Veterinary Regulations

Xylazine Legislation Advances as Veterinarians Push to Protect Access

Fri, 27 Mar 2026 16:53:43 GMT

The Senate Judiciary Committee today advanced the Combatting Illicit Xylazine Act by a vote of 19–3, marking a significant step forward for bipartisan legislation aimed at addressing the growing role of xylazine in overdose deaths. The bill is led by Chuck Grassley (R-IA) and Catherine Cortez Masto (D-NV), and has drawn broad bipartisan support from lawmakers, veterinary organizations and federal agencies.

As momentum builds in Congress, veterinary leaders are working to ensure those efforts do not unintentionally disrupt animal care. The focus has shifted to how regulation can be implemented without restricting access for the veterinarians and producers who rely on the drug every day.

In the U.S. House Energy and Commerce Subcommittee hearing held Thursday afternoon, stakeholders from law enforcement, public health and veterinary medicine outlined the risks and realities surrounding xylazine use.

Xylazine’s Dual Reality

Xylazine occupies a unique position in the U.S. drug landscape. It is a widely used veterinary sedative with a long track record of safety and effectiveness, yet it has also emerged as a concerning component of the illicit drug supply, frequently detected alongside fentanyl and other opioids.

Its growing presence in human drug use has raised alarm among lawmakers and public health officials. Federal officials and lawmakers have pointed to the growing presence of xylazine in the illicit drug supply as a key driver of concern. Because xylazine is not an opioid, its effects are not reversed by naloxone, complicating overdose response and increasing risk.

At the same time, veterinary professionals emphasize its role in animal care is both established and difficult to replace.

Speaking during the hearing, Fred Gingrich, DVM, executive director of the American Association of Bovine Practitioners, underscored the need for balance:

“We believe this legislation represents a thoughtful, balanced and urgently needed solution that both addresses the serious human health threat and preserves access to this essential drug for legitimate veterinary use. The veterinary community is deeply concerned about the public health crisis caused by the rapid proliferation of illicit xylazine being found in combination with fentanyl and other opioids.”

A Cornerstone of Veterinary Practice

For more than five decades, xylazine has been a foundational tool in veterinary medicine, particularly in large animal practice. Its value lies not only in its pharmacologic effects but also in its practicality in real-world conditions.

“As a non-narcotic, FDA-approved veterinary sedative, xylazine has been used for over 50 years to facilitate the safe handling, restraint and treatment of a broad range of animal species. It is particularly important for use in livestock, zoo and wildlife species, as well as in research settings,” Gingrich says.

In cattle, its importance is even more pronounced. Effective sedation is not simply a matter of convenience — it is essential for safe handling, proper treatment and minimizing stress.

“In cattle, there is no safe practical alternative for sedation. Without xylazine, veterinarians and producers face significantly increased risks of injury, and animals may be subjected to unnecessary stress or harm during medical procedures,” Gingrich says.

The Risk of Regulatory Overreach

As concern about illicit xylazine has grown, so too has interest in bringing the drug under federal control. The U.S. Drug Enforcement Administration has indicated a desire to schedule xylazine under the Controlled Substances Act.

However, current law presents a critical limitation. The Controlled Substances Act does not allow the DEA to create exemptions for specific user groups, including veterinarians. Gingrich emphasizes administrative scheduling alone could restrict veterinary access, increase regulatory burden and disrupt supply.

“Administrative scheduling would unintentionally restrict how veterinarians use the drug and create burdensome regulatory barriers and jeopardize the continuing availability of the drug in the legitimate marketplace. A disruption in the availability of xylazine would have profound consequences,” Gingrich says.

Gingrich also notes supply constraints could amplify the impact of regulatory changes, with only a limited number of manufacturers currently producing the drug. In a low-margin market, additional regulatory or financial burdens could further threaten availability.

A Legislative Path Forward

The Combatting Illicit Xylazine Act would classify xylazine as a Schedule III substance under the Controlled Substances Act, enabling better tracking of its manufacture and distribution while strengthening enforcement against illicit use. At the same time, it includes provisions to ensure veterinarians, producers and researchers can continue to access the drug.

The bill also addresses how veterinary medicine differs from human healthcare, particularly in how drugs are prescribed, dispensed and used in real-world settings. In large animal practice, veterinarians often work with farm owners, employees and caregivers rather than a single individual patient and may rely on responsible on-farm use under veterinary oversight.

Support for the bill is broad, spanning veterinary organizations, law enforcement groups and federal agencies, reflecting a rare alignment across sectors.

What Is at Stake for Veterinary Practice

For veterinarians, the implications of the legislation not passing are immediate:

Increased risk of injury during handling and procedures
Reduced ability to perform timely and humane interventions
Greater stress on animals during restraint
Operational challenges for producers, particularly those with limited facilities

These risks extend beyond clinical settings, affecting the broader agricultural system where safe and efficient animal handling is essential.

Avoiding a Fragmented Approach

In the absence of federal action, several states have already begun exploring or implementing their own restrictions on xylazine. While well-intentioned, these efforts raise concerns about a potential patchwork regulatory system that could complicate compliance and disrupt supply chains.

A unified federal framework aims to prevent that outcome by establishing consistent standards while maintaining access for legitimate users.

Veterinary organizations, including the American Veterinary Medical Association and the AABP, have taken an active role in shaping policy discussions.

“Legislative action on xylazine is not only preferable, but it is essential. The legislation has been endorsed by all 50 state veterinary medical associations and numerous national stakeholder groups,” Gingrich says.

As lawmakers weigh next steps, the challenge is clear: addressing a growing public health threat without disrupting a long-established tool in veterinary medicine. Regulation must be precise enough to target misuse while preserving access to a drug that remains central to safe and humane animal care.

What's Driving Canada's Veterinary Drug Shortage and Why it Matters

Tue, 09 Dec 2025 17:52:05 GMT

In Canada, the veterinary community is ringing alarm bells. In late November, the national body representing veterinarians, the Canadian Veterinary Medical Association (CVMA), issued a stark warning : Veterinarians across the country are facing severe shortages of essential drugs, including antibiotics, sedatives, vaccines and other core animal-health products.

Tracy Fisher, president of the CVMA, warns that without reliable access to these medications, veterinarians cannot properly do their jobs, and animals suffer. They are asking both federal and provincial governments to address the issue.

This is not a problem confined to one sector of the profession. According to the CVMA, shortages are affecting companion animal and livestock practices alike, raising concerns not only about animal welfare but also about food safety and stability.

Regulatory Forces Behind the Drug Shortage

Medications that once formed the backbone of routine veterinary care are now increasingly unavailable, disrupting treatment decisions across species and practice types. Antibiotics, anesthetics and sedatives, vaccines and other foundational drugs are among those becoming difficult or impossible to source.

Regulatory changes appear to be a central driver. In 2017, Health Canada imposed new inspection standards requiring manufacturing facilities in other countries to be inspected by Canadian officials. This has increased the burden on companies supplying the Canadian market. For some manufacturers, the cost of these inspections has outweighed the benefit of maintaining approval in a relatively small market.

As a result, Canada has seen a steady erosion of veterinary drug availability. CVMA estimates suggest up to 40% of medications previously accessible to Canadian veterinarians are no longer on the market. While some of these products remain available in the U.S. and elsewhere, Canadian clinics are unable to legally source them, leaving practitioners with fewer and often less-ideal options.

“We’ve lost 40% of the medications that we used to have in the 1980s,” Fisher says. She believes Canada should license products if they have been approved in two other reliable countries with strong safety regulations. “[The drugs] already have the standards met in Europe, Great Britain and the U.S.. Eliminate some of the red tape and bureaucratic processes that are holding up some of these things.”

Why Canada’s Crisis Matters to Global Veterinary Medicine

For veterinary professionals outside Canada, this crisis offers a cautionary example of how quickly a stable system can unravel when regulatory pressure, economics and global supply chains collide.

Veterinary pharmaceuticals rely heavily on multinational manufacturing networks and imported active pharmaceutical ingredients. When compliance costs rise or markets shrink, manufacturers might quietly exit. Once a supplier disappears, alternatives are often limited or nonexistent. Canada’s experience shows how vulnerable veterinary medicine can be when redundancy is low.

Drug shortages also create clinical consequences. When first-line therapies vanish, veterinarians must adapt protocols, rely on substitutions or delay treatment entirely. In livestock systems, these gaps can ripple outward, affecting herd health, productivity and food supply chains. Sustained shortages risk broader impacts beyond the clinic, including public confidence in animal health systems.

What U.S. Veterinarians Should Take From This

The U.S. might not have experienced shortages on Canada’s scale, but the underlying pressures are familiar. Many veterinary drugs already come from a limited number of manufacturers, and global supply-chain disruptions have shown how quickly availability can change.

Canada’s situation is not a prediction of what will happen elsewhere, but it is a reminder of what could happen if market forces and regulatory frameworks drift out of balance. Monitoring availability trends, maintaining contingency plans for essential medications and engaging in discussions around regulatory flexibility could help prevent similar disruptions.

Canada’s veterinary drug shortages are more than an inconvenience. They represent a systemic failure that developed gradually. For the broader veterinary community, the lesson is clear: Access to essential medications cannot be taken for granted. Paying attention now might be the best way to ensure shelves do not go bare elsewhere.

Information on U.S. animal drug shortages and how to report them can be found on FDA’s website .

Keeping Livestock Shows Fair, Safe and Healthy

Wed, 24 Sep 2025 13:31:05 GMT

Big fairs, livestock shows and equine events are more than just exhibition grounds, they’re high-visibility stages where animal health, food safety, welfare and fair competition all come into focus. Veterinarians are often approached to serve as the veterinarian on record for such events, yet few have formal training in navigating the medical, regulatory and ethical responsibilities that come with the role.

