Policy on the Use of Non-Pharmaceutical Grade Drugs

Institutional Animal Care & Use Committee
Jun 5, 2023 12:00 pm

This policy outlines the IACUC requirements for using non-pharmaceutical grade substances in animal-based research.

  • Purpose

    This policy defines the expectations for the use of non-pharmaceutical grade drugs. The Guide for the Care and Use of Laboratory Animals, the Office of Laboratory Animal Welfare (OLAW), and the United States Department of Agriculture (USDA) all state that pharmaceutical-grade chemicals, biologics and other substances, when available, must be used in laboratory animals. This includes anesthetics, analgesics, and any substances administered experimentally, and apply to non-survival as well as long term studies.

  • Applicability

    This policy applies to research, teaching, and testing activities involving animals, conducted under the auspices of the U-M, and applies to all locations under the purview of the U-M IACUC.


    Pharmaceutical Grade

    A drug, biologic, or reagent that is approved by the Food and Drug Administration (FDA) for use in humans or animals or for which a chemical purity standard has been established by the United States Pharmacopeia-National Formulary (USP-NF), or British Pharmacopeia (BP). These standards are used by manufacturers to help ensure the products are of the appropriate chemical purity and quality, in the appropriate solution or compound, to ensure stability, safety, and efficacy. The FDA maintains a database listing approved commercial formulations for human drugs (the Orange Book) and veterinary drugs (the Green Book). For chemicals, a certificate of analysis is usually available upon request. 

    Non-Pharmaceutical Grade

    Chemicals or compounds that do not meet or exceed requirements of USP/NF/BP and may have higher levels of impurities that can introduce unwanted variables or toxic effects. Sterile pharmaceutical grade preparations that are reconstituted, diluted, mixed or have other substances added are also considered non-pharmaceutical grade. 

  • Policy

    1. Whenever possible, chemicals, biologics and other substances used in animal research must be pharmaceutical grade.
      1. A database of pharmaceutical grade drugs is available at www.accessdata.fda.gov/scripts/cder/daf
      2. Drug compounds sold by chemical manufacturers (e.g., Sigma-Aldrich®) are typically reagent grade and NOT pharmaceutical grade.
    2. The use of non-pharmaceutical grade substances in animal-based research requires IACUC approval and must be based on either:
      1. Unavailability of an acceptable veterinary or human pharmaceutical-grade compound, or
      2. Scientific necessity.
    3. In accordance with the Guide and OLAW, the following must be considered when administering a non-pharmaceutical grade drug to animals:
      1. Stability, potency, and sterility of formulation;
      2. The storage and preparation procedures; and
      3. How expiration or beyond use dates will be determined.
    4. Non-pharmaceutical grade substances are available in a spectrum of quality and consistency. The following order of choice should be applied when determining the appropriate substance to use:
      1. Drug formulation prepared using FDA-approved drugs or vehicles (e.g., saline) or acquired from a Pharmacy Compounding Accreditation Board or FDA-registered compounding pharmacy.​
      2. Drug formulation prepared using USP-NF grade chemicals or substances (generally manufactured under Current Good Manufacturing Practice (CGMP) regulations in a FDA-registered facility with quality control testing).
      3. Drug formulations prepared using non-USP grade chemicals or substances.
  • Compliance

    The provisions of this policy are under the direction and oversight of the U-M’s IACUC. The IACUC will, if necessary, suspend research or implement sanctions if policy infractions should occur.


For questions, additional detail, or to request changes to this policy, please contact the Office of the Assistant Vice President for Research, Director of the Animal Care and Use Office at acuoffice@umich.edu or (734) 763-8028.