Veterinary Feed Directive FAQ – General Topics

A “veterinary feed directive (VFD) drug” (as defined in 21 CFR 558.3(b)(6)) is a drug intended for use in or on animal feed under the professional supervision of a licensed veterinarian and the use of the VFD drug is limited by: 1) an approved new animal drug application filed pursuant to section 512(b) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 2) a conditionally approved application filed pursuant to section 571 of the FD&C Act, or 3) an index listing pursuant to section 572 of the FD&C Act.

Use of animal feed bearing or containing a VFD drug (VFD feed) must be authorized by a lawful VFD (21 CFR 558.6(a)(1)). [Source: FDA GFI 120]

When a new animal drug application is submitted to FDA’s Center for Veterinary Medicine (CVM) for approval, CVM evaluates the drug for safety and effectiveness, and as part of the review process, determines whether the drug will be an over-the-counter (OTC) drug, a prescription (Rx) drug, or a VFD drug (limited to drugs used in or on animal feed). [Source: FDA GFI 120]

A “combination veterinary feed directive (VFD) drug” (or “combination VFD drug”) is a combination new animal drug (as defined in 21 CFR 514.4(c)(1)(i)) intended for use in or on animal feed under the professional supervision of a licensed veterinarian (and at least one of the new animal drugs in the combination is a VFD drug) and the use of the combination VFD drug is limited by:

• an approved application filed pursuant to section 512(b) of the FD&C Act,
• a conditionally approved application filed pursuant to section 571 of the FD&C Act, or
• an index listing pursuant to section 572 of the FD&C Act

Use of animal feed bearing or containing a combination VFD drug must be authorized by a lawful VFD (21 CFR 558.3(b)(12)). If any component drug in an approved, conditionally approved, or indexed combination drug is a VFD drug, the combination drug is a combination VFD drug and its use must comply with the VFD requirements.

[Source: FDA GFI 120]

All new animal drugs, including VFD drugs, approved for use in or on animal feed are placed in one of two drug categories, Category I or Category II (21 CFR 558.3(b)(1)). Category I drugs require no withdrawal period at the lowest use level in each species for which they are approved. Category II drugs either require a withdrawal period at the lowest use level for at least one major species for which they are approved or are regulated on a “no-residue” basis or with a zero tolerance because of carcinogenic concern regardless of whether a withdrawal period is required in any species.

A medicated feed mill license is required if the VFD drug used to manufacture a Type B or Type C medicated feed is a Category II, Type A medicated article (21 CFR 558.4(a)). A list of Category II drugs is located in 21 CFR 558.4(d). A medicated feed mill license is not required if the VFD drug used to manufacture a Type B or Type C medicated feed is a Category I, Type A medicated article, with the exception of certain liquid and free-choice medicated feeds.

[Source: FDA GFI 120]

No, you do not need a VFD to obtain medicated feed for the purpose of performing research on a drug for use in or on a medicated feed. The VFD regulations apply to the use of VFD drugs and VFD feed for approved, conditionally approved, and indexed indications. When investigating a new indication during the approval process, or performing tests in vitro or in animals used only for laboratory research purposes, the VFD regulations do not apply. Instead, the requirements in 21 CFR part 511 “New Animal Drugs for Investigational Use” apply. When pursuing a new animal drug approval, the requirements in 511.1(a) or 511.1(b) may apply depending on the purpose for the research trial.

For research solely involving tests in vitro or laboratory research animals, the requirements in 21 CFR 511.1(a) apply.

[Source: FDA GFI 120]

A “veterinary feed directive” (VFD) is a written (nonverbal) statement issued by a licensed veterinarian in the course of the veterinarian’s professional practice that orders 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, producer, 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 (21 CFR 558.3(b)(7)). A VFD may also be referred to as a VFD order.

