Beyond-use dates under USP <795> and <797>: what compounding software must get right
A beyond-use date (BUD) is the date and time after which a compounded preparation must not be used. It is different from a manufacturer’s expiry date, and it must appear on every label. The revised USP chapters <795> (non-sterile) and <797> (sterile) became official on 1 November 2023 and changed how BUDs are assigned.
Non-sterile preparations — USP <795>
When there is no specific stability information, USP <795> sets default BUDs by type of preparation:
| Type of preparation | Default BUD | Storage |
|---|---|---|
| Aqueous, without preservative | 14 days | Refrigerated |
| Aqueous, with preservative | 35 days | Room temperature or refrigerated |
| Non-aqueous dosage forms | 90 days | Room temperature or refrigerated |
| Solid dosage forms | 180 days | Room temperature or refrigerated |
A longer BUD needs supporting stability data. For oral liquids, magic mouthwashes and topical preparations, the formula record should state which category applies and why.
Sterile preparations — USP <797>
USP <797> assigns BUDs by category:
- Immediate-use preparations: administration must begin within 4 hours of the start of preparation.
- Category 1 (prepared in a segregated compounding area): up to 12 hours at room temperature or 24 hours refrigerated.
- Category 2 (prepared in a cleanroom suite): BUD depends on how the preparation was made and stored. For example, an aseptically prepared CSP made only from sterile starting components, without sterility testing, has a BUD of 4 days at room temperature, 10 days refrigerated or 45 days frozen.
- Category 3: longer BUDs, allowed only with additional requirements such as sterility testing.
In every case, the BUD can be no longer than the stability of the drug in that container and diluent — whichever is shorter wins. Always confirm values against the current official chapter.
What software must get right
- Assign the BUD automatically from the product, diluent, category and storage — never leave it blank.
- Use date and time, not only a date, for short BUDs.
- Take the shortest applicable limit between the chapter default and product stability.
- Carry the BUD through stock: a premixed batch released into stock keeps its BUD, and dispensing should always take the earliest-expiring batch first.
- Print it clearly on every label and block the use of expired stock.
This article summarizes publicly available USP guidance for pharmacy professionals. Check the current official USP chapters and your regulator’s requirements before applying any BUD.