Health & Saf. Code, § 109315 · Article 2. Prohibitions and Enforcement
Health & Saf. Code, § 109315
Text — As published in the Legislative Counsel's database, tables dated October 18, 2026 (pubinfo_2025.zip)
The board shall issue an order refusing to permit the application to become effective, if, after due notice to the applicant and opportunity for a hearing, the board finds any of the following:
(a) The investigations, reports that are required to be submitted to the board pursuant to subdivision (2) of Section 109300 do not include adequate tests by all methods reasonably applicable to show whether or not a drug, medicine, compound, or device is safe for use in the diagnosis, treatment, alleviation, or cure of cancer.
(b) The results of tests specified in subdivision (a) show that a drug, medicine, compound or device is unsafe for use under the conditions specified in subdivision (a) or do not show that the drug, medicine, compound, or device is safe for use under the conditions.
(c) The methods used in, and the facilities and controls used for, the manufacture, processing, and packing of a drug, medicine, compound, or device are inadequate to preserve its identity, strength, quality, and purity and with respect to a device are inadequate to preserve its safety or effectiveness.
(d) Upon the basis of the information submitted to it as part of the application, or upon the basis of any other information before it with respect to a drug, medicine, compound, or device, it has insufficient evidence to determine whether the drug, medicine, compound, or device is safe for use under the conditions specified in subdivision (a).
(e) Evaluated on the basis of the information submitted to it as part of the application and any other information before it with respect to the drug, medicine, compound, or device, there is a reasonable doubt that the drug, medicine, compound, or device will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the proposed labeling or advertising thereof.
(f) The application contains any untrue statement of a material fact.
Notes and commentary — not statutory text
History
Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.
Source of truth
- Edition
- As published in the Legislative Counsel's database, tables dated October 18, 2026 (pubinfo_2025.zip)
- Official file
- https://leginfo.legislature.ca.gov/faces/codes_displaySection.xhtml?lawCode=HSC§ionNum=109315.
- Text hash
- sha256 8a8281994f4c636aa1d5861de5d3b38a8e3a6a906e39e2ec20e90611d1496dbf
- Composed by
- compose_ca.py 2026-10-22: the Legislative Counsel's CAML content files read by a tokenizer (caml_readers.reader_a); an independent xml.etree reading (caml_readers.reader_b) agrees on every section
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