[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: 10CFR35.300]

[Page 582-583]
 
                            TITLE 10--ENERGY
 
                CHAPTER I--NUCLEAR REGULATORY COMMISSION
 
PART 35--MEDICAL USE OF BYPRODUCT MATERIAL--Table of Contents
 
   Subpart E--Unsealed Byproduct Material--Written Directive Required
 
Sec. 35.300  Use of unsealed byproduct material for which a written 
directive is required.


    A licensee may use any unsealed byproduct material prepared for 
medical

[[Page 583]]

use and for which a written directive is required 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 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]