Drugs and DevicesMisbranded Drugs Or Devices
Section § 111330
This law states that a drug or medical device is considered misbranded if the information on its label is false or misleading in any way.
Section § 111335
Section § 111340
This law states that a drug or device is considered misbranded if its label doesn't include certain required information. First, the label must show the name and location of the manufacturer, packer, or distributor. It also needs to accurately state the quantity of the contents, using weight, measure, or numerical count. However, slight differences in quantity are acceptable, and specific rules for label placement, prominence, and exceptions for small packages are set by regulations.
Section § 111345
In simple terms, this law says that a drug or medical device is considered misbranded if the important information required on its label isn't clear or easy to read. The required information needs to stand out clearly against other text or designs on the label so that an average person can easily see and understand it when buying and using the product.
Section § 111355
This law ensures that any drug is considered misbranded unless its label includes certain key information. This includes the drug's established name, and if it contains multiple ingredients, the amount and name of each active ingredient, along with specific substances like alcohol or bromides. For nonprescription drugs, both active and inactive ingredients' details must comply with federal standards.
The rule for stating ingredient quantities applies to all drugs, but nonprescription drugs that are also cosmetics and meet federal label rules are exempt, except for certain specific substances. The department can exempt some nonprescription drugs from quantity declarations if it's safe for public health. Prescription drug labels must highlight the drug's established name prominently. These labeling changes don't apply to drugs shipped to retailers or wholesalers before 1980, but they must comply by 1981.
Section § 111360
This section of the law says that a drug will be considered misbranded unless the manufacturer, packer, or distributor includes certain information in all drug advertisements and descriptions. Specifically, they must clearly state the drug's established name, provide a breakdown of the ingredients, and identify the manufacturer. Additionally, they must include a summary of side effects, contraindications, and effectiveness as required by regulations. These regulations align with federal laws but may include additional state-specific rules.
Section § 111365
This law states that a prescription drug is considered misbranded if the official name of the drug or its ingredient isn't displayed on the label in a font size that's at least half as large as the brand name. This helps ensure consumers can clearly identify the drug's generic name alongside its brand name.
The health department can set rules allowing for exceptions to this rule if it's deemed unnecessary to protect people’s health and safety.
Section § 111375
This section states that a drug or device is considered misbranded unless its labeling includes the following: directions for use, warnings against use in specific health conditions or by children if it's dangerous, and warnings about unsafe dosages or methods of use. Labels must use clear and necessary warnings to protect users.
The state department can exempt a drug or device from these labeling requirements if it's determined unnecessary for public health. Drugs or devices exempt under a specific federal law are also exempt from these requirements, although the department may choose to apply the rules regardless of federal exemptions.
Section § 111376
This law allows California's health department to make rules about mifepristone, a drug used for medication abortions, and decide whether these drugs need to follow specific regulations, even if it goes against federal rules.
The law also states that if mifepristone's labeling changes or it loses FDA approval, the state's usual rules won't apply as long as it is still recommended by the World Health Organization and the label was accurate during manufacturing, unless there's an urgent health or safety issue.
Section § 111380
This law states that a drug is considered misbranded if it claims to be one recognized in an official medical reference, but isn't packaged and labeled according to that reference's standards. However, the packaging method can be changed if the department approves it.
Section § 111385
This law says a drug or device can be considered "misbranded" if it could deteriorate without proper packaging or labeling. If the health department thinks precautions are needed for public safety, they can require specific packaging or labeling through regulations. However, if the drug or device is already listed in an official reference book and the department wants more requirements, they must first notify the book's editors and give them time to update it.
Section § 111390
This law states that a drug or device is considered misbranded if its packaging is designed in a way that could mislead consumers.
Section § 111395
This law states that a drug is considered mislabeled or misbranded if any of the following are true: it mimics another drug, is sold under a different drug's name, or if its package contents have been partially or fully swapped with something else.
Section § 111397
This law explains how foreign dangerous drugs are classified as misbranded in California. If a drug is not approved by the U.S. FDA or it comes from outside the official U.S. supply chain, it is considered misbranded. However, if a drug is legally imported under certain federal guidelines, like for clinical research or during drug shortages, it's not considered misbranded.
Section § 111400
This law says a drug or device is considered 'misbranded' if using it as directed on its label could harm your health. This includes the suggested amount to take, how often to take it, or for how long.
Section § 111415
This law says that if a drug is just meant to add color to other drugs, it has to follow specific packaging and labeling rules. If it doesn't, the drug is considered to be misbranded.
Section § 111420
This law states that a drug or device is considered misbranded if it has someone else's trademark, trade name, or similar identifying mark placed on it, or on its container, without permission.
