This interactive Florida Veterinarian Ebook contains 15 hours of continuing education. To complete click the Complete Your CE button at the top right of the screen.
FLORIDA Veterinarian Continuing Education
Elite Learning
COMPLETE YOUR CE BY THE 5/31 DEADLINE
Mandatory courses included in this book: Dispensing Veterinary Prescription Drugs: An Overview Florida Laws and Rules: Veterinary Practice
ELITELEARNING.COM/BOOK Complete this book online with book code: VFL1524 This book fulfills all 15 hours of your home study allowance $195.00
WHAT’S INSIDE
THIS COURSE FULFILLS THE REQUIREMENT FOR DRUG DISPENSING Chapter 1: Dispensing Veterinary Prescription Drugs: An Overview (Mandatory)
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[1 CE hour] 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. THIS COURSE FULFILLS THE REQUIREMENT FOR LAWS AND RULES GOVERNING VETERINARY MEDICINE Chapter 2: Florida Laws and Rules: Veterinary Practice (Mandatory) 6 [2 CE hours] To remain current on the scope of practice for veterinarians, it is essential that they be updated on new rules being passed or introduced. This course will review Florida’s rules on these matters, as well as the new acts recently enacted in the last few years. As a licensed veterinarian, it is imperative to be judicious in understanding the laws and rules governing the profession. This course will review the recently adopted rules, rule changes or amendments that, in particular, impact the profession and the practice of veterinary medicine. Chapter 3: Advanced Anesthesia for Small Animals 19 [1 CE hour] This course will give a review of the common anesthetic drugs. It will cover the effects that you will see as well as any contraindications of each drug. This course will include the many pre-operative drugs, induction agents, inhalation agents, and pain medications. It will also briefly cover local and regional nerve blocks. Chapter 4: Avian Influenza and Highly Pathogenic Avian Influenza 26 [2 CE hours]
Avian influenza is a highly contagious viral respiratory illness of birds, which tends to circulate primarily within the avian population but can occasionally affect domestic animals. It is important for all veterinarians to have a basic understanding of this virus so they can provide appropriate guidance to their clients and the community. Chapter 5: Canine Influenza [2 CE hours] This course is designed to provide veterinarians with information on the historical background and epidemiology of canine influenza, as well as practical information related to diagnosis, treatment, and prevention. With this information, veterinarians will be more prepared for canine influenza outbreaks in their community, and also more
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prepared to educate dog-owning clients and address their concerns. Chapter 6: Diagnosis and Treatment of Feline Inappropriate Elimination
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[3 CE hours] Inappropriate elimination can often be resolved with early intervention by finding the underlying problem, if it is a behavioral issues then there are ways to correct this behavior. Chapter 7: Feline Heartworm Disease: It’s More Common Than You Think
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[2 CE hours] Feline heartworm disease is a significant risk to the health of cats throughout the United States. Although Dirofilaria immitis has traditionally been regarded as a parasite of dogs, recent research has demonstrated that feline infections are far more common than veterinarians once thought. These infections often remain undiagnosed, however, given the wide variation in clinical signs of feline heartworm disease and the challenges of obtaining an accurate diagnosis with currently available diagnostic tests. If feline heartworm infection is detected or suspected based on tests, treatment is similarly challenging. There is no single “best” treatment for heartworm disease in cats; most cases are treated symptomatically, with a guarded prognosis. Chapter 8: Heartworm Disease in Dogs 58 [2 CE hours]
Heartworm infection is a serious parasitic infection in dogs, with worldwide distribution. Testing for heartworms can be complicated and controversial, as can determining treatment options. In this course, you will learn about recent developments in heartworm testing, treatment, and prevention, allowing you to better serve your canine patients. Final Examination Answer Sheet
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©2024: All Rights Reserved. Materials may not be reproduced without the expressed written permission or consent of Colibri Healthcare, LLC. The materials presented in this course are meant to provide the consumer with general information on the topics covered. The information provided was prepared by professionals with practical knowledge in the areas covered. It is not meant to provide medical, legal or professional services advice. Colibri Healthcare, LLC recommends that you consult a medical, legal or professional services expert licensed in your state. Colibri Healthcare, LLC has made all reasonable efforts to ensure that all content provided in this course is accurate and up to date at the time of printing, but does not represent or warrant that it will apply to your situation or circumstances and assumes no liability from reliance on these materials.
