How long can we keep this nonsterile compound before we have to throw it out?

Under revised USP 795, a beyond-use date (BUD) is the date after which a compounded nonsterile preparation (CNSP) must not be used. Absent a USP–NF compounded-preparation monograph or CNSP-specific stability information, default maximum BUDs are keyed to water activity (Aw): non-preserved aqueous (Aw ≥ 0. 6) ≤ 14 days refrigerated only; preserved aqueous (Aw ≥ 0. 6) ≤ 90 days at controlled room temperature or refrigerated; other nonaqueous dosage forms (Aw < 0.

A jar left on the shelf past its BUD is a patient-safety problem and an inspection problem on the same label. Get the educational default table straight — then confirm against your licensed USP 795 text and throw it out on time.

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BUD is not the manufacturer’s expiration

Manufacturer expiration dates apply to the unopened commercial product as labeled. Once you compound a CNSP, you assign a BUD for that preparation under USP 795. Mixing those two clocks is how jars stay on the shelf months past the book date.

This page summarizes published USP 795 patterns for education. It is not legal advice, not a substitute for your licensed USP text or PIC judgment, and not a promise about any inspection outcome.

  • Write the BUD (and the reference you used) on the label and in the compounding record / MFR as your SOP requires.
  • Staff should discard on the BUD — not when the bottle “looks fine.”
  • Ask Compounding AI Pro with your formula and storage condition for a cited starting point, then verify in your licensed chapter.

Water activity decides which default row you use

When you do not have a monograph or CNSP-specific stability package, revised USP 795 keys default maximum BUDs to water activity (Aw). Aw ≥ 0.6 is the aqueous pattern; Aw < 0.6 is the nonaqueous pattern. Preserved vs non-preserved aqueous also changes the row.

  • Know whether your CNSP is aqueous (Aw ≥ 0.6) or nonaqueous (Aw < 0.6) before you pick a default.
  • Non-preserved aqueous and preserved aqueous are different rows — do not collapse them.
  • If Aw is unknown, treat the assignment conservatively and confirm with your PIC / formulation data — do not guess up.

Default maximum BUD pattern (verify in licensed text)

Educational default maximums commonly summarized from revised USP 795 when no monograph or CNSP-specific stability information applies:

  • Non-preserved aqueous (Aw ≥ 0.6): ≤ 14 days refrigerated only.
  • Preserved aqueous (Aw ≥ 0.6): ≤ 35 days at controlled room temperature or refrigerated.
  • Nonaqueous oral liquids (Aw < 0.6): ≤ 90 days at controlled room temperature or refrigerated.
  • Other nonaqueous dosage forms (Aw < 0.6): ≤ 180 days at controlled room temperature or refrigerated.

When you can extend — and when you cannot

Going past those table defaults is not a vibe check. Extending requires stability-indicating data appropriate to the CNSP. For aqueous CNSPs, antimicrobial effectiveness testing is part of the extension pattern described in the chapter — confirm the exact requirements in your licensed USP 795 text.

Even with that data, the BUD still maxes at 180 days — it is not unlimited. It also cannot outrun the earliest dating of any component or the integrity limits of the container-closure system.

  • No stability package → stay inside the default row that matches Aw / preservation.
  • Aqueous extension → expect antimicrobial effectiveness testing requirements; verify in licensed text.
  • Even with stability-indicating data (and AET for aqueous as applicable), the extension still maxes at 180 days.
  • Ingredient or container dating shorter than the table or the 180-day cap → use the shorter date.

What staff should do mid-shift

If the label BUD is today or past, discard per SOP. Do not stretch dating because “auditors never check” — that culture is how shops fail the same citation twice.

If the MFR or compounding record is missing the BUD reference source, fix the documentation path before the next batch. Missing BUD sources on formulas is a recurring inspector theme.

  • Read the BUD on the label before you dispense or restock.
  • Discard on date — document per SOP.
  • Escalate unclear Aw / preservation calls to the PIC, not the break-room consensus.

State boards can use a different USP edition

National USP chapters update on their own calendar. Your board may still enforce an older adopted edition or add documentation overlays. Compounding AI Pro speeds the USP core question; you still verify which edition and extras your inspector will use.

FAQ

Is the BUD the same as the manufacturer’s expiration date?
No. Manufacturer dating is for the commercial product as labeled. After compounding, you assign a CNSP BUD under USP 795. Educational only — confirm in your licensed text.
We preserved an aqueous CNSP — do we still get only 14 days?
No. The 14-day refrigerated-only default is the non-preserved aqueous row (Aw ≥ 0.6). Preserved aqueous (Aw ≥ 0.6) uses a longer educational default — ≤ 35 days at controlled room temperature or refrigerated. Verify the exact row in your licensed USP 795.
Can we keep it longer if it looks and smells fine?
No. Appearance is not a stability study. Past the BUD, do not use it. Extensions need appropriate stability-indicating data (and AET for aqueous extensions per chapter pattern) and still max at 180 days — not unlimited with data.
Does this page replace my state board’s rules?
No. It is educational USP 795 framing. Boards may enforce a different adopted edition or add overlays. Verify locally with your PIC and board.

Related

Educational information only. Not legal advice. Not an inspection-outcome guarantee. Keep a current USP Compendium subscription. PIC judgment and your board still govern.