Section § 111425
If a drug or medical device is made in California at a facility that doesn't have the proper license, it is considered misbranded.
Section § 111430
If a drug or device is made in a facility that hasn't properly registered with the U.S. Secretary of Health, Education, and Welfare, it will be considered mislabeled or misbranded.
Section § 111435
A drug is considered 'misbranded' if its packaging or labeling doesn't follow specific regulations set out in Sections 108685 or 108700.
Section § 111440
Section § 111445
Section § 111450
This law makes it illegal to accept or deliver any drug or medical device that is incorrectly labeled or presented in a misleading way.
Section § 111455
This law makes it illegal for anyone to change or damage the label on a drug or medical device in a way that causes it to be misleading or incorrectly branded.
Section § 111460
This law states that a drug or device meant for export is not considered mislabeled if it meets certain conditions. First, it must meet the foreign buyer's specifications. Second, it must comply with the laws of the country it's being sent to. Third, the shipping package must clearly indicate that the product is intended for export. However, if the product is sold within the United States, these exceptions do not apply, and it must follow regular labeling laws.
Section § 111465
This law states that a drug or device is considered misbranded in California if it is supposed to follow the FDA's rules for tamper-resistant packaging but fails to meet these standards. These rules come from specific parts of the federal regulations.
Section § 111470
This law states that certain drugs and medical devices can only be sold with a prescription from a licensed healthcare provider, either as a written prescription or a promptly documented oral order. The types of drugs include those that are habit-forming, potentially harmful or toxic, require professional oversight for safe use, or cannot be safely self-administered without professional direction. Additionally, if a prescription doesn't specify the number of refills, a pharmacist must get a new prescription from the healthcare provider before refilling it.
Section § 111475
If a drug or medical device is sold in violation of certain regulations, it is considered mislabeled or misbranded when it's available for purchase.
Section § 111480
This California law explains that certain prescription drugs or devices do not have to follow specific labeling requirements if they meet certain criteria. Prescription labels must show essential details like the drug name, directions, patient and prescriber names, issue date, and dosage information. Specific rules apply to drugs used for medication abortion. Additional rules are in place for medications dispensed through unit dose systems in healthcare facilities.
However, this exemption does not apply to drugs dispensed through mail-order practices that diagnose, or in violation of related laws.
Section § 111485
This law allows the department to decide whether certain drugs or devices must follow specific safety requirements. If the federal government decides a drug doesn't need these requirements, it's automatically exempt in this state too. However, the department can still choose to apply or remove these requirements for any drug or device, regardless of federal decisions.
Section § 111490
This law explains how drugs and devices are considered 'misbranded' based on their labeling instructions before being dispensed. For drugs and devices covered by another law, Section 111470, they're misbranded if their labels don't include a caution about requiring a prescription or being restricted to certain professionals. On the other hand, items not covered by Section 111470 should not have these cautionary labels, or they are also deemed misbranded.
Section § 111495
This law makes it clear that nothing in the article changes existing legal responsibilities concerning drugs, particularly those classified as controlled substances under California laws starting with Section 11000 or federal law. This means all current and future rules about these drugs must still be followed as they are.
Section § 111500
This law allows doctors, dentists, podiatrists, or veterinarians to give their patients drugs directly if needed for treatment. However, these drugs must have all the required labeling information, except for a prescription number.
Section § 111505
This section defines terms related to the distribution and labeling of legend drugs, which are controlled substances. A 'distributor' is someone who sells legend drugs under their own label but doesn't make them. 'Legend drugs' are those controlled by U.S. or California substance laws. 'Solid dosage forms' refer to pills like capsules or tablets. 'Code imprint' is a unique identifier, like a series of letters or numbers, used by manufacturers or distributors to label their drugs, which can include the National Drug Code.
Section § 111510
This law requires that all solid form prescription drugs (legend drugs) in California must have a marking or imprint that identifies both the drug and the company that manufactured or distributed it, to prevent misuse and aid identification. If a company only repackages drugs, they do not need to add an imprint.
Drug manufacturers and distributors must submit their list of drugs and corresponding imprints to the state's health department, which shares this information with poison control centers and healthcare providers. These lists must be updated annually.
The law allows exemptions if imprinting is impractical due to the drug's size or other qualities. Drugs that do not comply with imprinting requirements are considered misbranded. This regulation applies to all relevant drugs sold in California from January 1, 1983.
Pharmacists, pharmacies, and wholesalers are only liable for willful violations, except under certain conditions specified in the Business and Professions Code. The rules don't apply to drugs purchased before 1983, those under investigation, or drugs made for individual patients by licensed practitioners.