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VETERINARIAN CONTINUING EDUCATION 2024
Book Code: VFL1524
FREQUENTLY ASKED QUESTIONS
What are the requirements for license renewal? License Expires
CE Hours
Mandatory Subjects
1 hour of drug dispensing 2 hours of laws and rules governing the practice of veterinary medicine
30 (15 hours are allowed through home-study)
Biennial renewals are due on May 31 of even years
How much will it cost?
Course Title
CE Hours
Price
Course Code
Chapter 1: Dispensing Veterinary Prescription Drugs: An Overview ( Mandatory) Chapter 2: Florida Laws and Rules: Veterinary Practice (Mandatory)
1
$25.00
VFL01VP
2 1 2 2 3 2 2
$50.00
VFL02LR
Chapter 3: Advanced Anesthesia for Small Animals
$25.00 VFL01AA
Chapter 4: Avian Influenza and Highly Pathogenic Avian Influenza
$50.00 $50.00 $50.00 $50.00 $50.00
VFL02AV VFL02CI VFL03FE VFL02HD VFL02HW
Chapter 5: Canine Influenza
Chapter 6: Diagnosis and Treatment of Feline Inappropriate Elimination Chapter 7: Feline Heartworm Disease: It’s More Common Than You Think
Chapter 8: Heartworm Disease in Dogs Best Value - Save $155.00 - All 15 Hours
15 $195.00 VFL1524
How do I complete this course and receive my certificate of completion? See the following page for step by step instructions to complete and receive your certificate. Are you a Florida board-approved provider? Yes. Colibri Healthcare, LLC, is a board-approved provider of continuing education by the Florida Board
of Veterinary Medicine – (Provider #0008051). Are my hours reported to the Florida board?
No, the Florida Board of Veterinary Medicine requires licensees to certify at the time of renewal that he/ she has complied with the continuing education requirement. The board performs audits at which time proof of continuing education must be provided. Is my information secure? Yes! We use SSL encryption, and we never share your information with third-parties. We are also rated A+ by the National Better Business Bureau. What if I still have questions? What are your business hours? No problem, we have several options for you to choose from! Online at EliteLearning.com/Veterinarian you will see our robust FAQ section that answers many of your questions, simply click FAQs at the top of the page, e-mail us at office@elitelearning.com, or call us toll free at 1 -888-857-6920 , Monday - Friday 9:00 am - 6:00 pm, EST. Important information for licensees: Always check your state’s board website to determine the number of hours required for renewal, mandatory topics (as these are subject to change), and the amount that may be completed through home-study. Also, make sure that you notify the board of any changes of address. It is important that your most current address is on file.
Licensing board contact information: Florida Division of Professions I Board of Veterinary Medicine 2601 Blair Stone Road I Tallahassee, FL 32399-0783 I Phone (850) 487-1395 I Fax (850) 488-8040 Website: http://www.myfloridalicense.com/DBPR/veterinary-medicine/
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Book Code: VFL1524
VETERINARIAN CONTINUING EDUCATION 2024
HOW TO COMPLETE THIS BOOK FOR CREDIT
Please read these instructions before proceeding. IF YOU’RE COMPLETING ALL COURSES IN THIS BOOK: • Go to EliteLearning.com/Book and enter code VFL1524 in the book code box, then click GO . • If you already have an account created, sign in with your username and password. If you don’t have an account, you’ll be able to create one now.
• Follow the online instructions to complete your final exam. Once you finish your purchase, you’ll receive access to your completion certificate. IF YOU’RE ONLY COMPLETING CERTAIN COURSES IN THIS BOOK: • Go to EliteLearning.com/Book and enter code that corresponds to the course below, then click GO . Each course will need completed individually
COURSES YOU’VE COMPLETED
HOURS
PRICE
CODE TO ENTER
All 15 hours in this correspondence book
VFL1524 VFL01VP
15 $195.00
Dispensing Veterinary Prescription Drugs: An Overview ( Mandatory)
1
$25.00
Florida Laws and Rules: Veterinary Practice (Mandatory)
2
$50.00
VFL02LR
Advanced Anesthesia for Small Animals
1
$25.00
VFL01AA
Avian Influenza and Highly Pathogenic Avian Influenza
2
$50.00
VFL02AV
Canine Influenza
2
$50.00
VFL02CI
3
$50.00
VFL03FE
Diagnosis and Treatment of Feline Inappropriate Elimination
Feline Heartworm Disease: It’s More Common Than You Think
2
$50.00
VFL02HD
Heartworm Disease in Dogs
2
$50.00
VFL02HW
By mail • Fill out the answer sheet and evaluation found in the back of this booklet. Please include a check or credit card information and e-mail address. Mail to Elite, PO Box 37, Ormond Beach, FL 32175 . • Completions will be processed within 2 business days from the date it is received and certificates will be e-mailed to the address provided. • Submissions without a valid e-mail will be mailed to the address provided.
