I received the following message from AFIA regarding a VFD form that had been available on the American Veterinary Medical Association (AVMA) website. If you accept VFD’s : Continue reading “AVMA VFD Form removed from website…”
It has been 15 months since the changes in VFD drugs has taken effect. Inspections are happening. Are you a VFD Manufacturer or a VFD Distributor who has yet to receive or process a VFD? Are you thinking it is not something you will ever need to do? Are you wondering how to get off the list? This is how you can do that…
January 1, 2017 marked the beginning of an expanded list of drugs that fall under VFD regulation. Click here to watch an FDA’s overview video on this rule and its importance to the industry.
CFD’s membership in AFIA affords us the opportunity to offer our membership valuable training tools offered to AFIA members. Due to high demand, AFIA created a training module on VFD preparedness, which targets retail distributors (i.e. farm stores and co-ops), something previously unavailable.
Used with permission by AFIA.
On Jan. 1, 2017, certain antimicrobial drugs of human medical importance will change marketing status from over-the-counter to Veterinary Feed Directive (VFD). The American Feed Industry Association supports the judicious use of antimicrobial drugs and is working to ensure members are prepared for the upcoming change. AFIA is notifying members of new resources available to help ensure all groups are fully prepared to comply with the VFD rule.
Through recent efforts within the industry, there have been many resources and trainings for veterinarians and feed distributors. Much of this information has not been disseminated to the small producers and feed distributors, however. The Farm Foundation, NPF has partnered with the Animal Health Institute (AHI) to develop educational resources for producers, feed distributors and veterinarians. The first resource is a website containing educational materials from various sources.
The Farm Foundation and AHI have a campaign to inform farmers and ranchers of the pending changes. Information is disseminated through a series of informational radio interviews circulated through the news service of the National Association of Farm Broadcasters.
A point-of-sale card has been created, which is designed to alert producers of the Jan. 1, deadline and the need to prepare. The card refers people to the website for more detailed information. It can be placed in the feed section and/or at a checkout counter and is available in three formats:
Used with permission by AFIA.
CFD recently sent information on requirements for FDA notification and supplier acknowledgements. There are a number of information sessions being conducted by various organizations. When members have attended those they have provided additional information to CFD and we appreciate that… The following is noteworthy…
- Documentation required for a VFD can only be stored electronically when in compliance with Federal Rules known as Part 11. This is essentially a secured server environment. CFD recommends that all documentation be maintained on paper initially. AFIA is working with the FDA to eliminate this mandate and we will keep you posted.
- VFD cannot provide for automatic refills. The time period is limited to 6 months.
- Pulsing regiments are not permitted.
- To use Bovatec in conjunction with a VFD drug the VFD must include that direction.
- Record retention requirements for documentation vary by state. Federal requirements are 2 years.
“Over the past several years, the FDA has taken important steps toward fundamental change in how medically important antibiotics can be legally used in feed or water for food-producing animals. Now, the agency is moving to eliminate the use of such drugs for production purposes (i.e., growth promotion and feed efficiency) and bring their remaining therapeutic uses in feed and water under the supervision of licensed veterinarians – changes that are critical to ensure these drugs are used judiciously and only when appropriate for specific animal health purposes. The Veterinary Feed Directive (VFD) final rule is an important part of the agency’s overall strategy to ensure the judicious use of medically important antimicrobials in food-producing animals”.
As a feed manufacturer or a store that sells medications fed to animals that fall under this law what do you need to do?
Step 1: Identify the medications, combinations, premixes and products that require a VFD. At the 2016 CFD annual meeting Dr. Eric Reid presented a list of the most common drugs used by members that will now require a VFD:
– Hyrgomycin B
This list is not all inclusive, some have trade names, some are part of a product where the other ingredient doesn’t need a VFD, but those products will still need a VFD. Be diligent in finding out which products will need a VFD. See below for more information from CFD to define these requirements…
Step 2: Register with the FDA: There is a one-time registration requirement. To comply, send a letter to the FDA stating that your company is a distributor or animal feed products under 21 CFR part 558 Veterinary Feed Directive. Include: your company name and business address; signature and date of at least one owner. Mail the notification to:
Food and Drug Administration
Center for Veterinary Medicine
Division of Animal Feeds (HFV-220)
7519 Standish Place
Rockville, MD 20855 or faxed to: 240-453-6882
Step 3: Define a process for obtaining and retaining VFD documents. Key components of this process should include:
- Obtaining the VFD prior to manufacturing the feed.
- VFD must be written and signed by a Veterinarian.
- It can be a paper document or sent electronically.
- It can be delivered by the Veterinarian, Customer or a Nutritionist.
- Must contain specific information: Refer to this website for details: http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/ucm455415.htm
- Can only be used for the specified time period.
- Must be retained for 2 years.
Step 4: Train employees: All employees who receive and process orders must be trained in this requirement.
CFD Commonly Ordered Items:
|Item #||Description||Item #||Description|
|1100010||Aureomycin 4 g 5 lb.||1800654||Tylan 40|
|1100034||Aureomycin 4G 50 lb||1800411||Neo/Terra 10/10|
|1104042||AS 700 2g||1800006||Aureomix S 10/10|
|1104046||AS 700 3.5g||1800005||Aureo SP 250|
|1800651||Aureomycin 100||1104038||Terramycin 4 g|
|5575320150||Scours & Pneumonia Treatment Concentrate 50#||1104044||CTC 10 g|
|0232123||Scours & Pneumonia Treatment Concentrate 20#||1800648||Aureo 50|
|5575320239||Scours & Pneumonia Treatment Concentrate 4.34#||1800649||Aureo 90|
|1117530||Scours & Pneumonia Treatment 6.4 oz||1100020||Aureo 20 g|
|1127530||Scours & Pneumonia Treatment 6#||1800688||Sulmet 12.5% liquid|
|2500101||CFD 20-20 AM with OTC (to be discontinued by MFG)||1800576||Terramycin Scour tabs|