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Frequent Visitor
Posts: 1
Registered: ‎05-03-2011

USP 795 Batching & Beyond Use

Any information on how to address non sterile batching & beyond use products for liquid medications in oral syringes based on USP 795?

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

Re: USP 795 Batching & Beyond Use

[ Edited ]

Cynthia,

 

I am not sure what you are looking for from reading your question.  USP 795 was recently updated and there are specific requirements re: master formulation records and BUD.  I have attached a copy of the latest USP 795, which help you answer your questions. 

Eric S. Kastango, MBA, RPh, FASHP

It's all about the patient.
Visitor
Posts: 3
Registered: ‎05-30-2017
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Re: USP 795 Batching & Beyond Use

I think the original poster had the same question I have, which I've found multiple possible answers depending on interpretations.  Firstly, how do we determine if a liquid medication is "aqueous"?  Is this term referring to liquid or specifically a liquid with water content?  Do we need to determine if there is water content in a liquid preperation from the manufaturer to determine this?  Secondly, when repackaging a 150 ml newly opened bottle of non-sterile oral liquid medication into 15 x 10 ml oral syringes (non-sterile/non HD), what is the BUD to be assigned?  Obviously, if the manufacturer's EXP of the medication is earlier, that is it.  However, the general rule is unclear.  USP <795> seems to say non-aqueous formulations have a max BUD of 6 months, IF that's referring to repackaging an oral liquid into oral syringes.  USP General Notices and Requirements says, "For nonsterile solid and liquid dosage forms that are packaged in single-unit and unit-dose containers, the beyond-use date shall be one year from the date the drug is packaged."  I've seen some hosptials put a 1 year BUD on some repackaged oral syringes.  Could you please advise on this?

 

Scott Blackburn, PharmD, BS, BA

Pharmacy Intern

Expert
Posts: 1,152
Registered: ‎02-23-2010
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Re: USP 795 Batching & Beyond Use

The assigned BUD to be assigned 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.
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Advisor
Posts: 13
Registered: ‎09-25-2017
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Re: USP 795 Batching & Beyond Use

Hi Scott,

Where did you find the information in general notices and requirements?  This is all I found:

 

GENERAL NOTICES AND REQUIREMENTS

The General Notices and Requirements section (the General Notices) presents the basic assumptions, definitions, and default conditions for the interpretation and application of the United States Pharmacopeia (USP) and the National Formulary (NF).
Requirements stated in these General Notices apply to all articles recognized in the USP and NF (the “compendia”) and to all general chapters unless specifically stated otherwise
 
Thank you,
Sue