Establishing BUDs USP 800

Sterile Hazardous Compounding <800>

Establishing BUDs
Sterile Hazardous Compounding <800>

 

Purpose/ Applicability:  To provide guidelines for establishing BUDs / expiration dates of sterile compounded hazardous products.

Scope: Applies to all sterile hazardous compounding / preparations, as well as the open vials of chemotherapy that are being utilized.

 

Definition(s):

BUD : Beyond Use Date

CSTD : Closed System Transfer Device

Equipment: N/A

Procedure:

Background

  • The medication dispensary does not have the capabilities to compound sterile hazardous products that have any non-sterile starting components
    • We lack a non-sterile hazardous hood to complete the initial processes/procedures safely
  • The hazardous cleanroom is currently only utilized for immediate-use chemotherapy preparations

 

Chemotherapy

  • Open chemotherapy vials
    • The expiration date of chemotherapy vials once opened is based upon manufacturer data from package inserts as well as data from the manufacturer of our CSTDs
    • The chart below provides expiration dates for opened vials as well as which vials are single use only

*BUD differs depending on storage conditions

Refrigerated

  Non-Refrigerated

 

Open vial exp

 

Open vial exp

Dacarbazine (DTIC)

SDV

  Carboplatin

14 days

Doxorubucin

SDV

  Cytarabine

SDV

Mitoxantrone

14 days

  Dexrazoxane (Zinecard)

SDV

Tanovea

SDV

  Elspar (Asparginase)

SDV

Vinblastine

28 days

  Mitomycin

SDV

Vincristine

SDV

  *Cyclophosphamide  (frozen)

3 months

Vinorelbine

SDV

 

 

*Cylophosphamide

28 days

 

 

  • Cyclophosphamide preparation
    • Needs to be properly reconstituted with NaCl for 20 mg/mL concentration
      • 500 mg vial reconstituted with 25 mL
      • 1 gm vial reconstituted with 50 mL
      • 2 gm vial reconstituted with 100 mL
    • Can be further diluted to a minimum concentration of 2 mg/mL if requested using D5W or ½ NS
    • Storage
    • Repackage into 5 mL glass vials, put in chemo bag, and store in freezer (in pharmacy) for up to 3 months
    • Service needs to inform us 1 day ahead of time when they intend to use so that the medication can be pulled from the freezer, taken into the HD room, and allowed to thaw in the refrigerator
    • Medication should then be pulled up in the appropriate quantity and dispensed in a equashield syringe to the service

 

  • Dispensed chemotherapy
    • Chemotherapy should be dispensed for immediate use
      • In some cases, chemotherapy must be delayed until someone is available to complete treatment and therefore we have come up with the following guidelines
    • The beyond use date for dispensed chemotherapy can be found in the following table:

 

Dispensing Method

RT expiration

Freezer expiration

Syringe

4 hours

N/A

Vial

Manufacturers exp or 28 days (whichever is shortest)

*Cyclophosphamide : 3 months frozen

Bag

24 hours

N/A

 



Keywordsbeyond use, best by, use by   Doc ID130908
OwnerJenny C.GroupUofI College of Veterinary Medicine Teaching Hospital
Created2023-09-06 14:36:11Updated2023-09-07 14:37:48
SitesUniversity of Illinois College of Veterinary Medicine Teaching Hospital
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