05-08-2011 11:32 AM - edited 05-08-2011 11:32 AM
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.
05-30-2017 12:55 PM
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
06-07-2017 08:32 AM
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.