Speaker 3
so it kind of comes back to if this wasn't what we were planning then then we're going to have to do some homework to make sure that that we're allowed to kind of salvage this but but yeah kind of interesting
Speaker 2
well and i think you know scott has mentioned this several times there's the concern of the toxicity of the products to the animals right of that concern right but probably the overarching concern is the potential toxicity to humans being administered in a food product right so so yeah i i think like scott has mentioned several times see what's on the label and those that that is the answer to the question right now if it's if it doesn't have grazing restrictions then you might have to work through some of these other questions about is there an animal toxicity concern or is there a nitrate you know with the product itself or a nitrate toxicity concern with the feed so
Speaker 4
the products themselves so just to that point i guess is the the concentrated products prior to dilution are pretty potent and that's really the only time that you would have in at least where so the way they're applied is on a dilute 0.00 some percent and the toxic dose is pretty high like triple digit mig per kid which is i mean we could get into toxic doses for a while but that's they're pretty safe from that standpoint especially as applied and once those products dry they're typically not a problem from a medical standpoint but you've got the legal considerations with whatever the label says it's going to trump all of that
Speaker 1
that's that's the key that's the trump card is what's on the label and what we're supposed to do because it's not just that are they toxic or not but is it legal because at the end of the day and this is what you said Brian is it's a food producing animal and we have to be sure that we manage it accordingly excellent good information scott does a great job if you haven't listened to the bovine science with bci he's got some toxicology cases that he goes through there that he's built up over the years and very interesting to listen to him work through a case when sometimes things do go wrong but in this case this is an ounce of prevention here make sure that we read the labels we know what's in there and Philip you talked about some of the nutritional side brian i want to i want to turn back to you and ask about compounding so we talked the other day and we talked about a couple different definitions but i want to start with give me your definition of compounding and what that actually means and then we'll dive into what's the role of that in cattle production
Speaker 2
yeah so when we talk about compounding we're talking about pharmaceutical compounding because i think if you ask dust and about compounding you get away different answers so so pharmaceutical compounding the definition is it's the customized manipulation of a drug product and so that is changing it's really changing the drug in any way and we in veterinary medicine as a whole we typically will do compounding especially in small animal companion animal practice where we have a tablet that's too concentrated usually for very small animals so we have to dilute that drug or we have to change the flavoring of that drug so the animals will will actually make it palatable right or make it a concentration that works for a very small animal in food animal it is very hard to get to a point where we should be considering compounded products okay and so and i should say it's a customized manipulation of a drug formulation that's the legal definition of compounding but really what it means is i've changed that product any way from what is on the label so if i dilute that drug unless it's a drug that is supposed to be like we have to mix it or something to actually formulate that like it comes in two bottles and we mix them together that's not compounding that's following the label but if i were to add sterile saline to a product any of that is compounding and so and i mentioned there's to get to it in food animals legally there's a stepwise path that we should take so if i'm considering using a drug product in a food animal the first step is i should be using a product that's labeled for that use in that species okay and if i don't if i don't have that let's say there are no options available meaning there's nothing marketed doesn't mean it i don't have it in my truck or my farm i could get it but it means there's nothing on the market that meets that criteria the next step would be to use a drug that's labeled in another food animal species and we do that because we hope that there is some some information we can use to establish a withdrawal time so back to our earlier conversation a lot of this really centers around having violative drug residues and so so labeled product for that species first labeled product for another food animal species would be the second step the third step would be labeled product in a human or companion animal species right that's step three and then the fourth step is compounding and so it's really for food animal applications it's really hard to get to that last step and to be and i maybe we should get skydvald in this conversation too because compounding for toxic antidotes is probably the one place where we can get to we we can probably justify that but the and the last piece they'll say about compounding is it should it always has to be and food animals always has to be from a we're only compounding from labeled from approved drug products we can't compound from bulk chemical and and again that's all about residue concerns so scott scott deals with antidotes and like there are some situations where compounding is probably necessary to do that yeah that's a frustrating part is we don't have
Speaker 4
any fda approved antidotes for food animals period and that i mean it brings in a lot of problems because those are they've proven to be effective over time they're just not approved per se at the moment and there's there needs to be more work done on that front and we're kind of involved in that at the moment but it's you know it's a long stepwise process to get that done but right now again there's just nothing that's FDA approved for anecdotal use in food animals
Speaker 3
so this sounds to me uh brian correct me if i'm wrong but like if if um both in human medicine pharmacies and it's and companion animal doves and cats and horses and things like that that are not food animals compounding is not uncommon uh and uh and again like you said a lot of times it's adding a flavoring or it's adding you know a carrier or something like that but what you're telling me is as a veterinarian i might be doing that with my companion animal species but it's probably unlikely that that is appropriate for a food animal is that
Speaker 2
is that safe enough to say yeah it uh we always teach the students like to get to that four step is extremely difficult to food animal there can't
Speaker 3
be a drug that's
Speaker 4
labeled for this
Speaker 3
species there can't be a drug that's labeled for another food animal species there can't be a drug that's labeled for uh human or veterinary use that's you know companion animal that would
Speaker 2
serve my need yep
Speaker 3
all of those have to be no there isn't no there isn't no there isn't and then it's like okay well then my solution is to go to a compounded drug and and i agree that that would it's almost never that that's the path that i would
Speaker 2
go down yeah and and cost is never a valid reason to bypass any of those steps so that makes it even less and the other thing about if you look at the compounding regulations it's always done for an individual patient right and so we shouldn't be doing this for routine use and and really the thing about and that that is done unfortunately but the reason we don't want to support that is because it bypasses basically those people that are doing that they are they're selling a drug bypassing the approval process and that undermines the impetus for pharmaceutical companies to go through the process right and so it actually undermines our chances of getting new drug products from from large manufacturers so it
Speaker 3
would seem to me that you know we're counting on those companies to do the work to prove that it's safe and effective and that no one did that and that's
Speaker 2
just the thing is with a compounded product there's no proof of safety efficacy stability there's no proof of what's actually in that bottle so yeah
Speaker 1
absolutely and you mentioned food animals several times and this is obviously different than other species so when we're talking about cattle what what about the scenario where there's one animal that is basically a I'm going to say a pet right or it's not going to go into the food chain do these rules still apply because it's a because it's still a cow or can I do something different for an individual
Speaker 2
cow nope the food animal status is defined by the species not the use and we get this question all the time with potbellied pigs potbellied pigs are pets for all intents and purposes but for regulatory reasons they are considered swine they are a food
Speaker 1
animal so it doesn't matter the actual use of that individual animal and it goes back to the same type of concerns that we have when we talked about soybean hay it's the withdrawal time it's is it going to be effective what are some of the things that we can do so great job Brian going through that appreciate you joining us and thanks dr Fritz for joining us if you have other questions you'd like to ask us you can send us an email at bci at ksu.edu