Labeling
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.

Definition(s):

MFR: Master Formulation Record
CR: Compounding Record

Equipment: N/A

Procedure:

Background

• 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

Chemotherapy

• 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