Medical Uses of Radioactive Materials
The NRC regulates the medical use of by-product materials by enforcing
10CFR35; similar regulations are implemented by the states for naturally
occurring and accelerator-produced radionuclides. However, the Agree-
ment States regulate both categories of radionuclides. The revised 10CFR35
has been in effect as of October 24, 2002 when all NRC-regulated states
were required to adopt all new regulations. However, the Agreement
States have been given a three-year grace period (October, 2005) to
adopt these regulations, after which time 10CFR35 will be effective for
medical use of by-product material equally for all states in the United
States.
There are six categories of medical uses of radioactive materials accord-
ing to 10CFR Part 35. They are: (1) radiopharmaceuticals for uptake, dilu-
tion, and excretion (10CFR35.100); (2) radiopharmaceuticals for imaging
and localization including generators and kits (10CFR35.200); (3) ra-
diopharmaceuticals for therapy (10CFR35.300); (4) sealed sources for
brachytherapy (10CFR35.400); (5) sealed sources for diagnosis such as
sources of^125 I and^153 Gd for bone mineral analysis (10CFR35.500); and (6)
sealed sources for teletherapy such as sources of^60 Co and^137 Cs in telether-
apy units or gamma stereotactic radiosurgery units (10CFR35.600).
The regulations for the medical use of all radioactive materials are given
in 10CFR35, but radiopharmaceuticals under categories 1, 2, and 3 only
are relevant in nuclear medicine. These radiopharmaceuticals must be
approved for human clinical use by the FDA under an IND or NDA. The
99mTc activity is eluted from the (^99) Mo-99mTc generator and reagent kits are
used to prepare 99mTc-labeled radiopharmaceuticals according to instruc-
tions given by the manufacturer in the package inserts. Only reagent kits
that are approved by the FDA under an IND or NDA may be used for
radiopharmaceutical preparation.
Applications, Amendments, and Notifications
As already mentioned, applications for a license and its renewals must be
made by the licensee’s management for the medical uses of by-product
materials. Amendments to the license must be made by the licensee’s man-
agement for the following:
(a) Appointment or discontinuation of an authorized user, radiation safety
officer, authorized medical physicist, or authorized nuclear pharmacist
(b) Change of name or address of the licensee
(c) Change or addition of the use areas
(d) Use of excess or new by-product materials not permitted before in the
license
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