CFR > Title 10 - Energy > CHAPTER I—NUCLEAR REGULATORY COMMISSION > PART 35—MEDICAL USE OF BYPRODUCT MATERIAL > SUBPART C—General Technical Requirements (§35.60 to §35.92) > 35.63—Determination of dosages of unsealed byproduct material for medical use.

35.63—Determination of dosages of unsealed byproduct material for medical use.

(a) A licensee shall determine and record the activity of each dosage before medical use.
(b) For a unit dosage, this determination must be made by—
(1) Direct measurement of radioactivity; or
(2) A decay correction, based on the activity or activity concentration determined by—
(i) A manufacturer or preparer licensed under § 32.72 of this chapter or equivalent Agreement State requirements; or
(ii) An NRC 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
(iii) A PET radioactive drug producer licensed under § 30.32(j) of this chapter or equivalent Agreement State requirements.
(c) For other than unit dosages, this determination must be made by—
(1) Direct measurement of radioactivity;
(2) Combination of measurement of radioactivity and mathematical calculations; or
(3) Combination of volumetric measurements and mathematical calculations, based on the measurement made by:
(i) A manufacturer or preparer licensed under § 32.72 of this chapter or equivalent Agreement State requirements; or
(ii) A PET radioactive drug producer licensed under § 30.32(j) of this chapter or equivalent 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 retain a record of the dosage determination required by this section in accordance with § 35.2063.

Code of Federal Regulations

[67 FR 20370, Apr. 24, 2002, as amended at 72 FR 55931, Oct. 1, 2007]