[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: 10CFR32.21]

[Page 517]
 
                            TITLE 10--ENERGY
 
                CHAPTER I--NUCLEAR REGULATORY COMMISSION
 
PART 32--SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN 
ITEMS CONTAINING BYPRODUCT MATERIAL--Table of Contents
 
               Subpart A--Exempt Concentrations and Items
 
Sec. 32.21  Radioactive drug: Manufacture, preparation, or transfer for 

commercial distribution of capsules containing carbon-14 urea each for 
``in vivo'' diagnostic use for humans to persons exempt from licensing; 
Requirements for a license.

    (a) An application for a specific license to manufacture, prepare, 
process, produce, package, repackage, or transfer for commercial 
distribution capsules containing 37 kBq (1 [mu] Ci) carbon-14 urea 
(allowing for nominal variation that may occur during the manufacturing 
process) each for ``in vivo'' diagnostic use, to persons exempt from 
licensing under Sec. 30.21 of this chapter or the equivalent 
regulations of an Agreement State will be approved if:
    (1) The applicant satisfies the general requirements specified in 
Sec. 30.33 of this chapter, provided that the requirements of Sec. 
30.33(a) (2) and (3) of this chapter do not apply to an application for 
a license to transfer byproduct material manufactured, prepared, 
processed, produced, packaged, or repackaged pursuant to a license 
issued by an Agreement State;
    (2) The applicant meets the requirements under Sec. 32.72(a)(2) of 
this part;
    (3) The applicant provides evidence that each capsule contains 37 
kBq (1 [mu] Ci) carbon-14 urea (allowing for nominal variation that may 
occur during the manufacturing process);
    (4) The carbon-14 urea is not contained in any food, beverage, 
cosmetic, drug (except as described in this section) or other commodity 
designed for ingestion or inhalation by, or topical application to, a 
human being;
    (5) The carbon-14 urea is in the form of a capsule, identified as 
radioactive, and to be used for its radioactive properties, but is not 
incorporated into any manufactured or assembled commodity, product, or 
device intended for commercial distribution; and
    (6) The applicant submits copies of prototype labels and brochures 
and the NRC approves these labels and brochures.
    (b) Nothing in this section relieves the licensee from complying 
with applicable FDA, other Federal, and State requirements governing 
drugs.

[62 FR 63640, Dec. 2, 1997, as amended at 66 FR 64738, Dec. 14, 2001]