NAC639.67065. Medium-risk sterile compounding: Process and storage.

     1. A compounded drug product is a medium-risk sterile compounded drug product if:

     (a) The compounded drug product is required to be sterile for its effective administration;

     (b) The sterile compounded drug product is compounded using aseptic techniques pursuant to one of the conditions listed in NAC 639.67061 as a condition for a low-risk sterile compounded drug product; and

     (c) One or more of the following conditions are present:

          (1) Individual or small doses of sterile drug products are combined or pooled to prepare the final compounded drug product that will be administered to multiple patients or to one patient multiple times;

          (2) The compounding process includes complex aseptic manipulations other than a single-volume transfer;

          (3) The compounding process uses more than three commercially manufactured sterile drug products or other entries of a sterile drug product into one container, including, without limitation, a bag or vial, to make the final compounded drug product;

          (4) The final compounded drug product does not contain broad-spectrum bacteriostatic substances and will be administered over a period which exceeds 24 hours; or

          (5) The compounding process requires an unusually long duration, as determined by the managing pharmacist, including, without limitation, the period required to complete dissolution or homogeneous mixing.

     2. Unless sterility testing or potency limitations allow for a different period, the period of storage before administration of a medium-risk sterile compounded drug product must not exceed:

     (a) Thirty hours at a controlled room temperature that is at least 20 degrees Celsius (68 degrees Fahrenheit) but not more than 25 degrees Celsius (77 degrees Fahrenheit);

     (b) Nine days at a temperature that is at least 2 degrees Celsius (36 degrees Fahrenheit) but not more than 8 degrees Celsius (46 degrees Fahrenheit); or

     (c) Forty-five days in a solid frozen state that is -10 degrees Celsius (14 degrees Fahrenheit) or colder.

     (Added to NAC by Bd. of Pharmacy by R035-06, eff. 9-18-2008)