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May 26, 2023 • 18 mins

The US Food and Drug Administration Guidance for Industry #263, or GFI 263, goes into effect nationally in the US in early June 2023. The new mandate changes the approved marketing status of certain antimicrobial drugs from over the counter to prescription status. Drugs that were commonly found on retail shelves and through online sources will no longer be available for purchase by the public and will only be accessible by veterinarian prescription.

In this episode, Dr. Michael Costin, Associate Director in the Division of Animal and Public Health at the American Veterinary Medical Association (AVMA), explains the background and reason for GFI 263's enactment. Dr. Costin also talks about how it impacts not only the veterinary profession but also consumers who raise, breed and care for companion and large animals. Dr. Joanne Carlson, ISVMA President, hosts the conversation.

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Episode Transcript

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Unknown (00:01):
Hello and welcome to the veterinary today podcast
produced by the Illinois StateVeterinary Association, commonly
known as the ISVMA veterinarytoday has been created for
veterinary professionals,but can also be informative for
anybody interested in veterinarymedicine and practice.
Its goal is to share the latesttrends and developments in the

(00:22):
veterinary profession fromindividuals making news in the
veterinary profession.
This podcast shows informationthat allows veterinary
professionals to better serveclients and their pets
livestock, manage their practiceand to establish a more
informed, knowledgeable andengaged clinic staff. I'm Kelley
McLaughlin, your podcastmoderator Glad to have you
here. Join Carlson is the ownerand operator of loving care

(00:46):
animal clinic in Palatine andpresident of the is VMAs.
Board of Directors and yourveterinary today podcast
host and joins me once again.
Hello, Dr.
Carlson. I Joey so great tobe back with you.
I'm excited to share thepertinent information once again
about the veterinary professionin Illinois with our listeners.
Absolutely.
For this podcast.
We're looking ahead intoJune when a nationwide law goes

(01:10):
into effect affecting the waycustomers have access to
over the counter medicationsthat could previously buy online
or at retail stores but startingin June will only have access to
those meds by veterinaryprescription.
Correct Joey. It's the guidancefor industry number 263
or GFI 263 issued by the USFood and Drug Administration

(01:32):
that changes the approvedmarketing status of certain
antimicrobial drugs fromover the counter to prescription
drugs.
Approximately 91 differentantibiotics are going to be
transitioning from over thecounter to prescription.
Once this change goes intoeffect.
These popular drugs can only beused with animals under the
care and control of a licensedveterinarian and impacts mostly

(01:53):
animals intended for foodproduction.
But also some small animalsituations.
Yeah, certainly could affect alot of people who are currently
rely on the convenience ofpurchasing the drugs from you
know, just from over the counterretailer Dr.
Carlson for this podcast.
We've invited Dr.
Michael Costin, AssociateDirector of the Division
of animal and public health atthe American Veterinary Medical

(02:14):
Association or the AVMA tohelp us understand how GFI
263 will impact not onlyveterinary professionals
but also consumers who raiseand breed and care for companion
animals and large animals towelcome to veterinary today. Dr.
Costin.
Good afternoon.
Thank you for the invitation.
I'm excited to be here today.
We're so glad you could joinus Dr.

(02:35):
Costin. To really establish anunderstanding of what we're
discussing today. Can you pleasegive us a little intro into
what GFI 263 is and why it'sbeing implemented?
Sure. So back on June 10 of2021 The US Food and Drug
Administration finalizedguidance for industry 263, or as
you stated earlier, gfi 263.

(02:55):
Now what GFI 263 does is anoutline of the process that
animal drug sponsors orpharmaceutical companies do to
voluntarily change the approvedmarketing status of certain
medically importantantimicrobial drugs from
over the counter or OTC toprescription or RX. Now

(03:16):
once this change is made, theseimportant drugs can only be
used in animals under thesupervision of a licensed
veterinarian.
Now even if the animals are notintended for food production, so
everything from pet dogs andcats to backyard poultry,
and from pet rabbits and pigsto large livestock farms, the
same restrictions are goingto apply.
All of these medically importantantibiotics will require a

(03:38):
prescription from a veterinarianin order to be used. Now the
process that was outlinedin GFI 263 is part of the FDA is
broader effort to combatantimicrobial resistance
which is a serious threat toanimal and public health.
The increasing threat ofantimicrobial resistance to both
human and animal healthcompelled the FDA to take

(03:59):
action.
Now Antimicrobial Use and humansanimals and the environment
contributes to the developmentof antimicrobial resistance.
GFI 263, puts the responsibilityfor the use of medically
important antimicrobialsinto the hands of veterinarians,
veterinarians who are trained tounderstand not only when these
medications are needed, but alsowhat is the appropriate drug to

(04:20):
use the appropriate doseduration and administration
method to resolve infection andprotect animal health and
our food supply.
The veterinarians expertise iscritical to ensuring the
responsible use of antibioticsand ailments.
So Dr.
Costin, I'm just curious,what are the most commonly used
products that might be affectedby this and when is the hard

