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§ 30195. Special Requirements for Issuance of Specific Licenses.

17 CA ADC § 30195Barclays Official California Code of RegulationsEffective: July 1, 2022

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
Effective: July 1, 2022
17 CCR § 30195
§ 30195. Special Requirements for Issuance of Specific Licenses.
Currentness
In addition to the requirements set forth in Section 30194, specific licenses for certain specialized uses will be issued only if the following conditions are met:
(a) For human use of radioactive material limited to medical purposes, the applicant submits documentation demonstrating that they are capable of complying with the regulations governing the medical use of radioactive material in title 10, Code of Federal Regulations, Part 35 (10 CFR 35) (January 1, 2021), which is hereby incorporated by reference with the exceptions listed at subsections (a)(1) through (a)(15) below, and upon issuance of a license maintains compliance with said regulations:
(1) Title 10, Code of Federal Regulations, sections 35.1, 35.5, 35.7, 35.8, 35.10, 35.11(c), 35.12, 35.13, 35.14, 35.15, 35.18, 35.19, 35.26, 35.65, 35.4001, and 35.4002 are not incorporated by reference.
(2) Any references to the United States Nuclear Regulatory Commission (NRC) or any component thereof shall be deemed to be a reference to the “Department” as defined in section 30100.
(3) Any reference to 10 CFR 35, section 35.5 shall be deemed to be a reference to section 30293.
(4) Any reference to “Person” in 10 CFR 35 shall be deemed to be a reference to the term “Person” as defined in section 114985(c) of the Health and Safety Code.
(5) Any reference to “Licensee” in 10 CFR 35 shall be deemed to be a reference to the term “User” as defined in section 30100.
(6) Any reference to “Byproduct material” in 10 CFR 35 is replaced by the term “Radioactive Material” as defined in section 30100.
(7) The definition of the term “Agreement State” in 10 CFR 35, section 35.2 is replaced by the definition of the term “Agreement State” as defined in section 30100.
(8) The definition of the term “Sealed source” in 10 CFR 35, section 35.2 is replaced by the definition of the term “Sealed source” as defined in section 30100.
(9) The definition of the term “Dentist” in 10 CFR 35, section 35.2 is modified to mean an individual possessing a current and valid license to practice as a dentist pursuant to the California Dental Practice Act specified in Business and Professions Code Section 1600 et seq.
(10) The definition of the term “Pharmacist” in 10 CFR 35, section 35.2 is modified to mean an individual possessing a current and valid license to practice as a pharmacist pursuant to the California Pharmacy Law specified in Business and Professions Code Section 4000 et seq.
(11) The definition of the term “Podiatrist” in 10 CFR 35, section 35.2 is modified to mean an individual possessing a current and valid license to practice as a podiatrist pursuant to California Business and Professions Code sections 2460 et seq.
(12) The definition of the term “Physician” in 10 CFR 35, section 35.2 is modified to mean an individual possessing a current and valid license to practice as a physician and surgeon or as an osteopathic physician and surgeon pursuant to the California Medical Practice Act specified in Business and Professions Code Section 2000 et seq.
(13) The reference to section 19.12 found in 10 CFR 35, section 35.27(b)(1) shall be deemed to be a reference to section 30255.
(14) The following 10 CFR 35 provisions shall read or are revised as indicated:
(A) Section 35.50(c)(3) shall read “Has experience with the radiation safety aspects of the types of use of byproduct material for which the individual is seeking simultaneous approval both as the Radiation Safety Officer and the authorized user on the same new medical use license or new medical use permit issued by a Commission master material licensee. The individual must also meet the requirements in paragraph (d) of this section.”
(B) Section 35.55(a)(1) shall read “Have graduated from a pharmacy program accredited by the Accreditation Council for Pharmacy Education (ACPE) (previously named the American Council on Pharmaceutical Education) or have passed the Foreign Pharmacy Graduate Examination Committee (FPGEC) examination.”
(C) Section 35.57 shall read or is revised as indicated:
1. The date July 1, 2022 is substituted for the date January 14, 2019 found in subdivisions (a)(1) and (b)(1), and for the date October 24, 2005 found in subdivisions (a)(2) and (a)(3).
2. Subdivision (b)(2) shall read “Physicians, dentists, or podiatrists not identified as authorized users for the medical use of byproduct material on a license issued by the Commission or an Agreement State, a permit issued by a Commission master material licensee, a permit issued by a Commission or an Agreement State broad scope licensee, or a permit issued in accordance with a Commission master material license of broad scope on or before July 1, 2022, need not comply with the training requirements of subparts D through H of this part for those materials and uses that these individuals performed on or before July 1, 2022, as follows:”.
(15) Nothing in this incorporation by reference shall be construed to authorize the Department to approve of specialty boards or medical specialty boards for meeting training requirements specified in 10 CFR 35.
(b) For use of multiple quantities of types of radioactive material for research and development or for processing for distribution:
(1) The applicant has a radiation safety committee of at least three members which must evaluate all proposals for, and maintain surveillance over, all uses of radioactive material. Committee members shall be knowledgeable and experienced in pertinent kinds of radioactive material use and in radiation safety.
(2) The applicant has a radiation safety officer, who is a member of the radiation safety committee, and who is supported by a staff of a size and degree of competence appropriate to deal with radiation safety problems that might be encountered.
(3) The applicant furnishes a detailed statement of the qualifications, duties, authority, and responsibilities of the radiation safety committee and of the staff radiation safety group.
(c) Except as provided in paragraphs (1), (2), and (3), for use of radioactive material in the form of a sealed source or in a device that contains the sealed source, the application either identifies the source or device by the manufacturer and model number by which the source or device was registered with either the Department, pursuant to section 32.210 of title 10, Code of Federal Regulations, Part 32 (10 CFR 32.210), incorporated by reference in section 30196, the U.S. Nuclear Regulatory Commission (NRC), or an Agreement State other than this state; or provides the information identified in 10 CFR 32.210(c), incorporated by reference in section 30196:
(1) For sources or devices manufactured before October 23, 2012 that are not registered with the Department under 10 CFR 32.210, incorporated by reference in section 30196, or with an Agreement State, and for which the applicant is unable to provide all categories of information specified in 10 CFR 32.210(c), the applicant provides:
(A) All available information identified in 10 CFR 32.210(c), incorporated by reference in section 30196, regarding the source, and, if applicable, the device; and
(B) Sufficient additional information to demonstrate that there is reasonable assurance that the radiation safety properties of the source or device are adequate to protect health and minimize danger to life and property. Such information shall include a description of the source or device, a description of radiation safety features, the intended use and associated operating experience of the applicant, and the results of a recent leak test;
(2) For sealed sources and devices allowed to be distributed without registration of safety information in accordance with 10 CFR 32.210(g)(1), incorporated by reference in section 30196, the applicant may supply only the manufacturer, model number, and radionuclide and quantity; and
(3) If it is not feasible to identify each sealed source and device individually, the applicant may propose constraints on the number and type of sealed sources and devices to be used and the conditions under which they will be used, in lieu of identifying each sealed source and device.
(d) An application from a medical facility or educational institution to produce Positron Emission Tomography (PET) radioactive drugs for noncommercial transfer to licensees in its consortium, as defined in section 30195.4(b), that are authorized for medical use pursuant to subsection (a), includes:
(1) A request for authorization for the production of PET radionuclides, or evidence of an existing license issued by the Department, the NRC under 10 CFR 30, or an Agreement State other than this State for a PET radionuclide production facility within its consortium from which it receives PET radionuclides;
(2) Evidence that the applicant is qualified to produce radioactive drugs for medical use by meeting one of the criteria in 10 CFR 32.72(a)(2), incorporated by reference in section 30196;
(3) Information identified in 10 CFR 32.72(a)(3), incorporated by reference in section 30196 regarding the PET drugs to be noncommercially transferred to members of its consortium; and
(4) If the applicant is a pharmacy, in addition to satisfying the requirements in paragraphs (1), (2), and (3), the applicant shall also provide identification of all individuals authorized to prepare the PET radioactive drugs and documentation that each individual meets the requirements of an authorized nuclear pharmacist as specified in 10 CFR 32.72(b)(2), incorporated by reference in section 30196.

