reglab/statecodes huggingface dataset:
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 1 - PRODUCTION AND DISTRIBUTION OF BIOLOGICS › Article 5 - CONTAINERS AND LABELING › Section 972 - Containers and Labeling

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) No
						biological product either for human or animal use shall be distributed except in the
						original final container bearing the original label of the manufacturer; provided,
						however, that a licensed laboratory may purchase products from other producers
						likewise licensed by the State, and repack and relabel such products in smaller
						containers; provided, there are no changes, substitutions or additions in the
						product or the label, and further provided, that all such repacked biological
						products shall bear on the label the name of the manufacturer as well as the name of
						the distributor together with a statement that the product has been repacked. All
						such repacked products are subject to the requirements of Sections
						1600 to
						1621,
						inclusive, Health and Safety Code, and are not exempted from inspection and license
						by the department.
(b) The labels of all
						biologic products on the containers for general distribution shall show the name of
						the product, the lot number that will identify the lot or batch in the record of the
						manufacturer, the expiration date, and the name of the manufacturer. The expiration
						date shall be based on a period of duration approved by the department.
(c) The labels on all bottles and individual
						packages of bacterial vaccines (bacterins) shall give the correct name of the
						organism concerned and mixed bacterins shall give the names of each organism
						according to the classification of Bergey in the mixture and the proportion that
						each organism represents in the mixture. The concentration may be expressed in
						number per mil or in terms of a turbidity standard acceptable to the
						department.
(d) The labels on products
						requiring refrigeration or maintenance of uniform temperatures to avoid
						deterioration, shall specify the temperature range within which the product shall be
						maintained.
(e) To prevent accidental
						use, all stocks of labels and advertising not accepted by the department shall be
						destroyed.
1. Repealer
						  of subsection (e) and relettering of subsection (f) to (e) filed 8-16-71; effective
						  thirtieth day thereafter (Register 71, No. 34).
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 1 - PRODUCTION AND DISTRIBUTION OF BIOLOGICS › Article 6 - ADVERTISING › Section 977 - Advertising

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) No statements
						regarding preventive or therapeutic value shall be made either on labels or
						circulars or in any form of advertising that are not in accord with the opinion held
						by the recognized authorities of the medical profession and no descriptive matter or
						discussion of mode of action of the product or theory of its applicability may be
						used that is not acceptable to the same authorities.
(b) No mention of the department shall be made in
						advertising either directly or indirectly.
(c) All advertising matter, statements, and
						representations pertaining to biologics licensed under Sections
						1600 to
						1620,
						Health and Safety Code, shall be submitted to the department at least 30 days prior
						to their use by the licensee.
1. Amendment
						  filed 3-5-76; effective thirtieth day thereafter (Register 76, No.
						  10).
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 1 - PRODUCTION AND DISTRIBUTION OF BIOLOGICS › Article 7 - SAMPLES › Section 982 - Potency

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
Licensees producing, processing or distributing biologics
						  for which a potency test is recognized or prescribed by the United States Department
						  of Health, Education, and Welfare, shall upon the request of the department, provide
						  a representative sample of each lot of such product for purposes of checking. The
						  particular lot so sampled shall not be distributed until approval is given by the
						  department.
1. Amendment
						  filed 3-5-76; effective thirtieth day thereafter (Register 76, No.
						  10).
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 1 - PRODUCTION AND DISTRIBUTION OF BIOLOGICS › Article 8 - VACCINE CULTURE › Section 987 - Vaccine Culture

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
No culture shall be used in the preparation of live culture
						  vaccine unless it is nonvirulent or has sufficiently low virulence as not to be
						  reasonably likely to produce the disease in the inoculated person, or be dangerous
						  from the standpoint of contagion. Such cultures must be tested and approved by the
						  department before use.
1. Amendment
						  filed 3-5-76; effective thirtieth day thereafter (Register 76, No.
						  10).
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 1 - PRODUCTION AND DISTRIBUTION OF BIOLOGICS › Article 9 - PREPARATION AND DISTRIBUTION OF WHOLE BLOOD (HUMAN) › Section 998 - Personnel of Blood Banks and Their Auxiliaries

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) Physicians and surgeons, clinical laboratory
						bioanalysts, clinical laboratory technologists, clinical laboratory technologist
						trainees and nurses who comprise the staff of the blood bank shall be duly licensed
						by or registered in the State of California. The staff may include such other
						persons, when approved by the director, as may be necessary for the proper operation
						of the blood bank, including volunteer workers.
