CHAPTER 1. General Provisions and Definitions

Chapter 1 added by Stats. 1995, Ch. 415, Sec. 6.

§§ 109875–110040 · 43 sections

§ 109875 This part shall be known as the Sherman Food, Drug, and Cosmetic Law.
§ 109880 Unless the context otherwise requires, the definitions set forth in this article govern the construction of this part.
§ 109885 “Advertisement” means any representations, including, but not limited to, statements upon the products, its packages, cartons, and any other container,…
§ 109890 “Antibiotic drug” means any drug , except drugs for use in animals other than humans, composed in whole or in part of any form of penicillin, streptomycin,…
§ 109895 “Color additive” means a substance that satisfies both of the following requirements: (a) It is a dye, pigment, or other substance made by a process of…
§ 109900 “Cosmetic” means any article, or its components, intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to, the human…
§ 109905 “Counterfeit”, as used in respect to any food, drug, device, or cosmetic, means a food, drug, device, or cosmetic that bears or whose package or labeling…
§ 109910 “Department” means the State Department of Health Services.
§ 109915 “Director” means the State Director of Health Services.
§ 109920 “Device” means any instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any…
§ 109925 (a) “Drug” means any of the following: (1) An article recognized in an official compendium. (2) An article used or intended for use in the diagnosis, cure,…
§ 109930 “Federal act” means the federal Food, Drug, and Cosmetic Act, as amended (21 U.S.C. Sec. 301 et seq.).
§ 109935 “Food” means either of the following: (a) Any article used or intended for use for food, drink, confection, condiment, or chewing gum by man or other animal.…
§ 109940 “Food additive” means any substance, the intended use of which results or may reasonably be expected to result, directly or indirectly, in the substance…
§ 109945 “Food and drug inspector” means any authorized agent of the Bureau of Food and Drug of the department, who shall have the powers set forth in Section 106500.
§ 109947 “Food processing facility” means any facility operated for the purposes of manufacturing, packing, or holding processed food. Food processing facility does not…
§ 109948 (a) “Home medical device retail facility” is an area, place, or premises, other than a licensed pharmacy, in and from which prescription devices, home medical…
§ 109948.1 (a) “Home medical device services” means the delivery, installation, maintenance, replacement of, or instruction in the use of, home medical devices used by a…
§ 109950 “Immediate container” does not include any package liner.
§ 109951 “Infant formula” shall have the same definition as that term is used in the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 321(z)). The department shall…
§ 109955 “Label” means a display of written, printed, or graphic matter upon a food, drug, device, or cosmetic or upon its immediate container.
§ 109960 “Labeling” means any label or other written, printed, or graphic matter upon a food, drug, device, or cosmetic or upon its container or wrapper, or that…
§ 109965 “Local health department” means the health department of a city, county, city and county, or local health district that qualifies for state assistance pursuant…
§ 109970 “Manufacture” means the preparation, compounding, propagation, processing, or fabrication of any food, drug, device, or cosmetic. The term “manufacture”…
§ 109971 “Medical food” means any product that meets the definition of medical food in the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 360ee(b)(3)). The…
§ 109975 “New device” means any of the following: (a) Any device the composition, construction, or properties of which are such that the device is not generally…
§ 109980 “New drug” means either of the following: (a) Any drug the composition of which is such that the drug is not generally recognized, among experts qualified by…
§ 109985 “Official compendium” means the latest edition of the United States Pharmacopoeia, the latest edition of the Homeopathic Pharmacopoeia of the United States, or…
§ 109990 “Package” means any container or wrapper that may be used by a manufacturer, producer, jobber, packer, or dealer for enclosing or containing any food, drug,…
§ 109992 “Pasteurized in-shell eggs” means shell eggs that have been pasteurized by any method approved by the federal Food and Drug Administration, the Department of…
§ 109995 “Person” means any individual, firm, partnership, trust, corporation, limited liability company, company, estate, public or private institution, association,…
§ 110000 “Pesticide chemical” means any substance that alone, in chemical combination, or in formulation with one or more substances, is an “economic poison” within the…
§ 110005 “Potentially hazardous food” means any food capable of supporting growth of infectious or toxigenic micro-organisms when held at temperatures above 45 degrees…
§ 110010 “Prescription” means an oral order given individually for the patient for whom prescribed directly from the prescriber to the furnisher or indirectly by means…
§ 110010.1 “Prescription device” means any device limited to prescription use under Section 111470.
§ 110010.2 “Prescription drug” means any drug limited to prescription use under Section 111470.
§ 110015 “Principal display panel” means that part of a label most likely to be displayed, presented, shown, or examined under normal and customary conditions of…
§ 110020 “Raw agricultural commodity” means any food in its raw or natural state. It includes, but is not limited to, any fruit that is washed, colored, or otherwise…
§ 110025 (a) “Substantial evidence” means evidence consisting of adequate and well-controlled investigations, including clinical investigations, by experts qualified by…
§ 110030 The provisions of this part regarding the selling of any food, drug, device, or cosmetic include, but are not limited to, all of the following: (a) The…
§ 110035 All regulations pertaining to any food, drug, device, or cosmetic adopted by the department that are in effect on the effective date of this part shall remain…
§ 110036 All laws and regulations pertaining to industrial hemp products shall remain in effect until the adoption of regulations pursuant to the federal law that…
§ 110040 This part shall be so construed as to not be in conflict with the Food and Agricultural Code, or with the Alcoholic Beverage Control Act, Division 9…