Definitions

As used in this section and section 21a-70e: (1) “Biologic” means a biological product, as defined in 42 USC 262(i), as amended from time to time, that is regulated as a drug under the federal Food, Drug and Cosmetic Act, 21 USC 301 et seq.; (2) “Department” means the Department of Consumer Protection; (3) “Medical device” means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent or other similar or related article, including any component, part or accessory, that is: (A) Recognized in the official National Formulary or the United States Pharmacopeia or any supplement thereto; (B) intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, in persons or animals; or (C) intended to affect the structure or function of the body of a person or animal, and that does not achieve its primary intended purposes through chemical action within or on such body and that is not dependent upon being metabolized for the achievement of its primary intended purposes; and (4) “Pharmaceutical or medical device manufacturing company” means any entity that: (A) Is engaged in the production, preparation, propagation, compounding, conversion or processing of prescription drugs, biologics or medical devices, either directly or indirectly, by extraction from substances of natural origin or independently by means of chemical synthesis or by a combination of extraction and chemical synthesis; or (B) is directly engaged in the packaging, repackaging, labeling, relabeling or distribution of prescription drugs, biologics or medical devices. “Pharmaceutical or medical device manufacturing company” does not include a health care provider, physician practice, home health agency, hospital licensed in this state, wholesale drug distributor licensed in this state or a retail pharmacy licensed in this state.