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Code · California · Health and Safety Code

§ 109325

443 words·~2 min read·/ca/health-and-safety-code/109325·

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This article and Article 1 (commencing with Section 109250) shall not apply to the use of any drug, medicine, compound, or device intended solely for legitimate and bona fide investigational purposes by experts qualified by scientific training and experience to investigate the safety and therapeutic value thereof unless the department shall find that the drug, medicine, compound, or device is being used in diagnosis or treatment for compensation and profit. In order to qualify for an exemption under this section there shall be on file with the federal Department of Health, Education, and Welfare a current and unrevoked investigational new drug application issued pursuant to subdivision
(i)of Section 505 of the federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 355(i)), or the following conditions shall be complied with:
(a)The label of the drug, medicine, compound, or device shall bear the 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)The drug, medicine, compound, or device has had adequate testing on appropriate experimental animals to demonstrate a lack of toxicity and hazard sufficient to permit its use in or on human beings and to establish with clarity the margins of safety ordinarily recognized by experts qualified by scientific training and experience to investigate the safety and effectiveness of the drugs, substances, or devices.
(c)The drug, medicine, compound, or device is to be used solely for investigational use by, or under the direction of, an expert qualified by scientific training and experience to investigate the safety and effectiveness of the drug, medicine, compound, or device.
(d)A written statement signed by the expert has been filed with the board. The statement shall show what facilities the expert will use for the investigation to be conducted by him or her, and that the drug, medicine, compound, or device will be used solely by him or her or under his or her direction for the investigation. The statement 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.
(e)Complete records of the investigation shall be kept by the expert and all records shall be made available by the expert for inspection upon the request of any agent of the board at any reasonable hour as long as the expert desires exemption.
(f)The expert shall inform any persons who participate in the investigation as patients, that the drug, medicine, compound, or device is being used for investigational purposes and shall obtain the consent of the persons or their representatives.
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