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CFR › Title 10 › Chapter I › Part 35 › Subpart D › Section 35.100

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 2013-01-01

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

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2013-03-19; vol. 78 # 53 - Tuesday, March 19, 2013
    1. 78 FR 16922 - Physical Protection of Byproduct Material
      GPO FDSys XML | Text
      NUCLEAR REGULATORY COMMISSION
      Final rule.
      Effective Date: This final rule is effective on May 20, 2013. Compliance Date: Compliance with this final rule is required on March 19, 2014.
      10 CFR Parts 20, 30, 32, 33, 34, 35, 36, 37, 39, 51, 71, and 73

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.

United States Code
U.S.C. : Title 42 - THE PUBLIC HEALTH AND WELFARE

§ 2014 - Definitions

§ 2021 - Cooperation with States

§ 2021b - Definitions

§ 2111 - Domestic distribution

§ 2201 - General duties of Commission

§ 2232 - License applications

§ 2233 - Terms of licenses

§ 5841 - Establishment and transfers

USC : Title 44 - PUBLIC PRINTING AND DOCUMENTS

§ 3504 note - Authority and functions of Director

Title 10 published on 2013-01-01

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

  • 2013-03-19; vol. 78 # 53 - Tuesday, March 19, 2013
    1. 78 FR 16922 - Physical Protection of Byproduct Material
      GPO FDSys XML | Text
      NUCLEAR REGULATORY COMMISSION
      Final rule.
      Effective Date: This final rule is effective on May 20, 2013. Compliance Date: Compliance with this final rule is required on March 19, 2014.
      10 CFR Parts 20, 30, 32, 33, 34, 35, 36, 37, 39, 51, 71, and 73