Legal Guidelines Flashcards
What did the Pure Food and Drug Act of 1906 do?
Required proper labelling of all drugs and proven effectiveness, prohibits adulteration and misbranding in interstate commerce
What law requires proper labeling of all drugs?
Pure Food and Drug Act of 1906
What law requires that all drugs are proven effective?
Pure Food and Drug Act of 1906
What law prohibits misbranding and adulteration for drugs in interstate commerce?
Pure Food and Drug Act of 1906
When was the Pure Food and Drug Act passed?
1906
What did the Harrison Narcotics Act of 1914 do?
Stopped recreational use of opium, requires practitioners to be registered and document use of narcotics, restricted and taxed products that help create narcotics
What law required all practitioners to be registered and document the use/ dispensing of narcotics?
Harrison Narcotics Act of 1914
What law restricted and taxed products used to create narcotics?
Harrison Narcotics Act of 1914
What did the Food, Drug, and Cosmetic Act of 1930 do?
Created the USP and National Formulary, bans false product claims, requires PPI and exact labeling
What law created the USP and National Formulary?
Food, Drug, and Cosmetic Act of 1930
What did the Durham-Humphrey Act of 1951 do?
Defined OTC and prescription and added a new label stating dispensing without a prescription is illegal
What law defined OTC and prescription drugs?
Durham-Humphrey Act of 1951
What did the Kefauver-Harris Amendment of 1962 do?
Required proof of a drug’s effectiveness and safety, requires accurate side effect information, and prevented generic names from being marketed
What law reqiured proof of a drug’s effectiveness and safety before approval?
Kefauver-Harris Amendment of 1962
What did the Comprehensive Drug Abuse Act and Prevention Act of 1970/ Controlled Substances Act require?
Created the drug schedules and required record keeping and security of Scheduled drugs
What law created the Drug Schedules?
Controlled Substances Act
What did the Poison Prevention Act of 1970 require?
Required child-proof caps for all drugs
What law required child-proof caps?
Poison Prevention Act of 1970
What did the Medical Device Amendment of 1976 do?
Created three regulatory classes for medical devices
In the Medical Device Amendment of 1976, what is a Class I device?
General controlled devices with low risk for human use
In the Medical Device Amendment of 1976, what is a Class II device?
Performance standard device with moderate risk for human use
In the Medical Device Amendment of 1976, what is a Class III device?
High risk for human use and requires premarket approval
What did the Resource Conservation and Recovery Act of 1976 do?
gives EPA authority in disposal of hazardous substances
What did the Orphan Drug Act do?
Regulates orphan drugs and encouraged development of treatments for rare diseases
What does HIPAA stand for?
Health Insurance Portability and Accountability Act
What does HIPAA do?
Defined Protected Health Information and required patient authorization to transmit PHI
When we received a drug recall notice, what must we do?
Act on the recall immediately and remove medication from inventory and place in designated place
