Subpart D—Unsealed Byproduct Material—Written Directive Not Required

§ 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; 69 FR 55738, Sep. 16, 2004; 70 FR 16363, Mar. 30, 2005; 71 FR 15009, Mar. 27, 2006; 72 FR 55931 Oct. 1, 2007]