[Source: FDA GFI 120]

To be lawful, a VFD must be issued and used in compliance with all applicable requirements in 21 CFR 558.6(a)1 and 21 CFR 558.6(b). These include the requirement that a VFD must be issued by a veterinarian licensed to practice veterinary medicine operating in the course of the veterinarian’s professional practice and in compliance with all applicable veterinary licensing and practice requirements, including issuing the VFD in the context of a veterinarian-client-patient
relationship (VCPR) as defined by the state (21 CFR 558.6(b)(1)). If applicable VCPR requirements as defined by such state do not include the key elements of a valid VCPR as defined in FDA’s regulations at 21 CFR 530.3(i), the veterinarian must issue the VFD in the context of a valid VCPR as defined in 21 CFR 530.3(i).

[Source: FDA GFI 120]

In those States that require a VCPR that includes the key elements of the Federally-defined VCPR in order for a veterinarian to issue a VFD, the veterinarian issuing the VFD must be operating within the context of a VCPR as that term is defined by the State. FDA considers State VCPR definitions that, at a minimum, address the concepts that the veterinarian:
(1) engage with the client to assume responsibility for making clinical judgments about patient health,
(2) have sufficient knowledge of the patient by virtue of patient examination and/or visits to the facility where patient is managed, and
(3) provide for any necessary follow-up evaluation or care

meet the key requirements of the Federally-defined VCPR as set forth in 21 CFR 530.3(i). In all other cases, the veterinarian must be operating within the context of a valid VCPR as defined by FDA in 21 CFR 530.3(i) (21 CFR 558.6(b)(1)(ii)).

In States where the veterinary practice requirements do not require that a VFD be issued within the context of a State-defined VCPR that includes the key elements of a valid VCPR as defined in Federal regulations at 21 CFR 530.3(i), the VFD must be issued within the context of a Federally-defined valid VCPR as defined at 21 CFR 530.3(i) (21 CFR 558.6(b)(1)(ii)).

FDA has worked with State regulatory authorities to verify whether their State has VCPR requirements in place that apply to the issuance of a VFD and include the key elements of the Federally-defined VCPR. 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 is available online3 and the list is updated periodically as FDA receives and verifies information from States if they change their VCPR definition or its applicability.

[Source: FDA GFI 120]

No. A VFD is required to authorize the use of a VFD drug in a medicated feed, regardless of whether the approved use is for a food producing or non-food producing animal. [Source: FDA GFI 120]

21 CFR 558.6(b)(3) requires the following information to be fully and accurately included on the
VFD:

• Veterinarian’s name, address, and telephone number;
• client’s name, business or home address, and telephone number;
• premises at which the animals specified 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 (refills) 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.”;
• affirmation of intent for combination VFD drugs as described in 21 CFR 558.6(b)(6); and
• veterinarian’s electronic or written signature.
  In addition to the information described above that must be included on the VFD, the
  veterinarian also may, at his or her discretion, include on the VFD the following additional
  information as described in 21 CFR 558.6(b)(4) to more specifically identify the animals he or
  she is authorizing to be treated using the VFD feed:
• 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.

[Source: FDA GFI 120]

For purposes of the VFD regulations, the term “client” typically refers to the person responsible for the care and feeding of the animals receiving the VFD feed. As described in the definition of the term “veterinary feed directive,” the client may be the owner of the animals or other caretaker (see 21 CFR 558.3(b)(7)). [Source: FDA GFI 120]

We expect that the veterinarian would enter information about the physical location of the animals referred to in the VFD that would be sufficiently descriptive to allow someone to locate the animals. Typically, the street address for the facility would be an appropriate way to identify the animals’ location; however, other generally recognized geographical indicators, such as a global positioning system (GPS) coordinate or Federal grazing land identification information (allotment), may be appropriate if a street address does not exist.

We recognize that an address for a facility may not provide enough information to identify the location of animals in a case where the VFD is meant to authorize the VFD feed to be provided to a very specific group of animals. As a result, the veterinarian may use his or her discretion to enter additional information on the VFD that more specifically describes the location of the animals, such as the site, pen, barn, stall, tank, or other descriptor (21 CFR 558.6(b)(4)(i)). The veterinarian should consult with the client to determine whether the animals will remain at this more specific location until the expiration date of the VFD.

