Minnesota Administrative Rules

6800.8700 RECORD KEEPING.

A pharmacist handling radiopharmaceuticals shall maintain records of acquisition and disposition of radiopharmaceuticals for at least two years.

In the case of investigational radiopharmaceuticals, the pharmacy records shall include an investigators protocol for the preparation of radiopharmaceuticals, a copy of the Human Use Committee approval, a copy of the approved patient consent form, and a letter from the "manufacturer-sponsor" indicating that the physician requesting the radiopharmaceutical is a qualified investigator.

Additional records shall be maintained as required by statute or rule of any other state or federal agency.

Statutory Authority:

MS s 151.06

History:

18 SR 1145

Published Electronically:

September 21, 2011