GLOBAL - In an exclusive, candid, 90-minute interview with editors from the VFD News Centers and Poultry Health Today, William Flynn, DVM, MS, deputy director for science and policy for FDA’s Center for Veterinary Medicine, clarified some hazy points of the new veterinary feed directive (VFD) regulations that take effect January 1, 2017.
Part 1: All food animals
Making the transition
Q: Let’s discuss scheduling. What if medicated feed is received on the farm toward the end of December? How does that feed need to be managed? For example, if the feed was made and shipped just prior to January 1, can you confirm that a VFD is needed as of January 1 to use that product?
WF: Yes. I know this is a question of concern, and there’s been a lot of work leading up to the January 1 date. Clearly, this was a reason why we set out a 3-year timeline — to provide time for all affected stakeholders to really start preparing.
We’ve been working with the pharmaceutical companies that market these products to look at ways of helping to manage inventories in preparation for the January 1 date. There are already some newly labeled products entering distribution channels, and other strategies have been in the works to try and manage inventories — recognizing that we ultimately have to transition a large number of products from old to new labeling.
The objective is that, as of January 1, products affected by the updated VFD rule will be used according to the new set of conditions. As of January 1, it’s our desire that VFD drugs not be used for growth promotion or feed efficiency because that would no longer be a legal use. And as of January 1, VFD drugs should be used under the oversight or authorization of a veterinarian.
Technically, that’s what we would like — right? That would be ideal, but we also recognize that it’s not going to be physically possible in some cases to get all that done on that target date. The reality is that on the stroke of midnight January 1, there will be some product — including at the farm level — that won’t be labeled according to the new use conditions. We understand there’s going to be a transition period that folks have to work through. There may be feed that’s literally in the feed bin on January 1 and that feed has to be fed through, although new batches of feed with a VFD drug coming in clearly would need to be under a VFD.
So, for existing feed and from a compliance standpoint, VFD feed should technically be used under a VFD as of January 1, but I would say our compliance focus, particularly as we begin the new year, is education.
Our intent is, by no means, to be looking to catch folks or take action immediately upon implementation of the updated VFD regulation. During the initial phase, we hope folks are using due diligence as soon as possible to use up the feed they have and get their animals and the use of VFD products under a VFD authorization from a vet. Again, any kind of inspection or compliance activities we’re doing in the early phases of this initiative as we begin the new year are going to be focused on education and making sure folks understand the new requirements.
Q: It sounds like FDA is going to be pretty flexible and understanding the first couple weeks of 2017. If the veterinarian is away for the holidays, for instance, and he or she is not available, you’re saying it’s not the end of the world.
WF: Exactly. We want to stick to January 1 as our target date, but we understand we’re going to have to provide some flexibility so folks can deal with the feed that’s moving through the system and get those products under the authorization of a veterinarian.
I think this is what folks are concerned about — that enforcement action might be taken against them immediately if they’re not in compliance. But again, we recognize we need to provide some flexibility and are taking that into account and in our instructions to field inspectors. The main instruction to them in the early stages is if you’re inspecting a particular facility, and there are issues, the main focus is making sure the producer, the feed mill or whoever’s involved understands the requirements and really focus on it as an educational opportunity.
Certainly, down the road and as we move further into the year, we’ll have to shift more to a compliance or enforcement mode at some point if we still see problems in a given operation.
Laboratory versus clinical diagnoses
Q: Laboratory diagnosis increases costs for producers, and sometimes animals need to be treated before lab results can be obtained. With that in mind, is a laboratory diagnosis a prerequisite for the VFD? Or is a clinical diagnosis by a veterinarian acceptable?
WF: Diagnosis intersects with basic principles related to the practice of veterinary medicine. We understand that and aren’t intending to define specifically what those standards are. We look to the expertise of licensed veterinarians and the established standards of practice and, in some cases, the requirements or recommendations that may be established at the state level.
The VFD regulation, however, requires that for a VFD to be valid, there must be a veterinary-client-patient relationship (VCPR) — and that’s the area we’re most interested in. There has to be a legitimate relationship between the vet and client, which requires the veterinarian to have sufficient knowledge of animals that enables him to make a general or preliminary diagnosis.
We aren’t defining specifically what the vet would take into account to make that diagnosis, and we recognize it may include a variety of things — clinical signs, the history of the animal operation, lab testing, their basic professional expertise.
