10 CFR §35.100

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗

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:
1. (1)A manufacturer or preparer licensed under § 32.72 of this chapter or equivalent Agreement State requirements; or
2. (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. (1)An authorized nuclear pharmacist;
2. (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. (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.