(04:41):
cutoff date that we cananticipate these products
not being available in retailstores?
Well, let me answer your firstquestion first. So some of the
commonly common productsthat are sold in retailers
that will be impacted by this.
Are you know anything that'smedically Careers clitic farm

(07:15):
family, your ISVMA is withyou. It's membership renewal
time. As a veterinarian or CVTmember of the ISVMA.
Your association always hasyour best interests in mind.
The ISVMA protects and promotesthe veterinary profession in
Illinois and your license topractice founded by members for

(07:37):
members, your ISVMA promisesto be a legislative and
political advocate for theprofession, engage membership
for new career opportunitiesand to promote a career in
veterinary medicine to untappedindividuals, advanced careers
through numerous continuingeducation opportunities, inform

(07:57):
members and the public about whowe are and what we do in our
communities and lead in ourcommunities as premier health
care providers.
renew your membership today. Ifyou haven't yet joined
look for a recently sent emailfrom the ISVMA directly linking
you to your membership profile.
Join us today during our annualmembership drive currently

(08:19):
underway.
Your ISVMA is with you.
So really, this prescriptionstatus protects animals
and people and I'm just curious,you know, how do you think this
will impact veterinarians?
It shouldn't be too bad. Sowhat I think's going to
happen is we're going tosee, some new clients will be

(08:39):
calling on veterinarianseeking to establish a
relationship and seekingadvice and assistance with their
animals.
I see, you know, seeing that youwere a large animal dairy
veterinarian, how you know, ingeneral, do you see that
creating more herd healthexams are what do you feel?
Is there something that wecan kind of put a little,

(09:00):
you know, spin on it as far aswill this cause the veterinarian
to have to maybe do one herdhealth check per year or a
few or what are your thoughtson that?
Well, on the food animal side, alot of time the veterinarians
are visiting their clients intheir farms more frequently
than once a year. We doanticipate as this will impact

(09:21):
both the large and the smallanimal veterinarians, primarily
in having clients they'venot worked with before calling
upon them because they'regoing to need to establish that
relationship with theveterinarian establish the
veterinary client patientrelationship, in order to have
access to the antimicrobialsthey might need to treat
animals.
Exactly.

(09:41):
infections in their And as weall know, the VCPR so important
and has to be established.
What steps will veterinarianssuch as us need to take to
ensure affected clientsneeds are met in a timely
manner?
First thing I thinkveterinarians should be reaching
out to their clients proactivelyand letting them know this
change.
Just coming, when it's going tostart and why it's occurring.

(10:04):
I believe this will precipitateconversations with the clients.
And in that communication,I believe that veterinarians
should ask their clients tocontact them if they have
been using over the countermedications on their animals
without the veterinariansknowledge by doing so, that
will allow the veterinarianand the client to have

(10:24):
discussion about why they'reusing those medications.
and for what reasons, and allowthat discussion to occur,
which will allow theveterinarian to better assist
their client going forward.
Yes, I completely concurwith that.
I know that there's severaltimes in my small animal
practice that folks will havebrought a new puppy and they'll
say, Oh, we already do wormingwith this product, or that,

(10:47):
or we've already given thema specific antibiotic.
And I'll often say, you knowwhy. So I think just it's going
to open up more of a discussion.
And also it puts the, youknow, the prescription roll in
the hands of the animal healthprofessionals that we are. So do
you think we'll need to beimplement any new administrative
procedures and keeping records?

(11:10):
No, I believe the recordsrequirements remain the
same. And that does depend onstate somewhat.
So as you mentioned earlier,I'm I'm licensed in Wisconsin,
are required record requirementsare seven years. I'm not quite
sure what Illinois are, but therecords requirements haven't
changed. I see.
Okay. And, you know, anytimewhen there's something new, such

(11:31):
as this gfi 263.
I'm just wondering if you canpredict any sort of confusion
by the veterinarians, the clientand specifically some of these
large animal, you know, breedoperators, because those are
the ones it seems like it'sgoing to impact the most. What
are your thoughts on thatdoctor?
Well, anytime there's changed,it can lead to some confusion.
Right.

(11:53):
That said, the AVMA has is notalone, in letting people
know about the upcomingchanges. I know FDA has been
very active spreading the word,speaking with and answering
questions from thepharmaceutical industry,
distributors and retailers.
And I've actually seen signsand some of the retailers
in their animal health sectionsletting their customers

(12:13):
know about the upcoming change.
Many of the AVMA is alliedveterinary associations, the
national ones like bovinepractitioners, swine vets, small
ruminant practitioners, AmericanAssociation of avian
pathologists, they've beenletting their members know about
the upcoming changes.
Additionally, producergroups and associations
have been letting their membersknow groups like National

(12:35):
Academies, Beef Association,National Pork Producers,
Council, American sheepindustry, so there's a lot of
different groups letting theirmembership know, their client
base know that this change iscoming.
But ultimately, it dependson people seeing one of those
messages.
And being aware that this ishappening.

