§ 35.25 - Supervision.  


Latest version.
  • (a) A licensee that permits the receipt, possession, use, or transfer of byproduct material by an individual under the supervision of an authorized user as allowed by § 35.11(b) of this part shall:

    (1) Instruct the supervised individual in the principles of radiation safety appropriate to that individual's use of byproduct material and in the licensee's written quality management program;

    (2) Require the supervised individual to follow the instructions of the supervising authorized user, follow the written radiation safety and quality management procedures established by the licensee, and comply with the regulations of this chapter and the license conditions with respect to the use of byproduct material; and

    (3) Periodically review the supervised individual's use of byproduct material and the records kept to reflect this use.

    (b) A licensee that permits the preparation of byproduct material for medical use by an individual under the supervision of an authorized nuclear pharmacist or physician who is an authorized user, as allowed by § 35.11(c), shall:

    (1) Instruct the supervised individual in the preparation of byproduct material for medical use and the principles of and procedures for radiation safety and in the licensee's written quality management program, as appropriate to that individual's use of byproduct material;

    (2) Require the supervised individual to follow the instructions given pursuant to paragraph (b)(1) of this section and to comply with the regulations of this chapter and license conditions; and

    (3) Require the supervising authorized nuclear pharmacist or physician who is an authorized user to periodically review the work of the supervised individual as it pertains to preparing byproduct material for medical use and the records kept to reflect that work.

    (c) A licensee that supervises an individual is responsible for the acts and omissions of the supervised individual.