Policy on the Use of Non-Pharmaceutical Grade Drugs

Institutional Animal Care & Use Committee
Jan 31, 2015 1:15 pm

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

  • Policy

    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 animals1-4. This includes anesthetics, analgesics, and any substances administered experimentally, and apply to non-survival as well as long-term studies.

    To meet this requirement, the use of non-pharmaceutical grade substances in animal-based research requires prior IACUC approval and must be based on either:

    1. Unavailability of an acceptable veterinary or human pharmaceutical-grade compound
    2. Scientific necessity

    Additional factors the Guide and OLAW state that must be addressed include:

    1. Stability, potency, and sterility of formulation;
    2. The storage and preparation procedures;
    3. How expiration or beyond use dates will be determined.

    By definition, a pharmaceutical grade substance is an FDA-approved veterinary or human drug. A database is available at http://www.accessdata.fda.gov/scripts/cder/drugsatfda.
    NOTE: Drug compounds sold by chemical manufacturers (e.g., Sigma-Aldrich®) are typically reagent grade and NOT pharmaceutical grade.

    Any non-FDA approved substance is therefore considered to be non-pharmaceutical grade and requires justification in the IACUC application. These substances are available in a spectrum of quality and consistency. The following order of choice should be applied:

    1. Drug compounded from an FDA-approved drug or an active pharmaceutical ingredient manufactured in conformance with current Good Manufacturing Practice and meeting United States Pharmacopeia/National Formulary/British Pharmacopeia (USP/NF/BP) standards. This includes drugs acquired from a Pharmacy Compounding Accreditation Board or FDA-registered compounding pharmacy.
    2. USP-grade chemical or substance used to formulate a needed dosage form (e.g., electrolytes, amino acids, DMSO, dextrose, or methylcellulose powder).
    3. Non-pharmaceutical grade or non-USP grade compounds: (e.g., analytical, or reagent grade chemicals, such as those from Sigma-Aldrich®; peptides; or oligonucleotides used to compound or formulate a needed dosage form).

    NOTE: Dilutions or formulation modifications to an FDA-approved veterinary or human drug or biologic also require IACUC approval to ensure safety, efficacy, proper storage, and assignment of expiration dates.