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Re: Drug Storage/Expiration--ANSWER FROM FDA

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Hey folks,

I received an answer from the FDA regarding this issue. Review the

attached text from an email that I received. Hopefully this will

clear up any confusion. Thanks!!

D. Stone

--------------------------------------------------------------------

Thank you for your message to the Center for Drug Evaluation and

Research (CDER), one of the five centers within the Food and Drug

Administration (FDA).

After checking there are no regulations that cite the specific

information you are requesting.

However, when the expiration date on a label states only the month and

year it means that the product will have the identity, strength,

quality and purity it purports or represents to posses through the

last day of the specified month.

Provisions regarding expiration dating on drug labeling can be found

in 21 CFR 201.17 and 21 CFR 211.137. You can review these

regulations at

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm

Sincerely,

Division of Drug Information

D202D

This communication is consistent with 21 CFR 10.85 (k) and constitutes

an informal communication that represents our best judgment at this

time but does not constitute an advisory opinion, does not necessarily

represent the formal position of FDA, and does not bind or otherwise

obligate or commit the agency to the views expressed.

> >

> > According to my DSHS regional field reps if it expires on 03/09

> that is the

> > first day of March. Only differs when an exact specific date is

on

> the drug.

> > example 3/31/09.

> >

> > Andy

> > **************Get a jump start on your taxes. Find a tax

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> 26+Filing&ncid=emlcntusyelp00000004)

> >

> >

> >

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