| (II) an identifier that ensures that the syringe, vial,
or other container can be correlated with the information on the transport
radiation shield.
(2) A licensee shall possess and use instrumentation
to measure the radioactivity of radioactive drugs and shall have procedures
for the use of the instrumentation. The licensee shall measure, by
direct measurement or by a combination of measurements and calculations,
the amount of radioactivity in dosages of alpha, beta, or photon-emitting
radioactive drugs before transfer for commercial distribution. In
addition, the licensee shall:
(A) 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;
(B) check each instrument for constancy and proper
operation at the beginning of each day of use; and
(C) make, maintain, and retain records of the tests
and checks required in this paragraph for inspection by the department
in accordance with subsection (mm) of this section.
(3) A licensee described in paragraph (1)(A)(iii) or
(iv) of this subsection shall prepare radioactive drugs for medical
use as defined in §289.256 of this title with the following provisions.
(A) Radioactive drugs shall be prepared by either an
authorized nuclear pharmacist, as specified in subparagraphs (B) and
(D) of this paragraph, or an individual under the supervision of an
authorized nuclear pharmacist as specified in §289.256(s) of
this title.
(B) A pharmacist shall be allowed to work as an authorized
nuclear pharmacist if:
(i) the individual qualifies as an authorized nuclear
pharmacist as defined in §289.256 of this title;
(ii) the individual meets the requirements specified
in §289.256(k)(2) and (m) of this title, and the licensee has
received from the department, an approved license amendment identifying
this individual as an authorized nuclear pharmacist; or
(iii) the individual is designated as an authorized
nuclear pharmacist in accordance with subparagraph (D) of this paragraph.
(C) The actions authorized in subparagraphs (A) and
(B) of this paragraph are permitted in spite of more restrictive language
in license conditions.
(D) A licensee may designate a pharmacist, as defined
in §289.256 of this title, as an authorized nuclear pharmacist
if:
(i) the individual was a nuclear pharmacist preparing
only radioactive drugs containing accelerator-produced radioactive
material; and
(ii) the individual practiced at a pharmacy at a government
agency or federally recognized Indian Tribe or at all other pharmacies
before the effective date of this rule as noticed by the NRC or the
department.
(E) The licensee shall provide the following to the
department:
(i) a copy of each individual's certification by a
specialty board whose certification process has been recognized by
the NRC, the department, or an agreement state as specified in §289.256(k)(1)
of this title; or
(ii) the department, NRC, or another agreement state
license; or
(iii) the permit issued by a broad scope licensee or
the authorization from a commercial nuclear pharmacy authorized to
list its own authorized nuclear pharmacist; or
(iv) documentation that only accelerator-produced radioactive
materials were used in the practice of nuclear pharmacy at a government
agency or federally recognized Indian Tribe or at all other locations
of use before the effective date of this rule as noticed by the NRC
or the department; and
(v) a copy of the Texas State Board of Pharmacy licensure
or registration, no later than 30 days after the date that the licensee
allows, in accordance with subparagraph (B)(i) and (iii) of this paragraph,
the individual to work as an authorized nuclear pharmacist.
(F) The radiopharmaceuticals for human use shall be
processed and prepared according to instructions that are furnished
by the manufacturer on the label attached to or in the FDA-accepted
instructions in the leaflet or brochure that accompanies the generator
or reagent kit.
(G) If the authorized nuclear pharmacist elutes generators
or processes radioactive material with the reagent kit in a manner
that deviates from instructions furnished by the manufacturer on the
label attached to or in the leaflet or brochure that accompanies the
generator or reagent kit or in the accompanying leaflet or brochure,
a complete description of the deviation shall be made and maintained
for inspection by the department in accordance with subsection (mm)
of this section.
(4) A licensee shall satisfy the labeling requirements
in subsection (r)(1)(C) of this section.
(5) Nothing in this subsection relieves the licensee
from complying with applicable FDA, or other federal and state requirements
governing radioactive drugs.
(s) Specific licenses for the manufacture and commercial
distribution of products containing depleted uranium for mass-volume
applications.
(1) In addition to the requirements in subsection (e)
of this section, a specific license to manufacture products and devices
containing depleted uranium for use in accordance with §289.251(f)(3)(D)
of this title or equivalent regulations of the NRC or an agreement
state, will be issued if the department approves the following information
submitted by the applicant:
(A) the design, manufacture, prototype testing, quality
control procedures, labeling or marking, proposed uses, and potential
hazards of the product or device to provide reasonable assurance that
possession, use, or commercial distribution of the depleted uranium
in the product or device is not likely to cause any individual to
receive in any period of one year a radiation dose in excess of ten
percent of the limits specified in §289.202(f) of this title;
and
(B) reasonable assurance is provided that unique benefits
will accrue to the public because of the usefulness of the product
or device.
(2) In the case of a product or device whose unique
benefits are questionable, the department will issue a specific license
in accordance with paragraph (1) of this subsection only if the product
or device is found to combine a high degree of utility and low probability
of uncontrolled disposal and dispersal of significant quantities of
depleted uranium into the environment.
(3) The department may deny any application for a specific
license in accordance with this subsection if the end use(s) of the
product or device cannot be reasonably foreseen.
(4) Each person licensed in accordance with paragraph
(1) of this subsection shall:
(A) maintain the level of quality control required
by the license in the manufacture of the product or device, and in
the installation of the depleted uranium into the product or device;
(B) label or mark each unit to:
(i) identify the manufacturer of the product or device
and the number of the license under which the product or device was
manufactured, the fact that the product or device contains depleted
uranium, and the quantity of depleted uranium in each product or device;
and
(ii) state that the receipt, possession, use, and commercial
distribution of the product or device are subject to a general license
or the equivalent and the requirements of the NRC or of an agreement
state;
(C) assure that before being installed in each product
or device, the depleted uranium has been impressed with the following
legend clearly legible through any plating or other covering: "Depleted
Uranium";
(D) furnish a copy of the following:
(i) the general license in §289.251(f)(3)(D) of
this title to each person to whom the licensee commercially distributes
depleted uranium in a product or device for use in accordance with
the general license in §289.251(f)(3)(D) of this title;
(ii) the NRC's or agreement state's requirements equivalent
to the general license in §289.251(f)(3)(D) of this title and
a copy of the NRC's or agreement state's certificate; or
(iii) alternately, a copy of the general license in §289.251(f)(3)(D)
of this title to each person to whom the licensee commercially distributes
depleted uranium in a product or device for use in accordance with
the general license of the NRC or an agreement state;
(E) report to the department all commercial distributions
of products or devices to persons for use in accordance with the general
license in §289.251(f)(3)(D) of this title.
(i) The report shall be submitted within 30 days after
the end of each calendar quarter in which such a product or device
is commercially distributed to the generally licensed person and shall
include the following:
(I) identity of each general licensee by name and address;
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