Beyond-Use Dating (BUD)
Beyond-use dating (BUD) is the date after which a compounded preparation should not be used, determined by the pharmacy based on USP standards and the stability characteristics of the specific formulation.
Exam Tip
BUD is the last safe-use date for compounded preparations. Know default BUDs: aqueous = 14 days refrigerated, non-aqueous = 90 days, solid = 180 days (USP 795). BUD cannot exceed the earliest ingredient expiration.
What Is Beyond-Use Dating?
Beyond-use dating (BUD) is the date or time assigned by the pharmacy to a compounded preparation that indicates the last date the product can be safely used. BUD differs from a manufacturer's expiration date, which applies to commercially available products.
BUD vs. Expiration Date
| Feature | Beyond-Use Date (BUD) | Expiration Date |
|---|---|---|
| Assigned by | Compounding pharmacy | Manufacturer |
| Applies to | Compounded preparations | Commercial products |
| Based on | USP standards + stability data | FDA-required stability testing |
| Appears on | Pharmacy label | Manufacturer label |
USP 795 BUD Guidelines (Non-Sterile Compounding)
| Dosage Form | Default BUD (no stability data) |
|---|---|
| Aqueous solutions | 14 days (refrigerated) |
| Non-aqueous formulations | 90 days |
| Solid dosage forms | 180 days |
USP 797 BUD Guidelines (Sterile Compounding)
| Category | ISO 5 (Clean Room) | Segregated Compounding Area |
|---|---|---|
| Category 1 | 12 hours (room temp) or 24 hours (refrigerated) | 12 hours (room temp) or 24 hours (refrigerated) |
| Category 2 | Per stability data (up to 9 days refrigerated) | Per stability data (up to 9 days refrigerated) |
Key Points for Pharmacy Technicians
- Always label compounded preparations with the BUD
- BUD cannot exceed the earliest expiration date of any ingredient
- Refrigeration generally extends BUD
- Stability-indicating testing can justify longer BUDs
- Water-containing preparations have shorter BUDs due to microbial growth risk
Exam Alert
BUD is heavily tested on the ExCPT within the Dispensing Process domain. Know the default BUDs for non-sterile (USP 795) and sterile (USP 797) preparations, and remember that BUD can never exceed the shortest ingredient expiration date.
Study This Term In
Related Terms
USP 795 and USP 797 (Compounding Standards)
USP 795 and USP 797 are United States Pharmacopeia chapters that establish minimum standards for non-sterile compounding (795) and sterile compounding (797), including personnel training, facilities, equipment, and quality assurance requirements.
Compounding Pharmacy
A compounding pharmacy prepares customized medications by mixing, combining, or altering ingredients to create preparations not commercially available, following USP 795 (non-sterile) and USP 797 (sterile) standards.
Aseptic Technique
Aseptic technique is a set of practices and procedures used in sterile compounding to prevent microbial contamination of compounded sterile preparations (CSPs), including proper gowning, hand hygiene, and manipulation within a laminar airflow hood.
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