There have been several questions in this forum re: beyond-use dating and how to assign them when trying to manage drug shortages. The information you need to address this issue and many others about USP 797 is available in the chapter (I have attached another copy of the chapter that can be searched with Adobe Reader/Acrobat) or in the vast amount of journal articles published on sterile compounding since the Chapter became effective in 2004. Doing an internet search using Google or your favorite search engine will be very effective in identifying helpful resources.
Re: BUD-->first, you need to determine what risk level your compounding activity falls into. Based on examples from the chapter, prepackaging medication from a source vial into small doses should be considered medium risk level compounding. I have attached an excellent article written by Patti Kienle, who explains how to determine BUD from that point. If you want to extend BUD, it is important to remember that sterility testing according to USP 71 must be conducted for each batch of drug each and every time you do it. This is an expensive and lengthy process. This is very difficult time in pharmacy and we need to take great care in maximizing our limited drug inventories while protecting our patients from receiving contaminated medications.
So, we are having some debate here about classifying this process: we have 50 ml size vial (without bacteriostatic), we withdraw into 50 ml sterile vials for injection. Is this low or medium risk? It seems low to me because it is one product, one withdraw. Others consider it medium because it does not have bacteriostatic in it. Can you assist us in following the rationale here. thanks
On an earlier post by you (Topic BUDs 3/14/11) you stated that compounding unit dose syringes from a vial was low risk as long as there was not more than 3 punctures to the vial. Regardless of whether the vial is single or multi-dose, if there is only one puncture (with a sterile spike) and then unit dose syringes withdrawn from the vial, how would this be classified. There seems to be conflicting information.
I can appreciate the potential confusion but aren't you making multiple aseptic connections to the dispensing pin? A dispensing pin, depending on its design actually creates a direct opening between the air in the compounding environment and the contents of the vial. Vial septum will typically self-seal. To me, punctures are approximately equivalent to aseptic connections to a pin or some type of extensive tube. Risk levels are associated with the risk of contamination and there are lots of ways that aseptic breaches can occur.
If you are making multiple CSPs (more than 3) from a multiple-dose vial with no further dilution of the drug, I would consider this low-risk, because you have a preservative system that has not be diluted. If you use a multiple-dose vial to make multiple CSPs (more than 3) that is further diluted, then you would have a medium-risk level CSPs. These are MY interpretations of the chapter. It's all about risk. The more sticks/connections, more risk. If you dilute a drug with a preservative, then the antimicrobial drug is no longer that its optimal concentration and most likely will not be effective.
Let me ask you this then, regarding a single dose vial...If a single-dose vial is punctured in the hood (ISO Class 5), would it retain its 6 hour BUD if removed from the hood (taken to the pass thru window for checking purposes), but never puctured ouside of an ISO Class 5 environment? Since our pharmacists are not inside the clean room with the compounding technicians, the techs have to bring the vial along with the finished product to the pass thru window so the pharmacist can check it. Can they take this vial back to the hood and use it again within the 6 hour window as long as stopper penetration is not made ouside the ISO Class 5 environment?
The vial, according to the chapter needs to stay in the ISO Class 5 environment at all times. The issue is the self-sealing capacity of the vial septum material. Latex had great self-sealing properties but now many of the vial septa are made with synthetic materials that may not self-seal as well or actually create a hole and when exposed to air cleanliness worse than ISO Class 5, you risk contamination of the vial .
