AVMA Seeks Feedback on Compounding

Compounding is an important treatment option that is used every day by practicing veterinarians. Consistent with the Food and Drug Administration (FDA) Extra-Label Drug Use regulations, compounding is the customized manipulation of an FDA-approved drug(s) by a veterinarian, or by a pharmacist upon the prescription of a veterinarian, to meet the needs of a particular patient.

Compounding has come under federal scrutiny due to a lethal fungal meningitis outbreak in humans that occurred last fall. Any new legislation or regulations that are put forward could impact how veterinarians are able to compound in the future.

At the AVMA, we agree that we need to ensure that the needs of animal patients and their doctors are met, which is why we are very carefully reviewing our current Compounding and Compounding from Unapproved (Bulk) Substances policies. We need to be able to communicate AVMA policies that best reflect the needs of the veterinary profession. The policies will serve as the basis for our positions on legislation, which the Governmental Relations Division will advocate in Washington, D.C.

Most significantly for veterinary medicine is the issue of compounding from “bulk” to create medicines for use in animals. Compounding from bulk involves the use of unapproved, raw, active ingredients, a practice that is currently illegal per the FDA.

It is important that AVMA members review the Compounding and Compounding from Unapproved (Bulk) Substances proposed revisions and provide feedback on the NOAH Discussion Groups during the next 30 days. After review of member feedback and the concepts that have been brought forward by our volunteer governance groups (AVMA members volunteer their time on AVMA’s entities that are designed to review member needs, scientific reports, and existing laws and regulations, and bring expert opinions together), the AVMA’s Executive Board will consider any recommended policy revisions, probably in early summer 2013.

We thank you for your interest and engagement on this issue and encourage you to provide feedback on the proposed policy revisions.

47 thoughts on “AVMA Seeks Feedback on Compounding

  1. I work with a coalition of compounding pharmacies who sponsor MyMedsMatter.com, a public affairs website that facilitates communication between people concerned about potential new legal restrictions on access to compounded medications and their Congressional representatives. Last month, an attorney at Duane Morris posted a blog in which she reviewed the issue of whether or not compounding from bulk APIs is illegal, as some groups currently believe. In it she concludes that “nothing in the Federal Food, Drug, and Cosmetic Act (FDCA), its accompanying regulations or the case law declares compounding animal drugs from bulk ingredients illegal” and that “FDA has agreed that AMDUCA and this regulation do not give FDA the authority to prohibit compounding from bulk ingredients.” Here’s a link to the complete blog: http://www.duanemorris.com/alerts/compounding_animal_drugs_from_bulk_ingredients_4847.html

  2. Pharmaceutical control needs to stop in both veterinary and human medicine–In the 14 years I’ve been practicing I feel as if we have become slaves to the drug makers-using “whats available right now” and usually at escalating prices–where is doxycycline right now–yes I need it all day long in Montauk NY–thank goodness for Wedgewood compounding!! We are infested with ticks and diseases requiring Doxy!! Please take the control away from the pharmaceutical companies and put it back in the doctor’s hands–were it was meant to be!!!!!

  3. In certain situations compounding is an important and maybe only tool in the prevention and treatment of diseases in veterinary medicine. As veterinarians we need access to this method of medicating those patients that require special modalities of tretment.

  4. As a small animal and exotic animal practitioner for the past thirty years, I have relied on and hope to continue to rely on compounded medications. Due to the tremendous size variations and the limited availability of commercial products, we have unique needs to be able to adequately treat these patients. Restricting the use of compounded products would limit my abilities to treat these patients as well as making it cost prohibitive for many clients. I certainly hope that the AVMA will advocate for the welfare of our patients and push for continuing to allow us to exercise the same rights that physicians enjoy by not limiting our access to compounded products.

  5. I have read many of the above posts, but let’s be honest, as a full time practitioner, attempting to take the time to read and research every statement, acronym, or otherwise is impractical. I agree with all the posts, that however our compounded drugs come to be, without them, to practice quality medicine, and allow us to appropriately dose each patient becomes much more difficult and puts our patients at risk. Furthermore, as stated in many other posts, the number of back-ordered drugs that we run into on a daily basis is astounding. I am an “in the trenches veterinarian”, thus I have a poor understanding how drugs like doxycycline (an age old antibiotic), diazepam (an age old benzo), etc. can become so back ordered that we can’t get our hands on them for weeks or months at a time. Quite honestly, I don’t care HOW the drugs get to be compounded, using an API, or pre-packaged pure drug, or otherwise, as long as our compounding pharmacies can still get us what we need when “big pharma” so often lets us down and leaves us hanging without options. Thanks for your consideration in representing US (the veterinarians in the trenches) on this issue.