Dr. Caitlin Dobecka, the current official vet for the State Fair of Texas, talks about her experience in the role, and how veterinarians can ensure everything behind the scenes is working, not just what the public sees. Dobecka hopes she can start a dialogue on working such events, as there are currently no official guidelines in place.

“I used to keep these kinds of jobs like my best kept secret and that was a huge mistake on my part,” Dobecka says. “I was younger in my career, and I was a little bit fearful of telling other veterinarians what my protocols were because, to be honest, I wasn’t very confident in them. I didn’t have a manual or a playbook to go by.”

She now embraces the value of sharing experiences, so that they can be collaborated on and built upon. While there might be a lot of variation across events, some key considerations should hold true.

Considerations for Veterinarians at Livestock Events

Clear Contract and Expectations

Before hooves hit the ground, a strong written contract is essential. This needs to detail exactly what the expectations are along with your ideal and non-negotiable items. Essential information includes:

What services will be provided and how much of your time do they need
What equipment and materials are required and what is provided
How much staff support is available
What paperwork is required (health certificates, proof of vaccination, licenses)
How compensation will be handled

Dobecka emphasizes: “Don’t forget that you are the expert when it comes to public health, veterinary medicine and animal welfare. So yes, they need to tell you what they need from you, but don’t be afraid to speak up and say: ‘Actually, based on this schedule and the number of animals, I think you need a lot more from me, or maybe less from me.’”

Biosecurity and Animal Health Protocols

Preventing disease is preferable to reacting to disease. Biosecurity starts before the animal leaves home with a thorough health inspection. Consider both what is required of incoming animals and how to best manage animal health on-site including certified veterinary inspections, arrival inspections, unloading procedures to catch issues early and securing isolation/quarantine areas for sick animals. Pre-event planning should solidify what to do with a sick animal

Event Rules and Regulations

Events are governed by state, federal and event-specific rules. Contract veterinarians need to be familiar with the event rules pertaining to animal health, welfare and exhibition rules. Further, they must have protocols in place and facilities ready for emergencies, mortalities, euthanasia or necropsy.

Drug Testing

Drug testing can be a major responsibility for event veterinarians to ensure fairness in competition. Be certain to have clear protocols for sample collection, chain of custody and who oversees testing. Ensure there are enough staff to separate emergency care from drug-testing duties to avoid conflict of interest and contamination

One other consideration is whether security is appropriate for your event.

“Professional security is recommended for high competition events,” Dobecka says. “When you’re focusing on the drug testing, you need someone else to be enforcing the rules. Sometimes, after a really long day of showing, there’s alcohol involved, there’s 45 people in the family, and some of them want to be the one to pull the blood … but just keep them out of the area.”

Facilities, Team and Logistics

Ensure the layout, staff, and available tools are appropriate for the tasks you need to perform. Have a separate veterinary space and an animal isolation area away from the public eye. Have a loose animal protocol in place to protect human and animal safety. To avoid fatigue, organize a capable team working in shifts with scheduled rest times.

Speaking on having animals inside show rings: “Event producers, exhibitors, stock contactors, organizers; everyone needs to be on board,” Dobecka says. “Anytime we have a rodeo, we have a preproduction meeting. … It gets really old, but it is really important. … We need to be on the same page about what’s going to happen if we have an animal emergency.”

Ethics, Public Relations and Communication

Along with medical care, veterinary staff at events are also stewards of public trust and animal welfare. Be transparent with exhibitors about what is or isn’t possible within the rules. Veterinarians are often pressured to work miracles for exhibitors, but the rules need to be prioritized. Establish beforehand who will communicate with the media about any questions, concerns or publicity; consider someone with specific media training.

Benefits and Challenges

Doing this type of veterinary work can be both demanding and rewarding. While you might face challenges related to taking time away from your regular practice, and potential emotional and physical stress with high-stakes events, the benefits are also very real. You take the credit for protecting animal welfare and maintaining public and exhibitor trust in the fairness of competition.

Livestock events are complex. The success of these events depends on advance planning, clear contracts and rules, appropriate infrastructure and staffing, rigorous biosecurity, and transparency. When all of that comes together and the show goes on, both animals and people come out better for it.

UDSA to Hold Listening Sessions Addressing the Rural Veterinary Shortage

Tue, 23 Sep 2025 17:26:29 GMT

Last month, Secretary of Agriculture Brooke Rollins announced the Rural Veterinary Action Plan, which will enhance the support available for rural veterinarians across the US. The plan includes the following action items:

Improve Veterinary Grant Programs
Better Understand the Rural Veterinary Shortage
Recruit and Retain Veterinarians
Catalog Federal Resources Available to Veterinarians
Work with Stakeholders to Understand the Barriers to Entry and Increase Recruitment in Rural Areas

This plan aims to address the rural veterinary shortage due to the low percentage of veterinary school students that come from rural areas or express an interest in rural practice, along with the low number of recent grads entering production animal medicine.

As a part of the working with stakeholders action item, USDA will be hosting two virtual listening sessions for the veterinary workforce on Sept. 29 and 30. The following USDA agencies will be represented at these sessions:

National Institute of Food and Agriculture
Economic Research Service
Food Safety and Inspection Service
Animal and Plant Health Inspection Service
Rural Development

These sessions will begin with a short update on the current veterinary landscape followed by stakeholder comments for the remainder of the meeting. Interested parties are invited to participate and must register for these sessions in advance. Both sessions will cover the same topics.

Register for the September 29 Session

Register for the September 30 Session

Is Leadership an Innate Quality, or Can it be Learned?

Tue, 15 Jul 2025 16:27:26 GMT

Most of us have heard the expression “natural born leader” and can immediately call to mind people in our lives who exemplify that. They seem to have some innate qualities – confidence, great decision-making skills, problem solving abilities, to name a few – that make them instinctively effective at leading and inspiring other people.

But what if you don’t consider yourself a natural leader, and you want or need to be one to succeed in your organization or to run your veterinary practice effectively?

The good news – most essential leadership skills can be learned and developed over time through formal learning, practical experience and an abundance of hard work.

An article in ScienceDaily estimates that around 70% of leadership ability can be developed while 30% is influenced by innate qualities:

Learned components (70%) – These include skills acquired through experience, mentorship, formal leadership development programs and self-directed learning.

Innate components (30%) – These are qualities like charisma, confidence, social awareness and emotional resilience. However, such natural tendencies alone don’t guarantee effective leadership.

Not An Either/Or Scenario

It’s encouraging to me – and I hope it is to you – that most essential leadership skills can be learned, developed and applied. They aren’t just a matter of nature versus nurture; they’re most usually a combination of both.

Looking ahead, there are two upcoming opportunities to develop and hone your leadership skills:
1. American Association of Bovine Practitioners Annual Conference , Sept. 11-15, 2025, Omaha, Neb.
2. American Veterinary Medical Association annual Veterinary Leadership Conference , Jan. 8-10, 2026, Chicago, Ill.

One final thought on leadership. If you’re far along in your career and the topic of leadership makes you shrug your shoulders in a been-there, done-that sort of way, consider becoming a mentor to a younger or new practitioner. AABP has a host of mentor opportunities, and your skills, encouragement and listening ears will be just what another veterinarian out there needs now. Learn more at www.aabp.org.

Your next read: Build A Biosecurity Plan Like You Would Eat An Elephant

Build A Biosecurity Plan Like You Would Eat An Elephant – One Bite At A Time

Thu, 13 Mar 2025 15:41:02 GMT

If biosecurity plans were easy to develop, perhaps most U.S. beef producers would have done one long before now, but there is no easy button for such a plan, and the task can be daunting.

The best strategy to get started is to tackle the challenge like you would eat an elephant, says Lisa Pederson, Extension beef quality specialist with North Dakota State University (NDSU) and North Dakota beef quality assurance (BQA) coordinator. How do you do that?

“One bite at a time,” she says.

Pederson addressed how to develop a practical biosecurity plan in a recent webinar, “Building A Resilient Cowherd,” which was sponsored by the National Cattlemen’s Beef Association (NCBA). The webinar also featured Dr. Julia Herman, NCBA beef cattle specialist veterinarian, and Casey Fanta, seedstock manager for Wulf Cattle, based in Morris, Minn.

Prevention Beats A Cure
Biosecurity is the cheapest and most effective means of disease prevention, according to Pederson. She points out that trichomoniasis is a good example of a disease where biosecurity is the most important preventive measure.

(Lindsey Pound)

Herman shares three benefits of biosecurity: 1. Fewer disease challenges mean better animal health. 2. A decreased germ load also results in better animal health. 3. Better animal health means improved potential for economic gains.

Financial implications
Pederson says producers who might have balked in the past about developing a biosecurity plan are more interested today, because of the economic value of cattle.

“Bred cows, four to five years of age, are selling for $2,500 to $3,000 each and maybe more,” Pederson notes. “Bred heifers have pretty easily been selling here in the North for $3,000 to $3,500. All weights of feeder cattle have been selling for $2,000 to $3,000 each. Finished cattle are selling for well over $3,000 a head.”

Fanta says good vaccination and nutritional programs have been foundational to the enduring success Wulf Cattle has experienced in the beef industry.

“Whatever your program is, I feel it’s very important to have protocols in place, a system for the health and well-being of those cattle from the time that they’re born,” Fanta explains. “It all equates to the long-term health and success of your operation.”

Increased risk potential from foreign disease entering the U.S. is another reason veterinarians and beef producers can benefit from developing biosecurity plans.

“The majority of producers have not dealt with a new, highly contagious disease,” Herman says.

