reglab/statecodes huggingface dataset:
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 1 - General Provisions › Section 111246.

111246. Commencing January 1, 2002, any product used for the treatment of lice or scabies in human beings that contains the pesticide Lindane shall not be used or sold in the state.
(Added by Stats. 2000, Ch. 326, Sec. 2. Effective January 1, 2001.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 2 - Adulterated Drugs or Devices › Section 111250.

111250. Any drug or device is adulterated if it consists, in whole or in part, of any filthy, putrid, or decomposed substance.
(Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 2 - Adulterated Drugs or Devices › Section 111255.

111255. Any drug or device is adulterated if it has been produced, prepared, packed, or held under conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.
(Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 2 - Adulterated Drugs or Devices › Section 111260.

111260. Any drug or device is adulterated if the methods, facilities, or controls used for its manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with current good manufacturing practice to assure that the drug or device meets the requirements of this part as to safety and has the identity and strength, and meets the quality and purity characteristics that it purports or is represented to possess.
(Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 2 - Adulterated Drugs or Devices › Section 111265.

111265. Any drug or device is adulterated if it is packaged and its container is composed, in whole or in part, of any poisonous or deleterious substance that may render the contents injurious to health.
(Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 2 - Adulterated Drugs or Devices › Section 111270.

111270. Any drug or device is adulterated if it bears or contains for the purpose of coloring only a color additive that is unsafe within the meaning of Section 111240.
(Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 2 - Adulterated Drugs or Devices › Section 111275.

111275. Any drug or device is adulterated if it is a color additive, the intended use of which in or on drugs or devices is for the purpose of coloring only, and it is unsafe within the meaning of Section 111240.
(Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 2 - Adulterated Drugs or Devices › Section 111280.

111280. Any drug is adulterated if it purports to be, or is represented as, a drug that is recognized in an official compendium, and its strength differs from, or its quality or purity falls below, the standards set forth in the compendium. Such determination as to strength, quality, or purity shall be made in accordance with the tests or methods of assay set forth in the compendium, or in the absence of or inadequacy of the tests or methods of assay, those prescribed under authority of this part. No drug defined in an official compendium shall be deemed to be adulterated under this section because it differs from the standard of strength, quality, or purity set forth in the compendium, if its difference in strength, quality, or purity from the standard is plainly stated on the label.
(Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 2 - Adulterated Drugs or Devices › Section 111285.

111285. Any drug or device is adulterated if its strength differs from, or its purity or quality is below, that which it is represented to possess.
(Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 2 - Adulterated Drugs or Devices › Section 111290.

111290. Any drug or device is adulterated if any substance has been mixed or packed with it so as to reduce its quality or strength or if any substance has been substituted, wholly or in part, for the drug or device.
(Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 2 - Adulterated Drugs or Devices › Section 111295.

111295. It is unlawful for any person to manufacture, sell, deliver, hold, or offer for sale any drug or device that is adulterated.
(Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 2 - Adulterated Drugs or Devices › Section 111300.

111300. It is unlawful for any person to adulterate any drug or device.
(Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 2 - Adulterated Drugs or Devices › Section 111305.

111305. It is unlawful for any person to receive in commerce any drug or device that is adulterated or to deliver or proffer for delivery any drug or device.
(Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 2 - Adulterated Drugs or Devices › Section 111310.

111310. While any regulation described in Section 110090 relating to any color additive is in effect, any drug or device that bears or contains the color additive in accordance with the regulation shall not be considered adulterated.
(Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 2 - Adulterated Drugs or Devices › Section 111315.

111315. Any drug or device intended for export shall not be deemed to be adulterated under this part if it satisfies all of the following requirements:
(a)  It accords to the specifications of the foreign purchaser.
(b)  It is not in conflict with the laws of the importing country.
(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.
(Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 2 - Adulterated Drugs or Devices › Section 111320.

111320. Any device is adulterated that fails to meet the applicable performance standard, if any, as provided in Section 111245.
(Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 2 - Adulterated Drugs or Devices › Section 111325.

