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Contributor
Posts: 15
Registered: ‎10-11-2016
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BUD of chemotherapy meds

For chemotherapy (hazardous) meds, there's a debate within our department regarding the Beyond Use Dating.

 

If we're compounding a chemotherapy (i.e. cytarbine in NS), it would be patient specific and it would be less than 2 entries into a container and it's sterile to sterile in an ISO Class 7 clean room with an ISO 8 ante room. Would this be considered low risk and therefore have a 48hr RT BUD?

 

However a group of the other pharmacist believe the nature of the med is chemotherapy and would be considered medium risk although it's not making a batch (for multiple patients, or one patient multiple times). But it may be due to 'complex manipulations'.

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Expert
Posts: 1,174
Registered: ‎02-23-2010
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Re: BUD of chemotherapy meds

rxln,

 

I agree with you that mixing chemotherapy does NOT get factored into the risk level.  One dose compounded under the conditions you describe, I would consider this CSP is a low-risk.  Assuming the cytarabine is chemically stable for 48-hours room temperature, then you can assign the room temp is 48-hours. Hope this helps. 

 

Going forward, this resource will be shut down later this month. To support Simplifi users, CriticalPoint has created a Peer Network.  I will ask that you search our “Frequently Asked Questions” database as well as an “Ask the Experts” forum where you can post questions and view responses to other questions your peers have posted.  Please visit the CriticalPoint Peer Network to learn more about it. 

 

By funneling all questions into the “Ask the Expert” and “FAQs” sections of the Peer Network, CriticalPoint will be able to efficiently make information widely available to all members rather than limit it to a one on one exchange. Additionally, by joining the Peer Network, you will have access to other resources such as Instructional Videos,  Featured Articles, White Papers and more that are available now in one central Best Practices Compounding clearinghouse.

 

You can also visit the CriticalPoint website (www.criticalpointce.com) and explore our monthly Sterile Compounding Pearls under the Resources Tab.  I look forward to hearing more from you in the CriticalPoint Peer Network!  Thanks.

Eric S. Kastango, MBA, RPh, FASHP

It's all about the patient.