Multi-Dose Vial: Meaning and the 28-Day Rule
[Glossary · Quality, storage and rules]

Multi-dose vial

Also called multiple-dose vial, MDV · Reviewed

Definition: A multi-dose vial holds more than one dose and is made to be entered more than once. CDC says that once opened, it should be dated and thrown away within 28 days unless the manufacturer states another date. The 10 mL Depo-Testosterone vial and compounded GLP-1 vials are common examples.

What CDC and FDA say

CDC defines a multi-dose vial as one that contains more than one dose and is approved for repeated use. Citing USP chapter 797, it says the vial should be dated when opened and discarded within 28 days unless the manufacturer states another date, and that a vial should be assigned to a single patient whenever possible.

For compounded GLP-1 vials, FDA says multi-dose vials of sterile medicine should be used within 28 days after first use, thrown away after that even if medicine is left, and entered with a new sterile needle and syringe for each dose.

The manufacturer's date can be different. The Lantus label, for example, says not to use an opened vial more than 28 days after first use, and some pens carry longer in-use limits.

Worked example

How many weekly doses fit in 28 days

  1. A 2 mL vial at 2.5 mg/mL holds 2 × 2.5 = 5 mg.
  2. Say the dose is 0.25 mg, the Wegovy label starting dose: 0.25 ÷ 2.5 = 0.1 mL, which is 10 units on a U-100 syringe.
  3. Opened on day 1, weekly doses fall on days 1, 8, 15 and 22. That is 4 doses, or 1 mg, inside 28 days.
  4. About 4 mg is still in the vial at the 28-day mark. The rule is about contamination risk, not about running out.

Why it matters when you track doses

The clock starts at the first puncture, not the purchase date, so the open date is the one to write down. Dose Track saves each vial with its mix date and concentration, which keeps the open date next to the doses drawn from it.

Read more on Dose Track: How long mixed peptides last · Reconstitution calculator

General education drawn from labels and published studies, not personal medical advice. Your prescriber, pharmacist and the label that came with your product are the final word.

Frequently asked questions

How long is a multi-dose vial good for once opened?+
CDC says 28 days unless the manufacturer states another date. FDA gives the same 28-day guidance for compounded GLP-1 vials.
Should I use the leftover medicine after 28 days?+
FDA says to throw the vial away after 28 days even if medicine is left, because contamination risk rises over time.
Does a multi-dose vial need a new needle each time?+
Yes. FDA says to use a new sterile needle and syringe for each dose drawn from a compounded multi-dose vial.