What is the general rule for beyond-use dating on repackaged medications?

What is the general rule for beyond-use dating on repackaged medications?

• A. Should be 1 year.
• B. Should be 25% of the remaining manufacturer's expiration whichever comes first.
• C. Should be 6 months or 25% of the remaining manufacturer's expiration whichever comes first unless otherwise indicated by the manufacturer.
• D. Should be 3 months after repackaging.

Answer: (C)

When medications are repackaged into another container, a new beyond-use date must be assigned to reflect stability after handling. The general rule is that this date is the earlier of six months or 25% of the remaining time on the original manufacturer’s expiration, unless the manufacturer specifies a different BUD for that repackaged product. For example, if the product has 18 months left before expiration, 25% is 4.5 months, so the BUD is 4.5 months. If there are 9 months left, 25% is 2.25 months, so the BUD is 2.25 months. If the original expiration is very soon (e.g., 4 months left), 25% is 1 month, so the BUD is 1 month. If the manufacturer provides a different BUD for repackaged forms, you follow that. This approach helps ensure potency and safety after repackaging.

When medications are repackaged into another container, a new beyond-use date must be assigned to reflect stability after handling. The general rule is that this date is the earlier of six months or 25% of the remaining time on the original manufacturer’s expiration, unless the manufacturer specifies a different BUD for that repackaged product.

For example, if the product has 18 months left before expiration, 25% is 4.5 months, so the BUD is 4.5 months. If there are 9 months left, 25% is 2.25 months, so the BUD is 2.25 months. If the original expiration is very soon (e.g., 4 months left), 25% is 1 month, so the BUD is 1 month. If the manufacturer provides a different BUD for repackaged forms, you follow that. This approach helps ensure potency and safety after repackaging.