So, the short answer is “no.” The main issue is that the vet must be involved.
Q: Is there a specific way that FDA wants veterinarians to document a clinical diagnosis?
WF: The VFD regulations don’t define that specifically. From FDA’s standpoint, it’s our expectation there would be some medical records maintained regarding the decisions that veterinarians make involving dispensing products. But again, we’re looking to the standards of practice for veterinarians in terms of them maintaining sufficient records around the services they provide to clients and to the animals they’re treating.
Q: So, even though the VFD regulations don’t require specific records to justify issuing a VFD, would a site report or some other type of documentation summarizing the situation be good for veterinarians to have on hand?
WF: Yes. If for some reason we ask a veterinarian about involvement in a particular situation, I think certainly there would be an expectation that there’s some documentation showing that the veterinarian in fact does have a relationship with that operation — that the veterinarian has been providing services to a given operation and including information about their diagnosis and dispensing of products.
Even though we do not define specifically the kinds of records a veterinarian must keep, we would expect them to maintain some medical records around the services they’re providing to a given operation.
Q: So, in summary, a laboratory diagnosis is a nice thing to have when necessary or the schedule permits, but it is not a prerequisite for a VFD.
WF: Correct. As you said, it’s not a prerequisite and it’s really up to the clinical judgment of the veterinarian. There may be a number of other factors in addition to clinical signs they’re aware of in terms of a particular operation — what’s been experienced on that particular operation in the past, what they know about the animals and the source of the animals, and a whole number of other factors a veterinarian would take into account to determine the appropriate course of therapy for a group of animals.
Syncing mature products to today’s health problems
Q: Let’s talk about product labels. Dr. Flynn, as you know, many of today’s feed medications were registered more than 40 or 50 years ago. They’ve been used responsibly and, as a result, they’re still highly effective against a broad range of respiratory or enteric diseases. Yet, when these products were registered, poultry- and livestock-management practices, facilities and disease pressures were considerably different than they are today.
There are some diseases on these labels — atrophic rhinitis in pigs or swine dysentery, for example — that really aren’t big clinical problems in today’s herds. Similar situations exist for other species. By the same token, we’re aware that updating these labels would require a tremendous investment of resources by both the sponsors and FDA.
At long last, my question: If a poultry or livestock veterinarian is confident that the particular broad-spectrum antibiotic is going to be effective against the problem at hand but there’s not an exact match on the product label, what options do they have?
Is there any situation where a veterinarian could draw on his or her scientific training, experience and intuition of disease complexes and write a VFD if the suspected problem is somehow related to what’s on a product’s label?
How much latitude do veterinarians have in trying to connect the dots?
WF: Under the VFD regulations, veterinarians are limited to using that product according to the label — the specific indications of use and conditions of use that are outlined on that product label. In some cases, the labels are very, very specific regarding the indications for use and that limits the flexibility they have, but in other cases, the labels are a little bit broader.
Q: Let’s say we have pigs or chickens with an obvious respiratory or enteric problem and the veterinarian needs to do something quickly to manage the outbreak and relieve suffering.
The veterinarian is not exactly sure what pathogens are in play. But if he or she thinks that, say, tylosin or chlortetracycline might be effective, could the veterinarian look at the label and say, “Well, there’s a good chance that one of those bugs on the label is in there, so I’ll check this box and go on my gut feeling.”
Is that a reasonable course of action given the circumstances?
WF: Yes, if they have a respiratory disease or a pneumonia case, for instance, and are reaching for a VFD drug that is approved in feed for treating respiratory disease or pneumonia in that animal, that would be acceptable. In these cases, we need to look to the veterinarian to use their clinical judgment. This goes back to that general or preliminary diagnosis in the VCPR that we spoke about earlier.
For VFD or prescription products, our main concern is that there’s veterinary oversight. That’s our primary objective — that the veterinarian is involved and is consulting with the producer and helping make decisions around the use of that product and selecting the product for the given circumstance, based on their judgment of that circumstance.
But again, there are some limitations. Because of the way the law is written, animal drugs administered in feed must be used according to the label indications.
Q: So, in summary, if a veterinarian is making a clinical diagnosis and wants to use a particular broad-spectrum antibiotic for a condition or pathogen that is, in their best judgement, potentially related to an indication on the product’s label, could they feel comfortable writing a VFD for that feed medication?
