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The Days of OTC Antibiotics Are Numbered
By Terry Smith Written to make people aware of FDA changes Information in this article was obtained from various web-sites dealing with GFI #263
When the Food and Drug Administration (FDA) started implementing Guidance for Industry #213 or the Veterinary Feed Directive (VFD) in 2017, it was focused on veterinary oversight of medically important antibiotics administered to livestock via feed and/or water. This left a significant loophole for those products that were available over-the-counter (OTC). On June 11, 2021, FDA published Guidance for Industry #263 which allowed them to close this loophole by removing all remaining medically important antibiotics from OTC status. The rationale behind Guidance for Industry #263 is: “Any antibiotic use can contribute to antibiotic resistance, so it's important to avoid unnecessary or inappropriate uses of antibiotics. GFI #263 puts the responsibility for the use of medically important antibiotics into the hands of veterinarians, who are trained to understand not only when these medications are needed, but also what is the appropriate drug, dose, duration, and administration method to resolve infection and protect animal health and our food supply. The veterinarian's expertise is critical to ensuring the responsible use of antibiotics in animals.” Once this change is made, these important drugs can only be used in animals under the supervision of a licensed veterinarian, even if the animals are not intended for food production. From pet dogs and cats to backyard poultry, and from pet rabbits and pigs to large livestock, the same restrictions apply. All these medically important antibiotics will require a prescription from a veterinarian to be purchased and used. When Guidance #263 was published on June 11, 2021, drug manufacturers had a two-year period to make label changes and come into compliance with the guidance. It recommended that manufacturers of medically important antimicrobial drugs that continued to be available OTC and were approved for use in companion animals and food producing animals, regardless of how the medication was administered, to voluntarily bring these products under veterinary oversight or prescription marketing status. These product labels will now contain the prescription (Rx) statement, "Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian." Products with the RX label can only be purchased with a prescription even if they are available before the June 11, 2023 date. All products covered under Guidance #263 will be removed from OTC availability by June 11, 2023. It is expected is that OCT products will disappear from store shelves as manufacturers finalize label changes and refine their marketing and distribution channels to assure compliance with prescription requirements. The FDA Center for Veterinary Medicine CVM will not object if OTC-labeled products that entered distribution channels before June 11, 2023, continue to be sold and used until such products have been depleted as long as the expiration date is good. Timelines for depletion may vary but should be consistent with normal sales volume and expiration dates for a given product. When the VFD was put in place in 2017, some suppliers no longer stocked antibiotics and declined to offer products as they unable to meet the legal burden of acting as a “Pharmacy” which required them to review veterinary authorized prescriptions and track refills of those prescription products. Under Guidance # 263, licensed suppliers who continue to stock products with the Rx label will only being able to sell to someone has a veterinary prescription.
Medications transitioning to Rx by June 11, 2023· Oxytetracycline · Sulfisoxazole · Oxytetracycline, Polymyxin B · Sulfamethazine · Sulfabromomethazine · Erythromycin · Tylosin · Sulfadimethoxine · Sulfomyxin · Sulfachlorpyridazine · Spectinomycin · Lincomycin · Chlortetracycline · Penicillin G Procaine, Novobiocin · Dihydrostreptomycin, Penicillin G Procaine · Tetracycline · Penicillin G Procaine · Dihydrostreptomycin · Penicillin G Benzathine, Penicillin G Procaine · Gentamicin · Cephapirin · Cephapirin Benzathine
