Source: https://www.aasv.org/jshap/issues/v25n1/v25n1advocacy.html
Timestamp: 2018-01-18 15:42:26
Document Index: 663088515

Matched Legal Cases: ['§530', 'art 11', 'art 11', 'art 11', 'art 11', 'art=11']

Advocacy in action: Change – the one constant (Jan '17)
It’s a time of change. I thought this might be a good opportunity to review some of the critical aspects of the new world order involving feed-grade antibiotics. In the process of recovering from your New Year’s celebration and focusing on the presidential inauguration, it may have slipped your mind that the revised regulations governing the Veterinary Feed Directive (VFD)1 have now taken full effect. The manufacturers agreed to remove the growth promotion claims from their product labels and transition all medically important feed grade antibiotics to VFD status by December 31, 2016.
These regulatory changes, in conjunction with the implementation of Guidance for Industry (GFI) #209 and #213,2 are designed to eliminate the growth promotion uses of medically important antimicrobials and enhance veterinary oversight of antimicrobial use in livestock. This means that as of January 1, the use of any feed-grade antibiotic with a VFD label is subject to the new rules. This includes tilmicosin, florfenicol, and avilamycin, which were all approved as VFD drugs, as well as most other products traditionally marketed over-the-counter (OTC).
A list of “medically important” antimicrobials can be found in FDA’s Guidance #152 Appendix A.3 Basically, all swine antibiotics were affected except bacitracin, carbadox, bambermycin, ionophores, and tiamulin. These antibiotics will remain available for growth promotion and (or) OTC distribution.
ensure the VFD includes all required information (refer to the list in the AASV VFD brochure4). While there is no FDA-approved standardized VFD form, the agency did provide a sample form that veterinarians can use. In addition, many of the drug manufacturers have also produced forms for their specific VFD drugs. Access to all these sample forms is available on the AASV VFD Web page.5
provide the distributor and client with a copy of the VFD order either in hard copy or electronic form or by fax;
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:
The veterinarian has engaged with the client to assume responsibility for making clinical judgments about patient health,
The veterinarian has sufficient knowledge of the patient by virtue of patient examination and (or) visits to the facility where the patient is managed, and
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).6 The FDA has compiled 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 available on the FDA Web site.7
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.
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.
The veterinarian issuing the VFD must comply with the veterinary practice act regulations in effect in the state in which the animals that are to receive the VFD feed reside.
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.
In another change, the VFD may now be transmitted to the feed manufacturer-distributor and to the client electronically (ie, 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.
If any drug in an approved combination drug product is a VFD drug, the use of that combination must comply with the VFD rule.
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).
Electronic VFD orders issued by veterinarians must be compliant with 21 CFR part 11, and electronic VFD orders received and electronically stored by distributors and clients must also be compliant with 21 CFR part 11.8 Part 11 of 21 CFR does not apply to paper records that are, or have been, transmitted by electronic means (such as facsimile, e-mail attachments, etc).
There are additional requirements to meet if a veterinarian also distributes VFD feed.
It should also be noted that as of January 1, all medically important water medications transitioned from OTC to prescription status. What this means is that access to these products will now have to comply with the pharmacy laws in each individual state, just like any other prescription product. You will need to refer to the individual state veterinary practice acts and state pharmacy laws to determine how to legally prescribe and dispense water medications.
In summary, as of January 1, 2017 all VFD-labeled products became subject to the new VFD rules and all medically important water medications transitioned to prescription status. Additionally, all growth-promotion claims were removed from all medically important antibiotics, making it illegal to utilize those products for the purpose of growth promotion. 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.9 The agency has also published an additional draft guidance document, GFI #120, which answers many of the most frequently asked questions.10 All these documents can be found online, as referenced below. In addition, AASV has a wealth of information available on the AASV VFD Web page including a series of frequently asked questions with the official responses from FDA.5
1. Final Rule: Veterinary Feed Directive. Available at https://www.federalregister.gov/articles/2015/06/03/2015-13393/veterinary-feed-directive. Accessed 11 November 2016.
2. Guidance for Industry #213. Contains Nonbinding Recommendations. Guidance for Industry. New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions with GFI #209. Food and Drug Administration. Available at http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM299624.pdf. Accessed 1 December 2016.
3. FDA Guidance for Industry #152. Available at http://www.fda.gov/downloads/ AnimalVeterinary/GuidanceCompliance Enforcement/GuidanceforIndustry/ucm052519.pdf. Accessed 11 November 2016.
4. Changes in the Veterinary Feed Directive (VFD): What the swine veterinarian needs to know. https://www.aasv.org/documents/VFD.pdf. Accessed 11 November, 2016.
5. AASV Veterinary Feed Directive. Available at https://www.aasv.org/aasv%20website/Resources/Antimicrobial%20Use/VFD.php. Accessed 11 November 2016.
6. Animal Medicinal Drug Use Clarification Act of 1994. Available at http://www.ecfr.gov/cgi-bin/text-idx?SID=054808d261de27898e02fb175b7c9ff9&node=21:6.0.1.1.16&rgn=div5. Accessed 11 November 2016.
7. FDA listing of state VCPR requirements. Available at http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/ucm460406.htm. Accessed 11 November 2016.
8. 21 CFR Part 11 compliance. Available at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11. Accessed 11 November 2016.
9. VFD Final Rule Fact Sheet. Available at http://www.fda.gov/AnimalVeterinary/ DevelopmentApprovalProcess/ucm449019.htm. Accessed 11 November 2016.
10. Guidance #120 VFD Frequently Asked Questions. Available at http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM052660.pdf. Accessed 11 November 2016.