10 CFR 35.100 - Use of unsealed byproduct material for uptake, dilution, and excretion studies for which a written directive is not required.

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§ 35.100 Use of unsealed byproduct material for uptake, dilution, and excretion studies for which a written directive is not required.
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) 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]

Title 10 published on 2014-01-01

The following are only the Rules published in the Federal Register after the published date of Title 10.

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  • 2014-12-19; vol. 79 # 244 - Friday, December 19, 2014
    1. 79 FR 75735 - Organizational Changes and Conforming Amendments
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      NUCLEAR REGULATORY COMMISSION
      Final rule.
      This final rule is effective on December 19, 2014.
      10 CFR Parts 1, 2, 30, 31, 32, 34, 35, 37, 40, 51, 61, 62, 70, 71, 72, 73, 74, 75, 140, and 150

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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.

  • 2014-12-19; vol. 79 # 244 - Friday, December 19, 2014
    1. 79 FR 75735 - Organizational Changes and Conforming Amendments
      GPO FDSys XML | Text
      NUCLEAR REGULATORY COMMISSION
      Final rule.
      This final rule is effective on December 19, 2014.
      10 CFR Parts 1, 2, 30, 31, 32, 34, 35, 37, 40, 51, 61, 62, 70, 71, 72, 73, 74, 75, 140, and 150