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.

“Label” means a display of written, printed, or graphic matter upon a food, drug, device, or cosmetic or upon its immediate container.

“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 accompanies any food, drug, device, or cosmetic.

“Local health department” means the health department of a city, county, city and county, or local health district that qualifies for state assistance pursuant to Chapter 3 (commencing with Section 101175) of Part 3 of Division 101, or any city health department of a city that has had its own health department for 12 years or more.

“Manufacture” means the preparation, compounding, propagation, processing, or fabrication of any food, drug, device, or cosmetic. The term “manufacture” includes repackaging or otherwise changing the container, wrapper, or labeling of any food, drug, device, or cosmetic in furtherance of the distribution of the food, drug, device, or cosmetic. The term “manufacture” does not include repackaging from a bulk container by a retailer at the time of sale to its ultimate consumer.

“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 department shall review all changes to the federal definition of “medical food” 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 submit a report to the Senate Health and Human Services Committee and the Assembly Health Committee 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.

“New device” means any of the following:

“New drug” means either of the following:

as a result of investigations to determine its safety and effectiveness for use under these conditions, has become so recognized, but that has not, otherwise than in the investigations, been used to a material extent or for a material time under the conditions.

“Official compendium” means the latest edition of the United States Pharmacopoeia, the latest edition of the Homeopathic Pharmacopoeia of the United States, or the latest edition of the National Formulary, or any supplement to any of these.

“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, device, or cosmetic.

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

“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 Food and Agriculture, or the department.

“Person” means any individual, firm, partnership, trust, corporation, limited liability company, company, estate, public or private institution, association, organization, group, city, county, city and county, political subdivision of this state, other governmental agency within the state, and any representative, agent, or agency of any of the foregoing.

“Pesticide chemical” means any substance that alone, in chemical combination, or in formulation with one or more substances, is an “economic poison” within the meaning of Section 12753 of the Food and Agricultural Code of this state or the Federal Insecticide, Fungicide, and Rodenticide Act (61 Stat. 163; 7 U.S.C. Sec. 135 et seq.), and that is used in the production, storage, or transportation of any raw agricultural commodity.

“Potentially hazardous food” means any food capable of supporting growth of infectious or toxigenic micro-organisms when held at temperatures above 45 degrees Fahrenheit.

“Prescription” means an oral order given individually for the patient for whom prescribed directly from the prescriber to the furnisher or indirectly by means of a written order signed by the prescriber that bears the name and address of the prescriber, the license classification of the prescriber, the name and address of the patient, the name and quantity of drug or device prescribed, the directions for use, and the date of issue.

“Prescription device” means any device limited to prescription use under Section 111470.

“Prescription drug” means any drug limited to prescription use under Section 111470.

“Principal display panel” means that part of a label most likely to be displayed, presented, shown, or examined under normal and customary conditions of display for retail sale.

“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 treated in its unpeeled natural form prior to marketing.

drug or device.

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:

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 in effect until the department adopts regulations pursuant to this part which repeal the regulations.

All laws and regulations pertaining to industrial hemp products shall remain in effect until the adoption of regulations pursuant to the federal law that authorizes industrial hemp products. At that time, the department shall adopt new regulations either as necessary pursuant to the federal law or deemed necessary to protect consumers.

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 (commencing with Section 23000) of the Business and Professions Code, and the regulations adopted pursuant thereto.