NAC639.67073. Immediate-use sterile compounding: Preparation and labeling.

     1. A sterile compounded drug product is an immediate-use sterile compounded drug product if:

     (a) The compounded drug product is intended only for the purpose of emergency care or immediate care of a patient;

     (b) The compounding of the drug product occurs in an environment other than an ISO Class 5 environment and the compounding process consists of simple aseptic measuring and transfer manipulations performed with not more than six sterile nonhazardous commercial drug products and diagnostic radiopharmaceutical drug products, excluding infusion solutions or diluents;

     (c) The preparation procedure occurs continuously without delays or interruptions and does not exceed 1 hour unless a period longer than 1 hour is required for the reconstitution of the compounded drug product;

     (d) During compounding and before the administration of the compounded drug product, no part of the drug product or critical surfaces and ingredients of the drug product is directly exposed to contact contamination, including, without limitation, human touch, cosmetic flakes or particulates, blood or other bodily substances of a person or nonsterile inanimate sources; and

     (e) Except as otherwise provided in paragraph (c), the administration of the compounded drug product begins not later than 1 hour after the start of the preparation of the compounded drug product and the compounded drug product is fully administered as soon as practicable but not longer than 24 hours after the administration of the compounded drug product began or the compounded drug product is disposed of promptly and safely.

     2. If an immediate-use sterile compounded drug product is not immediately administered by direct injection into a patient by the person who compounded it, the compounded drug product must bear a label which includes, without limitation:

     (a) The name and, if the patient has an identification number, the identification number of the patient;

     (b) The name and amount of each ingredient of the compounded drug product;

     (c) The initials of the person who compounded the compounded drug product; and

     (d) The exact date and time of expiration of the compounded drug product.

     3. An immediate-use sterile compounded drug product must not be stored for later use.

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