Title: Section 16.123 - Specific licenses for certain medical uses of byproduct materials

Specific licenses for certain medical uses of byproduct materials.

(a) Purpose and scope. This section contains requirements for the medical uses of byproduct materials that are subject to specific licenses. These requirements are in addition to, and not a substitute for, other requirements in this Part. Any license issued prior to the effective date of this regulation that references paragraph (b) shall be deemed to reference paragraph (d).

(b) Definitions. Whenever used in this section, or in federal regulations incorporated herein, the following terms shall have the following meanings:

(1) "Authorized medical physicist" means an individual who is authorized to practice medical physics pursuant to Article 166 of the Education Law and:

(i) meets the definition and the training requirements for an authorized medical physicist set forth in 10 CFR §§ 35.2, 35.51 and 35.57; or

(ii) is named as a radiation therapy physicist on a medical use radioactive materials license issued by the Department and meets the requirements set forth in 10 CFR § 35.59.

(2) "Authorized nuclear pharmacist" means an individual who is authorized to practice pharmacy pursuant to Article 137 of the Education Law and:

(i) meets the requirements for an authorized nuclear pharmacist in 10 CFR § 35.55(a) and § 35.59; or

(ii) is identified as an authorized nuclear pharmacist on:

(a) a specific license issued by the Nuclear Regulatory Commission or Agreement State that authorizes medical use or the practice of nuclear pharmacy;

(b) a permit issued by a Nuclear Regulatory Commission master material licensee that authorizes medical use or the practice of nuclear pharmacy;

(c) a permit issued by a Nuclear Regulatory Commission or Agreement State broad scope medical use licensee that authorizes medical use or the practice of nuclear pharmacy; or

(d) a permit issued by a Nuclear Regulatory Commission master material license broad scope medical use permittee that authorizes medical use or the practice of nuclear pharmacy; or

(iii) is identified as an authorized nuclear pharmacist by a commercial nuclear pharmacy that has been authorized to identify authorized nuclear pharmacists; or

(iv) was a nuclear pharmacist preparing only radioactive drugs containing accelerator-produced radioactive material, and the individual practiced at a pharmacy at a federal government agency or Federally recognized Indian Tribe before November 30, 2007 or at all other pharmacies before August 8, 2009, or an earlier date as noticed by the Nuclear Regulatory Commission.

(3) "Authorized user" means an individual who is authorized to practice medicine pursuant to Article 131 of the Education Law and:

(i) meets the applicable requirements in 10 CFR §§ 35.59 and 35.190(a), 35.290(a), 35.390(a), 35.392(a), 35.394(a), 35.490(a), 35.590(a), or 35.690(a); or

(ii) is identified as an authorized user on:

(a) a Nuclear Regulatory Commission or Agreement State license that authorizes the medical use of byproduct material;

(b) a permit issued by a Nuclear Regulatory Commission master material licensee that is authorized to permit the medical use of byproduct material;

(c) a permit issued by a Commission or Agreement State specific licensee of broad scope that is authorized to permit the medical use of byproduct material; or

(d) a permit issued by a Commission master material license broad scope permittee that is authorized to permit the medical use of byproduct material.

(4) "Medical use" means the intentional internal or external administration of byproduct material or the radiation from byproduct material to patients or human research subjects under the supervision of an authorized user.

(5) "Positron emission tomography facility" is a facility operating a cyclotron or accelerator for the purpose of producing PET radionuclides.

(6) "Prescribed dosage" means the specified activity or range of activity of unsealed byproduct material as documented in a written directive, or in accordance with the directions of the authorized user for procedures performed pursuant to 10 CFR §§ 35.100 and 35.200. Further details concerning this referenced code are contained in subdivision (c) of this section.

(7) "Prescribed dose" means:

(i) for gamma stereotactic radiosurgery, the total dose as documented in the written directive;

(ii) for teletherapy, the total dose and dose per fraction as documented in the written directive;

(iii) for manual brachytherapy, either the total source strength and exposure time or the total dose, as documented in the written directive; or

(iv) for remote brachytherapy afterloaders, the total dose and dose per fraction as documented in the written directive.

(8) "Radiation safety officer" means an individual who:

(i) meets the requirements set forth in 10 CFR §§ 35.50(a) or (c)(1) and 35.59; or

(ii) is identified as a radiation safety officer on a specific medical use license issued by the Nuclear Regulatory Commission or Agreement State or a medical use permit issued by a Nuclear Regulatory Commission master material licensee.

(9) "Sealed source" means any byproduct material that is encased in a capsule designed to prevent leakage or escape of the byproduct material.

(10) "Treatment site" means the anatomical description of the tissue intended to receive a radiation dose, as described in a written directive.

(c) Approved medical uses of byproduct materials. A licensee may use byproduct materials on human beings for the particular uses set forth below, provided that the licensee meets all applicable requirements of this Part:

(1) Use of unsealed byproduct material for uptake, dilution and excretion studies;

(2) Use of unsealed byproduct material for imaging and localization studies;

(3) Use of unsealed byproduct material for which a written directive is required;

(4) Use of sources for manual brachytherapy;

(5) Use of sealed sources for diagnosis;

(6) Use of sealed source in a remote afterloader unit, teletherapy unit or gamma stereotactic radiosurgery unit; or

(7) Other specific medical uses of byproduct material or radiation from byproduct material, as licensed by the Department.

