Site Map

Expiration Dating of Unit Dose Repackaged Drugs

by Uriah
(Dallas)

Use the 1/4 method to determine the expiration date of a medication repackaged on: March 10, 2013. The stock bottle expiration date is 3/2016.

Please show steps to solve.

Comments for Expiration Dating of Unit Dose Repackaged Drugs

Click here to add your comments

What the federal law requires.
by: Anonymous

In this particular situation, the 1/4 method would not be compliant. For those reading this asking what the 1/4 method is, it refers to the old FDA law for repackaging that says to cut the expiration date for repackaged dosages to 25 percent of their remaining expiration. In this case, that would be 36 months, divided by 4, which would be 9 months.

When the law was revised a few years ago, they changed to to either 25 percent of the remaining expiration time -or- 6 months, whichever is less.

So, in this case it's 6 months = 9/13

The law is on the FDA website: (Copy and paste)

http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm074409.htm
Expiration Dates for Unit Dose Packs
by: Anonymous

Typically, the date you would put is one year from the day you pack that drug. But, that doesn't mean that it's still good. It has to have some kind of date. And, of course we cant just make one up. If the drug is still good up to 3 years after that it will still work. Maybe not as strong or maybe stronger? Or, depending on the med... it may not work at all... hope this helps

Click here to add your comments

Join in and ASK your Questions! It's easy to do. How? Simply click here to return to Pharmacy Tech Questions.