We also understand that some groups of animals that are of similar age, weight range, etc., are managed in a similar manner, but may be housed in different physical locations. For example, a group of weaned pigs may be moved out of a nursery facility and transferred to multiple growout facilities for finishing. If a VFD is intended to authorize the use of a VFD feed in an identified group (approximate number) of animals that are located at more than one physical
location, it is acceptable for a veterinarian to include multiple specified locations for that group of animals on the VFD. In the preamble of the 2015 VFD final rule, we stated that “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)” (80 FR 31708 at 31720, June 3, 2015, see response to Comment 27).

[Source: FDA GFI 120]

Yes, it is allowed. It is optional to group two or more premises on one VFD or on separate VFDs and depends on whether one VFD can be written to cover the animals on multiple premises. In the preamble to the 2015 VFD final rule, we discussed how VFDs may be written for groups of animals with a similar age, weight range, etc., that are managed in a similar manner but housed at multiple premises. In the preamble of the 2015 VFD final rule, we stated, “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)” (80 FR 31708 at 31720, June 3, 2015, see response to Comment 27). Alternatively, the veterinarian may choose to write separate VFDs for each premise.

[Source: FDA GFI 120]

The expiration date on the VFD specifies the last day the VFD feed can be fed. In other words, 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)).

[Source: FDA GFI 120]

In certain cases, FDA determines the expiration date of a VFD (the number of days the VFD feed can be fed to the animal before the VFD expires) as part of the approval, conditional approval, or index listing of that drug. The VFD expiration date defines the period of time for which the authorization to feed an animal feed containing a VFD drug is lawful. The expiration date for the VFD must not extend beyond the expiration date specified in that drug’s approval,
conditional approval, or index listing (21 CFR 558.6(b)(3)(v)).

In cases where the expiration date is not specified in the approval, conditional approval, or index listing, the expiration date of the VFD must not exceed 6 months after the date of issuance (21 CFR 558.6(b)(3)(v)). This provision allows veterinarians, based on their medical judgment and knowledge of the animal production operation, to determine on a case-by-case basis whether the maximum 6-month period is an appropriate expiration date for the VFD, or whether a more limited period is warranted. The veterinarian will use his or her medical judgment to determine what expiration date is appropriate for the VFD, based on many factors including, but not limited to, the type of animal production facility and operation, the VFD drug or combination VFD drug at issue, the intended use of the VFD drug, and the health status, treatment history, and lifecycle of the animals.

The date of expiration should be calculated by the calendar date, not the number of days. For example, using a 6-month expiration date for a VFD, if the VFD is written on July 10, then the expiration date would be January 10 of the following year. Using the same example, with a 6- month expiration date but with the VFD written on the last day of the month, the VFD expiration date would be the last day of the sixth month even if that month has fewer days. Thus, in this example, if the VFD is written on August 31, the expiration date would be the following February 28 during a regular calendar year, or February 29 during a leap year.

[Source: FDA GFI 120]

The VFD expiration date defines the period of time for which the authorization to feed an animal feed containing a VFD drug is lawful. This period of time may be specified in the approved labeling of a given VFD drug or, if not specified in the labeling, the veterinarian must specify an expiration date for the VFD that does not exceed 6 months (21 CFR 558.6(b)(3)(v)). The duration of use is a separate concept from the expiration date, and determines the length of time, established as part of the approval, conditional approval, or index listing process, that the animal feed containing the VFD drug is allowed to be fed to the animals. This period of time is specified in the labeling of the VFD drug. For example, for swine, the currently approved VFD drug tilmicosin has an expiration date of 90 days and a duration of use of 21 days. This means that when the VFD is issued, the client has 90 days to obtain the VFD feed and complete the 21- day course of therapy. It is unlawful to feed the VFD feed to animals after the VFD expiration date (21 CFR 558.6(a)(2)).

[Source: FDA GFI 120]

The approximate number of animals is the potential number of animals of the species and production class identified on the VFD that will be fed the VFD feed or combination VFD feed at the specified premises by the expiration date of the VFD (21 CFR 558.6(b)(3)(viii)).

