Section 1602.5 Of Article 2. Human Whole Blood And Human Whole Blood Derivatives From California Health And Safety Code >> Division 2. >> Chapter 4. >> Article 2.
1602.5
. (a) No person shall engage in the production of human whole
blood or human whole blood derivatives unless the person is licensed
under this chapter and the human whole blood or human whole blood
derivative is collected, prepared, labeled, and stored in accordance
with both of the following:
(1) The standards set forth in the 13th Edition of "Standards for
Blood Banks and Transfusion Services," as published by the American
Association of Blood Banks and in effect on November 15, 1989, or any
amendments thereto or later published editions or amendments
thereto. These shall be the standards for all licensed blood banks
and blood transfusion services in the state.
(2) Those provisions of Title 17 of the California Code of
Regulations that are continued in effect by subdivision (c) or that
are adopted pursuant to subdivision (b).
(b) The department may, by the adoption of regulations, establish
and require compliance with requirements in addition to, or in lieu
of, those in subdivision (a) as the department deems appropriate to
reflect changing technology or to improve the safety of human whole
blood or human whole blood derivatives. Any standards adopted
pursuant to this subdivision shall be adopted after consultation with
representatives of the American Association of Blood Banks.
(c) Until the time superseded by any regulation adopted pursuant
to this section, all of the provisions of Group 1 (commencing with
Section 950) of Subchapter 1 of Chapter 2 of Part 1 of Title 17 of
the California Code of Regulations shall remain in effect with the
exception of the following:
(1) Subdivisions (i) to (k), inclusive, of Section 997.
(2) Sections 999 and 1001.
(3) Subdivisions (a) to (c), inclusive, of Section 1002.
(4) Paragraphs (2) and (3) of subdivision (e) of Section 1002.
(5) Subdivisions (f) and (g) of Section 1002.
(6) Paragraphs (2) to (6), inclusive, of subdivision (h) of
Section 1002.
(7) Subdivisions (i), (k), and ( l) of Section 1002.
(8) Subdivisions (a) to (c), inclusive, of Section 1004.
(9) Sections 1010, 1012, 1013, 1014, 1024, and 1024.1.
(10) Subdivisions (a), (b), and (e) of Section 1025.
(11) Paragraphs (1) to (3), inclusive, of subdivision (c) of
Section 1025.
(d) (1) Any amendment to the 13th Edition of "Standards for Blood
Banks and Transfusion Services," any later editions, or any
amendments thereto, published by the American Association of Blood
Banks shall become effective in California 90 days after the
effective date of this section, or 90 days after publication by the
association, unless the department sends written notice, within such
a 90-day period, to all persons licensed under this chapter to engage
in the production of human whole blood or human whole blood
derivatives, indicating which portions shall not become effective.
(2) The department may determine that no portion of any amendments
or later editions shall become effective. The department shall
determine that no portion of an amendment or later edition shall
become effective pursuant to this section whenever the department has
not received a copy of the amendment or later edition by the date it
is published by the American Association of Blood Banks.