Section 657.8.7. Procurement, storage, and recall of drugs and devices.

       8.7(1) Source. Procurement of prescription drugs and devices shall be from a drug wholesaler licensed by the board to distribute to Iowa pharmacies or, on a limited basis, from another licensed pharmacy or licensed practitioner located in the United States.

       8.7(2) Sufficient stock. A pharmacy shall maintain sufficient stock of drugs and devices to fulfill the foreseeable needs of the patients served by the pharmacy.

       8.7(3) Manner of storage. Drugs and devices shall be stored in a manner to protect their identity and integrity.

       8.7(4) Storage temperatures. All drugs and devices shall be stored at the proper temperature, as defined by the following terms:

        a.           “Controlled room temperature” means temperature maintained thermostatically between 15 degrees and 30 degrees Celsius (59 degrees and 86 degrees Fahrenheit);

        b.          “Cool” means temperature between 8 degrees and 15 degrees Celsius (46 degrees and 59 degrees Fahrenheit). Drugs and devices may be stored in a refrigerator unless otherwise specified on the labeling;

        c.           “Refrigerate” means temperature maintained thermostatically between 2 degrees and 8 degrees Celsius (36 degrees and 46 degrees Fahrenheit); and

        d.           “Freeze” means temperature maintained thermostatically between -20 degrees and -10 degrees Celsius (-4 degrees and 14 degrees Fahrenheit).

       8.7(5) Product recall. There shall be a system for removing from use, including unit dose, any drugs and devices subjected to a product recall.