FDA Releases Draft Guidance on Animal Drug Compounding

The document is designed to help ensure compounded drugs are available when appropriately prescribed by a veterinarian.
Share
Favorite
Close

No account yet? Register

ADVERTISEMENT

As part of its overall efforts to address compounded drugs, the U.S. Food and Drug Administration (FDA) released a draft “Guidance for Industry (GFI) #230, Compounding Animal Drugs from Bulk Drug Substances,” on May 18.

Current law does not permit compounding of animal drugs from bulk drug substances, but the FDA recognizes that there are limited circumstances when an animal drug compounded from bulk drug substances could be an appropriate treatment option. The FDA’s GFI #230 outlines specific conditions under which the agency generally does not intend to take action against state-licensed pharmacies, veterinarians, and facilities registered as outsourcing facilities when drugs are compounded for animals from bulk drug substances.

The Drug Quality and Security Act, which amended the human drug compounding provisions in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and created a new section 503B of the FD&C Act for outsourcing facilities, provides certain statutory exemptions for compounded human drugs, but the law does not apply to drugs compounded for animal use.

There are circumstances where there is no approved drug that can be used or modified through compounding to treat a particular animal with a particular condition. In those limited situations, an animal drug compounded from bulk drug substances can be an appropriate treatment option

Create a free account with TheHorse.com to view this content.

TheHorse.com is home to thousands of free articles about horse health care. In order to access some of our exclusive free content, you must be signed into TheHorse.com.

Start your free account today!

Already have an account?
and continue reading.

Share

Written by:

Related Articles

Stay on top of the most recent Horse Health news with

FREE weekly newsletters from TheHorse.com

Sponsored Content

Weekly Poll

sponsored by:

Where do you primarily feed your horse?
287 votes · 287 answers

Readers’ Most Popular

Sign In

Don’t have an account? Register for a FREE account here.

Need to update your account?

You need to be logged in to fill out this form

Create a free account with TheHorse.com!