A single-dose vial is for one patient and one injection. A multiple-dose vial gets 28 days after it's opened unless the manufacturer says otherwise. Here's what FDA, CDC, and The Joint Commission actually say, and how to order so you're not throwing money in the sharps bin.
· 5 min read
Written and clinically reviewed by Jacob Fuchs, PharmD
Reviewed on
A single-dose vial is for one patient and one injection. Whatever's left goes in the trash. A multiple-dose vial has passed antimicrobial effectiveness testing. Once it's opened, it gets 28 days unless the manufacturer's label gives a different date. And "single-use" isn't a real package type anymore. FDA retired the term.
That's the whole answer. The rest of this is the part that saves you money.
FDA defines the package types in its 2018 labeling guidance (FDA):
| Package type | FDA definition, in short | What it means on the shelf |
|---|---|---|
| Single-dose container | Not required to meet antimicrobial effectiveness testing; "designed for use with a single patient as a single injection/infusion" | One patient, one injection. Done. |
| Multiple-dose container | Has met antimicrobial effectiveness testing requirements, or is excluded from them by FDA regulation | Can be entered more than once, within the limits below |
| Single-patient-use container | "Intended to be used multiple times for a single patient" | Several uses, but only ever for one person |
About "single-use": FDA says it's "retiring the term 'single-use'" because people used it as if it meant the same thing as single-dose (FDA). If an older box or a coworker says "single-use," treat it as single-dose.
28 days, unless the manufacturer says otherwise. CDC says an opened multiple-dose vial "should be dated and discarded within 28 days unless the manufacturer states another date," and that the beyond-use date "should never exceed the manufacturer's original expiration date" (CDC).
The Joint Commission adds three details that cause most of the survey findings (The Joint Commission):
So, a vial expires March 31. You open it March 20. It's done March 31, not April 17. The 28 days never outlive the expiration date.
Not in a clinic. CDC is blunt: "Never use medications packaged as single-dose vials for more than one patient." Don't pool leftovers from several vials. Don't save the rest for later, "even on the same patient" (CDC).
If someone really needs to split a single-dose vial, CDC sends that question to pharmacy professionals and USP , the sterile compounding standard. Splitting a vial means compounding, and it isn't something to do at the procedure-room counter.
Away from the patient. CDC says (CDC):
That last rule is the one that wrecks the math. A 30 mL vial that rides along on a cart into the exam room becomes one patient's vial, and the rest is waste.
Most people compare price per milliliter. Compare price per milliliter you actually use.
1. Count how much you really use in 28 days once a vial is opened, not per month on paper. If you open a 30 mL multi-dose vial and use 8 mL before day 28, you paid for 30 and used 8. 2. Ask where the drug gets drawn up. If it's drawn up in the treatment room, a multiple-dose vial will turn into a single-patient vial anyway. Single-dose vials may waste less. 3. Check the label's discard date for the opened vial. It isn't always 28 days. 4. Check the ingredient list. Multiple-dose vials pass antimicrobial effectiveness testing, often because they contain a preservative. Some uses call for a preservative-free product, which is usually single-dose. Your clinicians make that call. Purchasing just needs to order the right package. 5. Order by the full NDC. The single-dose and multiple-dose versions of the same drug have different NDCs. A substitute can quietly switch you from one to the other. Here's how NDCs work.
Premier Pharma supplies licensed clinics, surgery centers, physician offices, and pharmacies. Every product page lists its NDC. For example, we carry lidocaine 1% in 5 mL single-dose vials and 30 mL single-dose vials, and progesterone 50 mg/mL in a 10 mL multiple-dose vial. For a full injectable buying checklist, see our anesthesia supplies purchasing guide. Open a free account. Credential review typically takes 1–2 business days.
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