Current through Register Vol. 38, No. 18, March 15, 2024
(a) A general license shall be issued to any
physician, veterinarian in the practice of veterinary medicine, clinical
laboratory or hospital to receive, acquire, possess, transfer or use the
following radioactive materials for IN VITRO clinical or laboratory tests not
involving internal or external administration of radioactive material, or
radiation therefrom, to human beings or animals:
(1) iodine-125 in units not exceeding ten
microcuries each;
(2) iodine-131 in
units not exceeding ten microcuries each;
(3) carbon-14 in units not exceeding ten
microcuries each;
(4) hydrogen-3
(tritium) in units not exceeding 50 microcuries each;
(5) iron-59 in units not exceeding 20
microcuries each;
(6) cobalt-57 in
units not exceeding ten microcuries each;
(7) selenium-75 in units not exceeding ten
microcuries each;
(8) mock
iodine-125 reference or calibration sources in units not exceeding 0.05
microcuries of iodine-129 and 0.005 microcurie of americium-241 each. This
general license is subject to the provisions of Paragraphs (b) to (f) of this
Rule.
(b) No person
shall receive, acquire, possess, use or transfer radioactive material pursuant
to the general license established in Paragraph (a) of this Rule until he has
filed agency form "Certificate IN VITRO Testing with Radioactive Material Under
General License", with the agency and received from the agency a validated copy
of the agency form with certification number assigned. The physician, clinical
laboratory or hospital shall furnish on the agency form the following
information and such other information as may be required by the form:
(1) name and address of the physician,
clinical laboratory or hospital;
(2) the location of use;
(3) a statement that the physician, clinical
laboratory or hospital has appropriate radiation measuring instruments to carry
out IN VITRO clinical or laboratory tests with radioactive material as
authorized under the general license in Paragraph (a) of this Rule and that
these tests will be performed only by personnel competent in the use of the
instruments and in the handling of the radioactive material.
(c) A person who receives,
acquires, possesses or uses radioactive material pursuant to the general
license established in Paragraph (a) of this Rule:
(1) shall not possess at any one time,
pursuant to the general license in Paragraph (a) of this Rule at any one
location of storage or use a total amount of iodine-125, iodine-131, and
iron-59 in excess of 200 microcuries;
(2) shall store the radioactive material,
until used, in the original shipping container or in a container providing
equivalent radiation protection;
(3) shall use the radioactive material only
for the uses authorized in Paragraph (a) of this Rule;
(4) shall not transfer the radioactive
material to a person who is not authorized to receive it pursuant to a license
issued by the agency, the U.S. Nuclear Regulatory Commission, or an agreement
state, nor transfer the radioactive material in any manner other than in the
unopened, labeled shipping container as received from the supplier;
and
(5) shall dispose of the mock
iodine-125 reference or calibration sources described in Subparagraph (a)(8) of
this Rule as required by Rule.1628 of this Chapter.
(d) The general licensee shall not receive,
acquire, possess, or use radioactive material pursuant to Paragraph (a) of this
Rule:
(1) except as prepackaged units which
are labeled in accordance with the provisions of a specific license issued by
the U.S. Nuclear Regulatory Commission, or an agreement state which authorizes
the manufacture and distribution of iodine-125, iodine-131, carbon-14,
hydrogen-3 (tritium), selenium-75, mock iodine-125 (of iodine-129 and
americium-241), or iron-59 for distribution to persons generally licensed under
Paragraph (a) of this Rule or its equivalent; and
(2) unless the following statement, or a
substantially similar statement which contains the information called for in
the following statement, appears on a label affixed to each prepackaged unit or
appears in a leaflet or brochure which accompanies the package:
(A) This radioactive material may be
received, acquired, possessed, and used only by physicians, clinical
laboratories, or hospitals and only for IN VITRO clinical or laboratory tests
not involving internal or external administration of the material, or the
radiation therefrom, to human beings or animals.
(B) Its receipt, acquisition, possession,
use, and transfer are subject to the regulations and a general license of the
United States Nuclear Regulatory Commission, or, of a state with which the
Commission has entered into an agreement for the exercise of regulatory
authority. (Name of Manufacturer).
(e) The physician, clinical laboratory or
hospital possessing or using radioactive material under the general license in
Paragraph (a) of this Rule shall report in writing to the agency, any changes
in the information furnished in the "Certificate IN VITRO Testing with
Radioactive Material Under General License" agency form within 30 days after
the effective date of the changes.
(f) Any person using radioactive material
pursuant to the general license in Paragraph (a) of this Rule is exempt from
the requirements of Sections.1000 and.1600 of these Rules with respect to
radioactive material covered by the general license. The new drug provisions of
the Federal Food, Drug, and Cosmetic Act also govern the availability and use
of any specific diagnostic drugs in interstate commerce.
Authority
G.S.
104E-7;
104E-10(b);
Eff. February 1, 1980;
Amended Eff. January 1, 1994;
Transferred and Recodified from
15A NCAC
11.0314 Eff. February 1,
2015.