What’s the Difference Between Beyond-Use Date and Expiration Date?

Written by Alyssa Billingsley, PharmD | Reviewed by Joshua Murdock, PharmD, BCBBS Published on March 28, 2022

Key takeaways:

• A beyond-use date is the last date you can safely use a compounded medication. It’s determined based on several factors by the pharmacy making the medication.
• An expiration date is the last date a manufacturer can guarantee the potency and safety of a medication. It’s determined by stability testing data from the manufacturer.
• Using a medication after its beyond-use date or expiration date can be risky. Talk to your pharmacist if you have questions about your particular medication.

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You’re probably familiar with expiration dates. After all, you’ve likely seen them on medications, supplements, and over-the-counter (OTC) products before. But you might be surprised to learn that not all medications have expiration dates. Instead, some have beyond-use dates. How exactly are these dates different?

Compounded medications have beyond-use dates. These are medications custom made for you by a compounding pharmacy. Hospitals and some retail pharmacies also dispense them. Compounds are prescribed when FDA-approved treatment options aren’t available or can’t be used — in some cases due to an allergy.

Compounds aren’t FDA-approved. And they haven’t gone through extensive stability testing like commercial products. So, pharmacies determine a beyond-use date based on factors like ingredients, storage, and more.

Keep reading to learn more about beyond-use dates. We’ll cover what they are, how they’re determined, and how they’re different from expiration dates.

What is a beyond-use date?

The beyond-use date (or “BUD”) is the last date you can safely use a compounded medication. Compounded medications are made just for you. So, they don’t go through the same FDA-approval and testing processes as mass-produced commercial medications. Beyond-use dates are sometimes applied to commercial medications, too. But we’ll discuss that later.

A beyond-use date is meant to minimize your risks when taking a compounded medication. For example, the medication may break down into ineffective or harmful substances after a period of time. And germs could start growing and contaminate the product. Unlike commercial medications, extensive testing hasn’t been done to assess these risks. 

How is a beyond-use date determined?

The United States Pharmacopeia (USP) is a set of nationally-recognized standards for medications, dietary supplements, and foods. The standards for compounded medications are meant to ensure their quality. Beyond-use dates are an important part of these standards.

Most states incorporate USP standards into their respective pharmacy laws. So, most pharmacies apply USP standards when determining beyond-use dates. Right now, these standards are in the process of being updated. But there are a few specific factors pharmacies take into account when determining a beyond-use date.

Examples of these factors include:

• If it’s a non-sterile compound. Non-sterile medications include those taken by mouth, applied to the skin, or inserted rectally or vaginally. The beyond-use date usually depends on the ingredients.
• If it’s a sterile compound. Sterile medications are higher risk than non-sterile compounds. So, they have more conservative beyond-use dates. That’s because these medications are injected into a vein, inhaled into your lungs, or put into your eye. Risk level can vary by compound and how it’s made.
• Dosage form. Solid dosage forms, like tablets, capsules, and suppositories, have longer beyond-use dates. Oral liquids usually have shorter beyond-use dates. Topical creams typically fall somewhere in-between.
• Water content. Some medications contain water-based (aqueous) ingredients. Water-based ingredients tend to shorten the beyond-use date. 
• Storage. Sometimes the beyond-use date can change based on how the medication is stored — whether it’s refrigerated, frozen, or kept in a specific container.
• Ingredient expiration dates. Pharmacies combine several ingredients together to make a compound. If one of these ingredients is going to expire earlier, the beyond-use date is shortened to this date.
• When it was made. The beyond-use date is calculated from the day the compounded medication is made by the pharmacy. 

Where is the beyond-use date typically listed on medications?

Some states might have different requirements for where pharmacies need to put the beyond-use date. But you can usually find it on the prescription label.

In some cases, the beyond-use date on the label may be specific to a particular type of storage. For example, the date may be based on keeping the medication in the freezer. If it’s stored in the fridge or at room temperature, it might have a shorter beyond-use date. Your pharmacist should give you instructions for how to store it properly. 

What’s the difference between a beyond-use date and expiration date for medications?

We’ve already discussed beyond-use dates. Now, we need to define an expiration date. This date is used for FDA-approved medications. It’s also used for many OTC products.

The expiration date is the last day a manufacturer can guarantee the potency (strength) and safety of a medication. This date is specific to a particular medication in its designated container under specific storage conditions. 

Unlike beyond-use dates, an expiration date is determined by the results of stability testing. This testing is performed by the manufacturer, and the results are verified by the FDA. 

Compounded medications don’t undergo this type of testing. Remember: Compounds are made for a specific person. So, they aren’t sitting on pharmacy shelves for long periods of time like commercial medications. In many cases, they’re meant to be used within 30 days of being made.

Now, this is where things can get a little fuzzy. Sometimes beyond-use dates are also applied to commercial medications. For example, a medication’s expiration date is no longer guaranteed if it’s moved to a different container. Pharmacies routinely do this when filling prescriptions — they take medications from a larger stock bottle and place them into a smaller vial. 

The medication’s expiration date was based on the original bottle. So, it’ll have a beyond-use date when it’s stored in the new bottle (vial). This is usually the original expiration date or 1 year after repackaging, whichever is shorter. The medication shouldn’t be used after this new date.

What should I do with my medication if it’s past the beyond-use date?

Using medications and OTC products past their expiration date can be risky. And there can be risks to using a compound after its beyond-use date, too. As covered earlier, this is the last date you can safely use it. At minimum, it may not work as well. In some cases, it could be harmful.

Using a compound after its beyond-use date is especially risky if it’s a sterile medication. That’s because it could become contaminated with harmful germs or substances over time. Introducing these elements into your body can be dangerous. One example of harm caused by contaminated sterile injections is the multistate fungal meningitis outbreak from 2012. 

Contact your pharmacist if you have questions about your medication’s beyond-use date. It’s also important to let them know if you notice any changes in color, consistency, or smell. This could be a sign of a problem, even if it’s within the listed beyond-use date.

The bottom line

Compounded medications have beyond-use dates that are determined by the pharmacy. They’re meant to minimize your risks when using the product. Beyond-use dates are also used for FDA-approved medications when they change containers or packaging.

Expiration dates are used for FDA-approved medications and many OTC products. They’re determined by the manufacturer and verified by the FDA. 

Using medications past their beyond-use date — or expiration date — can have risks. Talk to your pharmacist if you have questions about when to stop using your medication.