California Health and Safety Code

§ 109325

HSC § 109325 Effective Jan 1, 1996Div. 104 · Part 4 · Ch. 4 · Art. 2

Statute text

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.

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Legislative history

Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.