Section § 109875

Explanation
This section simply states the official name of a particular set of laws: the Sherman Food, Drug, and Cosmetic Law.
This part shall be known as the Sherman Food, Drug, and Cosmetic Law.

Section § 109880

Explanation

This law section means that the definitions provided in the article should be used to understand the meanings of terms in this part of the law, unless it is clear they should be understood differently.

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

Section § 109885

Explanation

This law defines an 'advertisement' as any type of communication or representation intended to encourage people to buy or use food, drugs, devices, or cosmetics. This includes labels, packaging, or any other method of communication that might influence purchasing decisions.

“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.

Section § 109890

Explanation

This section defines what an 'antibiotic drug' is. It's a drug intended for humans and includes any medicine partly or fully made of substances like penicillin, streptomycin, and others. These substances either naturally occur from microorganisms or are chemically synthesized to kill or stop the growth of microorganisms. However, it does not include drugs made just for animals.

“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.

Section § 109895

Explanation

This law defines what a "color additive" is. A color additive is basically a substance such as a dye or pigment that can change the color of food, drugs, cosmetics, or the human body. To qualify as a color additive, the substance must meet two conditions: it is derived from a natural or synthetic source, and it changes color when mixed with other items.

However, if a substance is used only for non-coloring purposes, it doesn't qualify as a color additive under this law. The term "color" here includes black, white, and gray. The law also excludes certain chemicals, like pesticides or plant nutrients, which influence a plant's natural color, from being considered color additives.

“Color additive” means a substance that satisfies both of the following requirements:
(a)CA Health & Safety Code § 109895(a)  It is a dye, pigment, or other substance made by a process of synthesis or similar artifice, or extracted, isolated, or otherwise derived, with or without intermediate or final change of identity, from a vegetable, animal, mineral, or other source.
(b)CA Health & Safety Code § 109895(b)  When added or applied to a food, drug, device, or cosmetic, or to the human body or any part 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.

Section § 109900

Explanation

This section defines what counts as a "cosmetic." It includes any product used on the human body for cleaning, beautification, or enhancing attractiveness. However, plain soap is not considered a cosmetic.

“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.

Section § 109905

Explanation

This section defines what "counterfeit" means for foods, drugs, devices, and cosmetics. It happens when these items are mislabeled or packaged to look like they’re made by a different company than they really are, using unauthorized trademarks or similar symbols. If a product falsely claims to be created or distributed by another company, it's considered counterfeit.

“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.

Section § 109910

Explanation

This law section defines "Department" as the State Department of Health Services.

“Department” means the State Department of Health Services.

Section § 109915

Explanation

This section defines the term "Director" as the State Director of Health Services.

“Director” means the State Director of Health Services.

Section § 109920

Explanation

This law defines a 'device' as any tool or equipment such as instruments, machines, or implants. It can include parts and accessories, recognized medically, and used for diagnosing or treating diseases in people or animals. Additionally, these devices might change the structure or function of a body without using chemical actions or metabolism to work.

“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:
(a)CA Health & Safety Code § 109920(a)  Recognized in the official National Formulary or the United States Pharmacopoeia, or any supplement to them.
(b)CA Health & Safety Code § 109920(b)  Intended for use in the diagnosis of disease or other condition, or in the cure, mitigation, treatment, or prevention of disease in humans or any other animal.
(c)CA Health & Safety Code § 109920(c)  Intended to affect the structure or any function of the body of humans or any other animal and that does not achieve any of its principal intended purposes through chemical action within or on the body of humans or other animals and that is not dependent upon being metabolized for the achievement of any of its principal intended purposes.

Section § 109925

Explanation

This section defines what qualifies as a 'drug' under the law. A drug can include items listed in official pharmaceutical references, those used to diagnose or treat diseases in humans or animals, products that affect body structure or function (excluding food), and components of these items. However, the term 'drug' does not cover devices, certain labeled foods with federal claims, or cannabis products, even if intended for external use.

