• VFD: Steps to implement by Jan. 1, 2017 • VFD: Key takeaways and resources
BACKGROUND: FOOD AND DRUG ADMINISTRATION (FDA) GUIDANCE DOCUMENTS
CENTER FOR VETERINARY MEDICINE’S ULTIMATE GOAL Judicious use of medically important antimicrobial drugs in food animals. 1) Phase out use of all medically important antibiotics in feed for growth claims. Moves water-soluble powders with these same antibiotics to prescription (Rx).
2) Bring therapeutic uses of all medically important antibiotics under oversight of veterinarians.
Help ensure safe food and sustainable use of antimicrobials for humans and animals.
FDA GUIDANCE DOCUMENTS • *Full timeline in addendum
GUIDANCE 152 Oct. 23, 2003
GUIDANCE 209 April 13, 2012
GUIDANCE 213 Dec. 12, 2013
Defines Medically Important Antibiotics Defines Judicious Use of Antibiotics Defines Process to Implement 209 and Veterinary Feed Directive Regulation
Coccidiostats, ionophores and bacitracin when in combination with medically important antibiotics
Affected by Guidance #213 and VFD regulation
Coccidiostats, ionophores and bacitracin
Unaffected by Guidance #213 and VFD
Medically important water-soluble antibiotics
Convert to prescription status
Extra-label use of medically important feed additive antibiotics Medically important antibiotics used for growth promotion and/or feed efficiency 7
VFD: KEY REQUIREMENTS
OVERVIEW OF THE REVISED VFD REQUIREMENTS
VFD REQUIREMENTS Issued on a validtoveterinarianIssuedby byaalicensed licensedveterinarian veterinarianbased in accordance veterinarianclient-patient relationship (VCPR) client-patient relationship (VCPR)
Complies with approved label Includes required key components
A copy of the regulation can be found here: https://www.federalregister.gov/articles/2015/06/03/201513393/veterinary-feed-directive
VFD REQUIREMENTS Issued by a licensed veterinarian based on a valid veterinarianclient-patient relationship (VCPR) •
Issuing DVM must: –
Be licensed to practice veterinary medicine in state where animals are fed
Be operating in the course of the veterinarian’s professional practice and in compliance with all applicable veterinary licensing and practice requirements
Issue a VFD in the context of a VCPR as defined by the state where the animals are fed
Federal Regulation on VCPR: http://www.gpo.gov/fdsys/pkg/CFR-2015title21-vol6/pdf/CFR-2015-title21-vol6-part530.pdf
– The following link provides a state by state list: • http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/ucm4604 06.htm
Complies with approved label •
Extra-label use of medicated feed, including medicated feed containing a VFD drug or a combination VFD drug, is not permitted.
The VFD must include the statement: “Use of feed containing this veterinary feed directive (VFD) drug in a manner other than as directed on the labeling (extra-label use) is not permitted.”
VFD REQUIREMENTS Includes required key components
Veterinarian/Client information Medication information Animal information
CATTLE: AUREO® S 700 DRAFT VFD FORM
SWINE: AUREOMIX® S 40/40 DRAFT VFD FORM
VFD: STEPS TO IMPLEMENT BY JAN. 1, 2017
SUGGESTED NEXT STEPS FOR PRODUCERS Get ready to implement by Jan. 1, 2017 Establish a valid veterinarian-client-patient relationship (VCPR) Review list of current medications to determine what might require a VFD Begin discussions about how the new VFD regulation will impact use of products Have operations create a VFD “lead” Discuss record-keeping procedures WE ARE COMMITTED TO SUPPORTING YOU IN THE RESPONSIBLE USE OF ANTIBIOTICS AND PREPARING FOR A SMOOTH TRANSITION TO THE NEW VFD REQUIREMENTS. 18
TRANSITION LABELING •
Transition labeling will begin to appear in the market early to mid-2016.
Sponsors must submit all revised labeling to Center for Veterinary Medicine
Dec 8-10, 2016
Removal of growth promoting claim from medically important medicated feed additives begins
Jan 1, 2017
New VFD label requirements are instituted
TRANSITION LABELING DURING 2016*
* Transition labeling could be seen during the first half of 2016 21
FINAL LABELING BEGINNING Jan. 1, 2017
“Caution: Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian.”
“Use of feed containing this veterinary feed directive (VFD) drug in a manner other than as directed on the labeling (extra-label use) is not permitted”
FDA Inspection (Feed Distributor/DVM) • First Stop is the Feed Dealer/Distributor and they will obtain several VFD’s – The inspector will review the VFD’s for accuracy (Is the form filled out correctly) – At the feed dealer the inspector will also check for the submission of a distribution letter, possession of necessary acknowledgement letters, proper VFD document storage (2 years), proper label statements, and then routine feed mill GMP issues.
• DVM Questions: – Is the DVM licensed in the states VFD is being fed? – Does the DVM know the VCPR requirements in their state and or federal requirements and can they demonstrate proper VCPR with the location getting medicated feed? – Does the veterinarian keep copies of the VCPR as required by regulation. 23
FDA Inspection: Producer • Does the client keep copies of VFD orders for at least 2 years? • Did the client feed the VFD feed to the authorized number of animals on the VFD order? • Did the client feed the VFD feed for the identified duration on the VFD order? • Did the client stop feeding the VFD feed prior to the expiration date on the VFD order? • Did the client follow the withdrawal period for the VFD feed, if any? • Did the client follow any special instructions or caution statements on the VFD order, if any? • If a combination VFD feed was fed, was its use consistent with the affirmation statement on the VFD order? • Does the client have labels for VFD feeds? If Yes, – Does the feed label contain the VFD Caution statement? – Did the drug level on the label match the drug level on the VFD form? – Is the drug level and indication on the VFD form consistent with the approval?
VFD: KEY TAKEAWAYS AND RESOURCES
VFD: KEY TAKEAWAYS As of Jan. 1, 2017, all medicated feed additives containing medically important antibiotics must be prescribed through a VFD.
No extra-label use of products. All VFDs will have a maximum of a six-month expiration date (unless otherwise noted on the product label).
The veterinarian, distributor and client all must maintain a copy of VFD records for two years.
A VCPR should be established. Caution statements will be required: “Caution: Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian.” 26
ZOETIS RESOURCES ResponsibleAntibioticUse.com
Thank you John W. Hallberg, D.V.M., PhD Director, US Regulatory Affairs 333 Portage Street, KZO-300-403SW, Kalamazoo, MI 49007 Office: 269.359.9210 Mobile: 269.760.1948 [email protected]