The use of medically important antimicrobial drugs in food-producing animals should be limited to those uses that are considered necessary for assuring animal health.

Further defines Medically Important Antimicrobials as outlined in GFI #152.

The use of medically important antimicrobial drugs in food-producing animals should be limited to those uses that include veterinary oversight or consultation.

Guidance for animal pharmaceutical companies to voluntarily revise the FDA-approved use conditions on the labels of medically important antimicrobial drugs to remove production indications.

• Voluntarily remove label indications for production uses:
  • “increased rate of weight gain”
  • “improved feed efficiency”
     
• Remaining labels will be for therapeutic uses:
  • “treatment”
  • “control”
  • “prevention” 

Change the current over-the-counter (OTC) status to bring the remaining appropriate therapeutic uses under veterinary oversight for medically important antimicrobial drugs

• Change from OTC to veterinary feed directive (VFD) status for medicated feed products
  • Drugs Transitioning from OTC to VFD Status
    
     
• Change from OTC to veterinary prescription (Rx) status for medicated drinking water products
  • Link on Drugs Transitioning from OTC to Rx  

The new rules and changes only affect medically important antimicrobials.  There are a number of important products used and delivered through feed or water that will not be affected by the changes, including:

Expect to see some transitional labeling before and after the Jan 1, 2107 date as the manufacturing process works the new labels into the production system. For example:

Source: https://mwi.naccvp.com/product/view/3690440

Definition - A VFD is a written (nonverbal) statement issued by a licensed veterinarian in the course of the veterinarian’s professional practice that authorizes the use of a VFD drug or combination VFD drug in or on an animal feed. This written statement authorizes the client (the owner of the animal or animals or other caretaker) to obtain and use animal feed bearing or containing a VFD drug or combination VFD drug to treat the client’s animals only in accordance with the conditions for use approved, conditionally approved, or indexed by the FDA. A VFD is also referred to as a VFD order.

Source: http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/ucm455416.htm

FDA approves drugs in these two separate regulatory categories for drugs that require veterinary supervision and oversight for their use. When the drug being approved is for use in or on animal feed (a medicated feed), FDA approves these drugs as a VFD drug. When the drug being approved is not for use in or on animal feed, the drug is approved as a prescription drug.

When the VFD drug category was created, the Act made it clear that VFD drugs are not prescription drugs. This category was created to provide veterinary supervision without invoking state pharmacy laws for prescription drugs that were unworkable for the distribution of medicated feed.

Source: http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/ucm455416.htm

Prescription (Rx) products and Veterinary Feed Directive (VFD) drugs can be dispensed only by or upon the lawful written order of a licensed veterinarian.

• Rx products must bear the legend:
  • "Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian."
     
• Veterinary Feed Directive (VFD) drugs, combination VFD drugs, and feeds containing VFD drugs or combination VFD drugs must prominently and conspicuously display the following cautionary statement:
  • ‘‘Caution: Federal law restricts medicated feed containing this VFD drug to use by or on the order of a licensed veterinarian.’’
     

Source: http://www.fda.gov/AnimalVeterinary/ResourcesforYou/ucm268128.htm#Classifying_RX_and_OTC_Animal_Drugs

http://www.gpo.gov/fdsys/pkg/FR-2013-12-12/pdf/2013-29696.pdf

Use of a VFD feed requires the professional supervision of a licensed veterinarian. 

The veterinarian-client-patient relationship (VCPR) is the basis of professional supervision. Veterinarians who issue a VFD order must practice veterinary medicine in compliance with all applicable veterinary licensing and practice requirements, including issuing the VFD in the context of a VCPR as de?ned by the state. If applicable VCPR requirements as de?ned by such state do not include the key elements of a valid VCPR as de?ned by Federal law, the veterinarian must issue the VFD in the context of a valid VCPR as de?ned by the Federal law.

For a list of State vs. Federal VCPR requirement application see:  http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/ucm460406.htm

For resources on establishing a VCPR and associated documents see: http://cares.dairyknow.umn.edu/best-practices/drug-residues/

• must be licensed to practice veterinary medicine;
• must be operating in the course of the veterinarian’s professional practice and in compliance with all applicable veterinary licensing and practice requirements;
• must write VFD orders in the context of a valid client-patient-relationship (VCPR);
• must issue a VFD that is in compliance with the conditions for use approved, conditionally approved, or indexed for the VFD drug or combination VFD drug;
• must prepare and sign a written VFD providing all required information;
• may enter additional discretionary information to more specifically identify the animals to be treated/fed the VFD feed;
• must include required information when a VFD drug is authorized for use in a drug combination that includes more than one VFD drug;
• must restrict or allow the use of the VFD drug in combination with one or more OTC drug(s);
• must provide the feed distributor with a copy of the VFD;
• must provide the client with a copy of the VFD order;
• must retain the original VFD for 2 years, and
• must provide VFD orders for inspection and copying by FDA upon request.

