Veterinary Feed Directive
FAQ
General Topics
(Clicking on the source link at the end of each answer or topic section will take you to the original document from which the questions and answers were derived.)
- Veterinary Feed Directive (VFD) Drugs
- What is a Veterinary Feed Directive Drug?
- A “veterinary feed directive (VFD) drug” is a drug intended for use in or on animal feed which is limited by an approved new animal drug application filed pursuant to section 512(b) of the Federal Food, Drug, and Cosmetic Act (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 to use under the professional supervision of a licensed veterinarian (21 CFR 558.3(b)(6)). 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]
- Who determines whether a drug is VFD drug?
- 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]
- What is a “combination veterinary feed directive drug”?
- A "combination veterinary feed directive (VFD) drug” is a combination new animal drug (as
defined in § 514.4(c)(1)(i)) intended for use in or on animal feed which 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 to use under the professional supervision of a licensed veterinarian, and at
least one of the new animal drugs in the combination is a VFD drug. Use of animal feed bearing or containing a combination VFD drug must be authorized by a lawful veterinary feed directive (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]
- A "combination veterinary feed directive (VFD) drug” is a combination new animal drug (as
defined in § 514.4(c)(1)(i)) intended for use in or on animal feed which 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 to use under the professional supervision of a licensed veterinarian, and at
- What are Category I and Category II drugs and what is their relevance to VFD?
- 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 species for which they are approved, or are regulated on a “no-residue” basis or with a zero tolerance because of a carcinogenic concern regardless of whether a withdrawal period is required. 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 license is not required if the VFD drug is Category I with the exception of certain liquid and free-choice medicated feeds.[Source: FDA GFI 120]
- All new animal drugs, including VFD drugs, approved for use in or on animal feed are placed in
- If I am a university researcher and I want to perform research on a drug in medicated feed, do I need a VFD to obtain the medicated feed?
- 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 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 that is not related to pursuing a new animal drug approval, the requirements in 21 CFR 511.1(a) apply. 21 CFR part 511 can be viewed at: http://www.ecfr.gov.[Source: FDA GFI 120 DRAFT]
- 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 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.
- Veterinary Feed Directive (VFD)
- What is a Veterinary Feed Directive?
- A “veterinary feed directive” 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 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]
- What is required for a VFD to be “lawful”?
- To be lawful, a VFD must be issued and used in compliance with all applicable requirements in
21 CFR 558.6. This includes the requirement that a VFD must be issued by a veterinarian
licensed to practice veterinary medicine operating in the course of his/her 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]
- To be lawful, a VFD must be issued and used in compliance with all applicable requirements in
21 CFR 558.6. This includes the requirement that a VFD must be issued by a veterinarian
licensed to practice veterinary medicine operating in the course of his/her 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
- Does the state or federal definition of a veterinarian-client-patient relationship
apply?
- 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. 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)). FDA considers states with VCPR definitions that at least 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 to include the key elements of the
federally-defined VCPR as set forth in 21 CFR § 530.3(i).
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), FDA is requiring that the VFD 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 online and the list will be updated periodically as FDA receives and verifies information from States if they change their VCPR definition or its applicability.[Source: FDA GFI 120 DRAFT]
- 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. 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)). FDA considers states with VCPR definitions that at least 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 to include the key elements of the
federally-defined VCPR as set forth in 21 CFR § 530.3(i).
- Are VFDs only required for food producing animals?
- 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 DRAFT]
- Information on the VFD
- What specific information must the veterinarian include on the VFD order and
what information is optional?
- 21 CFR 558.6(b)(3) requires the following information to be fully and accurately included on the
VFD order:
• The veterinarian’s name, address, and telephone number;
• the client’s name, business or home address, and telephone number;
• the premises at which the animals specified in the VFD are located;
• the date of VFD issuance;
• the expiration date of the VFD;
• the name of the VFD drug(s);
• the species and production class of animals to be fed the VFD feed;
• the approximate number of animals to be fed the VFD feed by the expiration date of the VFD;
• the indication for which the VFD is issued;
• the level of VFD drug in the feed and duration of use;
• the withdrawal time, special instructions, and cautionary statements necessary for use of the drug in conformance with the approval;
• the number of reorders (refills) authorized, if permitted by the drug approval, conditional approval, or index listing;
• 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”;
• an affirmation of intent for combination VFD drugs as described in 21 CFR 558.6(b)(6); and
• the 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]
- 21 CFR 558.6(b)(3) requires the following information to be fully and accurately included on the
VFD order:
- Who is the “client” for the purpose of filling the VFD?
- 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]
- What information should be included on the VFD to describe the “premises” at
which the animals are located?
- 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 a global
positioning system (GPS) coordinate 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. 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).[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 a global
positioning system (GPS) coordinate may be appropriate if a street address does not exist.
- What is an “expiration date” on the VFD?
- 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]
- How is the “expiration date” determined by the veterinarian for a VFD?
- 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 6-month expiration date example, but having 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]
- 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)).
- What is the “duration of use” and how does it relate to the "expiration date"?
- 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 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
- What is the “approximate number of animals” on the VFD?
- 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]
- Can a VFD authorize either the approved pioneer or approved generic VFD
drug(s)?
- The veterinarian is required to write the name of the VFD drug on the VFD (21 CFR
558.6(b)(3)(vi)). The veterinarian may choose to write the trade name of the approved pioneer
or an approved generic (if available) VFD drug or the established name of the VFD drug (i.e.,
active drug ingredient) 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.[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)). The veterinarian may choose to write the trade name of the approved pioneer
or an approved generic (if available) VFD drug or the established name of the VFD drug (i.e.,
active drug ingredient) to complete this requirement.
