The Food, Drug and Cosmetic Act will require amendment to allow conditional approval, an antidote index and create an expert panel or panels for antidotes. The use of unapproved antidotes in food-producing animals must be accompanied by human food safety concerns. Compounding may be the answer for antidote availability in food-producing animals on an emergency basis when the need is great and the risk is small. While this approach for food-animals presents an alternative, it may not be practical. In reality, an INAD is required by one or more of the chemical manufactures when bulk chemicals are intended for the therapeutic use in food animals.
Some antidotes are expensive, require large amounts to treat many animals or are unstable.
Local antidote distribution sites could be established that are managed by colleges of veterinary medicine, state diagnostic laboratories or agricultural departments, state boards of veterinary medicine or veterinary associations. The advantage of antidote depots would be the availability of antidotes on a regional basis, prevent stockpiling at compounding pharmacies and ensure that antidotes would only be used for treating toxicosis. Presently, there is no single solution for increased antidote availability. Antidote availability in the future may depend upon a combination of regulatory discretion, compounding, new legislation and the establishment of antidote depots. Interested parties are encouraged to ban together in order to draft new legislation.