IACUC POLICY ON EXPIRED DRUGS AND MATERIALS FOR ANIMAL RESEARCH (Revised January 2009)

To be in compliance with USDA Policies and the Animal Welfare Regulations, and NIH Guidelines, UCSF's Institutional Animal Care and Use Committee (IACUC) has in effect the following policy:

1. No expired drugs or fluids are allowed for use on animals in research or instruction. All expired drugs, including anesthetics and analgesics, must be discarded on or before their date of expiration. No expired drugs are allowed for use on animals, even for terminal procedures.

2. All dilutions and mixtures of drugs are to be discarded after one month from the date of preparation unless a longer dilution shelf-life is specified by the manufacturer. Dilutions and mixtures of drugs may change the chemical composition of a drug and could alter its shelf life. For this reason, even if it is earlier than the manufacturer’s drug expiration date, all dilutions or mixtures made from a drug must be discarded after one month.

3. No expired medical materials or devices may be used beyond their expiration date; they must be separated from other materials and discarded. The one exception to this is use for acute terminal procedures, if the attached form is submitted to and approved by the IACUC. See IACUC Guidelines for the Use of Expired Medical Materials or Devices in Acute Terminal Procedures in Animals Used in Research or Instruction

4. Only pharmaceutical grade drugs or fluids are allowed for use on animals in research or instruction. In compliance with the NIH and USDA regulations, non-pharmaceutical grade drugs, such as those purchased through Sigma, are to be used only when there is no pharmaceutical grade alternative available. If your study requires the use of non-pharmaceutical grade compounds, use should be justified in section I of the RIO protocol. Please see the UCSF Guidelines on Reconstituting Non-Pharmaceutical Grade Compounds.

5. The IACUC recommends that each laboratory establish an inventory procedure to facilitate the identification and discarding of expired drugs. Disposal services for expired drugs and/or controlled substances are available at no cost to the investigator by calling EH&S at 415-476-0544.

6. All medical materials and supplies used in live animals, including acute procedures, should be individually labeled. If items are not individually labeled, they must be kept in a drawer, bin, cabinet or other container clearly labeled with the PI’s name. The LARC area supervisor in LARC shared procedures rooms, or the Principal Investigator for all other shared-use laboratories, shall be authorized to discard materials which cannot be clearly identified by owner, whether or not they have reached their expiration date. EH&S will be contacted to arrange for disposal of unidentifiable contents.

7. Any incident of noncompliance with this policy will be referred to the Institutional Animal Care and Use Committee and appropriate sanctions will be applied, up to and including suspension of the approval of the research protocol for which the expired drug or material is being used. Any expired drugs or materials identified or discovered during inspections will be discarded immediately.

Guidelines for Implementation:
The following are general guidelines suggested to implement this policy:
1. Store all drugs in one location (to make checking easier). Please contact LARC if you would like assistance in obtaining a lockable box for your drugs.
2. Consider assigning the inventory responsibilities to one specific individual, with another individual assigned as backup.
3. Establish an inventory system which minimizes the amount of drug or medical supplies on hand.
4. Perform regular monthly checks of your inventory and discard all expired drugs or medical materials.
5. Contact your suppliers to see if they will accept the return of some expired drugs or medical supplies for credit. Some do.
6. Place all expired drugs and medical materials in a clearly labeled container while they await pickup for disposal or return to manufacturer.

For questions about this policy, call the office for Institutional Animal Care and Use Committee Office at 476-2197.

To arrange for disposal of all expired drugs or medical supplies, contact EH&S at 415-476-0544.