Compounding Beyond-Use Date Determination: USP Guidelines Explained
Learn how to assign beyond-use dates for non-sterile and sterile compounded preparations using current USP chapter guidelines.
Beyond-Use Dates vs. Expiration Dates
A beyond-use date (BUD) is assigned by the pharmacy to a compounded preparation, while an expiration date is assigned by the manufacturer to a commercially available product. Understanding BUD assignment is critical for the PTCB exam and compounding practice.
Non-Sterile Compounding (USP 795)
Default BUD Guidelines
When no stability data is available for a non-sterile compound, USP 795 provides default beyond-use dates based on the dosage form and water content:
- Non-aqueous formulations: Up to 180 days or the earliest expiration of any ingredient
- Aqueous formulations: Up to 14 days when stored in a refrigerator
- Solid dosage forms: Up to 180 days or the earliest ingredient expiration date
Extending the BUD
Pharmacies can assign longer BUDs when they have published stability studies or conduct their own stability testing that supports extended dating.
Sterile Compounding (USP 797)
Category-Based BUDs
USP 797 assigns BUDs based on the conditions under which preparations are compounded. Category 1 preparations made in a segregated compounding area receive shorter BUDs than Category 2 preparations made in classified cleanroom environments.
Documentation and Labeling
Every compounded preparation must display the BUD prominently on the label. The compounding record should document the rationale for the assigned BUD, referencing the applicable USP chapter or stability data source.
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