Veterinary Feed Directive Final Rule Effective Oct. 1; FDA Issues Final VFD Guidance

Source: American Feed Industry Association

The U.S. Food and Drug Administration published a final rule on the veterinary feed directive June 3. The rule will go into effect Oct. 1. There are several primary changes required by the final rule; however, the changes to growth promoting antimicrobials requested by FDA will not take place until late next year with an effective date of Jan. 1, 2017, when VFDs will be required for use of such drugs. The American Feed Industry Association will be addressing existing inventory at a later date.

FDA has provided a pre-publication copy of the final Guidance for Industry on VFD that contains updated questions and answers. It can be accessed here. There are minor changes made from the draft issued in June.

AFIA with the National Grain and Feed Association met with FDA on Sept. 24, to discuss certain VFD form concerns and other issues related to the implementation of the final rule on Oct. 1. During the meeting, FDA stated it will allow at least an additional month for changes to be implemented before enforcement begins. This will allow firms until the end of October to make the changes. After the meeting, AFIA and NGFA filed a joint letter asking FDA for a total of three months (until Jan. 1, 2016) to implement the required changes detailed below. AFIA will keep you apprised of FDA's decision.

The VFD final rule requirements involve changes to the VFD form, who maintains the original VFD copy (the veterinarian writing the VFD) and how FDA controls the veterinarian/patient/client relationship--which is not a function of feed distributors.

The primary changes to the VFD form can be found here on the draft form. The changes involve the following after Oct. 1:

The veterinarian must change items on the form as follows:

• The species and class of animals to be treated must be added.

• There is no longer a requirement for the veterinarian to determine the amount of Type C medicated feed to be added. This will be determined by the feed distributor.

• The veterinarian's license number and state are no longer required on the form.

• The veterinarian's intention statement for approved combination drugs is a new requirement and the following statements must be added to the form, and one of the statements must be marked (for combinations only). They are as follows:

• "This VFD only authorizes the use of the VFD drug(s) cited in this order and is not intended to authorize the use of such drug(s) in combination with any other animal drugs."

• "This VFD authorizes the use of the VFD drug(s) cited in this order in the following FDA-approved, conditionally approved or indexed combination(s) in medicated feed that contains the VFD drug(s) as a component.'' [List specific approved, conditionally approved or indexed combination medicated feeds following this statement.]

• "This VFD authorizes the use of the VFD drug(s) cited in this order in any FDA-approved, conditionally approved or indexed combination(s) in medicated feed that contains the VFD drug(s) as a component." AFIA suggests the veterinarian mark the third statement to allow the feed mill to determine what drugs are approved for use in combination with a VFD drug.

• After the VFD legend statement at the bottom of the VFD form, the following statement must be added: "Use of feed containing this veterinary feed directive drug in a manner other than as directed on the labeling (extralabel use) is not permitted."

The final rule directs the veterinarian to maintain the original copy and copies be provided to the producer and feed distributor (see questions below). VFD forms must be maintained for two years from the expiration date of the VFD.

Other issues regarding expiration date, delivery of feed and method of retaining VFD copies are covered in details below of a meeting with FDA officials earlier this month. Some questions were unanswered and will be taken up at a later date. These were deemed not essential for the implementation of the final rule at this time.  

During the meeting with FDA, NGFA and AFIA asked a series of questions on the VFD form, and stated concerns and other issues related to the implementation of the final rule on Oct. 1. Below are the questions posed and answers provided.

Question 1. We believe over time VFDs will come mostly via one of the electronic systems. However, in the lead up to that, we think many will be by multi-pack carbon with the feed mill getting the last carbon. Why did that change? It was not in the proposed rule and it will likely lead to some mistakes due to the nature of the no carbon required packets.

Answer: FDA made this change to reinforce the "original" VFD order under the revised regulation that no longer needs to be provided to the VFD feed distributor within five days. FDA will further evaluate this issue.

Question 2. We've heard differing answers to the following issue. If a veterinarian writes a lawful VFD, scans it and sends it to the feed distributor or producer, does the veterinarian have to use a Part 11 (21 CFR, Part 11) compliant system? The guidance was unclear. If so, can we get something started on Part 11 deletion from this rule as was done with the Food Safety Modernization Act final rules (a petition perhaps)?