USDA Brochure; VFD Requirements for Veterinarians

Required Information on a VFD Form / Order

• veterinarian’s name, address, and telephone number;
• client’s name, business or home address, and telephone number;
• premises at which the animals speci?ed in the VFD are located;
• date of VFD issuance;
• expiration date of the VFD;
• name of the VFD drug(s);
• species and production class of animals to be fed the VFD feed;
• approximate number of animals to be fed the VFD feed by the expiration date of the VFD;
• indication for which the VFD is issued;
• level of VFD drug in the feed and duration of use;
• withdrawal time, special instructions, and cautionary statements necessary for use of the drug in conformance with the approval;
• number of reorders (re?lls) authorized, if permitted by the drug approval, conditional approval, or index listing;
• statement: “Use of feed containing this veterinary feed directive (VFD) drug in a manner other than as directed on the labeling (extralabel use), is not permitted”;
• an affirmation of intent for combination VFD drugs as described in 21 CFR 558.6(b)(6); and veterinarian’s electronic or written signature.

You may also see the following optional information on the VFD:

• a more specific description of the location of the animals (for example, by site, pen, barn, stall, tank, or other descriptor the veterinarian deems appropriate);
• the approximate age range of the animals;
• the approximate weight range of the animals; and any other information the veterinarian deems appropriate to identify the animals at issue.

A lawful VFD has to be complete.

Source: http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/ucm071807.htm

As the client, a producer must:

• Have a valid Veterinary-Client-Patient-Relationship (VCPR) with a licensed veterinarian in the state where the animals are located
• Only feed animal feed bearing or containing a VFD drug or a combination VFD drug (a VFD feed or combination VFD feed) to animals based on a VFD issued by a licensed veterinarian;
• Not feed a VFD feed or combination VFD feed to animals after the expiration date on the VFD;
• Provide a copy of the VFD order to the feed distributor if the issuing veterinarian sends the distributor’s copy of the VFD through you, the client;
• Maintain a copy of the VFD order for a minimum of 2 years
• Provide VFD orders for inspection and copying by FDA upon request.

Source: http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/ucm455413.htm

USDA Brochure: VFD Requirements for Producers

Under VFD regulation, a "distributor" means any person who distributes a medicated feed containing a VFD drug to another person.

As a Distributor you must do the following:

• file a one-time notice with FDA of intent to distribute VFD drugs;
• notify FDA within 30 days of any change in ownership, business name, or business address;
• fill a VFD order only if the VFD contains all required information;
• ensure that the distributed animal feed containing the VFD drug or combination VFD drug complies with the terms of the VFD and is manufactured and labeled in conformity with the approved, conditionally approved, or indexed conditions of use for such drug;
• ensure all labeling and advertising prominently and conspicuously displays the following cautionary statement: “Caution: Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian.";
• retain VFD orders for two years from date of issuance;
• retain records of the receipt and distribution of all medicated animal feed containing a VFD drug for 2 years;
• provide VFD orders for inspection and copying by FDA upon request;
• retain records of VFD manufacturing for 1 year in accordance with 21 CFR part 225 and make such records available for inspection and copying by FDA upon request;
• obtain, as the originating distributor (consignor), an acknowledgement letter from the receiving distributor (consignee) before the feed is shipped; and
• retain a copy of each consignee distributor’s acknowledgement letter for 2 years.

All distributors of VFD feed must notify FDA before they distribute for the first time. A distributor must also notify FDA within 30 days of a change in ownership, business name, or business address.

Source: http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/ucm455414.htm

USDA Brochure; VFD Requirements for Distributors

• The veterinarian is required to issue a written (nonverbal) VFD
• The veterinarian must send a copy of the VFD to the distributor via hardcopy, facsimile (fax), or other electronic means.
• If in hardcopy, the veterinarian is required to send the copy of the VFD to the distributor either directly or through the client.
• Veterinarian must retain the original VFD in its original form (electronic or hardcopy) and must send a copy to the distributor and client.
  • Digital scan of a signed hardcopy is not recognized as a digital signature (must be part 11 compliant)
• The veterinarian must keep the original VFD for two years (electronic or hardcopy).
• All parties involved (veterinarian, client, distributor) must keep a copy of VFD for 2 years.

“Extralabel use” is de?ned in FDA’s regulations as actual or intended use of a drug in an animal in a manner that is not in accordance with the approved labeling.

Examples of Extralabel use of a feed medication:

• Feeding the animals VFD feed for a duration of time that is different from the duration specified on the label,
• Feeding VFD feed formulated with a drug level that is different from what is specified on the label
• Feeding VFD feed to an animal species different than what is specified on the label

Extra-label use of VFD feed (or any other medicated feed) is not permitted.

The following Statement is required on all VFD forms: “Use of feed containing this veterinary feed directive (VFD) drug in a manner other than as directed on the labeling (extralabel use), is not permitted”

Source: http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/ucm455413.htm

Concurrent use or combination drugs are the use of more than one feed grade antibiotic (drug) at the same time.

Not all approved feed grade drugs are approved/labeled to be feed in combination.

The feeding of multiple feed grade drugs that are not an approved combination would be considered Extralabel use and not allowed under FDA regulations.

When issuing a VFD one of the requirements for the veterinarian is to allow or not allow approved combinations or other VFD or OTC feed grade drugs.

Veterinarians should work with manufactures on approved combination uses.