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Laws & Regulations

Chapter Two.

QuestionAnswer
A statutory plan passed by Congress or any legislature that is a "bill" until it is enacted and becomes law. Its an Act.
What is an Adulteration? Mishandling of medication that can lead to contamination, impurity, falsification of contents. Loss of drug quality or potency.
A change in the original law or act. Amendment.
Derived from barbituarate acid. Barbiturate.
Who is the Board of Pharmacy? State board that regulates the practice of pharmacy within the state.
What is a boxed warning? Its placed in the prescriping information or package insert of the package. Its lists potential side effects.
Regulated by the Drug Enforcment Administration. Scheduled I through V. A Controlled substance.
What is drug diversion? Intentional misuse of a drug intended for medical purposes.
Who is the Drug Enforcement Administration? Agency that enforces laws and regulations related to controlled substances.
Book that detailed information on medication. Drug facts and Comparisons.
What is Drug Utilization Evaluations? An increase in medication safety and efficacy.
Responsible for assuring the safety, effiacy, and security of human and veterinary drugs. The Food and Drug Administration. (FDA)
Act for protecting patients rights. Health Insurance Portibility and Accountability Act of 1996. (Hipaa)
Requires a prescription for dispensing. Legend Drug.
Document providing chemical product informations. What is Material Data Safety Sheet?
A state and federal operated insurance program. What is Medicaid?
Federal and state operated insurance program for citizens over the age of 65. What is Medicare.
What is Misbranding? Labeling of a product that is false or misleading.
What is Monograph? Comprehensive info on a medications actions within the class of drugs. It list: Generic and trade names, ingredients, dosages and side effects.
A drug that in moderate doses dulls the senses, relieves pain. But if taken in excessive amounts can be addictive. I am a Narotic.
10-digit number that indiciates specifics of a prescription drug or an insulin product. National Drug Code (NDC)
What is Negligence? Legal concept that describes an action taken without the forethought that should have been taken by a reasonable person of similar competency.
Oversees safety in the workplace. What is Occupational Safety and Health Administration? (OSHA)
What is Omnibus Budget Reconcilliation Act of 1990? (OBRA 90) Congressional Act that changed reimbursement limits and mandated drug utilizations evaluations.
Medication is that can be purchased without a prescription. Over the Counter. (OTC)
What is the Physicians Desk Reference? (PDR) Compiles and publishes select manufacturer-provided package inserts and prescribing info. Useful for Health Professionals.
Descibes the five levels of assessment of the fetal effects caused by a drug. Pregnancy Category.
Term used to describe a patients personal health data. What is Protected Health Information. (PHI)
What is The Joint Commission? Independent nonprofit organization that accredits hospitals and other health care organizations in the United States.
Injury or harm to a person intentionally or cause of negligence. Tort.
What is United States Pharmacopeia? (rUSP) A nonprofit organization that establishes documentation on product, drug quality standards and information.
What is the United States Pharmacopeia-National Formulary? (USP-NF) Publication of the USP that contains standards for medications, dosage forms, drug substances. Exipients, medical devices and dietary supplements.
Created by: Lguston
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