(a)CA Health & Safety Code § 109925(a) “Drug” means any of the following:
(1)CA Health & Safety Code § 109925(a)(1) An article recognized in an official compendium.
(2)CA Health & Safety Code § 109925(a)(2) An article used or intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in human beings or any other animal.
(3)CA Health & Safety Code § 109925(a)(3) An article other than food, that is used or intended to affect the structure or any function of the body of human beings or any other animal.
(4)CA Health & Safety Code § 109925(a)(4) An article used or intended for use as a component of an article designated in paragraphs (1) to (3), inclusive.
(b)CA Health & Safety Code § 109925(b) The term “drug” does not include any device.
(c)CA Health & Safety Code § 109925(c) Any food for which a claim (as described in Sections 403(r)(1)(B) (21 U.S.C. Sec. 343(r)(1)(B)) and 403(r)(3) (21 U.S.C. Sec. 343(r)(3)) or Sections 403(r)(1)(B) (21 U.S.C. Sec. 343(r)(1)(B)) and 403(r)(5)(D) (21 U.S.C. Sec. 343(r)(5)(D)) of the federal act), is made in accordance with the requirements set forth in Section 403(r) (21 U.S.C. Sec. 343(r)) of the federal act, is not a drug under subdivision (b) solely because the label or labeling contains such a claim.
(d)CA Health & Safety Code § 109925(d) Cannabis product, including any cannabis product intended for external use, is not a drug.

Section § 109930

Explanation

This section defines the term 'Federal act' as referring to the federal Food, Drug, and Cosmetic Act, including any amendments to it.

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

Section § 109935

Explanation

This law defines what is considered "food" for legal purposes. It includes any items intended to be consumed as food, drink, sweets, spices, or chewing gum by humans or animals. It also covers any materials used to make these food items or their components.

“Food” means either of the following:
(a)CA Health & Safety Code § 109935(a)  Any article used or intended for use for food, drink, confection, condiment, or chewing gum by man or other animal.
(b)CA Health & Safety Code § 109935(b)  Any article used or intended for use as a component of any article designated in subdivision (a).

Section § 109940

Explanation

This law describes what is considered a 'food additive.' It's any substance that is used in food production and may end up in food or change food properties. This covers substances used during manufacturing, packaging, storing, or treating food items. However, it specifically excludes certain items from being 'food additives,' such as pesticide chemicals on raw agricultural products, color additives, and substances approved before the Food Additives Amendment of 1958 and certain other specified acts.

“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:
(a)CA Health & Safety Code § 109940(a)  A pesticide chemical in or on a raw agricultural commodity.
(b)CA Health & Safety Code § 109940(b)  A pesticide chemical that is used, or intended for use, in the production, storage, or transportation of any raw agricultural commodity.
(c)CA Health & Safety Code § 109940(c)  A color additive.
(d)CA Health & Safety Code § 109940(d)  Any substance used in accordance with a sanction or approval granted prior to the enactment of the Food Additives Amendment of 1958 (72 Stat. 1784), pursuant to the federal act; the Poultry Products Inspection Act (71 Stat. 441; 21 U.S.C. Sec. 451 et seq.); the Meat Inspection Act of March 4, 1907 (34 Stat. 1260), as amended and extended (21 U.S.C. Sec. 71 et seq.); or the Food and Agricultural Code of this state.

Section § 109945

Explanation

A 'food and drug inspector' is someone officially appointed by the Bureau of Food and Drug. This person has specific powers described in another law section, Section 106500.

“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.

Section § 109947

Explanation

This law defines a 'food processing facility' as a place used for making, packaging, or storing processed food. It specifically excludes certain types of facilities: those defined as food facilities in a different section, registered cottage food operations, and facilities that only store, handle, or process dried beans.

“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.

Section § 109948

Explanation

This law defines what a 'home medical device retail facility' is. It clarifies that such a facility is any place where prescription devices and services related to home medical devices are sold or prepared, unless it's a licensed pharmacy. However, it specifically excludes areas within licensed facilities that store supplies for direct patient treatment, such as hospitals or emergency rooms. It also does not include locations within licensed home health agencies or hospices that store supplies solely for treating patients, provided these supplies are used based on a healthcare professional's prescription.

