Chapter Terms
- brand name
- the name under which the manufacturer markets a drug; also known as the trade name
- child-resistant container
- a medication container with a special lid that cannot be opened by 80% of children 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
- 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
- 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 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
- malpractice
- a form of negligence in which the standard of care was not met and was a direct cause of injury
- National Association of Boards of Pharmacy (NABP)
- an organization that represents the practice of pharmacy in each state and develops pharmacist licensure exams
- 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
- orphan drug
- a medication approved by the FDA to treat rare diseases
- plaintiff
- one who files a lawsuit for the courts to decide
- professional standards
- guidelines of acceptable behavior and performance established by professional associations
- reciprocation
- the administrative process for relicensure of pharmacists in another state
- 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
- 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
- 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