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
USP 795 limits: nonpreserved aqueous 14 days refrigerated; preserved aqueous 35 days; nonaqueous oral liquid 90 days; other nonaqueous forms 180 days. These are maximums subject to stability and component limits. Category 1 sterile BUD: 12 hours room temperature or 24 hours refrigerated.
What Is a Beyond-Use Date?
A beyond-use date (BUD) is the date, or date and time, after which a compounded preparation must not be used. The compounder assigns it using the applicable USP chapter, formulation stability, packaging, storage conditions, component limits, and required quality controls. A manufacturer's expiration date applies to its tested commercial product and container; it cannot simply be copied onto a compounded preparation.
USP 795: Nonsterile Preparations
The revised chapter's limits in the absence of a USP-NF compounded preparation monograph or preparation-specific stability information depend on water activity, not just whether the product is a liquid or solid.
| Preparation | BUD limit | Storage |
|---|---|---|
| Nonpreserved aqueous, water activity at least 0.60 | 14 days | Refrigerated |
| Preserved aqueous, water activity at least 0.60 | 35 days | Controlled room temperature or refrigerated |
| Nonaqueous oral liquid, water activity below 0.60 | 90 days | Controlled room temperature or refrigerated |
| Other nonaqueous dosage forms, water activity below 0.60 | 180 days | Controlled room temperature or refrigerated |
These are limits, not guarantees that every formulation remains stable that long. Shorten the BUD when ingredient expiration, chemical stability, packaging, or storage requires it. A supported extension must meet the chapter's additional requirements; refrigeration alone does not justify a longer BUD.
USP 797: Sterile Preparations
| Category/process | Maximum BUD examples |
|---|---|
| Category 1, ISO Class 5 PEC, including one in an unclassified segregated compounding area | 12 hours at controlled room temperature or 24 hours refrigerated |
| Category 2, aseptically processed from only sterile starting components, without sterility testing | 4 days at controlled room temperature, 10 days refrigerated, or 45 days frozen |
| Category 2, aseptically processed with one or more nonsterile starting components, without sterility testing | 1 day at controlled room temperature, 4 days refrigerated, or 45 days frozen |
| Other Category 2 processes and Category 3 | Use the applicable process/testing/storage table and satisfy every additional requirement |
Category 2 and 3 generally require a cleanroom suite; a qualifying pharmaceutical isolator has separate placement requirements under USP 797. A Category 2 preparation cannot be made in an unclassified segregated compounding area merely by choosing a BUD from a stability study. Category 3 has additional personnel, environmental, stability, and release-testing requirements; its longest limits are not universal defaults.
Technician Responsibilities
- Use the pharmacist-approved formulation record and assigned storage conditions.
- Record and label the exact BUD, including the time when applicable.
- Check component expiration and applicable opened-container limits.
- Escalate missing stability information or conflicts to the pharmacist.
- For an infusion, administration must begin before the BUD; the BUD does not itself establish the infusion's hang time.
Exam Alert
Distinguish a BUD from a manufacturer's expiration date. For nonsterile preparations, identify water activity and preservative status. For sterile preparations, identify the category, starting components, process, testing, and storage before selecting a limit.
Sources: USP BUD fact sheet, hosted by the Mississippi Board of Pharmacy; USP 797 FAQs.
Study This Term In
Free CE RadioThird-party resources · We may earn a commission from purchases.
ExCPT Study Guide 2026-2027: Complete CPhT Review + 1440 Questions and Detailed Answer Explanations for the NHA Certified Pharmacy Technician Exam (12 Full-Length Exams)
By Test Prep, Newstone
$24.99 · 
Practice exams on ExamEdge
Study resources on Achievable
Study guide on MometrixFree CE RadioThird-party resources · We may earn a commission from purchases.
PTCB Exam Prep 2026-2027: Complete Study Guide + 6-Week Study Plan + 3060 Questions and Detailed Answer Explanations for the Pharmacy Technician Certification Exam (E-Learning Access)
By Test Prep, Newstone
$34.99 ·
Take courses on UdemyPrep course on AchievablePractice exams on ExamEdgeRelated 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.
Your AI study companion · 10 free interactions a day
Stay Updated
Get free exam tips and study guides delivered to your inbox.