Medications Repackaging

Introduction

A unit-dose medication distribution system uses medications packaged in unit-dose or single-unit packages.

  • A single-unit package contains one dosage form of medication (e.g., one capsule, one 5 ml volume of liquid, etc.).
  • A unit-dose package contains the dose of a medication ordered for a patient (e.g. two 250 mg tablets for a 500 mg dose).

However, not all medications are available from the manufacturer in single-unit or unit-dose packages. Hence, pharmacies sometimes have to purchase medications in bulk containers and repackage them in unit-dose or single-unit packages.



Important Elements

Department's policy and procedures for repackaging should clearly outlines the following elements.

  • Space or facility requirements
    • Clean with adequate lighting and ventilation, as well as temperature and humidity controls
    • Food and beverages must not be allowed in the repackaging area.
  • Labelling format
    • Generic name of medication
    • Name of manufacturer or distributor
    • Dosage form, including special designations (e.g. extended release)
    • Route of administration if other than oral, e.g. topical use
    • Strength
    • Special notes (e.g. refrigerate, shake well, do not chew)
    • Beyond-use dates
    • Facility's control or LOT number
  • Assignment of beyond-use dates (BUDs)
  • Personal protective equipment (PPE)
  • Setup, operation and cleaning of equipment
  • Required records, including
    • Documentation of orientation and competence of personnel
    • All activities related to the maintenance, cleaning, inspection and calibration of equipment
    • Records of all activities related to the repackaging operation
  • Quality assurance, e.g.
    • Repackage only one medication at a time
    • Prepare only the number of labels that will be needed for the repackaging run. Do not prepare extra labels.
    • Inspect the medication colour, odour, appearance and markings before repacking
    • Verify that labels are correct
    • Store finished packages at appropriate conditions of light, temperature and humidity
    • A sample of the completed product should be kept until the medication expires and should be examined periodically for signs of deterioration
  • Selection of repackaging containers and other materials

NOTE: Misinterpretation of information on labels can result in medication errors.



Beyond-Use Dates

Factors to consider when determining the BUD placed on each repackaged medication include

  • Data available in the current literature
  • Nature of the medication
  • Characteristics of the package
  • Storage conditions of the medication
  • State laws and regulations

In the absence of stability data for the drug product in the repackaged container, USP General Chapter 1146 (Packaging Practice: Repackaging a Single Solid Oral Drug Product into a Unit-dose Container) suggests the beyond-use dating period of 1 year or the time remaining until the expiration date, whichever is shorter.



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