Repackaging of Medications from Other Pharmacies

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Nursing facilities have sometimes requested their LTC pharmacy to repackage medications obtained from a community or mail-order pharmacy in conventional bottle and vial packaging. The facility hopes to obtain the special packaging they need while allowing the resident to obtain medications through their pharmacy benefit plan. Although the goal is understandable, this strategy is not necessarily a suitable answer to the problem.

In 1998, the American Society of Consultant Pharmacists asked legal counsel to provide an opinion on the legality of a pharmacy repackaging medications dispensed by another pharmacy.  In summary, the following problems are presented when a pharmacy is asked to repackage medications from another pharmacy:

  • This practice may be inappropriate under the Food and Drug Administration’s Compliance Policy Guide (CPG 7132b.10), especially since community pharmacies rarely provide lot numbers and manufacturer expiration dates on labels of their dispensed prescriptions
  • The pharmacy that repackages increases its risk of liability because it assumes responsibility for the medications dispensed by the original pharmacy
  • This practice may also violate state laws

For these reasons, pharmacies are generally advised not to repackage medications dispensed by another pharmacy unless certain provisions are in place to protect the integrity of the product and communicate lot and expiration information.   However, some state mandate that long-term care pharmacies repackage medications under certain circumstances. 

Examples of states that allow/mandate repackaging (not an exhaustive list):

Examples of states that do not allow repackaging (not an exhaustive list):

ASCP Comment Letters to States Opposing Mandated Repackaging:

Pharmacies Repackaging Bulk Medications into Unit-Dose

FDA Guidance on Repackaging Medications from Bulk Into Unit-Dose

Food and Drug Administration (FDA) issued draft guidance on expiration dating of unit-dose repackaged drugs. The guidance would revise FDA's enforcement policy regarding expiration dating of nonsterile, unit-dose repackaged drugs by using a standard similar to the U.S. Pharmacopeia (USP) standard that calls for the beyond use date to be one year from the date the drug is packaged into the unit-dose container or the expiration date on the manufacturer’s container, whichever is earlier, unless stability data or the original manufacturer’s product labeling indicates otherwise. Additionally, the repackaged drug must be in solid dosage form and comply with the Class A standard of USP; the original bulk container of drug product has not been opened previously and the contents are repackaged in one operation; and the repackaging and storage of the drug are done in a controlled environment consistent with instructions on the label. View the guidance here (PDF).  

USP Standards on Repackaging

  • USP standards are available in the USP/NF publication, which is accessible only to subscribers.
  • Within the USP/NF, Chapters 681 and 1146 are the most applicable to pharmacies that are repackaging medications:
    • <681>  REPACKAGING INTO SINGLE-UNIT CONTAINERS AND UNIT-DOSE CONTAINERS FOR NONSTERILE SOLID AND LIQUID DOSAGE FORMS
    • <1146>  PACKAGING PRACTICE—REPACKAGING A SINGLE SOLID ORAL DRUG PRODUCT INTO A UNIT-DOSE CONTAINER

These USP chapters contain information on beyond-use or expiration dating of repackaged medications, labeling, storage, reprocessing, and more.

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