This part shall be known as the Sherman Food, Drug, and Cosmetic Law.

Unless the context otherwise requires, the definitions set forth in this article govern the construction of this part.

“Advertisement” means any representations, including, but not limited to, statements upon the products, its packages, cartons, and any other container, disseminated in any manner or by any means, for the purpose of inducing, or that is likely to induce, directly or indirectly, the purchase or use of any food, drug, device, or cosmetic.

“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, chlortetracycline chloramphenicol, bacitracin, or any other drug intended for human use containing any quantity of any chemical substance that is produced by micro-organisms, and that has the capacity to inhibit or destroy micro-organisms in dilute solution, including a chemically synthesized equivalent, or any derivative thereof.

“Color additive” means a substance that satisfies both of the following requirements:

of the body, it is capable, alone or through reaction with any other substance, of imparting color to the food, drug, device, or cosmetic, or to the human body or the part of the human body, to which it is added or applied.

The term “color additive” does not include any material that the department, by regulation, determines is used, or intended to be used, solely for a purpose or purposes other than coloring.

The term “color,” as used in this section, includes black, white, and intermediate grays.

This section does not apply to any pesticide chemical, soil, or plant nutrient, or other agricultural chemical, solely because of its effect in aiding, retarding, or otherwise affecting, directly or indirectly, the growth or other natural physiological process of produce of the soil and thereby affecting its color, whether before or after harvest.

“Cosmetic” means any article, or its components, intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to, the human body, or any part of the human body, for cleansing, beautifying, promoting attractiveness, or altering the appearance.

The term “cosmetic” does not include soap.

“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 bears, without authorization, the trademark, trade name, or other identifying mark, imprint, or device, or any likeness or trademark, trade name, or other identifying mark, imprint, or device of a manufacturer, processor, packer, or distributor, other than the actual manufacturer, processor, packer, or distributor, or that falsely purports or is represented to be the product of, or to have been packed or

distributed by, the other manufacturer, processor, packer, or distributor.

“Department” means the State Department of Health Services.

“Director” means the State Director of Health Services.

“Device” means any instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, that is any of the following:

or prevention of disease in humans or any other animal.

“Federal act” means the federal Food, Drug, and Cosmetic Act, as amended (21 U.S.C. Sec. 301 et seq.).

“Food” means either of the following:

“Food additive” means any substance, the intended use of which results or may reasonably be expected to result, directly or indirectly, in the substance becoming a component of the food or otherwise affecting characteristics of the food. This includes any substance or radiation source intended for use in producing, manufacturing, packing, treating, packaging, transporting, or holding any food.

The term “food additive” does not include any of the following:

“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.

“Food processing facility” means any facility operated for the purposes of manufacturing, packing, or holding processed food. Food processing facility does not include a food facility as defined in Section 113785, a cottage food operation that is registered or has a permit pursuant to Section 114365, or any facility exclusively storing, handling, or processing dried beans.

medical devices, and home medical device services are furnished, sold, or dispensed at retail.

licensed home health agency or licensed hospice, as long as all prescription devices are furnished to these patients only upon the prescription or order of health care practitioners authorized to prescribe or order home medical devices or who use home medical devices or who use home medical devices to treat their patients.

and prefilled cylinders.

“Immediate container” does not include any package liner.

“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 review all changes to the federal definition of “infant formula” before those changes are incorporated by reference pursuant to this section. Within six months after the effective date of any changes to the federal definition, the department shall complete its review

of the changes, and post a report on its Internet Web site that describes the changes and makes a recommendation as to whether it is appropriate to incorporate the changes by reference pursuant to this section. Any change to the federal definition shall take effect pursuant to this section one year after the effective date of the federal change, unless a law that specifically prohibits the change from taking effect is enacted and becomes effective.