Question of the Day September 13, 2015 In May, 2015, FDA issued Draft Guidance #230 titled, Compounding Animal Drugs from Bulk Drug Substances, which “Contains Nonbinding Recommendations." Did the FDA just set up the perfect situation for resolving the issue of whether it has authority to regulate animal drug compounding? If challenged in court and the FDA wins, no action by Congress is needed. If challenged in court and the FDA loses, the FDA has a strong chance of getting Congress to act. If challenged in court and the FDA loses and Congress fails to act, then the FDA is off the hook if another incident like the polo pony incident occurs. What are the odds that someone in the compounding industry will challenge in court this new guidance?