The U.S. Food and Drug Administration (FDA) issued an update guidance, titled Compounding Animal Drugs from Bulk Drug Substances. This guidance is a continuation of the FDA’s practice of exercising enforcement discretion with regard to animal drug compounding from bulk drug substances in certain situations. It is intended to provide additional clarity and details about FDA’s current thinking on this topic.
Who is this guidance intended for?
This guidance is intended for veterinarians, State-licensed pharmacies, and Federal facilities interested in compounding animal drugs from bulk drug substances for use in nonfood-producing animals.
What issues does the guidance address?
The guidance examines:
- The types of drugs compounded from bulk drug substances that FDA has determined present the greatest risk to human and animal health.
- The circumstances under which FDA does not generally intend to take enforcement action for violations of the FD&C Act’s requirements fro cGMP and more.
View the official guidance page for a detailed summary and to download the complete guidance document.