QCS Session #7 - API or Approved Product: Where do we start with veterinary compounds?

The FDA Center for Veterinary Medicine currently considers any compound prepared from active pharmaceutical ingredients to be a New Animal Drug subject to all statutory requirements for manufactured pharmaceuticals. In 1996, FDA began interpreting the extra label drug use provisions of the Animal Medicinal Drug Use Clarification Act to permit use of approved FDA products as starting ingredients when compounding but held strong to the interpretation that bulk drug substances could not legally be used to prepare a compound for use in animals. Unfortunately, using an FDA approved product as a component of a compound is not always possible and is often problematic even if an approved product is available. This presentation reviews the advantages and disadvantages of using approved products versus active pharmaceutical ingredients in preparing veterinary compounds and will outline a decision-making approach for pharmacists and pharmacy technicians in selecting components that will result in preparations of optimal quality.