111325. A drug or device is deemed adulterated under the laws of this state if it is subject to regulations issued by the United States Food and Drug Administration as set forth in Parts 200, 211, 314, and 800 of Volume 21 of the Code of Federal Regulations, as amended, relating to tamper-resistant packaging, but is not in compliance therewith.
(Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 3 - Misbranded Drugs or Devices › Section 111330.

111330. Any drug or device is misbranded if its labeling is false or misleading in any particular.
(Amended by Stats. 2000, Ch. 796, Sec. 7. Effective January 1, 2001.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 3 - Misbranded Drugs or Devices › Section 111335.

111335. Any drug or device is misbranded if its labeling or packaging does not conform to the requirements of Chapter 4 (commencing with Section 110290).
(Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 3 - Misbranded Drugs or Devices › Section 111340.

111340. Any drug or device is misbranded unless it bears a label containing all of the following information:
(a)  The name and place of business of the manufacturer, packer, or distributor.
(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.
(Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 3 - Misbranded Drugs or Devices › Section 111345.

111345. 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.
(Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 3 - Misbranded Drugs or Devices › Section 111360.

111360. 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)  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)  The formula showing quantitatively each ingredient of the drug to the extent required for labels under Section 111355.
(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)  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.
(Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 3 - Misbranded Drugs or Devices › Section 111365.

111365. 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.
(Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 3 - Misbranded Drugs or Devices › Section 111375.

111375. Any drug or device is misbranded unless its labeling bears all of the following information:
(a)  Adequate directions for use.
(b)  Such adequate warnings against use in pathological conditions or by children where its use may be dangerous to health.
(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.
(Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 3 - Misbranded Drugs or Devices › Section 111380.

111380. 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.
(Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 3 - Misbranded Drugs or Devices › Section 111385.

111385. 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.
(Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 3 - Misbranded Drugs or Devices › Section 111390.

111390. Any drug or device is misbranded if its container is so made, formed, or filled as to be misleading.
(Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 3 - Misbranded Drugs or Devices › Section 111395.

111395. Any drug is misbranded in any of the following cases:
(a)  It is an imitation of another drug.
(b)  It is offered for sale under the name of another drug.
(c)  The contents of the original package have been, wholly or partly, removed and replaced with other material in the package.
(Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 3 - Misbranded Drugs or Devices › Section 111397.

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) 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.
(Added by Stats. 2014, Ch. 492, Sec. 13. (SB 600) Effective January 1, 2015.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 3 - Misbranded Drugs or Devices › Section 111400.

111400. 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.
(Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 3 - Misbranded Drugs or Devices › Section 111415.

111415. 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.
(Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 3 - Misbranded Drugs or Devices › Section 111420.

111420. 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.
(Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 3 - Misbranded Drugs or Devices › Section 111425.

111425. A drug or device is misbranded if it was manufactured in this state in an establishment not duly licensed as provided in this part.
(Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 3 - Misbranded Drugs or Devices › Section 111430.

111430. 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.
(Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 3 - Misbranded Drugs or Devices › Section 111435.

111435. Any drug is misbranded if its packaging or labeling is in violation of an applicable regulation issued pursuant to Section 108685 or 108700.
(Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 3 - Misbranded Drugs or Devices › Section 111440.

111440. It is unlawful for any person to manufacture, sell, deliver, hold, or offer for sale any drug or device that is misbranded.
(Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 3 - Misbranded Drugs or Devices › Section 111445.

111445. It is unlawful for any person to misbrand any drug or device.
(Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 3 - Misbranded Drugs or Devices › Section 111450.

111450. 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.
(Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 3 - Misbranded Drugs or Devices › Section 111455.

111455. 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.
(Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 3 - Misbranded Drugs or Devices › Section 111460.

111460. 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)  It accords to the specifications of the foreign purchaser.
(b)  It is not in conflict with the laws of the importing country.
(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.
(Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 3 - Misbranded Drugs or Devices › Section 111465.

111465. 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.
(Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 3 - Misbranded Drugs or Devices › Section 111470.

111470. 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)  A habit forming drug to which Section 111350 applies.
(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)  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)  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.
(Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 3 - Misbranded Drugs or Devices › Section 111475.

111475. 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.
(Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 3 - Misbranded Drugs or Devices › Section 111480.

