A licensee may use any unsealed byproduct material prepared for medical use and for which a written directive is required that is—

Terms Used In 10 CFR 35.300

  • Agreement State: means any State with which the Commission or the Atomic Energy Commission has entered into an effective agreement under subsection 274b of the Atomic Energy Act of 1954, as amended. See 10 CFR 35.2
  • Authorized nuclear pharmacist: means a pharmacist who—

    (1) Meets the requirements in §§35. See 10 CFR 35.2

  • Authorized user: means a physician, dentist, or podiatrist who—

    (1) Meets the requirements in §§35. See 10 CFR 35.2

  • 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. See 10 CFR 35.2
  • Pharmacist: means an individual licensed by a State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico to practice pharmacy. See 10 CFR 35.2
  • Physician: means a medical doctor or doctor of osteopathy licensed by a State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico to prescribe drugs in the practice of medicine. See 10 CFR 35.2
  • Written directive: means an authorized user's written order for the administration of byproduct material or radiation from byproduct material to a specific patient or human research subject, as specified in §35. See 10 CFR 35.2

(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]