By fax • Fill out the answer sheet and evaluation found in the back of this booklet. Please include credit card information and e-mail address. Fax to (386) 673-3563 . • All completions will be processed within 2 business days of receipt and certificates e-mailed to the address provided. • Submissions without a valid e-mail will be mailed to the address provided.
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VETERINARIAN CONTINUING EDUCATION 2024
Book Code: VFL1524
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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Animal medical devices A medical device, as defined in the act, is:
The term “drug” means articles recognized in the official U.S. Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States, or official National Formulary; articles intended to diagnose, mitigate, treat, cure, or prevent disease; and non-food items intended to affect the structure or function of the body. A new animal drug is defined (in part) as “ any drug intended for use for animals other than man, the composition of which is not generally recognized among experts qualified by scientific training and experience as safe and effective for use under the conditions prescribed, recommended or suggested in its labeling. ” There are, for all practical purposes, no animal drugs that are not also new animal drugs. The Green Book, accessible from the CVM home page, contains a searchable database of all FDA-approved animal drugs. 5 Unapproved new animal drugs may be distributed if the drug will be used for research, that is, for the collection of data intended to be submitted in support of approval. Investigational New Animal Drug (INAD) regulations provide that such drugs may be distributed for use only by experts, qualified by scientific training and expertise, to investigate the safety and effectiveness of animal drugs. Before a new animal drug receives FDA approval, the sponsor must establish that the new animal drug is safe and effective: ● Safe includes safety to the animal, safety of food products derived from the animal, safety to persons administering the drug or otherwise associated with the animal, and safety in terms of the drug’s environmental impacts. ● Effective means that the product will consistently and uniformly do what the labeling claims it will do. Drug sponsors submit a new animal drug application (NADA) along with supporting data, including all adverse effects associated with the drug’s use. The FDA performs a detailed and comprehensive review, determining whether data were developed in accordance best practices and evaluating the data for safety and efficacy. For drugs used in food animals, the drug producer must also demonstrate that drug residues are safe for human consumption and provide acceptable analytical methods capable of detecting the drug and its metabolites in animal tissue. be properly administered, and the course of the disease can be followed to assess treatment success. Prescription products must bear the legend: “ Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.” The same drug substances can be marketed in different forms, intended for use by different routes of administration and in different species of animals. Thus, these drug products may be labeled prescription in some cases and over-the counter (OTC) in others. 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. 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.
An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component part, or accessory, which is … intended for use in the diagnosis of disease, or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body of man or other animals and which does not achieve any of its principal intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its principal intended purposes. Articles such as screening test kits for drug residues are regulated as animal medical devices. Animal medical devices do not require premarket FDA approval, but they are subject to provisions of the act related to misbranding and adulteration. For example, an animal medical device is misbranded if the labeling is false or misleading, if it does not have adequate directions for use by a layperson, or if it is dangerous to animal or human health when used as directed. The FDA relies on veterinarians and other users to report unsafe animal medical devices. If adequate directions cannot be written for lay use, the animal medical device is deemed unsafe for use except under the supervision of a licensed veterinarian. Therefore, its label must bear the statement: “Caution: Federal law restricts this device to sale by or on the order of a licensed veterinarian.” Examples of animal medical devices required to bear the prescription legend include transcutaneous electronic nerve stimulators, pulse magnetic field devices, and lasers. Animal grooming aids The act defines a cosmetic as pertaining only to human use, so products intended for cleansing or promoting attractiveness in animals are not subject to FDA control. However, if such products are intended for a therapeutic purpose, they are subject to regulation as new animal drugs. Drug approval process Classifying prescription and over-the-counter animal drugs The FDA determines the marketing status (prescription, over- the-counter, or VFD) of animal drugs based on whether it is possible to prepare “adequate directions for use” that would allow a layperson to use the drugs safely and effectively. Safe use includes safety to the animal, safety of food products derived from the animal, safety to the persons associated with the animal, and safety in terms of the drug’s impact on the environment. Effective use assumes that an accurate diagnosis can be made with a reasonable degree of certainty, the drug can 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.
