Labeling USP 800

Sterile Hazardous Compounding <800>

Sterile Hazardous Compounding <800>


Purpose/ Applicability:  To provide guidelines for labeling sterile hazardous compounded preparations to ensure error prevention and quality control.

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


MFR: Master Formulation Record
CR: Compounding Record

Equipment: N/A



  • Any sterile hazardous product that is prepared should be labeled immediately after preparation and must follow applicable legal requirements (both federal and state)
    • Syringe, vial, or bag must be labeled appropriately as well as the chemotherapy bag which the product is being dispensed in
  • Components of label should be displayed prominently and understandably
  • The label format should match prescriber order and MFR or CR if being compounded



  • Prior to being labeled – a pharmacist must check the chemotherapy product being used as well as the amount in the syringe to verify accuracy
    • When adding cytosar (cytarabine) into a bag for CRIs, the quantity drawn up in the syringe should be approved by a pharmacist prior to adding to the saline bag
    • The attached line should also be primed prior to dispensing
  • Following this check, the label should be flagged on the syringe, carefully, to not cover up any mL markings for the person administering the medication
  • The label and medication should once again be checked by the operator pulling up the chemotherapy prior to being bagged
  • The item should then be bagged in a chemotherapy bag with another label signifying what medication is inside the bag, for the patient
  • Each label must state the amount to be given, if it will be diluted, and how it will be given to the patient (IV, IM, SC, IC)


Expiration Dates

  • Chemotherapy that is not SDV, must have expiration date of the opened vial written on the bin / card to ensure that the medication is disposed of properly

Keywordslabeling, identification   Doc ID130910
OwnerJenny C.GroupUofI College of Veterinary Medicine Teaching Hospital
Created2023-09-06 15:40:10Updated2023-09-07 15:38:09
SitesUniversity of Illinois College of Veterinary Medicine Teaching Hospital
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