(b) Director of Blood Bank. The blood bank and its
						auxiliaries shall be under the direction of a physician and surgeon duly licensed by
						the State of California, and who shall have a minimum of six months experience in
						blood bank methods, transfusion principles, and transfusion practices, satisfactory
						to the department. Attending Physician refers to the duly licensed physician and
						surgeon supervising blood collection activities.
(c) Laboratory Personnel. The laboratory personnel
						shall be licensed pursuant to the Clinical Laboratory Laws (California Business and
						Professions Code, Division 2, Chapter 3), except that unlicensed persons may be used
						to assist licensed personnel under their supervision, so long as such unlicensed
						persons do not perform laboratory tests or render judgment on such tests.
1. Amendment
						  of subsection (b) filed 7-31-68; effective thirtieth day thereafter (Register 68,
						  No. 29).
2. New NOTE filed 3-20-84 (Register 84, No.
						  12).
Note: Authority cited: Sections
							 208 and
							 1603,
							 Health and Safety Code. Reference: Section
							 1603(c),
							 Health and Safety Code.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 1 - PRODUCTION AND DISTRIBUTION OF BIOLOGICS › Article 9 - PREPARATION AND DISTRIBUTION OF WHOLE BLOOD (HUMAN) › Section 999 - Blood Bank Equipment, Facilities and Manual. [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. Change
						  without regulatory effect repealing section and adopting new NOTE filed 7-13-98
						  pursuant to section
						  100, title 1, California Code of
						  Regulations (Register 98, No. 29).
Note: Authority cited: Sections
							 1602.5
							 and
							 100275,
							 Health and Safety Code. Reference: Section
							 1602.5,
							 Health and Safety Code.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 1 - PRODUCTION AND DISTRIBUTION OF BIOLOGICS › Article 9 - PREPARATION AND DISTRIBUTION OF WHOLE BLOOD (HUMAN) › Section 1000 - Blood Bank Records; Identification of Human Blood with Its Donor

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) A system which carries through from donor to
						recipient must be used to identify the blood. This shall be accomplished by having
						blood container and pilot tube labels identified with the donor before venesection.
						The labels and personal history shall carry the same identification number. These
						labels shall accompany the donor to the collection room and shall be applied to the
						blood container and pilot tubes while it is still possible to check accurately the
						identity of the blood with the donor and his history. Other documents related to the
						blood such as invoices, if used, shall also contain the same identification
						number.
(b) Every California licensed
						blood bank shall obtain reports of reactions in individuals receiving its blood, or
						blood derivatives, where it appears that these materials from the blood bank may be
						implicated in such reactions. Reporting shall include also any illness whose cause
						may be related to transfusion of blood or blood derivatives provided by the blood
						bank. Forms for these purposes may be devised by the blood bank as a reminder to the
						transfusion services and as encouragement to them to comply with this
						requirement.
(c) In addition to the
						applicable portions of the regulations set forth in Section
						963 and the first two paragraphs of
						this section, the blood bank shall keep complete records of each donor, which shall
						include all information specified in Section
						1002. Records are required also which
						contain information related to the disposition of all blood collected or
						distributed.
(d) These records shall be
						kept for an interval of not less than five years after the expiration date of the
						blood unit involved. All such records shall be correlated in such a way that
						checking the complete history of each blood unit may be quickly and conveniently
						performed.
(e) Records of refrigerator
						temperatures shall fulfill the requirements contained in Section
						1002(g)(2) of these
						regulations.
(f) All blood bank records
						shall be dated.
1. New NOTE
						  filed 3-20-84 (Register 84, No. 12).
Note: Authority cited: Sections
							 208 and
							 1603,
							 Health and Safety Code. Reference: Section
							 1603,
							 Health and Safety Code.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 1 - PRODUCTION AND DISTRIBUTION OF BIOLOGICS › Article 9 - PREPARATION AND DISTRIBUTION OF WHOLE BLOOD (HUMAN) › Section 1001 - Labels. [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. Repealer
						  of subsection (k) filed 4-20-77; effective thirtieth day thereafter (Register 77,
						  No. 17). For prior history, see Register 76, No. 10.
2. Change without
						  regulatory effect repealing section and adopting new NOTE filed 7-13-98 pursuant to
						  section 100, title 1, California Code of
						  Regulations (Register 98, No. 29).
Note: Authority cited: Sections
							 1602.5
							 and
							 100275,
							 Health and Safety Code. Reference: Section
							 1602.5,
							 Health and Safety Code.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 1 - PRODUCTION AND DISTRIBUTION OF BIOLOGICS › Article 9 - PREPARATION AND DISTRIBUTION OF WHOLE BLOOD (HUMAN) › Section 1002 - Requirements - Donors, Medical History, Blood Collection, Storage and Testing

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) Responsibilities.
						Final responsibility for the acceptance of donors rests with the attending
						physician.