  6. April 19, 2013

    Dear AVMA Executive Board:

    As a veterinary professional, I rely on compounded preparations to provide unique solutions for my patients. I understand that the AVMA is considering a policy that would support only a limited list of bulk APIs for use in compounded prescriptions.

    This policy would reinforce the FDA’s current misinterpretation of its own guidelines, yield to pressure from the pharmaceutical industry and could ultimately keep me from prescribing compounds made from bulk APIs as I deem necessary in my practice. This would make it harder for me to treat my patients according to their needs and would inevitably lead to unnecessary suffering or death.

    I would hope that, as an organization that represents my interests, you will not advocate for any action that would make it harder for me to treat my patients as I see fit. Instead of helping to restrict my rights and reduce my options to prescribe compounded medications in a new policy, the AVMA must take a stand to allow me to continue exercising the same rights that physicians enjoy.


    Sam Strauss, DVM

    Medical Director

    Weston Road Animal Hospital
    4585 Weston Road
    Weston, FL 33331

    AVMA Membership Number 43439
    Other Memberships: AAHA, AVMA, Florida VMA, Broward County VMA, AAV, ARAV

  7. Our practice is blessed with 400-500 cat visits per month in Atlanta, GA. My ability to practice safe, high-quality, often, immediately required or emergent medicine has already been challenged without medications available in an appropriate dose in our FELINE EXCLUSIVE PRACTICE. The use of compounded medication–very small dosages and, often unique routes of administration are particularly VITAL to our practice. Specifically, owner and patient compliance is a challenge when trying to administer conventional formulations such as pills and capsules. Our feline patients range from less than a pound to 27 pounds! We rely heavily on compounded metronidazole, doxycycline, as well as other liquid suspensions formulated with bitter reducers and without artificial sweetners, sugar alcohols, etc that may be detrimental to our feline patients. As well, a limited, but vital transdermal delivery system needs to continue—we need microdoses of heart and blood pressure medications, medications for cats that have emergent urinary blockage and risk kidney failure, asthma and acute respiratory disease relapses that can all culminate in sudden death and horrific suffering. Human pediatric patients are NEVER denied access to ANY medication deemed necessary by competent medical practitioners—why are veterinary practices and the animal patients we treat threatened with such egregious and inhumane limitations? The AVMA MUST ADVOCATE for our ability to practice high quality safe and effective medicine in all species by not restricting the number of bulk APIs for use in compounded prescriptions for animals.


  8. I feel my practice/patients would suffer greatly if I were unable to keep access to medications compounded by Compounding Pharmacies from API’s or bulk sources. Often times, there is no other alternative to such medications(for fractious animals, when dosing proves difficult, or if a medication is unavailable). They are an ESSENTIAL part of my practice. Many pet owners are unable to medicate their pets, period- and often it is just not feasible to do it in hospital as often as the medication is required. Our clients are always pleasantly surprised when we have an alternative to offer, and of course in many instances, it is life saving for the animal (quality of life, or literally…). For many folks, it is PRICELESS to have an easier method to pilling and cost is irrelevant… PLEASE SUPPORT NOT LIMITING BULK API’S and/or make it more difficult for practices like mine to provide the quality of care our clients and patients DESERVE. Thanks for the outlet to lend our support!

  9. I want to thank all of you who provide your thoughts on our AVMA@Work blog relative to veterinary compounding. We appreciate your comments. What would be especially helpful is if you could give us very specific feedback to the 2 proposed policy revisions to the AVMA’s COMPOUNDING and COMPOUNDING FROM UNAPPROVED (BULK) SUBSTANCES policies. The comment period ends Monday, April 22, so we encourage you to visit our NOAH Discussion Groups today so that you can help us as we formulate our new policies. Here is the link to the NOAH discussion on compounding: (https://www.avma.org/Members/Community/Discussions/Pages/AVMA-NOAH-Discussion-Boards.aspx?action=ViewPosts&fid=2&tid=211)
    You can find the links to the proposed revisions in the first post on the NOAH discussion thread.

