Source: http://www.law.cornell.edu/cfr/text/10/35.200
Timestamp: 2014-09-02 12:21:43
Document Index: 677241747

Matched Legal Cases: ['art 35', '§ 35', '§ 32', '§ 30', '§ 35', '§ 35']

10 CFR 35.200 - Use of unsealed byproduct material for imaging and localization studies for which a written directive is not required. | LII / Legal Information Institute
CFR › Title 10 › Chapter I › Part 35 › Subpart D › Section 35.200 10 CFR 35.200 - Use of unsealed byproduct material for imaging and localization studies for which a written directive is not required.
§ 35.200
A manufacturer or preparer licensed under § 32.72 of this chapter or equivalent Agreement State requirements; or
A PET radioactive drug producer licensed under § 30.32(j) of this chapter or equivalent Agreement State requirements; or
Excluding production of PET radionuclides, prepared by:
An authorized nuclear pharmacist;
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
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;
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
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 55932, Oct. 1, 2007]