(1) As used in this part:(1) “Commissioner” means the commissioner of health;(2) “Department” means the department of health;(3) “Emergency use authorized product” means a medical product that the federal food and drug administration has authorized for use during a public health emergency under Section 564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-3);(4) “FDA” means the federal food and drug administration;(5) “FDA-approved” means the FDA has granted a product a license following a comprehensive pre-market clinical trial review process, determined that the product's benefits outweigh its risks for the intended use, and made the grant of such license contingent upon ongoing post-marketing surveillance to assess whether the product maintains its safety and efficacy under real-world conditions;(6) “FDA-authorized” means the use of a product is permitted through an emergency use authorization protocol which allows the use of medical products during public health emergencies based on available evidence, prior to full approval;(7) “Labeling” means the FDA-approved product information and includes prescribing information, carton and container labeling, medication guides, patient package inserts, and instructions for use;(8) “Local health department” means a county or regional health department in this state;(9) “Mask” means a face covering, such as a surgical mask, medical-grade N95, or cloth facial covering worn for medical purposes;(10) “State executive branch” means the governor, members of the governor's cabinet, the leadership of an executive branch agency or department of this state other than the commissioner of health, and an executive branch agency or department of this state other than the department; and(11) “Vaccine” means a substance intended for use in humans to stimulate the body's immune response against an infectious disease or pathogen, including products intended to provide passive immunity, such as monoclonal antibodies.
(1) “Commissioner” means the commissioner of health;
(2) “Department” means the department of health;
(3) “Emergency use authorized product” means a medical product that the federal food and drug administration has authorized for use during a public health emergency under Section 564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-3);
(4) “FDA” means the federal food and drug administration;
(5) “FDA-approved” means the FDA has granted a product a license following a comprehensive pre-market clinical trial review process, determined that the product's benefits outweigh its risks for the intended use, and made the grant of such license contingent upon ongoing post-marketing surveillance to assess whether the product maintains its safety and efficacy under real-world conditions;
(6) “FDA-authorized” means the use of a product is permitted through an emergency use authorization protocol which allows the use of medical products during public health emergencies based on available evidence, prior to full approval;
(7) “Labeling” means the FDA-approved product information and includes prescribing information, carton and container labeling, medication guides, patient package inserts, and instructions for use;
(8) “Local health department” means a county or regional health department in this state;
(9) “Mask” means a face covering, such as a surgical mask, medical-grade N95, or cloth facial covering worn for medical purposes;
(10) “State executive branch” means the governor, members of the governor's cabinet, the leadership of an executive branch agency or department of this state other than the commissioner of health, and an executive branch agency or department of this state other than the department; and
(11) “Vaccine” means a substance intended for use in humans to stimulate the body's immune response against an infectious disease or pathogen, including products intended to provide passive immunity, such as monoclonal antibodies.