Ready for Guidance #263? New antibiotics regs kick in this week

By Teodora Lyubomirova

- Last updated on GMT

Getty/Monty Rakusen
Getty/Monty Rakusen

Related tags antibiotic reduction Antibiotic resistance Fda Antimicrobial resistance Antibiotics Livestock

Medically important antimicrobial drugs should be labeled as prescription products from June 11, 2023, as part of FDA efforts to improve antimicrobial stewardship and slow the development of antimicrobial resistance.

The Food and Drug Administration has said that while sales data on antimicrobials sold or distributed for use in food-producing animals does not necessarily reflect actual usage, but that sales volume can be a key indicator of market trends.

The latest FDA's most recent report covering year 2021 shows that domestic sales and distribution of antibiotics for use on food-producing animals has decreased by less than 1% year on year, though compared to 2015 – a peak year of sales – the decrease was 38%.

The Natural Resources Defense Council is a non-profit environmental advocacy group that analyzes the use of antibiotics in the US livestock sector. The NPO states that as a whole, the US sector continues to uses a higher amount of antibiotics compared to Europe. “We found the intensity of livestock antibiotic use for 2020 was nearly twice as high in the US (170.8mg/kg of livestock) as for livestock production across Europe as a whole (91.6mg/kg of livestock),” said David Wallinga, MD, a senior health officer, food, agriculture and health, people and communities program at the NPO.

In the US dairy industry, antibiotics are used for treatment and prevention of bacterial infections in cows, and farmers are required to adhere to a set of rules when administering antibiotics. Conventional dairies can only harvest milk from an animal that’s been treated with antibiotics after the withholding period, while organic dairies must remove the animal from the herd and can never again market its milk as certified organic.

But under FDA’s new guidance #263, set to come into force on June 11, 2023 following a two-year implementation period, certain drugs will only be accessible via prescription or if bought directly from a veterinarian. Vets would not be required to examine each animal, however, as long as they have established relationship (VCPR) with the farmer.

Products labeled as over-the-counter that are already in distribution will be allowed to deplete, the FDA has said, but pharmaceutical companies whose products fall under the new guidance have been asked to ensure all new products are labeled as prescription products.

How to build a veterinary-client-patient relationship?

The FDA says the most straightforward way to ensure dairy operations are not negatively affected by the new rule is to set up a plan with a vet who is familiar with their herd and can determine what antibiotics are needed; set protocols for common conditions in order to have access to the drugs required to treat them, and schedule routine visits to encourage disease prevention.

A list of approved new animal drug applications affected by the guidance can be viewed on the FDA website​.

Related topics Regulation & Safety