[Source: FDA GFI 120]

The veterinarian is required to write the name of the VFD drug on the VFD (21 CFR 558.6(b)(3)(vi)). To complete this requirement, the veterinarian may choose to write the established name of the VFD drug (i.e., active drug ingredient), or the proprietary name (i.e., trade name) of the approved pioneer or an approved generic (if available) VFD drug.

Established Name on VFD
When the veterinarian uses a VFD with the established name of a VFD drug on it, the distributor may fill the VFD using VFD feed manufactured from any VFD drug containing the same active drug ingredient approved for the use, i.e., from either an approved pioneer or an approved generic.

Proprietary Name on VFD
When the veterinarian uses a VFD with the proprietary name of a VFD drug on it, he/she may choose to specify that a substitution by the distributor of the VFD feed of either the pioneer or generic VFD drug identified under a proprietary name on the VFD is not allowed; or the veterinarian may choose to remain silent, i.e., not specify that a substitution is not allowed.

When the veterinarian specifies that a substitution of a proprietary name of the VFD drug is not allowed, the distributor must fill the VFD using VFD feed manufactured from the VFD drug identified by the proprietary name (21 CFR 558.6(b)(3)(vi).

When the VFD is silent about whether substitution is allowed, then substitution is allowed, and the distributor may fill the VFD using VFD feed manufactured from any VFD drug containing the same active drug ingredient approved for the use, i.e., from either an approved pioneer or an approved generic (80 FR 31708 at 31720, June 3, 2015). In other words, any pioneer or generic VFD drug may be used to substitute for any other pioneer or generic drug containing the same active drug ingredient, provided that the substituting drug is approved for the same feeding regimen and uses as the drug written on the VFD, either alone or in a combination with other drugs, as the drug identified on the VFD. The use of a VFD drug must be consistent with the representative labeling for use in the Type B and Type C medicated feeds containing the new animal drug (Blue Bird label) 4 for the VFD drug (pioneer or generic) the distributor uses, and the
labeling of the VFD feed must be consistent with the Blue Bird label for the VFD drug (pioneer or generic) the distributor actually uses in the VFD feed.

[Source: FDA GFI 120]

In cases where a VFD drug is approved for use at multiple drug concentrations, or levels, for a single indication, the veterinarian may issue a single VFD covering all those approved drug levels intended to be used, and the approved duration(s) of feeding the VFD feed at the approved drug level(s) for the indication.

If a VFD drug is approved for use within a range of drug levels, then the veterinarian may specify a particular drug level within that range or authorize use at any drug level within the range by putting the entire authorized range on the VFD.

The veterinarian may also use the “special instructions” area of the VFD to provide more specific instructions about the use of a drug that is approved for use within a range of drug levels. For example, if a VFD drug can be used within a certain drug level within the approved range and the veterinarian would like the client to use a higher drug concentration within that range for a certain part of the treatment duration and a lower drug concentration within that range for another part of the treatment duration, the special instructions area could be used for that purpose. The distributor should then provide the client batches of VFD feed that include the different drug levels specified in the special instructions area of the VFD.

[Source: FDA GFI 120]

The veterinarian may need to authorize on the VFD the use of more than one level of the VFD drug in feed to achieve the delivery of the approved dosage. This may be necessary for reasons such as variations in animal weights or feed intake over the course of therapy. For example, the veterinarian could determine that the drug level in the VFD feed should be 20 g/ton at feed intake of 2% body weight, 40 g/ton at feed intake of 1% body weight, or 15 g/ton at feed intake of 2.5% body weight to ensure consumption at the approved dosage of X mg/head/day or X mg/unit body weight/day. The veterinarian should put these discrete drug levels in the drug level area on the VFD and explain in the special instructions area that the observed feed intake will dictate which of the drug levels on the VFD is to be used. This will ensure that the instructions on the VFD are consistent with the approved labeling for the VFD drug (including the Blue Bird label).

However, it would not be appropriate for the veterinarian to specify these discrete drug levels as a range of 15-40 g/ton. Such an action would be of limited use to the distributor and client and could conflict with the approval and the approved Blue Bird label

[Source: FDA GFI 120]

The estimated body weight of the animals does not generally need to be included on the VFD for the VFD to be valid. However, there may be instances when information related to the body weight of the animals may need to be included on the VFD as part of the information from the approval. For example, the approved conditions of use for some applications stipulate the body weight of treated animals (e.g., feed to animals >700 lbs. body weight). In this situation, this information would need to be identified on the VFD as part of the description of species and production class.

