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    USE Drugs Chemicals Lab Animal

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    Amal Thomas
    These guidelines describe the use of drugs and chemicals administered to laboratory animals at the University of Iowa. Drugs used for therapeutic purposes should be pharmaceutical grade when available. For experimental purposes, pharmaceutical grade should be used when possible, otherwise the scientific necessity for an alternative must be justified. Non-pharmaceutical grade substances require scientific justification in approved animal protocols. All drugs must be properly prepared, stored, labeled and discarded to maintain safety and efficacy.

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    USE Drugs Chemicals Lab Animal

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    These guidelines describe the use of drugs and chemicals administered to laboratory animals at the University of Iowa. Drugs used for therapeutic purposes should be pharmaceutical grade when available. For experimental purposes, pharmaceutical grade should be used when possible, otherwise the scientific necessity for an alternative must be justified. Non-pharmaceutical grade substances require scientific justification in approved animal protocols. All drugs must be properly prepared, stored, labeled and discarded to maintain safety and efficacy.

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    These guidelines describe the use of drugs and chemicals administered to laboratory animals at the University of Iowa. Drugs used for therapeutic purposes should be pharmaceutical grade when available. For experimental purposes, pharmaceutical grade should be used when possible, otherwise the scientific necessity for an alternative must be justified. Non-pharmaceutical grade substances require scientific justification in approved animal protocols. All drugs must be properly prepared, stored, labeled and discarded to maintain safety and efficacy.

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    8 views5 pages

    USE Drugs Chemicals Lab Animal

    Uploaded by

    Amal Thomas
    These guidelines describe the use of drugs and chemicals administered to laboratory animals at the University of Iowa. Drugs used for therapeutic purposes should be pharmaceutical grade when available. For experimental purposes, pharmaceutical grade should be used when possible, otherwise the scientific necessity for an alternative must be justified. Non-pharmaceutical grade substances require scientific justification in approved animal protocols. All drugs must be properly prepared, stored, labeled and discarded to maintain safety and efficacy.

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    Download as pdf or txt
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    Published on Vertebrate Animal Research (https://animal.research.uiowa.

    edu)
    Home > Policies and Guidelines > Substance Administration - Use of Drugs and Chemicals in Laboratory Animals (Guideline)

    Substance Administration - Use of Drugs and Chemicals in


    Laboratory Animals (Guideline)
    Guidelines: The IACUC has provided a set of guidance documents (Policies, Guidelines, and Informational Sheets) for use when planning
    animal procedures at the University of Iowa. An exception to a Guideline must be described and justified in the Animal Protocol and approved
    during the normal review process.

    Purpose:

    These guidelines describe the use of drugs and other chemicals administered to laboratory animals at the University of Iowa. “ The NIH Office of
    Laboratory Animal Welfare (OLAW) and the United States Department of Agriculture (USDA) both have determined that the use of non-
    pharmaceutical-grade compounds should be based on (1) scientific necessity, (2) non-availability of an acceptable veterinary or human
    pharmaceutical-grade compound, and (3) specific review and approval by the institutional ACUC.”1 The use of drugs falls into one of two usage
    categories. These guidelines apply to drugs used for experiments or for therapeutic purposes . 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
    FDA – Food and Drug Administration
    USP/NF – United States Pharmacopeia/National Formulary
    BP – British Pharmacopeia
    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.
    Phosphate buffered saline (PBS) if tissue culture grade and sterile
    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

    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 Purposes2


    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:
    1. FDA-approved veterinary or human pharmaceutical compound
    2. FDA-approved pharmaceutical compound used to compound a needed dosage/formulation
    3. USP/NF or BP pharmaceutical grade compound used to compound a needed dosage/formulation
    4. Analytical grade bulk chemical used to compound a needed dosage/formulation
    5. 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

    Anesthetic Agents for Aquatic Species


    The most commonly used anesthetic agent for fish and frogs in our facilities is tricaine methanesulfonate, or MS-222. This agent is available as
    an FDA-approved veterinary drug under the labels Finquel or Tricaine-S. As a result, we recommend the use of these veterinary pharmaceutical-
    grade products according to the product label, which involves dilution in the appropriate aquatic habitat water from the housing facility, followed
    by buffering with sodium bicarbonate to an appropriate pH. Benzocaine may also be used. Dosage and storage instructions contained in the
    IACUC Guidelines on Anesthesia should be followed, unless otherwise described and justified in the Animal Protocol.

    Preparation and Handling of Drugs/Chemical Agents


    Agents to be administered to animals must be handled and stored so as to maintain sterility and efficacy
    Appropriate closed sterile containers (e.g. injection vials, red-topped blood tubes) must be used, rather than snap-cap or screw-top
    containers
    The smallest amount of agent suspension/dilution/mixture should be used to minimize storage time prior to administration
    The rubber injection port/cap should be swabbed with alcohol prior to insertion of the needle
    Use a clean, sterile container for each preparation (do not reuse)
    Use new sterile needles for each entry into a sterile container
    Maintain needles in a sterile manner prior to injection
    Do not rest needles on non-sterile surfaces
    The re-use of needles for multiple animals is strongly discouraged due to loss of sharpness and biosecurity/cross-contamination
    concerns
    Examine multiple-dose injection vials/tubes prior to use for evidence of physical or chemical contamination
    Discard any substance meeting any of the following criteria:
    Particulate matter
    Precipitation of solids
    Turbid or discolored appearance
    Mislabeled or unlabeled container
    Damage to the rubber stopper compromising integrity
    All containers must be labeled with:
    Name of the drug(s)/chemical(s) contained
    Concentration of the drug/chemical
    Date of expiration (see below)

    Expiration of Drug Dilutions/Mixtures


    Sterile dilutions or mixtures of drugs may result in a shorter effective expiration date than the expiration date of the individual components,
    due to risk of contamination and dilution of preservatives
    An expiration date of six (6) months from the date of preparation, or the earliest expiration date for any single component (if less than six
    months), is recommended unless scientifically justified otherwise3

    Expired Drugs
    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”
    For information on storage and destruction of expired DEA controlled substances, please refer to the controlled substances link
    below

    DEA Controlled Substances


    Information on DEA controlled substances [1]

    References:

    1) "Guidelines for the Use of Non-Pharmaceutical Grade Compounds in Laboratory Animals." Oacu.od.nih.gov. 8 Jan. 2010.

    2) OLAW FAQ F.4 [2] Accessed 2/11/13.

    3) Beyond-use Dating of Extemporaneously Compounded Ketamine, Acepromazine, and Xylazine: Safety, Stability, and Efficacy over Time.
    JAALAS 48.6 (2009): 718-26.

    Last Reviewed By the IACUC 11/11/2020

    Source URL: https://animal.research.uiowa.edu/iacuc-guidelines-use-drugs-and-chemicals-laboratory-animals

    Links:
    [1] https://animal.research.uiowa.edu/dea-drug-enforcement-administration-information
    [2] http://grants.nih.gov/grants/olaw/faqs.htm#useandmgmt_4

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