BUD Timing Protects Safety & Payment.

A dose after its Beyond-Use Date (BUD) is unsafe and unbillable. That one fact drives more denials—and more patient safety risks—than almost anything else in home infusion. Every payer knows it. Every inspector knows it. And every pharmacy or nurse who has scrambled to explain “why the dose was given late” knows it too. This isn’t about theory. It’s about timing, documentation, and protecting both the patient and your claim. The Core Rule: Never Cross the BUD USP <797> Pharmaceutical Compounding—Sterile Preparations makes BUD the anchor for safe use. The BUD is not a suggestion. It’s the deadline for safe administration based on stability and sterility data. Once the clock runs out: The dose is unsafe to give The claim is unsafe to bill What to Document (Every Time) To protect both safety and payment, your infusion note needs four time stamps: Pack-out time – when the product left the pharmacy Delivery ETA – expected courier arrival Visit start/stop (EVV) – when the nurse was actually onsite BUD deadline – the absolute latest time the drug can be given Put them together, and you have an airtight audit trail. The Real-World Rule: If ETA Slips Past BUD, Don’t Gamble If the courier’s ETA is already bumping against the BUD window, reschedule before the nurse ever leaves the driveway. That’s cheaper, safer, and cleaner than sending a nurse, discovering the miss, and trying to explain it away later. Example in Practice Drug compounded Friday 16:00 → BUD set for Saturday 14:00 Courier ETA = Friday 18:00 Nurse visit = Friday 18:30 EVV shows dose given at 19:00 → Safe, billable, compliant But if delivery ran late and the nurse arrived Saturday 15:00 → Unsafe, unbillable, claim denied..

Why it matters for Specialty Pharmacies?

Specialty pharmacies live in the world of high-cost biologics, strict storage needs, and skeptical payers. The fastest way to lose money—and trust—is to skip timing documentation. By embedding BUD timing into your nursing note and scheduling process, you: Protect patients from expired doses Prevent avoidable denials Create CMS-compliant, payer-ready documentation without scrambling for proof later

Bottom Line
BUD is your hard stop. Miss it, and you lose both safety and payment. Document pack-out, ETA, EVV times, and BUD every single visit. If timing slips, reschedule before the nurse arrives. That’s how you protect patients, staff, and revenue in one move.

References
1. USP <797> Pharmaceutical Compounding—Sterile Preparations
2. CMS Home Infusion Therapy Services Benefit: Frequently Asked Questions
3. USP <1079> Good Storage and Shipping Practices