The health risks to the beef industry, and the U.S. livestock industry overall, are real and concerning. One is the new world screwworm, which is currently advancing through Central America and into southern Mexico. NCBA has undertaken extensive education efforts with producers in recent months regarding this threat

Another concern, Herman references, is the potential for foot-and-mouth (FMD) disease to enter the U.S. FMD was first discovered in the U.S. in 1870 and eradicated in 1929. Herman says while FMD is not a human health or food safety threat, it would have a significant economic impact on the country’s livestock industry.

This map shows the location of FMD as well as disease-free countries. The disease was found in a water buffalo in Germany in January. More recently, FMD has been found in Hungary.

(WOAH)

NCBA has worked with industry stakeholders on the Secure Beef Supply (SBS) Plan to help producers voluntarily prepare for FMD. If an outbreak does occur, Herman says having an enhanced biosecurity plan in place will help prevent exposing “naïve” cattle to the disease during an outbreak. More information from NCBA is available at Biosecurity Resources

More information specific for veterinarians is available from the American Association of Bovine Practitioners at aabp.org

Producers Need Help
Bovine veterinarians are in a position of trust and leadership to help beef producers understand the importance of a having biosecurity plan and how to create one. Pederson encourages producers routinely to work closely with their veterinary practitioner.

“A strong relationship means more than preg testing and Bangs vaccinating, and calling with calving problems,” Pederson says. “Strong relationship means you use veterinarians for their brains and disease knowledge. Engage them to help you identify biosecurity strengths and weaknesses of your operations.”

For producers who have not started developing a biosecurity plan, it’s a case of veterinarians helping them walk before they can run. Pederson references an elephant cartoon she once found online.

“I like to think about where you can take easy bites of the elephant to eat first,” she says. “Pretty soon, with one bite at a time, you can have that elephant eaten.”

With a biosecurity plan, the point is it can’t be developed all at once, but it can be accomplished one small step at a time when producers, especially with their veterinarian’s help, stick with it until it’s completed.

Five Easy Bites
Here are five factors that are important to consider in a basic biosecurity plan.

1. Help producers identify and develop their team of partners and advisers.
Sit down with producers and talk about the benefits of a biosecurity plan, advises Pederson. Discuss who would be good to include on their team, which might include veterinarians, key employees, nutritionists, Extension specialists, BQA state coordinators, state veterinarian and others.

Build a team that can help you identify risks and how to address them.

(Lisa Pederson)

2. Create a basic communications plan, one that will be straightforward to implement when a crisis does occur.
Help producers create the plan in advance of any crisis, emphasizes Herman.

“We really need to be prepared ahead of time,” she says.

Some of the topics to include in the plan and questions to answer are: Why is there a need to communicate? Who needs to be reached? How will the producer communicate and who with internally and externally? Who needs to know about the plan?

Make sure the plan is written down, so everyone is working off the same document. Also, help the producer decide if the plan needs to be posted in a break room, barn or other facility on the property for quick reference.

3. Address low-hanging fruit. Consider the biosecurity practices that can be adopted with some careful thought but little or limited expense.

The single most important one, Pederson says, is to have separate footwear and clothing for wearing on and off the farm/ranch.

Diseases and pests hitch rides on dirt, dust, manure, critters, shoes, clothes, vehicles and so much more. Remove manure, mud and other organic matter regularly and disinfect as well. As Pederson says: “You can’t disinfect a turd.”

First things to consider implementing are those practices that are of little cost but offer a high reward.

(Lisa Pederson)

4. Have a quarantine/isolation plan for new animals coming on the farm or ranch, whether purchased or acquired.
Isolate new cattle and other livestock for at least 21 days, ideally without the option for nose-to-nose contact. Do not allow for shared feed or water. The isolation can allow you and producers time for observation, testing, vaccination and revaccination, Pederson says.

There are many ways a disease can enter a farm, Herman adds. “Wildlife, rodents and birds are just a few examples,” she says. “That’s why an integrated pest management plan is important.”

5. Help producers adopt good record-keeping practices, if they haven’t done so already.
Pederson says items to keep track of include livestock purchases and sales, as well as livestock movements to exhibitions, rodeos and shows. Good records will be imperative to have should a novel disease outbreak occur, she adds.

Your next read: Hungary Confirms Foot-and-Mouth Disease Outbreak in Cattle

Preventing a One Health Crisis: How Science is Informing New Policy

Wed, 05 Feb 2025 14:05:37 GMT

The current One Health crisis brought about by the challenge of viral diseases and the need to improve the level of biosecurity practiced across species has spurred the American Veterinary Medical Association (AVMA) to take a big step forward to protect animals.

On Jan. 10, the House of Delegates of the AVMA voted unanimously to approve a resolution entitled “Biosecurity.” This resolution, authored by Scott Dee, DVM, and sponsored by the Minnesota Veterinary Medical Association, is based on scientific research documenting the ability of an evidence-based biosecurity programs to control PRRSV infection across a large-scale pork production system for an extended period.

“Globally, herds, flocks, companion animals, and exotic wildlife populations are at risk of infection by multiple agents, including porcine reproductive and respiratory syndrome virus (PRRSV), and African swine fever virus (ASFV) in pigs, along with highly pathogenic avian influenza virus (HPAIV) infection in multiple avian and mammalian species, resulting in a documented spillover into humans,” explains Dee. “Therefore, to protect the health and welfare of all that are at risk, veterinarians must practice biosecurity that is science-based, as historically, the practice of animal biosecurity has been long on marketing and short on science, resulting in mixed messages to animal owners and the public.”

Dee says the research not only proved the efficacy of science-based biosecurity, but also raised the question of how this new information could be leveraged beyond pigs and PRRSV for the benefit of “ all people short and tall, and all creatures great and small.”

Approval of the resolution led to an AVMA policy on biosecurity, as follows:

• Diseases of animals can be transmitted in many ways, including direct and indirect oral, airborne, and vector borne routes of transmission.

• Because of these many risks, prevention of disease transmission through the practice of biosecurity is critical to protecting the health and welfare of all species.

• To be effective, biosecurity programs should be, based on scientific evidence and current best practice(s) as applicable.

• The AVMA supports the protection of the health and welfare of animals through the practice of science-based biosecurity and encourages its members to become familiar with this approach.

“Since an AVMA policy on biosecurity did not previously exist, this was a logical first step to take,” Dee says. “As mentioned in the policy, all veterinarians across all species should become familiar with the science of biosecurity, follow an evidence-based approach to practice it in the field, and strive to bring answers to existing questions.”

Using scientific information from pivotal publications to write policy for the benefit of the profession is a novel approach when dealing with critical matters that affect animal and human health, Dee explains. Read more from the AVMA meeting here.

Unapproved Use of Aspirin in Dairy Cattle Prompts Reminder for Pork Industry

Tue, 14 Jan 2025 18:00:53 GMT

The increased use of aspirin (acetylsalicylic acid) to treat pyrexia and pain in dairy cattle infected with highly pathogenic avian influenza (HPAI) H5N1 prompted FDA to issue a warning to producers and veterinarians in October. Previously, FDA had stated that aspirin use was of low regulatory concern. However, due to its increased use because of H5N1, FDA has shifted its stance.

“The U.S. Food and Drug Administration understands that veterinarians and dairy farmers may be treating lactating dairy cattle for pyrexia and pain with aspirin and wants to clarify that there are no FDA-approved aspirin products for use in cattle,” FDA said in a letter to veterinarians . “There are FDA-approved products for controlling pyrexia and pain in lactating dairy cattle that are safe, effective, and have established milk and meat withdrawal periods.”

How Does This Affect the U.S. Swine Industry?
The same regulations that guide the use of aspirin in dairy cattle also guide its use in swine, reminded Locke Karriker, DVM, professor at Iowa State University College of Veterinary Medicine and American Association of Swine Veterinarians (AASV) president-elect, in a recent Swine Health Information Center/AASV webinar.

“Currently, those regulations mean that there is no legal pathway to use aspirin in swine and it should be avoided,” Karriker says.

Under the Animal Medicinal Drug Use Clarification Act (AMDUCA), veterinarians may use only FDA-approved human or animal drug in food-producing species under specific conditions in an extra-label manner. The extra-label use of unapproved drugs in food-producing species is prohibited.

All FDA-approved animal products are required to carry one of the following statements on the label:

“Approved by FDA under NADA # XXX-XXX” (for brand name animal drugs), or
“Approved by FDA under ANADA # XXX-XXX” (for generic animal drugs).

With no legal pathway to use true aspirin in swine, experts are looking into other potential treatments and other nonsteroidals and how they may be evaluated.

“The industry, veterinarians and university-based clinical scientists are working to develop alternatives to aspirin use while exploring the development of products that contain aspirin and conform to regulatory requirements,” Karriker says. “This includes cooperation among the professional veterinary organizations for bovine, poultry and swine medicine as well as dialog with the FDA directly.”

Dusty Oedekoven, DVM, chief veterinarian for the National Pork Board, says this situation is a good example why involvement of a licensed, accredited veterinarian is important in providing timely care for animals while ensuring regulatory compliance and food safety.

“My recommendation to producers is to consult with your herd veterinarian regarding the use of any animal health products, including aspirin products (acetylsalicylic acid),” Oedekoven says.

Karriker adds that depending on the case context and clinical signs, there may be several options that do have a legal status.

Learn more here from this list of resources compiled by AASV:

Extra-label Drug Use (AMDUCA)

FDA AMDUCA website — Resource information from the FDA regarding AMDUCA.

AMDUCA and Extra-label Drug Use in Swine — A brochure providing an algorithm for the use of drugs in an extra-label manner and describing additional restrictions for the extra-label use of cephalosporins and fluoroquinolones.

AVMA: Extralabel Drug Use (ELDU) Algorithm — An online algorithm.