WF: There is a legal obligation to use the product on label. Once again, I’ll use respiratory disease as an example. You may have Product A that’s approved for respiratory disease in cattle and Product B that’s approved for foot rot but not for respiratory disease. If they’re making a diagnosis of respiratory disease, then obviously, they need to be reaching for and authorizing the use of a product that has a respiratory disease on the label. They can’t authorize a product that only has a foot rot claim for treatment of respiratory disease.
But in terms of diagnosing respiratory disease, we’re not interested in second-guessing the veterinarian. The veterinarian needs to use clinical judgment to determine whether or not they are in fact dealing with respiratory disease.
Q: I don’t mean to belabor this, Dr. Flynn, but I just want to be clear for our readers. If there’s a respiratory disease in a flock or herd and there’s a particular antibiotic the veterinarian feels will be effective and it at least has one respiratory claim, the veterinarian in his or her clinical judgment and experience could feel confident issuing a VFD for that product. Is that correct?
WF: Yes, that’s accurate. Labels on these products are sometimes more specific and sometimes not. Some may specify respiratory disease associated with bacteria X, Y or Z. The veterinarian may not have confirmed diagnostics that prove its bacteria X, Y or Z, but if the clinical syndrome is one they feel, based on experience, is consistent with that respiratory disease and the history suggests it’s often associated with one of those bacteria, then, yes — I think that would be acceptable.
It’s not as though we’re saying a veterinarian is obligated to get more diagnostics if their clinical judgment leads them to believe this is the appropriate product to use.
Q: What about medically important water-soluble antibiotics? Is there still an extra-label option for those? And if not, would a veterinarian have the same clinical latitude that you described for medically important medicated feed additives that require a VFD?
A: Our thinking would be the same in terms of veterinarians using their clinical judgment when diagnosing disease and determining the appropriate treatment. However, there is more latitude legally regarding a scenario that involves a water-soluble antibiotic product. Current law permits a veterinarian to prescribe (under certain conditions) that a water-soluble product be used in an extra-label manner, but extra-label use of drugs in or on animal feed is not permitted.
Feed mill requirements
Q: Let’s switch gears to the feed mill. We know a VFD is needed before the medicated feed is fed to animals. However, can a feed mill order and inventory a VFD medication without having a VFD from the veterinarian?
WF: Yes, as long as it’s for a Type A medicated article, which is a concentrated product, versus Type B, which is a premix, and Type C, which is the actual finished feed. We consider Types B and C medicated feeds.
Q: What notifications are required for Type B or Type C feed that contains a VFD medication?
WF: If you’re a distributor intending to sell Type B or C medicated feed products that contain a VFD drug, you must send a one-time notification to FDA that you’re going to distribute these products. We call this the distributor notification letter. The letter to FDA says, in essence, that “I intend to be in the business of distributing feed containing VFD drugs.” This is mainly so FDA knows who’s out there distributing this feed.
Q: Is this notification letter in a standardized form that can be downloaded from FDA’s website?
WF: Yes, and it’s available via our website under “Notifications” [www.ecfr.gov Title 21; 558.6 (c ) (5, 6 and 7)].
Q: What’s an acknowledgement letter and how does it differ from the distribution notification?
WF: The acknowledgement letter is sent by a distributor who will be receiving Type B or C feed containing a VFD drug to the originating distributor providing the feed. The originating distributor selling that feed cannot distribute it to the receiving distributor until the receiving distributor sends that acknowledgement letter stating the feed will not be fed to animals without a VFD.
If the receiving distributor, in turn, plans to sell the feed to anyone else, they can’t do so until they have an acknowledgement letter from their receiving distributor. It’s a bit of a daisy chain.
The acknowledgement letter enables VFD feed to move through distribution channels without a VFD or before a VFD is required.
Q: Is there any requirement for how long an acknowledgement letter has to be retained by a distributor?
WF: Yes. An acknowledgment letter may be written to cover one or more shipments of a VFD feed with an open-ended duration. In that instance, the acknowledgment letter must be kept for 2 years from the date of last shipment distributed under the acknowledgment letter.
Q: Do distributors have to obtain acknowledgement letters for every shipment?
WF: That question has come up before. No, you don’t have to have an acknowledgement letter for every shipment. If you have an ongoing relationship with the distributor you’re shipping to, I think you’re fine.
Preparing for audits
Q: After the dust settles and FDA starts conducting audits to make sure everyone is complying with the rules, what can veterinarians, feed mills and producers expect from an FDA audit? And how should they go about preparing for one?
