By Sarah Schieck Boelke, UMN Extension Swine Educator
Originally printed in The LAND - as the July 7, 2023 Swine & U Column
Have you noticed any changes with injectable medications that you previously bought for your pigs or other livestock at your local farm supply store? If you haven’t, you will notice these changes the next time you want to purchase an injectable antibiotic for your pigs from a farm supply store. Especially if these antibiotics are considered medically important. The reason is because on June 11, 2023, the U.S Food and Drug Administration (FDA) implemented Guidance for Industry (GFI) #263, which has 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). What this means is many livestock antibiotics that were OTC 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.
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.
Knowing when a withdrawal period end is important so that producers know that drug residues have dropped below the tolerance levels and the meat, or milk products if a dairy animal, 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.
The treatment records for livestock should include:
Sarah Schieck Boelke is a UMN Extension Swine Educator based in Willmar. She can be reached at schi0466@umn.edu or 320-235-0726 ext. 2004.
Originally printed in The LAND - as the July 7, 2023 Swine & U Column
Have you noticed any changes with injectable medications that you previously bought for your pigs or other livestock at your local farm supply store? If you haven’t, you will notice these changes the next time you want to purchase an injectable antibiotic for your pigs from a farm supply store. Especially if these antibiotics are considered medically important. The reason is because on June 11, 2023, the U.S Food and Drug Administration (FDA) implemented Guidance for Industry (GFI) #263, which has 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). What this means is many livestock antibiotics that were OTC 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.
What does “medically important” mean?
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 five-year plan for supporting antimicrobial stewardship in veterinary settings. In January 2017 GFI #213 was successfully implemented, with OTC medically important antimicrobials used in feed or drinking water of livestock changed to Veterinary Feed Directive (VFD) or prescription marketing status. In January 2017 FDA also made the following changes:- 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.
- 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 VFD is needed to purchase medicated feed and a Rx 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.
How are producers affected?
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 VFD’s and antibiotics delivered through the water as outlined in GFI #213 implemented in January 2017.What does it mean to have a Veterinarian-Client-Patient Relationship?
A veterinarian-client-patient relationship is commonly referred to as a VCPR. A VCPR can be defined by each state. Federal minimum requirements state that 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 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 end is important so that producers know that drug residues have dropped below the tolerance levels and the meat, or milk products if a dairy animal, 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.
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 (example, intramuscular, orally, or topically)
- Name of the person who gave the drug.
- Length of the withdrawal period
- Date the withdrawal period ends.
Principles for using antibiotics responsibly.
When producers get certified in Pork Quality Assurance (PQA) 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.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 time needed for the desired clinical response.Principle 3: Use antibiotics only when they provide measurable benefits.
The FDA approves products based on their safety and efficacy. The agency also considers the risk to public health from antibiotic resistant bacteria. The producer must assess the potential economic benefits for the farm when considering antibiotic use. Benefits such as reduced mortality, morbidity and improved animal welfare.Principle 4: Fully implement management practices for responsible use of animal-health products into daily operations.
Keeping medication records is a good way to ensure antibiotics are being used correctly on the farm.Principle 5: Maintain a working veterinary-client-patient relationship.
A veterinarian should help a producer develop a herd health plan for the farm and assist the farm in all medication decision-making.Guidelines to help producers when using antibiotics.
The National Pork Board has developed six guidelines to help producers, in consultation with a veterinarian, to use antibiotics responsibly.- Guideline 1: Use professional veterinary input as the basis for all antibiotic decision-making.
- Guideline 2: Antibiotics should be used for prevention, control, or treatment only when there is an appropriate clinical diagnosis or herd history to justify their use.
- Guideline 3: Limit antibiotic use for prevention, control, or treatment to ill or at-risk animals, treating the fewest animals indicated.
- Guideline 4: Antibiotics that are important in treating infections in human or veterinary medicine should be used in animals only after careful review and reasonable justification.
- Guideline 5: Mixing together injectable or water medications, including antibiotics, by producers is illegal.
- Guideline 6: Minimize environmental exposure through proper handling and disposal of all animal health products, including antibiotics.
Other strategies to keep pigs healthy.
Responsible antibiotic use is just one part of a farm’s whole herd health management plan. The other management strategies that farms should include to keep their pigs healthy include:Biosecurity - prevent diseases from entering the herd or transmitting from the herd to another barn or neighboring site of pigs.
- Know that the movement of people, pigs, vehicles, and other equipment can carry diseases from one barn to another and from one farm site to another.
- Thoroughly clean, disinfect and dry facilities/rooms between pig groups. This includes feeders, waterers, and other equipment that is used. Also clean, disinfect and dry vehicles and equipment that goes from one pig site to another.
Vaccinations - successful vaccination programs depend on targeted use of vaccines at the right time for the right health concern.
- Producers should work with their veterinarian to create a vaccination program that is customized for their herd to help control and prevent diseases.
- Use diagnostics to confirm health issues.
- Always use vaccines according to label directions
- Properly store and handle vaccines to ensure viability.
- Watch labels for expiration dates.
Environment – provide pigs with the proper environment needed for their age, weight, and stocking density.
- Manage barn temperature to meet the pigs’ needs at their given age and weight.
- Adjust ventilation systems to manage air flow and humidity levels to provide fresh air.
- Eliminate drafts.
Management - consider making management changes to reduce the need for antibiotic use.
- Producers should consider weaning pigs at an appropriate age for their production system. The appropriate weaning age will vary between farms because of differences in genetics, nutrition programs, health status, management, and housing types.
Other disease strategies - work closely with a veterinarian to see where other strategies can help manage overall pig health.
- A veterinarian can assist in developing strategies to reduce disease risk through pig flows, herd health monitoring, disease surveillance and appropriate diagnostics.
Sources and additional resources
- Food and Drug Administration - https://www.fda.gov/animal-veterinary/news-events/cvm-updates
- National Pork Board – www.porkcheckoff.org/pqa and www.porkcheckoff.org/antibiotics
Sarah Schieck Boelke is a UMN Extension Swine Educator based in Willmar. She can be reached at schi0466@umn.edu or 320-235-0726 ext. 2004.
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