A review of FDA antibiotic guidelines

As the cattle industry continues to focus on beef quality and increasing consumer acceptance and demand for beef, it's critical for producers to understand the importance of following Food and Drug Administration (FDA) guidelines when administering antibiotics. There's also a need to understand the consequences and risks if regulations are violated. The ultimate risk is consumer fear and a reduction in beef demand.

“In the age of immediate digital communications and media, a single news event of the inappropriate or violated use of antibiotics in beef production can lead to millions of dollars of damage to consumer demand,” says Mitch Johnson, Shawnee Mission, KS. He's a livestock product manager for Bayer Corporation. “It's critical to our industry that veterinarians and producers understand the overall FDA guidelines for antibiotic usage and adhere to these regulations.”

Key FDA regulations and discussion points:

Veterinary client patient relationship (VCPR):

  • A VCPR must be in place for a cattle producer to purchase and use a prescription antibiotic.

  • There are general guidelines which describe what constitutes a VCPR.

Extra label drug use:

  • A veterinarian, under certain circumstances, may prescribe an antibiotic for food animal production different from its FDA label use requirements. Certain requirements must be met (e.g., establishing proper withdrawal times for meat and milk) in order to prescribe extra label drug use.

  • Extra label drug use is prohibited for some antibiotics.

  • A producer may be violating extra label drug laws by purchasing an over-the-counter antibiotic and using in an off-label manner (e.g., administering penicillin at twice the labeled dosage level).

Purchasing and using adulterated antibiotics (e.g. illegal compounded products):

  • Use of compounded antibiotics in food producing animals, is strictly regulated under the FDA's AMDUCA(Animal Medicinal Drug Use Clarification Act).

  • “Compounded” antibiotics are often produced in violation of FDA manufacturing and regulatory requirements and they can have significant risks of causing injury to the animal and may cause residues in milk and tissue in violation of FDA laws.

Emerging Diseases And The Vet Profession

Of all “emerging” human infections, 80% are animal based — and confined animals are of particular concern to sleuthing out viral diseases. This underscores the significance of the veterinary profession as a key player in collaborative research associated with the threats of bioterrorism and emerging infectious diseases.

Outlined in the Centers for Disease Control's (CDC) working paper “Influenza Pandemics: How They Start, How They Spread and Their Potential Impact,” the reservoir for Type A influenza viruses is wild birds, but influenza A viruses also infect animals such as pigs and horses, as well as people.

The last two pandemic viruses were combinations of bird and human influenza viruses. Many believe that these new viruses emerged when an intermediate host, such as a pig, was infected by both human and bird influenza A viruses simultaneously. Thus, a new virus was created.

Events in Hong Kong in 1997, however, showed that this is not the only way that humans can become infected with a novel virus. Sometimes, an influenza virus can “jump the species barrier” and move directly from animals to humans and cause disease, says the CDC.

This discussion has redirected attention to the importance of veterinarians in all phases of preparedness, planning and response to bioterrorism/emerging infectious disease initiatives. International dialogue regarding the veterinary profession as a lead in identifying emerging diseases is needed to bridge one of the most serious gaps associated with current unmet needs, says the CDC.

At an International Conference on Emerging Infectious Diseases, the U.S. Agency for International Development (USAID), World Health Organization (WHO) and other international organizations were encouraged to join forces with the veterinary community. CDC says the veterinary educational model, which looks at populations rather than individual patients, might serve as a model for the medical community.