10 CFR 35.300, Use of Unsealed Byproduct Material for Which a Written Directive Is Required
Unsealed Byproduct Material-Written Directive Required
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
(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
(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
(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
(d) Prepared by the licensee for use in research in accordance with an Investigational New Drug (IND) protocol accepted by FDA.
Federal Register
, 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]
External Links