Professor Oklahoma State University Stillwater, Oklahoma, United States
Disclosure(s):
Lara K. Maxwell, DVM, PhD, DACVCP: No financial relationships to disclose
After years of discussion between regulatory agencies, pharmacies, veterinarians, and various advocates, the legal and ethical issues surrounding the safe and effective use of compounded drugs has recently been clarified by new law and FDA guidance. An outbreak of fungal meningitis in people associated with an injectable, compounded steroid led directly to the Drug Quality and Security Act (DQSA)in 2013. The DQSA transformed the compounding of drugs for people, establishing separate 503A and 503B facilities. Although the term “503B” is now used by some veterinary compounding pharmacies, DQSA does not apply to veterinary practice. However, the FDA subsequently issued Guidance for Industry (GFI) 256, which provided enforcement discretion in allowing animal drug compounding from bulk substances and went into effect in 2023. This talk will consider how these compounding guidelines affect equine practice. We will also discuss the currently ubiquitous online pharmacies that purport to sell unapproved animal drugs and foreign animal drugs. Although this discussion is equine focused, the concepts are broadly applicable to all veterinary species.
Learning Objectives:
Determine how the Drug Quality and Security Act and Guidance for Industry 256 apply to different categories of compounded equine drugs.
Identify how the term “unapproved animal drug” applies to different equine medications.
Recognize red flags that suggest that an online pharmacy might not be following legal and ethical guidelines.