AMDUCA Revisited — JSHAP article describing AMDUCA in swine medicine.

Your Next Read: I’m Going Into 2025 With Increased Concerns About HPAI H5N1

What The Trump Administration's Mass Deportation Plans Could Mean for Agriculture

Mon, 23 Dec 2024 16:47:42 GMT

Farmers and food industry leaders are warning that President-elect Donad Trump’s plans to deport millions of immigrants could devastate agriculture — an industry in which immigrants make up a good chunk of the workforce.

Nearly half of all farmworkers are undocumented, and industries such as dairy and meatpacking plants are especially vulnerable to labor shortages.

“Admittedly, there are some people who slip through,” says Scott VanderWal, vice president of the American Farm Bureau Federation. “Perspective employers are required to take documentation that appears to be legal and valid. There are times when that’s not the case and then ICE [U.S. Immigration and Customs Enforcement] comes in and cleans house, the workers disappear and go wherever they take them and the employers are left without help.”

While the H-2A visa program has grown, it only covers seasonal work and cannot replace year-round jobs at meat processing plants and on dairy and pork farms.

“Our packing plants need labor. Many of our farms use temporary visa labor — educated, skilled individuals work on our sow farms,” says Lori Stevemer, president of the National Pork Producers Council. “We have been experiencing an increased number of denials over the past year, which really makes it a challenge to find workers. The H-2A visa doesn’t work well when we have animals that need care 24/7, year-round.”

Experts say mass deportations would disrupt food production, raise prices and jeopardize the stability of U.S. agriculture.

Deportation falls under the Department of Homeland Security. President-elect Trump has selected South Dakota Republican Gov. Kristi Noem to lead that agency.

“With Governor Noem at the helm, she’s going to bring common sense to that discussion and make sure we don’t close businesses, make sure we get everyone in line, get the workforce in line and then make sure we’re following our country’s rules,” says Hunter Roberts, secretary of South Dakota’s Department of Agriculture and Natural Resources.

Meanwhile, farm groups continue to urge for reforms to immigration policies or a guest worker program to secure a stable workforce.

“At the same time as controlling the border, we need to overhaul our labor system,” VanderWal says. “We need to make H-2A apply to your own workers or come up with a decent program that will help.”

We need some type of H-2A visa reform to allow those workers to stay year-round, Stevemer adds.

Even then immigration is likely to continue to be a political hot potato in 2025, and labor shortages will continue to top the list of challenges for agriculture.

Protecting the Herd from New World Screwworm

Wed, 18 Dec 2024 20:43:00 GMT

by Kim Brackett, NCBA Policy Division Chair

Every cattle producer knows that pests are a challenge to our operation, but some pests are far more dangerous than others. One of the new threats to our herd comes from the New World screwworm, which is currently advancing through Central America into southern Mexico and could soon be at our border.

The New World screwworm (NWS) is a fly that has a particularly gory way of harming our cattle. Female NWS flies lay their eggs in open wounds or body orifices and when the larvae hatch, they burrow deep into the skin like a screw driving into wood. These maggots feed on cattle’s tissue, causing larger wounds as they go.

NWS flies and their burrowing larvae cause extensive damage to cattle and infestations can spread rapidly. In 1966, we eradicated screwworms in the United States through sterile insect technique. The U.S. Department of Agriculture (USDA) bred sterile male NWS flies that mated with wild female screwworms and failed to produce offspring. Eventually, these flies died out in the U.S. and now they only exist in a handful of South American countries.

Unfortunately, these flesh eating flies are now on the march north.

Since 2022, USDA’s Animal and Plant Health Inspection Service (APHIS) has confirmed the presence of New World screwworms in Costa Rica, Nicaragua, Honduras, and Guatemala. Just last month, screwworms were discovered in southern Mexico, which raised red flags for us at the National Cattlemen’s Beef Association (NCBA).

Once in Mexico, it is easy for screwworms to travel north and appear on our southern border. These flies can hitch a ride on people, livestock, or wild animals, not to mention the thousands of vehicles and cargo containers traveling through Mexico to the United States.

We know how devastating it would be if New World screwworm returned to the United States, which is why NCBA is raising the alarm now. First, we are communicating with Mexico’s cattle industry leaders so they can begin the process of screening for these flies and push for eradication efforts in their country. We are also supporting USDA-APHIS to bolster the use of sterile flies. Recently, we have been concerned that our existing sterile flies might not be getting the job done, and NCBA is pushing for more flies and better flies that will help us beat back these pests.

Although we haven’t confirmed any New World screwworms in the United States, we need you to be on high alert. New World screwworms have orange eyes, a metallic blue or green body, and three dark stripes across their backs. If you see any suspicious flies, please alert your local veterinarian, extension agent, or contact USDA-APHIS Veterinary Services.

Please also pay close attention to your cattle and watch for any open wounds or sores. If cattle exhibit irritated behavior, head shaking, you notice the smell of decaying flesh, or spot maggots in a wound, seek treatment from a veterinarian immediately. Proper wound treatment and prevention is the best way to protect your farm or ranch from a screwworm infestation. NCBA is also sharing the latest updates through our website. I encourage you to visit www.ncba.org/NWS for all the latest information on how to protect your operation.

NCBA is always on the clock to protect the U.S. cattle industry from threats like New World screwworm. Through your vigilance and NCBA’s advocacy, we can protect the United States cattle herd.

Kim Brackett is an Idaho rancher and serves as Policy Division Chair of the National Cattlemen’s Beef Association (NCBA).

USDA Reports First H5N1 Detection in Swine

Wed, 30 Oct 2024 23:30:32 GMT

USDA announced on Oct. 30 the first reported case of H5N1 in a pig in an Oregon backyard farm. It’s important to note there is no concern about the safety of the nation’s pork supply as a result of this finding, USDA said. This farm is a non-commercial operation, and the animals were not intended for the commercial food supply.

“The confirmed case in Oregon poses no threat to consumer health or food safety; properly handled and cooked pork products remain safe for consumption,” Bryan Humphreys, National Pork Producers Council (NPPC) CEO said in a statement. “The entire pork industry remains committed to safeguarding food safety and human and animal health.”

The case was discovered on a backyard farm that includes a mix of poultry and livestock, including swine. The Oregon Department of Agriculture announced on Friday, Oct. 25, that poultry on this farm represented the first H5N1 detection in Crook County, Oregon. On Tuesday, Oct. 29, the USDA National Veterinary Services Laboratories also confirmed one of the farm’s five pigs to be infected with H5N1, marking the first detection of H5N1 in swine in the U.S., USDA reports.  

“The livestock and poultry on this farm shared water sources, housing, and equipment; in other states, this combination has enabled transmission between species. Although the swine did not display signs of illness, the Oregon Department of Health and USDA tested the five swine for H5N1 out of an abundance of caution and because of the presence of H5N1 in other animals on the premises,” USDA wrote.

The swine were euthanized to facilitate additional diagnostic analysis. Although test results were negative for two of the pigs, and test results are still pending for two others.  
The farm has been quarantined to prevent further spread of the virus. Other animals on the farm include sheep and goats that remain under surveillance.  

“USDA’s National Veterinary Services Laboratories (NVSL) has conducted genomic sequencing of virus from the poultry infected on this farm, and that sequencing has not identified any changes to the H5N1 virus that would suggest to USDA and CDC that it is more transmissible to humans, indicating that the current risk to the public remains low,” USDA wrote.

H5N1 detections include viral genome sequencing to provide additional information of interest to medical professionals and the research community to improve understanding of the virus. Genetic sequencing for these samples is underway, but results may be inconclusive due to low viral levels in the samples, USDA said.   

Pork Producers Practice Biosecurity to Protect Pigs
Biosecurity is critical to eradicating H5N1 and other viruses. Not only does biosecurity protect the health of livestock, but it also protects the health of farmworkers and their families. For more information on protecting farmworkers, visit the CDC’s website .
___________________________________________________________________________
10 Powerful Take Homes to Enhance Biosecurity on Your Pig Farm
___________________________________________________________________________

The pork industry has worked alongside USDA’s Animal and Plant Health Inspection Service (APHIS) since 2009 to carry out the swine influenza surveillance program to identify influenza viruses circulating in swine, proactively detect reassortment viruses that could impact public health, and gain knowledge to contribute to improved animal health diagnostics and vaccines, NPPC pointed out in a statement.

“Pork producers have always been proactive and diligent about implementing biosecurity plans as part of their daily production practices to assure animals wellbeing and food safety,” Lori Stevermer, NPPC president and Minnesota pork producer said. “This detection serves as a reminder for producers of all sizes to understand and address influenza virus risks.”

What’s Next?
USDA recently approved two vaccine field safety trials for vaccine candidates designed to protect dairy cows from H5N1, and continues to explore vaccine options for other species.   As USDA takes additional steps to protect the health of livestock, it will continue to work closely with CDC to protect the health of people and FDA to protect the safety of the food supply.

“These collective, collaborative efforts have helped protect farmworkers and farmers, the health and welfare of livestock animals, and reaffirmed the safety of the nation’s food supply. The U.S. government remains committed to addressing this situation with urgency,” USDA said.

Learn more about USDA’s response to HPAI in dairy cattle.

The situation is being monitored by local public health officials, Oregon Health Authority, Oregon State Veterinarian, Oregon Department of Agriculture, as well as USDA and U.S. Department of Health and Human Services.   

Read More:
Get the Facts Straight on Highly Pathogenic Avian Influenza
Animal Health Experts Open Up About Future Disease Preparedness
How the Swine Industry Responded to H5N1 Outbreak in Dairy Cattle
A Message to the Ag Industry about H5N1

FDA Reorganizes Animal Drug Evaluation Structure to Better Align Innovative Products, Generic Drugs

Mon, 07 Oct 2024 16:07:08 GMT

The U.S. Food and Drug Administration is announcing that it is reorganizing the Office of New Animal Drug Evaluation (ONADE) within the Center for Veterinary Medicine (CVM) into two separate offices that will handle pre-market evaluation of originator animal products and generic drugs. The reorganization implementation will take place October 20, 2024.

