FDA antibiotic regulations for pork producers

FDA antibiotic regulations 

In January 2017 the U.S. Food and Drug Administration (FDA) implemented Guidance for Industry (GFI) #213 which changed Over-the-Counter (OTC) medically important antimicrobials used in feed or drinking water of livestock to Veterinary Feed Directives (VFD) or prescription marketing status. In January 2017, the FDA also changed regulations for on-farm antibiotic use in food-animal production. These changes were to

• Stop the use of medically important antibiotics for growth promotion in food-animal production.
  • “Medically important” refers to antibiotics used in human or animal medicine, or antibiotics in the same family of those medications.
• Bring therapeutic use of antibiotics in feed and water – to treat, control, or prevent specific diseases – under additional veterinary oversight.

In June 2023 the FDA implemented GFI #263, which encourages drug companies of medically important antimicrobial drugs approved for use in animals to voluntarily bring over-the-counter (OTC) antibiotics under veterinary oversight by labeling them as prescription (Rx). This means veterinary oversight increased for the remaining therapeutic applications of treatment, control, and prevention.

GFI #213 made this apply to both in-feed and water-delivered antibiotics. With GFI #263 this now also applies to injectable medications too.

Regulations

• Medically important antibiotics are only for therapeutic use.
  • Non-therapeutic use of medically important antibiotics isn’t allowed.
  • Antibiotics aren’t labeled for growth promotion.
• Veterinary oversight increased for the therapeutic use of both in-feed and water-delivered antibiotics.
• OTC use of medically important antibiotics for mass medication (feed or water) is not allowed.
  • You need a veterinary feed directive to purchase medicated feed.
  • You need a prescription to purchase water medication.
• You must follow the manufacturers’ labels on in-feed medications. You can’t use medicated feed in an extra-label fashion.

How are producers affected?

Producers will need to have a veterinary-client-patient relationship to obtain VFDs, water medications, or injectable antibiotics through their veterinarian. 

What is a veterinarian-client-patient relationship (VCPR)?

A veterinarian-client-patient relationship is commonly referred to as a VCPR. A VCPR can be defined by each state. Each state can define a VCPR differently. Minnesota’s VCPR requirements match the federal requirements. The federal minimum requirements state:

• The producer must work with a veterinarian to accept responsibility for making clinical decisions about the animals’ health.
• The veterinarian must examine the animals or visit the facility to gain knowledge of the animals.
• The veterinarian must be available to provide needed follow-up exams or care.

Veterinary feed directives

A VFD is a written statement by a licensed veterinarian, that allows VFD medication use in an animal feed. A veterinarian must fill out the VFD form correctly and send a copy to the producer and feed mill.

Rules for VFDs

• Keep records for 2 years.
• Have documentation: original, email, or fax is okay.
• Don’t practice extra-label use.
• Order for approximate number of animals or days to feed.
• Don’t refill unless it’s on the label.
• Can be written for multiple premises if the pigs are under the same ownership and fed by the same mill.
• A State/Federal VFD is required.
• VFD expires within 6 months of when it was issued.  

Impacts on on-farm feed manufacturers

Producers with on-farm feed mills that only mix for themselves must give distributors a VFD when buying their medicated ingredients. Producers need to have a current VFD on file to feed the medicated feed to their pigs.

Producers mixing feed to give away or sell are distributors and must submit a one-time acknowledgement letter to the FDA. Keep the letter on file and have a current VFD for every batch of medicated feed.

Record keeping of medications

The FDA encourages all livestock producers to maintain records of all medications, including vaccinations given to an animal. Medication and treatment records are a good way to know which animals were treated, which drug was given, how it was given, and when the withdrawal period ends.

Records that adequately document an animal’s treatment history are an excellent way to prevent illegal drug residues and ensure food safety by knowing withdrawal periods have ended.

Knowing when a withdrawal period ends is important so that producers know when drug residues have dropped below the tolerance levels and the meat or milk products of animals are safe for consumption.

It is illegal for a producer to send an animal to slaughter for food consumption or sell milk when the withdrawal period has not ended.

The treatment records for livestock should include:

• Name of the drug used.
• Identity of the animal treated (pigs can be identified individually or by pens).
• Date the drug was administered, each day if drug is administered more than once.
• Total dose given.
• How the drug was given (intramuscular, orally, topically, etc.).
• Name of the person who gave the drug.
• Length of the withdrawal period.
• Date the withdrawal period ends.

VFD records are to be kept for 2 years and other medication records are to be kept for 1 year. Records can be kept either on paper or in electronic form. Medication record templates can be found on the National Pork Board’s website along with other Pork Quality Assurance (PQA) materials.