On April 26, 2024, the Food and Drug Administration’s (FDA) Center for Veterinary Medicine (CVM) announced that it has finalized Guidance For Industry (GFI) #120, Veterinary Feed Directive Regulation Questions and Answers (Revised) (Final Guidance). The Final Guidance replaces CVM’s revised draft guidance issued in March 2019. While CVM’s core recommendations remain the same, the Final Guidance substantively revises two Q&As specific to veterinarians and one specific to manufacturers and dealers that serve as distributors. CVM’s overarching goal in making the revisions is to better align GFI#120 with existing industry practices and clarify flexibilities to reduce regulatory burden on veterinarians, producers, and distributors.
Background
Before Congress enacted the Animal Drug Availability Act (ADAA) in 1996, new animal drugs could be dispensed only via prescription or over-the-counter. The ADAA created a new category of products called veterinary feed directive (VFD) drugs, which are drugs intended for use in or on animal feed under the professional supervision of a licensed veterinarian. The regulatory requirements for distributing and using VFD drugs are codified in 21 C.F.R. § 558.6.
As we previously reported, FDA published a final rule in June 2015 (2015 VFD Final Rule) amending its VFD regulation to clarify and streamline requirements concerning the production of VFD drugs. The regulations also outlined the process by which veterinarians may authorize the use of VFD drugs, including medically important antimicrobials when needed for specific animal health purposes. Shortly after publishing the 2015 VFD Final Rule, FDA issued a draft guidance document that explained the regulations in a question and answer format.
Less than four years later, FDA published a revised draft guidance document in March 2019 (2019 Draft Guidance) to provide additional information to assist veterinarians, VFD feed distributors, and other stakeholders in complying with the VFD regulations. Since then, stakeholders have asked FDA to clarify several issues, including those relating to the amount of VFD drug in feed, requirements for individuals who distribute VFD feeds, and the expiration of medicated feeds.[1] In response to these comments, CVM revised sections of GFI#120 to clarify its VFD requirements including by providing additional examples to better distinguish the roles and responsibilities of involved parties.
Key Revisions Made in the Final Guidance
Q&As Specific to Veterinarians
The Final Guidance substantively revises two Q&As specific to veterinarians. First, CVM revises Q&A Section III.A.15, which addresses situations where the label for the VFD drug uses the dosage (e.g., mg/head/day) instead of the level of the drug (e.g., g/ton) in the feed. In the 2019 Draft Guidance, CVM noted that in these situations, a veterinarian must write the VFD to specify the drug(s) in terms of “g/ton” in feed. CVM also advised veterinarians to work with distributors and clients to identify the nutritional formulation and consumption rate that may be necessary to determine an appropriate drug level that is consistent with the approval.
CVM eases its position in the Final Guidance. CVM acknowledges that there may be situations where the VFD drug labeling (including Blue Bird labels) expresses the drug level in feed in a manner other than “g/ton”—for example, in mg/lb feed, %, or ppm. In such circumstances, CVM now states that a veterinarian may prepare the VFD using “either the units reflected on the VFD drug labeling or in terms of its level in the feed.” If the VFD drug’s approved labeling does not provide the allowable level(s) of a VFD drug in feed, the veterinarian should determine an appropriate level of the drug for the feeding situation.
Second, CVM revises Q&A, Section III.A.25, which addresses a veterinarian’s options when a client requests a new VFD to replace the former/old VFD that will soon expire. In the 2019 Draft Guidance, CVM stated simply that a veterinarian may not fill out the new VFD ahead of time and date it to begin when the previous VFD expires. In the Final Guidance, CVM provides additional flexibility by explaining that, although a veterinarian may not write a new VFD in advance of the expiration of a current VFD, there are two ways the veterinarian may transition animals from a VFD that is expiring to a new VFD:
- The veterinarian may issue a new VFD and at the same time cancel the existing VFD following the procedures described in Question III.A.7 of the Final Guidance.
- The veterinarian may use the special instructions area of the new VFD to authorize the transition of the animals from the old VFD to the new VFD.CVM further illustrates this option by providing an example of how the veterinarian would utilize this approach in practice.
Q&As Specific to Manufacturers and Dealers that Serve Distributors
The Final Guidance substantively revises Q&A Section III.B.15, which outlines the responsibilities of VFD feed manufacturers and dealers in three different scenarios: (1) the manufacturer ships the feed to a dealer who intends to distribute it further; (2) the manufacturer delivers the feed to the client at the direction of a dealer; and (3) the manufacturer delivers the feed to the client but the dealer serves only in a limited support capacity (e.g., processing the sale). The 2019 Draft Guidance addressed only the scenario in which the manufacturer delivers the feed to the client and the dealer handles the transaction without taking physical possession of the VFD feed.
In the first scenario, CVM clarifies that the manufacturer qualifies as a distributor under 21 C.F.R. § 558.3(b)(9). The manufacturer’s dealer is also considered a distributor because it further distributes the VFD feed to the client. As distributors, both the manufacturer and the dealer must submit a one-time distributor notification to FDA and follow the other distributor requirements set forth in 21 C.F.R. § 558.6. Because the manufacturer ships to another distributor (here, the dealer), the manufacturer must obtain an acknowledgment letter from the dealer before shipping the VFD feed, in accordance with 21 C.F.R. § 558.6(c)(8), but it need not receive or maintain a copy of the VFD.
In the second scenario, both the manufacturer and the dealer act as distributors. Even though the dealer does not physically distribute the VFD feed, the dealer is involved in distribution as a party to the transaction. Similar to the first scenario, both the manufacturer and the dealer must submit a one-time distributor notification to FDA and follow the other distributor requirements set forth in 21 C.F.R. § 558.6. Because the manufacturer is shipping the VFD feed directly to the client, the manufacturer must obtain an acknowledgement letter as well as a copy of the VFD from the dealer before shipping the feed.
In the third and final scenario, CVM clarifies that the dealer would not meet the “distributor” definition because it would not be a party to the distribution transaction. Consequently, neither the dealer nor any other party that is solely involved in facilitating the transport of the VFD feed (e.g., third-party logistics provider) or transporting the VFD feed (e.g., shipping or hauling companies) would be subject to the distributor requirements of 21 C.F.R. § 558.6.
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