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Thursday, February 28, 2013

University of Iowa IACUC Guidelines: Use of Drugs and Chemicals in Laboratory Animals With Useful Flow Chart Submitted by kzobeck on Fri, 02/22/2013 - 14:53


These guidelines describe the requirements regarding the use of drugs and other chemicals administered to laboratory animals at the University of Iowa. The use of drugs falls into one of two usage categories: therapeutic purposes or experimental use. These guidelines apply to both categories of administration. Deviation from these guidelines must be described and justified in an IACUC-approved Animal Protocol. 
The use of non-pharmaceutical grade compounds in animals may be necessary and appropriate, but must be scientifically justified in an IACUC-approved Animal Protocol.

Definitions
  • Pharmaceutical grade compound: Drug, biologic, or reagent which is approved by the FDA or for which a chemical purity standard has been established by USP/NF or BP.
  • Non-pharmaceutical grade compound:  Any substance which does not meet the above definition of pharmaceutical grade, including:
    • Analytical grade bulk chemical: ~99% purity chemical, Certificate of Analysis typically available
    • Pharmaceutical grade drug compounded with non-pharmaceutical grade vehicle or other substance
  • FDA – Food and Drug Administration
  • USP/NF – United States Pharmacopeia/National Formulary
  • BP – British Pharmacopeia
Drugs Administered for Therapeutic Purposes
  • Current standards for the veterinary therapeutic care of research animals state that pharmaceutical grade medications should be used for routine medical treatment
  • Examples of therapeutic purposes include:
    • Sedation and anesthesia for surgery or other procedures
    • Relief or treatment of disease or injury  
    • Pain control (analgesia)
    • Euthanasia
  • Drugs used for veterinary care, either as part of an IACUC-approved Animal Protocol or an OAR veterinarian-approved treatment plan, should be obtained from a veterinary supply or from a pharmaceutical supplier licensed by the FDA, if available from such sources
Substances Administered for Experimental Purposes(1)
When developing a proposal to administer a substance to an animal, the following factors should be considered:
  • Purity/grade 
    • The following order of choice should be applied:
      • FDA-approved veterinary or human pharmaceutical compound
      • FDA-approved pharmaceutical compound used to compound a needed dosage/formulation
      • USP/NF or BP pharmaceutical grade compound used to compound a needed dosage/formulation
      • Analytical grade bulk chemical used to compound a needed dosage/formulation
      • Other grades and sources of compounds
  • Safety
  • Efficacy
  • Sterility
  • Pyrogenicity
  • Stability
  • pH/osmolality
  • Site/route of administration
  • Pharmacokinetics
  • Physiological compatibility
  • Quality control
The following questions should be considered when deciding what formulation(s) to use for your animal experiments:
Scientific Justification
  • In situations where use of a non-pharmaceutical grade substance is necessary and appropriate, the following sample text may be used and/or modified to illustrate scientific justification in your Animal Protocol:
    • No pharmaceutical-grade human or veterinary drug is available
    • A pharmaceutical-grade drug is available, but is not compatible with the concentration, formulation, delivery, or vehicle requirements of experimental administration
    • A pharmaceutical-grade drug is available, but the use of a non-pharmaceutical grade product is required to replicate methods from previous studies because results must be directly compared to the results of replicated studies
Expired Drugs
  • Must not be administered to any animal without explicit IACUC approval
  • All expired drugs, including anesthetics and analgesics, must be segregated and clearly mark “EXPIRED” on or before the labeled date of expiration
  • All dilutions and lab-formulated drug/chemical mixtures are to be labeled and considered expired according to the earliest expiration date of any component
  • If any component of a dilution or lab-formulated mixture has no labeled expiration date, it is to be considered expired after a maximum of one month after the date of preparation, unless otherwise described
  • For information on storage and destruction of expired DEA controlled substances, please refer to the controlled substances link below
DEA Controlled Substances
References:
1) OLAW FAQ F.4: http://grants.nih.gov/grants/olaw/faqs.htm#useandmgmt_4 Accessed 2/11/13.
Last Updated 2/11/13
Source found here