BACKGROUND

Per the Guide for the Care and Use of Laboratory Animals and the USDA Animal Welfare Act Regulations, all drugs used in conjunction with animal research must be used before their expiration dates and should be acquired, stored, their use recorded, and disposed of legally and safely. This includes any drugs that need to be diluted or compounded.  Compounding is defined as combining, mixing, or altering ingredients of a pharmaceutical grade drug to create a medication tailored to the needs of an individual.

IACUC Policy

Drug Dilution

If you need to compound a drug for injection accuracy, aseptic techniques are to be followed.  Drugs requiring dilution are to be mixed with an appropriate diluent in a separate sterile container to reach required working concentration. The compounded drugs’ container must be sterile, and opaque if compounding light sensitive drugs. Eppendorf tubes or screw cap test tubes do not provide a secure aseptic access barrier for extended storage and cannot be used for this purpose. Empty sterile containers with a rubber cap should be used as allows aseptic mixing and multi-access of your compounded drug solutions. The top of the container should be disinfected with 70% alcohol on clean gauze prior to accessing with needle and syringe. Post-compounding, containers should be stored in a dark place when not in use.  Exceptions to this guideline require IACUC approval.

The label on the container of the compounded drug must include:

• Full name of the drug/compound with final concentration.
• Preparation date and initials of preparer.
• Expiration date of diluted or compounded substances is 30 days from the date of preparation or sooner per manufacturer recommendations.

Use of Expired Materials

Each lab must identify one individual within the lab to track materials within the lab that have expiration dates and oversee the proper disposal of the expired materials.  This individual should be identified in the IACUC protocol by including the duty under “Responsibilities for this Protocol” in the “Personnel Information” section.

All drugs must be discarded on or before the manufacturer’s expiration date.  Additionally, bags of fluids and sterile vials are considered expired one month (30 days) after first needle puncture).  No expired drugs or fluids are allowed for use on animals for research or instruction.  Expired drugs and materials must be clearly labeled as expired and stored separately from non-expired materials.

Expired anesthetics, analgesics, and euthanasia solutions must never be used and must be disposed of properly.

Some expired materials may be used in non-survival procedures, but sterility of these expired materials must be maintained if they are intended for use in animals. These materials include:

• Medical Materials (e.g., catheters, suture, sterile gloves)
• Medications (e.g., antibiotics, fluids)

If there is a question about whether or not an expired material/medication could have a negative impact on an animal, please contact a DLAR veterinarian.

Disposal of expired materials

Controlled substances:

Expired controlled substances must be kept secure in a locked drawer/cabinet that can only be accessed by the License Holder or authorized users.

Expired controlled substances must be clearly labeled as expired, kept secure, and segregated from non-expired controlled substances.

Contact the Office of Environmental Health and Safety (OEHS) for pick-up of expired controlled substances.

Medications:

Contact the Office of Environmental Health and Safety (OEHS).

Non-medical Materials (e.g. cleaning products):

Contact the Office of Environmental Health and Safety (OEHS) or refer to the package insert for proper disposal.

Medical materials and other waste:

Review the Biological Waste Disposal Chart provided by OEHS for disposal guidelines of both contaminated and uncontaminated materials. Additional information on the disposal of hazardous materials can be found on the OEHS website.

Approved: December 2012

Revisions Approved: 10/2017, 12/2019, 6/2020, 4/2024