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Institutional Animal Care and Use Committee

Guideline #15

Use of Expired Medical Materials for Research Animals

1. References:  USDA Policy #3

2. Purpose/Scope: The KSU Institutional Animal Care and Use Committee (IACUC) Guideline for use of Expired Medical Materials closely mirrors the current USDA Policy #3 on use of expired medical materials. The 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 to be 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 either dispose of all such materials or appropriately label them as “expired – for non-survival use only,” and segregate them in a physically separate location from non-expired medical materials.

2.4. For acute terminal procedures, 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. Drugs administered to relieve pain or distress, and emergency drugs, 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.

2.6. Facilities allowing the use of expired medical materials in acute terminal procedures should have a written policy covering the use of such materials, and/or require investigators to describe in their animal activity proposals the intended use of expired materials.

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 may ask the researchers to develop a plan for routinely checking their inventory to minimize having expired substances.

3. Supersedes: IACUC Guideline #15: Use of Expired Medical Materials for Research Animals 07/21/2011.