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FDA Requirements for Multi-Unit Vials

In busy, cash-strapped hospitals, using a single drug vial for multiple patients can save time and money. If not handled correctly, however, multidose vials raise the risk of potentially disastrous, disease-spreading contamination. To maximize safety, the Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC) and Joint Commission have issued requirements for the correct handling and use of multidose vials. The Safe Injection Practices Coalition has synthesized these requirements into a single resource at http://www.oneandonlycampaign.org.

  1. Infection Control

    • The main hazard of multidose vials is contamination of the drug through repeated access using improper procedures. The result: possible transmission of hepatitis viruses, HIV and other pathogens to patients. According to "Infection Control Resource," contaminated multidose vials caused almost 30 widespread infections between 1983 and 2003.

      To avoid contaminating a drug--and possibly transmitting disease--the CDC recommends using single-dose vials whenever possible. If you must use a multidose vial, restrict its use to a single patient, if possible, and make sure to follow the required administration procedures.

      Remember that although a multidose vial may be used multiple times, needles and syringes may not. The CDC and Joint Commission--the agency that accredits hospitals--require that you use a new, sterile needle and syringe every time you access a drug vial. This requirement applies even if you're injecting the drug into an IV port and not directly into the patient's bloodstream. You must discard both needle and syringe after a single use, even if future injections are intended for the same patient.

      Also remember to always use aseptic technique. Don't touch or otherwise contaminate a drug vial's diaphragm before inserting the needle.

      Check to see if the vial must be refrigerated after first use. Also check the package instructions to see how the storage temperature should be monitored.

    Timely Disposal

    • The FDA requires that drug makers label each vial--including multidose vials--with an expiration date. However, that date applies only until the first dose is withdrawn. Once you pierce a vial's diaphragm, you ordinarily have only 28 days before you must discard the vial and any drug left in it. When you take the first dose from a multidose vial, you'll need to label the vial with a discard date that's 28 days later.

      In some cases, the discard time may be shorter or longer than 28 days--if the drug maker's expiration date is sooner than that, for instance, or if the maker specifies a longer time based on FDA-approved research. Vaccines are exempt from the 28-day requirement and can be used until the end of the month shown in the drug maker's expiration date unless directed otherwise on the package.

    Hospital Policy

    • Most hospitals have policies for multidose vials based on Joint Commission requirements. Make sure you're familiar with the policy at your hospital or agency.

      To help ensure the correct use of multidose vials, the Safe Injection Practices Coalition suggests designating an infection control officer, developing a written infection control policy, and training agency staff in infection control.

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