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Why veterinarians are deeply concerned about FDA's proposed guidance for Industry (GFI) for Compounding Animal Drugs from Bulk Substances.
2015 survey of veterinarians shows that proposed FDA guidance on the use of medications that are “very important” to their practices and to patients’ medical outcome would have a large negative impact on them and their patients.
FDA is regulating the practice of veterinary medicine via the GFI, which it is not authorized, or qualified, to do.
- The GFI requires veterinarians to justify, in writing, why they want to use a compounded medication, by documenting on the prescription that:
- There is a “clinical need” to treat a certain animal with a certain compounded medication;
- There is no FDA approved drug that can be prescribed off label to treat the condition for which the veterinarian is prescribing the drug; and
- The patient is not a food producing animal.
- The GFI mandates that veterinarians include on their prescriptions a citation to a section of the Food Drug Cosmetic Act (FDCA) and its accompanying regulations.
- FDA could disagree with a veterinarian’s determination that there is a clinical need to treat a certain animal with compounded medications OR that there is no FDA approved drug that can be prescribed off label to treat the condition.
- Veterinarians are the only practitioners who FDA has singled out and required to justify, in writing on their prescriptions, why they are using compounded medications to treat their patients.
The GFI is an unprecedented and dangerous intrusion into the state regulated practice of veterinary medicine.
- The GFI limits a veterinarian’s ability to treat by prohibiting compounding pharmacies from providing veterinarians with office stock.
- Most states allow compounding pharmacies to compound animal drugs for veterinarians to have on hand to use in their practice.
- Veterinary clinics often act as emergency rooms and hospitals for animals making office stock critical to animal health.
- Manufactured drugs are often not suitable to treat animal patients, and certain compounded medications must be immediately available to prevent unnecessary animal suffering and ensure positive health outcomes for animals.
- The GFI limits a veterinarian’s ability to treat by prohibiting veterinarians from dispensing compounded medications
- As it is the standard of care, state veterinary practice acts specifically include dispensing of medication as part of the practice of veterinary medicine.
- Veterinarians with ambulatory practices that travel to a farm, stable, ranch or zoo need the ability to dispense compounded medications.
Via the GFI, FDA is bullying veterinarians and second guessing their medical judgment.
- The prescription requirements are intimidating, and require a working knowledge of the FDCA.
- The GFI intrudes on the state regulated practice of medicine by limiting access to office stock and prohibiting veterinarians from dispensing compounded drugs.
- The treating veterinarian—not FDA—is in the best position to determine how to treat her animal patients.
- By prohibiting veterinarians access to all medication required to treat animals, the GFI will cause the treating veterinarian to patch together a suboptimal treatment plan.