Examples
Worked examples
- Is an instance
An IV admixture compounded in a Category 2 (ISO 7 buffer room / ISO 8 anteroom) environment under USP 797 is assigned a BUD from the current 797 BUD tables based on that category, storage condition, and any supporting stability data.
- Is an instance
An aqueous oral suspension compounded under USP 795 with no formulation-specific stability data is assigned a conservative default BUD from the current 795 tables for aqueous formulations.
Counter-examples
Looks similar, but isn't
- Not an instance
Drawing up and administering a manufacturer-prepared, ready-to-use injectable exactly per its FDA-approved labeling, with no further manipulation, is not compounding — no BUD is assigned, and the manufacturer expiration date governs instead.
Editorial commentary
See the operational definition above for how a beyond-use date is set. A few points worth expanding on:
BUD vs. expiration date
An expiration date is assigned by the manufacturer to the original, unopened, commercially produced drug product, based on formal stability testing of that exact product and its packaging. A BUD is assigned by the compounder at the time of compounding, applies only to the specific compounded preparation just made, and is necessarily more conservative than a manufacturer’s expiration date because it typically rests on less extensive (or no) preparation-specific stability data.
Worked examples
- A hospital pharmacy compounds a patient-specific IV admixture in an ISO Class 7 buffer room served by an ISO Class 8 anteroom (a Category 2 environment under USP <797>). The BUD assigned reflects that Category 2 environment, the drug’s storage condition, and whatever stability information applies — and is set using the current <797> BUD tables, not a fixed rule of thumb.
- A community pharmacy compounds an oral suspension from crushed tablets and an aqueous suspending vehicle (nonsterile, under USP <795>). Because the formulation is aqueous and no published stability study covers this exact formulation, the pharmacist assigns a BUD from <795>’s conservative default tables for aqueous oral formulations rather than an arbitrarily longer date.
Counter-example
Administering a manufacturer-prepared, ready-to-use injectable exactly according to its own FDA-approved labeling — drawing it up and giving it without combining it with anything else or altering it — is not compounding at all, so no BUD is assigned; the product’s manufacturer expiration date governs instead, and USP <797>/<795> do not apply to that act.
Related USP chapters
See USP 797: Sterile Compounding Requirements Explained and USP 795: Nonsterile Compounding Requirements Explained for the full chapter requirements each BUD framework sits inside, and USP 797 vs. USP 795 for a direct comparison. USP <800> (see USP 800 Cleanroom Requirements) does not itself define a separate BUD framework; a hazardous-drug CSP still gets its BUD from whichever of <797> or <795> applies to it.
Machine-readable encodings
Use in your systems
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"description": "A beyond-use date (BUD) is the date, or date and hour, established by a compounding pharmacist after which a compounded preparation must not be used, stored, or transported. It is set at the time of compounding and is distinct from a manufacturer's expiration date, which applies only to the original, unopened, commercially manufactured product. Under USP General Chapter 797 (sterile preparations, current since November 1, 2023), the BUD is determined primarily by the CSP Category the preparation was compounded under (Category 1, 2, or 3, reflecting the degree of verified environmental control), together with the storage condition (controlled room temperature, refrigerated, or frozen), the dosage form, and any supporting sterility or stability testing or applicable stability data. Under USP General Chapter 795 (nonsterile preparations, also current since November 1, 2023), the BUD is determined primarily by whether the formulation is aqueous or nonaqueous, the dosage form and packaging, the storage condition, and whether supporting stability data exists — the chapter provides conservative default periods to use when no such data is available. In both chapters, the current chapter text and the USP Compounding Compendium contain the exact, category-specific and formulation-specific tables a compounder should use to assign a BUD to a given preparation; a value copied from a pre-2023 reference will not reflect the current framework.",
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