NAC639.67057. Procedures following breach of seal of single-dose and multi-dose containers.

     1. If, in the course of compounding a drug product, the seal of a single-dose container, including, without limitation, a bag, bottle, syringe or vial of a sterile drug product, is breached, the time and date of the breach must be marked upon the container and the contents of the container may be used:

     (a) Within 1 hour after the breach of the seal if:

          (1) The breach occurred in an environment with an air quality that is worse than ISO Class 5; and

          (2) The container is subsequently stored in an environment with an air quality that is worse than ISO Class 7;

     (b) Within 6 hours after the breach of the seal if:

          (1) The breach of the seal occurred and the contents of the container were used in an environment with an air quality that satisfies or exceeds ISO Class 5; and

          (2) The container is subsequently stored in an environment with an air quality that satisfies or exceeds ISO Class 7; or

     (c) Within 24 hours after the breach of the seal if the breach occurred in an environment with an air quality that satisfies or exceeds ISO Class 5 and the container remains in an environment with an air quality that satisfies or exceeds ISO Class 5.

     2. If, in the course of compounding a drug product, the seal of a multi-dose container is breached:

     (a) The container must be stored according to the requirements of the manufacturer; and

     (b) The contents of the container may be used within 28 days after the breach of the seal occurred.

     3. Any drug product that is not used within the periods set forth in subsection 1 or 2 may not be used and must be destroyed.

     4. If the seal of a single-use ampule is breached or the entire seal has been removed from a multi-use vial and the contents are not used at the time of the breach, the contents may not be used and must be destroyed.

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