Section § 111330

Explanation

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.

Any drug or device is misbranded if its labeling is false or misleading in any particular.

Section § 111335

Explanation
A drug or device is considered 'misbranded' if its labeling or packaging doesn't meet the standards set out in the specific regulations starting from Section 110290. Essentially, if the packaging or labels are incorrect or misleading, it's against the rules.
Any drug or device is misbranded if its labeling or packaging does not conform to the requirements of Chapter 4 (commencing with Section 110290).

Section § 111340

Explanation

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.

Any drug or device is misbranded unless it bears a label containing all of the following information:
(a)CA Health & Safety Code § 111340(a)  The name and place of business of the manufacturer, packer, or distributor.
(b)CA Health & Safety Code § 111340(b)  An accurate statement of the quantity of the contents in terms of weight, measure, or numerical count.
Reasonable variations from the requirements of subdivision (b) shall be permitted. Requirements for placement and prominence of the information and exemptions as to small packages shall be established in accordance with regulations adopted pursuant to Section 110380.

Section § 111345

Explanation

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.

Any drug or device is misbranded if any word, statement, or other information required by or under this part to appear on the label or labeling is not prominently placed on the label or labeling with conspicuousness, as compared with other words, statements, designs, or devices in the labeling, and in terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.

Section § 111355

Explanation

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.

(a)CA Health & Safety Code § 111355(a)  Any drug is misbranded unless its label bears, to the exclusion of any other nonproprietary name except the applicable, systematic chemical name or the chemical formula, all of the following information:
(1)CA Health & Safety Code § 111355(a)(1)  The established name of the drug, if any.
(2)CA Health & Safety Code § 111355(a)(2)  If it is fabricated from two or more ingredients, the established name and quantity of each active ingredient, including the kind and quantity or proportion of any alcohol, and also including, whether active or not, the established name and quantity or proportion of any bromides, ether, chloroform, acetanilide, acetophenetidin, antipyrine, atropine, hyoscine, hyoscyamine, codeine, arsenic, digitalis, digitalis glycosides, mercury, ouabain, strophanthin, strychnine, barbituric acid, or any derivative or preparation of any substances contained therein.
(3)CA Health & Safety Code § 111355(a)(3)  For nonprescription drugs, the quantity or proportion of each active ingredient and the established name of each inactive ingredient in accordance with Sections 502(e)(1)(A)(ii) and (iii) of the federal act (21 U.S.C. 352(e)(1)(A)(ii) and (iii)).
(b)CA Health & Safety Code § 111355(b)  The requirement for stating the quantity of the active ingredients of any drug, including the quantity or proportion of any alcohol, and also including, whether active or not, the quantity or proportion of any bromides, ether, chloroform, acetanilide, acetophenetidin, antipyrine, atropine, hyoscine, hyoscyamine, codeine, arsenic, digitalis, digitalis glycosides, mercury, ouabain, strophanthin, strychnine, barbituric acid, or any derivative or preparation of any substances contained therein, shall apply to all drugs, including prescription drugs and nonprescription drugs. However, the requirement for declaration of quantity shall not apply to nonprescription drugs that are also cosmetics, as defined in Section 201(i) of the federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 321(i)) and that are labeled in compliance with federal labeling requirements concerning declaration of ingredients including active ingredients and also the quantity and proportion of any alcohol, except that the quantity or proportion of the following ingredients, whether active or not, shall be declared: bromides, ether, chloroform, acetanilide, acetophenetidin, antipyrine, atropine, hyoscine, hyoscyamine, codeine, arsenic, digitalis, digitalis glycosides, mercury, ouabain, strophanthin, strychnine, barbituric acid, or any derivative or preparation of any substances contained therein. The department may exempt any nonprescription drug from the requirement of stating the quantity of the active ingredients, other than those specifically named in this subdivision, upon a showing by the applicant through evidence satisfactory to the department that the granting of the exemption will not endanger the public health. For any prescription drug the established name of the drug or ingredient, as the case may be, on the label and on any labeling on which a name for the drug or ingredient is used shall be printed prominently and in type at least half as large as that used thereon for any proprietary name or designation for the drug or ingredient.
The changes made in this section by Chapter 943 of the Statutes of 1978 shall not apply to any drug shipped by a manufacturer or packer to a retailer or wholesaler before January 1, 1980. Any such drugs so shipped shall comply with this section on and after January 1, 1981.

Section § 111360

Explanation

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.