Answer: If the VFD order is created electronically, then the electronic system used must be Part 11 compliant. A veterinarian may handwrite a VFD order, scan the order and send via an electronic system that is not Part 11 compliant. Electronic VFD orders received by the feed distributor (i.e., from a Part 11 compliant system or scan of paper VFD order sent as email attachment) may be stored electronically by the feed distributor only if the electronic storage system is Part 11 compliant. Otherwise, the electronic VFD order received by the feed distributor must be printed as a paper copy and stored.

FDA indicated a willingness to re-visit this issue. For example, the new preventive controls rule for animal food allows required records to be created and stored electronically via non-compliant Part 11 systems.

Question 3. We have some issues with when products can be shipped to a producer's facility. AFIA was told originally that VFD-containing feeds could be shipped to a producer's operation but not to the facility where the animals were located unless the producer had a valid VFD. That's particularly problematic for many operations, especially aquaculture ones, where there are few aquatic health professionals, limited feed mills stocking aqua drugs and long distances frequently from those feed distributors to the producers. Can producers receive VFD feeds, but hold them apart from the animals until a VFD is received?

Answer: If the animal producer is a distributor, as defined by the regulation, then the producer can receive VFD feed without a VFD order. If the animal producer is a distributor, they are obligated to complete and send the required "one-time distributor notification" to FDA and provide the required written "acknowledgement letter" to the shipping distributor.

If the animal producer is not a distributor, then the producer needs a VFD order to receive a VFD feed, either Type B or Type C. However, the producer's feed mill can receive Type A medicated articles (premixes) with an acknowledgement letter and notice to FDA. To receive a Category II, Type A premix, the producer's feed mill also must have an approved medicated feed mill license.

FDA maintains on its website a publically available list of parties that have provided the agency VFD distributor notifications.

Question 4. Similarly, we've been told that Type B supplements cannot be shipped to a producer without a valid VFD. As VFDs do not work with a Type B, how can this work? Many producers have grind and mix and need Type B products on hand to use quickly when there's an outbreak after receiving a valid VFD.

Answer: FDA addresses this issue within the revised VFD rule (80 FR 31708 at 31713):

"When a Type B VFD feed is distributed to a client-recipient (animal producer), the animal producer may manufacture a Type C VFD feed to either feed the VFD feed to his or her own animals and/or further distribute the Type C VFD feed to another distributor or client-recipient. If the Type B VFD feed is being shipped to an animal producer who is not a distributor, the animal producer must provide a VFD for the receipt of the Type B VFD feed from the distributor. If the Type B VFD feed is being shipped to an animal producer who is a distributor that has sent a one-time notification to FDA, the animal producer must supply either an acknowledgment letter or a VFD for the receipt of the Type B VFD feed from the distributor. (Note: In order for the animal producer to receive a Type B or Type C VFD feed without a VFD in hand, he or she must have previously notified FDA that he or she is a distributor.) If the animal producer provides an acknowledgment letter to the distributor from whom the animal producer receives the VFD feed, the animal producer must either receive an acknowledgment letter or a VFD prior to further distributing the VFD feed to another person, or have a VFD on hand prior to feeding the Type C VFD feed to his or her own animals. The definition of acknowledgment letter in (§558.3(b)(11)) clarifies that when an animal producer is acting as a distributor as defined in (§ 558.3(b)(9)), they may provide an acknowledgment letter even if they are the ultimate user of some of the VFD feed."

FDA also provided the following additional information about this issue:

• VFD notification and acknowledgement letter requirements apply to Type B and C medicated feeds, not to Type A medicated articles.

• If a VFD order is written for a Type C feed, the VFD feed distributor may provide the appropriate Type B feed to the producer to accommodate the VFD order, so as long as the Type B VFD feed has the same drug and the same indications for use as the Type C VFD order.   

Question 5. The feed industry has been operating under the impression that the expiration date on the VFD was the last date it could be mixed, just like a Rx from a doctor. Now FDA is saying this date is the last date the VFD-drug can be used. This becomes a problem when we realize the feed will not be completely fed by that date. Should the feed be shipped and notice be given that the producer needs to contact the veterinarian about continuing to use after the expiration date, as all of the feed can be made and shipped in most cases?