WF: Whether it’s the veterinarian, producer or a feed distributor or manufacturer, each of those parties has certain obligations under the VFD regulation. We have information available outlining the obligations of each that is available on our website and in brochures for each of these stakeholders.
As far as preparing for what to expect if an FDA inspector shows up at your facility, I think the best recommendation is to be familiar with and understand what your particular obligations are regarding the VFD rules. That’s what they’ll be looking at.
Veterinarians, for example, are responsible for making sure they have provided all the necessary information and the information is accurate. Have you included all the information you need to provide? Are you issuing a VFD in the context of a valid VCPR?
Similarly, for a feed distributor, there are certain pieces of information they need. They should not be filling an order for VFD feed unless they actually have a complete VFD from a veterinarian.
My recommendation would be to make sure you have in hand the things you need — like a complete VFD form — whether you’re the vet, producer or feed mill — and that you’re familiar with the VFD requirements. Then everything should be fine.
Q: If violations are found, does the FDA or do state licensing officials initiate enforcement? How does that work?
WF: Initially, we don’t envision initiating action on anyone immediately, particularly if it’s our first visit and we find problems. Mainly that’s an educational opportunity. Certainly if there are multiple visits where problems are found and on a return visit there’s been no effort made to correct issues, there’s the potential for action to be taken.
It may vary a little bit, but I think the FDA is responsible for the oversight or the implementation of the VFD regulation and would take action relative to violations of that regulation.
In cases that involve the practice of veterinary medicine, state licensing boards would be involved since FDA is not responsible for licensing veterinarians. FDA maintains contact with state licensing boards.
Q: Can you please give an example of when FDA would take action? In what circumstances would the agency step in? And what would it do?
WF: Say a veterinarian gives information that is not accurate and in some way does not comply with the requirements in the VFD regulation. That may be a circumstance where we may need to take some action to make sure the problem is corrected. There are a variety of things we could do. It may start with something like a warning letter and could escalate from there if the issue isn’t corrected.
There may be issues that veer into practice issues and raise the question of whether there is a valid VCPR. Here is where there may be some crossover between FDA and the state licensing board.
If a feed mill isn’t meeting its obligations under the VFD regulation, again, we might take action.
Part 2: Pork topics
On-farm feed mills
Q: Many pork operations have on-farm feed mills and manufacture feed for their pigs only. The complexes are all at one site. Do these on-farm mills need any special paperwork to obtain premixes containing the VFD medications?
WF: Basically, to obtain a VFD premix (Type B medicated feed) or a finished Type C feed, you either need to have a VFD from a licensed veterinarian or you need to provide an acknowledgment letter to the supplier indicating that you will not feed it to your pigs without a VFD.
You do not need a VFD or an acknowledgement letter to obtain a Type A medicated article containing a VFD drug. However, regardless of whether obtained as a Type A article, or as a Type B or C feed, a VFD is required in order to administer medicated feed containing a VFD drug to your animals.
Q: So, if there’s an individual owner of this feed mill, and he’s going to manufacture feed that he’s going to send to his farms on another site, possibly in another state, will the producer need a distribution letter?
WF: No. If you’re manufacturing medicated feed solely for the purpose of moving it from point A to point B, where you own the animals, you’re not selling it or “distributing” it to another person, so therefore you are not considered a distributor.
In those situations, a single VFD authorization could cover that, provided that the various locations/premises to which the feed is going are listed on the actual VFD order.
The only exception occurs when there’s a large operation that has more than one feed-manufacturing site supplying feed to the various locations/premises. You need to have a separate VFD for each manufacturing site.
Q: In summary, if there’s one feed mill producing VFD feed going to various sites but still owned by that company, only one VFD is required. But if it’s the same company with two feed mills, they would require two VFDs.
WF: Yes. As long as you can identify the locations where the feed is going, that’s fine. You can cover it all under one authorization, as long as it’s tied to one manufacturing site. If at any time you’re planning to sell some of that medicated feed, now you are a distributor and you would need a distributor letter.
Managing VFDs with pig flow
Q: Pigs and other livestock are not always as consistent in feed consumption as chickens. What happens if, for example, a swine VFD medication such as chlortetracycline is indicated for a treatment period of no more than 14 days. However, because feed consumption was less than expected, there’s still some medicated feed remaining on day 15.
