Section 335.2030  Assay of Radiopharmaceutical Dosages

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 of this Part or equivalent U.S. Nuclear Regulatory Commission, Agreement State or Licensing State requirements; or

B)        An Agency, U.S. Nuclear Regulatory Commission, Agreement State or Licensing 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.

c)         For other than unit dosages, this determination shall be made by:

1)         Direct measurement of radioactivity by the licensee;

2)         Combination of measurement of radioactivity and mathematical calculations; or

3)         Combination of volumetric measurements and mathematical calculations, based on the measurement made by a manufacturer or preparer licensed under Section 335.30 of this Part or equivalent U.S. Nuclear Regulatory Commission, Agreement State or Licensing 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.

(Source:  Amended at 30 Ill. Reg. 9029, effective April 28, 2006)