NAC639.476. Prepackaging of drugs.  


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  •      1. A pharmacy may prepackage drugs in quantities suitable for distribution within the facility or institution. The prepackaging may be performed only by a pharmacist or a pharmaceutical technician.

         2. The label of a prepackaged unit must include:

         (a) The generic or trade name of the drug, its strength and the dosage form;

         (b) The lot number;

         (c) The expiration date of the drug; and

         (d) The quantity of the drug if the unit dose does not equal the unit of use.

         3. A record of a prepackaged drug must be maintained that includes:

         (a) The generic or trade name of the drug, its strength and the dosage form;

         (b) The pharmacy’s lot number;

         (c) The name of the manufacturer;

         (d) The manufacturer’s lot number;

         (e) The manufacturer’s expiration date for the drug;

         (f) The quantity per package, if more than one tablet or capsule is in a unit dose package;

         (g) The number of packages;

         (h) The date it was packaged and the assigned expiration date; and

         (i) The initials of the responsible pharmacist.

         4. Stock packages, prepackaged units and control records must be inspected by the pharmacist before the drugs may be included in regular stock.

     (Added to NAC by Bd. of Pharmacy, eff. 3-27-90; A 9-12-91; 11-15-93)