Any time blood is collected under license, adequate medical
						  care for the donor shall be provided. Blood shall be drawn from the donor under the
						  supervision of a physician or registered nurse trained in the procedure. Blood may
						  be collected when a physician is not present on the premises under the following
						  conditions:
(1) The medical director and
						his medical advisory committee, if he has one, must approve.
(2) The employee placed in charge, in the absence
						of a qualified physician must be a registered nurse.
(3) The nursing staff and medical director must
						have a mutually clear understanding of the criteria for donor selection.
						Consultation with the medical director by telephone from mobile unit operations
						about certain donors may be necessary.
(4) A qualified physician or emergency medical
						facility shall be available nearby. Having a physician or emergency medical facility
						available is for the purpose of attending to donors who have a severe reaction or
						accident related to the blood donation. "Available" means no longer than 15 minutes
						away.
(5) Written emergency standing
						orders for donor care must be prepared by the medical director and be made available
						to the nursing staff. Appropriate training and refresher courses in emergency
						resuscitative methods must be planned. The nursing staff must be given special
						training on the symptomatology and emergency treatment of such conditions as cardiac
						and vascular disease, syncope, fractures, etc.
The attending physician shall sign all donor records, except
						  that he may delegate the responsibility for signature to an employee of the blood
						  bank whose license permits him to perform functions related to medical practice when
						  under medical supervision.
Irrespective of location, the blood bank under whose license
						  the blood is to be processed shall be responsible for all personnel engaged in
						  examining donors and collecting blood, as well as the space and equipment
						  used.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 1 - PRODUCTION AND DISTRIBUTION OF BIOLOGICS › Article 9 - PREPARATION AND DISTRIBUTION OF WHOLE BLOOD (HUMAN) › Section 1002.1 - Use of AIDS Antibody (HTLV-III) Test by Blood Banks. [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. New
						  section filed 3-8-85 as an emergency; effective upon filing (Register 85, No. 15). A
						  Certificate of Compliance must be transmitted to OAL within 120 days or emergency
						  language will be repealed on 7-8-85.
2. Repealer filed 5-22-85 as an
						  emergency; effective upon filing (Register 85, No. 22). A Certificate of Compliance
						  must be transmitted to OAL within 120 days or emergency language will be repealed on
						  9-19-85.
3. Emergency language filed 3-8-85 and 5-22-85 expired by
						  operation of Government Code Section
						  11346.1
						  (Register 87, No, 2).
Note: Authority cited: Sections
							 208 and
							 1603,
							 Health and Safety Code. Reference: Section
							 1603,
							 Health and Safety Code.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 1 - PRODUCTION AND DISTRIBUTION OF BIOLOGICS › Article 9 - PREPARATION AND DISTRIBUTION OF WHOLE BLOOD (HUMAN) › Section 1003 - Exceptions for Emergency Purposes

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
In the event that an emergency occurs as defined in Chapter
						  7 (California Emergency Services Act), Division 1, Title 2 of the Government Code
						  deviation from the provisions of Section
						  1001 and subsections (a) through (h) of
						  Section 1002 of this Article will be
						  permissible. The extent of deviation shall be determined by the blood bank director
						  with concurrence by the department and shall be commensurate with the degree of
						  emergency.
1. Amendment
						  filed 10-25-72; effective thirtieth day thereafter (Register 72, No.
						  44).
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 1 - PRODUCTION AND DISTRIBUTION OF BIOLOGICS › Article 9 - PREPARATION AND DISTRIBUTION OF WHOLE BLOOD (HUMAN) › Section 1004 - Reporting Requirements

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a)
						Notification of Positive Laboratory Finding for Syphilis. To assist the local health
						officer in the discharge of his duties under Section
						3110 and
						3194 of
						the Health and Safety Code, any person who is in charge of a blood bank in which a
						laboratory examination of any specimen derived from a donor yields serological or
						other evidence of syphilis shall promptly notify the health officer of the local
						health jurisdiction of the address of the donor. This notification shall contain the
						type of specimen, the date it was obtained, the nature and result of the test
						performed, and the name, address, and the date of birth of the donor who provided
						the specimen.
The notification may be made by mailing or otherwise
						  delivering a legible copy of the laboratory report containing all of the required
						  information or by a telephone communication which is documented in the blood bank's
						  records.
(b) The notifications
						required in this section are confidential and not open for public
						inspection.
1. New
						  section filed 3-5-76; effective thirtieth day thereafter (Register 76, No.
						  10.)
2. Amendment of subsection (a) filed 3-8-85 as an emergency;
						  effective upon filing (Register 85, No. 15). A Certificate of Compliance must be
						  transmitted to OAL within 120 days or emergency language will be repealed on
						  7-8-85.
