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ASHP Technical Assistance Bulletin on Repackaging Oral Solids and Liquids in Single Unit and Unit Dose Packages
To maximize the benefits of a unit dose drug distribution system, all drugs must be packaged in single unit or unit dose packages.a However, not all drugs are commercially available in single unit (or unit dose) packages. Therefore, the institutional pharmacist must often repackage drugs obtained in bulk containers (e.g., bottles of 500 tablets) into single unit packages so that they may be used in a unit dose system.
Certain precautions must be taken if the quality of drugs repackaged by the pharmacist is to be maintained. The guidelines presented herein will assist the pharmacist in developing procedures for repackaging drugs in a safe and acceptable manner:
- The packaging operation should be isolated, to the extent possible, from other pharmacy activities.
- Only one drug product at a time should be repackaged in a specific work area. No drug products other than the one being repackaged should be present in the immediate packaging area. Also, no labels other than those for the product being repackaged should be present in the area.
- Upon completion of the packaging run, all unused stocks of drugs and all finished packages should be removed from the packaging area. The packaging machinery and related equipment should then be completely emptied, cleaned, and inspected before commencing the next packaging operation.
- All unused labels (if separate labels are used) should be removed from the immediate packaging area. The operator should verify that none remains in the packaging machine(s). If labels are prepared as part of the packaging operation, the label plate (or analogous part of the printing apparatus) should be removed or adjusted to “blank” upon completion of the run. This will help assure that the correct label is printed during any subsequent run. There should be a procedure to reconcile the number of packages produced with the number of labels used (if any) and destroyed (if any) and the number of units or volume of drug set forth to be packaged.
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