Any drug subject to Section 111470 is misbranded unless the manufacturer, packer, or distributor of the drug includes, in all advertisements and other descriptive matter issued or caused to be issued by the manufacturer, packer, or distributor with respect to that drug, a true statement of all of the following:
(a)CA Health & Safety Code § 111360(a)  The established name, printed prominently and in a type at least half as large as that used for any proprietary name of the drug.
(b)CA Health & Safety Code § 111360(b)  The formula showing quantitatively each ingredient of the drug to the extent required for labels under Section 111355.
(c)CA Health & Safety Code § 111360(c)  The name and place of business of the manufacturer that produced the finished dosage form of the drug, as prescribed by regulations issued by the department. This subdivision applies only to advertisements or descriptive matter issued for drugs manufactured in finished dosage form on or after April 1, 1973.
(d)CA Health & Safety Code § 111360(d)  Such other information, in brief summary relating to side effects, contraindications, and effectiveness as shall be required by regulations promulgated by the department.
Regulations relating to side effects, contraindications, and effectiveness issued pursuant to Section 502(n) of the federal act (21 U.S.C. Sec. 352(n)) are the regulations establishing information requirements relating to side effects, contraindications and effectiveness in this state. The department may, by regulation, make other requirements relating to side effects, contraindications, and effectiveness whether or not in accordance with the regulations adopted under the federal act.

Section § 111365

Explanation

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.

Any drug subject to Section 111470 is misbranded unless the established name of the prescription drug or prescription drug ingredient is printed on the label prominently and in type at least half as large as that used for the proprietary name or designation on the label, labeling, or advertising.
The department may, by regulation, establish exemptions from the requirements of this section when compliance with this section is not considered necessary for the protection of health and safety.

Section § 111375

Explanation

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.

Any drug or device is misbranded unless its labeling bears all of the following information:
(a)CA Health & Safety Code § 111375(a)  Adequate directions for use.
(b)CA Health & Safety Code § 111375(b)  Such adequate warnings against use in pathological conditions or by children where its use may be dangerous to health.
(c)CA Health & Safety Code § 111375(c)  Adequate warning against unsafe dosage or methods or duration of administration or application.
Warnings shall be in a manner and form as are necessary for the protection of users.
If the department determines that any requirement of subdivision (a), as applied to any drug or device, is not necessary for the protection of the public health, the department may adopt regulations exempting the drug or device from these requirements.
Any drug or device exempted under Section 502(f) of the federal act (21 U.S.C. Sec. 352(f)) is exempt from the requirement of this section. The department, however, may adopt any regulation including a drug or device within, or excluding a drug or device from the requirements of this section, whether or not the inclusion or exclusion of the drug or device is in accord with the federal act.

Section § 111376

Explanation

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.

(a)CA Health & Safety Code § 111376(a) The department may adopt regulations relating to brand name or generic mifepristone or any drug used for medication abortion by including brand name or generic mifepristone or any drug used for medication abortion within, or excluding brand name or generic mifepristone or any drug used for medication abortion from, the requirements of this article, whether or not the inclusion or exclusion of the drug is in accordance with federal law.
(b)CA Health & Safety Code § 111376(b) Notwithstanding any other state law, and consistent with Sections 1 and 1.1 of Article I of the California Constitution, this article shall not apply to brand name or generic mifepristone in the event of a labeling change or in the absence of its United States Food and Drug Administration approval if it is recommended for use by the World Health Organization and its labeling was true and accurate at the time of manufacture, except if the state deems it necessary to address an imminent health or safety concern regarding brand name or generic mifepristone.

Section § 111380

Explanation

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.

Any drug is misbranded if it purports to be a drug that is recognized in an official compendium and it is not packaged and labeled as prescribed in the official compendium. The method of packaging, however, may be modified with the consent of the department.

Section § 111385

Explanation

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.

Any drug or device is misbranded if the department determines that the drug or device is liable to deterioration, unless it is packaged in that form and manner and its label bears a statement of the precautions, as the department, by regulation, may require as necessary for the protection of public health. Such regulations shall not be established for any drug or device recognized in an official compendium, unless the department has informed the appropriate body, charged with the revision of the official compendium, of the need for that packaging or labeling requirements and that body has not prescribed the requirements in a reasonable length of time.

Section § 111390

Explanation

This law states that a drug or device is considered misbranded if its packaging is designed in a way that could mislead consumers.

Any drug or device is misbranded if its container is so made, formed, or filled as to be misleading.

Section § 111395

Explanation

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.

Any drug is misbranded in any of the following cases:
(a)CA Health & Safety Code § 111395(a)  It is an imitation of another drug.
(b)CA Health & Safety Code § 111395(b)  It is offered for sale under the name of another drug.
(c)CA Health & Safety Code § 111395(c)  The contents of the original package have been, wholly or partly, removed and replaced with other material in the package.

