ML Maker Label Studio

USP 797 Beyond-Use Date (BUD) Calculator

Calculate a sterile compounding beyond-use date from a USP <797> (2023) category, storage condition, sterility testing status, and compounding date/time.

Cited standard: USP <797> (2023), Health & Clinical

Compounding Inputs

Applied to Category 2 BUD selection in this matrix.
Uses the date/time entered here; no live clock is used.
Self-tests: not run

Results

Beyond-use date/time
Enter inputs to calculate
Matrix cell used
Not calculated
BUD limit
Not calculated
Compounded at
Not calculated
Storage condition
Not calculated

Label Text

Calculate to generate label text.
USP <797> BUDs are maximum limits under the selected matrix cell; facility policy, preparation characteristics, package integrity, and current regulation may require a shorter date.

USP <797> (2023) BUD Matrix Used

Category / condition Controlled room temp Refrigerator Freezer
Immediate Use 4 hours 4 hours 4 hours
Category 1 12 hours 24 hours Not applicable
Category 2, without passing sterility test 4 days 10 days 45 days
Category 2, with passing sterility test 30 days 45 days 60 days

About the USP 797 Beyond-Use Date (BUD) Calculator

Pharmacists, sterile compounding supervisors, and quality teams use a USP 797 BUD calculator to assign beyond-use dates for compounded sterile preparations based on category, storage condition, sterility assurance, and preparation details. The page helps standardize label review and batch documentation while reminding users to apply the shortest applicable date from USP, labeling, or facility policy.

How it works

  1. Select the compounding category and preparation conditions.
  2. Choose the storage condition, such as controlled room temperature, refrigerator, or freezer.
  3. Enter preparation date and time for the compounded sterile preparation.
  4. Review the calculated beyond-use date and label wording.
  5. Apply the shorter date if manufacturer labeling, sterility testing, or facility policy is stricter.

Frequently asked questions

What does BUD mean under USP 797?

BUD means beyond-use date, the date or time after which a compounded sterile preparation must not be used, stored, or transported. It is based on sterility, stability, storage, and compounding conditions.

Is a USP 797 BUD the same as a manufacturer expiration date?

No. Manufacturer expiration dates apply to approved products in their original packaging. A compounded sterile preparation receives a BUD based on USP 797 and any stricter stability or labeling limits.

Why do storage conditions change the BUD?

Temperature affects microbial risk and chemical stability. USP 797 assigns different BUD limits depending on whether the preparation is stored at controlled room temperature, refrigerated, or frozen.

Can sterility testing extend a BUD?

Only when USP 797 conditions for the relevant category and testing pathway are met. Facilities must also consider stability data, container closure, preservatives, and their own policies.

References