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November 6, 2009

Compounded Drugs Have Helped Horsemen For Ages

Photo by Douglas Lees

Not Generic Drugs

Since compounded drugs and generic drugs are both cheaper than brand-name drugs, some people have the misconception that they are the same thing.

Generic drugs, however, have been through the FDA-approval process and demonstrated their bio-equivalence to the “pioneer brand-name” drug they are duplicating. The pioneer drug has undergone the research necessary to bring it to market and has undergone the scrutiny of blinded controlled studies to demonstrate safety and efficacy in accordance with federal laws. Therapeutic consistency, product quality, accurate shelf life and scientifically substantiated labeling are federally mandated on these pioneer products.

The generics are the same as the brand-name pioneer drug in dosage form, efficacy, safety, strength, route of administration, quality, and intended use, and are brought to market after the patent on the pioneer drug expires. Generic drugs and their ingredients must be manufactured under Good Manufacturing Practices in federally inspected plants, just like the pioneer approved drugs. Generic drugs can always be identified by the ANADA (abbreviated new animal drug application) number on their label.

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