3. Repealer and new subsection (a) filed 4-2-85 as an emergency;
						  effective upon filing (Register 85, No. 15). A Certificate of Compliance must be
						  transmitted to OAL within 120 days or emergency language will be repealed on
						  7-31-85.
4. Subsection (a) repealed by operation of Government Code
						  Section
						  11346.1(g)
						  (Register 85, No. 37).
5. Repealer and new subsection (a) filed 9-11-85
						  as an emergency; effective upon filing. Certificate of Compliance included (Register
						  85, No. 37).
6. Change without regulatory effect repealing subsections
						  (a)-(c), relettering subsections, and amending NOTE filed 7-13-98 pursuant to
						  section 100, title 1, California Code of
						  Regulations (Register 98, No. 29).
Note: Authority cited: Sections
							 1603,
							 1603.1(g),
							 100110
							 and
							 100275,
							 Health and Safety Code. Reference: Sections
							 1600-
							 1616,
							 Health and Safety Code.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 1 - PRODUCTION AND DISTRIBUTION OF BIOLOGICS › Article 10 - PREPARATION AND DISTRIBUTION OF NORMAL HUMAN PLASMA › Section 1010 - Procurement of Blood for Plasma Processing. [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. Repealer
						  and new Article 11 (Sections
						  1010 through
						  1022) filed 10-25-66; effective
						  thirtieth day thereafter (Register 66, No. 37). For history of previous Article 11,
						  see Registers 56, No. 2 and 59, No. 17.
2. Amendment of subsection (b)
						  filed 11-24-69; effective thirtieth day thereafter (Register 69, No.
						  48).
3. Renumbering of Article 11 to Article 10 and amendment filed
						  3-5-76; effective thirtieth day thereafter (Register 76, No. 10).
4.
						  Change without regulatory effect repealing section and amending NOTE filed 7-13-98
						  pursuant to section
						  100, title 1, California Code of
						  Regulations (Register 98, No. 29).
Note: Authority cited: Sections
							 1603,
							 100110
							 and
							 100275,
							 Health and Safety Code. Reference: Sections
							 1600-
							 1620,
							 Health and Safety Code.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 1 - PRODUCTION AND DISTRIBUTION OF BIOLOGICS › Article 10 - PREPARATION AND DISTRIBUTION OF NORMAL HUMAN PLASMA › Section 1011 - Personnel and Equipment

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
Blood shall be processed into plasma only in blood banks
						  adequately staffed and equipped for that purpose. The individual directly in charge
						  of plasma processing shall be a physician and surgeon duly licensed by the State of
						  California or an individual sufficiently trained in laboratory procedures relating
						  to blood banking and plasma processing and whose qualifications have been approved
						  by the department. The staff may include other trained persons necessary for the
						  proper operation of plasma processing.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 1 - PRODUCTION AND DISTRIBUTION OF BIOLOGICS › Article 10 - PREPARATION AND DISTRIBUTION OF NORMAL HUMAN PLASMA › Section 1012 - Single Donor Plasma and Single Donor Fresh Frozen Plasma (Antihemophilic). [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. Amendment
						  filed 4-1-71; effective thirtieth day thereafter (Register 71, No.
						  14).
2. Renumbering from Section
						  1022 and amendment filed 10-25-72;
						  effective thirtieth day thereafter (Register 72, No. 44). For history of former
						  Section 1012, see Register 71, No.
						  14.
3. Amendment filed 3-5-76; effective thirtieth day thereafter
						  (Register 76, No. 10.
4. Change without regulatory effect repealing
						  section and adopting new NOTE filed 7-13-98 pursuant to section
						  100, title 1, California Code of
						  Regulations (Register 98, No. 29).
Note: Authority cited: Sections
							 1602.5
							 and
							 100275,
							 Health and Safety Code. Reference: Section
							 1602.5,
							 Health and Safety Code.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 1 - PRODUCTION AND DISTRIBUTION OF BIOLOGICS › Article 10 - PREPARATION AND DISTRIBUTION OF NORMAL HUMAN PLASMA › Section 1013 - Storage. [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1.
						  Renumbering from Section
						  1019 and amendment filed 10-25-72;
						  effective thirtieth day thereafter (Register 72, No. 44). For history of former
						  Section 1013, see Register 71, No.
						  14.
2. Amendment filed 3-5-76; effective thirtieth day thereafter
						  (Register 76, No. 10.)
3. Change without regulatory effect repealing
						  section and adopting new NOTE filed 7-13-98 pursuant to section
						  100, title 1, California Code of
						  Regulations (Register 98, No. 29).
