SWINE&U

SWINE & U

On June 11, the U.S. Food and Drug Administration implemented Guidance for Industry #263. Drug companies which manufacture over the counter antibiotics under veterinary oversight are now labeling them as prescription. What this means is many livestock antibiotics that were available over the counter will now be prescription medications. The affected antibiotics will still be available to livestock producers, but producers must work with their veterinarian to obtain a prescription.

By Sarah Schieck Boelke

Veterinary oversight increased for the remaining therapeutic applications of treatment, control and prevention. This applies to both in-feed and water-delivered antibiotics. With GFI #263 this now also applies to injectable medications.

Over-the-counter usage of medically important antibiotics used in mass medication (feed or water) were eliminated. A veterinary feed directive is needed to purchase medicated feed and a prescription is needed to purchase water medication.

Medicated feed cannot be used in an extra-label fashion, so manufacturers’ labels on in-feed medications must be followed.

animals were treated, which drug was given, how it was given, and when the withdrawal period ends. Records which 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 to know that drug residues have dropped below the tolerance levels; and the meat or milk products are safe for consumption. It is illegal for a producer to send an animal to slaughter for food consumption, or sell milk, if the withdrawal period has not ended.

one year. Records can be kept either on paper or electronic farm. Medication record templates, along with other Pork Quality Assurance materials, can be found on National Pork Board’s website www.porkcheckoff.org/ pqa.

Using antibiotics responsibly

When producers get certified in Pork Quality Assurance, they learn how to use antibiotics responsibly. There are five principles to guide producers in using antibiotics responsibly to ensure both swine and public health.

You might be asking yourself, what does medically important mean? An antibiotic is considered medically important if it is used, or antibiotics in the same family of medications are used, in human or animal medicine.

FDA believes good antibiotic use in animals helps slow the development of antimicrobial resistance and preserve the effectiveness of these drugs for both humans and animals.

Current antibiotic regulations

FDA GFI #263 is part of FDA’s fiveyear plan for supporting antimicrobial stewardship in veterinary settings. In January 2017, GFI #213 was successfully implemented, with over the counter medically important antimicrobials used in feed or drinking water of livestock changed to veterinary feed directive — or prescription marketing status.

Medically important antibiotics are limited to the therapeutic purposes of treatment, control and prevention of specific diseases.

Non-therapeutic use of medically important antibiotics is not permitted. Antibiotics are no longer labeled for growth promotion.

Producers will need to have a veterinary-client-patient relationship to obtain a prescription for injectable antibiotics through their veterinarian. This is similar to how producers currently work with their veterinarians to obtain veterinary feed directives and antibiotics delivered through the water as outlined in GFI #213.

A veterinarian-client-patient relationship is commonly referred to as a VCPR. A VCPR can be defined by each state. Federal minimum requirements state a veterinarian must be engaged with producers to assume responsibility for making clinical judgements about the animals’ health in the producers’ herds. The veterinarian must have sufficient knowledge of the animals by examination of the animals or visits to the facility where the animals are managed — or both. The veterinarian must be available to provide any needed follow-up evaluation or care. Minnesota’s VCPR requirements align with the federal requirements mentioned. Record keeping of medications. FDA encourages all livestock producers to maintain records of all medications — including vaccinations given to an animal. Medication/treatment records are a good way to know which

The treatment records for livestock should include the name of the drug used; identity of the animal treated (pigs can be identified individually or by pens); the date the drug was administered (each day if drug is administered more than once); and the total dose given. Record must also show how the drug was given (example: intramuscular, orally or topically); the name of the person who gave the drug; the length of the withdrawal period; and the date the withdrawal period ends.

Veterinary feed directive records are to be kept for two years and other medication records are to be kept for

Principle 1 — Take appropriate steps to decrease the need for the application of antibiotics. Having and implementing a herd health plan is key to maintaining animal health and productivity. A herd health plan should include preventive strategies, such as biosecurity programs, appropriate animal husbandry, including proper ventilation and nutrition, hygiene, routine health monitoring and vaccination programs, for keeping pig healthy and decreasing the need for antibiotics.

Principle 2 — Assess the advantages and disadvantages of all antibiotic uses. The advantages and disadvantages of antibiotic use that producers should consider include animal health, welfare, environment, food safety, and economic impact. If antibiotics are used, producers should minimize the use by treating only those animals that need treatment for the length of