The AVMA needs our members’ help in developing a response to U.S. Food and Drug Administration’s (FDA) draft guidance that could substantively impact veterinarians’ abilities to use compounded medications. We ask that you please respond to a short questionnaire that we emailed Thursday to members so we can better understand your compounding needs.
Why is this happening now? Well, for several years, the AVMA has been in discussions with the FDA on the need for veterinarians to compound from bulk drug substances to care for our animal patients. Following a severe outbreak of fungal meningitis, which infected over 700 Americans and killed 64, Congress in 2013 enacted the Drug Quality and Security Act. The law significantly changed how compounding is done for humans – and while the legislation only targeted human healthcare, the FDA has now published draft Guidance For Industry #230, which would modify FDA’s enforcement activities related to animal compounding, to bring it more in line with those for humans.
The FDA’s draft guidance outlines a framework for the agency to use enforcement discretion for the compounding of animal drugs from “bulk drug substances.” Bulk drug substances are the active pharmaceutical ingredients used to manufacture drug products or for the preparation of compounded medications; the term “bulk” does not refer to the quantity of the substance.
The FDA contends that all compounding from bulk drug substances is illegal. This new guidance lays out specific provisions for compounding by: state-licensed pharmacies, licensed veterinarians, and a new category of facilities termed “outsourcing facilities.” Created for human healthcare as part of the 2013 Drug Quality and Security Act, outsourcing facilities are required to register with the FDA and meet current good manufacturing practices. Most importantly for the veterinary profession, these facilities would be the sources for office stock of preparations compounded from bulk drug substances for emergent needs. Per the draft guidance, outsourcing facilities would only be allowed to use bulk drug substances included in a list FDA is currently developing.
Thank you, in advance, for completing the survey questionnaire that we emailed to members, providing information that will assist us in responding to the FDA in a way that supports your ability to provide quality care for your animal patients.
For more information on veterinary drug compounding and the FDA’s draft guidance, visit avma.org/compounding.