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§ 951. Issuance of License.


Barclays Official California Code of Regulations Currentness
Title 17. Public Health
Division 1. State Department of Health Services
Chapter 2. Laboratories
Subchapter 1. Service Laboratories
Group 1. Production and Distribution of Biologics
Article 1. Licenses (Refs & Annos)
17 CCR § 951
§ 951. Issuance of License.
(a) All persons desiring to produce process or distribute biologics shall make application to the department on a form provided by the department, and shall supply such other information as may be required by the department for the intelligent appraisal of the status of the laboratory, the product to be licensed, and the personnel with respect to the intent and purpose of the law.
(b) Licenses shall not be issued to any person not at the time fully prepared, equipped and actually processing (though not distributing), but the department will provide anyone contemplating the establishment of a processing laboratory with full information concerning the requirements and conditions for the preparation of the products that it is proposed to manufacture or distribute.
(c) A license shall not be issued unless and until the establishment is prepared to operate under the direct supervision of a competent person trained in bacteriological technic and in the preparation of biologics as defined in Section 1601, Health and Safety Code, whose qualifications have been approved by the department.
(d) A license shall not be issued unless the condition of the establishment and methods of preparation are such as to reasonably insure that the biologics produced will not be contaminated, dangerous, or harmful.
(e) A license shall not be issued for the preparation of any biologic as defined in Section 1601, Health and Safety Code, if advertised so as to mislead or deceive the purchaser, or if the package or container in which the same is intended to be sold, bartered, exchanged, or shipped, bears or contains any statement, design, or device which is false or misleading in any particular.
(f) A license shall not be issued for a biologic product that has been specifically forbidden or disapproved by the United States Department of Health, Education and Welfare excepting products that may be specifically approved by the department, for experimental purposes but not for general sale and distribution.
(g) A license shall not be issued for the processing or distributing of any product without satisfactory scientific evidence of therapeutic or prophylactic value.
1. Amendment of subsection (f) filed 3-5-76; effective thirtieth day thereafter (Register 76, No. 10).
This database is current through 7/24/20 Register 2020, No. 30
17 CCR § 951, 17 CA ADC § 951
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