Look up the maximum beyond-use date for a compounded sterile or nonsterile preparation under the 2023 USP revisions, based on category, sterilization method, sterility testing, and storage condition.
Controlled room temperature (20–25°C)
This calculator is an informational reference to the 2023 USP <797> and <795> revisions. It is not regulatory advice and does not replace the official USP text, state board requirements, your facility’s SOPs, or pharmacist judgment. Always verify the assigned BUD against the current official chapters and your ingredient expiration dates.
Maximum beyond-use dates by category, sterilization method, and storage. All values assume compliance with the chapter’s facility, personnel, and release requirements.
| Preparation | Room temp (20–25°C) | Refrigerator (2–8°C) | Freezer (−25 to −10°C) |
|---|---|---|---|
| Category 1 | ≤ 12 hours | ≤ 24 hours | — |
| Category 2 · aseptic, untested, nonsterile component(s) | 1 day | 4 days | 45 days |
| Category 2 · aseptic, untested, sterile components only | 4 days | 10 days | 45 days |
| Category 2 · aseptic, sterility tested | 30 days | 45 days | 60 days |
| Category 2 · terminally sterilized, untested | 14 days | 28 days | 45 days |
| Category 2 · terminally sterilized, sterility tested | 45 days | 60 days | 90 days |
| Category 3 · aseptic, sterility tested | 60 days | 90 days | 120 days |
| Category 3 · terminally sterilized, sterility tested | 90 days | 120 days | 180 days |
Maximum BUDs in the absence of a valid stability program, capped by the shortest ingredient expiration date.
| Dosage form | Maximum BUD | Storage |
|---|---|---|
| Aqueous (water activity ≥ 0.60), no antimicrobial preservative | 14 days | Must be stored in a refrigerator (2–8°C). |
| Aqueous (water activity ≥ 0.60), preserved | 35 days | Store at controlled room temperature or refrigerated per the formulation. |
| Nonaqueous oral liquid (water activity < 0.60) | 90 days | Store per the formulation record. |
| Other nonaqueous dosage form (capsules, ointments, suppositories, etc.) | 180 days | Store per the formulation record. |
Related reading: What is a BUD? · Media fill · USP <797> compliance software
An expiration date is assigned by a manufacturer after formal stability studies on a manufactured product. A beyond-use date (BUD) is assigned by the compounder to a compounded preparation using the limits in USP <795> and <797>, and is typically much shorter because compounded preparations have not undergone the same stability and sterility programs.
Category 2 CSPs range from 1 to 90 days depending on how they were made: aseptically processed without sterility testing is limited to 1–4 days at room temperature (depending on whether nonsterile starting components were used), 4–10 days refrigerated, and 45 days frozen. Sterility testing extends aseptically processed CSPs to 30/45/60 days and terminally sterilized CSPs to 45/60/90 days (room/refrigerated/frozen).
Category 3 CSPs — up to 180 days for terminally sterilized preparations stored frozen — require sterility testing on every batch plus enhanced requirements, including more frequent personnel requalification (every 3 months), sporicidal cleaning frequencies, specified garbing, and stability data supporting the assigned date.
Once a multiple-dose container is punctured, it should not be used for more than 28 days unless the manufacturer specifies otherwise on the labeling.
For nonsterile preparations under USP <795>, a longer BUD may be supported by a valid stability program within chapter limits. For sterile preparations under USP <797>, the category tables are ceilings — the path to longer dating is meeting the requirements of a higher category (for example, Category 3), not stability data alone.
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