Current through Register Vol. 48, No. 12, March 22, 2024
a) A licensee shall determine and record the
activity of each dosage before medical use.
b) For a unit dosage, this determination
shall be made by:
1) Direct measurement of
radioactivity by the licensee; or
2) For radiopharmaceuticals with a photon
emitting radionuclide not requiring a written directive, a decay correction
based on the activity or activity concentration determined by:
A) A manufacturer or preparer authorized
under Section
335.30 or
equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements;
or
B) An Agency, U.S. Nuclear
Regulatory Commission or Agreement State licensee for use in research in
accordance with a Radioactive Drug Research Committee-approved protocol or an
Investigational New Drug (IND) protocol accepted by FDA; or
C) A PET radioactive drug producer licensed
under 32 Ill. Adm. Code
330.260(c)(23)
or the equivalent regulations of the U.S.
Nuclear Regulatory Commission or an Agreement State.
c) For other than unit dosages,
this determination shall be made by:
1) Direct
measurement of radioactivity by the licensee;
2) A combination of measurement of
radioactivity and mathematical calculations; or
3) A combination of volumetric measurements
and mathematical calculations based on the measurement made by a manufacturer
or preparer licensed under Section
335.30 or
equivalent U.S. Nuclear Regulatory Commission or Agreement State
requirements.
d) Unless
otherwise directed by the authorized user, a licensee may not use a dosage if
the dosage does not fall within the prescribed dosage range or if the dosage
differs from the prescribed dosage by more than 20 percent.
e) A licensee shall maintain a record of
dosage determinations required by subsection (a) of this Section for 5
years.
f) The record shall contain:
1) The radiopharmaceutical;
2) The patient's or human research subject's
name, or identification number if one has been assigned;
3) The prescribed dosage, the determined
dosage, or a notation that the total activity is less than
1.1 MBq (30 mCi);
4) The date and time of the dosage
determination;
5) If more than 15
minutes have elapsed between the time of dosage determination and dosage
administration, the date and time of dosage administration; and
6) The name of the individual who determined
the dosage.
AGENCY NOTE: If a unit dose has been manipulated in any
way, it is no longer considered a unit dose and shall be measured by the
licensee before administration.
