Why the compounding form-letter emails aren’t helping

Image by GOKLuLe (Own work) [CC BY-SA 3.0], via Wikimedia Commons

Image by GOKLuLe (Own work) [CC BY-SA 3.0], via Wikimedia Commons

We’ve been receiving a large number of form-letter emails, presumably driven by the efforts of a compounding pharmacy or group of pharmacies in response to a recent Federal Register notice calling for comments. Although we understand and appreciate the underlying concerns behind sending these messages, what we really need is specific information from members so that we can advocate effectively on behalf of the profession regarding the FDA’s compounding guidance.

We understand that the legality of FDA’s regulation of veterinary compounding is and has been questioned. But what we’re focused on right now is the need to weigh in on and help shape the FDA’s new Guidance for Industry and its intent to create a positive bulk API list. What we can’t afford to do is dig in our heels and refuse to provide input. We don’t want to miss the opportunity to help shape the guidance and protect the profession’s access to as many necessary medications as we can. We’ve asked for an extension of the comment period for the solicitation of bulk drug substance nominations, and we are eager to hear whether our request has been approved.

We’re fully aware of the burdens and potential negative impact that the proposed guidance could create for veterinarians, and we’re aggressively pursuing the issue. What we need from our members right now is the following:

  • A list of the most commonly used compounded medications in your clinic and why they are medically necessary, in which species, and for what conditions.
  • Suggestions for inclusion on the list (and  “every possible bulk ingredient” is not useful to the effort), and justification for their inclusion.
  • Any scientific evidence of safety and efficacy of the products proposed, such as peer-reviewed literature.

We fully intend to continue advocating for our profession’s access to critical medications. But part of that is the need to work within the existing system, including participation in the federal public comment opportunities, in order to make effective and efficient progress. Please provide us with information that we can use to advocate effectively and prevent the loss of access to these products.

13 thoughts on “Why the compounding form-letter emails aren’t helping

  1. Doxycycline, Metronidazole, Gabapentin, Calcitriol, Trilostane, and Tramadol are all compounded into liquid or chews due to needing dosages for small animals that are unavailable other than through compounding.

    Transdermal methimazole and tramadol are needed for patients that cannot take oral medication.

    Buprenorphine sustained release 3-day injectable does not have a substitute for fractious cats that cannot be medicated by their owners.

  2. We use many compounded products to the benefit of our clients and pets. Not only do they enable use to provide better veterinary care through these products, but they often make necessary medicines more cost effective for the client.
    This is a list of all the compounded products we use in our practice.

    Apomorphine injectable: to induce vomiting, has no substitute, saves pets from toxic substances and stomach foreign bodies.

    Oral buprenorphine: a very necessary pain relief medication for cats (which there are little to choose from)

    Oral Doxycycline: This used to be a fairly economic antibiotic, but severely escalated in price a couple of years ago.
    Why? no one seems to know!
    There is no substitute, especially when treating tickborne disease, leptospirosis, blood parasites, and respiratory infections. I can dispense a two week supply of the compounded product for under $50, if I script it into a human pharmacy it would be over $1000.

    Oral Metronidazole (low dosage): A very necessary medication for treating parasites, enteritis, and numerous bacterial diseases in small dogs and cats. The human generic product is very foul tasting when broken up , and does not allow for proper dosing.

    Transdermal Methimazole: This product has become a mainstay for the treatment of hyperthyroid in cats who can’t tolerate the oral medication, and for owners who can’t afford I131 treatment.

    Ophthalmic Cyclosporine and Tacrolimus: both instrumental in treating dry eye. Brand name products are hard to apply and for some clients not economically feasible.

    Oral Trilostane: for the treatment of Cushings disease, much easier to dose and much more economical than the brand name (which for many is not economically feasible)

    Oral Cisapride: very necessary for treatment of feline constipation and colon diseases, no longer available on human market

    These are just a few of the many products veterinarians rely on through compounding pharmacies. The drug industry seems to like jerking the veterinarians around by pulling long used necessary products off the market, or severely increasing prices as to make them economically unviable. We are constantly turning to our compounding pharmacies to bail us out when this happens.