(a)CA Health & Safety Code § 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 devices, or home medical device services are sold, fitted, or dispensed pursuant to prescription. “Home medical device retail facility” includes, but is not limited to, any area or place in which prescription devices, home medical devices, or home medical device services are stored, possessed, prepared, manufactured, or repackaged, and from which the prescription devices, home medical devices, and home medical device services are furnished, sold, or dispensed at retail.
(b)CA Health & Safety Code § 109948(b)  “Home medical device retail facility” shall not include any area in a facility licensed by the department where floor supplies, ward supplies, operating room supplies, or emergency room supplies of prescription devices are stored or possessed solely for treatment of patients registered for treatment in the facility or for treatment of patients receiving emergency care in the facility.
(c)CA Health & Safety Code § 109948(c)  “Home medical device retail facility” shall not include any area of a home health agency licensed under Chapter 8 (commencing with Section 1725) of, or a hospice licensed under Chapter 8.5 (commencing with Section 1745) of Division 2 where the supplies specified in subdivision (c) of Section 4057 of the Business and Professions Code are stored or possessed solely for treatment of patients by a 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.

Section § 109948.1

Explanation

This section defines 'home medical device services' as activities related to the delivery, installation, maintenance, replacement, or instruction of home medical devices. These services help sick or disabled individuals live at home.

It specifies that 'home medical devices' include items like oxygen systems, ventilators, CPAP machines, hospital beds, wheelchairs, apnea monitors, and other similar devices used in home care settings.

The law also clarifies what is not considered a 'home medical device,' such as devices used by hospitals during regular patient care, prosthetics, AEDs, and devices provided through a doctor's office or pharmacist.

(a)CA Health & Safety Code § 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 sick or disabled individual to allow the individual to be maintained in a residence.
(b)CA Health & Safety Code § 109948.1(b)  “Home medical device” means a device intended for use in a home care setting including, but not limited to, all of the following:
(1)CA Health & Safety Code § 109948.1(b)(1)  Oxygen delivery systems and prefilled cylinders.
(2)CA Health & Safety Code § 109948.1(b)(2)  Ventilators.
(3)CA Health & Safety Code § 109948.1(b)(3)  Continuous Positive Airway Pressure devices (CPAP).
(4)CA Health & Safety Code § 109948.1(b)(4)  Respiratory disease management devices.
(5)CA Health & Safety Code § 109948.1(b)(5)  Hospital beds and commodes.
(6)CA Health & Safety Code § 109948.1(b)(6)  Electronic and computer driven wheelchairs and seating systems.
(7)CA Health & Safety Code § 109948.1(b)(7)  Apnea monitors.
(8)CA Health & Safety Code § 109948.1(b)(8)  Low air loss continuous pressure management devices.
(9)CA Health & Safety Code § 109948.1(b)(9)  Transcutaneous Electrical Nerve Stimulator (TENS) units.
(10)CA Health & Safety Code § 109948.1(b)(10)  Prescription devices.
(11)CA Health & Safety Code § 109948.1(b)(11)  Disposable medical supplies including, but not limited to, incontinence supplies as defined in Section 14125.1 of the Welfare and Institutions Code.
(12)CA Health & Safety Code § 109948.1(b)(12)  In vitro diagnostic tests.
(13)CA Health & Safety Code § 109948.1(b)(13)  Any other similar device as defined in regulations adopted by the department.
(c)CA Health & Safety Code § 109948.1(c)  The term “home medical device” does not include any of the following:
(1)CA Health & Safety Code § 109948.1(c)(1)  Devices used or dispensed in the normal course of treating patients by hospitals and nursing facilities, other than devices delivered or dispensed by a separate unit or subsidiary corporation of a hospital or nursing facility or agency that is in the business of delivering home medical devices to an individual’s residence.
(2)CA Health & Safety Code § 109948.1(c)(2)  Prosthetics and orthotics.
(3)CA Health & Safety Code § 109948.1(c)(3)  Automated external defibrillators (AEDs).
(4)CA Health & Safety Code § 109948.1(c)(4)  Devices provided through a physician’s office incident to a physician’s service.
(5)CA Health & Safety Code § 109948.1(c)(5)  Devices provided by a licensed pharmacist that are used to administer drugs that can be dispensed only by a licensed pharmacist.
(6)CA Health & Safety Code § 109948.1(c)(6)  Enteral and parenteral devices provided by a licensed pharmacist.