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Book Code: VFL1524
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● 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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Extra-label use of drugs may be considered by food animal veterinarians only when there is no approved new animal drug containing the same active ingredient in the required dosage form and concentration (unless the approved drug has been found to be clinically ineffective). The veterinarian must also make an informed diagnosis, establish an appropriate withdrawal time to avoid illegal drug residues (or keep the animal out of the food supply if no scientific information exists), and institute Labeling of drugs prescribed for extra-label use At a minimum, the following label information is recommended: 1. The name and address of the prescribing veterinarian. 2. The established name of the active ingredient(s). 3. Directions for use specified by the practitioner (including animal identification; dosage, frequency, and route of administration; and duration of therapy). 4. Cautionary statements specified by the veterinarian. 5. Veterinarian’s specified withdrawal/discard time(s) for meat, milk, eggs, or any food that might be derived from the treated animals. Because extra-label use of animal and human drugs in nonfood- producing animals (companion, sporting, exotic, etc.) does not ordinarily pose a threat to the public health, extra-label use of animal and human drugs is permitted in these species within the context of a VCPR, except where the public health is threatened. Limitations to extra-label use provisions of AMDUCA The following specific extra-label uses are prohibited: 1. Extra-label use in an animal of an approved animal or human drug by a lay person (except under the supervision of a licensed veterinarian). 2. Extra-label use of an approved new animal drug or human drug in or on an animal feed. 3. Extra-label use resulting in any residue that may present a risk to the public health. 4. Extra-label use resulting in any residue above an established safe level, safe concentration, or tolerance. FDA may also prohibit the extra-label use of an approved new animal or human drug or class of drugs in animals if FDA determines that: 1. An acceptable analytical method has not been established or cannot be established. Reporting adverse drug reactions Users of new animal drug products are encouraged to notify the product’s manufacturer of any unexpected or adverse reactions resulting from the use of that product. The manufacturer is responsible for reporting rates of injury, toxicity, and sensitivity reactions to the FDA, along with unexpected incidence or severity of side-effects associated with use and failure of the drug to exhibit expected pharmacological action. FDA scientists analyze these data to determine whether modifications are needed in the drug’s labeling, dosage level, and so on to mitigate future adverse reactions. In extreme instances, the Types of FDA regulatory actions The objective of FDA regulatory programs is to ensure compliance with the federal Food, Drug, and Cosmetic Act. Specific enforcement activities include actions to correct and prevent violations, remove violating products or goods from the market, and punish offenders. The range of enforcement activities varies depending on the severity of an infraction. Actions include: ● Warning letter s. Sent to individuals or firms, advising them of violation and requesting a written response outlining corrective actions. ● Seizure . An action brought against an adulterated or misbranded FDA-regulated product to remove specific violating goods from commerce.