    Getting member feedback on these policies is critical, because we recognize there’s a balance to be struck between the necessity to use FDA-approved drugs with known safety and efficacy, while also meeting the compounding needs of veterinarians and their patients. We all recognize that compounding is a critical tool for specific patients with special needs that can’t be met by FDA-approved drugs.

    We are hearing that the Senate is drafting federal legislation that could be introduced very soon. Therefore, our volunteer governance groups are going to be working as quickly as possible to solidify the AVMA’s compounding policies so that we can use them to advocate on your behalf on Capitol Hill, in defense of your compounding needs.

    Ron DeHaven, DVM, MBA

  10. the FDA’s attempt to limit bulk API’s will deny essential, proper care to millions of animals….compounders need API’s to continue to provide access to essential medications/therapies…

  11. I agree with everything said. The veterinary prefession needs compounding if we are to do right by our patients, clients and oath!

  12. Compounding is required for gold standard of care when commercial product is ( repeatedly) unavailable.

  13. Compounding medications is a vital component to our practice. Without it, I know that many of our patients would not be able to receive the care they need. We see over 50,000 patients in our hospital and so many of these patients have benefited.

  14. Compounded medications fill a niche which commercial manufactures are not able to meet. Many of the small animal patients my practice sees require a dosing schedule that is only available by compounding. The recent shortages and extreme fluctuations in medication prices further supports the need for compounded medications. My practice depends on compounding to better support the needs of patients. The AVMA needs to support compounding to better care for our patients.

  15. Compounding is an indispensable part of my ability to practice effective veterinary medicine. Please don’t take this vital tool out of the hands of responsible practitioners.

    • Thank you for your feedback, Dr. Lavely and Colleagues. I want to assure you that many of our volunteer veterinarians working on the compounding policies are practitioners who underscore their need for various therapeutic options, including compounding at times. Currently, FDA contends compounding from raw active ingredients (“bulk”) is already outside what the federal rules allow. (FDA is the lead federal authority on drugs and its Extralabel Drug Use Rules indicate nothing shall be construed as permitting compounding from bulk.) A new PDF is available for AVMA members to view, titled “Compounding: Are you following the rules?” which answers some of the most common questions we hear. At the same time, AVMA-member feedback on the proposed policy revisions is still welcome through the AVMA’s NOAH Discussion Group.

    • I don’t know about the rest of you, but I’m sick and tired of the FDA stepping on my professional toes by enacting and enforcing ridiculous rules that restrict my access to beneficial drugs that I use in my practice. I hope that we, as a collective group, and the AVMA can bring some sense to these disconnected bureaucrats

  16. As a veterinary professional, I rely on compounded preparations to provide unique solutions for my patients. I understand that the AVMA is considering a policy that would support only a limited list of bulk APIs for use in compounded prescriptions. This policy would reinforce the FDA’s current misinterpretation of its own guidelines, yield to pressure from the pharmaceutical industry and could ultimately keep me from prescribing compounds made from bulk APIs as I deem necessary in my practice. This would make it harder for me to treat my patients according to their needs and would inevitably lead to unnecessary suffering or death. I would hope that, as an organization that represents my interests, you will not advocate for any action that would make it harder for me to treat my patients as I see fit. Instead of helping to restrict my rights and reduce my options to prescribe compounded medications in a new policy, the AVMA must take a stand to allow me to continue exercising the same rights that physicians enjoy.

    I am a feline practitioner, almost exclusively. Our practice also sees some small exotic mammal pets. Treatment of both these patient populations often requires the use of compounded medications because the dosages are small and compliance is difficult due to inability of owners to give conventional formulations such as pills and capsules, and unwillingness of our patients to take medications in these formats. We rely heavily on compounded azithromycin suspension, compounded prednisolone suspension, compounded metronidazole suspension, and compounded methimazole suspension and methimazole transdermal gel for successful treatment of these patients. Please send a message to veterinarians who care exclusively or primarily for felines, small exotic mammals, and birds, as well as, and probably more importantly, their clients, that the AVMA cares about these species, by not restricting the number of bulk APIs for use in compounded prescriptions for animals.

