Importance of FDA Approval

FDA Pioneer Drug
A pioneer drug is a brand name animal drug as submitted and approved through the FDA review process.¹

Medical devices
A medical device does not achieve its primary intended purposes through chemical action within or on the body of animals and is not dependent upon being metabolized for the achievement of its primary intended purposes. It is also not a generic form of an FDA-Approved drug. The key difference between an animal drug and an animal device is how the product works, because a drug relies on a chemical action occurring in or on the animal’s body and needs to be metabolized to work.²

Compounded drugs
A compounded drug is any drug manipulated to produce a new dosage form drug. Legal compounding requires a valid veterinarian-client-patient relationship (VCPR). Use of compounded drugs should be limited to unique needs in specific animals and to those uses for which a response to therapy can be monitored, or those for which no other method or route of drug delivery is practical or available. It is illegal to compound a specific product when there is an approved drug form of that product except to make a different dosing form. However, the approved product must be used to make the compounded new dose form. Bulk compounding and sales is illegal. The prescribing veterinarian and owner should remember that compounded drugs are not subject to the FDA-Approval process for testing for safety, efficacy, stability, potency and consistency of manufacturing. Consistency from one batch to another, amount of the stated drug substance, and safety and efficacy for the intended use cannot be ensured.¹

Oral joint supplements
An oral joint supplement is loosely classified as a nutraceutical. The term “nutraceutical” combines the word “nutrient” (nourishing food or food component) with “pharmaceutical” (a medical drug) and describes a broad list of products sold under the premise of being a dietary supplement (i.e., a food) but for the expressed intent of treatment or prevention of disease. The variety of claims to aid in equine joint health are often unsupported. The potential difference between a feed and a nutraceutical is that a nutraceutical is unlikely to have an established nutritive value. Feeds are required to have nutritive value and are accountable, by labeling, for these values. Joint supplements fall in between food and drug and have marketing advantages over both because they are not required to list ingredients or nutrient profiles as required by feeds, and in many cases are intended to treat or prevent disease without first undergoing proper drug approval.³