Feed distributors won’t need to provide VFD or letter to acquire Type A medications
US feed distributors will not need to provide a veterinary feed directive (VFD) or acknowledgment letter to animal health companies to obtain a Type A medicated article containing VFD medications, according to recent communication with FDA’s Center for Veterinary Medicine.
A “Type A medicated article” is a concentrated animal drug product used as a component in the manufacture of medicated premixes and feeds.
“The rule does not require that distributors send an acknowledgement letter to the drug sponsor [animal health company] for the Type A medicated article,” AskCVM said in a response to a recent query on this matter.
“In addition, the rule does not require that the [drug] sponsor keep any acknowledgment letter for distribution of a Type A medicated article.”
A few exceptions
In some instances, a drug sponsor may distribute Type B medicated feed (intermediate premix). In those situations, however, the agency said a drug sponsor would be considered a distributor and would be “subject to the distributor requirements of the rule and as such required to receive/keep an acknowledgement letter for the VFD feed the sponsor (acting as distributor) ships to other distributors.”
AskCVM defines a distributor as “… any person who distributes a medicated feed containing a VFD drug to another person. Such other person may be another distributor or the client-recipient of a VFD.”
Before a distributor ships an animal feed containing a VFD medication to another distributor, the distributor must obtain an acknowledgement letter from the distributor receiving the VFD feed [Section 504(a)(3) of the Federal Food Drug & Cosmetic Act (21 U.S.C. 354(a)(3)].
A description of what the acknowledgment letter must include can be found at 21 CFR 558.3(b)(11).
According to AskCVM, an acknowledgment letter from the distributor may be written to cover one or more shipments of a VFD feed with an open-ended duration. In that instance, the acknowledgment letter must be kept for 2 years from the date of last shipment distributed under the acknowledgment letter.
According to CVM, this communication does not constitute a written advisory opinion under Title 21 CFR 10.85, but rather is an informal communication under Title 21 CFR 10.85(k) which represents the best judgment of the employee providing it. This information does not necessarily represent the formal position of FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.
Posted on August 9, 2016