The realignment of ONADE into the Office of New Animal Product Evaluation (ONAPE) and the Office of Generic Animal Drugs (OGAD) comes at a critical time in the animal drug review program. This reorganization will enable ONAPE to continue to build capacity to support review of new and innovative technologies, which the center sees as the future of animal agriculture and animal health products.

At the same time, the agency has seen unprecedented growth in the generic animal drug review program over the past 8-10 years. Standing up OGAD as an independent office will provide for concentrated focus for the generic animal drug program and maximize the program’s effectiveness.

The reorganization also includes certain changes to CVM’s Office of Management (OM). The Records and Information Management Team, which resided in ONADE, will become part of OM’s Business Informatics Staff. Additionally, the new Financial Management Staff will be created by combining the Budget Planning and Evaluation Staff and Program and Resource Management Staff functions and resources under one Staff Director.

A full list of the changes can be found in the Federal Register notice .

For more information:

Registration Opens for NIAA 14th Annual Antibiotics Symposium

Tue, 10 Sep 2024 21:15:39 GMT

The National Institute for Animal Agriculture (NIAA) will host the 14th Annual Antibiotics Symposium in Denver, Colorado at the Colorado State University’s SPUR Campus from November 19-21, 2024.

Led by NIAA’s Antibiotics Council co-chairs, Dr. Heather Fowler and Dr. Alexandra Medley, the planning team is preparing a Symposium program that continues to lead animal agriculture’s work in a One Health approach to antimicrobial stewardship and combatting antimicrobial resistance (AMR). The 2024 Symposium will focus on Combatting AMR Together: Shared Commitment, Shared Success.

Drs. Fowler and Medley recently accepted their roles as co-chairs and have wasted no time selecting a planning team and brainstorming topics One Health leaders will find most valuable. Symposium topics will include barriers to reduction and stewardship in production, surveillance of use and resistance across sectors – human, animal, environment, metrics beyond antimicrobial use measurement, regulatory updates, and more. Animal agriculture benefits from the expertise and guidance of those on the 14^th Annual Antibiotics Symposium planning committee:

· Alexandra Medley, DVM, MPH, DACVPM - The Centers for Disease Control and Prevention

· Heather Fowler, VMD, PhD, MPH, DACVPM – National Pork Board

· KatieRose McCullough, PhD – The Meat Institute

· Chelsey Shively, DVM, PhD, DACAW – USDA, APHIS

· Kris Johannson, PhD, MBA – NIAMRRE

· Michelle Kromm, DVM, MPH, MAM, Diplomate ACPV – Food Forward, LLC

· Courtney Youngbar – Association of State and Territorial Health Officials

· Claudine Kabera, MPH – Food and Drug Administration

· Dan Kullot, DVM – Dairy Farmers of America

· Ryan Loseke, DVM – Loseke Feedyard

· Rebecca Campagna, DVM, MPH, DACVPM – National Association of State Public Health Veterinarians

· Karyn Havas, DVM, PhD – Pipestone Veterinary Services

This year’s program follows and builds upon multiple One Health engagements. In July, the National Pork Board (NPB) partnered with the National Institute for Animal Agriculture (NIAA) to convene a group of public health, animal health and swine professionals in Sioux Falls, South Dakota, to build relationships and explore opportunities for One Health collaborations.

The One Health farm to fork experience spanned all phases of on-farm swine production, a feed mill, truck wash, and processing plants in Minnesota, South Dakota and Iowa. The educational tour focused on biosecurity, animal wellbeing, and sustainability to create a dialogue between human health, animal health, and food safety professionals.

In August, NIAA convened animal agriculture leaders in Atlanta, Georgia to meet with human and animal health experts at the Centers for Disease Control and Prevention (CDC) prior to their antimicrobial resistance discussion with leaders at the 79th UN General Assembly. This latest convening built on previous meetings that began in 2018. A multi-day One Health discussion spanned animal agriculture priorities, foodborne illnesses, waterborne transmission, H5N1 updates and preparedness, fungal pathogens, worker safety, tours of CDC enteric pathogen laboratories, and more.

Through ongoing discussions and experiential learning tours with public health leaders, like these mentioned, animal agriculture leaders identify opportunities to concretely improve One Health outcomes. Additionally, farmers, ranchers, and veterinarians provide context about on-farm and ranch practices to increase public health officials’ understanding for enhanced investigations of foodborne, waterborne, and environmental disease outbreaks.

To register for the 14th Annual Antibiotics Symposium, please visit www.AnimalAgriculture.org. For assistance or media passes, please contact Morgan Young, Director of Communications and Outreach for the National Institute for Animal Agriculture at morgan.young@animalagriculture.org .

NIAA Welcomes New Antibiotics Council Co-Chairs

Thu, 29 Aug 2024 15:24:43 GMT

The National Institute of Animal Agriculture (NIAA) recently welcomed two new co-chairs to the Antibiotics Council: Dr. Heather Fowler from the National Pork Board and Dr. Alexandra Medley from the Centers for Disease Control & Prevention.

Since NIAA’s inception in 1916, its mission has been to convene leaders regarding important and developing topics. Councils were developed to collaborate, learn, and discuss current and emerging topics to provide platforms to exchange scientific information, find common ground, and seek resolutions across species segments. Participation in NIAA’s Councils is open to animal agriculture stakeholders. The purpose of the Antibiotics Council is to seek to enhance an animal agriculture industry that is aligned with judicious antibiotic use policies and practices.

Dr. Heather Fowler

(NIAA)

Dr. Heather Fowler is the Director of Producer and Public Health at the National Pork Board where she oversees public health as well as occupational safety and health issues as they relate to swine production in the United States. She completed her Veterinary Medical degree at the University of Pennsylvania School of Veterinary Medicine in 2010, a Master in Public Health in Applied Biostatistics and Epidemiology at the Yale School of Public Health in 2011, and a PhD in Environmental and Occupational Hygiene from the University of Washington School of Public Health in 2017. She is board certified in veterinary preventive medicine and has expertise in the areas of zoonotic disease, public health, worker safety and health, and One Health application.

Dr. Alexandra Medley

(NIAA)

Dr. Alexandra Medley is a veterinary epidemiologist currently serving as the Associate Director for Antimicrobial Resistance within the Division of Foodborne, Waterborne and Environmental Diseases at the Centers for Disease Control and Prevention. She received both her Master in Public Health and her Doctor of Veterinary Medicine from The Ohio State University and her Bachelor of Music from Oberlin College.

The Antibiotics Council also hosts annual Antibiotics Symposium. Co-chairs have selected the planning committee and are currently planning 14^th Annual Antibiotics Symposium in Denver, Colorado from November 19-21, 2024. Symposium topics will include an industry report on the current state of antibiotic stewardship, information on the latest antimicrobial stewardship and resistance research, regulatory updates, One Health collaborations, and more.

To register for the 14th Annual Antibiotics Symposium please visit www.AnimalAgriculture.org . For assistance with media registration, please contact Morgan Young, Director of Communications and Outreach for the National Institute for Animal Agriculture at morgan.young@animalagriculture.org .

Colorado Ramps Up Bird Flu Response, Requires Milk Testing

Wed, 24 Jul 2024 15:37:45 GMT

Colorado began requiring dairies to test milk supplies for bird flu every week, the state’s veterinarian told Reuters on Tuesday, as a federal team arrived to help investigate an escalating outbreak in cows that has spread to chickens and people.

The state’s new mandate aims to identify additional farms that could be infected and spread the disease to other dairies or poultry flocks, after the largest cluster of human cases to date in the United States occurred on a Colorado farm this month.

Bird flu infections linked to dairy cows have wiped out 3.1 million egg-laying chickens in Colorado in recent weeks, and poultry workers also tested positive.

Colorado has confirmed infections in 47 dairy herds since the U.S. outbreak in cows began in late March, with about 60% of its cases detected in the past month, according to U.S. data. Nationally, 13 states have reported infections in about 168 herds since spring.

In Colorado, the loss of millions of chickens triggered the requirement for licensed dairies with lactating cows to test bulk milk supplies weekly, state veterinarian Maggie Baldwin said in an interview. About 70% of the state’s laying hens were eliminated, according to U.S. data.

“We really said what we’re doing right now is not effective and we need to change strategy,” Baldwin said.

The U.S. Department of Agriculture since late April has required testing for lactating cows that are being shipped over state lines. The agency later launched a voluntary program to test bulk milk supplies .

A USDA epidemiological “strike team” arrived in Colorado this week to assess how the virus may be spreading among dairies there, Baldwin said. Workers or vehicles can carry the virus from farms.

If mandated testing reveals additional infections, Colorado can take further steps to contain the virus, Baldwin said.
Six Colorado farm workers tested positive for bird flu in July after culling chickens at an infected egg farm, the U.S. Centers for Disease Control and Prevention said.

More than 150 workers were exposed to the infected poultry, and 69 developed symptoms and were tested, according to the Colorado Department of Public Health and the Environment.

Colorado’s public health department reported a presumptive positive human case on a different Colorado poultry farm on Friday. About 350 people were involved in culling chickens at that farm, where 23 workers developed symptoms and were tested, the department told Reuters. The CDC has not confirmed the presumptive positive case.

Testing remains in progress, Colorado’s health department said on Tuesday.

