BY: SAMANTHA BARTLETT, DVM
The Federal Drug Administration’s (FDA) Center for Veterinary Medicine (CVM) has released new guidance regarding the compounding of drugs from bulk substances for veterinary use. Guidance for Industry (GFI) #256, Compounding Animal Drugs from Bulk Drug Substances, is intended to provide more clarification on using compounded drugs for veterinary use. The FDA CVM recognizes that there are many cases where established drug products will not work for a specific patient or condition and that the ability of veterinarians to obtain drugs compounded from bulk substances is vital to protect animal health.
Compounding is the process in which ingredients are combined, mixed or altered in an effort to tailor medication to the needs of an individual or small group of animals to treat a specific health condition. The FDA has already approved compounding of medication using approved drugs, however compounding with bulk substances is not approved by the FDA. These medications have not been evaluated for safety, efficacy or consistency and the label has not been verified as accurate and complete.
Essentially, the new guidance provides flexibility for pharmacists and veterinarians to compound animal drugs for individual patients or as needed for immediate or emergency use to keep as “office stock”, identifies safety issues that may arise with compounding medications, indicates types of animal drugs from bulk substances that pos risk to human and animal health and prioritizes these drugs for enforcement action. The guidance also indicates that enforcement action will be conducted for compounded drugs made with poor compounding practices as well as drugs that are copies of FDA-approved or indexed drugs on the market.
The agency intends to conduct outreach and guidance prior to implementing and enforcing the new guidance in fiscal year 2023. The FDA has created a reference library that includes information handouts for veterinarians and pharmacists and a webinar explaining the new guidance. Additional questions can be directed to the agency by email at AskCVM@fda.hhs.gov.
The AVMA has also published information to help understand the new guidance at https://www.avma.org/resources-tools/animal-health-and-welfare/animal-health/compounding/compounding-bulk-drug-substances.
