12-06-2017 09:05 AM
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.
12-06-2017 01:25 PM
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?
12-06-2017 04:33 PM
Yes, you can repackage dilaudid. I have attached the FDA repackaging guidance that will give you good information to consider. Hope this helps.
12-06-2017 07:41 PM
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,
12-06-2017 07:45 PM
12-07-2017 05:10 PM
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.