Chapter 1: Dispensing Veterinary Prescription Drugs: An Overview (Mandatory) 1 CE Hour Expiration Date : November 2, 2027 Learning objectives After completing this course, the learner will be able to:
List requirements for use of VFD drugs. Describe the conditions under which veterinarians may prescribe extra-label drugs. Describe the impacts of GFI 256, new guidance on the compounding of animal drugs from bulk substances.
Identify the agencies involved and areas of responsibility for federal regulation of animal health products, including animal drugs, feed, and devices. List FDA regulations for dispensing veterinary prescription drugs, including labeling requirements. Course overview This course fulfills Florida’s requirement for one hour of continuing professional education in the area of dispensing prescription drugs. After completing this course, veterinarians
will have renewed familiarity with the rules and regulations surrounding prescription drug dispensing, including recent changes related to the prescribing of compounded drugs.
REGULATION OF ANIMAL DRUGS
● The Animal Drug Availability Act of 1996 (ADAA) streamlined the animal drug approval process while adding a new category that included veterinary feed directive (VFD) drugs. According to the Food, Drug, and Cosmetic Act, animal drugs must be safe and effective for their intended use. A new animal drug is presumed unsafe until its application has been approved by the FDA. Additionally, the drug’s use and labeling must conform to the approved application, unless that drug is used in a legal extra-label manner by or on the order of a veterinarian. All FDA regulations are codified in Title 21 of the Code of Federal Regulations. 1 Parts 500-599 specifically address animal drugs and feed, discussing how to ensure that animal drugs are safe and effective for their intended uses and do not result in unsafe residues in food animals. also providing information about the behavior of vaccines and other immunobiologics under everyday field conditions. Adverse events may be reported to the following agents: ● Manufacturer . Many biologics manufacturers maintain veterinary services departments to handle such reports. They may also offer diagnostic advice, treatment recommendations, and guidance on product use. ● Center for Veterinary Biologics (CVB) . Once an adverse event has been reported to the manufacturer, the CVB may be contacted by submission of the electronic Adverse Event Report Form. 3 A PDF version of this form may also be downloaded at the website and submitted by fax or by mail. Adverse events may also be reported by calling the CVB at 800-752-6255. Pet foods Although pet food products do not require premarket approval by FDA, they are subject to requirements of the act. Pet foods may not be adulterated or misbranded, and they may not contain poisonous or harmful substances beyond established tolerances. They cannot be stored in harmful packaging materials and may not contain unsafe additives. Pet food labeling may not be false or misleading, and damage or inferiority may not be concealed. FDA regulations applying to pet foods are published in Title 21 of the Code of Federal Regulations. Specific regulations address additives, colorings, supplements, or other substances that are approved or generally recognized as safe for an intended use. 4
Under the federal Food, Drug, and Cosmetic Act, the Food and Drug Administration (FDA) has a mandate to ensure safety and effectiveness of drugs and devices, as well as the safety of the food supply. The FDA’s Center for Veterinary Medicine (CVM) is responsible for regulating drugs, foods, and medical devices used in animals. Two important amendments to the federal Food, Drug, and Cosmetic Act play a role in expanding the veterinarian’s authority in the area of drug use: ● The Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA) allowed veterinarians to use approved animal drugs in an extra-label manner and prescribe approved human drugs for use in animals, under certain specified conditions. Who has responsibility? The FDA is responsible for regulating animal drugs, feeds, devices, and many animal health products. However, some products come under the jurisdiction of other agencies. Pesticides Insecticides fall under the Federal Insecticide, Fungicide and Rodenticide Act, administered by the Environmental Protection Agency (EPA). However, parasite preventatives that act systemically are often regulated as drugs by the FDA. For example: ● Topically-applied flea control products: regulated by EPA. ● Oral flea control products: regulated by FDA. Information about EPA pesticide programs may be found on the agency’s website 2 . Veterinary biologics including vaccines The Veterinary Biologics Program of the U.S. Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) oversees the U.S. veterinary biologics industry. The term “veterinary biologics” refers to vaccines, bacterins, allergens, antibodies, antitoxins, toxoids, immunostimulants, and antigenic/ immunizing components of microorganisms intended to prevent, diagnose, manage, or cure disease in animals. Vaccines stimulate antibody production, aiding in disease prevention. Immunobiological reactions are often used as the basis of test kits for disease diagnosis. Antibody-containing products, such as serum derivatives, may be used to manage or cure disease. The veterinary biologics pharmacovigilance program conducts ongoing surveillance of adverse events. Surveillance allows the detection of products that are not performing as intended, while
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Book Code: VFL1524
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