Article 2 - Animal Blood and Blood Component Products Production and Biologics Production

California Food and Agricultural Code — §§ 9210-9212.5

Sections (4)

Amended by Stats. 2021, Ch. 752, Sec. 11. (AB 1282) Effective January 1, 2022.

(a)A person shall not engage in the production of animal blood and blood component products for retail sale and distribution except in a captive closed-colony commercial blood bank for animals licensed by the secretary or in accordance with Article 7 (commencing with Section 4920) of Chapter 11 of Division 2 of the Business and Professions Code.

(b)Notwithstanding subdivision (a), a community blood bank for animals operating pursuant to Article 7 (commencing with Section 4920) of Chapter 11 of Division 2 of the Business and Professions Code shall register blood and blood component products with the secretary in accordance with Article 5 (commencing with Section 9241).

§ 9211

Amended by Stats. 2010, Ch. 235, Sec. 10. (AB 1709) Effective January 1, 2011. Became operative on January 1, 2013, pursuant to Sec. 28 of Ch. 235.

No person shall engage in the production of biologics except as

permitted under federal law.

§ 9212

Amended by Stats. 2021, Ch. 752, Sec. 12. (AB 1282) Effective January 1, 2022.

The secretary shall license establishments as captive closed-colony commercial blood banks for animals that meet all of the following:

(a)Operate under conditions, and use methods of production, that are consistent with current standards of care and practice for the field of veterinary transfusion medicine to ensure that the animal blood and blood component products will not be contaminated, dangerous, or harmful.

(b)Produce animal blood and blood component products under the direct supervision of a person qualified in the field.

(c)Maintain onsite records containing information documenting how the animal was acquired and any history of blood draws or use of

anesthesia on the animal.

(d)Keep, house, or maintain all animal donors within California state boundaries.

§ 9212.5

Added by Stats. 2021, Ch. 752, Sec. 13. (AB 1282) Effective January 1, 2022.

(a)(1) The department shall discontinue its licensing program for commercial blood banks for animals that produce canine blood and blood component products sourced from captive closed-colony dogs within 18 months of making a finding and provision of notice as follows:

(A) Based on the quarterly reports required under Section 4920.6 of the Business and Professions Code, subdivision (c) of Section 9252, and subdivision (b) of Section 9253, every three months, the secretary shall calculate the total estimated amount of canine blood sold in California that quarter by community blood banks and, separately, the total estimated amount of canine blood that closed-colony blood banks sold in the state during the same period. This

information shall be publicly posted on the department’s internet website along with annual totals compiled each year.

(B) If the secretary finds that community blood banks sold an annual amount of canine blood in California that equals or exceeds the annual amount closed-colony blood banks sold in four consecutive quarters, then the secretary shall provide notice on the department’s internet website that discontinues its licensing program for closed-colony blood banks for dogs within 18 months from the date of that notice.

(2)The calculation of canine blood pursuant to this subdivision shall be done separately, with whole blood, packed red blood cells, and fresh frozen plasma being measured as separate amounts in estimated milliliters based on weight in grams.

(3)For purposes of this section, “canine blood” means

whole blood, packed red blood cells, and fresh frozen plasma.

(b)Upon enactment of this section, the secretary shall not accept any new applications to license a commercial blood bank for animals that produces canine blood or blood component products sourced from captive closed-colony dogs.

(c)Closed-colony blood banks may transition to community-sourced models and continue to operate in accordance with Article 7 (commencing with Section 4920) of Chapter 11 of Division 2 of the Business and Professions Code.