- In cases where a VFD drug is approved for use at multiple drug levels, or for use
in a range of drug levels, would one or multiple VFD orders have to be issued to
cover such drug uses?
- In cases where a VFD drug is approved for use at multiple drug concentrations, or levels, the veterinarian may issue a single VFD order 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). 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.[Source: FDA GFI 120]
- What additional information is required on a VFD authorizing the use of a
combination VFD drug?
- 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)(2)(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)(2)(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 combination medicated feeds following this statement.]
- "This VFD authorizes the use of the VFD drug(s) cited in this order in any FDAapproved, conditionally approved, or indexed combination(s) in medicated feed that contains the VFD drug(s) as a component."[Source: FDA GFI 120]
- 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)(2)(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)(2)(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):
- Do these regulations allow reorders and refills?
- 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]
- What is an “extralabel use” of a VFD drug and is it allowed?
- “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 on the label, feeding VFD feed formulated with a drug level that is different from what
is specified on the label, or feeding VFD feed to an animal species different than what is
specified on the label 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]
- “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 on the label, feeding VFD feed formulated with a drug level that is different from what
is specified on the label, or feeding VFD feed to an animal species different than what is
specified on the label would all be considered extralabel uses.
- VFD Transmission and Recordkeeping
- How can a VFD order be transmitted to the distributor?
- 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]
- Is the veterinarian required to send the original VFD order to the distributor?
- No, the veterinarian is not required to send the original paper copy 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]
- Can a VFD order be transmitted by telephone?
- The veterinarian is required to issue a written (nonverbal) VFD (21 CFR 558.6(b)(7)). Therefore, a VFD order may not be issued verbally, including verbal transmission by telephone. A VFD order may be sent by facsimile (fax).[Source: FDA GFI 120]
- Can a VFD order be transmitted to the distributor by the Internet?
- Yes. According to 21 CFR 558.6(b)(8), a VFD order 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 order (e.g., emailing a scanned VFD document) or using the Internet to transmit an electronic VFD order generated in a system that is shown to be in compliance with FDA’s regulations at 21 CFR part 11. For additional information about how part 11 applies to the VFD process, see discussion at question 8, “What is 21 CFR part 11 and how does it apply to the issuance of electronic VFDs?” below.[Source: FDA GFI 120]
- Who is responsible for distributing the VFD order?
- The veterinarian must retain the original VFD order 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 order 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 order is distributed to the client and the distributor.[Source: FDA GFI 120]
- How long must VFD orders be kept and who must keep them?
- All involved parties (veterinarian, client, 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]
- In what format can the “original VFD” order be kept?
- The veterinarian must retain the original VFD in its original form (electronic or hardcopy) (21 CFR 558.6(a)(4)).[Source: FDA GFI 120]
- What is 21 CFR part 11 and how does it apply to the issuance of electronic
VFDs?
- 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 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. 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]
- 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.
- Can a third-party server company require testing of its clients’ computers before
starting to transmit VFD orders?
- 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]
- How are feed delivery records going to be tied back to the VFD? Generally the feed mill have these records, but are the producers and the veterinarians going to have to have the feed delivery records as well?
- 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]
- Are there special provisions (secure servers, etc.) for how to store VFD or feed delivery records electronically for producers or veterinarians? Does it need to be stored in an approved electronic storage system? Can a producer have the feed mill electronically store the feed delivery records that can be retrieved during an FDA audit?
- 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]
- 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.).
- General questions
- What is the proper method of disposal for VFD feed that is no longer needed/left over?
- Disposal of the feed should be in a manner that is in accordance with State or local requirements for medicated feeds. [Source: Farm Foundation]
- Who is responsible for enforcement?
- 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]
- What are the associated penalties?
- 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]
- Does the FDA staff write a "warning ticket" before a "speeding ticket"?
- FDA intends to use a phased enforcement startegy for implentation 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 typically issues advisory actions such as untitled or warning letters prior to pursuing enforcement actions such as injunctions, seizures, monetary penalties, or criminal actions. Particularly egregious violations might warrant immediate enforcement action. [Source: Farm Foundation]
- Does a feed mill have to be in the same state as the animals/licensed vet?
- No. [Source: Farm Foundation]
- How do we get the CVM to answer questions?
- Questions for CVM can be emailed to AskCVM@ fda.hhs.gov [Source: Farm Foundation]
- Does the FDA have a timeline to eliminate all OTC antibiotics?
- Guidance for Industry 209 (GFI #209) outlines our current thinking on the judicious use of medically important antimicrobials in food-producing animals. Guidance for Industry 213 (GFI #213) outlines our recommendations for drug sponsors to voluntarily align their product use conditions for products administered through medicated feed or drinking water with GFI #209 by January 1, 2017. The primary concern underlying the judicious use principles outlined in GFI 209 is antimicrobial resistance in animals and humans. This includes antimicrobial drugs that are considered important for therapeutic use in humans. At this time there are no plans to change the marketing status of any additional products. However, we will continue to evaluate the appropriate marketing status of animal drugs based on the information available to us. [Source: Farm Foundation]
- Are educational materials available in Spanish? (many farm workers don't speak English)
- 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]
- Will there be a transition label for WSPs (Water Soluble Products)?
- 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]
- We have communicated the expectations for labeling to sponsors in a letter: http://www.fda.gov/downloads/AnimalVeterinary/SafetyHealth/AntimicrobialResistance/JudiciousUseofAntimicrobials/UCM482139.pdf
- Next year if a youth exhibitor is showing a pig at a Jackpot show (just a 1-2 day pig show, not terminal, and pigs will go back home) will the exhibitor have to have a copy of their VFD or prescription in their possession at the show if a FDA person asked for it or do they have time to produce it a later date?
- 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]
- What is the proper method of disposal for VFD feed that is no longer needed/left over?