The VFD regulation does not preclude the veterinarian from including information about the weight of the animals on the VFD. If the issuing veterinarian chooses to include the approximate weight range of the animals on the VFD, he or she can do so under 21 CFR 558.6(b)(4), which permits the veterinarian to include “(iv) Any other information the veterinarian deems appropriate to identify the animals specified in the VFD.”

When information about the animals’ body weight is necessary to determine the appropriate amount of feed, we encourage distributors, veterinarians, and clients to work together to share the necessary information about the animals to determine the appropriate amount of feed for the approximate number of animals authorized by the VFD.

[Source: FDA GFI 120]

A VFD authorizing the use of a combination VFD drug that contains two or more VFD drugs is required to include the name of the drugs in the combination, the indication(s) of use, the levels of the drugs in the VFD feed and duration of use, the withdrawal time, special instructions, and cautionary statements necessary for use of the combination VFD drug required by the approval (21 CFR 558.6(b)(5)) (i.e., the drug-specific information specified in 21 CFR 558.6(b)(3)(vi), (ix), (x), and (xi) for each VFD drug in the combination).

The veterinarian may expand or limit the use of a VFD drug along with one or more OTC animal drugs in an approved, conditionally approved, or indexed combination VFD drug by completing the drug-specific information specified in 21 CFR 558.6(b)(3)(vi), (ix), (x), and (xi) for the use of the VFD drug(s) and by including one of the following affirmation of intent statements (21 CFR 558.6(b)(6)):

• “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.”

[Source: FDA GFI 120]

If a veterinarian is authorizing a VFD drug in combination with an OTC drug(s) through the use of affirmation statements on the VFD, it is not required to list the withdrawal time, special instructions, and warning statements for the OTC drugs authorized in the combination. The VFD is required to include information for the VFD drug, i.e., the cautionary statements for the VFD drug and indication the VFD is authorizing. However, we do not object to the veterinarian including the cautionary statements for the OTC drugs on the VFD if he or she chooses to do so. In contrast, the requirements for labeling the resulting VFD feed are different than for the VFD order. If a combination is used, we would expect the labeling for the VFD combination feed to include all relevant cautions including those for the OTC drugs included in the combination VFD feed (21 CFR 558.6(c)(2)).

A VFD authorizing the use of a combination VFD drug that contains two or more VFD drug(s) is required to include the name of the drugs in the combination, the indication(s) of use, the levels of the drugs in the VFD feed and duration of use, the withdrawal time, special instructions, and cautionary statements necessary for use of the combination VFD drug required by the approval 21 CFR 558.6(b)(5)) (i.e., the drug-specific information specified in 21 CFR 558.6(b)(3)(vi),
(ix), (x), and (xi) for each VFD drug in the combination).

[Source: FDA GFI 120]

The regulation allows the issuing veterinarian to authorize reorders (refills) of the VFD only if reorders (refills) are explicitly permitted by the drug approval, conditional approval, or index listing. In cases where reorders (refills) are not specified on the labeling for an approved, conditionally approved, or index listed VFD drug, reorders (refills) are not permitted (21 CFR 558.6(b)(3)(xii)).

[Source: FDA GFI 120]

“Extralabel use” is defined 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 (21 CFR 530.3(a)). For example, feeding the animals VFD feed for a duration of time that is different from the duration specified in the labeling, feeding VFD feed formulated with a drug level that is different from what is specified in the labeling, or feeding VFD feed to an animal species different than what is
specified in the labeling would all be considered extralabel uses.

Extralabel use of medicated feed, including medicated feed containing a VFD drug or a combination VFD drug, is not permitted (21 U.S.C. 360b(a); 21 CFR 530.11(b) and 558.6(a)(3)). Use of medicated feeds, including those containing a VFD drug or a combination VFD drug, is limited to the approved, conditionally approved, or indexed conditions of use (21 U.S.C.360b(a); 21 CFR 558.6(a)(3)).

