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Policy: Use of Expired Drugs and Materials and Use of Non-Pharmaceutical–Grade Compounds in Animals (IACUC)

Policy: Use of Expired Drugs and Materials and Use of Non-Pharmaceutical–Grade Compounds in Animals (IACUC)

Policy

  • Pharmaceutical-grade compounds and medical-grade materials should be used in live animal procedures.
  • Non-pharmaceutical–grade compounds or drugs may be used only if an acceptable veterinary or human pharmaceutical grade product is not available.
  • Euthanasia, anesthesia, and analgesia agents may not be used beyond their expiration date, even for a terminal procedure.
  • Expired medical materials other than these agents may be used for terminal procedures if their use does not adversely affect animal well-being or compromise scientific validity.
  • Expired medical materials must be discarded or segregated in an appropriately labeled, physically separate location from non-expired materials.
  • Exceptions may be granted by the IACUC based on scientific necessity.

Background

Federal regulations indicate non-pharmaceutical-grade chemical compounds may only be used in animals after specific review and approval by the Institutional Animal Care and Use Committee (IACUC) for reasons such as scientific necessity or non-availability of an acceptable veterinary or human pharmaceutical-grade product1,2. Cost savings or convenience are not adequate justification1,2. Federal regulations1,2,3 also prohibit the use of expired medical materials such as drugs, fluids, or sutures. Such use is not acceptable veterinary practice and does not constitute adequate veterinary care as required by the Animal Welfare Act1,3.

Definition of “Drug” and “Medical” Material

The Federal Food, Drug, and Cosmetic Act4 indicates drugs or medical devices are articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or animals and articles (other than food) intended to affect the structure or any function of the body of man or animals. Pharmaceutical and medical materials are usually identified regarding intended use and usually have a manufactures’ expiration date. A package label or insert stating the item “is not intended for diagnostic use” or something similar indicates the product is not pharmaceutical or medical grade.

Records and Disposal of Drugs

Holders of Drug Enforcement Agency (DEA) and State of Illinois controlled drug licenses are required to keep detailed records of every use of the controlled drugs, and to follow specific procedures for disposal when the drugs expire or are no longer needed5,6,7. Expired drug containers should be clearly labeled “Not to be used.”

Responsibilities

Principle Investigator:

  • The principal investigator is responsible for ensuring that only pharmaceutical grade compounds and medical grade materials are administered to animals by project personnel.
  • The investigator and project personnel must allow internal and external inspectors access to drugs, materials, and storage areas.
  • Expired drugs or medical materials should be discarded according to campus regulations or stored separately and labeled as expired.
  • Because federal regulations require that “all expired medical materials found in a licensed or registered facility are to be brought to the attention of the responsible official” and because compliance with federal regulations is a condition of animal use, investigators and project personnel are responsible for bringing any expired materials in shared facilities to the attention of the person responsible for disposal.

IACUC:
The IACUC is responsible for implementation and oversight of this policy. The IACUC is responsible for semi-annual inspections of the animal facilities and farms to ensure that no non- pharmaceutical or unapproved expired medical materials are present.

Agricultural Animal Care and Use Program (AACUP):
AACUP veterinarians can assist investigators with the use of anesthetics and analgesics and other drugs in approved protocols. AACUP also provides consulting and training to investigators regarding drug use. 

Division of Animal Resources (DAR):
DAR maintains a DEA license and can provide investigators with drugs as well as assisting investigators with use of drugs in approved protocols. DAR also provides consulting and training to investigators regarding use of anesthetics and analgesics.

Exceptions

Exception for the Use of Non-Pharmaceutical Grade Sodium Pentobarbital for Perfusion/Euthanasia
On March 1, 2012, the representatives of OLAW, USDA, and AAALAC, Int’l. presented a webinar in which they clarified policies regarding non-pharmaceutical grade pentobarbital for use as a euthanasia agent accompanied by perfusion. They acknowledged that the exorbitant cost of pharmaceutical grade Nembutal (sodium pentobarbital) made it logistically unavailable. They also indicated that terminal perfusion not preceded by other experimental procedures could be considered euthanasia, and that non-pharmaceutical grade could be allowed if scientifically justified and approved by the IACUC. They indicated that the IACUC could craft a general policy, rather than reviewing each case.
The U of I IACUC will allow non-pharmaceutical grade sodium pentobarbital to be used for terminal perfusion when the preparation, storage and handling procedures which generally apply to non-pharmaceutical grade drugs, are followed. The recipe and instructions for such preparation are presented at the end of this policy. Researchers intending to use non-pharmaceutical pentobarbital in IACUC protocols must clearly state that they have read this policy and will use the indicated recipe and instructions for use, and will describe and justify any planned deviations from it.

Sodium Pentobarbital Recipe

IACUC Approved Recipe for Sodium Pentobarbital
Ingredients:
6 grams sodium pentobarbital
10 ml ethanol (95%)
40 ml propylene glycol USP
qs to 100 ml with 0.9% saline

1. Dissolve the pentobarbital powder in the ethanol.
2. Add 25 ml of saline (but only after the pentobarbital is completely dissolved), mix thoroughly.
3. Add 40 ml propylene glycol, mix.
4. Bring to final volume (100 ml) with 0.9% saline.

The pentobarbital concentration in the final solution is 60 mg/ml. Standard dose of 50 mg/kg i.p. in rats.

Notes
1. Stock solutions must be protected from light and maintained at 4°C no longer than 6 months.
2. Stock solutions must be passed through a sterile 0.2 micron filter prior to being stored.
3. Stock solutions must be prepared and stored in sterile tubes.
4. Working solutions can be prepared and maintained similar to stock solutions, but can be stored at room temperature for up to 30 days.
5. Transfer of solutions must utilize sterile supplies and techniques (e.g. sterile needles and syringes).
6. All containers must be labeled with material name, concentration, date prepared, storage requirements, expiration date, and the initials of the person making the solution.
7. Use must be recorded similar to other controlled substances.
8. Standard procedures for monitoring plane of anesthesia apply and supplemental dosing is to be given as needed.

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Approved: 12/2/2003
Revision approved: 08/04/2015
Updated: 08/12/2015

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