Section § 111397

Explanation

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.

(a)CA Health & Safety Code § 111397(a) Any foreign dangerous drug that is not approved by the United States Food and Drug Administration or that is obtained outside of the licensed supply chain regulated by the United States Food and Drug Administration, California State Board of Pharmacy, or State Department of Public Health is misbranded.
(b)CA Health & Safety Code § 111397(b) Any foreign dangerous drug that is imported lawfully under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 301 et seq.) or pursuant to an announcement by the United States Food and Drug Administration of the exercise of enforcement discretion for instances including, but not limited to, clinical research purposes, drug shortages, development of countermeasures against chemical, biological, radiological, and nuclear terrorism agents, or pandemic influenza preparedness and response is not misbranded.

Section § 111400

Explanation

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.

Any drug or device is misbranded if it is dangerous to health when used in the dosage, or with the frequency or duration prescribed, recommended, or suggested in its labeling.

Section § 111415

Explanation

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.

Any drug is misbranded if it is a color additive, intended for use in or on drugs for the purpose of coloring only and its packaging and labeling fail to conform to the packaging and labeling requirements adopted pursuant to Section 110090.

Section § 111420

Explanation

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.

A drug or device is misbranded if a trademark, trade name, or other identifying mark, imprint, or device of another person, or any likeness of the trademark, trade name, or other identifying mark, imprint, or device of another person, has been placed on the drug or device, or upon its container.

Section § 111425

Explanation

If a drug or medical device is made in California at a facility that doesn't have the proper license, it is considered misbranded.

A drug or device is misbranded if it was manufactured in this state in an establishment not duly licensed as provided in this part.

Section § 111430

Explanation

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.

A drug or device is misbranded if it was manufactured in an establishment not duly registered with the Secretary of Health, Education, and Welfare of the United States.

Section § 111435

Explanation

A drug is considered 'misbranded' if its packaging or labeling doesn't follow specific regulations set out in Sections 108685 or 108700.

Any drug is misbranded if its packaging or labeling is in violation of an applicable regulation issued pursuant to Section 108685 or 108700.

Section § 111440

Explanation
This law makes it illegal for anyone to make, sell, distribute, possess, or offer a drug or device if it has misleading labels or branding.
It is unlawful for any person to manufacture, sell, deliver, hold, or offer for sale any drug or device that is misbranded.

Section § 111445

Explanation
It's against the law for anyone to mislabel or misrepresent any drug or medical device.
It is unlawful for any person to misbrand any drug or device.

Section § 111450

Explanation

This law makes it illegal to accept or deliver any drug or medical device that is incorrectly labeled or presented in a misleading way.

It is unlawful for any person to receive in commerce any drug or device that is misbranded or to deliver or proffer for delivery any drug or device.

Section § 111455

Explanation

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.

It is unlawful for any person to alter, mutilate, destroy, obliterate, or remove the label or any part of the labeling of any drug or device if the act results in the drug or device being misbranded.

Section § 111460

Explanation

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.

Any drug or device intended for export shall not be deemed to be misbranded under this part if it satisfies all of the following requirements:
(a)CA Health & Safety Code § 111460(a)  It accords to the specifications of the foreign purchaser.
(b)CA Health & Safety Code § 111460(b)  It is not in conflict with the laws of the importing country.
(c)CA Health & Safety Code § 111460(c)  It is labeled on the outside of the shipping package to show that it is intended for export.
If the article is sold or offered for sale in domestic commerce, this section shall not exempt it from any of the provisions of this part.

Section § 111465

Explanation

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.

A drug or device is deemed misbranded under the laws of this state if it is subject to regulations issued by the United States Food and Drug Administration relating to tamper-resistant packaging, as set forth in Parts 200, 211, 314, and 800 of Volume 21 of the Code of Federal Regulations, as amended, but is not in compliance therewith.

Section § 111470

Explanation

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.

