Use of Pharmaceutical-Grade Chemicals and Other Substances

Introduction

Boston University is committed to observing Federal policies and regulations and AAALAC International standards for the humane care and use of animals. (National Research Council of the National Academies, 2011) This policy provides guidelines for the use of pharmaceutical-grade chemicals and other substances in live vertebrate animals.

Purpose

• To provide guidelines for the use of pharmaceutical-grade chemicals and other substances in live vertebrate animals.
• To outline how exceptions to this policy should be managed.

Definitions (National Institutes of Health, 2010)

  • Pharmaceutical grade compound: Drug, biologic, reagent, etc. which is approved for sale or distribution by the FDA or for which a pharmacopeial standard has been written/established by USP/NF, BP
  • Analytical grade bulk chemical: ~99% purity; Certificate of Analysis is usually available
  • Non-availability: Not commercially available from an active US vendor; includes formulations supplied as tablet, capsule, injectable, etc.
  • USP/NF: United States Pharmacopeia/National Formulary
  • BP: British Pharmacopeia
  • FDA: Food and Drug Administration; FDA approved compounds are manufactured using USP/NF compounds

Policy

Pharmaceutical grade chemicals and other substances will be used whenever they’re available for all animal-related procedures, even in acute procedures (National Research Council of the National Academies, 2011) (United States Department of Agriculture, 2011). Although the potential animal welfare consequences of complications are less evident in non-survival studies, the scientific issues remain the same. (Wolff, Garnett, Potkay, Wigglesworth, Doyle, & Thornton, 2003).

When selecting compounds the following order of choice should be applied (National Institutes of Health, 2010)

1. FDA approved veterinary or human pharmaceutical compounds
2. FDA approved veterinary or human pharmaceutical compounds used to compound a needed dosage form
3. USP/NF or BP pharmaceutical grade compound used in a needed dosage form

The two options below require justification

4. Analytical grade bulk chemical used to compound a needed dosage form
5. Other grades and sources of compounds

OLAW and the USDA have determined that the use of non-pharmaceutical-grade chemical compounds should be based on (Wolff, Garnett, Potkay, Wigglesworth, Doyle, & Thornton, 2003):

  1. Scientific necessity
  2. Non-availability of an acceptable veterinary or human pharmaceutical-grade compound
  3. Specific review and approval by the IACUC

Consideration will be given to the grade, purity, sterility, pH, pyrogenicity, osmolality, stability, site and route of administration, formulation, compatibility, and pharmacokinetics of the chemical or substance to be administered, as well as the inadvertent introduction of new variables, animal welfare and scientific issues relating to its use. (National Research Council of the National Academies, 2011)

The use or substitution of a non-pharmaceutical grade chemical when a pharmaceutical grade chemical is available will be considered an exception to our program of animal care and use and will need to be scientifically justified in an approved IACUC protocol. Note: Cost savings is not a justification for using non-pharmaceutical-grade compounds (United States Department of Agriculture, 2011)

Resources

Bibliography

National Institutes of Health. (2010, December 8). Retrieved September 27, 2011, from Office of Animal Care and Use: http://oacu.od.nih.gov/ARAC/documents/Pharmaceutical_Compounds.pdf

National Research Council of the National Academies. (2011). Guide for the Care and Use of Laboratory Animals. In Animal Care and Use Program (p. 31). Washington D.C.: The National Academies Press.

United States Department of Agriculture. (2011, March 25). USDA APHIS Animal Welfare. Retrieved August 24, 2011, from Animal Care Policy Manual: http://www.aphis.usda.gov/animal_welfare/policy.php?policy=3

Wolff, A., Garnett, N., Potkay, S., Wigglesworth, C., Doyle, D., & Thornton, V. (2003). Frequently Asked Questions about the Public Health Service Policy on Humane Care and Use of Laboratory Animals. Lab Animal, 33-36.

BU IACUC Approved: November 2011