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Practice Tip: The Physician Labeling Rule

By Joshua G. Schiller
April 29, 2008

On June 30, 2006, new regulations governing the format and content of prescription drug labels went into effect. These changes marked the first major overhaul of drug labeling rules in more than 25 years.

The primary purpose of the changes is to make labels more accessible to practicing physicians. When the FDA first issued the rule in December 2000, it expressed concern that product labels had become too cluttered as a result of growing chemical complexity of drugs and the effects of product liability litigation. The new label, including a 'highlights' section, a table of contents, and a streamlined adverse reaction section, is designed to return the product label to its originally intended purpose as a useful and clear tool for practicing physicians.

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