On May 19, FDA published its new expectations for the preparation of compounds from bulk active ingredients. The FDA welcomes comments by August 17, 2015. The preparation of compounds from bulk continues to be outside of the rules, per the FDA, yet the two new publications lay out activities against which FDA generally does not intend to take enforcement action. The AVMA has previously developed policies (see our Compounding page) that advocate the needed allowances for compounding in veterinary medicine. At the same time, we are reviewing the new FDA draft guidance to determine if these publications are aligned with veterinarians’ needs and AVMA’s policies.
Two draft FDA publications are available for comment:
• FDA’s Guidance For Industry #230 (also see the related Federal Register Notice) 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.
• FDA’s Federal Register Notice requesting nominations of bulk drugs would create a positive list, from which outsourcing facilities can create compounds to dispense to clients, or to veterinarians for administering in-office, in accordance with a veterinarian’s order or prescription. For nominations to be considered, the FDA requires the names of the needed drugs, as well as the specific scientific evidence that supports their safety and efficacy, among other information.
In addition to reviewing the newly proposed documents, we continue interacting with our volunteer governance groups who guide AVMA’s policy and advocacy activities. We also remain fully engaged with state and allied organizations, specialty veterinary medical organizations, veterinary pharmacists and other organizations.
Please look for additional information from us as we learn more. We plan to share more information in the future including our analysis of the guidance. We certainly welcome member ideas and feedback and we look forward to advocating for members on this critical issue.