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§ 30195.4. Additional Requirements for Specific Licenses Authorized Pursuant to Section 30195(d...

17 CA ADC § 30195.4Barclays 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 § 30195.4
§ 30195.4. Additional Requirements for Specific Licenses Authorized Pursuant to Section 30195(d).
Currentness
(a) Specific licenses authorizing, pursuant to section 30195(d), the production of positron emission tomography (PET) radioactive drugs for noncommercial transfer to licensees holding a specific license issued pursuant to section 30195(a) in its consortium, as defined in subsection (b), shall be subject to the following:
(1) Authorization does not relieve the licensee from complying with applicable FDA requirements, or other Federal, and State requirements governing radioactive drugs.
(2) The licensee shall:
(A) Satisfy the labeling requirements in title 10, Code of Federal Regulations section 32.72(a)(4) (10 CFR 32.72(a)(4)), incorporated by reference in section 30196, for each PET radioactive drug transport radiation shield and each syringe, vial, or other container used to hold a PET radioactive drug intended for noncommercial distribution to members of its consortium; and
(B) Possess and use instrumentation to measure the radioactivity of the PET radioactive drugs intended for noncommercial distribution to members of its consortium and meet the procedural, radioactivity measurement, instrument test, instrument check, and instrument adjustment requirements in 10 CFR 32.72(c), incorporated by reference in section 30196.
(3) If the licensee is a pharmacy, the licensee shall require that any individual that prepares PET radioactive drugs be:
(A) An authorized nuclear pharmacist who meets 10 CFR 32.72(b)(2), incorporated by reference in section 30196; or
(B) An individual who is under the supervision of an authorized nuclear pharmacist as specified in 10 CFR 35.27, incorporated by reference in section 30195(a).
(4) If the licensee is a pharmacy who allows an individual to work as an authorized nuclear pharmacist, the licensee shall ensure the individual meets 10 CFR 32.72(b)(5), incorporated by reference in section 30196.
(b) For purposes of subsection (a) and section 30195(d), “consortium” means an association of licensees authorized for medical use pursuant to section 30195(a) and a PET radionuclide production facility in the same geographical area that jointly own or share in the operation and maintenance cost of the PET radionuclide production facility that produces PET radionuclides for use in producing radioactive drugs within the consortium for noncommercial distributions among its associated members for medical use. The PET radionuclide production facility within the consortium may only be located at an educational institution or a medical facility.

Credits

Note: Authority cited: Sections 114975, 115000 and 131200, Health and Safety Code. Reference: Sections 114965, 114970, 115060, 115165, 115235, 131050, 131051 and 131052, Health and Safety Code.
History
1. New section filed 12-30-2014; operative 4-1-2015 (Register 2015, No. 1).
This database is current through 4/26/24 Register 2024, No. 17.
Cal. Admin. Code tit. 17, § 30195.4, 17 CA ADC § 30195.4
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