Possession, use, and calibration of instruments used to measure the activity of unsealed byproduct material.

(a) For direct measurements performed in accordance with § 35.63, a licensee shall possess and use instrumentation to measure the activity of unsealed byproduct material before it is administered to each patient or human research subject. (b) A licensee shall calibrate the instrumentation required in paragraph (a) of this section in accordance with nationally recognized standards or the manufacturer's instructions. (c) A licensee shall retain a record of each instrument calibration required by this section in accordance with § 35.2060.