Reporting by Tom Polansek in Chicago and Leah Douglas in Washington; Editing by Bill Berkrot

FDA Finalizes Guidance to Provide Further Clarity on Veterinary Feed Directives

Tue, 30 Apr 2024 20:56:48 GMT

On April 26, the U.S. Food and Drug Administration finalized Guidance for Industry (GFI) #120: Veterinary Feed Directive Regulation Questions and Answers to assist stakeholders involved with veterinary feed directives (VFDs) – veterinarians, VFD feed distributors (medicated feed mills, feed retailers) and clients (owners or other caretakers of the animals) – in complying with the Veterinary Feed Directive (VFD) final rule that published in 2015. The VFD final rule outlines the process for authorizing the use of approved animal drugs in the feed of food-producing animals that require veterinary oversight, including medically important antimicrobials when needed for specific animal health purposes. This final guidance also serves as a Small Entity Compliance Guide.

Although the core recommendations in final GFI #120 remain the same as the revised draft guidance issued in 2019, the language in the final guidance better aligns with existing industry practices and clarifies flexibilities to reduce the burden on veterinarians, producers, and distributors.

One way the FDA offers clarification is by including hypothetical scenarios to illustrate stakeholder responsibilities under the VFD final rule in a more tangible way. These changes were informed by public comment on the revised draft guidance and feedback from stakeholders during VFD inspections. The final guidance reflects a 2020 technical amendment to the VFD final rule, as well as updated contact information and links to online resources.

The FDA conducts VFD inspections to verify that antimicrobials used in or on the feed of food-producing animals are being authorized appropriately. These inspections also help to ensure that veterinarians, animal producers, and VFD medicated feed distributors have the information they need to comply with the VFD final rule.

According to FDA VFD inspection data, 95 percent of inspected stakeholders have been in compliance with the VFD final rule. The agency hopes that the clarifications detailed in final GFI #120 will further enhance stakeholder understanding and implementation of VFD requirements, in turn improving antimicrobial stewardship in veterinary settings.

More information is available here at the FDA Website .

New Regulations Proposed by FDA for Animal Drug Labeling

Mon, 18 Mar 2024 20:54:30 GMT

The U.S. Food and Drug Administration (FDA) is proposing new regulations to provide animal drug sponsors with predictable requirements for the labeling of prescription and over-the-counter new animal drugs, as well as new animal drugs for use in animal feeds. The proposed content and format of labeling would also benefit veterinarians, animal owners and animal producers by providing a more consistent presentation of information on the safe and effective use of these new animal drugs.

FDA has long followed certain practices for reviewing animal drug labeling, but these have not been codified in regulation. If finalized, the rule would create for the first time a comprehensive set of regulations establishing requirements for content and format of the labeling for approved and conditionally approved new animal drugs and would also help animal drug sponsors more efficiently prepare labeling for review.

The FDA is also proposing to amend or remove certain regulations to ensure consistency with the proposed new regulations. This would place all the labeling requirements regarding the content and format of approved or conditionally approved new animal drugs in one location in the Code of Federal Regulations. If the proposed regulations are finalized, existing labeling-related guidances for approved and/or conditionally approved new animal drugs would be amended or removed as appropriate to be compliant with the final regulations.

FDA is accepting public comments on the proposed rule for 90 days from the date of publication in the Federal Register. The public should submit either electronic or written comments on the proposed rule by June 10 to ensure the agency considers your comments on this proposed rule before it begins work on the final version of the rule.

Comments can be submitted electronically via the Federal eRulemaking Portal, or in writing to Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm 1061, Rockville, MD 20852. All submissions received must include the Docket No. FDA-2023-N-5160 for “Labeling Requirements for Approved or Conditionally Approved New Animal Drugs.”

If finalized, future new animal drug applications would need to comply with these proposed regulations. Sponsors of previously approved new animal drugs would need to comply with these proposed regulations on a staggered schedule, over the course of 6 years, according to a schedule based on application number.

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USDA Issues Permit for Santa’s Reindeer to Enter the U.S.

Fri, 22 Dec 2023 20:58:37 GMT

USDA’s Animal and Plant Health Inspection Service (APHIS) today issued a transit permit to Mr. S. Nicholas Claus of the North Pole, a distributor with Gifts and Good Cheer, Inc. The permit will allow reindeer to enter and exit the United States between the hours of 6 p.m. on Dec. 24, 2023, and 6 a.m. on Dec. 25, 2023, local time, through or over any U.S. border port.

“USDA is delighted to grant Mr. Claus and his reindeer a special permit to enter the United States, ensuring a seamless journey for the joy they bring each holiday season,” said Jenny Lester Moffitt, Under Secretary for Marketing and Regulatory Programs. “We extend a warm welcome to Mr. Claus and recognize the vital role of U.S. milk and cookies in fueling his festive flight.”

Veterinary officials ensured the reindeer met all entry requirements before issuing the permit. Dr. Rosemary Sifford, USDA’s Chief Veterinary Officer, stated: “At a recent inspection, the reindeer were found to be healthy and able to prance and paw with each hoof.”

It was noted on the health certificate that one reindeer, Rudolph, has a minor physical anomaly. However, APHIS indicated that Rudolph’s red nose, while bright, was normal for him and not a concern.

APHIS regulates the movement of cervids, including reindeer, to protect the health of America’s livestock population. The permitting process provides assurance that only healthy animals enter the United States.

USDA has confirmed that the reindeer will arrive pulling a wooden sleigh with jingling bells attached, filled with brightly wrapped gifts. Port personnel will clean and disinfect the runners and underside of the sleigh at the time of entry. They will also conduct a short visual inspection of the reindeer. Mr. Claus has been asked to disinfect his boots and thoroughly wash his hands. These measures are intended to prevent the entry of any livestock diseases the team may encounter during deliveries to farms and houses around the world prior to entering the United States.

Mr. Claus also provided an advance list of what port personnel should expect upon their arrival. This includes a variety of food items, all of which come from approved locations and none of which pose a threat to U.S. animal or plant health.

“It’s important that Gifts and Good Cheer, Inc. take all the right steps and precautions to protect against the potential introduction of pests and diseases,” explained Mr. Claus. “I appreciate USDA’s assistance every year as we gear up for our big night.”

House Passes Bill to Preserve Veterinary Use of Xylazine

Wed, 13 Dec 2023 20:45:55 GMT

The House of Representatives passed the Support for Patients and Communities Reauthorization Act on Tuesday. The Act, in part, fights the illicit use of xylazine in humans while preserving access to the drug for use in animals.

“For beef packers, xylazine is used to quickly and humanely sedate sick or injured cattle in a manner that can safely and effectively be administered by workers. Xylazine has both animal welfare and worker safety benefits at beef plants, and there are no equally safe and effective alternatives,” said Meat Institute President and CEO Julie Anna Potts.

Xylazine is used to a lesser degree in pigs than in beef. “But it is an issue for vets in general as DEA schedule drugs are a huge hassle and really limit access. It is one more limit on what we can do,” Jim Lowe, DVM, associate dean of Online Programs and Extension at the University of Illinois College of Veterinary Medicine told Farm Journal’s Pork earlier this month.

At issue is the concern that xylazine, a drug approved by the U.S. Food and Drug Administration for use in animals, is being imported illegally in powder form and added to fentanyl. Xylazine is not approved for human use.

The Combating Illicit Xylazine Act was included in the Support for Patients and Communities Reauthorization Act, H.R. 4531, approved by the House with a vote of 386-37.

“We appreciate the hard work of Congressmen Jimmy Panetta (D-CA) and August Pfluger (R-TX) and the Energy and Commerce Committee for including the xylazine measures in the bill passed by the House with strong bipartisan support,” said Potts. “We now call for swift Senate consideration.”

The bill will ensure the Drug Enforcement Agency (DEA) has the power to stop the illegal flow of xylazine to humans, while allowing its continued access for veterinary purposes.

Xylazine Bill Protects Veterinary Access to the Sedative

FDA Unveils Draft Guidance on Antibiotic Duration Of Use in the Feed of Food Animals

Thu, 28 Sep 2023 21:28:39 GMT

The U.S. Food and Drug Administration (FDA) announced earlier this week it has published draft guidance for defining appropriate duration of use for antibiotics used in the feed of food-producing animals.

The guidance aims to address an issue that critics say the FDA has neglected in its efforts to promote more judicious use of medically important antibiotics in livestock and poultry. Roughly one-third of medically important antibiotics approved for use in food-producing animals have no duration limit, meaning farmers can use those antibiotics in animal feed for extended periods of time to prevent disease—a practice critics say compensates for poor living conditions that promote disease in herds and flocks.

Advocates for more robust antibiotic stewardship in US meat production say the overuse of medically important antibiotics on US farms promotes antibiotic resistance and threatens the effectiveness of antibiotics that are critical for human and veterinary medicine. Some groups have called for the FDA to limit the duration of use for medically important antibiotics to 21 days.

In a 5-year action plan released in 2018, the FDA’s Center for Veterinary Medicine said that establishing appropriate duration limits would be one of its priorities.

Minimizing antibiotic exposure
The agency says the scope of the draft guidance is limited to drugs that are approved for use in animal feed, since antibiotics that have been approved in non-feed forms already have appropriately defined durations of use.

“FDA’s objective in issuing this guidance is to provide specific recommendations to animal drug sponsors on how to revise the product use conditions (e.g., dosage regimen, instructions for use) of affected products, as necessary, to better target when and for how long a drug may be used to effectively treat, control, or prevent the disease(s) for which the product is indicated,” the draft guidance states.

While compliance with the guidance is voluntary, the FDA says the revisions are, “intended to provide for the continued effective use of these products while minimizing the extent of antimicrobial drug exposure, thereby supporting efforts to mitigate the development of antimicrobial resistance.”

The public comment period on the draft guidance is open until December 26.

