[Code of Federal Regulations]
[Title 10, Volume 1]
[Revised as of January 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 10CFR35.100]

[Page 580]
 
                            TITLE 10--ENERGY
 
                CHAPTER I--NUCLEAR REGULATORY COMMISSION
 
PART 35--MEDICAL USE OF BYPRODUCT MATERIAL--Table of Contents
 
 Subpart D--Unsealed Byproduct Material--Written Directive Not Required
 
Sec. 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 Sec. 
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 a manufacturer or preparer licensed under Sec. 
32.72 of this chapter or equivalent Agreement State requirements; or
    (b) Prepared by:
    (1) An authorized nuclear pharmacist;
    (2) A physician who is an authorized user and who meets the 
requirements specified in Sec. Sec. 35.290, 35.390, or, before October 
24, 2004, Sec. 35.920; or
    (3) An individual under the supervision, as specified in Sec. 
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]