Note: Authority cited: Sections
							 1602.5
							 and
							 100275,
							 Health and Safety Code. Reference: Section
							 1602.5,
							 Health and Safety Code.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 1 - PRODUCTION AND DISTRIBUTION OF BIOLOGICS › Article 10 - PREPARATION AND DISTRIBUTION OF NORMAL HUMAN PLASMA › Section 1014 - Expiration Date. [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1.
						  Renumbering from Section
						  1020 and amendment filed 10-25-72;
						  effective thirtieth day thereafter (Register 72, No. 44). For history of former
						  Section 1020, see Register 71, No.
						  14.
2. Amendment filed 3-5-76; effective thirtieth day thereafter
						  (Register 76, No. 10.)
3. Change without regulatory effect repealing
						  section and adopting new NOTE filed 7-13-98 pursuant to section
						  100, title 1, California Code of
						  Regulations (Register 98, No. 29).
Note: Authority cited: Sections
							 1602.5
							 and
							 100275,
							 Health and Safety Code. Reference: Section
							 1602.5,
							 Health and Safety Code.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 1 - PRODUCTION AND DISTRIBUTION OF BIOLOGICS › Article 10 - PREPARATION AND DISTRIBUTION OF NORMAL HUMAN PLASMA › Section 1015 - Other Tests. [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. Repealer
						  filed 10-25-72; effective thirtieth day thereafter (Register 72, No.
						  44).
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 1 - PRODUCTION AND DISTRIBUTION OF BIOLOGICS › Article 10 - PREPARATION AND DISTRIBUTION OF NORMAL HUMAN PLASMA › Section 1016 - Filling the Final Container. [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. Repealer
						  filed 10-25-72; effective thirtieth day thereafter (Register 72, No.
						  44).
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 1 - PRODUCTION AND DISTRIBUTION OF BIOLOGICS › Article 10 - PREPARATION AND DISTRIBUTION OF NORMAL HUMAN PLASMA › Section 1017 - Labeling. [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. Repealer
						  filed 10-25-72; effective thirtieth day thereafter (Register 72, No.
						  44).
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 1 - PRODUCTION AND DISTRIBUTION OF BIOLOGICS › Article 10 - PREPARATION AND DISTRIBUTION OF NORMAL HUMAN PLASMA › Section 1018 - Diluent for Dried Plasma. [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. Repealer
						  filed 10-25-72; effective thirtieth day thereafter (Register 72, No.
						  44).
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 1 - PRODUCTION AND DISTRIBUTION OF BIOLOGICS › Article 10 - PREPARATION AND DISTRIBUTION OF NORMAL HUMAN PLASMA › Section 1021 - Requirements for Release. [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. Repealer
						  filed 10-25-72; effective thirtieth day thereafter (Register 72, No.
						  44).
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 1 - PRODUCTION AND DISTRIBUTION OF BIOLOGICS › Article 11 - PREPARATION OF OTHER BLOOD DERIVATIVES › Section 1024 - Red Blood Cells (Human). [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. Repealer
						  of Article 12 (§§
													1025-1026) filed 10-25-66; effective
						  thirtieth day thereafter (Register 66, No. 37). for former history of Article see
						  Registers 56, No. 2 and 61, No. 3.
2. Amendment filed 4-1-71; effective
						  thirtieth day thereafter (Register 71, No. 14).
3. Renumbering of Article
						  12 to Article 11 and amendment filed 3-5-76; effective thirtieth day thereafter
						  (Register 76, No. 10).
4. Change without regulatory effect repealing
						  section and amending NOTE filed 7-13-98 pursuant to section
						  100, title 1, California Code of
						  Regulations (Register 98, No. 29).
Note: Authority cited: Sections
							 1603,
							 100110
							 and
							 100275,
							 Health and Safety Code. Reference: Sections
							 1600-
							 1620,
							 Health and Safety Code.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 1 - PRODUCTION AND DISTRIBUTION OF BIOLOGICS › Article 11 - PREPARATION OF OTHER BLOOD DERIVATIVES › Section 1024.1 - Frozen Red Blood Cells. [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. New
						  section filed 3-5-76; effective thirtieth day thereafter (Register 76, No.
						  10).
2. Change without regulatory effect repealing section and amending
						  NOTE filed 7-13-98 pursuant to section
						  100, title 1, California Code of
						  Regulations (Register 98, No. 29).
