Happy New Year! The start of 2017 brings a big change to the livestock industry. The FDA announced on January 3, that it has completed implementation of Guidance for Industry #213.
This guidance began in 2013 to transition medically important antimicrobial drugs used in feed or drinking water of food-producing animals to veterinary oversight and eliminate the use of these products in animals for production purposes, such as growth promotion. The deadline for the transition to take place was January 1, 2017. The new regulation is now a reality.
So what does this mean for you?
Some drugs that were available without the involvement of a veterinarian now require a prescription for water soluble or a veterinary feed directive (VFD) for mass treatment in feed. Changes with these products have left some producers confused and scrambling to get their operation in compliance.
We've compiled a list of resources and information here in this guide to help clear up the confusion.
NOTE: VFDs and PRESCRIPTIONS are not the same! While both require a veterinarian's involvement, the FDA groups them in two separate categories:
Veterinary Feed Directive (VFD): When the drug being approved is for use in or on animal feed (a medicated feed), FDA approves these drugs as a VFD drug. VFDs do not need to be run through a pharmacy.
Prescription (Rx): When the drug being approved is not for use in or on animal feed, the drug is approved as a prescription drug. These must be run through a pharmacy!
This section covers some of the common questions that producers and dealers have about the new regulations.
1. What does the new regulation actually change?Certain drugs will no longer be able to be purchased without a veterinarian's involvement. Going forward, you'll need a script for certain water solubles and a veterinary feed directive (VFD) for certain medicated feeds.
2. But, why was the change made?
The goal of Guidance for Industry #213 is to ensure safe food and the sustainable use of antibiotics for animals and humans. The regulation requires a VFD for all medically important antimicrobial drugs, meaning those important in human health, administered in feed and a prescription for all medically important antibiotics used in water.
3. Which drugs have changed to Rx status?chlortetracycline, erythromycin, gentamicin, lincomycin, lincomycin/spectinomycin, neomycin, oxytetracycline, penicillin, spectinomycin, sulfadimethoxine, sulfamethazine, sulfaquinoxaline, tetracycline
A full list of Rx drugs and the products they are found in.
4. Which drugs have changed to VFD status?
chlortetracycline (CTC), chlortetracycline / sulfamethazine, chlortetracycline /sulfamethazine/ penicillin, hygromycin B, lincomycin, oxytetracycline (OTC), oxytetracycline / neomycin, penicillin, sulfadimethoxine / ormetoprim, tylosin, tylosin / sulfamethazine, virginiamycin
A full list of VFD drugs and the products they are found in.
5. Does it apply to vaccines?
No! Injectables are not affected by the new regulation.
6. What about feed through fly control?
Nope. As long as the product doesn't contain an antibiotic then it will keep its over the counter status.
7. How long do I need to keep records of VFDs and prescriptions?
The FDA requires that you keep these records for a minimum of two years. You are allowed to keep these records electronically.
8. What happens if I don't comply?
The bottom line is the FDA has implemented the new rule and everyone in the industry needs to comply. The FDA will be conducting audits and producers, feed mills and veterinarians should all be aware of what their role is with the new regulation and be prepared to provide the necessary information, such as a complete VFD forms.
9. What happens if I'm audited?
Poultry Health Today has released an interview with William Flynn, DVM, MS, deputy director for science and policy for FDA’s Center for Veterinary Medicine. In one part of the interview, Flynn answers questions about what to expect from a VFD audit.
This is new to all of us so it's hard to say what an audit will entail and what will happen if someone were to fail an audit. The best way to be prepared for an audit is to keep good records and follow the new regulation.
10. What if I have medicated feed or products that were purchased before January 1st, but are considered VFDs or Rx now?
The FDA set out a 3-year timeline to help smooth the transition. Products that are now VFDs or Rx cannot be sold with the old OTC label. The FDA acknowledges that there may be some product left over that was purchased over the counter before the January 1st deadline, but it's best that producers not abuse this transition period.
For Producers:
For Feed Mills and Dealers:
For Veterinarians:
In response to the regulation changes, we're happy to announce that we've opened VPSI Pharmacy! We'll be able to supply our customers with the medications prescribed by their vets. Prescriptions will be run through our pharmacy. VFDs will be run through our Goshen office.
NOTE: We will not be carrying narcotics.
VPSI Pharmacy is a closed door pharmacy. Prescription products will be delivered. Customers will not need to go to the pharmacy location.
At this time, we cannot fill prescriptions online. For customers of our physical locations and sales representatives, we have released a Pharmacy Announcement mailer that gives detailed instructions for submitting prescriptions and VFDs. You can view the mailer HERE.
Contact us or a salesperson near you, to hear about the full range of products, including Rx and VFDs, we offer and to have them delivered directly to your farm or operation.
We have compiled a comprehensive list of resources for you to reference in regards to the regulation changes.
Resources Directly from the FDA Website
Guidance for Industry Documents from the FDA Website
VFD Videos from the FDA Website
VFD Resources from Veterinary and Poultry Supply, Inc.
VPSI Pharmacy Information
Non-FDA VFD Resources
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