Purpose
This policy establishes limitations on usage of expired drugs and medical materials in animal research to protect the health and welfare of research animals and to ensure compliance with applicable federal, state, and local regulations. It also provides guidance for establishing expiration dates based on dilution and/or reconstitution.
Definitions
- Medical supplies:
- Any non-bioactive materials used to position, restrain, clean/disinfect, or handle the animal or the substances being given to the animal. This also includes any material that comes into direct contact with the animal. This includes, but is not limited to, items such as gloves, syringes, needles, gauze, suture material, catheters, etc.
- Equipment:
- Any instrument, device, or implant used to facilitate administration of substances or facilitate monitoring, imaging, etc. This includes, but is not limited to, items such as anesthetic vaporizers, stereotaxic devices, radiograph machines, etc.
- Substances:
- Anything that is given to the animal by any route (including topical). This includes experimental substances, clinical treatments, fluid replacements, as well as food items.
- One Month:
- Period defined by identical numerical dates of consecutive months (e.g., March 15th to April 15th) or a 31-day period, whichever is longer.
- Parenteral Administration:
- Any route of administration other than by mouth and includes intravenous (IV), intraperitoneal (IP), intramuscular (IM), subcutaneous (SQ), intraosseous (IO), ocular, or topical administration.
- Fluids for Parenteral Administration:
- Unaltered fluids administered as provided by the manufacturer (e.g. 0.9% NaCl, Lactated Ringers Solution, Hetastarch, PBS, etc).
- Mixtures or dilutions:
- Any products that are altered in any way from their original state by mixing solutions together or adding a solute to a liquid solution (e.g. diluting enrofloxacin by adding saline, mixing ketamine with xylazine, adding potassium to saline, etc).
- Note: Some compounds may be marketed as a powder that requires reconstitution after purchase. These should be reconstituted as per label directions, and the expiration date specified in the product instructions may be used.
Background
The use of expired medical supplies and substances is not considered to be acceptable veterinary practice and does not constitute adequate veterinary care as required by current animal care and use regulations. The use of expired anesthesia, analgesia, or euthanasia agents is prohibited. Other expired materials should not be used unless the manufacturer verifies efficacy beyond the expiration date, or the investigator is able to document to the satisfaction of the IACUC that such use would not negatively impact animal welfare or compromise the validity of the study.
Policy
Expired drugs, substances, or medical supplies are generally not allowed for use in live vertebrate animals or cephalopods. Under no circumstances may expired anesthetics, analgesics, and agents of euthanasia be used. Some expired medical supplies or substances may be used for acute terminal studies in which the health and well-being of the animal is not affected, and the scientific integrity of the experiment is not jeopardized. Their use must be specifically described and approved in the IACUC protocol.
All expired substances and supplies should be discarded on, or before, the expiration date if possible. If not immediately discarded, items must be clearly labelled (e.g., “Expired; not for use in animals”) and stored separately from in-date items. Expired controlled substances must remain in storage that meets DEA regulations and must be clearly labelled. Expired controlled substances must be disposed of by Reverse Distribution; contact UW Drug Services at drugsvcs@uw.edu for information about opportunities for reverse distribution.
Expiration dates will be enforced as described below. Exceptions to the manufacturer-recommended dates may be considered on a case-by-case basis if published scientific literature supports that use of alternate expiration dates. These exceptions must be reviewed and approved by the IACUC.
- For any substances or supplies with a pre-determined manufacturer’s expiration date, the enforced expiration date is the pre-printed date on the label unless the label specifies a date determined by reconstitution or puncture date.
- Items with expiration dates determined by puncture or reconstitution must be labelled with the date of puncture/date of reconstitution and new expiration date.
- Mixtures or dilutions of substances must be labelled with an expiration date of one month after mixing/diluting or with the manufacturer-determined expiration date of any of the components, whichever is soonest.
- Expiration dates of fluids for parenteral administration are determined by intended route of administration and storage conditions. Fluid containers (vials or bags) must be labelled with the date opened/punctured and expiration date as outlined below.
- Fluids used for IV or IP administration expire the same day as use.
- Fluids used for SQ administration expire one month after puncture if in multi-use vials. Fluids in bags expire the same day as puncture if stored at room temperature, or in two weeks if refrigerated. Fluids should additionally be labelled “Not for IV/IP use” or “SQ Use Only”.
- Fluid bags or vials intended for topical administration expire one month after puncture. Fluids for topical use stored in syringes expire 2 weeks after the syringe is filled. Fluids intended for topical use may be stored at room temperature (unless specified otherwise by manufacturer) and must additionally be labelled with “For Topical Use Only”.
- Autoclaved items in sterilization pouches do not require labelling with expiration dates. Items within packaging remain sterile until packaging is damaged in any way (e.g., torn, wet, or discolored).
- Medical equipment with maintenance, calibration, or certification requirements are considered expired and must not be used if this due date has passed. Examples of types of equipment with required maintenance include, but are not limited to, anesthesia vaporizers, fume hoods, and some radiation-emitting equipment.
References
- OLAW FAQ, “May investigators use expired pharmaceuticals, biologics, and supplies in animals?”
- Public Health Service Policy on Humane Care and Use of Laboratory Animals, Office of Laboratory Animal Welfare, National Institutes of Health, United States. Department of Health and Human Services. Washington, D.C., 2015.
- Guide for the Care and Use of Laboratory Animals. 8th ed., National Research Council. Washington, D.C., The National Academies Press, 2011.
- Matthews, K. A., & Taylor, D. K. (2011). Assessment of sterility in fluid bags maintained for chronic use. Journal of the American Association for Laboratory Animal Science: JAALAS, 50(5), 708–712.
Approval/Review Dates
Originally Approved: 01/18/2001
Last Reviewed/Revised by the IACUC: 09/21/2023