We know that you rely on us – your Animal Care & Use Program partners – to provide the tools and resources necessary for safeguarding animal welfare while conducting sound scientific research.
While it is clear that the administration and/or use of expired drugs and other substances can endanger animal health and compromise the validity of your results, navigating the many nuanced requirements for the proper management, storage, and maintenance of these materials may be challenging and, at times, confusing.
After extensive fact-finding and assessment, our Institutional Animal Care & Use Committee (IACUC) has approved several revisions to existing policies and guidelines to more clearly articulate programmatic expectations for the appropriate storage, labeling, and use of expired drugs and other medical materials in animal activities.
We ask that all individuals who handle or work with animals as part of their research operations review the following documents carefully to ensure that they understand their individual roles and responsibilities:
- Policy on the Use, Storage, and Expiration of Substances, Agents, and Medical Materials Used in Animals
- Guidelines on the Preparation of Injectable Substances and Agents Administered to Animals
For convenience, key policy and guideline changes are also summarized below in order of their potential impact(s) on daily research activities. All changes are effective immediately.
Summary of Key Changes & Expectations
Interest Area
Summary of New/Revised Expectations
Policy Title/Overview
All requirements related to the expiration, storage, and labeling of substances, agents, and medical materials can now be found in the renamed Policy on the Use, Storage, and Expiration of Substances, Agents, and Medical Materials Used in Animals
Preparation of Injectable Substances and Agents Guideline Title/Overview
Guidelines for aseptic preparation of injectable substances and agents can now be found in the renamed Guidelines on the Preparation of Injectable Substances and Agents Administered to Animals
Expiration and Use-By-Dates
Provided additional clarification on the following:
- Consistent with federal regulatory expectations, substances and agents expire in accordance with whichever date occurs first: Manufacturer-Provided Expiration Date or Use-By-Date
- Sterile bags of fluids accessed and/or connected directly to an animal through the use of an intravenous line/administration set have a Use-By-Date of 30 days after initial package/vial puncture, unless an earlier date is noted by the manufacturer
- NO expired agent or substance can be used as a stand-alone product or in any dilution in an animal activity
Product Dilutions
The U-M requirement that product dilutions expire 30 days after preparation has been eliminated. According to federal regulations, all manufacturer expectations, such as Use-By-Dates, must still be followed.
Guidance on how to identify when a diluted preparation displays signs of compromised integrity and should be discarded can be found in Section 9 of the Guidelines on the Preparation of Injectable Substances and Agents Administered to Animals.
Labeling Vials/Containers
Requirements can now be found in the Policy on the Use, Storage, and Expiration of Substances, Agents, and Medical Materials Used in Animals, which states that:
“all substances and agents must be labeled with their full name, concentration, and the relevant Expiration or Use-By-Date.”
Storage Requirements
Further clarified that ALL agents and substances must be stored according to manufacturer expectations, U-M requirements, and State of Michigan/DEA regulations.
Storing Medical Materials
Clarified that all materials must be stored according to manufacturer guidelines, in addition to existing policy language which states that:
“Expired medical materials must:
- Only be used in non-recovery procedures/surgeries,
- Be labeled as expired, and
- Stored separately from non-expired items”
Where to Get Additional Assistance
Members of both our veterinary care and compliance teams are available to answer any additional questions or concerns you may have about these changes.
- Questions about the use of specific drugs or other medical materials in animals should be directed to your ULAM Faculty Veterinarian.
- If you would like assistance with establishing a system to monitor for expired materials in your laboratory, please contact the Quality Assurance Team in the Animal Care & Use Office at [email protected].
Thank you for continuing to make the proper storage, administration, and use of drugs and other medical materials in animals a priority in your laboratory.