Chapter 2; Law and Ethics Flashcards
Civil Laws
laws that govern wrongdoings against a person or property, and generally charges are brought forth by another individual
Controlled Substances Act (SCA):
1970 act that was designed to help regulate drug use by creating rules and regulations for record keeping and dispensing, and requiring firms that handled controlled substances to register with the DEA; the act also organized controlled substances into a system of schedules based on the potential for abuse.
Drug Listing Act
1972 act established to create a list of marketed drugs for the Food and Drug Administration, which would assist with enforcing federal safety laws.
Durham-Humphrey Amendment (DHA):
1951 amendment that separated drugs into two categories: legend drugs (prescription drugs) and over the counter drugs (OTC); the amendment specified that news drugs can only be distributed through prescriptions (and should contain legends to that effect), but eventually may be changed to OTC status.
Ethics
system of values, principles, and duties that guide behavior.
Food, Drug, and Cosmetic Act (FDCA):
1938 act that helped ensure drugs being distributed were safe and fulfilled the reported claim of strength, purity, and quality
Health Insurance Portability and Accountability Act (HIPPA):
act established in 1996 that requires health care providers to provide a clear written explanation of how health information will be sued and disclosed
Kefauver-Harris Amendment (KHA)
1962 amendment that became part of the Food, Drug, and Cosmetic Act; the amendment was designed to institute higher safety measures for drugs approved by the Food and Drug Administration by requiring manufacturers to follow Good Manufacturing Processes (GMP)
Orphan Drug Act
1983 act created by the Food and Drug Administration to speed up the approval process for new medications intended to help people with urgent needs
Poison Prevention Packaging Act (PPPA):
1970 act created to reduce potential for accidental poisonings