Note: Authority cited: Sections
							 1602.5,
							 100110
							 and
							 100275,
							 Health and Safety Code. Reference: Sections
							 1600-
							 1616,
							 Health and Safety Code.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 1 - PRODUCTION AND DISTRIBUTION OF BIOLOGICS › Article 11 - PREPARATION OF OTHER BLOOD DERIVATIVES › Section 1025 - Plasmapheresis

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) Requirements:
(1) No more than 500 milliliters of whole blood
						shall be removed from a donor at one time, unless the donor's weight is 175 pounds
						or greater in which case no more than 600 milliliters of whole blood shall be
						removed from the donor at one time.
(2)
						A duly licensed physician and surgeon shall be available as described in Section
						1002(a) when
						plasmapheresis is performed.
(3) A
						system shall be employed which gives maximum assurance against any possibility of
						return of the separated red cells to an individual other than their
						donor.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 1 - PRODUCTION AND DISTRIBUTION OF BIOLOGICS › Article 11 - PREPARATION OF OTHER BLOOD DERIVATIVES › Section 1026 - Other Blood Fractions; Procedures; Standards; Consultative Service

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
Since procedures and standards for the preparation of other
						  blood fractions, such as immune serum globulin, albumin, etc., for transfusion
						  purposes are not as yet well suited for blood bank production, any biologies
						  producer operating under the license of the department shall submit a complete
						  protocol of procedures to be followed and shall be subject to the current
						  specifications of the department regarding such products. This shall include
						  specific licensure for the production of such materials, inspection, and the
						  maintenance of appropriate standards. Such standards as are necessary will, in
						  general, follow the usual blood banking procures with deviations general, follow the
						  usual blood banking procedures with deviations only for specific reason. Such
						  deviations and specific procedures shall be outlined in writing to the department by
						  the biologics producer. Potential producers of such biologics should avail
						  themselves of the consultative services of this department in order to provide for a
						  proper production procedure consistent with regulations of the department, thus
						  avoiding the installation of methods which must later be amended or
						  changed.
1. Amendment
						  filed 3-5-76; effective thirtieth day thereafter (register 76, No.
						  10).
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 1 - PRODUCTION AND DISTRIBUTION OF BIOLOGICS › Article 12 - TRANSPORTATION OF ETIOLOGIC AGENTS › Section 1027 - Definitions and Procedures to Be Followed

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) For the purpose of this article "person"
						includes laboratory, firm, association, corporation, co-partnership, and educational
						institutions, and "department" means State Department of Health.
(b) Etiologic Agents.
(1) For the purpose of this article microorganisms
						which may produce disease in man shall be referred to as etiologic agents.
(2) The provisions of this article do not apply to
						specimens transmitted to a laboratory operated by the State Department of Health or
						equivalent containers are used, or those of other public health department
						laboratories operating under certificates issued by the department.
(3) The provisions of this article do not apply to
						biological products licensed by the department or by the United States Department of
						Health, Education and Welfare.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 1 - PRODUCTION AND DISTRIBUTION OF BIOLOGICS › Article 13 - RESEARCH PROJECTS › Section 1028 - Waiver of Regulations

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
Notwithstanding the other provisions of Group 1, Subchapter
						  1, Chapter 2 of Part I (commencing with Section
						  950) of Title 17 relating to the
						  production and distribution of biologics, the Director may at his discretion waive
						  such regulations for research projects approved by the Director. The waiver shall be
						  for a specific period of time and subject to all conditions which the Director finds
						  necessary to protect the public health.
1. New
						  Article 13 (Section
						  1028)
						  filed 3-5-76; effective thirtieth day thereafter (Register 76, No.
						  10).
Note: Authority cited: Section
							 102 and
							 208,
							 Health and Safety Code. Reference: Sections
							 1600-1616, Health and Safety
							 code.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 2 - Clinical Laboratory Regulations › Article 1 - Definitions › Section 1029.5 - Accreditation Body. [Renumbered]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. New
						  section filed 3-19-97; operative 4-18-97 (Register 97, No. 12).
2.
						  Renumbering of former section
						  1029.5 to
						  1029 filed 11-12-2020; operative
						  1-1-2021 (Register 2020, No. 46).
Note: Authority cited: Section
							 1224,
							 Business and Professions Code; and Section
							 100275,
							 Health and Safety Code. Reference: Sections
							 1223,
							 1265,
							 1281
							 and
							 1288.5,
							 Business and Professions Code.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 2 - Clinical Laboratory Regulations › Article 1 - Definitions › Section 1029.6 - Accredited Institution. [Renumbered]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. New
						  section filed 3-19-97; operative 4-18-97 (Register 97, No. 12).
2. Change
						  without regulatory effect renumbering former section
						  1029.6 to section
						  1029.9 filed 5-14-2001 pursuant to
						  section 100, title 1, California Code of
						  Regulations (Register 2001, No. 20).