  3. My practice utilizes productson a daily basis that are not available commercially either due to back orders or just no commercial drugs available These products include dexamethasone, phenylbutazone, diclazuril, levamisole/ decoquinate , lactonase. Some of these products come and go from this list while others stay on this list regularly

  4. Pain medications for cats are essential for humane treatment post surgically and for many chronic conditions. With NSAIDS often being contraindicated due to the cat’s age and the potential for inducing renal failure, buprenorphine is an essential medication. As it is easily absorbed sublingually in cats, there is a constant need for compounding it (& flavoring it). Please don’t take this essential option away from us.

    Also, due to smaller dosages necessary for cats/small dogs, doxycyline, metronidazole, and chlorambucil often need to be compounded in smaller concentrations than are commercially available. Transdermal methimazole is essential for hyperthyroid cats as many will vomit on the oral form.

  5. Methimazole – transdermal gel for cats – used to treat hyperthyroidism – many cats do not allow owner’s to add medication to their food or administer medication to them directly whether it be a tablet or a liquid. The transdermal gel has allowed many clients to treat their hyperthyroid cats successfully.
    Prednisolone – transdermal gel for cats – used to treat IBD, allergic skin disease, cancer (lymphoma)
    Metronidazole – liquid for cats and small dogs – used to treat giardia, diarrhea, IBD, (available tablet size too large for small dogs and cats)
    Cyclosporin- ophthalmic drops for dogs – to treat KCS, (currently available product is an ointment which many owners have difficulty administering)
    Liquid/capsules for dogs – to treat Atopy
    Trilostane – liquid and capsules – to treat dogs for Cushings disease – ( limited mg sized capsules available)

  6. I have a question before I comment. Are we only asking for drugs that there is not an fda approved drug on the market? For example: potassium bromide. I can’t think of many things in that category. Otherwise there are fda approved products that could be compounded into different formulations.

  7. Definitely metronidazole and doxycycline in small mg for small cats/dogs, pocket pets, and exotic patients which are used for numerous diseases. Atenolol for small, elderly cats. Isuprel elixir for collapsing trachea. Ponazuril for coccidia. Those are the most common ones I can think of offhand. I’m sure avian/exotics vets will have a much longer list of necessary compounded meds.

  8. metronidazole liquid 125 mg/ml for small animals and those who can’t be pilled regularly. We keep liquid prednisolone in 2 mg/ml and 6 mg/ml. We use buprenorphine oral suspension as well as a compounded injectable. We have an antidiarrheal mix comparable to a discontinued product called amforol. We use 25 mg doxycycline tablets. More and more we will have to compound rather than use children’s oral liquids because they are switching to xylitol as a sweetener. As it is children’s preparations are in terrible flavors for use in cats who can’t appreciate sweet and wouldn’t want to if they could.

  9. Metronidazole in small mg. for small dogs in cats to treat diarrhea. We also use ponazuril compounded for coccidiosis cases as it is cheaper than mixing up Marquis for the individual cases we treat. We also utilize interferon for distemper and parovoviral enteritis cases. Seligiline chews, methimazole transdermal pens, liquid enrofloxacin oral, griseofulvin, and BNT Otic ointment are just a few of the other compounds in our practice.

  10. Metronidazole (for diarrhea), Gabapentin (for neuropathic pain), & Robaxin (for muscle relaxation) are the most commonly used compounded medications in our hospital. Sometimes cardiac medications such as Amlodipine need to be compounded to accurately dose a small patient.
    From time to time, compounding of medications may be necessary when the medication is on a manufacturer shortage or otherwise not readily available. An example is Doxycycline which is used to treat many infectious diseases as well as used in adjunctive treatment of heartworm disease.

  11. Metronidazole is a drug most useful for diarrhea, but very hard to dose with the readily available sizes of 250mg and 500mg, for the very small dog and cat patients.
    Being able to bulk compound this drug in smaller concentrations will allow much more appropriate dosing of these small patients, which are often the most common ones afflicted with enteric disease.