Source: https://www.ecfr.gov/cgi-bin/text-idx?mc=true&node=sp10.1.35.e&rgn=div6
Timestamp: 2020-06-05 16:32:51
Document Index: 314251918

Matched Legal Cases: ['art 35', '§35', '§35', '§35', '§35', '§35', '§35', '§32', '§30', '§35', '§35', '§19', '§35', '§20', '§20', '§35', '§35', '§35', '§35', '§35', '§35', '§35', '§35', '§35', '§35', '§35', '§35', '§35', '§35', '§35', '§35', '§35', '§35', '§35', '§35', '§35', '§35', '§35', '§35', '§35', '§35', '§35', '§35', '§35']

Title 10 → Chapter I → Part 35 → Subpart E
§35.300 Use of unsealed byproduct material for which a written directive is required.
§35.310 Safety instruction.
§35.315 Safety precautions.
§35.390 Training for use of unsealed byproduct material for which a written directive is required.
§35.394 Training for the oral administration of sodium iodide I-131 requiring a written directive in quantities greater than 1.22 gigabecquerels (33 millicuries).
A licensee may use any unsealed byproduct material identified in §35.390(b)(1)(ii)(G) prepared for medical use and for which a written directive is required that is—
(1) A manufacturer or preparer licensed under §32.72 of this chapter or equivalent Agreement State requirements; or
(2) A PET radioactive drug producer licensed under §30.32(j) of this chapter or equivalent Agreement State requirements; or
(2) A physician who is an authorized user and who meets the requirements specified in §§35.290, 35.390, or
(3) An individual under the supervision, as specified in §35.27, of the authorized nuclear pharmacist in paragraph (b)(1) of this section or the physician who is an authorized user in paragraph (b)(2) of this section; or
[67 FR 20370, Apr. 24, 2002, as amended at 68 FR 19324, Apr. 21, 2003; 71 FR 15009, Mar. 27, 2006; 72 FR 55932, Oct. 1, 2007; 83 FR 33107, July 16, 2018]
In addition to the requirements of §19.12 of this chapter,
(a) A licensee shall provide radiation safety instruction, initially and at least annually, to personnel caring for patients or human research subjects who cannot be released under §35.75. To satisfy this requirement, the instruction must be commensurate with the duties of the personnel and include—
(i) Routine visitation to hospitalized individuals in accordance with §20.1301(a)(1) of this chapter; and
(ii) Visitation authorized in accordance with §20.1301(c) of this chapter;
(b) A licensee shall retain a record of individuals receiving instruction in accordance with §35.2310.
(a) For each patient or human research subject who cannot be released under §35.75, a licensee shall—
(ii) A room, with a private sanitary facility, with another individual who also has received therapy with unsealed byproduct material and who also cannot be released under §35.75;
Except as provided in §35.57, the licensee shall require an authorized user of unsealed byproduct material for the uses authorized under §35.300 to be a physician who—
(a) Is certified by a medical specialty board whose certification process has been recognized by the Commission or an Agreement State and who meets the requirements in paragraphs (b)(1)(ii)(G) of this section. The names of board certifications that have been recognized by the Commission or an Agreement State are posted on the NRC's Medical Uses Licensee Toolkit web page. To be recognized, a specialty board shall require all candidates for certification to:
(2) Pass an examination, administered by diplomates of the specialty board, which tests knowledge and competence in radiation safety, radionuclide handling, quality assurance, and clinical use of unsealed byproduct material for which a written directive is required; or
(b)(1) Has completed 700 hours of training and experience, including a minimum of 200 hours of classroom and laboratory training, in basic radionuclide handling techniques applicable to the medical use of unsealed byproduct material requiring a written directive. The training and experience must include—
(ii) Work experience, under the supervision of an authorized user who meets the requirements in §§35.57, 35.390, or equivalent Agreement State requirements. A supervising authorized user, who meets the requirements in §35.390(b), must also have experience in administering dosages in the same dosage category or categories (i.e., §35.390(b)(1)(ii)(G)) as the individual requesting authorized user status. The work experience must involve—
(G) Administering dosages of radioactive drugs to patients or human research subjects from the three categories in this paragraph. Radioactive drugs containing radionuclides in categories not included in this paragraph are regulated under §35.1000. This work experience must involve a minimum of three cases in each of the following categories for which the individual is requesting authorized user status—
(2) Oral administration of greater than 1.22 gigabecquerels (33 millicuries) of sodium iodide I-131;2
2Experience with at least three cases in Category (G)(2) also satisfies the requirement in Category (G)(1).
