Section 10417 - Formulary of Inequivalent Generic Drug Types and Drug Products for Which Substitution Poses a Threat to Health and Safety(a) The generic drug types or drug products listed in the formulary below have been determined, pursuant to Business and Professions Code Section 4047.7, to have demonstrated clinically significant biological or therapeutic inequivalence and which, if substituted in accordance with Business and Professions Code Section 4047.6, would pose a threat to the health and safety of patients receiving such medications. FORMULARY
(b) Any person requesting the inclusion, addition, or deletion of any generic drug type or drug product to the formulary shall submit such request to the Department of Health Services in accordance with the following: (1) Submissions supporting the inclusion, addition, or deletion of any generic drug type or drug product to the formulary shall consist of evidence of adequate and well-controlled investigations, including clinical investigations, by experts qualified by scientific training and experience, on the basis of which it could be fairly and responsibly determined by the Director that a generic drug type or drug product demonstrates, or does not demonstrate, clinically significant biological or therapeutic inequivalence and which, if substituted for another drug product under the provisions of Section 4047.6 of the Business and Professions Code would pose a threat to the health and safety of patients receiving prescription medication.(2) Submissions shall adequately identify all drug products involved by name of manufacturer, lot number(s), and dosage form(s) and should demonstrate the condition(s) of use (e.g., duration, frequency, etc.) of any such drug product where substitution poses a threat to the health and safety of the patient.(3) Submissions shall be made in triplicate to Food and Drug Branch, Department of Health Services, Sacramento, CA 95814.(4) Any information submitted shall be considered to be public information.Cal. Code Regs. Tit. 17, § 10417
1. New section filed 5-14-76 as an emergency; effective upon filing (Register 76, No. 20).
2. Certificate of Compliance filed 9-8-76 (Register 76, No. 37).
3. Amendment filed 12-17-85; effective thirtieth day thereafter (Register 85, No. 51). Note: Authority cited: Section 4047.7, Business and Professions Code. Reference: Sections 4047.6 and 4047.7, Business and Professions Code.
1. New section filed 5-14-76 as an emergency; effective upon filing (Register 76, No. 20).
2. Certificate of Compliance filed 9-8-76 (Register 76, No. 37).
3. Amendment filed 12-17-85; effective thirtieth day thereafter (Register 85, No. 51).