The following drugs or devices, that are intended for use by man, shall be sold only upon a written prescription of a practitioner licensed by law to prescribe the drug or device, or upon an oral prescription of the licensee that is reduced promptly to writing and filed by the pharmacist, or by refilling the written or oral prescription if the refilling is authorized by the prescriber either in the original prescription or by oral order that is reduced promptly to writing and filed by the pharmacist:
(a)CA Health & Safety Code § 111470(a)  A habit forming drug to which Section 111350 applies.
(b)CA Health & Safety Code § 111470(b)  A drug or device that, because of its toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, is not safe for use except under the supervision of a practitioner licensed by law to administer the drug or device.
(c)CA Health & Safety Code § 111470(c)  A drug or device for which adequate directions cannot be written for persons, who are not practitioners licensed by law to prescribe the drug or device, for safe and effective self-medication or treatment by those persons, who are not practitioners licensed by law to prescribe the drug or device.
(d)CA Health & Safety Code § 111470(d)  A drug or device that is limited by an effective application under Section 505 of the federal act (21 U.S.C. Sec. 355) or Section 111550 to use under the professional supervision of a practitioner licensed by law to administer the drug or device.
If any prescription for the drug does not indicate the number of times it may be refilled, if any, the prescription may not be refilled unless the pharmacist obtains a new order from the practitioner.

Section § 111475

Explanation

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.

The act of selling a drug or device contrary to Section 111470 shall be deemed to be an act that results in the drug or device being misbranded while held for sale.

Section § 111480

Explanation

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.

(a)CA Health & Safety Code § 111480(a) A drug or device sold by filling or refilling a written or oral prescription of a practitioner licensed to prescribe the drug or device shall be exempt from the labeling requirements of Sections 111335, 111340, 111355, 111360, 111365, 111375, 111380, 111385, 111395, 111415, and 111420, if the drug or device bears a label displaying all of the following:
(1)CA Health & Safety Code § 111480(a)(1) Except when the prescriber orders otherwise, either the manufacturer’s trade name of the drug, or the generic name and the name of the manufacturer. Commonly used abbreviations may be used. Preparations containing two or more active ingredients may be identified by the manufacturer’s trade name or the commonly used name or the principal active ingredients.
(2)CA Health & Safety Code § 111480(a)(2) The directions for the use of the drug or device.
(3)CA Health & Safety Code § 111480(a)(3) The name of the patient(s).
(4)CA Health & Safety Code § 111480(a)(4) The name of the prescriber.
(5)CA Health & Safety Code § 111480(a)(5) The date of issue.
(6)CA Health & Safety Code § 111480(a)(6) The name, address of the furnisher, and prescription number or other means of identifying the prescription.
(7)CA Health & Safety Code § 111480(a)(7) The strength of the drug or drugs dispensed.
(8)CA Health & Safety Code § 111480(a)(8) The quantity of the drug or drugs dispensed.
(9)CA Health & Safety Code § 111480(a)(9) The expiration date of the effectiveness of the drug or device if the information is included on the original label of the manufacturer of the drug or device.
(b)CA Health & Safety Code § 111480(b) Brand name or generic mifepristone or any drug used for medication abortion sold by filling or refilling a written or oral prescription of a practitioner licensed to prescribe the drug or device shall be exempt from the labeling requirements of Sections 111335, 111340, 111355, 111360, 111365, 111375, 111380, 111385, 111395, 111415, and 111420, if the label complies with subdivision (g) of Section 4076 of the Business and Professions Code.
(c)CA Health & Safety Code § 111480(c) If a pharmacist dispenses a prescribed drug by means of a unit dose medication system, as defined by administrative regulation, for a patient in a skilled nursing, intermediate care or other health care facility, the requirements of subdivision (a) shall be satisfied if the unit dose medication system contains the information required pursuant to subdivision (a) or the information is otherwise readily available at the time of drug administration.
(d)CA Health & Safety Code § 111480(d) The exemption in subdivision (a) shall not apply to any drug or device dispensed in the course of the conduct of a business of dispensing drugs or devices pursuant to diagnosis by mail, or to a drug or device dispensed in violation of Section 111470.

Section § 111485

Explanation

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.

The department may, by regulation, remove any drug or device subject to Sections 111350 and 111550 from the requirements of Section 111470, when the requirements are not necessary for the protection of the public health. Any drug removed from the prescription requirements of the federal act by regulations adopted pursuant to the federal act is removed from the requirements of Section 111470. The department may, however, by regulation, continue the applicability of Section 111470 for any drug or device, or make these sections inapplicable to any drug or device, whether or not the inclusion or exclusion of the drug or device is in accordance with the regulations adopted pursuant to the federal act.

Section § 111490

Explanation

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.