Does that feed need to be discarded? Or can the medicated feed remain in the lines as long as the producer abides by the product’s designated withdrawal time?
WF: The challenge with this question is the legality, specifically around extra-label use for feed-use products. Technically speaking, the treatment duration needs to be followed. If it’s only 14 days, then you should use the medication only for the 14 days. Anything beyond that would require a reassessment by the veterinarian — essentially reauthorization for another course of therapy.
Q: So, on day 15, does the producer need to dump all that feed out of that line? Or could the producer finish the next 12 hours’ worth?
WF: The issue there — and you mentioned it earlier — is whether there are any drug-residue issues resulting from that extended duration. I understand the preference is not to dump feed, and we are not interested in feed being unnecessarily dumped, either.
However, so long as there is no significant public-health concern from a drug-residue issue and the veterinarian is aware of the situation, this is not likely to be a high priority for us from an enforcement standpoint.
Q: in summary, then, if it’s a 14-day treatment and you get into day 15, it would be acceptable to keep using the medicated feed as long as you consult with your veterinarian and honor the product’s withdrawal time?
WF: I can’t say that this is okay, legally. But from a compliance standpoint, it’s not something we would view as a high priority in a situation where you didn’t quite hit the mark with feed consumption and a little overlap — a day or so — particularly when it doesn’t represent a public-health concern. Any significant usage beyond that should require a new VFD.
Q: What happens if pigs are moved before they finish the VFD feed? Is it necessary to remove the feed completely from the bin? Or can the feed be stored in the bin until you have another group of pigs and your veterinarian has issued a VFD?
WF: If you have leftover medicated feed containing a VFD drug and the VFD authorization you had expired, you don’t have to get rid of that feed, provided there’s not a shelf-life issue. You can legally hold that feed on site. You just can’t feed it to animals until a new VFD is in place. This situation needs to be documented, however. There should be some record that the feed was held and then used for a new set of animals with a new VFD from a veterinarian.
Q: Let’s say we have a VFD that’s good for 6 months. What happens if new pigs are introduced to a site or barn where a VFD medication is already in use? Specifically, if we’re bringing in groups of nursery pigs and we’re loading that nursery with, say, 500 every week. Is a new VFD needed for each new group of incoming pigs? Or are they covered under the 6-month VFD that’s already in place for that barn and that age of pig?
WF: Yes, the 6-month VFD would cover the incoming pigs. The only qualifier here is that the VFD needs to authorize the drug’s use in a certain number of animals. For example, even if you have a VFD authorization that is valid for 6 months, the veterinarian was required to issue it on the approximate number of animals, not the quantity of feed.
So, if the understanding was that 5,000 head would be moved through a facility, that the expectation is that the capacity of that facility is 5,000 head over 6 months. At any given time, maybe there’s only 500 to 1,000 of those animals but the authorization is for up to 5,000 animals over a designated period of time.
Part 3: Poultry topics
Managing VFD records in integrated operations
Q: Under the new VFD rules, the veterinarian writing the order, the feed mill and the producer each has to keep a copy for 2 years.
Regarding integrated poultry companies, you said in a previously published interview, “If one firm represents the veterinarian, the feed mill and the client, it’s okay for the VFD to be stored in one place as long as everyone who needs a copy can access it and provide it to an FDA investigator upon request.”
Where should an integrated poultry company keep these copies? We’ve heard inspectors are usually going to go to feed mills first. So, should they keep them there, the veterinarian’s office or at the company’s main office? Does it matter?
WF: Yes, that’s a good question. It’s a question of accessibility. If a company is keeping only hard copies and the main office, feed mill and veterinarian’s office aren’t in the same location, and especially if they are far apart, it may be necessary to keep a copy at all three places so VFDs are readily accessible. I think that would be a safer, cleaner way to go because this way, if an issue arose, the information would be readily available.
Q: What if the company uses electronic copies that can be pulled up readily at the producer’s office, the veterinarian’s office and at the feed mill? Would that suffice and then would it be okay for an integrated company to have only the veterinarian’s original, electronic copy?
WF: As long as that information is accessible, I don’t see that as being an issue. The VFD regulation stipulates that the producer, veterinarian and feed mill each must retain VFDs for 2 years, but clearly in the case of an integrated operation, they’re all sort of one.