111480. Any 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, 111350, 111355, 111360, 111365, 111375, 111380, 111385, 111395, 111415, and 111420, if the drug or device bears a label displaying all the following:
(a)  Except where 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.
(b)  The directions for the use of the drug or device.
(c)  The name of the patient(s).
(d)  The name of the prescriber.
(e)  The date of issue.
(f)  The name, address of the furnisher, and prescription number or other means of identifying the prescription.
(g)  The strength of the drug or drugs dispensed.
(h)  The quantity of the drug or drugs dispensed.
(i)  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.
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 this section will be satisfied if the unit dose medication system contains the aforementioned information or the information is otherwise readily available at the time of drug administration.
The exemption 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.
(Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 3 - Misbranded Drugs or Devices › Section 111485.

111485. 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.
(Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 3 - Misbranded Drugs or Devices › Section 111490.

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)  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.
(Amended by Stats. 2000, Ch. 796, Sec. 12. Effective January 1, 2001.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 3 - Misbranded Drugs or Devices › Section 111495.

111495. 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.
(Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 3 - Misbranded Drugs or Devices › Section 111500.

111500. 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.
(Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 3 - Misbranded Drugs or Devices › Section 111505.

111505. For purposes of Section 111510, the following definitions shall apply:
(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)  “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)  “Solid dosage forms” means capsules or tablets intended for oral administration.
(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.
(Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 3 - Misbranded Drugs or Devices › Section 111510.

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)  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)  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)  A legend drug that does not meet the requirements is misbranded.
(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)  This section shall apply to all legend drugs sold in California on or after January 1, 1983.
(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)  The provisions of subdivisions (a) to (g), inclusive, shall not apply to any of the following:
(1)  Drugs purchased by a pharmacy, pharmacist, or licensed wholesaler prior to January 1, 1983, and held in stock for resale.
(2)  Drugs that are the subject of an investigation pursuant to Section 111590 or 111595.
(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.
(Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 4 - Experimental Use of Drugs › Section 111515.

111515. As used in this article, “experimental drug” means any of the following:
A drug intended for investigational use under Section 111595.
(Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 4 - Experimental Use of Drugs › Section 111520.

111520. No person shall prescribe or knowingly administer an experimental drug to another person in violation of this article.
(Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 4 - Experimental Use of Drugs › Section 111525.

111525. Prior to prescribing or administering an experimental drug, consent to the use of the drug shall be obtained in the method and manner specified in Chapter 1.3 (commencing with Section 24170) of Division 20.
(Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 4 - Experimental Use of Drugs › Section 111530.

111530. (a)  Notwithstanding the provisions of Section 24175, if the subject is a minor, consent shall be provided by a parent or guardian of the subject and shall also be provided by the subject if the subject is seven years of age or older.
(b)  Consent given pursuant to this section shall only be for the prescribing or administering of an experimental drug that is related to maintaining or improving the health of the subject or related to obtaining information about a pathological condition of the subject.
(Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 4 - Experimental Use of Drugs › Section 111535.

111535. Consent given pursuant to Section 111525 may be revoked at any time by either verbal or written communication to the practitioner supervising the administration of the experimental drug.
(Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 4 - Experimental Use of Drugs › Section 111540.

111540. Prior to administering an experimental drug, the experimental activity as a whole, including the consent procedures required by Section 111525, shall be reviewed and approved by a committee for the protection of human subjects that is acceptable, as determined by the department. A committee for the protection of human subjects that operates under a general or special assurance approved by the federal Department of Health, Education, and Welfare pursuant to Part 46 of Title 45 of the Code of Federal Regulations shall be an acceptable committee for purposes of this section. A copy of the consent procedures approved by a committee for the protection of human subjects shall be filed with the department prior to the commencement of the experiment.
(Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 4 - Experimental Use of Drugs › Section 111545.

111545. A person having an ownership interest in a skilled nursing facility or intermediate care facility, as those terms are defined in Section 1250, may not prescribe an experimental drug for a patient in the facility.
(Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 4.5 - Right to Try Act › Section 111548.

111548. This article shall be known and may be cited as the Right to Try Act.
(Added by Stats. 2016, Ch. 684, Sec. 1. (AB 1668) Effective January 1, 2017.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 4.5 - Right to Try Act › Section 111548.2.

