Interesting Facts About the Orange Book


The Approved Drug Products with Therapeutic Equivalence Evaluations is commonly known as the Orange Book.

The Orange Book is an important publication published by the FDA that serves as the gold standard reference for generic drug substitution. The full publication title is Approved Drug Products with Therapeutic Equivalence Evaluations, but it is commonly known as the Orange Book.1 Generic substitution laws are state specific and many require use of the Orange Book as a reference.

Here are 4 interesting facts about the Orange Book:

1. The Orange Book name can be attributed to the Halloween holiday.

The first print publication occurred October 1980, and the color orange was selected since it was almost Halloween. Donald Hare, a pharmacist who previously worked at the FDA is commonly referred to as 'the father of the Orange Book' and helped to select the book color. I have always found this bit of trivia fascinating and have discussed the naming history during my drug information class.

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