NAC639.6703. Labeling.

     1. Each pharmacist engaged in the practice of compounding nonsterile compounded drug products shall label each nonsterile compounded drug product, including, without limitation, any amount of the nonsterile compounded drug product that is in excess of the amount required by the prescription or chart order and any nonsterile compounded drug product that is compounded in bulk quantities. The label must include, without limitation:

     (a) The name of the final compounded drug product or the name of each active ingredient present in the nonsterile compounded drug product and, as appropriate, the concentration of each active ingredient in the final compounded drug product;

     (b) The internal control number assigned to the compounded drug product by the pharmacist; and

     (c) The beyond-use date of the compounded drug product.

     2. Except as otherwise provided in subsection 3 or in the published data or data of the manufacturer, or as otherwise determined to be earlier in the judgment of the pharmacist, the latest beyond-use date of a nonsterile compounded drug product is:

     (a) For nonaqueous liquids and solid formations, not later than the expiration date of the active ingredient present in the nonsterile compounded drug product with the earliest expiration date or 6 months after the date on which the nonsterile compounded drug product was compounded, whichever is earlier;

     (b) For compounds which contain nonsterile water, not later than 14 days after the date on which the nonsterile compounded drug product was compounded; and

     (c) For compounds other than those listed in paragraph (a) or (b), not later than the intended duration of the therapy or 30 days after the date on which the nonsterile compounded drug product was compounded, whichever is earlier.

     3. Except as otherwise provided in subsection 7 of NRS 639.2801, a pharmacy may use a beyond-use date that is later than the dates described in subsection 2 if the pharmacy can prove by appropriate testing or published data that the nonsterile compounded drug product is safe and effective using the extended beyond-use date.

     4. Each pharmacist engaged in the practice of compounding nonsterile compounded drug products shall ensure that each nonsterile compounded drug product, including, without limitation, any amount of the nonsterile compounded drug product that is in excess of the amount required by the prescription or chart order, and any nonsterile compounded drug product that is compounded in bulk quantities is stored in the pharmacy in a manner that:

     (a) Maintains the efficacy of the nonsterile compounded drug product; and

     (b) Ensures that the nonsterile compounded drug product remains free from contamination.

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