As everyone hopefully knows by now, the United States Food and Drug Administration (FDA) has issued a final rule revising the regulations governing the Veterinary Feed Directive (VFD).1 These changes to the VFD are a key part of FDA’s strategy to ensure these drugs are used judiciously and only when appropriate for specific animal-health purposes.
These regulatory changes, in conjunction with the implementation of Guidance for Industry (GFI) #2092 and GFI #213,2 are designed to eliminate the growth-promotion uses of medically important antimicrobials and enhance veterinary oversight of antimicrobial use in livestock. Pharmaceutical manufacturers have agreed to voluntarily remove the feed efficiency indications from affected product labels by December 2016. The new VFD rules take effect on October 1, 2015. This means that after that date, the use of any feed-grade antimicrobials with a VFD label will be subject to the new rules. This includes tilmicosin, florfenicol, and avilamycin, which are all currently VFD drugs labeled for use in swine.
A list of “medically important” antimicrobials can be found in FDA’s Guidance #152 Appendix A.2 Basically, all swine antibiotics will be affected except bacitracin, carbadox, bambermycin, ionophores, and tiamulin. These antibiotics will remain available for growth promotion or over-the-counter (OTC) distribution or both.
In order to comply with the new VFD rules, the veterinarian must
- Be licensed and operating in the course of normal practice in compliance with all state and federal regulations;
- Write VFD orders in the context of a veterinary-client-patient relationship (VCPR) as discussed below;
- Only issue a VFD that is in compliance with approved use;
- Prepare a written (nonverbal) VFD including the veterinarian’s signature;
- Ensure the VFD includes all required information (shown in Box 1). There is no FDA-approved standardized VFD form;
- Include certain drug-specific information for each VFD drug when authorizing drug combinations that include more than one VFD drug;
- When issuing a VFD combining VFD and OTC drugs, include on the VFD order an affirmation of intent either to restrict authorized use only to the VFD drug cited on the VFD form or to allow the use of the cited VFD drug in an approved combination with one or more OTC drug(s);
- Provide the distributor and client with a copy of the VFD order either in hardcopy or electronic form or by fax;
- Retain the original VFD for 2 years (the client and distributor must likewise retain their copies for 2 years); and
- Provide the VFD orders for inspection and copying by FDA upon request.
In addition, it should be emphasized that extra-label use of feed-grade antimicrobials remains ILLEGAL for both veterinarians and producers.
A valid VCPR must exist between the veterinarian, the client, and the animals to be treated in order to issue a VFD. However, there are numerous versions of the VCPR requirements, including versions associated with federal regulations governing extra-label drug use, the American Veterinary Medical Association’s model practice act, and state veterinary practice acts. For the purposes of issuing a VFD, FDA defaults to the VCPR requirements defined in the state veterinary practice act provided those requirements meet the following minimum standards:
1. The veterinarian has engaged with the client to assume responsibility for making clinical judgments about patient health,
2. The veterinarian has sufficient knowledge of the patient by virtue of patient examination, visits to the facility where the patient is managed, or both, and
3. The veterinarian is available to provide for any necessary follow-up evaluation or care.
If the state practice act either does not include a VCPR requirement or does not meet those minimum standards, the VCPR requirement to issue a VFD defaults to the VCPR as defined in association with the Animal Medicinal Drug Use Clarification Act (21 CFR § 530.3[i]).3 The FDA will compile a list of states that require a VCPR that includes the key elements of the federally defined VCPR in order for a veterinarian to issue a VFD. This list will be provided online.
Additional changes of interest
1. The veterinarian must assign an expiration date to the VFD. This date refers to the length of time during which the VFD is valid and the producer can feed the VFD feed, not the date on which the drug expires. The expiration date must comply with the VFD expiration date indicated on the VFD drug label if the product specifies an expiration date (the veterinarian cannot deviate from this date). If the product label does not indicate a specific date, the veterinarian must assign a date not to exceed 6 months from the date of issue.
2. There has been much discussion regarding refills. The veterinarian must specify the number of refills if refills are allowed according to the VFD drug label. Currently, there are no approved medications for which refills are allowed on the label. Thus, refills are illegal unless a future product approval allows refills.
3. The veterinarian issuing the VFD must comply with the veterinary practice act regulations in effect in the state in which the animals reside that are to receive the VFD feed.
4. In contrast to the current VFD requirements, the new rule requires that the veterinarian estimate the number of animals that will receive the VFD feed, rather than the volume of feed that needs to be produced.
5. In another change, the VFD may now be transmitted to the feed manufacturer or distributor and to the client electronically (eg, by fax or through a compliant third-party electronic database, but not by telephone) instead of only by hard copy. The veterinarian retains the original copy in whatever format it was generated. The distributor and client copies may be kept either as electronic copies or hard copy. All copies of the VFD must be retained for a minimum of 2 years by the veterinarian, client, and distributor.
6. If any drug in an approved combination drug product is a VFD drug, the use of that combination must comply with the VFD rule.
7. The veterinarian may write a VFD that covers animals in multiple locations (animal-production facilities) to be fed the VFD feed by the expiration date on the VFD, provided he or she can do so in compliance with professional licensing and practice standards and provided the VFD feed is supplied to such multiple locations by a single feed manufacturer (distributor).
8. Electronic VFD orders issued by veterinarians must be compliant with 21 CFR part 11,4 and electronic VFD orders received and electronically stored by distributors and clients must also be compliant with 21 CFR part 11,4 which does not apply to paper records that are, or have been, transmitted by electronic means (such as facsimile, e-mail attachments, etc).
9. There are additional requirements to meet if a veterinarian also distributes VFD feed.
In summary, effective October 1, 2015, all VFD-labeled products must comply with the new VFD rules. I have attempted to highlight the key responsibilities of the veterinarian, but I urge you to familiarize yourselves with the regulation. The FDA has compiled a fact sheet describing the background and reasons for the changes to the VFD.5 The agency has also published an additional draft guidance document, GFI #120,6 which answers many of the most frequently asked questions. All these documents can be found online as referenced.
1. Federal Register. Final Rule: Veterinary Feed Directive. Available at: https://www.federalregister.gov/articles/2015/06/03/2015-13393/veterinary-feed-directive. Accessed 14 July 2015.
2. Food and Drug Administration. Antimicrobial resistance. Available at: http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/ucm123614.htm. Accessed 18 July 2015.
3. Animal Medicinal Drug Use Clarification Act of 1994. Available at: http://www.ecfr.gov/cgi-bin/text-idx?SID=054808d261de27898e02fb175b7c9ff9&node=21:22.214.171.124.16&rgn=div5#se21.6.530_13. Accessed 14 July 2015.
4. US Food and Drug Administration. 21 CFR Part 11 compliance. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11. Accessed 14 July 2015.
5. US Food and Drug Administration. VFD Final Rule Fact Sheet. Available at: http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/ucm449019.htm. Accessed 14 July 2015.
6. US Food and Drug Administration. Guidance #120 VFD Frequently Asked Questions. Available at: http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM052660.pdf. Accessed 14 July 2015.