Sherman Food, Drug, and Cosmetic LawsGeneral Provisions and Definitions
Section § 109875
Section § 109880
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.
Section § 109885
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.
Section § 109890
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.
Section § 109895
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.
Section § 109900
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.
Section § 109905
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.
Section § 109910
This law section defines "Department" as the State Department of Health Services.
Section § 109915
This section defines the term "Director" as the State Director of Health Services.
Section § 109920
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.
Section § 109925
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.
Section § 109930
This section defines the term 'Federal act' as referring to the federal Food, Drug, and Cosmetic Act, including any amendments to it.
Section § 109935
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.
Section § 109940
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.
Section § 109945
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.
Section § 109947
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.
Section § 109948
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.
Section § 109948.1
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.
Section § 109950
This law clarifies that when mentioning an 'immediate container,' it does not refer to any inner packaging or liner within the container.
Section § 109951
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.
Section § 109955
This law defines a 'label' as any written, printed, or graphic information placed on a food, drug, device, or cosmetic or its immediate container.
Section § 109960
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.
Section § 109965
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.
Section § 109970
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.
Section § 109971
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.
Section § 109975
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.
Section § 109980
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.
Section § 109985
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.
Section § 109990
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.
Section § 109992
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.
Section § 109995
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.
Section § 110000
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.
Section § 110005
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.
Section § 110010
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.
Section § 110010.1
This law defines a "prescription device" as any medical device that must be used only with a prescription under the regulations of Section 111470.
Section § 110010.2
This section defines a 'prescription drug' as any drug that legally requires a doctor's prescription according to another specific section of the law.
Section § 110015
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.
Section § 110020
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.
Section § 110025
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.
Section § 110030
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.
Section § 110035
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.
Section § 110036
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.
Section § 110040
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.