About The Author

This article was written by Chris Dall, a news reporter for CIDRAP News, focusing on antimicrobial resistance and stewardship. Chris has written about health and medicine for the online health news startup PresentNation and worked for several years as a news producer at Minnesota Public Radio. He has a master’s degree in journalism from Emerson College in Boston. He enjoys writing about public health, infectious disease, and the history of medicine.

Over-The-Counter Livestock Antibiotics Officially a Thing of the Past

Thu, 08 Jun 2023 17:39:23 GMT

Farmers have had months to prepare, but on June 11, the FDA’s new directive “Guidance for the Industry #263” will officially go into effect. This means over-the-counter (OTC) livestock antibiotics will no longer be available through traditional retail channels. Instead, these antibiotics will now require a prescription from a licensed veterinarian.

According to the FDA, this is part of a broader effort to combat antimicrobial resistance, a serious threat to both animals and the public health. While livestock producers are continuously working to practice judicious antibiotic usage, this guidance will provide consumers with an extra layer of assurance.

“It’s a confidence thing,” says Jim Lowe, DVM, director of the College of Veterinary Medicine I-Learning Center at the University of Illinois. “The regulators have said, ‘Listen, we want some more oversight here, so we have more confidence in the supply chain.’ My perception is we’re not changing what we’re doing. We’re just going to document and tell people what we’re doing better. It’s about transparency.”

While the guidance states that livestock producers will need to obtain a valid prescription from a licensed veterinarian with whom they have a veterinarian-client-patient-relationship, the prescription status does not require that these products be purchased directly from a veterinarian. Instead, the FDA notes that you may be able to buy prescription animal drug products from various suppliers or distributors pending certain state requirements. These suppliers would then act as a “pharmacy” and customers would have to show a prescription prior to purchasing them.

For a complete list of antibiotics that will no longer be available over-the-counter, click here. Products unaffected by the change include ionophores, antiparaciticides, injectable and oral nutritional supplements, oral pro/prebiotics and topical non-antibiotic treatments. These products will continue to remain available through standard OTC marketing channels.

For more on Guidance for the Industry #263, read:

Preparing for Prescription-Only Antibiotics in Livestock Industry: Important Changes Ahead

Wed, 31 May 2023 18:24:03 GMT

While another month has come and gone for the 2023 production year, if you haven’t already heard, June will hold some significant changes for the livestock industry.

When it comes to livestock antibiotics, many products that have typically been used over-the-counter will now need a veterinary prescription.

“ Just as physicians have started to try and educate people to not utilize antibiotics in those cases, we’re really trying to have the same conversation with the livestock industry ,” says Mike Lormore, DVM, head of technical services over pork and cattle for Zoetis.

On June 11, the FDA’s Guidance for Industry (GFI) #263 will take effect, bringing 91 over-the-counter antimicrobial products under prescription oversight.

While the sales of antimicrobial injectables in 2021 declined by 11% from 2016 , Lormore says the FDA’s guidance is a result of a long conversation around improving the quality of and control systems around antimicrobial use in food production.

The guidance applies to all food animals , including cattle, hogs, ruminants (goats/sheep) and poultry. In addition, it also applies to animals not intended for food, such as horses, pet rabbits and backyard chickens.

“ W hile this change does not require the purchase of products from a veterinarian, going forward, producers will be legally required to obtain a prescription from a licensed veterinarian with whom the producer has a valid veterinary-client-patient relationship ,” says Becky Funk, DVM, and Jesse Fulton in a University of Nebraska-Lincoln article.

Specifically, the veterinary-client-patient relationship (VCPR) is a mutual agreement between the animal owner and the veterinarian where the veterinarian has an understanding of the animals on an operation, the type of care they’re given on a regular basis, their purpose, and the risk factors associated with management of those animals, Lormore explains.

Preparing for OTC Antibiotics to Go Prescription-Only

If you do not have a relationship with a veterinarian, start visiting with a local practitioner so they can become familiar with you and your animals on your operation.

Additionally, Linda Tikofsky, DVM and senior associate director of dairy professional services at Boehringer Ingelheim says, “I think the number one thing to do is just take inventory of what you’re using and what you won’t be able to purchase after June 2023. Go through your drug cabinet, take note of what you’re using and how often you’re using it.”

This will help you prepare for conversations with the veterinarian, discussing standard operating procedures and routine drug orders.

A full list of products to soon require a prescription can be found here .

For more information regarding these changes:

Over-The-Counter Access to Antibiotics is Going Away

Over-the-Counter Antibiotics: What You Need to Know Before June 11

If You ‘Doctor’ Livestock, a New Rule will Determine How or If You can Buy Antibiotics

Beef Implant Changes

For beef producers using growth-promoting implants, additional changes will be taking place in June.

While implants are labeled for sex, age or stage of production, until recently, implant labels did not include directions for reimplantation within the production stage for which they are intended, Sandy Stuttgen, DVM, senior outreach specialist and Taylor County Extension agriculture educator with the University of Wisconsin Extension.

To bring clarity, the FDA has defined specific production stages, which will be used to determine if and when a growth-promoting implant can be administered.

Beef cattle will still be allowed to receive multiple implants across different stages of production, including each of the following phases defined by FDA GFI 191:
• Beef Calves:
1) Pre-ruminant or ruminant beef calves nursing their dams from birth until 2 months of age
2) Ruminating and nursing their dams from 2 months of age to weaning
• Growing beef steers or heifers on pasture (stocker, feeder or slaughter): weaned and maintained on pasture and receiving most of their diet from grazing
• Growing beef steers or heifers in a drylot: weaned and maintained in a dry lot and fed harvested forage (possibly with supplement)
• Growing beef steers or heifers fed in confinement for slaughter: weaned growing and finishing animals confined in group pens or grow yards and fed progressively high-energy diet ad libitum as their sole ration until slaughter

For more on beef implant changes: Beef Cattle Implant Changes: What You Need to Know

Overall, as a good practice in administering any vaccine or implant, Stuttgen encourages producers read the product label and lean on your veterinarian to determine how the products should be best used in the operation.

Choose to be Confident In Your Competence

Tue, 31 Jan 2023 19:43:58 GMT

We have a choice.

It was 10 degrees F the other night when my phone rang. The words were what every vet doesn’t want to hear, “I think her uterus is out, Doc.”

Rushing through the house, I threw on some clothes and coveralls and was out the door. When I arrived, I knew we were in trouble. It was the biggest prolapse I’ve seen in my 10 years as a vet.

But this cow was a trooper. A small nudge and a couple words, and she shakily stood up. We proceeded to get her caught up, and I went to work. I removed her cleanings and lavaged this massive organ with gallon after gallon of dilute disinfectant, hoping to prevent infection.

Then the real work began. Hefting the 50-plus-pound uterus onto my chest, I began carefully massaging it back into mamma. It was slow but surprisingly easy to replace for its mass. Five short minutes later (and a couple four-letter words), and we had a replaced uterus. A miracle for its size and the cold! But mamma wasn’t out of the woods yet.

Standing in the headlock I knew she needed more. She was shaking and looked pretty shocky. Knowing my helper didn’t know how to IV, I returned to my truck for my trusty halter and some IV fluids plus calcium (Ca).

When I returned, things were going downhill. Mamma’s eyes were almost touching, and she was struggling to stand. I slammed my simplex on the Ca bottle hoping it was a Ca issue and not a fatal uterine artery rupture. But it wasn’t to be. Try as I might, I couldn’t get a jugular vein to pop. By the time I started to crawl into the pen in a desperate attempt via the milk vein, she had gone down and was agonal breathing. Her time and my time were up. She was dying.

Next to me my client says, “Doc, you did all you could.” I’m crestfallen. In the last 5 minutes I’ve gone from the elation of getting that massive uterus replaced to knowing my patient is going to die.

Now, I’m faced with the most difficult ending – a humane passing. You see, I’m a firm believer in the fact that we as veterinarians have been given the ultimate responsibility: to end suffering. No animal should have to suffer until its passing. Not when we can quietly and humanely end that suffering.

As I take my third trip to my truck, this time for my euthanasia gun, I’m hit with so many feelings. You see, I left my family’s dead cow business to avoid just this. I wanted to save lives, and I thought I had done just that a few minutes ago. Knowing this is the right thing, I steel my heart and perform this last right.

As I pack up my truck my client tries to console me that I did my best. And although the outcome is not what we wanted, there was nothing more I could do. I nodded my head and washed the blood and fluids off my waterproofs, numb to a situation that has played out more often than I would have liked over my last 10 years in practice.

Getting in my truck I’m struck with a realization. I’m sad. I’m sad about the cow, about my client’s misfortune, and most of all about feeling like a failure at my career. I didn’t get into this to put animals down. But here I am yet again, doing just that.

Then, deep down I feel something else, too, a sliver of a feeling. Inspiration. When I saw that uterus, I thought there was no way I could get it in. I had thought, “this is so bad, so very bad.” In fact, those were the first words out of my mouth. But I pushed it in. Using my years of experience. Using months of personal training and weightlifting to stay in shape. Most of all, using my brain to try and save this life.

This is when I made a conscious decision. I could dwell on the fact that I had to put mamma down, and that I had failed her. Or, I could make the choice to think about the win, the progression physically and mentally I’ve made and, in my own way, find the positive in the moment.

Thus the inspiration to share this story with you fellow vets – the same people who have lived this scenario and are similarly challenged emotionally and mentally on a daily basis.

Sometimes it’s not the case outcome that gets to us as much as our inability to savor the positive aspects of a case – to take a moment and realize just what we did and how far we’ve come. To realize we need to remain confident in our competence.

The next time a case like mine comes your way, that’s what I encourage you to do. Choose to look for the positives in the situation. Value your competence.

