What Is a Beyond-Use Date (BUD)?
Short answer
A beyond-use date (BUD) is the date or time after which a compounded preparation should not be stored or used. The compounder assigns it from the date and time of compounding. An expiration date is set by a manufacturer for an FDA-approved drug product after stability studies. Default BUDs in USP compounding chapters are shorter than most commercial expiration dates, and extending a BUD needs formulation-specific data from a stability-indicating method, usually HPLC.
BUD vs expiration date
USP defines beyond-use dates as the date or time after which a compounded sterile or nonsterile preparation may not be stored or transported, counted from compounding (USP BUD fact sheet). The date limits risk from chemical or physical breakdown, microbial growth and container-closure problems. An expiration date on a manufactured product is different: manufacturers set it after product-specific stability studies. Compounded preparations usually lack that full data package, so the compounder assigns a shorter BUD. FDA also notes that compounded drugs are not FDA-approved, so FDA does not verify their quality before they are marketed (FDA).
Default BUD limits for nonsterile compounding
When a pharmacy has no formulation-specific stability information, USP <795> (official November 1, 2023) sets maximum BUDs by preparation type, using water activity to sort aqueous from nonaqueous forms:
| Type of nonsterile preparation | Maximum BUD (no stability study) | Storage |
|---|---|---|
| Nonpreserved aqueous | 14 days | Refrigerator |
| Preserved aqueous | 35 days | Room temperature or refrigerator |
| Nonaqueous oral liquids | 90 days | Room temperature or refrigerator |
| Other nonaqueous dosage forms (including many solids) | 180 days | Room temperature or refrigerator |
Sources: USP, ASHP. These are ceilings. Use a shorter date when the API, diluent, container or published data require it. With CNSP-specific stability data from a stability-indicating method (and antimicrobial-effectiveness testing when required for aqueous preparations), <795> allows a BUD up to 180 days for that formulation and container (ASHP).
Strength testing is not the same as stability testing
USP’s Compounding Expert Committee explains that a strength (potency) test measures how much active ingredient is present, while a stability test must use a stability-indicating method that separates the drug from its degradants (USP). HPLC is the usual tool, but not every HPLC potency method is stability-indicating. If degradants co-elute with the drug peak, a sample can look like it still meets label claim when intact drug has already dropped. USP’s example of a 10 mg/mL preparation assayed at day 0, 30 and 60 shows that without a stability-indicating method those results cannot support a 60-day BUD (USP).
In a limited FDA survey of compounded products bought online, 10 of 29 products (34%) failed one or more quality tests, most often low potency (FDA survey). Potency checks catch under- or over-strength batches; stability-indicating studies justify how long a batch may be held.
Who needs BUD-related testing?
- 503A compounding pharmacies assigning default BUDs or extending a BUD with formulation-specific data.
- 503B outsourcing facilities supporting longer dating with validated methods and release testing.
- Pharmacies validating a new strength, vehicle or container-closure, where strength-over-time alone is not enough.
Testing at Renew Lab Group
Our Houston lab runs HPLC and LC-MS potency and purity testing for strength checks and for stability-indicating method work when a BUD extension is the goal. We also offer toxicology, ICP-MS, LAL endotoxin, microbiology, TOC and extractables/leachables. See our compounding pharmacy potency testing, HPLC testing lab, LC-MS testing services, content uniformity testing, how to read HPLC results and lab testing FAQ. To request testing, call 936-379-5515 or email info@renewlabgroup.com.
Related questions
Is a beyond-use date the same as an expiration date?
No. An expiration date is set by a manufacturer after stability studies on an approved product. A BUD is assigned by the compounder from the time of compounding and is usually shorter (USP, ASHP).
Can a pharmacy extend a BUD past the USP default table?
For nonsterile preparations, yes when formulation-specific stability data from a stability-indicating analytical method support it, up to a maximum of 180 days for that CNSP and container, with other chapter requirements met (ASHP).
Does a passing potency test prove stability?
No. USP states that stability requires a stability-indicating method that separates the intact drug from degradants; a plain strength test may miss degradation (USP).
Can Renew Lab Group help with BUD stability testing?
Yes. Our Houston HPLC lab supports potency and purity testing for compounding pharmacies, including work toward stability-indicating methods. For a quote, call 936-379-5515 or email info@renewlabgroup.com.
Talk to the lab about beyond-use date and stability testing
Tell us what you need tested and we’ll recommend a method and send a quote. Contact us at 936-379-5515 or info@renewlabgroup.com for current pricing, turnaround and sample requirements. Samples can be dropped off at our lab at 6001 Central Crest, Houston, TX 77092.
Sources
- USP Compounding Expert Committee: Strength and stability testing for compounded preparations (PDF)
- USP: Compounding standards and beyond-use dates (BUDs) fact sheet (PDF)
- FDA: Compounding and the FDA, questions and answers
- FDA: Report, Limited FDA Survey of Compounded Drug Products
- ASHP: The pharmacist’s guide to assigning a beyond-use date (PDF)
Researcher resources
- Shop Bacteriostatic and Sterile Water
- View Our Certificate of Analysis
- Free Reconstitution Calculator
- Compare BAC Water Products
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