| (E) details of quality control procedures to assure
that production sources and devices meet the standards of the design
and prototype tests;
(F) procedures and standards for calibrating sealed
sources and devices;
(G) instructions for handling and storing the sealed
source or device from the radiation safety standpoint. These instructions
are to be included on a durable label attached to the sealed source
or device or attached to a permanent storage container for the sealed
source or device, provided that instructions that are too lengthy
for the label may be summarized on the label and printed in detail
on a brochure that is referenced on the label; and
(H) a legend and methods for labeling sources and devices
as to their radioactive content;
(2) documentation that the label affixed to the sealed
source or device, or to the permanent storage container for the sealed
source or device, contains information on the radionuclide, quantity,
and date of assay, and a statement that the name of the sealed source
or device is licensed by the department for commercial distribution
to persons licensed for use of sealed sources in the healing arts
or by equivalent licenses of the NRC or any agreement state;
(3) documentation that in the event the applicant desires
that the sealed source or device be required to be tested for radioactive
material leakage at intervals longer than 6 months, the applicant
shall include in the application sufficient information to demonstrate
that the longer interval is justified by performance characteristics
of the sealed source or device or similar sources or devices and by
design features that have a significant bearing on the probability
or consequences of radioactive material leakage from the sealed source;
(4) documentation that in determining the acceptable
interval for testing radioactive material leakage, information will
be considered that includes the following:
(A) primary containment (sealed source capsule);
(B) protection of primary containment;
(C) method of sealing containment;
(D) containment construction materials;
(E) form of contained radioactive material;
(F) maximum temperature withstood during prototype
tests;
(G) maximum pressure withstood during prototype tests;
(H) maximum quantity of contained radioactive material;
(I) radiotoxicity of contained radioactive material;
and
(J) operating experience with identical sealed sources
or devices or similarly designed and constructed sealed sources or
devices; and
(5) the source or device has been registered in the
Sealed Source and Device Registry.
(p) Specific licenses for the manufacture and commercial
distribution of radioactive material for certain in vitro clinical or laboratory testing
in accordance with the general license. In addition to the requirements
in subsection (e) of this section, a specific license to manufacture
or commercially distribute radioactive material for use in accordance
with the general license in §289.251(f)(4)(G) of this title will
be issued if the department approves the following information submitted
by the applicant:
(1) documentation that the radioactive material will
be prepared for distribution in prepackaged units of:
(A) iodine-125 in units not exceeding 10 µCi
(0.37 megabecquerel (MBq)) each;
(B) iodine-131 in units not exceeding 10 µCi
(0.37 MBq) each;
(C) carbon-14 in units not exceeding 10 µCi (0.37
MBq) each;
(D) hydrogen-3 (tritium) in units not exceeding 50 µCi
(1.85 MBq) each;
(E) iron-59 in units not exceeding 20 µCi (0.74
MBq) each;
(F) cobalt-57 in units not exceeding 10 µCi (0.37
MBq) each;
(G) selenium-75 in units not exceeding 10 µCi
(0.37 MBq) each; or
(H) mock iodine-125 in units not exceeding 0.05 µCi
(1.85 kBq) of iodine-129 and 0.005 µCi (0.185 kBq) of americium-241
each;
(2) evidence that each prepackaged unit will bear a
durable, clearly visible label:
(A) identifying the radioactive contents as to chemical
form and radionuclide, and indicating that the amount of radioactivity
does not exceed 10 µCi (0.37 MBq) of iodine-125, iodine-131,
carbon-14, cobalt-57, or selenium-75; 50 µCi (1.85 MBq) of hydrogen-3
(tritium); 20 µCi (0.74 MBq) of iron-59; or mock iodine-125
in units not exceeding 0.05 µCi (1.85 kBq) of iodine-129 and
0.005 µCi (0.185 kBq) of americium-241; and
(B) displaying the radiation caution symbol in accordance
with §289.202(z) of this title and the words, "CAUTION, RADIOACTIVE
MATERIAL," and "Not for Internal or External Use in Humans or Animals";
(3) that one of the following statements, as appropriate,
or a substantially similar statement appears on a label affixed to
each prepackaged unit or appears in a leaflet or brochure that accompanies
the package:
(A) option 1:
Attached Graphic
(B) option 2:
Attached Graphic
(4) that the label affixed to the unit, or the leaflet
or brochure that accompanies the package, contains adequate information
as to the precautions to be observed in handling and storing the radioactive
material. In the case of a mock iodine-125 reference or calibration
source, the information accompanying the source shall also contain
directions to the licensee regarding the waste disposal requirements
of §289.202(ff) of this title.
(q) Specific licenses for the manufacture and commercial
distribution of ice detection devices. In addition to the requirements
of subsection (e) of this section, a specific license to manufacture
and commercially distribute ice detection devices to persons generally
licensed in accordance with §289.251(f)(4)(E) of this title will
be issued if the department approves the information submitted by
the applicant. This information shall satisfy the requirements of
Title 10, CFR, §§32.61 and 32.62.
(r) Specific licenses for the manufacture, preparation,
or transfer for commercial distribution of radioactive drugs containing
radioactive materials for medical use under §289.256 of this
title.
(1) In addition to the requirements in subsection (e)
of this section, a specific license to manufacture, prepare, or transfer
for commercial distribution, radioactive drugs containing radioactive
material for use by persons authorized in accordance with §289.256
of this title will be issued if the department approves the following
information submitted by the applicant:
(A) evidence that the applicant is at least one of
the following:
(i) registered with the United States Food and Drug
Administration (FDA) as the owner or operator of a drug establishment
that engages in the manufacture, preparation, propagation, compounding,
or processing of a drug in accordance with Title 21, CFR, §207.17;
(ii) registered or licensed with a state agency as
a drug manufacturer;
(iii) licensed as a pharmacy by the Texas State Board
of Pharmacy;
(iv) operating as a nuclear pharmacy within a federal
medical institution; or
(v) a positron emission tomography (PET) drug production
facility registered with a state agency;
(B) radionuclide data relating to the following:
(i) chemical and physical form;
(ii) maximum activity per vial, syringe, generator,
or other container of the radioactive drug; and
(iii) shielding provided by the packaging to show it
is appropriate for the safe handling and storage of the radioactive
drugs by medical use licensees;
(C) labeling requirements including the following:
(i) that 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 shall include the
following:
(I) the radiation symbol and the words "CAUTION, RADIOACTIVE
MATERIAL" or "DANGER, RADIOACTIVE MATERIAL;"
(II) the name of the radioactive drug or its abbreviation;
and
(III) the quantity of radioactivity at a specified
date and time (the time may be omitted for radioactive drugs with
a half-life greater than 100 days); and
(ii) that each syringe, vial, or other container used
to hold a radioactive drug to be transferred for commercial distribution
shall include the following:
(I) radiation symbol and the words, "CAUTION, RADIOACTIVE
MATERIAL" or "DANGER, RADIOACTIVE MATERIAL;" and
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