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§ 30192.5. General Licenses--In Vitro Testing.

17 CA ADC § 30192.5Barclays Official California Code of Regulations

Barclays California Code of Regulations
Title 17. Public Health
Division 1. State Department of Health Services (Refs & Annos)
Chapter 5. Sanitation (Environmental) (Refs & Annos)
Subchapter 4. Radiation
Group 2. Licensing of Radioactive Materials
Article 4. Licenses
17 CCR § 30192.5
§ 30192.5. General Licenses--In Vitro Testing.
Currentness
(a) A general license is hereby issued to any physician, veterinarian, clinical laboratory or hospital to possess and use radioactive material in prepackaged units for in vitro clinical testing, not exceeding the following:
Radionuclide
Maximum uCi* per unit
Maximum uCi total
Tritium
 
50
2,000
Carbon-14
 
10
2,000
Iron-59
 
20
200
Selenium-75
 
10
200
Cobalt-57
 
10
200
Iodine-125 or Iodine-131
 
10
200
Mock Iodine-125
Reference Source
Iodine-129
 
0.05
-
Americium-241
 
0.005
-
*  microcurie (uCi)
(b) The general licensee shall not possess or use radioactive material under the general license issued pursuant to subsection (a):
(1) Except as prepackaged units which are labeled in accordance with the provisions of a specific license issued by the United States Nuclear Regulatory Commission or a state with which the United States Nuclear Regulatory Commission has entered into an agreement for the exercise of regulatory authority; and
(2) Unless the prepackaged unit bears a label or is accompanied by a package insert containing the following or a substantially similar statement:
“This radioactive material may be received and used only by physicians, veterinarians, clinical laboratories or hospitals, and only for in vitro clinical or laboratory tests not involving internal or external administration of the material or the radiation therefrom to human beings or animals. The receipt, possession, use and transfer of this material is subject to the regulations and general license of the United States Nuclear Regulatory Commission or a state with which the Commission has entered into an agreement for the exercise of regulatory authority.”
(c) Persons who possess radioactive material under the general license issued pursuant to subsection (a), shall, with respect thereto, be exempt from the requirements of Group 3 of this subchapter, except that persons using Mock Iodine-125 shall comply with sections 20.2001, 20.2201 and 20.2202 of title 10, Code of Federal Regulations, Part 20, incorporated by reference in section 30253.

Credits

Note: Authority cited: Sections 114975, 115000 and 131200, Health and Safety Code. Reference: Sections 114965, 114970, 114985(g), 115000, 115060, 115165, 115230, 115235, 131050, 131051 and 131052, Health and Safety Code.
History
1. New section filed 7-7-86; effective thirtieth day thereafter (Register 86, No. 28).
2. Amendment of subsection (c) and Note filed 9-9-97; operative 10-9-97 (Register 97, No. 37).
3. Amendment of section and Note filed 6-8-2011; operative 7-8-2011 (Register 2011, No. 23).
4. Editorial correction amending column heading in subsection (a) (Register 2011, No. 24).
This database is current through 4/26/24 Register 2024, No. 17.
Cal. Admin. Code tit. 17, § 30192.5, 17 CA ADC § 30192.5
End of Document