procedures to assure that the identity of the treated animal(s) is/are carefully maintained. Extra-label medication use in food animals must always be supported by an appropriate medical rationale and cannot be used to enhance production. The prescribed or dispensed extra-label drug (prescription legend or over-the-counter) must bear labeling information that is adequate to ensure the safe and proper use of the product. 2. The extra-label use of the drug or class of drugs presents a risk to the public health. A prohibition on a drug or drug class may be a general ban or may be limited to a specific species, indication, dosage form, route of administration, or combination of factors. The following drugs are prohibited for extra-label use in all animals: 1. Chloramphenicol. 2. Clenbuterol. 3. Diethylstilbestrol (DES). 7. Furazolidone. 8. Nitrofurazone. 9. Sulfonamide drugs in lactating dairy cattle (except approved use of sulfadimethoxine, sulfabromomethazine, and sulfaethoxypyridazine). 10. Fluoroquinolones. 11. Glycopeptides. 12. Phenylbutazone in female dairy cattle 20 months of age or older. 13. Cephalosporins in cattle, swine, chicken, or turkeys (except for approved uses/formulations). 14. Adamantane in chickens, turkeys, and ducks. 15. Neuraminidase inhibitors in chickens, turkeys, and ducks. Extra-label use of drugs in treating food-producing animals for improving rate of weight gain, feed efficiency or other production purposes is prohibited under AMDUCA. A drug (including a bulk drug) may not be mixed into feed for any use or at a potency level not specifically permitted by the regulations in 21 CFR Part 558, even if prescribed by a veterinarian. adverse reactions may be so severe as to request withdrawal of approval of the drug. In the case of unapproved drugs and devices, reports should be submitted on Form FDA 1932a, Veterinary Adverse Reaction, Lack of Effectiveness, or Product Defect Report , which is available on the FDA website.12 FDA may occasionally need more detailed information about an incident, and the veterinarian may be called by an FDA staff veterinarian. Adverse reactions may also be reported by telephone by calling 888-FDA-VETS (888-332-8387). 4. Dimetridazole. 5. Ipronidazole. 6. Other nitroimidazoles. ● Injunction . An order by a court that requires an individual or corporation to do or refrain from violating or causing violations of the act. ● Criminal prosecution . May be recommended in appropriate cases for violation of Section 301 of the act. Misdemeanor convictions, which do not require proof of intent to violate the act, can result in fines (up to $500,000) and/ or imprisonment up to 1 year. Felony convictions, which apply in the case of a second violation or intent to defraud or mislead, can result in fines and/or imprisonment up to 3 years. FDA field offices conduct investigations that may lead to recommendations for enforcement/regulatory action. The action recommended will depend upon the nature of the violation and other factors.
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Book Code: VFL1524
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Interaction with the Food and Drug Administration The Food and Drug Administration is most effective in carrying out its mission under a policy of openness and free communication. Everyone is best served when there is clear understanding of FDA regulations and policies, as well as their administration. The FDA seeks to create confidence in programs that are intended to promote and protect the health and well- being of all. The FDA encourages anyone to contact the agency for assistance, to supply information, or to report a problem with a product. To help direct requests to the proper location for a rapid response, it offers the following guidance: References Title 21, Code of Federal Regulations. https://www.fda.gov/medical-devices/medical-device-databases/code- federal-regulations-title-21-food-and-drugs Pesticides. EPA. http://www.epa.gov/pesticides/ Adverse Event Reporting. APHIS, USDA. https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/veterinary- biologics/adverse-event-reporting/ct_vb_adverse_event FDA’s Regulation of Pet Food. https://www.fda.gov/animal-veterinary/animal-health-literacy/fdas-regulation-pet- food Animal Drugs @ FDA. https://animaldrugsatfda.fda.gov/adafda/views/#/search The veterinarian-client-patient relationship (VCPR). AVMA. https://www.avma.org/resources-tools/pet-owners/ petcare/veterinarian-client-patient-relationship-vcpr The Federal Register serves as a legal newspaper for making available to the public regulations and legal notices issued by federal agencies. It is published Monday through Friday by the Office of the Federal Register, National Archives and Records Administration, Washington, DC 20408. Distributed by the Superintendent of Documents, U.S. Government Printing Office, Washington, DC 20402. It is available at https://www.federalregister.gov
