● 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. 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. 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. 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 Recently, the CVM issued new guidance (GFI #256) on compounding veterinary drugs from bulk substances. The primary impact of this guidance, as it will be experienced by most veterinary practices, is to limit which drugs can be compounded and stocked by veterinary hospitals for clinical use. Veterinarians working with companion animals can only maintain compounded drugs from the List of Bulk Drug Substances for Compounding Office Stock Drugs for Use in Nonfood-Producing Animals in stock for use in their patients.10 In most cases, compounded drugs can still be ordered from a compounding pharmacy for an individual patient when there is a documented medical need. However, stocking compounded drugs for dispensing to a variety of patients (for example, compounded ear medications to be prescribed on an as-needed basis) will no longer be permissible in many cases. For more information on GFI #256, see the FDA CVM’s Frequently Asked Questions website.11 Under the provisions of the Animal Medicinal Drug Use Clarification Act of 1994, the FDA allows the extra-label use of drugs by veterinarians when the health of an animal is threatened or suffering or death may result from failure to treat. Any drug used in an extra-label manner is by definition a prescription drug, since the involvement of a veterinarian is required, and it may only be prescribed within the scope 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. 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 is a violation of 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 and diagnoses a
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. The FDA will hold responsible any individual in the production and marketing chain who can be shown to have caused (by
Compounding of animal drugs In general, compounding an animal drug from an active pharmaceutical ingredient (bulk drug) is not permitted by the act unless covered by an approved new animal drug application. This is true even if the compounder is a veterinarian or a pharmacist. However, CVM acknowledges the medical need for compounding may exist within certain areas of veterinary practice. The contemporary practice of veterinary medicine requires products to treat hundreds of conditions and diseases in dozens of species. Business and market realities in the animal health industry can only provide a fraction of products necessary for these indications. Consequently, veterinarians continue to require products to treat diseases or conditions in animals for which no FDA-approved product is available. Veterinarians must by necessity on occasion utilize products that are compounded to meet a specific patient’s medical need. Extra-label use of FDA-approved drugs in animals “Extra-label use” is defined as: Actual use or intended use of a drug in an animal in a manner that is not in accordance with the approved labeling. This includes, but is not limited to, use in species not listed in the labeling, use for indications (disease and other conditions) not listed in the labeling, use at dosage levels, frequencies, or routes of administration other than those stated in the labeling, and deviation from labeled withdrawal time based on these different uses.
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Book Code: VFL1524
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