{"data":{"id":"us/10-cfr-35.100","jurisdiction":"us","citation":"10 CFR 35.100","heading":"Use of unsealed byproduct material for uptake, dilution, and excretion studies for which a written directive is not required.","body":"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—\n(a) Obtained from:\n(1) A manufacturer or preparer licensed under § 32.72 of this chapter or equivalent Agreement State requirements; or\n(2) A PET radioactive drug producer licensed under § 30.32(j) of this chapter or equivalent Agreement State requirements; or\n(b) Excluding production of PET radionuclides, prepared by:\n(1) An authorized nuclear pharmacist;\n(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\n(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\n(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\n(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.","path":["Title 10—Energy","CHAPTER I—NUCLEAR REGULATORY COMMISSION","PART 35—MEDICAL USE OF BYPRODUCT MATERIAL","Subpart D—Unsealed Byproduct Material—Written Directive Not Required"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-10.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:09Z","sha256":"3fa4eaa5db490b361293c546d6537fd2766f154f96931ae4bd0dd861c011be08","source_id":"us-cfr","stale":true,"prev":"us/10-cfr-35.92","next":"us/10-cfr-35.190"},"notice":"GroundRules: Original legal text. Not legal advice."}