For information on approved drugs, regulations, policies, copies of guidelines, or CVM publications, consult the CVM website.13 For information by mail or to submit suggestions or comments, address a letter to: Center for Veterinary Medicine HFV-1 7519 Standish Place Rockville, MD 20855 CVM can also be contacted via telephone at 240-402-7002 or via email at AskCVM@fda.hhs.gov. Copies of Compliance Policy Guides 7125.37 Proper Drug Use and Residue Avoidance by Non-Veterinarians (7/09/93), and 7125.05 Responsibility for Illegal Drug Residues in Meat, Milk and Eggs (7/01/82) are available from Communications Staff, HFV-12, Center for Veterinary Medicine, 7519 Standish Place, Rockville, MD 20855. CPGs are also available on the FDA website (https://www.fda.gov/inspections-compliance-enforcement-and- criminal-investigations/compliance-manuals/manual-compliance-policy-guides) Food Animal Residue Avoidance Databank. http://www.farad.org/ List of Bulk Drug Substances for Compounding Office Stock Drugs for Use in Nonfood-Producing Animals. FDA.: https://www.fda.gov/animal-veterinary/animal-drug-compounding/list-bulk-drug-substances-compounding-office- stock-drugs-use-nonfood-producing-animals Q&A: GFI #256—Compounding Animal Drugs from Bulk Drug Substances. https://www.fda.gov/animal- veterinary/animal-drug-compounding/qa-gfi-256-compounding-animal-drugs-bulk-drug-substances How to Report Animal Drug and Device Side Effects and Product Problems. Re: https://www.fda.gov/animal- veterinary/report-problem/how-report-animal-drug-and-device-side-effects-and-product-problems Center for Veterinary Medicine. FDA. https://www.fda.gov/about-fda/fda-organization/center-veterinary-medicine 7. Which of the following statements is true about stocking compounded drugs in a practice’s pharmacy for use in that practice’s patients? a. Any compounded drug can be stored in your clinic for use within the context of a valid VCPR. b. Compounded drugs on the FDA’s List of Bulk Drug Substances for Compounding Office Stock Drugs for Use in Nonfood-Producing Animals can be stocked in a veterinary practice. c. No compounded drugs can be used in companion animals, regardless of the circumstances. d. Compounded drugs can only be prepared with an individual patient prescription. 8. Which of the following may be an appropriate scenario for the extra-label use of an animal drug? a. A groomer decides to administer a drug in an extra- label manner to a pet in his care. b. A human drug is added to cattle feed in an extra-label manner. c. Chloramphenicol is prescribed in an extra-label manner to treat a canine infection. d. A veterinarian prescribes an extra-label drug within the context of a VCPR. 9. Under what circumstances can a veterinarian prescribe extra-label drugs to a food animal patient within the context of a VCPR? a. There is no other available treatment option for a diagnosed disease that threatens the animal’s health. b. There is no available test to assess for the presence of drug residues in the animal’s tissue. c. The producer wants to increase weight gain and feed efficiency in his animals. d. The producer would like to add the drugs to his animals’ feed. 10. An FDA-approved animal drug is used in an approved manner, and an adverse drug reaction occurs. Who should
DISPENSING VETERINARY PRESCRIPTION DRUGS: AN OVERVIEW Final Examination Questions Select the best answer for each question and mark your answers on the Final Examination Answer Sheet found on page 68, or complete your test online at EliteLearning.com/Book 1. Which of the following agencies regulates topically-applied flea preventatives?
a. Food and Drug Administration. b. Environmental Protection Agency. c. Center for Veterinary Biologics. d. Animal and Plant Health Inspection Service.
2. Which of the following agencies issues regulations that apply to canned pet foods?
a. Food and Drug Administration. b. Environmental Protection Agency. c. Center for Veterinary Biologics. d. Animal and Plant Health Inspection Service.
3. Which of the following items would be subject to FDA regulation? a. A vaccine for canine parvovirus. b. A screening test kit for drug residues. c. A topical flea preventative. d. A non-therapeutic grooming aid for dogs. 4. In order for a drug to be approved for use in food animals, testing must be performed to ensure that drug residues are safe for human consumption. Who performs this testing? a. Food and Drug Administration. b. Center for Veterinary Biologics. c. Animal and Plant Health Inspection Service. d. The drug’s manufacturer. 5. According to federal requirements, which of the following pieces of information must be included on a veterinary prescription drug label? a. Client address.
b. Veterinarian’s name. c. Drug manufacturer. d. Generic name of the medication.
6. Medicated animal feed regulations dictate which of the following characteristics of the feed? a. Uses and duration of therapy. b. Uses and potency levels. c. Duration of therapy and potency levels. d. Duration of therapy and client characteristics.
the veterinarian contact? a. Drug manufacturer.
b. Food and Drug Administration. c. Center for Veterinary Biologics. d. Environmental Protection Agency.
Course Code: VFL01VP
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Book Code: VFL1524
EliteLearning.com/Veterinarian
Chapter 2: Florida Laws and Rules: Veterinary Practice (Mandatory) 2 CE Hours
Expiration Date : November 2, 2027 Learning objectives After completing this course, the learner will be able to: Describe the two (2) beliefs or reasons why licensing laws are established. Identify the sections from Florida’s Statutes and Administrative Code that apply to veterinarians. Discuss the violations and penalties for fraudulent and deceptive practices, according to Florida Statutes. List the acts that may constitute grounds for disciplinary action.
Identify the various types of premises permits to practice veterinary medicine. Summarize the law regarding medical patient records in terms of confidentiality, ownership and control, and the release of records. Summarize the minimum standards for ownership permits for practicing veterinary medicine. Explain the minimum standards for Limited-Service Veterinary Medical Practices.