111548.2. (a) Notwithstanding Section 110280, 111520, or 111550, a manufacturer of an investigational drug, biological product, or device may make available the manufacturer’s investigational drug, biological product, or device to an eligible patient pursuant to this article. This article does not require that a manufacturer make available an investigational drug, biological product, or device to an eligible patient.
(b) A manufacturer may do both of the following:
(1) Provide an investigational drug, biological product, or device to an eligible patient without receiving compensation.
(2) Require an eligible patient to pay the costs of, or associated with, the manufacture of the investigational drug, biological product, or device.
(c) (1) This article does not expand the coverage provided under Sections 1370.4 and 1370.6 of this code, Sections 10145.3 and 10145.4 of the Insurance Code, or Sections 14087.11 and 14132.98 of the Welfare and Institutions Code.
(2) This article does not require a health benefit plan to provide coverage for the cost of any investigational drug, biological product, or device, or the costs of services related to the use of an investigational drug, biological product, or device under this article. A health benefit plan may provide coverage for an investigational drug, biological product, or device made available pursuant to this section.
(d) If the clinical trial for an investigational drug, biological product, or device is closed due to the lack of efficacy or for toxicity, the investigational drug, biological product, or device shall not be offered. If notice of closure of a clinical trial is given for an investigational drug, biological product, or device taken by a patient outside of a clinical trial, the manufacturer and the patient’s primary physician shall notify the patient of the information from the safety committee of the clinical trial.
(e) If an eligible patient dies while being treated by an investigational drug, biological product, or device made available pursuant to this article, the patient’s heirs and health benefit plan, except to the extent the plan provided coverage pursuant to paragraph (2) of subdivision (c), are not liable for any outstanding debt related to the treatment or lack of insurance for the treatment.
(Added by Stats. 2016, Ch. 684, Sec. 1. (AB 1668) Effective January 1, 2017.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 4.5 - Right to Try Act › Section 111548.3.

111548.3. (a) Notwithstanding any other law, a state regulatory board shall not revoke, fail to renew, or take any other disciplinary action against a physician’s license based on the physician’s recommendation to an eligible patient regarding, or prescription for or treatment with, an investigational drug, biological product, or device if the recommendation or prescription is consistent with protocol approved by the physician’s institutional review board or an accredited independent institutional review board.
(b) The physician’s institutional review board or an accredited institutional review board shall biannually report the following information to the State Department of Public Health, the Medical Board of California, and the Osteopathic Medical Board of California:
(1) The number of requests made for an investigational drug, biological product, or device.
(2) The status of the requests made.
(3) The duration of the treatment.
(4) The costs of the treatment paid by eligible patients.
(5) The success or failure of the investigational drug, biological product, or device in treating the immediately life-threatening disease or condition from which the patient suffers.
(6) Any adverse event for each investigational drug, biological product, or device.
(c) A state agency shall not alter any recommendation made to the federal Centers for Medicare and Medicaid Services regarding a health care provider’s certification to participate in the Medicare or Medicaid program based solely on the recommendation from an individual health care provider that a patient have access to an investigational drug, biological product, or device.
(d) A violation of this section shall not be subject to Chapter 8 (commencing with Section 111825).
(Added by Stats. 2016, Ch. 684, Sec. 1. (AB 1668) Effective January 1, 2017.)
2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 4.5 - Right to Try Act › Section 111548.5.

111548.5. This article does not create a private cause of action, and actions taken pursuant to this article shall not serve as a basis for a civil, criminal, or disciplinary claim or cause of action, including, but not limited to, product liability, medical negligence, or wrongful death, against a manufacturer of an investigational drug, biological product, or device, or against any other person or entity involved in the care of an eligible patient for harm done to the eligible patient or his or her heirs resulting from the investigational drug, biological product, or device, or the use or nonuse thereof, if the manufacturer or other person or entity has complied with the terms of this article in relation to the eligible patient, unless there was a failure to exercise reasonable care.
(Added by Stats. 2016, Ch. 684, Sec. 1. (AB 1668) Effective January 1, 2017.)