Section § 109950

Explanation

This law clarifies that when mentioning an 'immediate container,' it does not refer to any inner packaging or liner within the container.

“Immediate container” does not include any package liner.

Section § 109951

Explanation

This California law refers to the definition of 'infant formula' as defined by federal law. If the federal definition changes, the California department in charge must review these changes within six months. They then need to publish a report online, recommending whether the changes should be adopted in California. Unless a new state law explicitly prohibits it, the federal changes will automatically become effective in California one year after the federal definition change.

“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.

Section § 109955

Explanation

This law defines a 'label' as any written, printed, or graphic information placed on a food, drug, device, or cosmetic or its immediate container.

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

Section § 109960

Explanation

This part of the law defines 'labeling' as any written, printed, or graphic information found on or with a food, drug, device, or cosmetic, including on its container or packaging.

“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.

Section § 109965

Explanation

This law section defines what a "local health department" is in California. It includes any health department of a city, county, or local health district that gets state support, and any city health department that's been around for at least 12 years.

“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.

Section § 109970

Explanation

This law defines "manufacture" for food, drugs, devices, and cosmetics. It includes making, processing, or packaging these items, and even changing their wrappers or labels for distribution. However, it does not cover repackaging by a retailer for sale to the consumer directly from a bulk container.

“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.

Section § 109971

Explanation

This law defines "medical food" according to the federal definition and outlines the process for updating California's definition when changes occur at the federal level. The state department must review any changes within six months, report to specific committees, and recommend whether to adopt those changes. Unless a new law blocks it, changes automatically take effect in California one year after the federal change.

“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.

Section § 109975

Explanation

A "new device" refers to any medical or scientific device that experts do not generally recognize as safe and effective based on scientific studies. This could be because either it hasn't been investigated thoroughly, or it has been studied but hasn't been widely used in practice.

“New device” means any of the following:
(a)CA Health & Safety Code § 109975(a)  Any device the composition, construction, or properties of which are such that the device is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of devices, as having been adequately shown, through scientific investigations to be safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling or advertising thereof.
(b)CA Health & Safety Code § 109975(b)  Any device the composition, construction, or properties of which are such that the device, as a result of such investigation to determine its safety and effectiveness for use under these conditions, has become so recognized, but which has not, otherwise than in the investigations, been used to a material extent or for a material time under the conditions.

Section § 109980

Explanation

This law defines what a 'new drug' is. A new drug is any medication whose safety and effectiveness are not generally recognized by experts, either because it hasn't been studied enough or it's not used significantly in the conditions identified in its labeling or ads. Alternatively, it could be a drug that is recognized as safe and effective because of investigations, but hasn’t been widely used otherwise.

“New drug” means either of the following:
(a)CA Health & Safety Code § 109980(a)  Any drug the composition of which is such that the drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling or advertising thereof.
(b)CA Health & Safety Code § 109980(b)  Any drug the composition of which is such that the drug, 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.

Section § 109985

Explanation

In simple terms, an "official compendium" is a term used to refer to the current editions of three major publications: the United States Pharmacopoeia, the Homeopathic Pharmacopoeia of the United States, and the National Formulary, or any updates to these documents.

“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.

Section § 109990

Explanation

This law defines what a "package" is in the context of food, drugs, devices, or cosmetics. A "package" refers to any container or wrapper used by manufacturers or dealers for enclosing these items. However, it doesn't include large shipping containers or wrappings used for bulk transportation to various distributors, or simple wrappings used by retailers for delivery to consumers, as long as those wrappings don't have any related printed information.

“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:
(a)CA Health & Safety Code § 109990(a)  Any shipping container or outer wrapping used solely for the transportation of a food, drug, device, or cosmetic in bulk quantity to any manufacturer, packer, processor, or wholesale or retail distributor.
(b)CA Health & Safety Code § 109990(b)  Any shipping container or outer wrapping used by any retailer to ship or deliver any food, drug, device, or cosmetic to any retail consumer if the container or wrapping bears no printed matter pertaining to any food, drug, device, or cosmetic.

Section § 109992

Explanation

The term "pasteurized in-shell eggs" refers to eggs that have been treated to kill harmful bacteria using methods approved by either the federal FDA, the Department of Food and Agriculture, or another relevant department.

