California Law (Last Updated: March 4, 2014) |
Health and Safety Code - HSC |
Division 104. ENVIRONMENTAL HEALTH |
Part 4. DRUGS, DEVICES, AND COSMETICS |
Chapter 4. Treatment of Cancer and Other Serious Diseases |
ARTICLE 2. Prohibitions and Enforcement |
Section 109300.
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The sale, offering for sale, holding for sale, delivering, giving away, prescribing or administering of any drug, medicine, compound, or device to be used in the diagnosis, treatment, alleviation, or cure of cancer is unlawful and prohibited unless (1) an application with respect thereto has been approved under Section 505 of the federal Food, Drug and Cosmetic Act, or (2) there has been approved an application filed with the board setting forth:
(a) Full reports of investigations that have been made to show whether or not the drug, medicine, compound, or device is safe for the use, and whether the drug, medicine, compound, or device is effective in the use;
(b) A full list of the articles used as components of the drug, medicine, compound, or device;
(c) A full statement of the composition of the drug, medicine, compound, or device;
(d) A full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of the drug, medicine, or compound or in the case of a device, a full statement of its composition, properties, and construction and the principle or principles of its operation;
(e) Such samples of the drug, medicine, compound, or device and of the articles used as components of the drug, medicine, compound, or device as the board may require; and
(f) Specimens of the labeling and advertising proposed to be used for the drug, medicine, compound, or device.