10 CFR 35.300 - Use of unsealed byproduct material for which a written directive is required.

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§ 35.300 Use of unsealed byproduct material for which a written directive is required.
A licensee may use any unsealed byproduct material 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]

Title 10 published on 2014-01-01

no entries appear in the Federal Register after this date.

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United States Code

Title 10 published on 2014-01-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 10 CFR 35 after this date.

  • 2014-07-21; vol. 79 # 139 - Monday, July 21, 2014
    1. 79 FR 42224 - Medical Use of Byproduct Material—Medical Event Definitions and Training and Experience
      GPO FDSys XML | Text
      NUCLEAR REGULATORY COMMISSION
      Draft guidance; request for comment.
      Submit comments by November 18, 2014. Comments received after this date will be considered if it is practical to do so, but the NRC is able to assure consideration only for comments received on or before this date.
      10 CFR Parts 30, 32 and 35