Brand-name Drugs (aka Pioneer Drugs)

Generic Drugs

Generic drugs are approved by the FDA and must contain the same active ingredients as the original formulation.¹

While generics don’t have to go through the full approval process like brand-name drugs do, the drugs do have to show bioequivalence (rate of drug absorption and extent to which it gets into general circulation following the administration).

Compounding Drugs

It’s easy to see why compounding is a confusing topic for horse owners. While some product compounding is legal, other compounding practices simply aren’t. Legally compounded drugs are provided by a veterinarian or a licensed pharmacist at the direction of the veterinarian. Let’s clarify the difference between legal compounding and illegal manufacturing.

Legal compounding activities

Legal Compounding is the manipulation of an FDA-approved drug for the purpose of meeting the needs of a specific patient.¹ An example of this is adding a flavor to a FDA-approved drug. For a drug to be legally compounded and made available to a horse owner, many rules apply, including, but not limited to:

• A valid veterinarian-client-patient relationship exists.¹
• A licensed veterinarian or pharmacist must compound the product.¹
• There may be no FDA-approved drug available.¹
• Compounders cannot assume the role of manufacturers and cannot produce the product from a bulk (aka raw) active ingredient.¹
• While there are times when a legally compounded medication could be a veterinarian’s only option, the AAEP cautions veterinarians to “limit the use of compounded drugs to unique needs in specific patients.”

Illegally Manufactured Drugs

These may be from one of the following sources:

ILLEGAL MANUFACTURING ACTIVITIES (by compounding pharmacies)

Unfortunately, equine drugs that do have FDA-approved versions available are often illegally manufactured by compounding pharmacies and advertised or sold to horse owners who are led to believe that they are the same as those legitimately on the market.

Currently, there are a number of compounding pharmacies illegally manufacturing
drugs that are marketed to horse owners as the equivalent of brand name drugs such as
ULCERGARD^® (omeprazole), GASTROGARD^® (omeprazole), Adequan^®, Banamine^®, Phenylbutazone, Protazil^® and Regu-Mate^®.

Illegal Manufacturers

These include those who are selling and marketing drugs that have not been reviewed by the FDA in any way. They often make it appear or even state that these products are “generics” but cannot provide an ANADA number. Some makers of illegal products will attempt to mislead you by stating that their product contains a drug that “is FDA-approved”. The truth is that there is no way of knowing where these manufacturers obtained their version of that base ingredient (drug) as it is not the same as that in the approved drugs which are undergoing constant safety, purity, and efficacy tests. Just because a product contains an FDA-regulated ingredient does not make it a FDA-approved product. These products:

Nutritional Supplements

Horse owners also have access to hundreds of nutritional and dietary supplements. While the FDA does not “object to the marketing of nutritional supplements for oral administration to companion animals,”¹ those supplements are not held to the safety and efficacy testing that FDA-approved drugs are. Their manufacturers cannot legally make any claims of disease prevention or treatment.²

However, a significant number of these products do make claims that cannot be substantiated by scientific data.³ Horse owners should be wary of using these products as a replacement for drugs that have undergone more extensive and critical scientific review. It’s never a bad idea to ask the manufacturer for peer-reviewed, published data that supports the product claims. Sure, it’s another step in the purchase process, but it’s an important one.

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