{"data":{"id":"us/10-cfr-35.300","jurisdiction":"us","citation":"10 CFR 35.300","heading":"Use of unsealed byproduct material for which a written directive is required.","body":"A 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—\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, 35.390, 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 an Investigational New Drug (IND) protocol accepted by FDA; or\n(d) Prepared by the licensee for use in research in accordance with 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 E—Unsealed Byproduct Material—Written Directive 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":"d2bcb4352b8a10b90a64caaa22eb0f5ad04aa9760a4070d6dd5844d34beb8396","source_id":"us-cfr","stale":true,"prev":"us/10-cfr-35.290","next":"us/10-cfr-35.310"},"notice":"GroundRules: Original legal text. Not legal advice."}