Laws Flashcards
what is the Pure Food and Drug act and when was is passed?
In 1906, this act was passed to mandate that meat products and poisonous patent medicines must be inspected and forbid the sale of adulterated products.
What is the Orphan Drug Act and when was it passed?
In 1983, Congress passed this act to stimulate the production of drugs for rare diseases.
What is the Medical Device Amendment and when was it passed?
In 1976, the FDA required life sustaining and supporting devices to have a premarket approval.
What is the Kefauver-Harris Amendment and when was it passed?
In 1962, Challenged the manufacturer’s accountability of the drugs effectiveness of their drug. Made manufacturers supply proof of effectiveness and safety.GMP and procedures were established.
What is the Controlled Substance act and when was it passed?
In 1970, The DEA was established to prevent the unauthorized distribution of narcotics. They established 5 classes of drugs- schedules C1-C5, C1 being the highest for potential abuse and isn’t medically accepted.
What is the Durham-Humphrey Act and when was it passed?
In 1951, prescription bottles were mandated to read “caution: federal law prohibits dispense without a prescription.” commonly known as legend drugs or Rx only.
What is the Food, Drug, and Cosmetic Act and when was it passed?
In 1938, FDCA limited interstate commerce to only safe and effective drugs. Required manufacturers to provide adequate information about the drug and how its used. Also required testing before marketed to the public. First time cosmetics, therapeutic devices were regulated
what is the poison prevention act of 1970?
all legends and controlled drugs must be dispensed in a child proof container.
medication dispensed w/out childproof must be signed and request should be kept on file.
what is an adulterated drug?
drug that is in a condition contrary to the intentions of the manufacturer
What is misbranded drugs?
The representations made by the manufacturer
What are the 2 ways to sell drugs in the U.S?
FDA approved
exempt thru 1962 amendment
What is a monograph?
a detailed document pertaining to a specific drug
What are the 5 principles?
Beneficence Fidelity Veracity Justice Autonomy
What are the 9 Ethical theories?
Consequentialism Nonconsequentialism Social Contracts The ethics of care Rights- based ethics Principle- based ethics Virtue- based ethics Law
