Section 35.100 - Use of unsealed byproduct material for uptake, dilution, and excretion studies for which a written directive is not requiredExcept 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:(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 , 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; 71 FR 15009 , Mar. 27, 2006; 72 FR 55931 , Oct. 1, 2007