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Section 109315 Of Article 2. Prohibitions And Enforcement From California Health And Safety Code >> Division 104. >> Part 4. >> Chapter 4. >> Article 2.
109315
. 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.
(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.