The VFD must include the 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.” (21 CFR 558.6(b)(3)(xiii)).

[Source: FDA GFI 120]

A veterinarian must send a copy of the VFD to the distributor in hardcopy, by facsimile (fax), or by electronic means. If the veterinarian sends the VFD in hardcopy, he or she must send the copy of the VFD to the distributor either directly or through the client (21 CFR 558.6(b)(8)).

[Source: FDA GFI 120]

No, the veterinarian is not required to send the original hardcopy to the distributor. The veterinarian must retain the original VFD in its original form (electronic or hardcopy). The distributor and client copies may be kept either as an electronic copy or hardcopy (21 CFR
558.6(a)(4)).

[Source: FDA GFI 120]

The veterinarian is required to issue a written (nonverbal) VFD (21 CFR 558.6(b)(7)). Therefore, a VFD may not be issued verbally, including verbal transmission by telephone. A VFD may be sent by facsimile (fax).

[Source: FDA GFI 120]

Yes. According to 21 CFR 558.6(b)(8), a VFD must be sent to the distributor “via hardcopy, facsimile (fax), or electronically.” The term “electronically” includes sending via the Internet. For example, transmitting the VFD “electronically” includes using the Internet to transmit the image of a paper VFD (e.g., emailing a scanned VFD document) or using the Internet to transmit an electronic VFD generated in a system that is shown to be in compliance with FDA’s regulations at 21 CFR part 11.

[Source: FDA GFI 120]

The veterinarian must retain the original VFD in its original form (electronic or hardcopy) (21 CFR 558.6(a)(4)). In addition, the veterinarian is required to send a copy to the distributor directly or, if sending the VFD in hardcopy, either directly or through the client (21 CFR 558.6(b)(8)), and the veterinarian is also required to give a copy of the VFD to the client (21 CFR 558.6(b)(9)). Thus, it is the veterinarian’s obligation to ensure that the VFD is distributed
to the client and the distributor.

[Source: FDA GFI 120]

All involved parties (veterinarian, client, and distributor) must retain a copy of the VFD for 2 years. The veterinarian is required to keep the VFD in its original format. The distributor and client copies may be kept as an electronic copy or hardcopy (21 CFR 558.6(a)(4)).

[Source: FDA GFI 120]

The veterinarian must retain the original VFD in its original form (electronic or hardcopy) (21 CFR 558.6(a)(4)).

[Source: FDA GFI 120]

21 CFR part 11 sets out the criteria under which the Agency considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be generally equivalent to paper records and handwritten signatures executed on paper.

21 CFR part 11 applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted under any FDA records requirements. Therefore, electronic VFDs issued by veterinarians must be compliant with 21 CFR part 11, and electronic VFDs received and electronically stored by distributors and clients must also be compliant with 21 CFR part 11. 21 CFR part 11 does not apply to paper records that are, or have been, transmitted by electronic means such as facsimile, email attachments, etc.

[Source: FDA GFI 120]

Whether or not third-party server companies require testing of their clients’ computers for compatibility with their systems before starting to provide the clients with their service is a business decision between third-party server companies and their clients and not an FDA requirement

[Source: FDA GFI 120]

The VFD regulation identifies three parties – veterinarian, client, and the VFD feed distributor – as the parties that are required to keep the record of a VFD. If one entity represents the veterinarian, the distributor, and the client, it is acceptable for the VFD to be stored in one location provided that everyone required to have a copy has access and can provide a copy to the FDA investigator upon request.

[Source: FDA GFI 120]

During an inspection we will review VFD orders and compare them to manufacturing records.  We would expect that the amount of medicated feed produced to fill that VFD, whether in one or several batches would be commensurate with the amount of feed necessary for the approximate number of animals the VFD authorizes to be fed.  The client and veterinarian are required to maintain the VFD record, but are not required to maintain feed delivery records under the final VFD rule. [Source: ISU]

Electronic records, such as an electronic VFD that meets the requirements of part 11, may be used in lieu of a paper VFD. As we have previously stated in GFI #120, part 11 applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted, under any FDA records requirements. Electronic VFDs issued by veterinarians must be compliant with part 11, and VFDs received and electronically stored by distributors and clients must be compliant with part 11. 21 CFR part 11 does not apply to paper records that are, or have been, transmitted by electronic means (such as facsimile, email attachments, etc.).