Answer: FDA expects the course of treatment of animals (feeding of VFD feed) is to end on or before the expiration date of VFD order.

Final Guidance #120 provides additional information on this issue:

• Page 21: 4. Can a client (producer) feed a VFD feed past the VFD expiration date? No. A VFD feed or combination VFD feed must not be fed to animals after the expiration date on the VFD (21 CFR 558.6(a)(2)).

• Page 22: 5. I have a VFD order that I would like to use to feed a VFD feed, but the order will expire before I can complete the duration of use on the order, what should I do? The client should contact his/her veterinarian to request a new VFD order. A VFD feed or combination VFD feed must not be fed to animals after the expiration date on the VFD (21 CFR 558.6(a)(2)).

FDA indicated that it would not hold a VFD feed distributor liable if it distributes a quantity of VFD feed that the producer does not completely feed by the expiration date of the VFD order. The producer is not permitted to feed a VFD feed after the expiration date of a VFD authorizing feeding of distributed VFD feed.

Question 6. Guidance #120 indicates that VFD feed distributed to multiple premises needs to come from a single distributor. We think that should be changed to provide greater flexibility to feed companies. Is that possible?

Answer: FDA's position is that a given VFD order should be associated with only three parties-producer, veterinarian and a single VFD feed distributor. If the animals that are to receive VFD feed are located in such a manner the VFD feed will be provided by multiple VFD feed distributors, then FDA requires a separate VFD order to be written for each VFD feed distributor.

Question 7. How do the VFD regulations affect extra-label use of medicated feeds for minor species? Is FDA going to act on the AFIA/National Aquaculture Association/Animal Health Institute petition from 2008 that addresses this issue?

Answer: We did not have time to address this question during the meeting. However, extra-label drug use of VFD feeds is not currently allowed.

Question 8. Can a VFD order received via email be lawfully stored in a feed distributor's computer system that is not Part 11 compliant? 

Answer: No, not under the current requirements. See question 2 above.

Question 9. Has FDA's Center for Veterinary Medicine decided how the veterinarian can notate that a generic may be authorized when a pioneer drug is listed on the VFD?

Answer: FDA addresses this issue within the revised VFD rule as follows (80 FR 31708 at 31720): 

"The veterinarian is required to write the name of the VFD drug on the VFD. The veterinarian may choose to write the name of the pioneer or a generic (if available) VFD drug to complete this requirement. The veterinarian may choose to specify that a substitution by the feed manufacturer of either the pioneer or generic VFD drug identified on the form is not allowed. If the veterinarian does not specify that a substitution is not allowed, the feed manufacturer may use either the approved pioneer or an approved generic VFD drug to manufacture the VFD feed. However, the feed manufacturer may not substitute a generic VFD drug for a pioneer VFD drug in a combination VFD feed if the generic VFD drug is not part of an approved combination VFD drug."

Question 10. Most veterinarians will not have the new VFD forms on Oct. 1. Can feed mills continue to work with the old forms if they don't involve combinations? Does CVM expect a soft implementation period for some months?

Answer: Yes, FDA will provide appropriate regulatory discretion during the transition, at least until the end of October.

Question 11. If a firm is manufacturing an investigational new animal drug product containing an antimicrobial, would a VFD be required?

• Major species

• Minor species

Answer: We did not have time to address this question during the meeting.

Question 12. If a clearance for a drug is expressed in mg/hd/day, the correct amount of drug can be delivered by an endless variety of feeding rates. Using chlortetracycline at 350 mg/hd/day as example, a customer could feed a 1 lb/hd/day product that contains 700 g/t, a 0.5 lb/hd/day product containing 1,400 g/t or a 0.25 lb/hd/day product containing 2,800 g/t. When visiting with his vet, a customer may not have made up his mind as to what feeding rate he intends to feed.

How does a vet express feeding rate/concentration options on the forms if they are written in strictly a g/t option?

How or WHY does a vet need to know what the feeding/grams per ton rate will be if the correct amount of drug is delivered to the animal (350 mg/hd/day)?

Answer: We did not have time to address this question during the meeting.

FDA asked that industry continue to provide questions/raise issues that FDA may address in its final guidance.

For more information or concerns, please contact Richard Sellers, AFIA senior vice president of legislative and regulatory affairs, at (703) 558-3569.