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Occasional Collector
Posts: 1
Registered: ‎03-19-2017
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Expiration dating on opened bottles of oral liquids

I saw a previous response that TJC allows facilities to have their own SOP, or you can use the manufacturer's guidelines or dating.  There was also a comment that the USP has its own guidelines.  Where in USP is the guideline?  I have found dating pertaining to the BUD of unit dosed oral liquids, and BUD of MDV of injectibles, but not bulk bottles of oral liquids specifically.  Any help?

 

Thank you

Established Member
Posts: 2
Registered: ‎04-01-2015
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Re: Expiration dating on opened bottles of oral liquids

Our facility is interested in the answer to this question as well.  Some bulk liquid products do specify a date after opening, but not all do.

 

Visitor
Posts: 3
Registered: ‎05-30-2017
0

Re: Expiration dating on opened bottles of oral liquids

Our facility is very interested in this as well.  There is a similar thread here: http://forums.pharmacyonesource.com/t5/Pharmacy-Practice/USP-795-Batching-amp-Beyond-Use/td-p/3925

Expert
Posts: 1,152
Registered: ‎02-23-2010
0

Re: Expiration dating on opened bottles of oral liquids

The assigned BUD can be one-year.  Obviously, if the manufacturer's expiration of the medication is earlier, the shorter of the two dates must be used.  USP <795> BUDs are assigned to compounded nonsterile preparations.  Aqueous solutions are ones with water (distilled water or better).  Hope this helps.  

Eric S. Kastango, MBA, RPh, FASHP

It's all about the patient.
Regular Visitor
Posts: 1
Registered: ‎12-29-2016
0

Re: Expiration dating on opened bottles of oral liquids

I apologize if my question is redundant, I just want to make sure i'm understanding this correctly. If I open a bulk bottle of, let's say Zyrtec liquid, and then use that bottle to draw up a few doses but don't empty the bottle completely, what is the BUD for the bulk bottle once opened? We have always instructed our staff to use a BUD of 1 year from the date packaged (or sooner depending on the original mfr expiration), but we've never had any guidelines regarding the original bulk bottle unless otherwise stated from the manufacturer (i.e. Trileptal is only good for 7 months once opened).

 

Any clarification would be appreciated.

 

Thank you!

-erin