“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.

Section § 109995

Explanation

This section defines the term "person" broadly to include not just individuals, but also entities like businesses, organizations, government bodies, and their representatives or agents.

“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.

Section § 110000

Explanation

This section defines what a "pesticide chemical" is. It refers to any substance that can act as an economic poison, either by itself, in combination with other chemicals, or in a formulated mix. To be considered a pesticide chemical, it must be used in growing, storing, or moving raw agricultural products. This definition follows the state and federal guidelines in the Food and Agricultural Code and the Federal Insecticide, Fungicide, and Rodenticide Act.

“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.

Section § 110005

Explanation

This law defines "potentially hazardous food" as any food that can allow harmful microorganisms to grow if it's kept warmer than 45 degrees Fahrenheit.

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

Section § 110010

Explanation

This law defines what a "prescription" is. It can be an oral order directly from the doctor to the person giving the medication, or a signed written order. This prescription must include the doctor's name, address, license classification, the patient's name and address, the drug or device details, usage instructions, and the date it was issued.

“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.

Section § 110010.1

Explanation

This law defines a "prescription device" as any medical device that must be used only with a prescription under the regulations of Section 111470.

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

Section § 110010.2

Explanation

This section defines a 'prescription drug' as any drug that legally requires a doctor's prescription according to another specific section of the law.

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

Section § 110015

Explanation

This law defines the "principal display panel" as the part of a product label that is most often seen or examined by customers when it is on display for sale in a typical retail setting.

“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.

Section § 110020

Explanation

This law defines a 'raw agricultural commodity' as any food that is in its original, unprocessed state. Even if a fruit is washed, colored, or otherwise treated but remains unpeeled and natural before being sold, it still counts as a raw agricultural commodity.

“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.

Section § 110025

Explanation

This law section defines "substantial evidence" for the effectiveness of a drug or device. It requires reliable and controlled research, like clinical trials conducted by qualified experts, proving that the drug or device works as claimed.

Furthermore, the department may accept results from just one strong clinical investigation combined with other supporting evidence as enough proof of effectiveness, based on scientific judgment.

(a)CA Health & Safety Code § 110025(a)  “Substantial evidence” means evidence consisting of adequate and well-controlled investigations, including clinical investigations, by experts qualified by scientific training and experience to evaluate the effectiveness of the drug or device involved, on the basis that it could be fairly and responsibly concluded by the experts that the drug or device will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling, proposed labeling, or advertising of any drug or device.
(b)CA Health & Safety Code § 110025(b)  If the department determines, based on relevant science, that data from one adequate and well-controlled clinical investigation, and confirming evidence, obtained prior to or after the investigation, sufficiently establish effectiveness, then the department may consider that data and evidence, to constitute substantial evidence for purposes of the preceding sentence.

Section § 110030

Explanation

This law covers various aspects of selling food, drugs, devices, and cosmetics, including their manufacturing, processing, and packaging. It also involves displaying or offering these products for sale and handling them in any business operation. Additionally, it governs the sale and distribution of these items in any establishment.

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)CA Health & Safety Code § 110030(a)  The manufacture, production, processing, and packing of any food, drug, device, or cosmetic.
(b)CA Health & Safety Code § 110030(b)  The exhibition, offer, possession, or holding of any food, drug, device, or cosmetic for sale, dispensing, giving, supplying, or applying in the conduct of any establishment.
(c)CA Health & Safety Code § 110030(c)  The sale, dispensing, giving, supplying, or applying of any food, drug, device, or cosmetic in the conduct of any establishment.

Section § 110035

Explanation

This law states that any current rules about food, drugs, devices, or cosmetics set by the department will stay active until new rules are put in place that specifically cancel them.

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.

Section § 110036

Explanation

This section states that current laws about industrial hemp products will stay in place until the federal government creates new rules regarding industrial hemp. Once those federal rules are set, California will update its own regulations, either to align with federal law or to ensure consumer safety.

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.

Section § 110040

Explanation

This law ensures that its provisions don't contradict or interfere with the rules in the Food and Agricultural Code or the Alcoholic Beverage Control Act.

It also aligns with the regulations related to these areas that have been officially established.

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.