What was the status of drug regulation in 19th century United States?
There was no effective drug regulation.
Which substance was widely used in 19th century medications in the US?
Opium was widely used.
What type of claims did many 19th century medicines make?
They made scientifically unsupported claims.
What contributed to the emergence of drug laws and agencies in the 20th century?
Drug injuries and deaths contributed to their emergence.
Which federal agency oversees drug safety and approval?
The Food and Drug Administration (FDA).
Which agency enforces controlled substances laws?
The Drug Enforcement Administration (DEA).
What state bodies oversee health and welfare related to pharmacy?
State boards of health and welfare agencies.
What are laws in government oversight?
Laws are overall rules passed by legislative branches.
Who passes laws to guide conduct?
Legislative branches of federal, state, and local governments.
What are regulations in relation to laws?
Regulations are legislated rules and procedures to carry out the law.
What do standards represent in oversight?
Standards are benchmarks or desired normal quality levels.
What does professional ethics mean?
Following a code of high professional standards.
What did the Food, Drug, and Cosmetic Act of 1938 create?
The Federal Food and Drug Administration.
What did the Food, Drug, and Cosmetic Act of 1938 require from drug manufacturers?
To obtain approval before releasing a new drug.
What is another name for the Comprehensive Drug Abuse Prevention and Control Act of 1970?
The Controlled Substances Act.
How many schedules of drugs with abuse potential does the Controlled Substances Act define?
Five schedules.
Who can classify new drugs or change a drug’s schedule?
The DEA (Drug Enforcement Administration).
What change did the DEA make in 2014 regarding hydrocodone combination products?
Reclassified them from Schedule III to Schedule II.
What did the Poison Prevention Packaging Act of 1970 require for most drugs?
Packaging in child-resistant containers.
What did the Hatch-Waxman Act of 1984 require manufacturers to prove for generic drugs?
Bioequivalence to the brand-name product.
What key resource sets standards for pharmacy practice by pharmacists?
The USP-NF.
Which USP-NF chapter addresses nonsterile compounding standards?
General Chapter <795>.
Which USP-NF chapter addresses sterile compounding standards?
General Chapter <797>.
Which USP chapter addresses handling hazardous substances in compounding?
General Chapter <800>.
What type of drugs does USP General Chapter <800> include in hazardous substance handling?
Chemotherapy drugs.
Who do legal responsibilities in pharmacy practice apply to?
Facility managers, pharmacists, and pharmacy technicians.
What types of lawsuits may pharmacy professionals face?
Criminal-law and civil-law lawsuits.
Who is a plaintiff in a lawsuit?
A party who brings a lawsuit.
Who is a defendant in a lawsuit?
A party against whom a lawsuit is brought.
Test your knowledge with 21 questions on Pharmacy Law and Professional Standards.
1. Which condition characterized drug use and medicine claims in the United States during the nineteenth century?
2. What development did drug-related injuries and deaths help produce during the twentieth century?
Review the complete course in the study sheet for Pharmacy Law and Professional Standards.
See study sheet →Import your course and AI generates flashcards in 30 seconds.
Flashcard generator