VCPRs and the poultry industry
Q: As you know, integrated poultry companies often have several hundred growers spread far and wide. How often does a poultry company veterinarian have to visit a given farm to establish and maintain the VCPR in accordance with the VFD rule?
WF: That question has come up before. It’s a little complicated and there are a couple factors to take into account. This spills over into veterinary practice standards, and you need to look at the requirements of individual states. Some state VCPR definitions specify the frequency of visits.
FDA has a list available online that lists each state and tells veterinarians whether their state definition contains key elements of the federal VCPR definition. If it does, they follow their state requirements, and they will need to see if the frequency of visits is specified.
If their state definition does not contain key elements of the federal definition, then they follow the federal definition. Although the federal definition does not specify the frequency of visits, there is some expectation that the veterinarian is familiar with the animal operation.
Although FDA has not established any minimum with regard to the number of visits, there is an expectation that the veterinarian has knowledge of the animal operation.
Another factor to consider is the VFD regulation as it relates to the expiration of the VFD authorization (not to be confused with the expiration of a drug). How long is that VFD authorization for?
There are a handful of VFD drugs with labels that define a specific expiration for authorized use, for example 45 or 90 days. If the time for authorized use is not designated on the product label, the veterinarian has the latitude to write an authorization for a given drug for up to 6 months. The veterinarian would need to provide a new authorization once that 6-month period has elapsed for a VFD drug. In this case, there’s an expectation that a veterinarian would revisit a given operation at least every 6 months.
Q: Let’s say there’s a large integrated poultry operation with hundreds of contract growers with some farms located hundreds of miles away. One of these farms has a respiratory disease outbreak. The veterinarian is familiar with the chicks placed on that farm because they’ve come from the company’s hatchery, and the veterinarian knows there’s a predisposition to a particular respiratory problem a certain time of year. However, the veterinarian either has never visited that particular farm or has not visited it in, say, 18 months.
Does the company veterinarian need to go out to that specific farm before issuing a VFD?
WF: FDA has not established any specific criteria as far as the frequency of visitation to maintain a VCPR. In states in which the state VCPR applies, CVM [FDA’s Center of Veterinary Medicine] refers veterinarians to their state authority regarding the frequency of visits. However, there is an expectation that, prior to issuing a VFD, the veterinarian needs to have sufficient knowledge of the animals by virtue of examination and/or visits to the facility where the animals are managed. If the veterinarian has never visited the specific farm where the animals are managed, this may bring into question whether the veterinarian has established a VCPR.
Q: There’s a lot of talk today in the human health-care industry about the value of telemedicine. Would it be acceptable for a veterinarian to issue a VFD based on signs of disease provided by a contract grower via a phone conversation, video or live-video transmission without visiting that farm?
WF: I think as communication technology rapidly advances, we all continue to struggle with where that line is drawn as far as the use of telemedicine and standards. We have expectations that a veterinarian issuing a VFD is familiar with the operations they’re providing services to and that there is some level of visitation and familiarity with those operations.
Clearly, we have not drawn any lines in the sand regarding a minimum threshold for visitation. But I think we’re still not quite at the point yet where we’re comfortable saying that a veterinarian can provide services to operations they’ve never, ever physically laid eyes on. I understand that the situation with integrated operations is somewhat unique, but we have to look at the situation more broadly in terms of all other situations that don’t involve integrated operations and where that line is.
While the thinking on this issue continues to evolve, FDA currently does not believe it is sufficient to establish a VCPR based solely on videos or photos. I think this is also an issue that the veterinary profession is continuing to look at. Obviously, resources are limited and the number of veterinarians is limited in terms of providing access to farms across the country. Today’s technology might be taken advantage of as a way to help.
Q: Is there a situation where the producer or grower might be able to use an IPhone and make a Facetime call with live video so the veterinarian can actually see and hear what’s going on in that poultry house or livestock farm?
WF: Yes, absolutely. I’m sure those kinds of technologies are being used today and can be very helpful in getting real-time information to veterinarians to help them provide services to their clients, the producers. These are great tools that can help in the interim if a veterinarian can only make visitations periodically. But, as noted previously, FDA currently does not believe it is sufficient to establish a VCPR based solely on videos or photos.
I guess the question that remains is what’s the minimum in terms of periodic, physical visits. This is where FDA has not established any minimum other than through the indirect notion that VFD authorizations can’t exceed 6 months and there is an expectation that a farm is being revisited at least on a 6-month cycle.
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