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

Code of Federal Regulations - Title 10: Energy (2011)

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Title 10: Energy

CHAPTER I: NUCLEAR REGULATORY COMMISSION

PART 35: MEDICAL USE OF BYPRODUCT MATERIAL

Subpart E: Unsealed Byproduct Material-Written Directive Required

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]


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