Animal User Requirement #5

Title: Determining Expiration Dates for Substances Used in Research Animals

Purpose: To give guidance to all personnel for best practices when it comes to determining expiration dates for commercially available and compounded materials given to research animals at the UW-Madison, and to educate personnel on the correct method for withdrawing liquids from multiuse vials or bags to help maintain them aseptically (see companion SOP).

DIRECTION:

Manufactured drugs

Follow the manufacturer’s/dispenser’s recommendations as printed on the bottle, box, tube or package insert for expiration date and storage conditions. If drugs are placed in a container other than that supplied by the manufacturer, or are altered by diluting or mixing, the new container must be labeled with the name of the substance, the concentration, and an expiration date.

Mixed preparations

When combining or diluting drugs, the smallest amount of a mixed preparation (i.e. only enough for immediate procedures) should be mixed. Leftover mixed preparations must be labeled with the name of the substance(s), the concentration, and an expiration date. If there is published data on the expected time of efficacy for a given drug combination that anticipated expiration date must be used. The expiration date for mixed preparations in which published data is not available must use the earliest expiration date of the component drugs or 30 days from the day of mixing whichever comes first .

If any of the following are noted than the mixed preparation must be discarded immediately:

  • Drug(s) have a change in color.
  • Precipitate or signs of vial/container contamination develop.
  • There is a noted loss of efficacy in the mixed preparation.

Bagged Fluids

If maintained in an aseptic manner:

  • Fluids for intravenous (IV) administration may be kept for 72 hours once an IV line is attached to the bag
    • An exception to this is fluid that contains dextrose or glucose, which must be disposed of after initial use.
  • Fluids for subcutaneous (SQ) administration may be kept for up to two weeks once a line is attached to the bag.
  • Fluids for external (e.g. wound flushing) use with lines attached to the bag may be kept until the bags expiration date if:
    • They remain visibly uncontaminated.
    • Are clearly labeled “For External Use Only”.
  • Fluids for injection without a line attached may be kept up to 30 days from the time of first withdrawal if:
    • They remain visibly uncontaminated.
Fluids for injection (e.g. normal saline, lactated Ringer’s solution) containing any additives must be labeled with the additive and the date the additive was placed in the fluid.

Sterile medical devices, supplies, and surgical packs: Are covered under: Policy 2011-041-v, Storage of Sterile Materials Used in Research Animals. Please see this policy for any questions about sterile medical devices, supplies, and surgical packs.