Cal. HSC § 1602.5 — California Code / Code hsc / Division 2 / Chapter 4 / Article 2 / Section 1602.5
Section 1602.5
Status: in_force

(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(c)  Until the time superseded by any regulation adopted pursuant to this section, all of the provisions of Group 1 (commencing with Section 950) of Subchapter 1 of Chapter 2 of Part 1 of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.

(e) This section does not apply to a clinical trial site storing or preparing for patient administration 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.