Anyone who adds drugs to feed is subject to the Federal Food, Drug and Cosmetic Act (the Act). Just as each label claim for a new animal drug must be approved, a drug must be specifically approved for administration in animal feed. When the new animal drug application for use of the drug in animal feed is approved, a notice is published in the Federal Register. The medicated feed must be labeled in accordance with the approved labeling.
A drug may only be mixed into feed for uses and at drug levels specifically permitted in the regulations (21 CFR Part 558.) The person or firm mixing a medicated feed containing a category II, Type A medicated article or certain liquid and free-choice feed, using Category I, Type A medicated articles that must follow proprietary formulas or specifications (21 CFR Part 558.4) must be registered with the FDA as a drug manufacturer and hold an approved medicated feed mill license.
It is a violation of the Act for drugs to be added for uses or at levels not specified in the regulations. Any individual authorizing the violation, as well as the individual illegally mixing the feed may be subject to regulatory action. Additionally, the feed itself may be subject to seizure. The agency will tolerate off-label use of drugs in the feed of minor species provided certain conditions are met, including the involvement of a licensed veterinarian. Compliance Policy Guide 615.115.
The Animal Drug Availability Act of 1996 (ADAA) amended the Act to establish a new category of drugs, veterinary feed directive (VFD) drugs. A drug approved for use in or on animal feed as a VFD drug is limited to use only under the professional supervision of a licensed veterinarian. Final regulations covering the use and distribution of VFD feeds (medicated feeds containing VFD drugs) were published in the Federal Register on December 8, 2000.
The VFD process is straightforward in practice. A veterinarian, operating within the confines of a valid veterinarian-client-patient relationship, examines and diagnoses animal conditions and determines whether a condition warrants use of a VFD drug. If it does, the veterinarian will issue signed VFD order containing information specified by regulation. Extra-label use of a VFD drug (or any drug) in or on an animal feed is strictly prohibited, i.e., not permitted by anyone, including the veterinarian. The veterinarian keeps a copy of the VFD order and provides the completed and signed original and a copy to the client. The client keeps the copy and gives the original VFD to the feed manufacturer issuing the VFD feed. The VFD order allows the VFD feed to be issued to the client for feeding to the animals.
Anyone intending to distribute VFD feeds must notify CVM prior to beginning distribution. Distributor includes the VFD feed manufacturer or anyone in the distribution chain who ultimately supplies VFD feed to an animal producer upon receiving a valid VFD order. The veterinarian could be a distributor of VFD feed. A VFD feed may not be distributed to a client without a signed, valid VFD. However, VFD feed may be sent down the distribution chain if the consignee, i.e., another distributor, provides the distributor with a signed acknowledgment letter affirming that it will only issue the VFD feed to a client upon receiving a valid VFD order holder or to another distributor upon receiving the acknowledgment letter.