Vet Corner
Drug Piracy and How it Affects Your Performance Horse
By Kenton Morgan, DVM, DACT
Dec 21, 2006

     For those of us in the equine industry, whether we are owners, trainers, grooms, riders, judges or veterinarians, our guiding principle should always be: What is best for the horse? When FDA-approved products are available, the practice of using non-approved medications, illegally compounded medications or manufactured medications is not in the best interest of the horse.

What is drug piracy?
In general, drug piracy is a term used to describe a practice whereby a product is produced that is very similar or identical to, an FDA-approved pharmaceutical. Another way to explain piracy is to produce a product with the intent to circumvent the drug approval process and provide for mass marketing of this product. This practice is most commonly associated with a segment of the pharmaceutical industry known as compounding pharmacy.

What is compounding pharmacy?
Compounding is a process to produce a medication by combining or altering ingredients for a patient in response to a licensed practitioner’s prescription.

Because there is a scarcity of approved medications for use in horses, there is a legitimate need for compounding in equine veterinary medicine. Some examples of legitimate compounding would include: crushing a tablet and creating a paste or gel to aid in the administration to the patient or mixing two anesthetics in the same syringe for use in your horse. Mixing antibiotics with IV fluids in a hospitalized equine patient is another example. This practice is necessary and widespread. There are many reputable compounders in the industry providing an important service to veterinarians and horse owners.

Who can prescribe a compounded veterinary drug?
A veterinarian may prescribe a compounded drug as long as a valid, veterinarian-client-patient relationship exists.

Who can legally compound a veterinary drug?
Only licensed veterinarians and pharmacists can compound veterinary drugs.

Is a compounded product the same as a “generic” drug?
No, a generic drug is identical or bioequivalent to a brand name or legend drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use. A generic drug is typically submitted for approval after the original (legend) drug comes off patent protection.

It is important to remember that generic drugs go through an FDA approval process and are manufactured at an FDA-approved facility.

Compounding pharmacies do not produce “generic” anything. Pirated drugs are not “generic” drugs.

What are the “rules” or criteria by which products are compounded?

1. When no approved animal or human drug is available that can be used in an extra-label manner to treat the condition

2. Compounding must be performed by a licensed pharmacist or veterinarian within the scope of a professional practice

3. Appropriate procedures are carried out to ensure safety and effectiveness of the product

4. Size of the compounding operation must be proportional to the established need for the product

5. All relevant state laws related to compounding are followed and all federal regulations are met ((CFR) 530).

Compounding is intended to be performed on a case-by-case or patient-by-patient basis, when nothing else is currently available in the appropriate form to treat a condition.

What constitutes illegitimate compounding?
(compounding for food-producing animals have additional criteria and will not be discussed here)

1. Compounding a veterinary drug from unapproved drugs or bulk drug products.
2. Compounding a veterinary drug if an approved veterinary or human drug exists
    to treat the condition.
3. Compounding veterinary drugs within a manufacturing environment.
4. Compounding veterinary drugs for resale.
5. Compounding drugs outside of state or federal regulations.
6. Compounding drugs which mimic FDA-approved products.

Drug piracy can involve one or more of these practices, but producing products on a large scale and/or producing a drug that mimics an approved product are two of the most common infractions associated with “piracy.”

What does all of this have to do with me and my performance horse?
FDA products go through years of development and testing before they are approved and can be sold. This is to assure that the products are safe and effective.

This process includes several components:
1. Toxicology
2. Target animal safety
3. Efficacy
4. Chemistry, manufacturing, controls
5. Labeling and FOI summary

With an approved product, you can be assured of the product’s safety, efficacy, purity, stability and consistency. The label clearly explains the proper way to use the medication.

With pirated products, there is no assurance of any quality parameters. These products have no requirement for analytical, microbial, stability, safety or efficacy.

Concerns when using pirated products on your horse:

1. The product may have no beneficial effect.
2. The product you use today may be totally “different” from the product you use
    next week.
3. The product may not be stable.
4. The product could pose a safety risk to your horse.

Summary
Legitimate compounding by a reputable pharmacy, on the order of a licensed veterinarian who has a professional relationship with your operation, is a necessary service to help provide optimal care for the horse.

The use of pirated drugs has no place in the equine industry and can pose a serious threat to the health of your horse.

© Copyright 2005 by SportHorseCM.com
Hosted by Usonyx Singapore Broadband Web Hosting Service