Arm & Hammer Animal and Food Production
5 Reasons Blog

Preparing for new regulations on over-the-counter antibiotics.

Posted August 12, 2022 by Dr. Joel Pankowski, Senior Technical Services Manager

In June 2021, the FDA finalized guidance for industry (GFI) #263, a directive that recommends sponsors of “medically important” antimicrobial drugs that are currently approved with over-the-counter (OTC) marketing status voluntarily revise the conditions of use of these products to reflect the need for professional oversight of a licensed veterinarian.

Now that we’re halfway through the two-year timeline set by the FDA, dairy producers may have questions on how this will impact their operation. Here are five considerations for dairy producers:

1. What are “medically important” antimicrobial drugs?

Put simply, medically important antibiotics are products that are used in both human and animal medicine. In GFI #209, the FDA stated that the development of resistance to medically important antimicrobial drugs—and the resulting loss of their effectiveness as antimicrobial therapies—poses a serious public health threat.

2. How is this different from the 2017 Veterinary Feed Directive?

In the 2017 directive, only medically important antibiotics in feed and water were removed from OTC channels. The new directive affects OTC antibiotics delivered via other methods like injectables, boluses, and intramammary mastitis tubes including:

  • Injectables: Liquamycin LA-200, Penicillin Injectable, Tylan
  • Boluses: Terramycin Scours Tablets, OXY 500 Calf Boluses, Albon, Sustain III Cattle & Calf Boluses, Supra Sulfa III Cattle & Calf Boluses
  • Intramammary Tubes: ToDAY and ToMORROW

3. Should I stock up on antibiotics?

Many producers might consider stocking up on medications transitioning from OTC to Rx status. However, antibiotics expire and can lose their effectiveness. Stocking up on these antibiotics can be a huge waste of money if they’re not needed before they expire.

4. When should I start looking for alternative solutions?

While guidance #263 isn’t slated for final implementation until June 11, 2023, many products will start disappearing from store shelves prior to that date. Waiting until June of 2023 could leave producers feeling blind-sided when once relied on products are no longer available. Producers should already start looking for long-term solutions.

5. What options are available?

Three well-researched, proven-effective options are prebiotics, probiotics and postbiotics. Prebiotics, probiotics and postbiotics modulate micro-organisms in the digestive tract. Prebiotics have been shown to improve immunity, bind harmful bacterial and mitigate the harmful effects of mycotoxins. Two prebiotics commonly used in calves are mannan-oligosaccharides (MOS) and beta-glucans—commonly referred to as Refined Functional Carbohydrates™—available in CELMANAX™ from ARM & HAMMER™. Probiotics such as Bacillus subtilis—available in CERTILLUS™ Performance from ARM & HAMMER—have been shown to populate the gut with “good” bacteria, improving immunity and reducing inflammatory responses in the digestive tracts of calves. Postbiotics are metabolites and microbial end products that aid in gut health —available in A-MAX™ and CELMANAX™. To learn more about prebiotics, probiotics, and postbiotics, check out this recent article by Dr. Sangita Jalukar.

To find out how you can prepare for FDA GFI #263 and how you can start incorporating long-term solutions like prebiotics and probiotics, contact your DVM or your nutritionist.

To learn more about FDA GFI #263, tune into Dr. Pankowski’s recent episode of Food Chain Chats.



About Dr. Joel Pankowski

Dr. Pankowski has a diverse background with animal nutrition companies including his current role as Senior Technical Services Manager at Arm & Hammer Animal and Food Production where he has been since May of 2011. Dr. Pankowski earned his bachelor’s and master’s degrees in animal science and dairy management from The Ohio State University and a Ph.D. in reproduction and epidemiology from Cornell University.



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