Showing posts with label Compounded Drugs. Show all posts
Showing posts with label Compounded Drugs. Show all posts

Wednesday, May 7, 2014

The Merck Veterinary Manual: Extra-Label Drug Use, Compounded Drugs, and Generic Drugs

A new animal drug (NAD) is “any drug intended for use in animals other than man... not recognized... as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling....” A drug's label includes the label on the product as well as any accompanying material in or on the package. A prescription drug is defined by whether or not adequate directions can be prepared for use of the drug by a layperson. Any drug for which this is possible must be sold as an over-the-counter preparation; any other product is a prescription product.

To use a NAD in a legal manner, the veterinarian must adhere to the specifications noted on the label. Otherwise, the drug is used in an extra-label manner. Extra-label drug use, whether actual or intended, occurs when the drug is used in a manner that is not in accordance with the approved label directions. This includes but is not limited to a different dosage, interval, route, indication, or species
 
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