(3) Parenteral administration of any radioactive drug that contains a radionuclide that is primarily used for its electron emission, beta radiation characteristics, alpha radiation characteristics, or photon energy of less than 150 keV, for which a written directive is required; and
(2) Has obtained written attestation that the individual has satisfactorily completed the requirements in paragraph (b)(1) of this section and is able to independently fulfill the radiation safety-related duties as an authorized user for the medical uses authorized under §35.300 for which the individual is requesting authorized user status. The attestation must be obtained from either:
(i) A preceptor authorized user who meets the requirements in §35.57, §35.390, or equivalent Agreement State requirements and has experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status; or
(ii) A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in §35.57, §35.390, or equivalent Agreement State requirements, has experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status, and concurs with the attestation provided by the residency program director. The residency training program must be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral Training of the American Osteopathic Association and must include training and experience specified in paragraph (b)(1) of this section.
[67 FR 20370, Apr. 24, 2002, as amended at 68 FR 75389, Dec. 31, 2003; 70 FR 16364, Mar. 30, 2005; 71 FR 15009, Mar. 27, 2006; 74 FR 33905, July 14, 2009; 83 FR 33107, July 16, 2018]
Except as provided in §35.57, the licensee shall require an authorized user for the oral administration of sodium iodide I-131 requiring a written directive in quantities greater than 1.22 Gigabecquerels (33 millicuries), to be a physician who—
(a) Is certified by a medical specialty board whose certification process includes all of the requirements in paragraphs (c)(1) and (2) of this section, and whose certification has been recognized by the Commission or an Agreement State. The names of board certifications that have been recognized by the Commission or an Agreement State are posted on the NRC's Medical Uses Licensee Toolkit web page; or
(b) Is an authorized user under §35.390 for uses listed in §35.390(b)(1)(ii)(G)(2) or equivalent Agreement State requirements; or
(2) Has work experience, under the supervision of an authorized user who meets the requirements in §§35.57, 35.390, 35.394, or equivalent Agreement State requirements. A supervising authorized user, who meets the requirements in §35.390(b), must also have experience in administering dosages as specified in §35.390(b)(1)(ii)(G)(2). The work experience must involve—
(3) Has obtained written attestation that the individual has satisfactorily completed the requirements in paragraphs (c)(1) and (2) of this section, and is able to independently fulfill the radiation safety-related duties as an authorized user for oral administration of greater than 1.22 gigabecquerels (33 millicuries) of sodium iodide I-131 for medical uses authorized under §35.300. The attestation must be obtained from either:
(i) A preceptor authorized user who meets the requirements in §35.57, §35.390, §35.394, or equivalent Agreement State requirements, and has experience in administering dosages as specified in §35.390(b)(1)(ii)(G)(2); or
(ii) A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in §35.57, §35.390, §35.394, or equivalent Agreement State requirements, has experience in administering dosages as specified in §35.390(b)(1)(ii)(G)(2), and concurs with the attestation provided by the residency program director. The residency training program must be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral Training of the American Osteopathic Association and must include training and experience specified in paragraphs (c)(1) and (2) of this section.
[67 FR 20370, Apr. 24, 2002, as amended at 68 FR 75389, Dec. 31, 2003; 70 FR 16365, Mar. 30, 2005; 71 FR 15010, Mar. 27, 2006; 74 FR 33905, July 14, 2009; 83 FR 33108, July 16, 2018]