Section 10401.1 - Investigation of Various Agents for the Diagnosis or Treatment of CancerExperts wishing to investigate the value of drugs, medicines, compounds or devices in the diagnosis or treatment of cancer under the exemption provisions of Section 1708 of the Health and Safety Code shall provide the following information, in 20 copies, to the Department for approval prior to initiating the investigation.
(a) A sample of the labeling of the drug, medicine, compound or device which shall include the name, quantity, lot number of the agent and name of manufacturer and also a statement "Caution: New drug (or medicine or compound or device). Use in the diagnosis, treatment, alleviation or cure of cancer limited by law to investigational use."(b) If the animal testing required by subsection (b) of 1708 has been done by or under the auspices of a person other than the applicant and the latter wishes to use the results of such testing as a part of his request for approval of the investigation, a signed authorization for use of the results from the person or persons responsible for such testing shall be provided.(c) The written statement signed by the expert shall show what facilities the expert will use for the investigation to be conducted by him; that the drug, medicine, compound or device will be used solely by him or under his direction for the investigation; and shall contain information identifying any assistant or agent of the expert who uses the drug, medicine, compound or device under the direction of the expert. It shall also include a study plan for the investigation to show that a significant number of cases and controls are to be studied, the duration of the study and all other details of the plan; a sworn statement that the agent is to be used solely for investigational purposes without compensation or profit; and a detailed outline of the training and experience of the expert, this latter requirement being met by submission of a curriculum vitae and a list of publications. Criteria for evaluation of effect shall be those adopted by the Cancer Advisory Council on April 12, 1967.(d) A copy of the consent form required by subsection (f) of 1708.(e) An acknowledgment that complete records will be kept.Cal. Code Regs. Tit. 17, § 10401.1
1. New section filed 7-30-69; effective thirtieth day thereafter (Register 69, No. 31).
2. Amendment of first paragraph filed 12-17-85; effective thirtieth day thereafter (Register 85, No. 51). Note: Authority cited: Sections 208 and 1704(a), Health and Safety Code. Reference: Sections 1707.1 through 1707.5, Health and Safety Code.
1. New section filed 7-30-69; effective thirtieth day thereafter (Register 69, No. 31).
2. Amendment of first paragraph filed 12-17-85; effective thirtieth day thereafter (Register 85, No. 51).