The U.S. Food and Drug Administration (FDA) announced in June 2021 that all medically important antimicrobials for food-producing animals and pets will move from over-the-counter (OTC) to prescription (Rx) effective June 2023.
This change impacts any product that contains the following:
- Oxytetracycline
- Penicillin
- Sulfa-based antibiotics (sulfadimethoxine and sulfamethazine)
- Tylosin
- Cephapirin and Cephapirin Benzathine
- Swine medications Lincomycin and Gentamicin
It’s a big deal that’s making waves across the industry, so we want to make sure everyone understands the change and has time to prepare for it.
Changes That Affect Your Animals
In 2018, the FDA laid out its 5-year action plan for supporting antimicrobial supervision by veterinarians. The plan aims to address antimicrobial resistance by only using medically necessary drugs assessed as necessary to treat, control or prevent certain diseases. Licensed veterinarians must determine the necessity, but you won’t have to order the prescriptions from the vet directly. You will, however, need to establish a Veterinary-Client-Patient Relationship (VCPR) if certain animals aren’t examined regularly.
Popular Products Will Require Prescriptions
After months of a penicillin shortage has created supply challenges of its own, soon producers will get hit with this change that once again impacts access to antibiotic therapy for animals. When you’ve used them for so long as OTC meds to treat pneumonia or shipping fever in your cattle or sheep, it’s going to take some getting used to.
Here’s an updated list (as of 11/15/22), sorted by active ingredient, of items we carry at PBS Animal Health that will require prescriptions starting in June 2023. We have tried to make the list as complete as possible and it includes the products we are aware of at this time. It is not an exhaustive list as there may be other affected items we do not carry. We’ve also created a printable version here for easy reference.
Cephapirin Based Active Ingredient
- ToDay Mastitis Treatment for Lactating Cows by Boehringer Ingelheim
- ToMORROW Dry Cow Mastitis Treatment by Boehringer Ingelheim
Gentamicin Active Ingredient
- Gentamicin Piglet Injection by Sparhawk
Lincomycin HCl Active Ingredient
- Lincomycin 300 Swine Injection by Durvet
- Lincomix Injectable Antibiotic for Swine by Zoetis
Novobiocin Sodium Active Ingredient
- Albadry Plus Suspension Dry Cow Formula by Zoetis
Oxytetracycline Active Ingredient
- Agrimycin 200 Oxytetracycline Injection by AgriLabs
- Bio-Mycin 200 Cattle and Swine Antibiotic Injection by Boehringer Ingelheim
- Calf Scour Boluses by Durvet This item has been discontinued.
- Duramycin 72-200 Injectable Antibiotic for Cattle and Swine by Durvet
- Liquamycin LA-200 Injection by Zoetis
- Noromycin 300 LA by Norbrook
- Oxy 500 Calf Boluses by Boehringer Ingelheim
- Oxytet 100 for Cattle by Norbrook
- Terramycin Calf Scours Tablets by Zoetis
- Terramycin Ophthalmic Ointment for Animal Use by Zoetis
Penicillin Based Active Ingredient
- Albadry Plus Suspension Dry Cow Formula by Zoetis
- Combi-Pen Injectable by Bimeda
- Dura-Pen Injectable by Durvet
- Go-Dry Penicillin G Procaine Dry Cow Mastitis Treatment by US Vet
- Masti-Clear Penicillin G Procaine Lactating Cow Mastitis Treatment by US Vet
- Penicillin G/Norocillin Injectable by Durvet
- PenOne Pro Penicillin G Injectable by VetOne
- Pro-Pen-G Injectable by Bimeda
Spectinomycin Active Ingredient
- SpectoGard Scour-Chek by Bimeda
Sulfonamides / Sulfa Based Active Ingredients
- Albon Cattle Boluses by Zoetis
- Di-Methox Injection 40% by AgriLabs
- SulfaMed Injection 40% by Bimeda
- Sustain III Boluses by Bimeda
Tylosin Active Ingredient
- Tylan 200 Tylosin Antibiotic for Cattle and Swine by Elanco
- Tylan 50 Injectable Antibiotic by Elanco
NOTE: Some of these products are tough to find in stock because of the penicillin shortage, but that’s a separate issue from the OTC status change. When you find them in stock, you can still order them through May 2023. Some customers mistakenly believe they need prescriptions now, but that’s not the case. The law won’t go into effect until June.