When is Compounding for Animals Legal?
Author(s): Siegner A Wes Jr
Issue: May/Jun 1999 - Compounding for Animals
View All Articles in Issue
Page(s): 188-191
Download in electronic PDF format for $75
Abstract: Compounding for animals is subject to very different and more restrictive federal requirements than is compounding for humans. The author, an attorney, discusses federal regulations, compounding to treat animals using approved human and animal drugs, and compounding with unapproved bulk drugs to treat animals. He concludes that pharmacists who follow the legal requirements and guidelines that apply to compounding drugs for humans when compounding for animals are asking for trouble with the US Food and Drug Administration. The legal requirements and US Food and Drug Administration policies for compounding drugs for animals are very different from, and more restrictive than, human requirements and policies. Reading the regulations and guidance that apply to animal compounding is essential to avoid regulatory problems.
Related Keywords: FDA, law, federal requirements, legal, animal compounding, animal drugs, regulations, bulk drugs, extralabel use, food-producing animals