Quick facts
Six key steps to meet FDA antibiotic regulations using the acronym USCARE:
- Understand as of January 1, 2017 therapeutic use (treatment, control, prevention) for specific animal health conditions is allowed only under direction of a veterinarian.
- Strengthen your veterinary-client-patient relationship (VCPR).
- Communicate with your feed mill: make sure the mill staff understand and have in place VFD record-keeping procedures.
- Assess your herd health and welfare plans.
- Renew your commitment to responsible antibiotic use. Stay up-to-date with Pork Quality Assurance Plus (PQA+) certification.
- Ensure your record-keeping agreement: Records for VFD must be kept for two years and prescription records for one year.
From PorkCheckoff
FDA antibiotic regulations
The U.S. Food and Drug Administration’s (FDA) regulations for on-farm antibiotic use in food-animal production took effect January 1, 2017. These efforts aim to
- Stop the use of medically important antibiotics for growth promotion in food-animal production.
- Medically important refers to antibiotics used in human or animal medicine, or antibiotics in the same family of those medications.
- Bring therapeutic use of antibiotics in feed and water – to treat, control, or prevent specific disease – under additional veterinary oversight.
- Medically important antibiotics are only for therapeutic use.
- Non-therapeutic use of medically important antibiotics isn’t allowed.
- Antibiotics aren’t labeled for growth promotion.
- Veterinary oversight increased for therapeutic use of both in-feed and water-delivered antibiotics.
- Over-the-counter (OTC) use of medically important antibiotics for mass medication (feed or water) isn’t allowed.
- You need a veterinary feed directive (VFD) to purchase medicated feed.
- You need a prescription (Rx) to purchase water medication.
- You must follow the manufacturers’ labels on in-feed medications. You can’t use medicated feed in extra label fashion.
What is a veterinarian-client-patient relationship (VCPR)?
Each state can define a VCPR differently. Minnesota’s VCPR requirements match the federal requirements. The federal minimum requirements state:
- The producer must work with a veterinarian to accept responsibility for making clinical decisions about the animals’ health.
- The veterinarian must examine the animals or visit the facility to gain knowledge of the animals.
- The veterinarian must be available to provide needed follow-up exams or care.
Rx water-soluble medications
All uses of the following medications require a prescription from a veterinarian.
Examples of trade names of medications are provided in the following format:
Established drug name- Examples of trade name(s)
- Apramycin
- Carbomycin/oxytetracycline*
- Chlortetracycline/sulfamethazine*- Aureomix® S
- Chlortetracycline- Aureomycin®, Chloronex, Chlortetracycline, Chlortetracycline Bisulfate, Chlortet-Soluble-O, Fermycin, Pennchlor™
- Gentamicin- Garacin®, GenGard®, GentaMed™, Gentocin®, Gentoral®
- Lincomycin- Linco, Lincomix®, Lincomycin, Lincomycin Hydrochloride, Lincosol, LincoMed
- Neomycin- Biosol®, Neo, NeoMed®, Neomycin, Neomycin liquid, Neomycin Sulfate, Neomix®, Neo-Sol®, Neosol-Oral
- Oxytetracycline- Agrimycin™, Oxy-Tet™, Oxytet®, Oxytetracycline HCL, Terramycin®, Tetroxy®, Tetroxy® HCA
- Streptomycin
- Sulfachloropyrazine
- Sulfachloropyridazine
- Sulfamerazine/ sulfamethazine/sulfaquinoxaline*
- Sulfamethazine- SMZ-Med™, Sulmet®, Purina® Sulfa
- Tetracycline- Duramycin, Polyotic®, Tetra-Bac, Tetracycline, Tetracycline hydrochloride, TetraMed®, Tet-Sol®, Tetrasol
Water-soluble medications that remained Rx
Tylosin- Bilovet™, Tylan®
Veterinary feed directives
A VFD is a written statement given by a licensed veterinarian, which allows VFD medication use in an animal feed. A veterinarian must fill out the VFD form correctly and send a copy to the producer and feed mill.
All feed uses of the following medications approved for swine use, alone and in combination with other medications, require a VFD.
Examples of trade names of medications are provided in the following format:
Established drug name- Examples of trade name(s)
Apramycin
Chlortetracycline (CTC)- Aureomycin®, Chloronex, Chlortetracycline, Chlortetracycline Bisulfate, Chlortet-Soluble-O, Fermycin, Pennchlor™
Chlortetracycline/sulfamethazine- Aureomix® S
Chlortetracycline/sulfamethazine/penicillin*
Erythromycin
Hygromycin B- Hygromix
Lincomycin- Linco, Lincomix®, Lincomycin, Lincomycin Hydrochloride, Lincosol, LincoMed
Neomycin (alone)- Biosol®, Neo, NeoMed®, Neomycin, Neomycin liquid, Neomycin Sulfate, Neomix®, Neo-Sol®, Neosol-Oral
Oxytetracycline (OTC)- OXTC®, Oxytetracycline, Pennox™, Terramycin®
Oxytetracycline/neomycin*- Neo-Oxy®, Neo-Terramycin®
Penicillin (only approved for production use)- Penicillin G Procaine
Sulfaquinoxaline
Tylosin- Tylan®, Tylosin®, Tylovet®
Tylosin/sulfamethazine*- Tylosin Plus Sulfamethazine, Tylan® Sulfa-G
Virginiamycin- Stafac®, Virginiamycin
*Fixed-ratio, combination drug
Medications expected to transition to VFD status if back on the market:
Oleandomycin (only approved for production use)
Sulfamerazine
Examples of trade names of medications are provided in the following format:
Established drug name- Examples of trade name(s)
- Avilamycin- Kavault™
- Florfenicol- Nuflor®
- Tilmicosin- Pulmotil®, Tilmovet®
- Keep records for 2 years.
- Have documentation: original, email, or fax is okay.
- Don’t practice extra-label use.
- Order for approximate number of animals or days to feed.
- Don’t refill unless it’s on the label.
- Can be written for multiple premises if the pigs are under the same ownership and fed by the same mill.
- A State/Federal VFD is required
- VFD expires within 6 months of when it was issued.
Impacts on on-farm feed manufacturers
Producers with on-farm feed mills that only mix for themselves must give distributors a VFD when buying their medicated ingredients. Producers need to have a current VFD on file to feed the medicated feed to their pigs.
Producers mixing feed to give away or sell are distributors and must submit a one-time acknowledgement letter to the FDA. Keep the letter on file and have a current VFD for every batch of medicated feed.
Medications unaffected by FDA regulation changes
Examples of trade names of medications are provided in the following format:
Established drug name- Examples of trade name(s)
Antimicrobials that aren’t medically important:
- Bacitracin- Solu-tracin, BMD® Soluble
- Tiamulin- Denagard®, TiaGard™, Tiagard™, Triamulox™
- Bambermycin- Flavomycin®
- Carbadox- Mecadox®
- Ionophores- Skycis®
Other medications:
- Anthelmintics (dewormers):
- Ivomec®
- Fenbendazole- Safe-Guard®AquaSol, Purina® Worm-A-Rest Litter Pack
- Beta agonists:
- Ractopamine- Paylean®, Engain™
Note: This information was adapted from an FDA fact sheet and was up-to-date as of November 1, 2017. As the industry transitions, Center for Veterinary Medicine anticipates additional changes to this information. Please check FDA for the most recent updates.