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Electronic Code of Federal Regulations

e-CFR data is current as of June 3, 2020

Title 10Chapter IPart 35 → Subpart E


Title 10: Energy
PART 35—MEDICAL USE OF BYPRODUCT MATERIAL


Subpart E—Unsealed Byproduct Material—Written Directive Required


Contents
§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.
§35.392   Training for the oral administration of sodium iodide I-131 requiring a written directive in quantities less than or equal to 1.22 gigabecquerels (33 millicuries).
§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).
§35.396   Training for the parenteral administration of unsealed byproduct material requiring a written directive.

§35.300   Use of unsealed byproduct material for which a written directive is required.

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—

(a) Obtained from:

(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

(b) Excluding production of PET radionuclides, prepared by:

(1) An authorized nuclear pharmacist;

(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

(c) Obtained from and prepared by an NRC or Agreement State licensee for use in research in accordance with an Investigational New Drug (IND) protocol accepted by FDA; or

(d) Prepared by the licensee for use in research in accordance with an Investigational New Drug (IND) protocol accepted by FDA.

[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]

§35.310   Safety instruction.

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—

(1) Patient or human research subject control;

(2) Visitor control, including—

(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;

(3) Contamination control;

(4) Waste control; and

(5) Notification of the Radiation Safety Officer, or his or her designee, and an authorized user if the patient or the human research subject has a medical emergency or dies.

(b) A licensee shall retain a record of individuals receiving instruction in accordance with §35.2310.

[67 FR 20370, Apr. 24, 2002, as amended at 68 FR 19324, Apr. 21, 2003]

§35.315   Safety precautions.

(a) For each patient or human research subject who cannot be released under §35.75, a licensee shall—

(1) Quarter the patient or the human research subject either in—

(i) A private room with a private sanitary facility; or

(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;

(2) Visibly post the patient's or the human research subject's room with a “Radioactive Materials” sign.

(3) Note on the door or in the patient's or human research subject's chart where and how long visitors may stay in the patient's or the human research subject's room; and

(4) Either monitor material and items removed from the patient's or the human research subject's room to determine that their radioactivity cannot be distinguished from the natural background radiation level with a radiation detection survey instrument set on its most sensitive scale and with no interposed shielding, or handle the material and items as radioactive waste.

(b) A licensee shall notify the Radiation Safety Officer, or his or her designee, and an authorized user as soon as possible if the patient or human research subject has a medical emergency or dies.

[67 FR 20370, Apr. 24, 2002, as amended at 68 FR 19325, Apr. 21, 2003]

§35.390   Training for use of unsealed byproduct material for which a written directive is required.

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:

(1) Successfully complete residency training in a radiation therapy or nuclear medicine training program or a program in a related medical specialty. These residency training programs must include 700 hours of training and experience as described in paragraphs (b)(1)(i) through (b)(1)(ii)(E) of this section. Eligible training programs must be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education, the Royal College of Physicians and Surgeons of Canada, or the Committee on Post-Graduate Training of the American Osteopathic Association; and

(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—

(i) Classroom and laboratory training in the following areas—

(A) Radiation physics and instrumentation;

(B) Radiation protection;

(C) Mathematics pertaining to the use and measurement of radioactivity;

(D) Chemistry of byproduct material for medical use; and

(E) Radiation biology; and

(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—

(A) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;

(B) Performing quality control procedures on instruments used to determine the activity of dosages, and performing checks for proper operation of survey meters;

(C) Calculating, measuring, and safely preparing patient or human research subject dosages;

(D) Using administrative controls to prevent a medical event involving the use of unsealed byproduct material;

(E) Using procedures to contain spilled byproduct material safely and using proper decontamination procedures;

(F) [Reserved]

(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—

(1) Oral administration of less than or equal to 1.22 gigabecquerels (33 millicuries) of sodium iodide I-131, for which a written directive is required;

(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]

§35.392   Training for the oral administration of sodium iodide I-131 requiring a written directive in quantities less than or equal to 1.22 gigabecquerels (33 millicuries).

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 less than or equal to 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 process 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)(1) or (2), §35.394, or equivalent Agreement State requirements; or

(c)(1) Has successfully completed 80 hours of classroom and laboratory training, applicable to the medical use of sodium iodide I-131 for procedures requiring a written directive. The training must include—

(i) Radiation physics and instrumentation;

(ii) Radiation protection;

(iii) Mathematics pertaining to the use and measurement of radioactivity;

(iv) Chemistry of byproduct material for medical use; and

(v) Radiation biology; and

(2) Has work experience, under the supervision of an authorized user who meets the requirements in §§35.57, 35.390, 35.392, 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)(1) or 35.390(b)(1)(ii)(G)(2). The work experience must involve—

