Podcast
Questions and Answers
Which type of veterinary drug is considered a controlled substance?
Which type of veterinary drug is considered a controlled substance?
What is required for veterinarians to prescribe prescription drugs?
What is required for veterinarians to prescribe prescription drugs?
Which of the following is an example of a biologic drug?
Which of the following is an example of a biologic drug?
What is the purpose of the Efficacy Testing of Biological Products for Animal Disease and Food Production Program?
What is the purpose of the Efficacy Testing of Biological Products for Animal Disease and Food Production Program?
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Which statement is true about prescription veterinary drugs?
Which statement is true about prescription veterinary drugs?
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What is the primary purpose of veterinary drug regulations?
What is the primary purpose of veterinary drug regulations?
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Which of the following best describes the regulation of narcotic drugs for veterinary use?
Which of the following best describes the regulation of narcotic drugs for veterinary use?
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Which agency maintains the list of Schedule II drugs that individuals can possess without a DEA registration?
Which agency maintains the list of Schedule II drugs that individuals can possess without a DEA registration?
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Which law or regulation governs the use, distribution, and manufacture of veterinary drugs in the United States?
Which law or regulation governs the use, distribution, and manufacture of veterinary drugs in the United States?
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What is the significance of a drug's patent expiration for veterinary medicine?
What is the significance of a drug's patent expiration for veterinary medicine?
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Which term is used to describe drugs that are classified as controlled substances?
Which term is used to describe drugs that are classified as controlled substances?
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What is the purpose of laws and regulations related to veterinary drugs?
What is the purpose of laws and regulations related to veterinary drugs?
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Study Notes
Veterinary Drugs and Regulations
Laws, regulations, and guidelines play a significant role in ensuring the safety and efficacy of veterinary drugs. These measures govern the use, distribution, and manufacture of drugs for both companion and production animals. In the United States, key laws and regulations include the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Animal Medicinal Drug Use Clarification Act (AMDUCA). Here we discuss several aspects of veterinary drug regulation: narcotics, patents, biologics, prescription, and controlled substances.
Narcotic Drugs
Narcotic drugs are classified as Schedule II controlled substances. Unlike most other drugs, veterinary narcotics can be purchased without a written prescription from a licensed veterinarian by pet owners, but only in accordance with State laws and regulations, typically requiring presentation of proof of ownership, such as a valid driver's license or ID card. The Drug Enforcement Administration (DEA) offers a list of Schedule II drugs that can be possessed by individuals without a DEA registration.
Patented Drugs
Patent protection extends to veterinary drugs like it does to human medicines. Patents give inventors exclusive rights to their discoveries for a specific time period. For example, the patent for the pain medication tramadol expired in 2014, permitting generic versions to become available after that point.
Biologic Drugs
Biological products are complex compounds derived from living organisms. The U.S. Food and Drug Administration (FDA) Center for Veterinary Medicine (CVM) regulates these drugs under the Efficacy Testing of Biological Products for Animal Disease and Food Production Program. Examples of biologic drugs include vaccines, antibodies, and immune therapies.
Prescription Drugs
Prescription veterinary drugs are those restricted by federal law to use by or on the order of a licensed veterinarian. Labeling for these drugs bears the statement: "Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian". To prescribe prescription drugs, veterinarians must comply with relevant regulations, such as the Veterinarian-Client-Patient Relationship (VCPR), which requires a physical examination of the patient, establishing a veterinarian-client relationship, and maintaining records of prescription drugs.
Controlled Substances
Controlled substances are defined by the Controlled Substances Act and include those with a high potential for abuse or dependence. Veterinary drugs classified as controlled substances follow specific guidelines for distribution, prescribing, and record-keeping.
In conclusion, veterinary drugs and regulations aim to ensure the safety, efficacy, and proper use of drugs for both companion and production animals. By understanding these regulations, veterinarians, pharmacists, and animal owners can make informed decisions about the use of veterinary medications, helping to maintain the health and well-being of animals.
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Description
Explore the laws and regulations governing veterinary drugs, including narcotics, patents, biologics, prescription drugs, and controlled substances. Learn about key regulations such as the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Animal Medicinal Drug Use Clarification Act (AMDUCA) in the United States.
