Health and Safety Code section 109300
(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.
Source:
Section 109300, https://leginfo.legislature.ca.gov/faces/codes_displaySection.xhtml?lawCode=HSC§ionNum=109300.
(updated Jan. 1, 1996; accessed Jun. 30, 2025).