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 1178 (Good Repackaging Practices) suggests that the beyond-use dates for repackaged drugs should be the manufacturer's expiration date from the original container or 6 months from the repackaging date, whichever is earlier.



Summary

The contents of the original bulk drug product to be repackaged are repackaged at one time unless the repackager has data and/or other scientific information from literature sources demonstrating that the drug product is not sensitive to exposure to moisture, oxygen, or light.
  • The unit-dose container–closure system must meet or exceed the original container's specification for light resistance.



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