What is the maximum beyond use date for blister packs, prescription vials, and unit doses?

The maximum beyond use date for blister packs, prescription vials, and unit doses is defined as one year from the date of packaging or the manufacturer's expiration date, whichever is sooner. This guideline is crucial because it ensures the medication remains effective and safe for use up to the specified time frame.

The rationale behind limiting the beyond use date is to account for the stability of the drug after it has been repackaged. Different dosage forms and packaging methods may affect the drug's stability, and adhering to this guideline provides a safeguard for patients. For instance, if a product has a manufacturer's expiration date of six months from the date of packaging and is repackaged into unit doses, the beyond use date must be set to six months, as it is the more limiting factor.

This standard reflects an understanding of pharmaceutical stability and the importance of ensuring that medications are used within their safe and effective time periods. It helps in preventing the dispensing of outdated or potentially ineffective medications, thereby protecting patient safety.