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Use of Pharmaceutical Grade and Non-Pharmaceutical Grade Substances in Vertebrate Animals (IACUC)

Last updated on April 2, 2024 3 min read Use of Pharmaceutical Grade and Non-Pharmaceutical Grade Substances in Vertebrate Animals (IACUC)

Purpose

Boston University (BU) is committed to observing Federal policies and regulations and the Association of Assessment and Accreditation of Laboratory Animal Care (AAALAC) International standards for the humane care and use of animals. This policy describes the use of pharmaceutical grade and non-pharmaceutical grade substances in vertebrate animals. Adherence to this policy is mandatory unless a specific exception has been approved by the IACUC.

Covered Parties

This policy is applicable to all persons responsible for conducting research, teaching, training, breeding, and related activities, hereinafter referred to collectively as “activities”, involving vertebrate animals conducted at or under the auspices of Boston University.

Policy

Pharmaceutical grade substances must be used, when available, for all vertebrate animal procedures. The use of pharmaceutical grade substances in animals ensures that the substances administered meet established documentable standards of purity and composition, and this helps ensure animal health and welfare, as well as the validity of experimental results.

When selecting substances for use in animals the following order of choice should be applied:

  1. FDA-approved veterinary or human pharmaceutical substances;
  2. FDA-approved veterinary or human pharmaceutical substances used to compound a needed dosage form;
  3. USP/NF or BP pharmaceutical grade substance used in a needed dosage form (also includes compounded products from any source);
  4. Analytical grade bulk chemical used to compound a needed dosage form (requires justification);
  5. Other grades and sources of substances (requires justification).

Dilutions and mixtures of substances are considered to be equivalent to pharmaceutical grade only when all ingredients within the solution/mixture are pharmaceutical grade.

Although pharmaceutical grade substances must be used whenever possible, the BU IACUC may approve the use of non-pharmaceutical grade substances (e.g., investigational substances; compounded substances; Schedule I controlled substances) under certain circumstances (e.g., when a pharmaceutical-grade product is not available, to test novel compounds, or the pharmaceutical grade substance is not concentrated enough to meet experimental requirements).

To obtain approval for the use or substitution of non-pharmaceutical grade substances in animals, the following criteria must be met:

  • A valid scientific justification is required;
  • Cost savings alone is not a valid justification;
  • Alternative acceptable pharmaceutical-grade substances are not available; and
  • Use of the non-pharmaceutical grade substance has been specifically reviewed and approved by the IACUCInstitutional Animal Care and Use Committee IACUC oversee...

For all non-pharmaceutical grade substances used in animals, the IACUC will consider, as applicable, the following: the grade and purity being proposed; the formulation of the final product; sterility; pyrogenicity; stability; pH; osmolality; site and route of administration; pharmacokinetics; physiological compatibility; storage and quality control.

Responsible Parties

Principal Investigators are responsible for: ensuring that pharmaceutical grade compounds are used whenever they are available; preparing and submitting applications; making modifications in applications in order secure IACUC approval; ensuring adherence to approved protocols; ensuring humane care and use of animals: ensuring that all personnel have completed required training; and reporting any adverse events to the IACUC.

The Animal Welfare Program and the Institutional Animal Care and Use Committee are responsible for overseeing implementation of and ensuring compliance with this policy.

Defined Terms

Pharmaceutical-grade substance: means any active or inactive drug, biologic, reagent, etc., manufactured under Good Manufacturing Practices (GMP) which is approved, conditionally approved, or indexed by the Food and Drug Administration (FDA) or for which a chemical purity standard has been written or established by a recognized compendia (e.g., United States Pharmacopeia-National Formulary (USP/NF) or British Pharmacopeia (BP)).

History

Effective Date: 04/02/2024
Next Review Date: 04/01/2027

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