  17. Having been in private practice for over 30 years, I do agree with others that having available compounded medications to use in my small animal patients has many times saved the lives of my patients. I believe we all agree that safety and efficacy are a must – I do remember the days when we ground up distasteful pills to administer to patients, knowing that at least we could get perhaps a little more of the medication into the pet this way. There must be some middle ground here – we must come up with a way to continue to provide these medications in a safe, effective and affordable way. Quality control concerns must be included in the resolution of this issue – my heart goes out to all the families affected by the human compounding disaster. There must be a way for this to be resolved in a way that all of our concerns are addressed – please AVMA take the time to come up with this way.

  18. Laboratory animal medicine is another area of practice where compounding is critical for ensuring quality of care. There are almost no approved products for laboratory animal species, and even with appropriate extra label use of approved products, most formulations are not suitable for administration to some of our smaller patients. Adverse effects from compounded drugs are undesirable for animal health and welfare reasons, and also for ensuring that quality data is derived from research models. In a research environment it is feasible to perform quality testing on compounded products using tools that are not available to private practicioners. I believe some combination of use of standards for preparation and quality control testing are prudent if they can be implemented in such a way that they do not limit access to necessary drugs. If our profession can bring a cogent proposal to FDA for their review, we are likely to better control the outcome. If we wait for FDA to come up with something it will almost certainly not meet our needs. Veterinary medicine has a small constituency with FDA compared to human medicine and we will be only a small blip on the radar if Avma doesn’t take the initiative to represent our needs on this issue.

  19. I feel it is essential to the health and well being of my patients to be able to provide them with compounded medications- in particularly due to their sometimes small size and need for lower doses of medications than many human formulations. Because I work in an emergency hospital, having these medications readily available overnight or on a weekend may make the difference between a sick or a healthy pet.

    Compounding pharmacies are an essential part of veterinary practice, and allow us to treat our patients with appropriate medications and dosages. I hope we will continue to be able to provide these valuable medications in the future.

  20. As a companion animal veterinarian, my ability to practice depends on the availability of safe, affordable medications formulated in a manner appropriate for administration to cats & dogs, who are not necessiarily cooperative. In order to do this, I frequently have no choice but to rely on medicines compounded by Compounding Pharmacies from APIs or bulk sources. Therefore, my patients and my practice depend on the willingnes and ability of my professional organisation, the AVMA, to preserve my access to & my right to dispense these compounded medications. I sincerely hope I can trust the AVMA to step up to this challenge and do the right thing for its members.

    • Amen! This is a CRUCIAL issue to all companion animal practitioners! I sincerely hope the AVMA has our back. I just toured one of the compounding pharmacies I use and they have quality control in place that would impress anyone. And the bulk meds they receive are tested for strength and consistency at an independent lab before using for drug preps. If that were a regulation, the threat of problems is greatly reduced.

    • Ditto that! Losing access to quality, compounded drugs would hamstring us in practice and terribly compromise the care we can give our patients. We rely on the AVMA to be our national advocate to preserve our ability to provide for the needs of our patients.

  21. I would like to add my perspective as both an AVMA volunteer and an academic Zoological Medicine clinician. I am currently serving as the zoo and wildlife representative for the AVMA Clinical Practitioners Advisory Committee (CPAC), which reports to the Council of Biologic and Therapeutic Agents (COBTA). We are a group of volunteers currently working on the compounding policies, amongst many other veterinary medical issues. I am a Clinical Associate Professor of Zoological Medicine (with board certification from the American College of Zoological Medicine), and Section Head of the Special Species Health Service, at the University of Wisconsin School of Veterinary Medicine. I spend a large percentage of my clinical duties seeing exotic pet patients, but I am also very much involved in zoo, aquaria, and wildlife medicine. As a member of CPAC/COBTA, it is our charge, along with other AVMA entities, to develop policies that will, ultimately, be finalized and approved by the AVMA Executive Board in order to advocate for, and protect, AVMA member needs in federal legislation in Washington, DC. Hence, I support the proposed revisions of the AVMA compounding document, and I have a vested interest in having ready access to compounded drugs.

