Section 15.05. Records and reports.

 

(1)  Specific records and reports shall be maintained describing the preparation of sterile pharmaceuticals in the pharmacy. These records and reports shall include:

(a) Training and competency evaluations of personnel.

(b) Documentation of refrigerator and freezer temperatures.

(c) Certification of laminar airflow hoods.

(2)  The following minimum labeling requirements shall be met for sterile pharmaceuticals prepared for a single patient if the pharmaceuticals are to be completely administered within 28 hours:

(a) The identity of all solutions and ingredients and their corresponding amounts, concentration or volumes on the final preparation container in such a manner as to allow the locating of problematic final products.

(b) The identity of personnel involved in preparation.

(c) The date and time of pharmacy preparation where applicable.

(d) The final sterile pharmaceuticals expiration date and storage requirements, where applicable.

History: Cr. Register, March, 2000, No. 531 , eff. 4-1-00.