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.
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Study guide on MometrixRelated 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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