Policy on Expired Drugs and Expired Pharmaceutical Grade-Compounds Used in Research, Teaching, and Testing

Reference(s):

• USDA Animal Care Resource Guide Policies AC 3.1. Policy: Expired Medical Materials; Policy: Pharmaceutical-Grade Compounds in Research

Background:

According to the federal regulations promulgated under the Animal Welfare Act and enforced by the USDA, the use of expired medical materials such as drugs, fluids, or suture material is not acceptable veterinary practice and does not constitute adequate veterinary care. Exceptions can only be made with specific approval by the IACUC.

Policy:

• Expired medical materials are not to be administered to animals. Exceptions may only be allowed after IACUC review and approval. Exceptions granted by the IACUC will be based scientific value and justification. Drug costs or convenience will not be considered reasons to permit their use.
• Expired medical materials must be discarded or segregated in an appropriately labeled, physically separate location from non-expired materials.

Investigator Responsibility:

• The principal investigator is responsible for ensuring that no medical materials administered to animals by his/her lab personnel are expired.
• The investigator must allow both internal and external inspectors access to medical material storage areas.
• Expired medical materials should be discarded according to campus regulations, or stored separately and labeled as expired.

Animal Facility Responsibility:

• The veterinary staff is responsible for ensuring that no expired medical materials are used for clinical cases.
• The animal facility and farm managers are responsible for ensuring that no expired medical materials are stored in the animal facility or farm.
• Expired medical materials should be discarded according to campus regulations, or stored separately and labeled as expired.

IACUC Responsibility:

• The IACUC is responsible for implementation and oversight of this policy.
• The IACUC is responsible for semi-annual inspections of the animal facilities and farms to ensure that no unapproved expired medical materials are present.

Approved by the IACUC – December 2, 2003