We understand that the legality of FDA’s regulation of veterinary compounding is and has been questioned. But what we’re focused on right now is the need to weigh in on and help shape the FDA’s new Guidance for Industry and its intent to create a positive bulk API list. What we can’t afford to do is dig in our heels and refuse to provide input. We don’t want to miss the opportunity to help shape the guidance and protect the profession’s access to as many necessary medications as we can. We’ve asked for an extension of the comment period for the solicitation of bulk drug substance nominations, and we are eager to hear whether our request has been approved.
We’re fully aware of the burdens and potential negative impact that the proposed guidance could create for veterinarians, and we’re aggressively pursuing the issue. What we need from our members right now is the following:
- A list of the most commonly used compounded medications in your clinic and why they are medically necessary, in which species, and for what conditions.
- Suggestions for inclusion on the list (and “every possible bulk ingredient” is not useful to the effort), and justification for their inclusion.
- Any scientific evidence of safety and efficacy of the products proposed, such as peer-reviewed literature.
We fully intend to continue advocating for our profession’s access to critical medications. But part of that is the need to work within the existing system, including participation in the federal public comment opportunities, in order to make effective and efficient progress. Please provide us with information that we can use to advocate effectively and prevent the loss of access to these products.