[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: 10CFR32.72]

[Page 533-534]
 
                            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 B--Generally Licensed Items
 
Sec. 32.72  Manufacture, preparation, or transfer for commercial 

distribution of radioactive drugs containing byproduct material 
for medical use under part 35.

    (a) An application for a specific license to manufacture, prepare, 
or transfer for commercial distribution radioactive drugs containing 
byproduct material for use by persons authorized pursuant to part 35 of 
this chapter will be approved if:
    (1) The applicant satisfies the general requirements specified in 10 
CFR 30.33;
    (2) The applicant submits evidence that the applicant is at least 
one of the following:
    (i) Registered or licensed with the U.S. Food and Drug 
Administration (FDA) as a drug manufacturer;
    (ii) Registered or licensed with a state agency as a drug 
manufacturer;
    (iii) Licensed as a pharmacy by a State Board of Pharmacy; or
    (iv) Operating as a nuclear pharmacy within a Federal medical 
institution.
    (3) The applicant submits information on the radionuclide; the 
chemical and physical form; the maximum activity per vial, syringe, 
generator, or other container of the radioactive drug; and the shielding 
provided by the packaging to show it is appropriate for the safe 
handling and storage of the radioactive drugs by medical use licensees; 
and
    (4) The applicant satisfies the following labeling requirements:
    (i) A label is affixed to each transport radiation shield, whether 
it is constructed of lead, glass, plastic, or other material, of a 
radioactive drug to be transferred for commercial distribution. The 
label must include the radiation symbol and the words ``CAUTION, 
RADIOACTIVE MATERIAL'' or ``DANGER, RADIOACTIVE MATERIAL''; the name of 
the radioactive drug or its abbreviation; and the quantity of 
radioactivity at a specified date and time. For radioactive drugs with a 
half life greater than 100 days, the time may be omitted.
    (ii) A label is affixed to each syringe, vial, or other container 
used to hold a radioactive drug to be transferred for commercial 
distribution. The label must include the radiation symbol and the words 
``CAUTION, RADIOACTIVE MATERIAL'' or ``DANGER, RADIOACTIVE MATERIAL'' 
and an identifier that ensures that the syringe, vial, or other 
container can be correlated with the information on the transport 
radiation shield label.
    (b) A licensee described by paragraph (a)(2)(iii) or (iv) of this 
section:
    (1) May prepare radioactive drugs for medical use, as defined in 10 
CFR 35.2, provided that the radioactive drug is prepared by either an 
authorized nuclear pharmacist, as specified in paragraphs (b)(2) and 
(b)(4) of this section, or an individual under the supervision of an 
authorized nuclear pharmacist as specified in 10 CFR 35.27.
    (2) May allow a pharmacist to work as an authorized nuclear 
pharmacist if:
    (i) This individual qualifies as an authorized nuclear pharmacist as 
defined in 10 CFR 35.2,
    (ii) This individual meets the requirements specified in 10 CFR 
35.55(b) or, prior to October 25, 2004, 10 CFR 35.980(b) and 35.59 and 
the licensee has received an approved license amendment identifying this 
individual as an authorized nuclear pharmacist, or
    (iii) This individual is designated as an authorized nuclear 
pharmacist in accordance with paragraph (b)(4) of this section.
    (3) The actions authorized in paragraphs (b)(1) and (b)(2) of this 
section are permitted in spite of more restrictive language in license 
conditions.
    (4) May designate a pharmacist (as defined in 10 CFR 35.2) as an 
authorized nuclear pharmacist if the individual is identified as of 
December 2, 1994, as an ``authorized user'' on a nuclear pharmacy 
license issued by the Commission under this part.
    (5) Shall provide to the Commission a copy of each individual's 
certification by the Board of Pharmaceutical Specialties, the Commission 
or Agreement State license, or the permit issued by a licensee of broad 
scope, and a copy of

[[Page 534]]

the state pharmacy licensure or registration, no later than 30 days 
after the date that the licensee allows, pursuant to paragraphs 
(b)(2)(i) and (b)(2)(iii) of this section, the individual to work as an 
authorized nuclear pharmacist.
    (c) A licensee shall possess and use instrumentation to measure the 
radioactivity of radioactive drugs. The licensee shall have procedures 
for use of the instrumentation. The licensee shall measure, by direct 
measurement or by combination of measurements and calculations, the 
amount of radioactivity in dosages of alpha-, beta-, or photon-emitting 
radioactive drugs prior to transfer for commercial distribution. In 
addition, the licensee shall:
    (1) Perform tests before initial use, periodically, and following 
repair, on each instrument for accuracy, linearity, and geometry 
dependence, as appropriate for the use of the instrument; and make 
adjustments when necessary; and
    (2) Check each instrument for constancy and proper operation at the 
beginning of each day of use.
    (d) Nothing in this section relieves the licensee from complying 
with applicable FDA, other Federal, and State requirements governing 
radioactive drugs.

[59 FR 61780, Dec. 2, 1994; 59 FR 65244, Dec. 19, 1994, as amended at 60 
FR 324, Jan. 4, 1995; 67 FR 20370, Apr. 24, 2002; 67 FR 62872, Oct. 9, 
2002; 67 FR 77652, Dec. 19, 2002]