Date: October 1998
Reference:   Administrative Panel on Laboratory Animal Care

DIRECTIONS: Review the following material. Keep copies of guidelines with applicable protocols. You may find it helpful to post a copy of these guidelines in your laboratory. Questions should be forwarded to the A-PLAC office, 723-4550.

TRAINING: Training in these techniques and the humane treatment of laboratory animals during the procedures is taught by the Veterinary Service Center (VSC) staff. All new personnel who will be performing these techniques should contact VSC staff for training (723-6735).

Most medical materials (e.g., drugs, fluids, disinfectant solutions, catheters, sutures, etc.) are imprinted with an expiration date, beyond which the manufacturer does not guarantee the safety or stability of the item. Use of expired materials without justification is considered inadequate veterinary care under the federal Animal Welfare Act. Since it is recognized that in some specific situations there may be a rationale to utilize expired materials (e.g., the items would be difficult to replace and there is reason to believe they should be considered safe), the A-PLAC has established the following guidelines for the conditional use of expired medical products.

1. DRUGS USED TO ALLEVIATE PAIN. It is unacceptable to use outdated anesthetics, analgesics, or other pharmacological agents on any animal. These materials may lose potency or degrade to toxic byproducts if stored after the expiration date, resulting in unpredictable effects which can jeopardize humane care even in a nonsurvival setting.
   
   
2. EXPIRED MATERIAL USE IN SURVIVAL STUDIES. In general, materials should not be used beyond the expiration date on any research animal that is unanesthetized or is to recover from an anesthetic procedure. If there is a need to utilize expired materials in a survival procedure, the protocol director (PD) should specifically provide this justification to the A-PLAC in a formal request for approval.
   
   
3. EXPIRED MATERIALS IN NONSURVIVAL STUDIES. When a nonsurvival procedure is being performed on an anesthetized animal, it may be appropriate to utilize expired IV support fluids (i.e., saline, electrolyte solutions, purified water, 5% dextrose, etc). These materials can be used only if the PD determines that use of expired materials would not be expected to jeopardize research results or have a negative impact on the physiology of the animal. If there is a need to utilize expired pharmaceutical compounds, the PD should specifically request approval for this use from the A-PLAC in writing.
   
   
4. STERILITY DATING. Items such as catheters, surgical instruments, sterile gloves, suture materials, and pressure transducers are often labeled with an expiration date to assure sterility. In general, after the expiration date these materials should be used only in procedures involving anesthetized animals in nonsurvival studies. If needed for survival studies, outdated items (or any items which may no longer be sterile) should be repackaged and resterilized before use. Resterilized items should be labeled with a new expiration date that is appropriate for packaging used. If the investigator obtains information from the manufacturer which documents that a particular material or instrument has been shown to remain sterile beyond the date on the packaging, a request to use the item in survival studies can be considered by the A-PLAC.
   
   
5. SEGREGATION. All expired materials that are to be kept in inventory and used as described above must be clearly and individually labeled as "Expired--for conditional use only" and be kept together in an area physically separate from all other medical materials and drugs. The area (drawer, cabinet, shelf, etc.) in which they are kept must also be labeled "Expired--for conditional use only." The use of computer-generated preprinted labels may make this process easier.
   
   
6. INVENTORY. In order to assure that expired items are identified in a timely fashion so that they can either be discarded or appropriately labeled for conditional use, each research group is strongly encouraged to inspect their drug storage areas on a regular basis (i.e., every 30 to 60 days). Experience at Stanford has shown that those labs which assign the responsibility for this task to one specific person have fewer problems with expired materials when inspected by the A-PLAC or outside agencies such as the USDA. A simple system using color-coded stickers can easily be instituted (contact the Veterinary Service Center for more information).