10 C.F.R. Subpart D—Unsealed Byproduct Material—Written Directive Not Required
Title 10 - Energy
Except for quantities that require a written directive under §35.40(b), a licensee may use any unsealed byproduct material prepared for medical use for uptake, dilution, or excretion studies that is— (a) Obtained from a manufacturer or preparer licensed under §32.72 of this chapter or equivalent Agreement State requirements; or (b) Prepared by: (1) An authorized nuclear pharmacist; (2) A physician who is an authorized user and who meets the requirements specified in §§35.290, or 35.390 and 35.290(c)(1)(ii)(G); 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 a Radioactive Drug Research Committee-approved protocol or an Investigational New Drug (IND) protocol accepted by FDA; or (d) Prepared by the licensee for use in research in accordance with a Radioactive Drug Research Committee-approved application or an Investigational New Drug (IND) protocol accepted by FDA. [67 FR 20370, Apr. 24, 2002, as amended at 68 FR 19324, Apr. 21, 2003; 69 FR 55738, Sept. 16, 2004; 70 FR 16363, Mar. 30, 2005; 71 FR 15009, Mar. 27, 2006] Except as provided in §35.57, the licensee shall require an authorized user of unsealed byproduct material for the uses authorized under §35.100 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 paragraph (c)(2) of this section. (The names of board certifications which have been recognized by the Commission or an Agreement State will be posted on the NRC's Web page.) To have its certification process recognized, a specialty board shall require all candidates for certification to: (1) Complete 60 hours of training and experience in basic radionuclide handling techniques and radiation safety applicable to the medical use of unsealed byproduct material for uptake, dilution, and excretion studies that includes the topics listed in paragraphs (c)(1)(i) and (c)(1)(ii) of this section; and (2) Pass an examination, administered by diplomates of the specialty board, that assesses knowledge and competence in radiation safety, radionuclide handling, and quality control; or (b) Is an authorized user under §§35.290, 35.390, or equivalent Agreement State requirements; or (c)(1) Has completed 60 hours of training and experience, including a minimum of 8 hours of classroom and laboratory training, in basic radionuclide handling techniques applicable to the medical use of unsealed byproduct material for uptake, dilution, and excretion studies. 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 §§35.190, 35.290, 35.390, or equivalent Agreement State requirements, involving— (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; and (F) Administering dosages of radioactive drugs to patients or human research subjects; and (2) Has obtained written attestation, signed by a preceptor authorized user who meets the requirements in §§35.190, 35.290, or 35.390, or equivalent Agreement State requirements, that the individual has satisfactorily completed the requirements in paragraph (a)(1) or (c)(1) of this section and has achieved a level of competency sufficient to function independently as an authorized user for the medical uses authorized under §35.100. [67 FR 20370, Apr. 24, 2002, as amended at 68 FR 19324, Apr. 21, 2003; 69 FR 55738, Sept. 16, 2004; 70 FR 16363, Mar. 30, 2005; 71 FR 15009, Mar. 27, 2006] Except for quantities that require a written directive under §35.40(b), a licensee may use any unsealed byproduct material prepared for medical use for imaging and localization studies that is— (a) Obtained from a manufacturer or preparer licensed under §32.72 of this chapter or equivalent Agreement State requirements; or (b) Prepared by: (1) An authorized nuclear pharmacist; (2) A physician who is an authorized user and who meets the requirements specified in §35.290, or 35.390 and 35.290(c)(1)(ii)(G); 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; (c) Obtained from and prepared by an NRC or Agreement State licensee for use in research in accordance with a Radioactive Drug Research Committee-approved protocol or an Investigational New Drug (IND) protocol accepted by FDA; or (d) Prepared by the licensee for use in research in accordance with a Radioactive Drug Research Committee-approved application or an Investigational New Drug (IND) protocol accepted by FDA. [67 FR 20370, Apr. 24, 2002, as amended at 68 FR 19324, Apr. 21, 2003; 69 FR 55738, Sept. 16, 2004; 70 FR 16363, Mar. 30, 2005; 71 FR 15009, Mar. 27, 2006] (a) A licensee may not administer to humans a radiopharmaceutical that contains more than 0.15 kilobecquerel of molybdenum-99 per megabecquerel of technetium-99m (0.15 microcurie of molybdenum-99 per millicurie of technetium-99m). (b) A licensee that uses molybdenum-99/technetium-99m generators for preparing a technetium-99m radiopharmaceutical shall measure the molybdenum-99 concentration of the first eluate after receipt of a generator to demonstrate compliance with paragraph (a) of this section. (c) If a licensee is required to measure the molybdenum-99 concentration, the licensee shall retain a record of each measurement in accordance with §35.2204. Except as provided in §35.57, the licensee shall require an authorized user of unsealed byproduct material for the uses authorized under §35.200 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 paragraph (c)(2) of this section. (The names of board certifications which have been recognized by the Commission or an Agreement State will be posted on the NRC's Web page.) To have its certification process recognized, a specialty board shall require all candidates for certification to: (1) Complete 700 hours of training and experience in basic radionuclide handling techniques and radiation safety applicable to the medical use of unsealed byproduct material for imaging and localization studies that includes the topics listed in paragraphs (c)(1)(i) and (c)(1)(ii) of this section; and (2) Pass an examination, administered by diplomates of the specialty board, which assesses knowledge and competence in radiation safety, radionuclide handling, and quality control; or (b) Is an authorized user under §35.390 and meets the requirements in §35.290(c)(1)(ii)(G), or equivalent Agreement State requirements; or (c)(1) Has completed 700 hours of training and experience, including a minimum of 80 hours of classroom and laboratory training, in basic radionuclide handling techniques applicable to the medical use of unsealed byproduct material for imaging and localization studies. The training and experience must include, at a minimum— (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; (E) Radiation biology; and (ii) Work experience, under the supervision of an authorized user, who meets the requirements in §§35.290, or 35.290(c)(1)(ii)(G), and 35.390, or equivalent Agreement State requirements, involving— (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 safely contain spilled radioactive material and using proper decontamination procedures; (F) Administering dosages of radioactive drugs to patients or human research subjects; and (G) Eluting generator systems appropriate for preparation of radioactive drugs for imaging and localization studies, measuring and testing the eluate for radionuclidic purity, and processing the eluate with reagent kits to prepare labeled radioactive drugs; and (2) Has obtained written attestation, signed by a preceptor authorized user who meets the requirements in §§35.290, or 35.390 and 35.290(c)(1)(ii)(G), or equivalent Agreement State requirements, that the individual has satisfactorily completed the requirements in paragraph (a)(1) or (c)(1) of this section and has achieved a level of competency sufficient to function independently as an authorized user for the medical uses authorized under §§35.100 and 35.200. [67 FR 20370, Apr. 24, 2002, as amended at 68 FR 19324, Apr. 21, 2003; 69 FR 55738, Sept. 16, 2004; 70 FR 16364, Mar. 30, 2005; 71 FR 15009, Mar. 27, 2006]
Title 10: Energy
PART 35—MEDICAL USE OF BYPRODUCT MATERIAL
Subpart D—Unsealed Byproduct Material—Written Directive Not Required
§ 35.100 Use of unsealed byproduct material for uptake, dilution, and excretion studies for which a written directive is not required.
§ 35.190 Training for uptake, dilution, and excretion studies.
§ 35.200 Use of unsealed byproduct material for imaging and localization studies for which a written directive is not required.
§ 35.204 Permissible molybdenum-99 concentration.
§ 35.290 Training for imaging and localization studies.