(d) Federal standards. All licensees shall comply with the provisions of the following federal regulations, which are hereby incorporated by reference, with the same force and effect as if fully set forth at length herein: Title 10 of the Code of Federal Regulations, Part 35, Medical Use of Byproduct Material. This code is published by the Office of the Federal Register National Archives and Records Administration. Copies may be obtained from the Superintendent of Documents, United States Government Printing Office, Washington D.C. 20402. This code is available for copying and inspection at the Regulatory Affairs Unit, New York State Department of Health, Corning Tower, Empire State Plaza, Albany, New York 12237. Notwithstanding any provision herein to the contrary, if a conflict occurs between the above referenced CFR and other provisions in this Part, compliance with the more restrictive regulation is required.

(e) General requirements applicable to all licensees authorized to use byproduct materials for medical purposes.

(1) Record Keeping Requirements. A licensee shall comply with all record keeping requirements set forth in Subpart L (Records) of Part 35 of 10 CFR. Further details concerning this referenced code are contained in subdivision (c) of this section.

(2) Reporting requirements: A licensee shall comply with all reporting requirements set forth in Subpart M (Reports) of Part 35 of 10 CFR as revised herein as follows: (i) in § 35.3045(c) and §35.3047(c), replace phrase "NRC Operations Center" with "Department"; (ii) in §35.3045(d) and § 35.3047(d), replace “By an appropriate method listed in § 30.6(a) of this chapter, the licensee shall submit a written report to the appropriate NRC Regional Office listed in § 30.6 of this chapter” with “shall submit a written report to the Department"; (iii) in § 35.3045(g)(1) and § 35.3047(f)(1), replace the term "NRC" with "Department"; and, (iv) in § 35.3067 replace "The report must be filed with the appropriate NRC Regional Office listed in § 30.6 of this chapter, by an appropriate method listed in § 30.6(a) of this chapter, with a copy to the Director, Office of Federal and State Materials and Environmental Management Programs." with "The report shall be filed with the Department".

(3) Training and experience requirements. A licensee shall ensure that all staff who are involved in the use of byproduct material pursuant to a specific license have the training and experience required by this Part.

(4) Other General Requirements. A licensee shall comply with requirements set forth in 10 CFR § 35.5, §35.6, §35.11(a)and (b), §35.24(b), (e), (f) and (g), §35.27, §35.40, §35.41, §35.49, §35.60, §35.61, §35.63, §36.67, §35.69, §35.70, §35.75, §35.80, §35.92 as modified herein as follows: in § 35.27(a)(1) and (b)(1), replace "19.12 of this chapter" with "16.13(c) of this Part".

(f) Requirements for the use of unsealed byproduct material for uptake, dilution and excretion studies. A licensee shall use unsealed byproduct material for uptake dilution and excretion studies only if authorized to do so by a specific license issued by the Department and provided that the licensee complies with 10 CFR §§ 35.100 and 35.190 and all applicable provisions of this Part.

(g) Requirements for the use of unsealed byproduct material for imaging and localization studies. A licensee shall use unsealed byproduct material for imaging and localization studies only if authorized to do so by a specific license issued by the Department and provided that the licensee complies with 10 CFR §§ 35.200, 35.204 and 35.290 and other applicable provisions of this Part.

(h) Requirements for the use of unsealed byproduct material for which a written directive is required. A licensee shall use unsealed byproduct material for which a written directive is required only if authorized to do so by a specific license issued by the Department and provided that the licensee complies with Subpart E (Unsealed Byproduct Material-Written Directive Required) of Part 35 of 10 CFR and other applicable provisions of this Part.

(i) Requirements for the use of sources for manual brachytherapy. A licensee may use sources for manual brachytherapy only if authorized to so by a specific license issued by the Department and provided that the licensee complies with Subpart F (Manual Brachytherapy) of Part 35 of 10 CFR.

(j) Requirements for the use of sealed sources for diagnosis. A licensee may use sealed sources for diagnosis only if authorized to do so by a specific license issued by the department and provided that the licensee complies with Subpart G (Sealed Sources for Diagnosis) of Part 35 of 10 CFR and other applicable provision of this Part.

(k) Use of sealed source in a remote afterloader unit, teletherapy unit or gamma stereotactic radiosurgery unit. A licensee may use a sealed source in a remote afterloader unit, teletherapy unit or gamma stereotactic radiosurgery unit only if authorized to so by a specific license issued by the department and provided that the licensee complies with Subpart H (Photon Emitting Remote Afterloader Units, Teletherapy Units and Gamma Stereotactic Radiosurgery Units) of Part 35 of 10 CFR and other applicable provisions of this Part.

(l) Other medical uses of byproduct material or radiation from byproduct material. A licensee may use byproduct material or a radiation source approved for medical use which is not specifically addressed in paragraphs 1 through 6 of subdivision (b) of this section if the licensee submits to the department information required by 10 CFR §35.12(b) through (d) and the licensee has received written approval from the Department in a specific license or license amendment and uses the material in accordance with specific conditions that the department deems necessary or desirable for the safest medical use of the material.

(m) General Use License. Any licensee who is licensed for one or more of the types of medical uses specified in paragraphs (1) through (6) of subdivision (b) of this section also is authorized to use radioactive material under the general license in Appendix 16-A, Table 6, Item (i) infra, for the specified "in vitro" uses without filing Form GEN 373 as required by Appendix 16-A, Table 6, Item (i), subdivision (2), infra, provided, however, that the licensee is subject to the other provisions of Appendix 16-A, Table 6, Item (i), infra.