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.

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.

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.

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.