    The bottom line; without compounding, I would not be able to practice veterinary medicine on a daily basis, and nearly 100% of my patients would have to forego medical treatment. Therefore, I see compounding as an absolute necessity for all practitioners of Zoological Medicine (zoo and aquaria animals, exotic pets, and both captive and free-ranging wildlife species). Please remember that compounding from FDA-approved drugs is currently legal. For example, if enrofloxacin tablets are crushed and properly mixed in a flavored suspension for use in a pet parrot, this is legal compounding. The primary issue is that the compounding of drugs from bulk (raw, active ingredients) products is not legal according to the FDA, the federal authority by which we are legally bound as veterinary medical practitioners. However, the AVMA recognizes that compounding of drugs from unapproved bulk substances for use in exotic, zoo, wildlife, and aquatic animals is medically necessary in certain situations and should be allowed when there is no approved product for that species and indication.

  22. Compounding is absolutely essential in providing the best care for some of our small animal patients when a drug is no longer available (e.g. ophthalmic vidarabine) or when a drug was never made (e.g. EDTA eyedrops) or when the commercially available form is not strong enough (e.g. 2% cyclosporine eyedrops). Furthermore, as licensed veterinarians we should be able to have compounded drugs in our pharmacy so we can start appropriate and recommended therapies immediately which for many eye diseases is essential to save vision and decrease pain. Waiting until a compounded medication arrives in the mail for many eye diseases may b too late.

  23. Concur that compounding isn’t my first choice, but it has, literally, saved the lives of a few and alleviated suffering in many patients who needed an odd dose, route, or formulation that wasn’t available in a FDA-licensed product. This encompasses the animal’s care giver, too. Some clients whose arthritis or other medical condition makes handling and administering the FDA-approved product nearly impossible; for example, compounded ophthalmic ointment works for several client who simply cannot make the FDA-approved eye drops hit the target. Where would many good old horses be without compounded pergolide, until recent history?

    Note that FDA products as well as non-FDA products have been recalled due to contamination, though anecdotally it seems that the compounded products have the most spectacular recalls (the human steriodal products compounded in MA, recalled in 2012, for example).

    That said, it would be impossible to treat some of our patients without compounded options. We veterinarians are intelligent enough to know when compounding should be an option, and our patients deserve for us to have that option.

  24. Compounding in Equine practice is overused. Other than some ophthalmic ointments and hormone products no longer available, the bulk of equine compounding is for cost reasons using bulk products. This is supposed to be illegal but occurs all the time. Bad medicine for the horse, no recourse for the owner, more money made for the vet. I am opposed to using unapproved bulk products for compounding unless those products have some kind of quality control.

  25. the drug supplies of ‘routine’ providers have been sketchy at best over the last several years. without compounding, competent administration of veterinary care would be severely compromised with these “shortages and backorders”. in the last 3 years, there have been far, far more drug recalls through traditional providers than through compounding pharmacies. why is anyone not suggesting better quality control of those groups?

  26. It is clear that without compounding pharmacies our profession will suffer as will our patients. Too many times our companion animal patients and exotics do not “fit” a commercially available drug prep. And when basic, essential drugs go on backorder or are unavailable for months, we must have a source to continue essential care of our patients. (i.e. prednisolone, diazepam were both recently unavailable for a length of time.) Our legislature has a tendency to be reactionary and pass laws without contemplating the repercussions. If compounding becomes illegal for veterinarians, it will force us to do our own “jury rigging” for our patients without any quality control or regulation. That is NOT in the best interest of our profession, and certainly not our patients.

  27. Compounding is essential in veterinary medicine. I think veterinary medicine without compounding is a pipedream. We’d all love to only use non-compounded, safer, approved medicines. But when drug X goes on backorder for 8 months and there are no safe alternatives, what are we supposed to do? Or when elderly Ms. Johnson can’t pill Fluffy or sneak liquid meds in her food, and needs a topical or otherwise would have to euthanize or surrender? Or when Squeakers is just too small for the lowest dose of the meds he needs? Often times, it’s not that we have no *better* alternatives, but rather that we have NO OTHER alternatives. Until we have alternatives, we cannot do without compounding as a profession.

  28. Veterinary use of compounded medications is far to common. Compounded medications should be considered a last resort, when no alternative exists or when a particular route of administration is required (such as when a cat can not be medicated other tang via topical medications). Lower cost or convenience are simply NOT legitimate reasons for compounding!
    That said, when compounding IS legitimately needed, it is a black box, with random expiration dates instead of any guarantee of stability or sterility. I think it is critical that compounding pharmacies be required to prove these factors in each batch of medication they produce, so we can rely on and trust use of these medications in our patients.

