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USP <800>
Although USP <800> is not yet compendial for
compounding business, veterinarians should be
aware of it for several reasons. It is the first and only
compounding regulation that specifically addresses
veterinary clinics. USP <800> focuses on protecting
staff from chronic handling of risky chemicals—not
just chemotherapeutics. For example, oclacitinib is
considered a hazardous drug by some pharmacists
and is handled as such at some veterinary animal
hospitals.
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GFI #256
The FDA's draft guidance #256 on compounding
specific to veterinary purposes is one of the most
important regulatory movements for veterinarians
to be aware of. It reflects the FDA's potential
added involvement in the regulation of veterinary
compounding.
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Historically, drugs compounded from
bulk drug substances have not been required to pass
through the FDA, and the FDA has focused mainly
on regulation of manufacturing for veterinarian use in
office, with the control over the practice of compounding
mainly being exerted at the state level. GFI #256 seeks
to clarify this involvement and the federal policy.
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More on #256 can be found in article 2 of this
series at cliniciansbrief.com/article/navigating-
compounding-regulations-what-veterinary-
community-needs-know.
Big takeaways
The compounding industry can be confusing and
frustrating to navigate, but due to its indispensable role in
veterinary medicine, it remains critical for veterinarians to
stay abreast of its rules and regulations. Below is a quick
recap of the most important elements to consider:
• Ultimately, veterinarians (and compounding
pharmacists) are responsible and liable for their use of
compounded animal drugs.
• Research your state compounding regulations (the
board of pharmacy and board of veterinary medicine)
for local guidance, and consider maintaining a good
relationship with your compounding pharmacy, as they
will be working to stay up-to-date on changes to state
and federal regulations as well.
• Use USP <795> and <797> chapters as gold
standards when applicable.
• Veterinary teams should stay aware of USP <800>
and when it may become compendial to compounding
businesses, as it aims to protect veterinary teams from
potentially hazardous drugs.
• Stay abreast of updates to GFI #256 to be
knowledgeable of its potential influence over veterinary
drugs: regulations.gov/docket/FDA-2018-D-4533
With these draft guidances and additional upcoming
changes to compounding regulations, now is an excellent
opportunity to have a voice in how the veterinary
compounding industry is shaped. Resources are
available to help stay knowledgeable of these changing
regulations and updates and to help your voice be heard.
• Join the USP mailing list to receive updates directly
from the USP: go.usp.org/hqs-signup-form
• Share your thoughts on the proposed updated
National Institute for Occupational Safety and
Health hazardous drug list: federalregister.gov/
documents/2020/05/01/2020-09332/hazardous-
drugs-draft-niosh-list-of-hazardous-drugs-in-
healthcare-settings-2020-procedures-and-risk
• State boards of pharmacy and state veterinary
medical associations are excellent resources for finding
regulations specific to your state: nabp.pharmacy/
about/boards-of-pharmacy
