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Policy#: 529-254

Title: REQUIREMENTS FOR ANIMAL USERS: Expired Medical Material

Effective: 6/8/2023

Link: http://redit.ucr.edu/OrApps/RED/Policies.aspx?k=154

I: Related Policies and Guidance

·         Guidance 529-260 Aseptic Rodent Surgery

·         Guideline 529-349 Rodent Anesthesia and Analgesia

·         Guideline 529-268 for Compounding and Secondary Container Use for Injectable Drugs

 

II: Background

The use of expired medical materials, such as sutures, anesthetics, syringes, fluids, and antibiotics, for survival surgical procedures in animals is unacceptable according to veterinary medicine and when providing adequate veterinary care. For acute terminal procedures, expired medical materials may be used if they do not adversely affect the animal's well-being or compromise the validity of the scientific study. However, drugs used for anesthesia, analgesia, and euthanasia must not be used beyond their expiration date under any circumstances. If researchers utilize expired medical materials, the items should be appropriately labeled and stored separately from non-expired medical materials.
 

III: Policy

Researchers are responsible for establishing and implementing procedures that allow easy identification of drugs and other expired medical materials. This includes dilutions or aliquots, which should also be labeled as described in the IACUC Guideline 529-268 for Compounding and Secondary Container Use for Injectable Drugs. All expired supplies must be labeled "Expired – Do Not Use" and stored separately from non-expired materials if immediate disposal is not possible.

When identifying the expiration date of a drug, the last day of the month stamped on the bottle would be the last month the drug can be used.

Example: Items stamped "3/21" may be used through March 31, 2021, and are outdated on April 1, 2021. Dispose of outdated items appropriately.

With the exception of anesthetics, analgesics, emergency medicine, and euthanasia drugs, expired medical material may be used for non-survival/terminal procedures as long as the following requirements are adhered to:

·         Materials are stored in a different location from materials that have not expired and used for survival procedures.

·         Materials are marked as "Expired – Do not use for Survival Procedures."

·         The use of expired medical materials does not adversely affect the animal’s well-being or compromise the validity of the scientific study.

IV: Removal and Disposal of Expired Medical Material

Researchers should implement a process that facilitates the identification and removal of expired drugs and other medical materials used for research involving animals. This may take the form of using Circle Dot Stickers to easily identify expiration dates or assigning monthly responsibility to one lab member, who would check and properly remove, label, or set aside for disposal all expired drugs. The IACUC reserves the right to make this recommendation a requirement if expired drugs or other medical materials are repeatedly identified in a particular laboratory.

V: References

1. OLAW FAQ, "May investigators use expired pharmaceuticals, biologics, and supplies in animals?"

2. The IACUC Administrators Guide to Animal Program Management, First edition, 2016.

Approved: 5/8/2023