Policies

Policy on the Use and Storage of Expired Drugs and Medical Materials in Animals

Institutional Animal Care & Use Committee

Aug 26, 2022 12:00 pm

This policy defines the expectations for the appropriate use and storage of expired drugs and medical materials.

Purpose

This policy defines the expectations for the appropriate use and storage of expired drugs and medical materials.
Applicability

This policy applies to research, teaching, and testing activities involving animals, conducted under the auspices of the U-M. It applies to field research and all campus locations, including Ann Arbor, Flint, and Dearborn.
Glossary Definitions
Non-Recovery Surgery

A surgical intervention in which an animal is euthanized before recovery from anesthesia.

Analgesia

Provides pain relief without loss of consciousness.

Related Terms:
Systemic Analgesic Pre-emptive Analgesia Multimodal Analgesia Anesthesia A/A

Anesthesia

This encompasses both of the following definitions:

Local Anesthesia: Temporarily induces loss of sensation to a specific part of the body. May provide pain relief.

Systemic Anesthesia: Temporarily induces loss of sensation with loss of consciousness. Only provides pain relief due to or during loss of consciousness.

Related Terms:
Local Anesthetic Surgical/Anesthetic/Sedation Record Analgesia A/A

Expiration Date

A date after which something must no longer be used.

Items marked month/day/year are expired the next day (e.g., a drug marked 11/2/2020 is expired on 11/3/2020).

Items stamped month/year are expired the first day of the next month (e.g., a suture marked 11/2020 is expired on December 1, 2020).

Some medical devices or materials may have a production date, and not and expiration date. Users must follow the manufacturer’s directions regarding appropriate use timelines.

Items that have been sterilized by laboratories should follow the Guidelines for the Storage of Sterile Items, which states that items will remain sterile indefinitely unless the packaging is damaged.
Policy
Expired fluids, vehicles, biologics, and drugs, including all anesthetics, analgesics, euthanasia agents, pharmaceuticals, therapeutics, and non-pharmaceutical grade drugs, cannot be administered to or used in animals for any experimental or veterinary procedure, including euthanasia.

These items must be clearly labeled as expired and segregated from non-expired items until they can be appropriately discarded.

Information on the preparation, storage, and expiration of Pharmaceutical grade drugs and sterile fluids can be found in the Guidelines on the Preparation, Storage and Expiration of Injectable Medications.

Expired controlled drugs and substances must be stored securely and according to U-M requirements and State of Michigan and DEA regulations.

More information on controlled substances can be found at https://research-compliance.umich.edu/maintain-security-storage-controls

Expired surgical materials and supplies, such as suture, gauze and catheters, can be used for non-recovery surgeries or anesthetic events (i.e., surgery, procedure or anesthetic event in which the animal is euthanized prior to recovery from anesthesia), provided that their usage does not adversely affect the animal’s well-being or potentially compromise the validity of the scientific study. These items must be:

Clearly labeled (e.g., “Expired: non-recovery use only”).

Segregated from non-expired items to avoid accidental use in recovery procedures.

Stored according to manufacturer’s recommendations.
Compliance

The provisions of this policy are under the direction and oversight of the U-M’s IACUC. The IACUC will, if necessary, suspend research or implement sanctions if policy infractions should occur.

Topic: Anesthesia and Analgesia Euthanasia Surgery

Questions?

For questions, additional detail, or to request changes to this policy, please contact the Office of the Assistant Vice President for Research, Director of the Animal Care and Use Office at acuoffice@umich.edu or (734) 763-8028.