NC State IACUC Standard on the Use and Expiration of Medical Materials

All drugs and sterile medical devices intended for use in live animals must be marked with an expiration date.

All expired materials, drugs, supplies, devices, that are to be kept in inventory and used for non-survival procedures must be clearly and individually labeled as “expired materials–for non-survival use only” and be kept together in an area physically separate from all other medical materials and drugs.

Expired materials may only be used for non-survival procedures where the use would not compromise the experiment.

Medical materials should be inspected every 30 to 60 days to identify and discard expired items.

Manufacturer recommendations must be followed for storage temperature and expiration date. If drugs are placed in another container that is not the original from the manufacturer it must be labeled with the name of the substance, the concentration, and an expiration date. Drugs for parenteral administration must be sterile and may not be aliquoted into non-sterile containers. Drugs that are diluted or mixed may be kept for up to 30 days. If peer-reviewed evidence is available for longer stability and efficacy that evidence must be provided in the protocol to keep solutions past 30 days.

Dilution, mixing, or transfer to a new container may cause the drugs to lose potency or degrade due to a change in pH, buffering, atmosphere (some drugs are packed under special gases), or precipitation. In addition, drugs that are not kept in a sealed, sterile container may become contaminated and subject to bacterial degradation. Many drugs are incompatible with other agents and cannot be mixed.

Prepackaged sterile medical devices must follow their printed expiration. Sterile devices may not be used for survival procedures after their expiration date. Items must be discarded or re-sterilized if applicable.

Instruments or supplies by must marked with the date that sterilization occurred and an external indicator. Items must be stored off the floor (at least 8 inches away)  in a closed container (cabinet) to avoid being contaminated. If packs are overhandled, become wet, fall on the floor, or are torn they are considered contaminated and must be resterilized in new material.  This covers cloth and paper wrapped items and items sealed in sterilization pouches. Shelf life is dependent on quality of wrap, storage conditions, and frequency of handling. If time-related storage of sterile items is used in a facility then the item must be labeled with an expiration date.

Single-use needles, as designated by the manufacturer, may not be reused. Multiple-use needles, like oral gavage needles, must be disinfected or sterilized (if appropriate) after each animal or animal group/cage (mice/rats).

Drug Mixtures and Non-Manufactured Drugs – All drug mixtures for parenteral administration must be sterile and prepared aseptically; if aliquote into a secondary container, sterile containers must be used. Drug mixtures for oral administration do not need to be sterile. Frozen aliquots can usually be kept indefinitely at -80°C or 24 hours at room temperature.

In general, IV fluid bags that have been punctured and delivered directly to the patient through a fluid line are considered expired after 24 hours of use if unrefrigerated, or 1 week if kept in a refrigerator. Fluid bags may be maintained as a sterile multi-use container for up to 30 days after puncture, as long as it is drawn up with a sterile needle. The punctured or open day must be marked on the bag.

If a drug is aliquoted unchanged into a sealed, sterile container then it will keep it’s original expiration date. The secondary container material must match the original container (e.g. glass or plastic). Drugs that come in dark containers must be covered in foil or an alternative light blocking material and stored in a dark area.

If drug mixtures or dilutions are compatible then their expected expiration is 30 days. If there is peer-reviewed evidence to extend the shelf life then that evidence must be provided in the protocol.