Based on the recent articles in the media, there seems to be confusion about the FDA’s intent to regulate unapproved animal drugs. I’ve spent a fair bit of time discussing this with the FDA, members of the Council on Biologic and Therapeutic Agents (COBTA) and the Clinical Practitioners Advisory Committee (CPAC), pharmacists and others, and I’d like to share with you my understanding of the situation.
In general, animal drugs need to be approved by the FDA for use in animals. However, FDA can elect to not actively enforce regulations against certain unapproved drugs (called “enforcement discretion”). For example, some animal drugs are unapproved but are still manufactured using current Good Manufacturing Practices and are drug-listed with the FDA.
The FDA wants to find a way to transition certain currently unapproved animal drugs into some type of “legally marketed” category. You might wonder what drugs FDA is specifically considering for transition. We’d like to know that, too, but we do understand from the FDA that the spirit of FDA’s proposal is to legalize just those unapproved animal drugs that are manufactured using current Good Manufacturing Practices and are drug-listed with the FDA (ie, manufactured drugs like electrolytes, parenteral vitamins, and some topical treatments, which are mentioned in FDA’s proposal).
Therefore, compounded drugs you prescribe for your individual patients are not believed to be a part of this particular initiative. Please know that AVMA’s volunteer councils and committees are drafting comments on FDA’s Unapproved Animal Drugs proposal, and our comments (currently due this Friday, though we are hopeful there will be a 60-day extension of the comment period) will be focusing on the topic at hand, which is the transitioning of certain commercial-scale manufactured drugs from an “unapproved” category to a “legally marketed” one.