Iowa Governor Announces Funding for ISU Veterinary Diagnostic Lab

Sat, 21 Jan 2023 14:30:11 GMT

Iowa Gov. Kim Reynolds announced $40 million in funding from American Rescue Plan Act dollars to help complete Phase 2 of Iowa State University’s Veterinary Diagnostic Laboratory (VDL). She has also proposed an additional $20M in her budget from the Rebuild Iowa Infrastructure Fund (RIIF)—$10M in FY24 and $10M in FY25—to total $60M in state support for the VDL project in a release from her office .

Construction of the front end of a new VDL in Ames is scheduled to be finished this year. The $75-million Phase 1 of the project does not cover the majority of the lab’s operations, Iowa Pork Producers Association noted in a statement. Phase 2, which is expected to cost $62.5 million, would provide an additional 70,000 square feet for laboratory testing, research and support functions.

“Pig farmers and cattle producers across Iowa are extremely grateful Governor Kim Reynolds is providing significant financial support to upgrade Iowa State University’s Veterinary Diagnostic Lab and we hope the Iowa legislature will join her in providing additional funding, as she has proposed,” said Iowa Pork Producers Association President Kevin Rasmussen, a farmer from Goldfield, in a joint statement with Iowa Cattlemen’s Association President Bob Noble of Riceville.

Gov. Reynolds explained that the VDL is critical to support and protect not only the Iowa agriculture industry and food supply, but the U.S. as well.

“The new state-of-the-art facility will keep Iowa State at the forefront in helping recognize foreign animal diseases that threaten the nation’s food supply well into the future. We sincerely appreciate her efforts and willingness to keep animal and human health as top priorities,” Rasmussen and Noble said in a release.

This investment will significantly expand the VDL’s capacity to support Iowa’s $32.5 billion animal agriculture industry and will keep this nationally-recognized lab on the forefront of cutting-edge technology, Reynolds said in the release.

“We are deeply grateful to Governor Reynolds for allocating these critical resources to construct Phase 2 of the Veterinary Diagnostic Laboratory,” Iowa State University President Wendy Wintersteen said in a release. “This funding will help ensure the VDL can continue to provide cutting-edge services and support to Iowa’s livestock and poultry producers.”

The state’s close relationship with the VDL has been essential in implementing the state’s response to the highly pathogenic avian influenza outbreak and Iowa Secretary of Agriculture Mike Naig said they rely on the VDL’s recommendations as Iowa continues to enhance foreign animal disease preparedness.

Editor’s Note: Fully accredited by the American Association of Veterinary Laboratory Diagnosticians, the VDL provides quality diagnostic services for animal species, including necropsy, bacteriology, serology, histopathology, virology, parasitology, molecular diagnostics, and toxicology as well as offering analytical services. The full-service laboratories at the VDL process upwards of 100,000 cases each year and conducts more than a million tests annually.

FDA to Resume Enforcement of all Federal VCPR Requirements for Veterinary Telemedicine

Fri, 06 Jan 2023 17:37:15 GMT

The Food and Drug Administration announced on Dec. 21, 2022, its withdrawal of Guidance for Industry #269, “Enforcement Policy Regarding Federal VCPR Requirements to Facilitate Veterinary Telemedicine During the COVID-19 Outbreak.”

The effective date of the decision is Feb. 21, which means that the FDA will again hold veterinarians to the federal requirements for the veterinarian-client-patient relationship beginning on that date. As stated by the FDA, the federal VCPR definition “requires animal examination and/or medically appropriate and timely visits to the premises where the animal(s) are kept” and “cannot be met solely through telemedicine.”

With the withdrawal of GFI 269, veterinarians using telemedicine to deliver patient care must be sure to establish a veterinarian-client-patient relationship that complies with federal requirements so they may, for example, issue a veterinary feed directive for a client.
GFI 269 was issued in March 2020 during the early days of the pandemic, when human illness and efforts to mitigate the spread of COVID-19 created challenges for in-person examinations of veterinary patients and the conduct of premise visits.

To help address these challenges and support the use of telemedicine to deliver patient care, GFI #269 indicated that the FDA would temporarily not enforce federal requirements for an in-person animal examination or premise visit to establish a VCPR for activities covered by the federal VCPR definition, including extralabel drug use and issuing veterinary feed directives.

Now, nearly three years later, the FDA says the conditions that created the need for the enforcement policy have evolved such that the policy is no longer needed. That means, as of Feb. 21, veterinarians will need to meet all the requirements of the federally defined VCPR, including an in-person examination or premise visit, to establish the relationship prior to engaging in covered activities. A VCPR that meets the federal definition cannot be established through telemedicine. Once established, the VCPR may be maintained via telemedicine between medically appropriate examinations and premise visits.

USDA Hands Responsibility of RFID Traceability Efforts to APHIS

Thu, 22 Sep 2022 04:19:45 GMT

There are new developments in the rules and tracing of cattle via RFID tags, AgDay’s Clinton Griffiths reports. The USDA has announced it will not finalize a plan introduced by the Trump Administration to approve Radio Frequency Identification (RFID) tags as the official ear tag for interstate movement of cattle.

Instead, the Animal and Plant Health Inspection Service (APHIS) will use the rule making process for future actions on RFID tags. APHIS has said this means all current approved ID methods can be used until further notice but adds the RFID tags provide the “best protection against the rapid spread of animal diseases,” Griffiths says.

FDA Issues Draft Guidance on Donor Eligibility and Manufacturing of Cellular Therapies for Animals

Mon, 27 Sep 2021 19:48:21 GMT

The U.S Food and Drug Administration issued for public comment two draft guidance documents that, if finalized, will help manufacturers of animal cells, tissues, and cell- and tissue-based products (ACTPs) understand current good manufacturing practice requirements (CGMPs) for new animal drugs under the Federal Food, Drug, and Cosmetic Act (FD&C Act). CGMPs help prevent contamination and help ensure ACTP quality. If finalized, the recommendations are intended to support the development of promising and innovative products that can benefit animal health.

“ACTPs have the potential to make significant changes in how we treat diseases and may provide novel therapies for unmet therapeutic needs of animals. We want to support manufacturers in the safe production of these promising products,” said Dr. Janet Woodcock, Acting Commissioner of the FDA. “It is important to note that the FDA is not imposing any new requirements on the manufacturers of ACTPs with these new draft guidance documents. These draft guidance documents, if finalized, are intended to assist manufacturers by providing product-specific recommendations that will help developers of these products meet existing FDA manufacturing requirements. Our goal is to help manufacturers be successful in their efforts to develop innovative products that can benefit animal health.”

In the draft guidance, ACTPs are defined as products that contain, consist of, or are derived from cells or tissues that are intended for implantation, transplantation, infusion or transfer into an animal recipient. Furthermore, ACTPs refer to products that meet the definition of a new animal drug. In the draft guidance, ACTPs include both cell-based products and animal stem cell-based products. ACTPs are most commonly investigated for regenerative medicine applications because they have the potential to repair diseased or damaged tissues in animals through regeneration and healing. Currently, these products are most commonly investigated and used in companion animals including dogs, cats, and horses; however, ACTPs may be also be developed for use in other species.

All new animal drugs are required to be manufactured in accordance with CGMPs to ensure that such drugs meet the requirements of the FD&C Act for safety, and to have the identity, strength, quality, and purity characteristics which they purport to or are represented to possess. Because the manufacture of ACTPs present unique considerations for complying with CGMPs, the FDA is issuing two draft guidance documents for industry.

The first draft guidance, #253, “Good Manufacturing Practices for Animal Cells, Tissues, and Cell- and Tissue-Based Products” provides manufacturers of ACTPs with recommendations for meeting requirements for CGMPs. It addresses the methods, facilities and controls used for manufacturing ACTPs, including steps in recovery, processing, storage, labeling, packaging and distribution. The draft guidance also addresses methods for preventing contamination and ensuring quality of the ACTP during manufacturing.

The second draft guidance #254, “Donor Eligibility for Animal Cells, Tissues, and Cell- and Tissue-Based Products”, if finalized, will assist sponsors, firms or establishments that participate in the manufacture of ACTPs or perform any aspect of the ACTP donor eligibility determination. Selecting appropriate donors is critical to product quality and preventing the transmission of disease.

The concepts and principles in these draft guidance documents are consistent with the FDA’s Center for Biologics Evaluation and Research’s (CBER’s) regulations (21 CFR 1271 subparts C and D) and associated guidance documents for human cells, tissues, and cellular and tissue-based products.

“The FDA is seeking to improve transparency by engaging early in the development process and informing industry of our draft recommendations now, while the industry is still taking shape, as we are receiving applications seeking approval of ACTPs for use in animals,” said Dr. Steven Solomon, director of the FDA’s Center for Veterinary Medicine. “As part of our commitment to fostering the development of innovative products in the most streamlined and efficient manner possible, we’re encouraging the ACTP industry to take advantage of our Veterinary Innovation Program, which is designed to assist product developers generate the appropriate data needed to support a new animal drug application.”

The FDA recommends sponsors and manufacturers of ACTPs contact the FDA early and often in the product development process to discuss considerations specific to the manufacture and approval of new animal drug products. The FDA has developed a process for these interactions through participation in its Veterinary Innovation Program, a program available to most ACTPs and aimed at providing greater certainty in the regulatory process, encouraging research and development, and supporting an efficient and predictable pathway to approval for these innovative products.

The FDA is accepting public comments on both draft guidance documents until November 22, 2021 so that we may consider comments before potentially issuing final guidance documents; however, comments on guidance documents are welcome at any time. Later this year, the FDA will also host a webinar to discuss the draft guidance documents for all interested stakeholders. Visit FDA.gov for more information.