These antibiotics are not being removed from the market, but are being brought under veterinary oversight in order to combat overuse/misuse due to OTC access. Guidance # 263 affects only medically important antibiotic products. Antiparasiticides, injectable and oral nutritional supplements, oral pro/prebiotics and topical non-antibiotic treatments will not be affected and will remain available OTC. Farmers and breeders who already have a VCPR (Veterinarian-Client-Patient-Relationship) place and purchase their animal health products from their veterinary office or distributors under an existing prescription system, will notice little change in their ability to obtain antibiotics. Farmers and breeders who don’t consult a veterinarian on a regular basis will need to establish a valid VCPR prior to purchasing these products as they start to disappear from OTC access. The definition of a valid VCPR may vary from state to state so check with the Animal Health Department in your state. |
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Poultry & Game Bird Medications |
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The Veterinary Feed Directive, which was effective 1/1/17, included a ban on water soluble antibiotics which can be sold over the counter. For the latest status of OTC antibiotics, see the article at the bottom of this page. These are the only medications not affected by the ban which can be sold without a prescription from a veterinarian. |
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BMD (Solu-Tracin) - 4.1 oz pkg. makes 50 gallons. Treats quail enteritis, mud fever & other diseases characterized by diarrhea. Contains Bacitracin/MD. For prevention: mix ⅛ tsp. to 1 gal. of water; for treatment mix ½ tsp. per gal. of water. |
$26.00
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Corid 20% Soluble Powder 10 oz. package Used to treat coccidiosis in growing chickens, turkeys, & laying hens. Mix 1 1/2 teaspoons Corid daily with 1 gallon fresh drinking water for 5 consecutive days as a treatment. When using as a treatment, provide to all birds in the flock at the signs of coccidiosis. |
$25.00 |
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Denagard 12.5% 1 liter bottle/33.8 ounces In chickens and turkeys, mycoplasmas can cause many disease: from respiratory problems and lameness to increased embryo mortality, infertility, and reproductive problems. Denagard has proved to provide exceptional activity against mycoplasmas and is used worldwide to help produce healthy and productive chicks and to control disease transmission. It can be used in laying birds to improve egg production. After years of use, it is still a successful therapy with little evidence of increased resistance among poultry disease-causing organisms. Preventative usage: 8 cc/ml (1.5 teaspoons) per gallon for 3 to 5 days; bottle will make about 134 gallons of solution. Treatment: 16 cc/ml (3 teaspoons) per gallon for 3 to 5 days, bottle will make about 67 gallons of solution. |
NA |
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Vetmulin 12.% Liquid Concentrate (Huvepharma) Generic for Denagard which is unavailable at this time due to production problems. It is the exact formulation and has the same %. tiamulin hydrogen fumarate as Denegard. |
1 liter/ $43.00 |
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Vet-RX 2 oz bottle Used to treat respiratory problems; conditions combs & legs of show poultry. Use full strength 1/4 tsp. per 1/2 cup of water to treat respiratory. |
$9.00 |
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Medications Labeled for Pigeons |
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1 Eye 1 Drop 1 Time 1 fluid oz. dropper bottle contains about 900 drops to treat one eye colds. |
$25 .00 |
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4 in 1 20% Powder - 100 gr. Package Treats Canker, E-Coli, Paratyphoid, & Coccidiosis. 1 teaspoon per gallon of water for 7 days. Makes 28 to 30 gallons. |
$25.00 |
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All-in-One 200 gram package All-in–One is a good medication for bird breeders who have small flocks. Instead of purchasing 5 different packages of products to treat the birds, purchase just this one medication. It contains Amprolium for the prevention and treatment of Coccidiosis. It also contains Ronidazole, an effective drug for the treatment of Canker (Trichomoniasis). All-In-One contains Levamisol which treats worms with the exception of Tape Worms. The medication contains Tylan to treat respiratory diseases. The fifth ingredient is a probiotics to rebuild gut bacteria, and to relieve stress. Dosage: 2 tsps. per gal for 5 days. Makes 28-30 gallons. |
$46.00
3 or more $43.00 each |
