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 identified in § 35.390(b)(1)(ii)(G) 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; 69 FR 55738, Sep. 16, 2004; 71 FR 15009, Mar. 27, 2006; 72 FR 55932 Oct. 1, 2007; 83 FR 33107, Jul. 16, 2018]