10 C.F.R. § 35.63 Determination of dosages of unsealed byproduct material for medical use.
Title 10 - Energy
(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. (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 a manufacturer or preparer licensed under §32.72 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.
Title 10: Energy
PART 35—MEDICAL USE OF BYPRODUCT MATERIAL
Subpart C—General Technical Requirements
§ 35.63 Determination of dosages of unsealed byproduct material for medical use.
