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:
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:
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Food and Drug Administration (FDA) issued draft guidance on expiration dating of unit-dose repackaged drugs.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
These USP chapters contain information on beyond-use or expiration dating of repackaged medications, labeling, storage, reprocessing, and more.