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Unexpected Unavailability of Commonly Used Therapeutic Drugs/Materials

Purpose

There are times when the IACUC approves protocols that include the use of common therapeutic drugs or materials, but subsequently, these drugs or materials become either temporarily or permanently unavailable. This could be due to various reasons including, but not limited to: a company discontinues production of the drug/material, a company changing the product in some what that makes its use unacceptable, a back-order on a drug, or an inordinate price increase of a product which essentially makes the product unavailable for use.

In order to help researchers maintain compliance with federal regulations when faced with this type of difficulty, and its implications for the affected animal care and use protocols, the UConn Health IACUC has instituted a policy on unexpected unavailability of commonly used therapeutic drugs and materials.

Action

1. When a researcher discovers that a drug or material is not available, he/she must consult with the Attending Veterinarian (AV) who will determine acceptable alternatives. These alternatives will be based on scientific requirements of the affected research protocol(s), the clinical requirements of the animals, and the professional judgment of the AV.

2. The AV will be responsible for informing the research community of the alternative(s) available for any drug or material used at the institution that is temporarily or permanently unavailable through the CCM pharmacy. It is the responsibility of the PI to consult with the AV to determine which alternative is best for his/her protocol(s).

3. If the drug/material is permanently unavailable, the IACUC gives authority to the AV to authorize changes to the affected protocols without a modification being immediately submitted to the IACUC. The AV will notify the IACUC Administrator of these instances. A modification will be required at whichever of the following instances first occurs during the course of the affected protocol:

  • Submission of the annual review of the protocol;
  • Submission of the 3 year renewal of the protocol; or
  • Submission of another required modification to the protocol.

4. If the drug/material is temporarily unavailable, the IACUC gives authority to the AV to authorize changes to the protocols without a modification being submitted to the IACUC, but the PI must work with the AV to assure a return to the original drug or material when that drug or material again becomes available. The AV will notify the IACUC Administrator of these instances.

5. This policy dos not allow for the change in an experimental drug without a modification being submitted to, and approved by, the IACUC.

This Policy has been approved by a majority vote of the IACUC members.

Effective Dates: April 26, 2018 thru March 31, 2021