(a)CA Health & Safety Code § 111490(a)  A drug or device that is subject to Section 111470 is misbranded if at any time prior to dispensing, its label fails to bear the statement “Caution: federal law prohibits dispensing without prescription,” or “Caution: state law prohibits dispensing without prescription,” or “R x only.” A drug or device to which Section 111470 does not apply is misbranded if at any time prior to dispensing its label bears the caution statement or “R x only” quoted in the preceding sentence.
(b)CA Health & Safety Code § 111490(b)  A device that is subject to Section 111470 is misbranded if, at any time prior to dispensing, its label fails to bear the statement “Caution: federal law restricts this device to sale by or on the order of a ____ ,” the blank to be filled in with the designation of the practitioner licensed to use or order use of the device. A device to which Section 111470 does not apply is misbranded if, at any time prior to dispensing, its label bears the caution statement quoted in the preceding sentence.

Section § 111495

Explanation

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.

Nothing in this article shall be construed to relieve any person from any requirement prescribed by or under authority of law with respect to drugs now included or that may hereafter be included within the classification stated in Division 10 (commencing with Section 11000) or in the applicable federal law relating to controlled substances.

Section § 111500

Explanation

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.

A physician, dentist, podiatrist, or veterinarian may personally furnish his or her own patient with drugs as are necessary in the treatment of the condition for which he or she attends the patient provided that the drug is properly labeled to show all the information required in Section 111480 except the prescription number.

Section § 111505

Explanation

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.

For purposes of Section 111510, the following definitions shall apply:
(a)CA Health & Safety Code § 111505(a)  “Distributor” means any corporation, person, or other entity, not engaged in the manufacture of a legend drug product, who distributes for resale and distribution a legend drug product under the label of the corporation, person, or entity.
(b)CA Health & Safety Code § 111505(b)  “Legend drug” means any controlled substance subject to the Federal Controlled Substances Act (Title II, P.L. 91-513) or subject to the Uniform Controlled Substances Act, Division 10 (commencing with Section 11000), and any drug described in Section 4211 of the Business and Professions Code or Section 111470.
(c)CA Health & Safety Code § 111505(c)  “Solid dosage forms” means capsules or tablets intended for oral administration.
(d)CA Health & Safety Code § 111505(d)  “Code imprint” means a series of letters or numbers assigned by the manufacturer or distributor to a specific drug, or marks or monograms unique to the manufacturer, distributor, or both. The National Drug Code may be used as a code imprint.

Section § 111510

Explanation

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.

(a)CA Health & Safety Code § 111510(a)  No legend drug in solid dosage form may be manufactured or distributed for sale in this state unless it is clearly marked or imprinted with a code imprint identifying the drug and the manufacturer or distributor of the drug. Manufacturers or distributors who only repack an already finished dosage form of a legend drug shall not have the responsibility to do the imprint.
(b)CA Health & Safety Code § 111510(b)  On or before July 1, 1982, manufacturers or distributors of legend drugs, depending on whether the manufacturer’s or distributor’s code imprint will appear on the surface of the solid dosage form, shall provide to the department a list of their legend drugs and the intended code imprints. The department shall provide for the distribution of the information required to be submitted under this subdivision to all poison control centers in the state. Manufacturers, distributors, and the department shall provide to any licensed health care provider, upon request, lists of legend drugs and code imprints provided to the department under this section, but may charge a reasonable fee to cover copying and postage costs. Updated lists shall be provided to the department annually or as changes or revisions occur.
(c)CA Health & Safety Code § 111510(c)  The department may grant exemptions from the requirements of this section upon application of a manufacturer or distributor indicating size or other characteristics that render the product impractical for the imprinting required by this section.
(d)CA Health & Safety Code § 111510(d)  A legend drug that does not meet the requirements is misbranded.
(e)CA Health & Safety Code § 111510(e)  It is the intent of the Legislature that all legend drugs having solid dosage forms be imprinted regardless of by whom they are distributed.
(f)CA Health & Safety Code § 111510(f)  This section shall apply to all legend drugs sold in California on or after January 1, 1983.
(g)CA Health & Safety Code § 111510(g)  Pharmacists, pharmacies, and licensed wholesalers shall only be liable for knowing and willful violations of this section, except that no liability shall accrue if the pharmacist acts pursuant to Section 4229.5 of the Business and Professions Code.
(h)CA Health & Safety Code § 111510(h)  The provisions of subdivisions (a) to (g), inclusive, shall not apply to any of the following:
(1)CA Health & Safety Code § 111510(h)(1)  Drugs purchased by a pharmacy, pharmacist, or licensed wholesaler prior to January 1, 1983, and held in stock for resale.
(2)CA Health & Safety Code § 111510(h)(2)  Drugs that are the subject of an investigation pursuant to Section 111590 or 111595.
(3)CA Health & Safety Code § 111510(h)(3)  Drugs that are manufactured by or upon the order of a practitioner licensed by law to prescribe or administer drugs and that are to be used solely by the patient for whom prescribed.