Biologics: licensure: registration.

Existing law requires the Secretary of Food and Agriculture to license establishments, including commercial blood banks for animals, that produce, or propose to produce, biologics and that meet specified requirements, provides requirements relating to the application for a license, and requires a certain license application fee and license renewal fee. This bill would delete the requirement that the secretary license those biologic establishments and would delete those related provisions regarding license applications and fees. Existing law prohibits the offer for sale or use of any biologic unless it is registered by the secretary, except that registration is not required of any biologic manufactured pursuant to the terms of a valid license issued by the United States Department of Agriculture unless the secretary finds that, due to local conditions, it is necessary that the biologic be registered. This bill would, instead, prohibit the offer for sale or use of any biologic unless the person has a valid license or permit issued by the United States Department of Agriculture. Existing law requires the secretary to register any biologic that meets certain requirements and a biologic that is produced in an establishment exempt from licensing and that meets certain requirements, provides requirements relating to the application for registration of a biologic, and authorizes the secretary to impose conditions on the production or use of biologics. This bill would delete the requirement that the secretary register biologics and would delete those related provisions regarding the registration application and the imposition of conditions. Existing law authorizes the secretary to adopt rules and regulations for the administration and enforcement of the provisions relating to biologics. This bill would delete that authority. Existing law provides various enforcement provisions that the secretary may undertake with respect to biologic licensees and registrants. This bill would delete those enforcement provisions. Existing law requires the Department of Food and Agriculture, or humane officers under contract with the department, to inspect commercial blood banks for animals licensed by the department at least once a year to ensure compliance with certain protocols. This bill would, instead, authorize humane officers to inspect commercial blood banks for animals to ensure compliance with certain husbandry standards, written protocol requirements, and with a requirement for the maintenance of an affiliation with an identified oversight veterinarian for the facility. This bill would also make various conforming changes and other technical changes.