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Below is an overview of the proposed
updates and the implications they could
have for veterinarians and compounders.
Unclear USP application to veterinary
compounding
USP guidelines can be considered applicable to all
compounding, including veterinary compounding, in
a pharmacy setting. However, there remains some
gray area with regard to the applicability of USP in
an individual veterinary clinic setting. Specifically, the
USP committee was asked to revoke the applicability
of compounding chapters <795> and <797> until the
USP published a veterinary-specific compounding
chapter.
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The committee responded, citing that
"USP <795> and <797> do not state compendial
requirements for animal drug compounding under
federal law. Section 503A of the Federal Food, Drug
and Cosmetic Act, which makes <795> and <797>
applicable to pharmacy compounding, applies only to
pharmaceuticals for human use."
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The committee further
stated that USP compounding chapters are only meant
to be informational for veterinary practitioners and may
serve as standards for best practices but are not legally
binding at the federal level.
So, where does that leave veterinarians and
compounders of animal medications? Although the
USP guidelines may be considered voluntary, they
are still worth clinicians' consideration when selecting
a veterinary compounding pharmacy to confirm a
pharmacy partner that adheres to these guidelines.
There is also state-level oversight: As detailed in the
second article in this series (cliniciansbrief.com/article/
navigating-compounding-regulations-what-veterinary-
community-needs-know), SBOP are responsible for all
compounding oversight. Most states—but not all—have
adopted USP <795> and <797> compounding standards
into their state laws.
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In addition, some states have
stricter compounding requirements than USP chapters.
Regardless, these state laws, policies, and rules hold
compounding regulations that may specifically address
veterinary compounding.
However, not all regulations and compounding
answers are clear cut. Some states like Colorado
have compounding regulations that do not mention
veterinary-specific compounding.
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Further, Colorado's
state board of veterinary medicine's practice act defers
governance of veterinary compounding to the state
board of pharmacy.
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SBOP regulations specific to each state can be found
at nabp.pharmacy/about/boards-of-pharmacy.
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