Note: Authority cited: Section
							 1224,
							 Business and Professions Code; and Section
							 100275,
							 Health and Safety Code. Reference: Sections
							 1223,
							 1265,
							 1281
							 and
							 1288.5,
							 Business and Professions Code.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 2 - Clinical Laboratory Regulations › Article 1 - Definitions › Section 1029.7 - Accredited College or University. [Renumbered]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. New
						  section filed 2-24-2000 as an emergency; operative 2-24-2000 (Register 2000, No. 8).
						  A Certificate of Compliance must be transmitted to OAL by 6-23-2000 or emergency
						  language will be repealed by operation of law on the following day.
2.
						  New section refiled 6-21-2000 as an emergency; operative 6-24-2000 (Register 2000,
						  No. 25). A Certificate of Compliance must be transmitted to OAL by 10-23-2000 or
						  emergency language will be repealed by operation of law on the following
						  day.
3. New section refiled 10-19-2000 as an emergency; operative
						  10-24-2000 (Register 2000, No. 42). A Certificate of Compliance must be transmitted
						  to OAL by 2-21-2001 or emergency language will be repealed by operation of law on
						  the following day.
4. Certificate of Compliance as to 10-19-2000 order
						  transmitted to OAL 2-21-2001 and filed 4-3-2001 (Register 2001, No.
						  14).
5. Renumbering of former section
						  1029.7 to
						  1029 filed 11-12-2020; operative
						  1-1-2021 (Register 2020, No. 46).
Note: Authority cited: Section
							 1224,
							 Business and Professions Code; and Section
							 100275,
							 Health and Safety Code. Reference: Sections
							 1260,
							 1261,
							 1261.5,
							 1263
							 and
							 1264,
							 Business and Professions Code.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 2 - Clinical Laboratory Regulations › Article 1 - Definitions › Section 1029.9 - Accredited Institution. [Renumbered]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. Change
						  without regulatory effect renumbering former section
						  1029.6 to section
						  1029.9 filed 5-14-2001 pursuant to
						  section 100, title 1, California Code of
						  Regulations (Register 2001, No. 20). For prior history, see Register 98, No.
						  7.
2. Renumbering of former section
						  1029.9 to
						  1029 filed 11-12-2020; operative
						  1-1-2021 (Register 2020, No. 46).
Note: Authority cited: Section
							 1224,
							 Business and Professions Code; and Section
							 100275,
							 Health and Safety Code. Reference: Section
							 120775,
							 Health and Safety Code.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 2 - Clinical Laboratory Regulations › Article 1 - Definitions › Section 1029.10 - Accusation. [Renumbered]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. New
						  section filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, No. 35). A
						  Certificate of Compliance must be transmitted to OAL by 12-26-97 or emergency
						  language will be repealed by operation of law on the following day.
2.
						  Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 and filed
						  2-9-98 (Register 98, No. 7).
3. Renumbering of former section
						  1029.10 to
						  1029 filed 11-12-2020; operative
						  1-1-2021 (Register 2020, No. 46).
Note: Authority cited: Section
							 1224,
							 Business and Professions Code; and Section
							 100275,
							 Health and Safety Code. Reference: Sections
							 1265,
							 1267,
							 1320,
							 1322
							 and
							 1326,
							 Business and Professions Code; Section
							 11503,
							 Government Code; and Section
							 14123,
							 Welfare and Institutions Code.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 2 - Clinical Laboratory Regulations › Article 1 - Definitions › Section 1029.11 - Antigen. [Renumbered]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. New
						  section filed 11-6-96 as an emergency; operative 11-6-96 (Register 96, No. 45). A
						  Certificate of Compliance must be transmitted to OAL by 3-5-97 or emergency language
						  will be repealed by operation of law on the following day.
2. Certificate
						  of Compliance as to 11-6-96 order transmitted to OAL 3-4-97 and filed 4-15-97
						  (Register 97, No. 16).
3. Renumbering of former section
						  1029.11 to new section
						  1029.25 filed 8-28-97 as an emergency;
						  operative 8-28-97 (Register 97, No. 35). A Certificate of Compliance must be
						  transmitted to OAL by 12-26-97 or emergency language will be repealed by operation
						  of law on the following day.
4. Certificate of Compliance as to 8-28-98
						  order transmitted to OAL 12-24-97 and filed 2-9-98 (Register 98, No.
						  7).
Note: Authority cited: Section
							 1224,
							 Business and Professions Code; and Section
							 100275,
							 Health and Safety Code. Reference: Section
							 120775,
							 Health and Safety Code.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 2 - Clinical Laboratory Regulations › Article 1 - Definitions › Section 1029.13 - Approved Public Health Laboratory. [Renumbered]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. New
						  section filed 3-19-97; operative 4-18-97 (Register 97, No. 12).
