Dispensing veterinary prescription drugs Because adequate directions for safe and effective lay use cannot be written for animal prescription drug products, such products can only be sold on the prescription or other order of a licensed veterinarian. Selling an animal prescription drug product to a layperson without a prescription is misbranding, subjecting the seller to civil and/or criminal penalties. A licensed veterinarian may legally use or dispense an animal prescription drug product only within the context of a valid veterinarian–client–patient relationship (VCPR). A valid VCPR is defined by the American Veterinary Medical Association as follows: A VCPR exists when all of the following conditions have been met: The veterinarian has assumed the responsibility for making clinical judgments regarding the health of the animal(s) and the need for medical treatment, and the client has agreed to follow the veterinarian’s instructions. The veterinarian has sufficient knowledge of the animal(s) to initiate at least a general or preliminary diagnosis of the medical condition of the animal(s). This means that the veterinarian has recently seen and is personally acquainted with the keeping and care of the animal(s) by virtue of an examination of the animal(s) or by medically appropriate and timely visits to the premises where the animal(s) are kept. Medicated animal feeds 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 compound in animal feed is approved, a notice is published in the Federal Register. 7 The medicated feed must be labeled in accordance with the approved labeling. A drug may be mixed into feed only for uses and at potency levels specifically permitted in the regulations. It Veterinary feed directives The Animal Drug Availability Act of 1996 (ADAA) amended the act to establish a new category of drugs, veterinary feed directive (VFD) drug, intended for use in or on feed under the 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. Extra-label use of a VFD drug is not permitted by anyone, including the veterinarian. The VFD process is straightforward in practice. A veterinarian, within the confines of a valid VCPR, examines
The veterinarian is readily available for follow-up evaluation, or has arranged for emergency coverage, in the event of adverse reactions or failure of the treatment regimen. 6 Veterinarians employed by drug manufacturers or distributors may not legally dispense prescripti on drug products to laypersons unless they meet the foregoing criteria. Similarly, practicing veterinarians or their employees may not legally sell animal prescription drug products to walk-in customers outside the context of a valid VCPR. What information needs to be included in the veterinarian’s prescription and included on the label of the dispensed product? ● Name and address of the dispenser. ● Serial number and date of the order or its filling. ● Name and address of the veterinarian who prescribed or ordered the drug. ● Directions for use. ● Any necessary warning and precautionary statements (including withdrawal times). Additional state or local requirements may also apply. To protect themselves and their clients, veterinarians should make efforts to ensure their instructions are followed, especially when prescribing or recommending drugs for food- producing animals. 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, and the feed itself may be subject to seizure. The agency may allow off-label use of drugs in the feed of minor species provided certain conditions are met, including the involvement of a licensed veterinarian. and diagnoses a condition. If the condition warrants a VFD drug, the veterinarian will issue a signed VFD. The veterinarian keeps a copy of the VFD 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. The VFD authorizes the VFD feed to be shipped to the client’s animal feeding operation. VFD feed manufacturers (including veterinarians) must notify CVM prior to distribution. A VFD feed may not be distributed to a client without a signed VFD. The FDA will hold responsible any individual in the production and marketing chain who can be shown to have caused (by an act of commission or omission) illegal residues or other contaminants in edible animal products. 8 If a veterinarian prescribes, dispenses, or treats an animal(s) with a drug that causes an illegal drug residue in edible products from the treated animal, the veterinarian may be held responsible for having caused a violation of law. Additional information on residue avoidance and withdrawal times can be found in the Food Animal Residue Avoidance Databank (FARAD). 9
Responsibility for illegal residues in meat, fish, milk, and eggs FDA is responsible for preventing illegal drug residues in human food products derived from treated animals. Illegal drug residues in edible products can constitute a hazard to the health of persons consuming such food. Failure to observe label withdrawal periods before slaughter or processing or failure to withhold milk are principal causes of illegal drug residues. Other causes include failure to follow other label directions, poor feed manufacturing practices, and human negligence.
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Book Code: VFL1526
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