. 1. (AB 785) Effective January 1, 2020.)
2023 California Code › Health and Safety Code - HSC › DIVISION 2 - LICENSING PROVISIONS › CHAPTER 4.1 - Tissue Banks › ARTICLE 1 - Definitions, Licensure, and Exceptions › Section 1635.2.

1635.2. The Legislature hereby declares its intent that the collection, processing, storage, or distribution of tissue for the purpose of transplantation, as regulated by this chapter, shall be deemed a service by those persons engaged in these activities. Therefore, the collection, processing, storage, or distribution of tissue for the purpose of transplantation, as regulated by this chapter, shall not be subject to the requirements of Division 2 (commencing with Section 2101) of the Commercial Code.
(Added by Stats. 1991, Ch. 801, Sec. 2.)
2023 California Code › Health and Safety Code - HSC › DIVISION 2 - LICENSING PROVISIONS › CHAPTER 4.1 - Tissue Banks › ARTICLE 2 - Regulation of Tissue Banks › Section 1639.

1639. (a)  The department may adopt rules and regulations governing the administration and enforcement of this chapter.
(b)  Regulations adopted by the department may include minimum standards for the following:
(1)  Safe preservation, transportation, storage, and handling of tissue acquired or used for transplantation.
(2)  Testing of donors to determine compatibility when appropriate.
(3)  Testing or assessment of donors to prevent the spread of disease through transplantation.
(4)  Equipment.
(5)  Methods.
(6)  Personnel qualifications.
(7)  Any other area concerning the operation or maintenance of a tissue bank, not inconsistent with this chapter, as may be necessary to carry out this chapter.
(c)  The department shall report to the Legislature by January 1, 2004, on the status of the regulations developed pursuant to this section.
(Amended by Stats. 2003, Ch. 464, Sec. 1. Effective January 1, 2004.)
2023 California Code › Health and Safety Code - HSC › DIVISION 2 - LICENSING PROVISIONS › CHAPTER 4.1 - Tissue Banks › ARTICLE 2 - Regulation of Tissue Banks › Section 1639.01.

1639.01. (a)  Notwithstanding Section 1639, the state department shall adopt, on or before July 1, 2004, rules and regulations governing licensed tissue banks engaged in the collection of human musculoskeletal tissue, skin, and veins for transplantation in humans. The regulations shall be substantially based upon the criteria used by tissue bank trade associations in their respective accreditation processes including, but not limited to, those of the Eye Bank Association of America and the American Association of Tissue Banks, and the scientific and technical data submitted by individual tissue banks.
(b)  Regulations adopted by the state department, pursuant to subdivision (a), shall include minimum standards for all of the following:
(1)  Safe preservation, transportation, storage, and handling of tissue acquired or used for transplantation.
(2)  Testing of donors to determine compatibility when appropriate.
(3)  Testing or assessment of donors to prevent the spread of disease through transplantation.
(4)  Equipment.
(5)  Methods.
(6)  Personnel qualifications.
(7)  Any other area concerning the operation or maintenance of a tissue bank, not inconsistent with this chapter, as may be necessary to carry out this chapter.
(c)  On or before July 1, 2003, the department shall report to the appropriate policy and fiscal committees of the Legislature regarding the status of the proposed regulations.
(Added by Stats. 2002, Ch. 929, Sec. 1. Effective January 1, 2003.)
2023 California Code › Health and Safety Code - HSC › DIVISION 2 - LICENSING PROVISIONS › CHAPTER 4.1 - Tissue Banks › ARTICLE 2 - Regulation of Tissue Banks › Section 1639.1.

1639.1. Any person desiring a license issued pursuant to Section 1639.3 shall file with the state department a verified application on forms prescribed by the state department containing all of the following:
(a)  The name of the applicant for licensure.
(b)  The street address of the tissue bank. If more than one street address is occupied by the tissue bank, all occupied street addresses shall be listed.
(c)  Whether the applicant is an individual, partnership, unincorporated association, or corporation.
(d)  Whether the applicant does business under a fictitious name, and, if so, the fictitious name and the name of the locality wherein any fictitious name permit is filed.
(e)  If the applicant is a partnership, the names of all the members of the partnership, or unincorporated association, whether general or limited.
(f)  If the applicant is a corporation, the name of the officers, directors, shareholders holding a 5 percent or more interest in the corporation, and any person, partnership, or corporation who or which has the responsibility to manage or conduct the day-to-day operation of the tissue bank.
(g)  The type of tissue collected, processed, stored, or distributed by the tissue bank.
(h)  The names, titles, and qualifications of the persons responsible for the collection, processing, storage, or distribution of tissue by the tissue bank.
(i)  Any process utilized by the tissue bank to ensure safe preservation, transportation, storage, and handling, of tissue acquired or used by the tissue bank.
(j)  Any process utilized by the tissue bank to determine if, when appropriate, donors have been tested to determine compatibility.
(k)  Any process utilized by the tissue bank to determine if donors have been tested or assessed for the transmission of disease through transplantation.
(Added by Stats. 1991, Ch. 801, Sec. 2.)
2023 California Code › Health and Safety Code - HSC › DIVISION 2 - LICENSING PROVISIONS › CHAPTER 4.1 - Tissue Banks › ARTICLE 2 - Regulation of Tissue Banks › Section 1639.2.

1639.2. (a)  Each license issued pursuant to subdivision (a) of Section 1639.3 before July 1, 1992, shall expire July 1, 1993. Every other license issued pursuant to subdivision (a) of Section 1639.3 shall expire 12 months from the date of issuance.
(b)  An application for renewal of a license issued pursuant to subdivision (a) of Section 1639.3 shall be filed with the state department not less than 30 days prior to its expiration date and shall be accompanied by the annual renewal fee required in Section 1639.5. Failure to make timely application or payment for renewal shall result by operation of law in expiration of the license on its expiration date.
(c)  Upon application and payment of the required fee, a renewal license issued under subdivision (a) of Section 1639.3 shall be renewed for one- or two-year periods, at the option of the licensee, as long as the licensee has been found to be in substantial compliance with this chapter and the rules and regulations adopted under this chapter during the preceding license period.
(d)   Any license issued pursuant to this chapter shall be forfeited by operation of law prior to its expiration date when one of the following occurs:
(1)  The tissue bank is sold or otherwise transferred.
(2)  The license is surrendered to the state department.
(Added by Stats. 1991, Ch. 801, Sec. 2.)