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Johns Hopkins Policy
on Use of Non-pharmaceutical Grade Medications
The Johns Hopkins University Animal Care and Use Committee (ACUC)
requires that, for all vertebrate species, pharmaceutical grade
medications1 be
used for sedatives, analgesics, and anesthetics that
are approved to be administered to prevent or alleviate pain
and/or distress that may be caused by procedures carried
out under an approved protocol.
If a Principal Investigator wishes to obtain approval to use
a non-pharmaceutical grade compound instead, the procedures for
the planned use (e.g., sterility of injected solutions) must
be reviewed and approved by the ACUC.
If the non-pharmaceutical grade compound is to be used in species
regulated under the Animal Welfare Act,2 a
scientific justification must be provided or pharmaceutical grade
formulations must be unavailable in order to obtain ACUC approval. 3
References:
1. For the purposes
of this policy, a pharmaceutical grade medication is one
that has been formulated for clinical use in humans or in
veterinary practice.
2. Species
regulated under the AWA include all warm-blooded animals
except that rats, mice, and birds that were bred for use
in research are explicitly excluded from coverage by the
Act (9 CFR, Part 1, Section 1.1.).
3. This requirement
is consistent with USDA Policy #3, which provides guidance
on interpretation of AWA regulations in 9 CFR, Part 2, Section
2.31 and 2.32.
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