The VFD is required to be signed by the veterinarian.  If the veterinarian chooses to sign the VFD electronically, the electronic signature needs to be part 11 compliant. We recommend that users check with Global Vet Link, or any other electronic VFD service provider to confirm that the software system is part 11 compliant. If a veterinarian signs a paper copy and scans the VFD to distribute a copy to the client/distributor, that is not considered an electronic signature.

Additional information about part 11 compliance, including information on how FDA intends to exercise enforcement discretion with regard to certain part 11 requirements during the reexamination of part 11, can be found in GFI Part 11, Electronic Records; Electronic Signatures—Scope and Application: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm125125.pdf [Source: ISU]

Disposal of the feed should be in a manner that is in accordance with State or local requirements for medicated feeds. [Source: Farm Foundation]

FDA intends to use a phased enforcement strategy for implementation of this final rule as OTC drugs become VFD drugs as a result of GFI #213 implementation. FDA first intends to provide education and training for stakeholders subject to this final rule such as veterinarians, clients (animal producers), feed mill distributors and other distributors. FDA will then engage in risk-based general surveillance, as well as for-cause inspection assignments. FDA intends to work closely with state regulatory partners and state boards of veterinary medicine in the enforcement strategy. In instances where a state VCPR applies the state may also pursue enforcement. 

[Source: Farm Foundation]

Prohibited acts and the associated penalties can be found in Section 301 to 304 of the FD&C Act (21 USC 331-334). Prohibited acts include the causing of a food to be adulterated or misbranded. There are several actions FDA can pursue for a violation of these prohibited acts including injunction, seizure, monetary penalties, and criminal charges. Section 303(a) of the FD&C Act (21 USC 333(a)) states the monetary and criminal penalties: “(1) Any person who violates a provision of section 331 if this title shall be imprisoned for not more than one year or fined not more than $1,000, or both. (2) Not withstanding the provisions of paragraph (1) of this section, if any person commits such a violation after a conviction of him under this section has become final, or commits such a violation with the intent to defraud or mislead, such person shall be imprisoned for not more than three years or fined not more than $10,000, or both.” 

[Source: Farm Foundation]

No. [Source: Farm Foundation]

Questions for CVM can be emailed to AskCVM@fda.hhs.gov [Source: Farm Foundation]

Currently, Veterinary Feed Directive brochures are available only in English. We agree that preparing educational materials for Spanish-speaking farm workers would be beneficial.  [Source: Farm Foundation]

We have communicated the expectations for labeling to sponsors in a letter: http://www.fda.gov/downloads/AnimalVeterinary/SafetyHealth/AntimicrobialResistance/JudiciousUseofAntimicrobials/UCM482139.pdf

As stated in the letter, CVM will review applications as they are received and in general will work toward coordinated approval dates for all similar applications by the end of December 2016. Our goal is to meet the January 1, 2017 implementation date.

Our primary goal is that on January 1, 2017, all affected products are being used in the market in accordance with the principles outlined in GFIs #209 and #213. Our expectation is that after January 1, 2017, product in distribution channels (i.e., no longer in the sponsor’s control) either is 1) labeled with “new” final printed label, 2) has a sticker affixed to the product that includes the “new” final label language, or 3) is labeled with “transitional label” statement(s).

Recognizing the complexity and scale of this effort, CVM intends to exercise as much flexibility as possible in relation to this transition period. However, we ask that affected drug sponsors exercise due diligence to transition to the new labeling in an expedient manner. [Source: ISU]

The VFD final rule requires that “All involved parties must make the VFD and any other records specified in this section available for inspection and copying by FDA upon request.”  (21 CFR 558.6(a)(5)).  Therefore, we would recommend that the exhibitor’s copy of a VFD or prescription be readily available. [Source: ISU]