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Amoxicillin 20% Powder 100 gr. Package Treats Canker, Paratyphoid, Salmonella, and respiratory problems. 1 teaspoon per gallon of water for 3-7 consecutive days. Treat Paratyphoid for 14 consecutive days. |
$25.00 |
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Amoxicillin Tablets 100 10mg. Tablets for the individual treatment of respiratory problems, paratyphoid, and e-coli. 1 tablet daily for 7 days. Paratyphoid 1 tablet daily for 23 days. (not pictured) |
NA |
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Doxycline 20% Powder - 100 grams pkg. Treats ornithosis, paratyphoid, mycroplasmsis, chalamydia, & respiratory in pigeons and cage birds. Use 1 teaspoon per gallon of water for 7 to 10 days. |
$25.00
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Doxy-Tyl - 100 gram pkg. Contains 10 grams Doxycline & 40 grams Tylosin for the treatment of respiratory infections, ornithosis, & mycoplasma. Use 1 teaspoon per gallon of water for 5 to 7 consecutive days. |
$33.00 |
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Doxy-Tyl Tablets 100 tables (20 mg doxycyclin and 5 mg Tylosin) for the individual treatment of respiratory problems. 1 tablet daily for 7 days. |
$23.00 |
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Enrofloxacin 20% Powder (Baytril) 100 grams Treats bacterial infections of the respiratory system, salmonella, mycroplasmsis, & E. Coli. 1 teaspoon per gallon of water for 4 to 6 consecutive days. Change water daily. |
$25.00
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Enrofloxacin Tablets (Baytril) 100 count 10 mg/tablet. Treats bacterial respiratory infections, salmonella, paratyphoid, mycroplasma, & E. Coli. 1 tablet per day for 3 to 7 days. |
$23.00 |
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Florfenicol 20% Powder 100 gram package. For the prevention and treatment of chronic respiratory disease. Bronchitis, pneumonia, air sac disease, & E. Coli, serious diarrhea, yellowish-brown or loose green stools in pigeons and other birds. Use 1 tsp. per 2 gallons water for 3-5 consecutive days. |
$26.00 |
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Linco-Spect 50 Powder 100 gram package for the treatment of Air sacculitis caused by either Mycoplasma synoviae or M. gallisepticum, CRD, and complicated CRD caused by Escherichia coli and M. gallisepticum. Dosage: 1 teaspoon per 2.5 gallons drinking water for 5-7 consecutive days. |
$35.00 |
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Metronidazole 20% Powder 250 gram package For the treatment of avian trichomoniasis (canker) in pigeons & blackhead in other birds. Use 1 teaspoon per quart of water for 5 to 7 days. |
$27.00 |
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Oxytetracycline 10% Powder 100 gram package (same active ingredient as Terramycin Powder which is no longer manufactured.) For control and treatment of infectious diseases caused by E-coli, Samonella, Pasteurella & Mycroplasma in birds. 1 tsp. per gallon of water for 5 to 7 days. |
$26.00 |
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Sull-Medt - 100 gram pkg. contains 99% Sulfamethazine sodium for the treatment of coryza, coccidiosis, acute fowl cholera, & salmonella in pigeons and other birds. Use 1 teaspoon per gallon of drinking water for 3 to 5 days. |
$25.00
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Trimethoprim/Sulfa Powder 100 gram pkg. For the treatment of Paratyphoid, E-Coli, Coccidiosis. Use 1 tsp. per gallon of water for 5 days.
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$25.00 |
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Tylosin Powder - 100 gram pkg. Use as an aid to prevent Chronic Respiratory Disease (CRD), Mycroplasma gallisepticum, Mycroplasma synoviae, and Necrotic Enteritis. Use 1 teaspoon per gallon of drinking water for 7 consecutive days. To insure proper mixing, add the water to the powder. Prepare fresh Tylosin solution every 3 days. Contains 99% Tylosin tartrate. |
$37.00 |
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Chicken Health Handbook by Gail Damerow 496 p, pb One-of-a-kind reference book covers the health problems that plague chickens of all breeds and ages. Practical charts identify common symptoms and causes of infection, while an alphabetic listing of diseases provides advice on treatment. You’ll find helpful descriptions of troublesome ailments of all types, from poor egg production to crooked toe syndrome. Practical remedies and gentle preventative care measures will help your beloved flock stay happy, healthy, and safe. |
$19.00 |