Veterinary Pharmacology and Drug Regulation

This set of vocabulary flashcards covers introductory pharmacology concepts, regulatory acts, drug classifications, and federal oversight agencies based on the lecture transcript.

Pharmacology

The study of agents used to treat, diagnose, and prevent disease.

Pharmacodynamics

The biochemical and physiological mechanism of what a drug does to the body.

Pharmacokinetics

The study of what the body does to a drug, specifically absorption, distribution, metabolism, and elimination.

Over-the-counter (OTC) drugs

Drugs that may be sold without a prescription because all features of use can be written in a manner easily understood by a lay person.

Labeled Use

A definition in the FD&CA that specifies the defined dosage, frequency, duration, and route of administration for a drug in a given species for a specified disease.

Prescription (Legend) drugs

Drugs requiring a veterinarian for disease diagnosis and monitoring because labeled use is not easily understood by a lay person.

Extra-Label Drug Use (ELDU)

The use of a drug in some manner other than what is specified on the official label.

Animal Medicinal Drug Use Clarification Act (AMDUCA)

The federal act that legalizes Extra-Label Drug Use (ELDU) by veterinarians under certain conditions and also legalizes compounding.

FDA "Orange Book"

The official resource where FDA-approved human drugs are listed.

FDA "Green Book"

The official resource where FDA-approved animal drugs are listed.

VCPR

Veterinary-Client-Patient Relationship; an active VCPR is a required condition for Extra-Label Drug Use (ELDU).

Compounding

A special form of ELDU involving the alteration of an original dosage form for ease of administration or when an approved drug does not exist.

Comprehensive Drug Abuse Prevention and Control Act (CDAPCA)

The federal regulation governing substances based on their abuse potential and addictiveness, categorized into five classes.

Schedule I Drugs

Controlled substances with no accepted medical use, such as LSD, marijuana, or heroin.

Schedule II Drugs

Controlled substances with medical use but high abuse potential (e.g., hydromorphone, fentanyl) requiring separate records and special order forms.

Center for Veterinary Medicine (CVM)

A branch of the FDA responsible for regulating drugs, feeds, and medical devices under FD&CA and AMDUCA.

Center for Veterinary Biologics (CVB)

A branch of the USDA APHIS responsible for regulating vaccines and biologics.

Drug Enforcement Agency (DEA)

The agency within the Department of Justice (USDOJ) that regulates controlled substances under the CDAPCA.

Environmental Protection Agency (EPA)

The federal agency responsible for the regulation of pesticides.