A move by the U.S. Food and Drug Administration (FDA) will change the status of over-the-counter “medically important” antimicrobial drugs used in animals to prescription (Rx) use only. The FDA’s Guidance for Industry #263 goes into effect on June 11, 2023. If you have a valid veterinary-client-patient relationship with your veterinarian, you will still have access to products. These animal products can still be purchased from your veterinarian or a distributor. If you don’t have a relationship with a licensed veterinarian, you won’t be able to purchase such products, many of which have long been available over the counter at your local co-op and farm supply store. Nebraska Farm Bureau spoke to Dr. Bill Flynn, DVM, MS, deputy director for the Center for Veterinary Medicine at the U.S. Food and Drug Administration, to walk through the process and answer questions farmers and ranchers might have about the new rule.
Q1. Dr. Flynn, can you walk us through a few of the basics of the new guidance coming from the FDA.
A1. On September 14, 2018, FDA unveiled a 5-year action plan for supporting antimicrobial stewardship in
veterinary settings. This plan builds upon the important steps the Center for Veterinary Medicine (CVM) has already taken to support the judicious use of antimicrobials in animals and is driven by the concept that medically important antimicrobial drugs should only be used in animals when necessary for the treatment, control or prevention of specific diseases. One action item included in this plan is to ensure that any medically important antimicrobial new animal drugs that continue to remain available as OTC products are brought under the oversight of licensed veterinarians. The purpose of this guidance is to provide sponsors with specific recommendations on how to facilitate voluntary changes to the approved conditions of use of these drugs to prescription marketing status. The voluntary process outlined in this guidance will help to ensure new animal drugs containing antimicrobials of human importance are administered only under veterinary oversight and only for therapeutic uses.
GFI #263 had a two-year implementation period that began June 11, 2021. At that time and within the GFI,
FDA stated its expectation that sponsors of affected products would convert the marketing status of medically
important antimicrobial that are available over-the-counter (OTC) to prescription (Rx) status and include
an Rx statement on the label.
Q2. What animals and products will be affected by this new guidance?
A2. Cattle, swine, poultry, small ruminants, equine, cats and dogs.
The list of approved new animal drug applications affected by GFI #263 is available on the FDA website. More information on specific products can be found by searching the application number on AnimalDrugs@FDA.
To help provide species specific information for the impacted products, FDA also created the following brochures:
- Antibiotic Stewardship in Beef and Dairy Cattle
- Antibiotic Stewardship in Poultry
- Antibiotic Stewardship in Sheep and Goats
Q3. Will a veterinarian be required to physically examine and/or personally administer the antibiotic to each animal?
A3. Although specific requirements vary by state, veterinarians are generally not required to examine each individual animal for which a prescription is issued, nor do they necessarily need to personally administer the treatment, as long as the veterinarian has established a valid VCPR with the farmer or rancher that owns or cares for the animal(s) in need of treatment.
Establishing a VCPR generally requires, among other things, that the veterinarian has become familiar with the
management of the animals on a given farm or ranch by examining the animals and/or visiting the facility where
the animals are managed.
Q4. Will livestock producers still be able to buy larger quantities of antibiotics in order to have them on hand?
A4. The prescription provided by the veterinarian, in the context of a valid VCPR, will include the quantity
and directions for use.
Veterinarians have specialized training and experience. Sometimes antimicrobial drugs may not be necessary for proper treatment or a different antimicrobial may be a better tool than the one you’re used to using. Providing animals with the most appropriate antimicrobial is more likely to effectively resolve the infection and reduce the need for repeated or extended courses of antimicrobial therapy. This will not only help to reduce AMR risks, but will help to ensure better health outcomes for animals and can also save time and money.
Creating a relationship with a veterinarian before livestock are sick will allow producers to develop a plan tailored to their livestock. Planning ahead with a veterinarian will ensure that producers can have the necessary products on hand to care for their livestock in a timely manner.
Q5. What are some steps livestock producers should take as we approach the deadline for this new guidance?
A5. Farmers and ranchers may want to consult with their veterinarian in advance of June 2023 to have a plan in place prior to the transition period, including a plan for getting access to appropriate antimicrobial products to address animal health issues when a veterinary visit is not feasible or not considered necessary by the veterinarian.