[Code of Federal Regulations]
[Title 10, Volume 1]
[Revised as of January 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 10CFR30.21]

[Page 460]
 
                            TITLE 10--ENERGY
 
                CHAPTER I--NUCLEAR REGULATORY COMMISSION
 
PART 30--RULES OF GENERAL APPLICABILITY TO DOMESTIC LICENSING OF BYPRODUCT MATERIAL--Table of Contents
 
Sec. 30.21  Radioactive drug: Capsules containing carbon-14 urea for ``in vivo'' diagnostic use for humans.

    (a) Except as provided in paragraphs (b) and (c) of this section, 
any person is exempt from the requirements for a license set forth in 
Section 81 of the Act and from the regulations in this part and part 35 
of this chapter provided that such person receives, possesses, uses, 
transfers, owns, or acquires capsules containing 37 kBq (1  Ci) 
carbon-14 urea (allowing for nominal variation that may occur during the 
manufacturing process) each, for ``in vivo'' diagnostic use for humans.
    (b) Any person who desires to use the capsules for research 
involving human subjects shall apply for and receive a specific license 
pursuant to part 35 of this chapter.
    (c) Any person who desires to manufacture, prepare, process, 
produce, package, repackage, or transfer for commercial distribution 
such capsules shall apply for and receive a specific license pursuant to 
Sec. 32.21 of this chapter.
    (d) Nothing in this section relieves persons from complying with 
applicable FDA, other Federal, and State requirements governing receipt, 
administration, and use of drugs.

[62 FR 63640, Dec. 2, 1997]

                                Licenses