Labeling USP 797
Sterile Non-Hazardous Compounding <797>
Labeling
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.
Definition(s):
CSP: Compounded sterile product
BUD: Beyond use date
Equipment: N/A
Procedure:
- The labels of repackaged sterile products should include the following:
- Name of drug including strength and dosage form
- Lot number
- Beyond use date
- Those being dispensed to the patient for inpatient/outpatient use must also include:
- The pharmacy's name, address and telephone number
- The date
- The pharmacy's identifying serial number for the prescription
- The patient's full name
- The amount dispensed
- The directions for use
- The prescriber's name
- The instructions for appropriate storage of the medication
- The Federal legend "Caution: Veterinary Use Only”
- Any other pertinent information or accessory cautionary labels
- Indication the preparation is compounded
- 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
- All compounded products will be labeled properly before they are stored or dispensed
- It is the pharmacists’ responsibility to ensure all prescriptions are labeled in accordance with the requirements