Compounding for the Veterinary Practice - Our Letter to the Editor of Veterinary Product News

Dear Ms. Logan,  

I received my latest issue of VPN today, and read with interest the article, “Compounding’s Place in Equine Medicine”.  I would like to make several comments about the article that could clarify the issue from the perspective of a compounding pharmacy.

First, I was disappointed to see in the “Editor’s Note” that a compounding pharmacy was not included in the roundtable discussion.  I would have probably not agreed to participate either.  Manufacturers like Lutipold Animal Health would prefer that compounding did not exist; then ALL medications would need to be purchased from manufacturers exclusively.

As to the question whether drug compounding is a beneficial (and therefore necessary) service provided to veterinary medicine, there seems to be universal agreement among practicing veterinarians.  The fact is that most vets could not treat some patients without the help of compounded prescriptions.  “Prescriptions” is the key word.  Compounding is only necessary when a doctor needs a unique drug dose (or dosage form) that is not available commercially.  In these cases, the doctor prescribes a compounded drug for an individual patient , which must be specially prepared by a pharmacy.  This is the TRIAD that is referred to.  The actual prescription is usually provided to the animal owner, however many prescriptions are sent to the vet on behalf of the customer.  Compounding outside of this relationship is a form of manufacturing that is then subject to FDA manufacturing regulations – something NO pharmacy is capable of complying with.

I will not deny that there are some “pharmacies” that are in fact manufacturers.  They violate pharmacy regulations by producing large quantities of drugs that are then sold without prescriptions.  In this case, they are acting as both manufacturers and distributors.  Because of the high markups on many drugs it is actually possible (sometimes) for a pharmacy to beat the price of the real manufacturer.  As was noted in the article, these “pharmacies” have but a fraction of the investment in facilities, and none of the costs associated with bringing the product through the expensive FDA approval processes.  Veterinarians using these “pirated” drugs are complicit in the violations of FDA regulations. 

It is also true that the veterinarian needs to clearly inform the animal owner that the drug they are prescribing is not commercially available, and therefore must be custom-made (that is, compounded.)  All doctors maintain the right to prescribe medications both for labeled and off-labeled uses.  Compounded drugs are no different, and may be legally prescribed when doctors, in their professional judgment, determine that they provide the desired treatment.

As for the provision of FDA regulations dealing with compounding from “bulk chemicals”, this is a hotly disputed area.   In fact, we have a lengthy article on our website that addresses this issue.  There are several key facts.  First, as Dr. Mitchell points out in the article, compounded drugs are particularly important in cases where manufactured doses have been discontinued.  Just because a drug doesn’t generate a profit for the drug manufacturer does not mean that it is not effective and relied on by many doctors.  Many drugs are discontinued for economic reasons.  The chemical suppliers still produce the raw ingredients in most cases, and this allows pharmacies to prepare compounded doses on a prescription basis.

The FDA’s policy has been that “bulk chemicals” should not be used for compounding for animals.  The rationale is that this would prevent the introduction of undesirable drugs into the food chain.  This reasoning is sound, however the FDA does not have a “written” exception for non-food animals (that is, pet dogs, cats, and horses, etc.)  This oversight was corrected in the FDA Modernization Act of 1997, however this law was subsequently ruled as unconstitutional because of other provisions, and was overturned pending a rewrite by Congress.

The irony of this regulation is that there are NO restrictions on the use of pharmaceutical-grade chemicals for compounding for humans!  As a pharmacy, we can legally compound a drug for a child, but cannot compound the same drug (under the strict letter of the law) for a cat – even though we use the same human-grade drug for both prescriptions.   This policy is obviously flawed and unenforceable, thus the FDA’s policy of “regulatory discretion” when we use bulk chemicals for non-food animals.  The reality is that millions of beneficial compounded prescriptions would not be possible without access to chemicals, and millions of animal owners would be denied access to life-saving medications.  The FDA does not want to be held liable for denying doctors crucial access to legitimate treatments.

The other point that should be made concerns the term “bulk chemicals”.  A typical compounded custom prescription may contain only a few grams or milligrams of each drug.  The fact is that most of our inventory of hundreds of drugs consists of less that one pound of each chemical, and in some cases only a few grams.  Readers should not picture pharmacies with 500-pound drums of powder.  In addition, pharmacies are required to obtain chemicals only from FDA-approved sources. 

The final point I would like to make is that ALL compounded drugs require a prescription.  As prescription drugs, they can only be sold once.  Compounding pharmacies are not wholesalers, and there is only one price for a compounded drug – the RETAIL price.  Veterinarians should not be marking up compounded drugs.  Dispensing fees are legitimate, however, as the article points out.  Likewise, a pharmacy cannot sell the drug to a vet at one price and to the animal owner at a higher price, unlike manufactured drugs that are routinely obtained from distributors and then sold to retail customers.  This regulation is also ignored by some pharmacies.

The bottom line is, as Dr. Stenbom points out, “compounding is an essential part of veterinary practice.”  At IPS, we have literally expanded the field of veterinary medicine in general, and specialty practice in particular.  Compounding allows us to provide a much wider variety of drugs and dosage forms than would otherwise be accessible.  Like all practices, compounding pharmacies are subject to regulations and standards.  As the owner of a pharmacy that performs compounding exclusively, I can attest that complying with these regulations is sometimes expensive and burdensome, but we do so to protect our right to continue to provide this essential service.  And I’m sure the thousands of veterinarians we work with, and the tens of thousands of animal owners, would agree that the drugs provided are essential.  Please contact me if you would like more information on the practice of prescription compounding.

Sincerely,  

Randy Reek

President, Island Pharmacy Services