INTRODUCTION
In Florida, the practice of veterinary medicine is covered mainly by Chapter 474 of Title XXXII of the statutes and Division 61G18 of the Administrative Code, as well as Chapter 455 of Title XXXII, which more generally covers businesses and professions but also contains laws specifically applying to veterinarians. The American Veterinary Medical Association (AVMA) frequently releases State Legislative Updates. For example, the March 2023 update featured scope-of-practice legislation in various states, the regulation of xylazine and the need to maintain veterinarians’ access to the drug, the use of cannabis and acupuncture in veterinary medicine, and other issues (AVMA, 2023). Florida-specific legislation in the March 23, 2023, AVMA report included FL S.B. 1492/FL H.B. 1581, which would tighten certain regulations concerning companion animals. This bill would create a registration system for dog breeders; set standards of care, including veterinary care, for dog breeders; and require
that a cause of death of a breeding female be presented to the state Department of Agriculture (AVMA, 2023; Florida Senate, 2023c). Changes to Florida Rule 61G18-18.001 would update the actions to be taken upon a veterinarian’s death, and changes to FL Rule 61G18-18.0015 would update the actions to be taken upon the termination or relocation of a veterinarian’s practice (AVMA, 2023). Other issues concerning Florida veterinarians are licensure, continuing education requirements, and terms of probation. This course will review updates in Florida’s rules on these matters. Licensed veterinarians must have an understanding of the laws and rules governing the profession. This course will review rule updates that impact the profession and the practice of veterinary medicine. Definitions (s. 474.202; Florida State Legislature, 2023) ● Animal : Any mammal other than a human being or any bird, amphibian, fish, or reptile, wild or domestic, living or dead. ● Board : The Board of Veterinary Medicine. ● Client : The owner or caretaker of an animal who arranges for its veterinary care. ● Department : The Department of Business and Professional Regulation. ● Immediate supervision or words of similar purport : A licensed doctor of veterinary medicine is on the premises whenever veterinary services are being provided. ● Limited-service veterinary medical practice : Offering or providing veterinary services at any location that has a primary purpose other than that of providing veterinary medical service at a permanent or mobile establishment permitted by the board; provides veterinary medical services for privately owned animals that do not reside at that location; operates for a limited time; and provides limited types of veterinary medical services, including vaccinations or immunizations against disease, preventative procedures for parasitic control, and microchipping. ● Mobile veterinary establishment and mobile clinic : A mobile unit which contains the same treatment facilities as are required of a permanent veterinary establishment or which has entered into a written agreement with another veterinary establishment to provide any required facilities not available in the mobile unit. The terms do not refer to the use of a car, truck, or other motor vehicle by a veterinarian making a house call.
PART I: FLORIDA LAW – VETERINARY MEDICAL PRACTICE (TITLE XXXII, CHAPTER 474) The AVMA represents the interests of veterinarians on federal legislative and regulatory issues that influence animal health, public health, and the veterinary profession. While the AVMA is focused on advancing veterinary medicine at the national level, Florida legislators have been working to protect the safety and welfare of animals and the public from incompetent and unethical practitioners by writing bills and amending laws. Veterinary licensing and practice in Florida are regulated by the Florida Board of Veterinary Medicine (the board).
Licensing laws are in place to protect the public and are based on two beliefs: (a) It takes special knowledge and skills to practice a profession, and (b) The public needs protection from incompetent and unethical practitioners (American Association of Veterinary State Boards [AAVSB, n.d.]). In this course, we review the legislative mandates that are most relevant to the competent and safe practice of veterinary medicine. The rules and statutes for veterinarians consist of Chapters 474 and 455, Florida Statutes, and Chapter 61G18, Florida Administrative Code (FAC). We will start with the statutes. To begin, we will review the definitions of terms that follow. Please note that if you would like to review the complete language of the legislation, you may access the board’s website. Because the practice of veterinary medicine is potentially dangerous to the public health and safety if it is conducted by incompetent or unlicensed practitioners, the purpose of the laws is to ensure that every veterinarian practicing in Florida meets minimum requirements for safe practice. Veterinarians who are not competent or who otherwise present a danger to the public shall be disciplined or prohibited from practicing in this state.
EliteLearning.com/Veterinarian
Book Code: VFL1524
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