Beyond-use dates on compounded semaglutide and tirzepatide

What a beyond-use date is

USP, the group that writes US compounding standards, defines a BUD as the date, or the hour and date, after which a compounded sterile preparation should not be used. The clock starts when the pharmacy makes the preparation, and the date warns that after it the preparation may be at higher risk of breaking down or becoming contaminated^[1].

USP's sterile compounding chapter, USP 797, sets the longest BUD a pharmacy may assign. The limit depends on how the drug was made, whether it passed sterility testing and how it is stored. For example, the lowest-risk category allows at most 12 hours at room temperature or 24 hours in a refrigerator, while preparations that are aseptically made and pass sterility testing can be dated up to 60 days at room temperature, 90 days refrigerated or 120 days frozen^[1]. A pharmacy can assign a shorter date than the maximum. States enforce USP standards through pharmacy rules; Iowa's compounding rule, for example, requires them^[5].

Why compounded semaglutide and tirzepatide vials carry one

Brand Wegovy, Ozempic, Zepbound and Mounjaro are FDA-approved, so their makers must submit stability testing and a proposed expiration date with storage conditions^[3]. A compounded vial is made by a pharmacy for a named patient and is not FDA-approved, so it gets a pharmacy-assigned BUD instead^[4][1]. See compounded semaglutide and compounded tirzepatide for the legal limits.

Beyond-use date vs expiration date

How a BUD differs from an expiration date

	Beyond-use date	Expiration date
Used on	Compounded preparations[1]	FDA-approved and other manufactured drugs[3]
Set by	The compounding pharmacy, within USP 797 limits[1]	The manufacturer, from stability testing[3]
Starts	When the preparation is compounded[1]	Applies while stored as the label directs[3]
What it means	Do not use, hold or move the preparation after it[1]	The period the product is known to stay stable[3]

Brand pens have their own in-use limits too. Our semaglutide storage and tirzepatide storage pages give the label rules for each pen and vial.

How to store a compounded vial

• Follow the pharmacy label. The storage directions on your vial label come from the pharmacy that made it; they apply to that preparation, not the brand drug.
• Keep it cold if the label says so. FDA says injectable GLP-1 drugs require refrigeration as indicated in their package inserts^[2].
• Check the delivery. FDA says some compounded GLP-1s have arrived warm or with too few ice packs, and recommends not using any injectable GLP-1 that arrives warm^[2].
• Write down the first-use date. FDA says to discard a multi-dose vial within 28 days of first use, even if medicine remains and even if the compounder's instructions allow longer^[2].
• New needle and syringe every time. FDA says reusing them can contaminate the medicine^[2].

If the date has passed

1. Do not use the vial, even if it looks fine. A BUD marks when the risk of breakdown or contamination rises^[1].
2. Call the pharmacy named on the label and ask for a replacement or a new fill. Ask your prescriber what to do about the dose you missed; do not change your dose on your own.
3. Ask the pharmacy how to dispose of the vial and used syringes.
4. If a new shipment arrives warm, do not use it and contact the pharmacy^[2].

What FDA says about compounded GLP-1 vials

FDA's guidance for patients focuses on in-use time, temperature and clean equipment: the 28-day discard rule, refrigeration, no warm shipments and a new sterile needle and syringe for each dose^[2]. FDA also warns against products sold as “research use only”, which carry no pharmacy label or BUD at all; see research-use-only GLP-1s. Sellers with FDA letters are in our warning letter tracker, and state rules are in our state law table.