Policy on the Use of Non-Pharmaceutical Grade Drugs

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. It applies to field research and all campus locations, including Ann Arbor, Flint, and Dearborn.

1. Whenever possible, chemicals, biologics and other substances use in laboratory animals must be 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
   2. Scientific necessity
3. 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; and
   3. How expiration or beyond use dates will be determined.
4. By definition, a pharmaceutical grade substance is an FDA-approved veterinary or human drug. A database is available at www.accessdata.fda.gov/scripts/cder/daf. 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 protocol. 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.
5. 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.

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.