    • I agree that compounding should not be our first option; however we inevitably end up using having to use these pharmacies whether it be because of a particular dose requirement, method of administration, previous script from another vet, discontinued label product etc. It is indeed a “black box” there is little to no legislation on not only product quality, but also there is no legislation regarding pricing. If a consumer wishes to call a compoounding pharmacy/or any pharmacy for that matter to obtain pricing, the pharmacist is obligated by law to disclose the price of the medication to the consumer. Traditionally we(veterinarians) have increased the price of our own in-house prescriptions as routine business expenses require. However, when I send home a bottle of phenbarbital the cost reflects diagnosis time, monitoring, personel, etc. When a consumer calls the compounding pharmacy and gets a quote less than mine, they feel I am ripping them off. I believe there should be legislation to remove this obligation as it does not reflect the costs required to care for the patient it only reflects the cost of the drug and the pharmacist time/rent on usually a usually less than high rent facility-not to mention that the pharmacist would not exist without the prescribing doctor. Such a mutual existance should not be undermined nor the doctor-patient trust be undermined by pharmacists advertising their drug costs.

  29. Compounding is a necessary requirement in order to effectively treat animals. When a product is temporarily or permanently out of production, such doxycycline and Terramycin, these are the ONLY effective drugs to treat some diseases. Does the FDA prefer the client order these drugs from the internet/Canada with an authorized prescription, or instead allow the system to be continued where the pharmacy in the U.S. and the DVM are responsible for the product used? I do not see the FDA inquiring as to why each month we see drugs on “back order” and when they come back on the market they are at a much higher rate (i.e. doxycycline at 10X cost at this time). Having the ability to treat all species of animals for over 30+ years many animals would have been lost if some of the compounding formulas were not available. I prefer to use commercially available drugs as a first choice option.

  30. Attached, please find an email, posted with the author’s permission, that gives a different take on the legality of compounding from bulk sources. For full disclosure purposes, the author is a RPH and one of the owner’s of Diamondback Compounding Pharmacy. I had reached out to him for his perspective and because our hospital has utilized their services to great benefit over the years. It appears, at least from his comments, that the issue is not as clear cut as the post from Dr. White-Shim indicated. I thought the AVMA members would benefit from this alternative perspective.

    Gary Block DVM, MS, DACVIM
    Ocean State Veterinary Specialists
    RI HOD Delegate

    Dear Dr. Block,
    In 2003 the FDA, under an emergency protocol and without public comment, issued
    a Compliance Policy Guideline to address various issues concerning compounding
    for veterinary use. One of the guidelines suggested that all veterinary compounding should be done from finished product (e.g.Tablets, capsules) and not from bulk active pharmaceutical ingredients (API). This statement has never been part of any law or statute (FDAMA, AMDUCA, PDUFA) nor is there any corresponding prohibition concerning compounding for use in humans. Congress has repeatedly asked the FDA to explain why something that is OK for Grandma is not OK for Rover. FDA has yet to respond. Likewise, Congress has never passed any laws which prohibit compounding from API. Nevertheless, FDA has always
    clung to the position that compounding from pure API is illegal, even though
    there are no laws on the books prohibiting it. (NOTE: If it is not a law, it cannot be broken, and is therefore, NOT illegal).
    The FDA is a self-funding administration, meaning it operates only so long as
    it collects fees. These fees are almost exclusively generated by New Drug
    Applications submitted by the big pharmaceutical manufacturers (Pfizer,
    Novartis) and to a lesser extent, drug distributors (MWI, Schein). So, the FDA
    has a vested interest in keeping Pharma happy, hence their suggestion of only
    compounding from finished product.
    Several pharmaceutical manufacturers and distributors have banded together to
    form the Animal Health Institute, an unassuming misnomer for another Big Pharma Lobbying group, aimed specifically at veterinary issues. AHI contributes
    several million dollars each year to the AVMA in the form of sponsorships and
    events, so AVMA has a vested interest in keeping these companies happy as well.
    In 2011 AVMA issued its informational brochure on prescription compounding, a
    brochure developed in collaboration with the Animal Health Institute. If you look at the contributors to the brochure, you will notice that not a single practicing compounding pharmacist or pharmacy organization was consulted. In the brochure AVMA adopted FDA’s position, that compounding from pure API is illegal. Understand, this means that every time you prescribe Potassium
    Bromide for a patient, you are performing an illegal activity. AVMA leadership
    has had the luxury of maintaining this position (and continuing to receive money from pharmaceutical companies) despite its negative impact on the practicing
    veterinarian, because no one was enforcing the prohibition (because no law is
    actually being broken).
    In the aftermath of the New England Compounding Center tragedy, the FDA and AHI smell blood. Congress is talking about passing some type of legislation
    regarding prescription compounding (not necessarily veterinary compounding) and
    both FDA and AHI are pressing their agenda. In response, several veterinary
    compounding pharmacies (including Diamondback Drugs) circulated an email to
    practicing veterinarians alerting them to the possible negative consequences were compounding from pure API to actually become illegal. While AVMA has not
    formally adopted a position, several AVMA board members have taken it upon
    themselves to “correct” the “misinformation” being circulated. Hence, the statement on the AVMA website.

