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accreditation the status achieved by a hospital, community college, college, or university that meets quality standards and fulfills the requirements designated by the accrediting organization
adulterated product a product that differs in drug strength, quality, and purity
anabolic steroid a synthetic, performance-enhancing drug that mimics the human hormone testosterone; due to abuse by athletes, this drug has been reclassified by the DEA as a controlled substance
brand name the name under which the manufacturer markets a drug; also known as the trade name
burden of proof the obligation of a person or party filing a lawsuit to provide evidence in order to prove a case
child-resistant container a medication container with a special lid that cannot be opened by 80% of children under age 5 but can be opened by 90% of adults; a container designed to prevent child access in order to reduce the number of accidental poisonings
civil law the areas of the law that concern U.S. citizens and the crimes they commit against one another
common law the system of precedents established by decisions in cases throughout legal history
controlled substance a drug with potential for abuse; organized into five schedules that specify the way the drug must be stored, dispensed, recorded, and inventoried
Controlled Substances Act (CSA) laws created to combat and control drug abuse
defendant one who defends against accusations brought forward in a lawsuit
Drug Enforcement Administration (DEA) the branch of the U.S. Justice Department that is responsible for regulating the sale and use of drugs with abuse potential
ethics standards of behavior that all professionals are encouraged to follow
Food and Drug Administration (FDA) the agency of the federal government that is responsible for ensuring the safety and efficacy of food and drugs prepared for the market
four Ds of negligence four areas of negligence, which include duty, dereliction, damages, and direct cause.
generic name a common name that is given to a drug regardless of brand name; sometimes denotes a drug that is not protected by a trademark; for example, acetaminophen is the generic drug name for Tylenol
law a rule that is designed to protect the public and is usually enforced through local, state, or federal governments
law of agency and contracts the general principle that allows an employee to enter into contracts on the employer's behalf
legend drug a drug that requires a prescription; labeled “Rx only” on medication stock bottle
licensure the process by which a state board grants permission to an individual to engage in a given occupation upon finding that the applicant has attained the minimum degree of necessary competency.
malpractice a form of negligence in which the standard of care was not met and was a direct cause of injury
misbranded product a product whose label includes false statements about the identity or ingredients of the container’s contents
National Association of Boards of Pharmacy (NABP) an organization that represents the practice of pharmacy in each state and develops pharmacist licensure exams
National Drug Code (NDC) a 10- or 11-character code that is assigned by the FDA to each drug product; each code is unique and identifies the manufacturer or distributor, the drug formulation, and the size and type of packaging
negligence a tort for not providing the minimum standard of care
new drug application (NDA) the process through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the United States
Occupational Safety and Health Administration (OSHA) an agency of the Department of Labor whose primary mission is to ensure the safety and health of U.S. workers by setting and enforcing regulations and standards
orphan drug a medication approved by the FDA to treat rare diseases
patent drug another name for an over-the-counter (OTC) medication
plaintiff one who files a lawsuit for the courts to decide
professional standards guidelines of acceptable behavior and performance established by professional associations
reasonable doubt the standard of proof or evidence that the plaintiff must provide in a case involving crimes against the local, state, or federal government
reciprocation the administrative process for relicensure of pharmacists in another state
registration the process of being enrolled on a list created by the state board of pharmacy; most state boards require pharmacy technicians to register with their state of practice
regulation a written rule and procedure that exists to carry out a law of the state or federal government
regulatory law the system of rules and regulations established by governmental bodies
schedule a listing of controlled substances categorized by the DEA according to their potential for abuse and physical or psychological dependence
standard a set of criteria to measure product quality or professional performance against a norm
standard of care the usual and customary level of practice in the community
state boards of pharmacy governing bodies responsible for the regulation of the practice of pharmacy within the state
statutory law a law passed by a legislative body at either the federal, state, or local level
tort the legal term for personal injuries that one citizen commits against another in a lawsuit
United States Pharmacopeia (USP) the independent, scientific organization responsible for setting official quality standards for all drugs sold in the United States as well as standards for practice
United States Pharmacopeia-National Formulary (USP-NF) a book that contains U.S. standards for medicines, dosage forms, drug substances, excipients or inactive substances, medical devices, and dietary supplements
USP–NF General Chapter (795) a chapter of the United States Pharmacopeia that contains national standards for pharmacies formulating nonsterile preparations
USP–NF General Chapter (797) a chapter of the United States Pharmacopeia that contains national standards for pharmacies formulating sterile preparations
Created by: softcrylic