Section 35.300 - Use of unsealed byproduct material for which a written directive is requiredA 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