    • After reading the posting from Dr. Gary Block and the incorporated message from the pharmacist/co-owner of Diamondback Drugs, I feel compelled to respond to clarify the role and motivation of AVMA in this veterinary compounding issue.

      The AVMA takes very seriously governmental regulations that negatively impact our members. Veterinarians working in private clinical practice, as well as veterinarians representing other disciplines such as pharmacology, comprise the Council on Biologic and Therapeutic Agents (COBTA) and its Clinical Practitioners Advisory Committee (CPAC). The COBTA and CPAC are comprised of veterinarians who volunteer to provide lead oversight over many drug-related AVMA policies, including those regarding compounding. It is the COBTA/CPAC and a number of other AVMA committees and councils that are suggesting the changes to our AVMA policies on compounding. These are AVMA members who understand the importance of advocating member needs for compounding. As stated by one of our volunteers, their discussions have focused on “preserving needed compounding (cisapride is a great example) while preventing illegal compounding from continuing that can put patients at risk as well as increase the liability of the veterinarian.” Contrary to the implications in the previous post, this initiative to change our compounding policies is being driven solely for the purpose of doing what will be best for our members.

      As Congress seeks to address the unfortunate incident of a lethal fungal meningitis outbreak in humans, we do see an opportunity to seek a legislative remedy for compounding issues negatively impacting veterinary medicine. That is an appropriate role of our Government Relations Division, but they need updated policies if we are going to take advantage of this legislative opportunity. Regardless, internally within the AVMA governance, we all agree that job #1 is to put in place policies that all of our relevant volunteer entities can support.

      It is the position of our council and committees that current federal rules do not allow for any compounding from raw active ingredients. What follows is some background to explain the basis for that belief.

      For many years, the AVMA has contended that certain compounding from raw active ingredients is medically necessary in limited circumstances: https://www.avma.org/KB/Resources/Reference/Documents/cpgdocket.pdf

      FDA contends compounds prepared from active pharmaceutical ingredients (ie, “APIs,” “bulk,” “raw, active ingredients”) are unapproved New Animal Drugs that therefore cannot be introduced into interstate commerce. The Food Drug and Cosmetic Act (FDCA) definition for “new animal drug”, found in section 201(v) [21 USC §321(v)], includes “any drug intended for use for animals other than man” that is “not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling thereof…”.

      We understand every Federal Court of Appeals that has considered this compounding issue has agreed that compounds prepared from bulk for animals are New Animal Drugs and therefore subject to the provisions of the FDCA that discuss unsafe, misbranded, adulterated requirements.

      AVMA’s understanding is human and animal compounding are regulated differently. § 503A was added in 1997 upon passage of the the Food and Drug Administration Modernization Act (FDAMA) and applies only to human drugs, exempting them from the section that deals with human drug approvals. Kindly see a relevant FDA web page detailing the current status of court decisions regarding compounding: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm134919.htm

      The FDA is a federally funded, appropriated agency. Part of its funding (being referred to in the pharmacy email) comes from user fees under the provisions of the Animal Drug User Fee Act. To help ensure adequate availability of veterinary drugs, the AVMA supports increased Congressional funding of the FDA Center for Veterinary Medicine for the New Animal Drug Application (NADA) approval process indexed to keep pace with cost increases. The AVMA supports user fees for new animal drug applications only if such fees are directed toward expediting the review and approval process for animal drug products. For additional details about FDA’s budget, see http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/BudgetReports/UCM291555.pdf.