2.
						  Renumbering of former section
						  1029.13 to new section
						  1029.30 filed 8-28-97 as an emergency;
						  operative 8-28-97 (Register 97, No. 35). A Certificate of Compliance must be
						  transmitted to OAL by 12-26-97 or emergency language will be repealed by operation
						  of law on the following day.
3. Certificate of Compliance as to 8-28-98
						  order transmitted to OAL 12-24-97 and filed 2-9-98 (Register 98, No.
						  7).
Note: Authority cited: Section
							 1224,
							 Business and Professions Code; and Section
							 100275,
							 Health and Safety Code. Reference: Sections
							 1206,
							 1241
							 and
							 1288.5,
							 Business and Professions Code.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 2 - Clinical Laboratory Regulations › Article 1 - Definitions › Section 1029.15 - Alternative Sanction. [Renumbered]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. New
						  section filed 3-19-97; operative 4-18-97 (Register 97, No. 12).
2.
						  Renumbering of former section
						  1029.15 to new section
						  1029.35 and new section
						  1029.15 filed 8-28-97 as an emergency;
						  operative 8-28-97 (Register 97, No. 35). A Certificate of Compliance must be
						  transmitted to OAL by 12-26-97 or emergency language will be repealed by operation
						  of law on the following day.
3. Certificate of Compliance as to 8-28-98
						  order transmitted to OAL 12-24-97 and filed 2-9-98 (Register 98, No.
						  7).
4. Renumbering of former section
						  1029.15 to
						  1029 filed 11-12-2020; operative
						  1-1-2021 (Register 2020, No. 46).
Note: Authority cited: Section
							 1224,
							 Business and Professions Code; and Section
							 100275,
							 Health and Safety Code. Reference: Stats. 1995, c.510, Section
							 1; and Section
							 1310,
							 Business and Professions Code.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 2 - Clinical Laboratory Regulations › Article 1 - Definitions › Section 1029.17 - CLIA Certificate. [Renumbered]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. New
						  section filed 3-19-97; operative 4-18-97 (Register 97, No. 12).
2.
						  Renumbering of former section
						  1029.17 to new section
						  1029.45 filed 8-28-97 as an emergency;
						  operative 8-28-97 (Register 97, No. 35). A Certificate of Compliance must be
						  transmitted to OAL by 12-26-97 or emergency language will be repealed by operation
						  of law on the following day.
3. Certificate of Compliance as to 8-28-98
						  order transmitted to OAL 12-24-97 and filed 2-9-98 (Register 98, No.
						  7).
Note: Authority cited: Section
							 1224,
							 Business and Professions Code; and Section
							 100275,
							 Health and Safety Code. Reference: Sections
							 1224,
							 1265,
							 1281
							 and
							 1288.5,
							 Business and Professions Code.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 2 - Clinical Laboratory Regulations › Article 1 - Definitions › Section 1029.19 - CLIA Exempt Status. [Renumbered]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. New
						  section filed 3-19-97; operative 4-18-97 (Register 97, No. 12).
2.
						  Renumbering of former section
						  1029.19 to new section
						  1029.50 filed 8-28-97 as an emergency;
						  operative 8-28-97 (Register 97, No. 35). A Certificate of Compliance must be
						  transmitted to OAL by 12-26-97 or emergency language will be repealed by operation
						  of law on the following day.
3. Certificate of Compliance as to 8-28-98
						  order transmitted to OAL 12-24-97 and filed 2-9-98 (Register 98, No.
						  7).
Note: Authority cited: Section
							 1224,
							 Business and Professions Code; and Section
							 100275,
							 Health and Safety Code. Reference: Stats. 1995, c. 510 (SB 113) Section
							 1(a)(6).
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 2 - Clinical Laboratory Regulations › Article 1 - Definitions › Section 1029.20 - Antibody. [Renumbered]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1.
						  Renumbering of former section
						  1029.9 to new section
						  1029.20 filed 8-28-97 as an emergency;
						  operative 8-28-97 (Register 97, No. 35). A Certificate of Compliance must be
						  transmitted to OAL by 12-26-97 or emergency language will be repealed by operation
						  of law on the following day.
2. Certificate of Compliance as to 8-28-98
						  order transmitted to OAL 12-24-97 and filed 2-9-98 (Register 98, No.
						  7).
3. Renumbering former section
						  1029.20 to
						  1029 filed 11-12-2020; operative
						  1-1-2021 (Register 2020, No. 46).
Note: Authority cited: Section
							 1224,
							 Business and Professions Code; and Section
							 100275,
							 Health and Safety Code. Reference: Section
							 120775,
							 Health and Safety Code.