NAC639.67061. Low-risk sterile compounding: Process and storage.

     1. A compounded drug product is a low-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 at a low risk of contamination; and

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

          (1) The compounding process involves aseptic manipulations that are performed entirely within an environment with an air quality of at least ISO Class 5 and uses only sterile ingredients, products, components and devices;

          (2) The compounding process involves only transferring, measuring and mixing manipulations and uses not 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;

          (3) The manipulations needed to compound the drug product are limited to aseptically opening ampules, penetrating sterile stoppers on vials with sterile needles and syringes, and transferring sterile liquids in sterile syringes to sterile administration devices, package containers or other sterile drug products and containers for storage and dispensing;

          (4) The final compounded drug product contains a volume of 15 milliliters or less of a radiopharmaceutical and has an expiration time of 18 hours or less per dosage unit, including, without limitation, a dosage unit of a radiopharmaceutical prepared from an eluate by using a molybdenum-99technetiym-99m generator; or

          (5) The final compounded drug product contains commercially manufactured cyclotron radiopharmaceuticals which contain preservatives and which have expiration times of 72 hours or less.

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

     (a) Forty-eight 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) Fourteen 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)