      In the end, it is my hope that we can avoid the finger-pointing and making allegations of evil intent and simply come together to agree on a strategy that will be best for our members. I assure you that is the only motivation for AVMA leadership – volunteers and staff alike.


      W. Ron DeHaven, DVM, MBA
      CEO, AVMA

  31. Safe and effective medications in palatable formulations in the correct sizes and produced by compounding pharmacies are critical for the treatment of my patients. Standard medications produced for human use are frequently unpalatable or the wrong size for many of my patients. Unpalatable means they aren’t given effectively by the owner of the pet and the wrong size means that effective treatment is not available to all my patients or that inaccurate pill splitting must occur. Verify the safety of these pharmacies, but don’t limit our ability to treat our patients.

  32. As a small animal veterinarian in a nonprofit practice, serving mostly income qualified clients, compounded medications are an integral part of our pharmaceutical arsenal. Compounded medications meet several needs, such as correct dosing, palatable administration/ease of dosing, combinations of medications in one dose, affordability, availability of backordered medication, just to name a few. With the advent of “big box” pharmacies competing for our clients’ business, the veterinary community has already lost control of part of our pharmaceutical market. Now it seems the option to compound specific medications is also being lost. I have to believe the rich pharmaceutical corporations are benefitting greatly from these changes, at our expense. Veterinarians are licensed professionals. Why should we not have the right to make the best choices for our clients, including how and where to obtain their medications? In the long run it isn’t the veterinarians that will be losing out, it will be the animals that we serve and protect every day. If we cannot obtain the necessary medications in an affordable way, the animals will suffer by not being treated. I am reminded every day about the harsh reality of today’s economics and the toll it is taking on a large percentage of the country. Maybe some people don’t realize that if the people are financially suffering, their pets are suffering even more. It would be a shame to lose the ability to provide for the needs of these people and animals because the big pharmaceutical businesses want to retain their wealth. I certainly hope the veterinary industry can fight the restrictive changes that are proposed or already in place, and get back the freedom to practice in the way we feel benefits our patients the most.

  33. As a veterinarian who sees cats and exotic species (small mammals, reptiles, and birds), compounding is completely essential to my everyday clinical practice. Some way must be found to keep this as an option for the veterinary community.

  34. Through 40yrs of practice mostly avian,exotic and wildlife ,I don’t believe I could have delivered tha quality of care that I was able without compounding. One of the current problems is that compounding is now an elective for most pharmacy students compared to 40 yrs ago (my brother had a year of compounding,my neice has had none) so make sure the pharmacy you select has a track record for quality control.

  35. Compounding has become a very necessary part of my practice. I need to have the flexibility to obtain drugs for all my patients, and it is often unavailable in the size/strength that I need; or I need an alternative route of administration for other species. What about the many ophthalmic medications like Tacrolimus or Terramycin that you can not obtain any other way? I agree that I want these products to be safe, but I also need them to be available and affordable for my client.

  36. why is a bulk ingredient considered unpproved? & who does the approving. Agree, compounding helps us to better treat the variety of patient sizes we encounter.

  37. Compounding is a necessary and critical part of my practice. The size variance of our patients, the need for alternate delivery systems in cats, the presence of xylitol in human medications and cost issues drive us back to the compounding pharamcy again and again. Furthermore the current state of drug shortages in the US makes the veterinary market continually vunerable. The suppliers are missing a critical medication for our hospital on a weekly basis. If not for the compounding pharmacies, we would be out of luck.

  38. Compounding is really become essential in the field of veterinary medicine. Due to species needs and animal size variance. The weak point is the obvious one, one compounder allowed the appropriate techniques to lapsea and so produced a lethal product. Our lack of oversight also. Was it lacking or did it fail for whatever reason.

  39. This group might want to spend some time investigating AND PUBLIClLY REPORTING what the causes and economics to both human and animal medical health care might are and why drive the need for compounding. As is typical of organizational and governmental responses there is now a knee jerk witch hunt on. However, the orignal sin was the greed driven collaborative absence of the applicaton of the orversight and regulation that was and is within the power of the states and the FDA.