What did the Federal Controlled Substances Act do? Why was it implemented? - correct answer Legislators very concerned in the 1960s about legal and
... [Show More] illegal drugs being abused
They were given the opportunity to design an act/law
Created the DEA to promulgate and enforce the law
Created a closed system between: manufacturer, distributors, prescriber, dispenser, and patient.
What did the Pure Food and Drug Act of 1906 do? - correct answer Prohibited the adulteration and misbranding of foods and drugs in interstate commerce; DID NOT have to be proven safe or effective; did not require the label to list ingredients, directions for use, or provide warnings
What did the Food, Drug, and Cosmetic Act do? (started in 1938) - correct answer Provides for the comprehensive regulation of all drugs introduced into interstate (and most intrastate) commerce
Under this act no new drug may be marketed and sold unless it has been proved SAFE ONLY for its intended use and approved by the FDA
Labels must contain adequate directions for use and warnings about habit-forming properties of certain drugs
Describe the FDCA - correct answer The purpose of the FDCA is to protect consumers from adulterated or misbranded foods, drugs, cosmetics, or devices; provided that no new drug could be marketed until proven safe for use under the conditions described on the label and approved by the FDA; also started the labeling requirements; applies to devices as well; all drugs before 1938 are exempt from the requirement that new drugs be proven safe
If you get in trouble with the board of pharmacy can you get in trouble with the government too? What about the a lawsuit with a patient? - correct answer Yes, you can have an administrative lawsuit, a civil lawsuit, and a criminal lawsuit separately for the same offense
What did the Durham-Humphrey Amendment of 1951 do? - correct answer Established 2 classes of drugs; prescription and OTC
Allows refills on prescriptions and oral prescriptions
Per the Durham-Humphrey Amendment; what must be labeled on a prescription medication - correct answer Caution: federal law prohibits dispensing without a Rx; they do not need adequate directions for use like OTC (talking about the MANUFACTURERS label here; there is no take this medication x amount of times daily on the manufacturer labeling)
What did the Kefauver-Harris Amendment of 1962 do? - correct answer Required all drugs to not only be proven safe but also EFFECTIVE [Show Less]