Labeling USP 797

Sterile Non-Hazardous Compounding <797>

Sterile Non-Hazardous Compounding <797>


Purpose/ Applicability:  To provide a guideline for appropriate labeling of finished preparations for dispensing in accordance with applicable law and regulations and standards of good practice.

Scope: This applies to all CSPs dispensed from the medication dispensary, regardless of if they are for stocking of the Cubex, inpatient, or outpatient use.



CSP: Compounded sterile product

BUD: Beyond use date


Equipment: N/A



  1. The labels of repackaged sterile products should include the following:
    1. Name of drug including strength and dosage form
    2. Lot number
    3. Beyond use date


  1. Those being dispensed to the patient for inpatient/outpatient use must also include:
    1. The pharmacy's name, address and telephone number
    2. The date
    3. The pharmacy's identifying serial number for the prescription
    4. The patient's full name
    5. The amount dispensed
    6. The directions for use
    7. The prescriber's name
    8. The instructions for appropriate storage of the medication
    9. The Federal legend "Caution: Veterinary Use Only”
    10. Any other pertinent information or accessory cautionary labels
    11. Indication the preparation is compounded


  1. When appropriate and/or applicable, hazardous or cytotoxic drugs must be labeled with:

a. Notification the compounded preparation is hazardous

b. Special handling precautions

c. Special storage instructions


  1. All compounded products will be labeled properly before they are stored or dispensed


  1. It is the pharmacists’ responsibility to ensure all prescriptions are labeled in accordance with the requirements


Keywordslabels, repackage, identification   Doc ID130897
OwnerJenny C.GroupUofI College of Veterinary Medicine Teaching Hospital
Created2023-09-06 15:02:47Updated2023-09-07 15:35:13
SitesUniversity of Illinois College of Veterinary Medicine Teaching Hospital
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