(12:56):
Is there a chance that somepeople are not aware?
Yes. And that's where theconfusion might come?
I see.
And, you know, there's, like yousaid, like, anything, that
change is always a littlechallenging for us.
Um, does the AVMA have anyliterature or anything
that could be shared on, youknow, such as Facebook or
anything like that anythingthat we could look at and,

(13:16):
you know, help you, I think theeasiest way to get some of your
listeners to our materials,if you if you go to the ad
Ma's main web page, and in thesearch bar, just type in
OTC to RX, that'll pull up alist of various resources
we have.
For two or three resources,there should be links to either

(13:39):
blog posts or social media ornews items we've put out over
the last year kind of lettingour membership know that this
change is coming.
Additionally, there's alink to a webpage that we've
put up which explains thereasoning behind the
implementation of GFI 263, aswell as some different resources
that we have available.
It also links to us numerousof the FDA is web pages,

(14:03):
some other resources that yourlisteners might be interested
in. And if you they want to goto the FDA is main webpage
and in their search bar, youtype in GFI 263 in the FDA
search bar that will take youto several of the pages and
resources they have available.
They have a list of theantimicrobials which will be

(14:26):
impacted by the implementationof this rule.
Additionally, they havea FAQ page that answers a lot of
people's commonly askedquestions.
Well, that sounds fantastic.
So it sounds like you'vebeen very busy about the this
GFI 263 Doctor Well, we've hadtwo years we've we've been
doing what we can to get themessage out. And hopefully we've

(14:50):
reached enough people that theconfusion that does occur is
minimal.
Yes and no from a public healthstandpoint, which is ironic. My
daughter just graduated fromcollege yesterday with a public
health degree And we've talked alot about populations, and we're
really looking at keeping thepopulation of us humans
safe. And, you know, when wethink about just the previous

(15:10):
two, three years, we really dosee how animals do impact our
health through the whole COVIDprocess and the where the
process that emanated from sothis seems like a really
good way to help keep ushealthy.
Thank you so much for forjoining us. And I really
glad that we could shed somelight on this and the ever

(15:31):
evolving world of veterinarymedicine.
Any other comments or thingsyou'd like to add?
Dr.
Costin?
I think the biggest thing is,for those who may not be
aware and for your veterinarylisteners, you know, we
anticipate the implementationof this rule impacting a couple
of groups and geographiesI guess, groups, we expect

(15:54):
both small and large animalthat's to notice this change
primarily from clients they maynot have worked with previously
calling and looking to establishthat relationship that is
established that VCPR And theseclients may have animals that
veterinarians don't normallywork with, we expect that this

(16:14):
will impact the hobbyist.
So people who may have backyardchickens, backyard pigs, some
small ruminants, geographically,we expect this change to
impact the rural areas whereveterinary coverage may not be
as extensive.
There are some people outthere who have not used to visit

(16:35):
veterinarians in the past,they've always gone to the like
the local farm store, to sourcesome of their meds, they
may not be able to do that, orthey won't be able to do that
now without a prescriptionfrom a veterinarian.
So the rural veterinariansmay see some new clients
calling.
Additionally, the fringes ofthe larger urban areas.
It's where a lot of thehobbyists are located.

(16:56):
Those people in their search forveterinarians, they may be
reaching out to companion animalthat's looking for help.
And we see this as anopportunity for those Companion
Animal Services to expand theirservices if they're interested
in doing so.
Absolutely.
I love chickens.
And I must say that I would loveto have them but my current

(17:18):
Association does not allow thembut I would love to see some
chicken folks and I youknow, also sheep, you mentioned
sheep, I just love sheep. SoI think that that's a great
possibility.
My last question for you isyou're from Kansas.
You live in Schaumburg,you know, suburb of Chicago.
Who do you root for and baseballdoctor?

(17:40):
Actually, I am originally fromChicago.
Oh, I won't give you the wholestory of how I ended up
in Kansas.
But I was raised a White Soxfan. Oh, my family's from the
south side. All right.
Well, you know what, obviously,I wrote for the Cubs, but
you know what it says Chicagoteam. So that's good. But it was
great chatting with youand have a great day.

(18:00):
Thank you for the invitation.
You know, for those listeners,if you do have a topic
suggestions, please reach outand send them to us because we
are open and we want to give theinformation that you would like
to hear.
Thank you, Dr. Costin andCarlson for all the discussion
and information surrounding thisimportant developments for
veterinarians and their clients.
Not only here in Illinois, butnationwide.

(18:21):
This concludes our veterinarytoday podcast again.
Thank you to our guests Dr.
Michael Costin, AssociateDirector of the Division
of animal and public healthwith the AVMA and of course
thank you Dr.
Carlson.
of loving care animal clinic andpalatine and president of the
ISVMA.
Your podcast host I'm JoeyMcLaughlin.
Thanks for listening and we'llbe back soon with another timely

(18:44):
topic on veterinary today.
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