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

234 words·~1 min read·/us/cfr/t10/s§ 35.100·

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

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]

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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.

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