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Visitor
Posts: 2
Registered: ‎12-06-2017
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Re: BUD

I would appreciate clarification on this as well. It was my understanding that if my organization had compounded any product and assigned it acceptable an USP BUD, if that same product was accessed a second time (after being removed from ISO 5 for a period of time), it would have a 1 hour BUD.

 

Example: I have precpackaged cefazolin 1 gm in a 10 mL syringe, stored in the fridge. I now have a dose I need for 0.5 g. If I remove 0.5 g from the original syringe, placing it into a new syringe, my new syringe has a BUD of 1 hour. All maniupulations done in ISO 5.

 

Is that correct?

 

Thanks so much. 

Rachel Schreffler 

Visitor
Posts: 2
Registered: ‎12-06-2017
0

Re: BUD

At our instutution - due to the national crisis of dilaudid inj shortage.

 

We are seriouly considering doing a straight draw from a MDV of Dilaudid [2mg/ml] - and batching (0.5 mg = 0.25 ml) syringes for the AcuDose with a 28-day BUD.

 

Is anyone else doing this or consider doing this?

 

 

thanks!

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

Re: BUD

Hi rmoore,

 

Yes, you can repackage dilaudid.  I have attached the FDA repackaging guidance that will give you good information to consider.  Hope this helps. 

Eric S. Kastango, MBA, RPh, FASHP

It's all about the patient.
Occasional Visitor
Posts: 2
Registered: ‎12-06-2017
0

Re: BUD

Where are you finding MDV? The only ones we see that are available are SDV and ampules.
Expert
Posts: 1,152
Registered: ‎02-23-2010
0

Re: BUD

Hi Rachael,

 

Using a compounded dose as a source container is quite common when doing neonate and pediatric doses.  Basically, you have made a compounded bulk package and can use it to create additional doses.  The chapter does not describe this process or provide guidance on a BUD.  It is my opinion that you can give this dose 24-hour dating. Hope this helps, 

Eric S. Kastango, MBA, RPh, FASHP

It's all about the patient.
Occasional Visitor
Posts: 2
Registered: ‎12-06-2017
0

Re: BUD

In reference to the microbial ingress study using Equashield which has a 0% exposure rate, the investigators purposefully contaminated the stoppers with GP and GN bacteria of SDV letting them incubate for 30 minutes. They then swabbed the vials like normal and attached the Equashield device. After 7 days (+ 2 days of incubation) there was no contamination among prepared products. We are having difficulty finding MDV of hydromorphone to prepare in batch and only have SDV to provide doses due to the shortages. Would it be acceptable to extend the BUD on prepared syringes to 7 days (stability studies show extended stability well over 30 days)? Otherwise, I'm not sure how we will provide this medication to our patients. What are other facilities doing? We are a level 2 trauma center with a robust ortho program so we utilize this medication often.
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Visitor
Posts: 2
Registered: ‎12-06-2017
0

Re: BUD

Thank you so much!!

-Rachel

Occasional Advisor
Posts: 6
Registered: ‎07-24-2017
0

Re: BUD

Regarding repackaging the dilaudid in syringe batches..

 

Since there are no studies to prove the stability of Dilaudid in the syringe container, do we need to do testing?

 

We were planning to unit dose Ativan MDV in syringes but we have no proof of syringe stability once we have removed the product from the original MDV vial.

 

Thank you for your input.