Guideline #15

Use of Expired Medical Materials for Research Animals

1. References: The Guide for the Care and use of Laboratory Animals: Eighth Edition; PHS Policy FAQ F.5 (https://olaw.nih.gov/faqs#/guidance/faqs?anchor=questionuseandmgmt_5)

2. Purpose/Scope: The KSU Institutional Animal Care and Use Committee (IACUC) provisions are as follows:

2.1. Most medical materials (drugs, fluids, disinfectant solutions, catheters, sutures, etc.) are imprinted with an expiration date. Beyond this date, the manufacturer does not guarantee sterility, safety, or stability of the item.

2.2. The use of expired medical materials is NOT considered acceptable veterinary practice and does NOT constitute adequate veterinary care as required by the regulations promulgated under the Animal Welfare Act.

2.3. It is the responsibility of the principal investigator, or other responsible individual, to dispose of all medical materials intended for use in survival procedures after the expiration date. If immediate disposal is not possible, expired supplies must be labeled "Expired - Do Not Use" and stored separately from non-expired materials.

2.4. For acute terminal (non-survival) procedures, where an animal is anesthetized during the study and euthanized without recovery, expired medical materials may be used – if their use does not adversely affect the animal’s well-being, or compromise the validity of the scientific study. Proper anesthesia, analgesia, and euthanasia are required for all such procedures.

2.5. Materials to be used in acute terminal procedures must be labeled “Expired – for non-survival use only,” and segregated in a physically separate location from non-expired medical materials.

2.6. Emergency drugs, euthanasia solutions, and drugs administered to relieve pain or distress, including analgesics, sedatives, and anesthetics, must NOT be used beyond their expiration date. These drugs may lose potency after the expiration date, resulting in unpredictable effects that can jeopardize humane animal use even in a non-survival setting.

2.7. The IACUC and the attending veterinarian (AV) are responsible for ensuring that proposed animal activities avoid, or minimize, discomfort, distress, and pain to the animal. These responsibilities cannot be adequately met unless the AV and the IACUC monitor the use of expired medical materials.

2.8. During the IACUC semi-annual inspection of animal care and use facilities, expired medical materials found will be brought to the attention of the responsible individual.

2.8.1. The IACUC may require on-the-spot removal or disposal of expired medical materials found during its semiannual inspection of facilities – if it is determined that their use is in violation of the USDA policy and/or this IACUC guideline.

2.8.2. The IACUC recommends that researchers develop a plan for routinely checking their inventory to minimize having expired substances. If expired drugs or other medical materials are repeatedly found at a location, the IACUC may make this recommendation a requirement for that location.

 

LAST REVIEWED AND ADOPTED BY THE IACUC: August 4, 2022