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. Repealer and new subsection (e) filed 10-12-72; effective thirtieth day thereafter (Register 72, No. 42).
2. Repealer of subsection (e) filed 7-7-86; effective thirtieth day thereafter (Register 86, No. 28).
3. Change without regulatory effect amending subsection (d) filed 11-1-91 pursuant to section 100, title 1, California Code of Regulations (Register 92, No. 5).
4. Repealer of subsections (a)-(b)(2), new subsections (a)-(a)(15), subsection relettering and amendment of Note filed 10-13-2010; operative 1-1-2011 (Register 2010, No. 42).
5. Editorial correction of subsection (a)(14) (Register 2010, No. 45).
6. Amendment subsections (a), (a)(14) and (a)(14)(A), repealer of subsections (c)-(c)(2) and new subsections (c)-(d)(4) filed 12-30-2014; operative 4-1-2015 (Register 2015, No. 1).
7. Amendment of subsections (a), (a)(2)-(3), (a)(5)-(8) and (a)(13), repealer and new subsections (a)(14)-(a)(14)(A) and new subsections (a)(14)(B)-(a)(14)(C)2. filed 3-30-2022; operative 7-1-2022 (Register 2022, No. 13).
This database is current through 4/12/24 Register 2024, No. 15.
Cal. Admin. Code tit. 17, § 30195, 17 CA ADC § 30195
End of Document