(i) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;

(ii) Performing quality control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey meters;

(iii) Calculating, measuring, and safely preparing patient or human research subject dosages;

(iv) Using administrative controls to prevent a medical event involving the use of byproduct material;

(v) Using procedures to contain spilled byproduct material safely and using proper decontamination procedures; and

(vi) Administering dosages to patients or human research subjects, that includes at least 3 cases involving the oral administration of less than or equal to 1.22 gigabecquerels (33 millicuries) of sodium iodide I-131; and

(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 less than or equal to 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, §35.392, §35.394, or equivalent Agreement State requirements and has experience in administering dosages as specified in §35.390(b)(1)(ii)(G)(1) or (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, §35.392, §35.394, or equivalent Agreement State requirements, has experience in administering dosages as specified in §35.390(b)(1)(ii)(G)(1) or (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 16364, Mar. 30, 2005; 71 FR 15009, Mar. 27, 2006; 74 FR 33905, July 14, 2009; 83 FR 33108, July 16, 2018]

§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).

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

(c)(1) Has successfully completed 80 hours of classroom and laboratory training, applicable to the medical use of sodium iodide I-131 for procedures requiring a written directive. The training must include—

(i) Radiation physics and instrumentation;

(ii) Radiation protection;

(iii) Mathematics pertaining to the use and measurement of radioactivity;

(iv) Chemistry of byproduct material for medical use; and

(v) Radiation biology; and

(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—

(i) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;

(ii) Performing quality control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey meters;

(iii) Calculating, measuring, and safely preparing patient or human research subject dosages;

(iv) Using administrative controls to prevent a medical event involving the use of byproduct material;

(v) Using procedures to contain spilled byproduct material safely and using proper decontamination procedures; and

(vi) Administering dosages to patients or human research subjects, that includes at least 3 cases involving the oral administration of greater than 1.22 gigabecquerels (33 millicuries) of sodium iodide I-131; and

(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]

§35.396   Training for the parenteral administration of unsealed byproduct material requiring a written directive.

(a) Except as provided in §35.57, the licensee shall require an authorized user for the parenteral administration requiring a written directive, to be a physician who—

(1) Is an authorized user under §35.390 for uses listed in §35.390(b)(1)(ii)(G)(3), or equivalent Agreement State requirements; or

(2) Is an authorized user under §35.490, §35.690, or equivalent Agreement State requirements, and who meets the requirements in paragraph (b) of this section; or

(3) Is certified by a medical specialty board whose certification process has been recognized by the Commission or an Agreement State under §35.490 or §35.690, and who meets the requirements in paragraph (b) of this section.

(b) The physician—

(1) Has successfully completed 80 hours of classroom and laboratory training, applicable to parenteral administrations listed in §35.390(b)(1)(ii)(G)(3). The training must include—

(i) Radiation physics and instrumentation;

(ii) Radiation protection;

(iii) Mathematics pertaining to the use and measurement of radioactivity;

(iv) Chemistry of byproduct material for medical use; and

(v) Radiation biology; and

(2) Has work experience, under the supervision of an authorized user who meets the requirements in §35.57, §35.390, §35.396, or equivalent Agreement State requirements, in the parenteral administrations listed in §35.390(b)(1)(ii)(G)(3). A supervising authorized user who meets the requirements in §35.390, §35.396, or equivalent Agreement State requirements, must have experience in administering dosages in the same category or categories as the individual requesting authorized user status. The work experience must involve—

(i) Ordering, receiving, and unpacking radioactive materials safely, and performing the related radiation surveys;

(ii) Performing quality control procedures on instruments used to determine the activity of dosages, and performing checks for proper operation of survey meters;

(iii) Calculating, measuring, and safely preparing patient or human research subject dosages;

(iv) Using administrative controls to prevent a medical event involving the use of unsealed byproduct material;

(v) Using procedures to contain spilled byproduct material safely, and using proper decontamination procedures; and

(vi) Administering dosages to patients or human research subjects, that include at least three cases of the parenteral administrations as specified in §35.390(b)(1)(ii)(G)(3); and

(3) Has obtained written attestation that the individual has satisfactorily completed the requirements in paragraphs (b)(1) and (2) of this section, and is able to independently fulfill the radiation safety-related duties as an authorized user for the parenteral administration of unsealed byproduct material requiring a written directive. The attestation must be obtained from either:

(i) A preceptor authorized user who meets the requirements in §35.57, §35.390, §35.396, or equivalent Agreement State requirements. A preceptor authorized user who meets the requirements in §35.390, §35.396, or equivalent Agreement State requirements, must have experience in administering dosages in the same 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, §35.396, 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 paragraphs (b)(1) and (2) of this section.

[83 FR 33108, July 16, 2018]

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