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Vet answers questions on FDA The Midwest Cattleman · March 30, 2023 · P7

antibiotic prescription requirement

OTC sales of antibiotics the label change?
are set to end; veterinary pre- FDA intends to allow exist-
scriptions are required start- ing stocks of OTC antibiotics
ing June 11. to be depleted, and a prescrip-
Veterinarians are getting tion will not be required for
their prescription pads ready use. However, if the antibiotic
as farmers will need them is being used extra-label (in a
for several antibiotics used manner that is not in accor-
to treat livestock starting in dance with the approved label
mid-June.
The final phase of the Food continued on page 17
and Drug Administration’s
efforts will bring all medical-
ly important antibiotics ap-
proved for animals under vet- PARAMOUNT
erinary oversight.
“This will end over-the-
counter sales of antibiotics,
and livestock owners will need
a prescription from a veteri- Elevate to a more valuable female.
narian if they want to contin-
ue to have access,” says Craig
Payne, University of Missouri For over a decade, Red Angus females have
Extension veterinarian. commanded more at auction than all other breeds,
While antibiotics won’t including Angus. According to Superior Livestock data,
necessarily need to be pur- Red Angus heifers brought nearly $17/cwt more –
chased from a veterinarian, a
prescription will be required that equates to a $92/head premium
regardless of where they are on a weaned replacement female.
purchased.
Many antibiotics went
through a similar transition To learn more about
in 2017, when FDA focused industry-leading
on feed antibiotics and OTC
antibiotics delivered in the stayability, visit
water. However, Payne says, RedAngus.org
some antibiotics remained
available OTC in the form of
injectables, intramammary
tubes and boluses.
FDA’s Guidance for Indus-
try 263 specifically addresses
those OTC antibiotics, and by
June 11, they must display
the following language on the
label: “Caution: Federal law
restricts this drug to use by
or on the order of a licensed
veterinarian.” Once antibiot-
ics have this revised labeling,
they will require a prescrip-
tion.
Considering the impact
of these changes, Payne an-
swers a few of the questions
livestock producers may have
about the latest antibiotic
guidance from the FDA:
Which antibiotics will
be affected?
See Chart - Top Right
For a complete list of anti-
biotics impacted by GFI 263,
visit the FDA website.
After June 11, will I need
a prescription to use anti-
biotics purchased before