California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 5 - Sanitation (Environmental) › Subchapter 2 - Foods and Drugs › Group 1 - RULES AND REGULATIONS › Article 2 - DRUGS AND DEVICES REGULATIONS › Drugs and Devices › Section 10401.1 - Investigation of Various Agents for the Diagnosis or Treatment of Cancer

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
Experts 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.
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.