How will the FDA’s Veterinary Feed Directive affect my business? VFD’s & Me How will the FDA’s Veterinary Feed Directive affect my business? Presented by CVA’s Quality Assurance Team Abby Simonsen, PCQI Lead Instructor 7/2016ARS

A little about me…..

VFD: Veterinary Feed Directive History: VFD law enacted in 1996 as part of the Animal Drug Availability Act Serves as an alternative to prescription (Rx) feed Directs that feed containing VFD drug(s) may only be distributed to animal producers under a veterinarian’s supervision and written order FDA VFD initial regulation directed that all Type A VFD drugs be designated as Category II (MFML required to handle Type A) Medically Important to Humans Drug classes that mirror those in human medical programs are being observed by FDA via the VFD to help limit the use in food producing animals to limit the resistance in human population to certain antimicrobial drugs Current VFD Drugs: Tilmicosin (Pulmitol for swine and beef) Florfenicol (Aquaflor and Nuflor for fish) Availamycin (Kavault for swine) new 2016

VFD: A Lot of moving parts Source: Matt Frederking /NGFA 2016

The VET/CLIENT Relationship!! X X What part affects me? The VET/CLIENT Relationship!!

VFd: What’s in, what’s not? VFD REQUIRED NO VFD REQUIRED Wormers (Banminth) Ionophores (Rumensin, Avatec, Bovatec) BMD Carbadox (Mecadox) Bambermycin (Flavomycin) Tiamulin (Denaguard) If you order VFD Drugs combined with non-VFD drugs, you still need a VFD from your veterinarian! Source: fda.gov/animalveterinary

VFD: Shipping & Billing Copy of VFD must accompany the feed delivery paperwork with the statement somewhere on the paper work Caution: Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian VFD may give vague or specific info on where feed is to be delivered Example 1: Customer: John Doe’s Funny Farm Location: 1257 Co Rd 17 Grow Finish Swine in Barn #7, Bins 6 & 7, 8 ton per bin/per delivery Example 2 Customer: John Doe’s Funny Farm Location: 1257 Co Rd 17 Fat Hogs-Barn is North of the house Example 3 Customer: John Doe’s Funny Farm Location: 1257 Co Rd 17 G/F Swine in Barn 7, Bins 6-7 Keep copy of VFD either in paper form with batching records or digitally

VFD: What is my responsibility as a producer? To only feed animal feed bearing or containing a VFD drug or a combination VFD drug to animals based on a VFD issued by a licensed veterinarian (VCPR) feed a VFD feed or combination VFD feed to animals by no later than the expiration date on the VFD (if you are going to feed past the date, ask vet for a new VFD to cover it) provide a copy of the VFD order to the distributor if the issuing veterinarian sends the distributor’s copy of the VFD through you, the client maintain a copy of the VFD order for a minimum of 2 years provide VFD orders for inspection and copying by FDA upon request Source: FDA 21CFR 558.6

VFD: Vet-Client-patient relationship VCPR is similar to your relationship with your family doctor. FDA will consider states with VCPR definitions that at least address the concepts that the veterinarian engage with the client to assume responsibility for making clinical judgments about patient health, have sufficient knowledge of the patient by virtue of patient examination and/or visits to the facility where patient is managed, and provide for any necessary follow-up evaluation or care to include the key elements of the federally-defined VCPR as set forth in 21 CFR § 530.3(i). Source: FDA 21 CFR 530.3 & 21 CFR 558.6

VFD: What do I need to place an order? We cannot fill your VFD Order if we don’t have all of this info! Here’s a list to keep handy to remember what the feed mills needs to fill your VFD order!

VFD: Where do I get the form? Vets own form or from drug manufacturers submit paper copies via fax, email or hand delivery Vets can fill out, electronically sign and submit online via Global Vet Link No phone call VFD’s will be accepted 2 year record keeping 1 copy to vet 1 copy to producer 1 copy to mill/feed store Example from Elanco Animal Health

Over 2,500 vet offices signed up 7,000 vets nationwide 16 years serving animal health and nutrition industry Doing E-VFD’s since 2005 FDA Compliant for 21CFR11 LINK between Vet, Producer and Mills Robust sales/service team Global Feed Link will be the program of choice for CVA Feed Mills. Paper, fax and emailed VFD’s will still be accepted.

Medicated Stock items will require a vfd or a script too Look for transitional labeling to appear on products in the fall of 2016. This will help you become familiar with the products you use and if you will need a VFD after January 1, 2017. Medicated Stock items will require a vfd or a script too Medicated mineral products Tubs Blocks Free choice Bagged medicated animal feeds and milk replacer Injectable Meds- script only Water soluble meds

VFD: Who is watching this? The FDA will be following the supply chain on VFD’s Starting with DISTRIBUTORS (feed mills, feed retails stores) Check record of VFD’s filled Check production/shipping dates of VFD orders Trace back to VET Check if vet is licensed Check if vet filled out correctly Trace back to PRODUCER/FEEDER Check if feed went to animals that were on VFD Check that feed was not fed past the VFD Expiration Date FDA VFD Inspection

We are here to be your partner in producing quality livestock to market. If there is any way we can assist you in your animal nutrition needs, please do not hesitate to contact your feed mill or a member of our sales and nutrition team in your area. Our years of experience coupled with strategic ties with companies like Purina Animal Health, Hubbard Feeds, Elanco, Phibro, and many others keep us poised to go where we need to, to get you the products you need.

THANKS FOR LISTENING! Any questions on VFD’s and Feed Safety? Contact: Abby Simonsen Abby.Simonsen@CVACoop.com or 402-307-0240