Link to an amendment published at 83 FR 33104, July 16, 2018.

1. (a) For any administration requiring a written directive, the licensee shall develop, implement, and maintain written procedures to provide high confidence that:

   1. (1) The patient's or human research subject's identity is verified before each administration; and
   2. (2) Each administration is in accordance with the written directive.

2. (b) At a minimum, the procedures required by paragraph (a) of this section must address the following items that are applicable to the licensee's use of byproduct material -

   1. (1) Verifying the identity of the patient or human research subject;
   2. (2) Verifying that the administration is in accordance with the treatment plan, if applicable, and the written directive;
   3. (3) Checking both manual and computer-generated dose calculations; and
   4. (4) Verifying that any computer-generated dose calculations are correctly transferred into the consoles of therapeutic medical units authorized by §§ 35.600 or 35.1000.
3. (c) A licensee shall retain a copy of the procedures required under paragraph (a) in accordance with § 35.2041.

[67 FR 20370, Apr. 24, 2002, as amended at 72 FR 45151, Aug. 13, 2007]