Introduction to Pharmacy Flashcards
(17 cards)
Pure food and drug act
1906- passed in response to death in people of untested medications
Shirley Ammendment
1912- medications must be safe and effective
Federal food, Drug and Cosmetic Act and creation of FDA
1938- how drugs are controlled today.
Kefauver-harris ammendment
1962- Restricts who medication can be tested on
Comprehensive Drug abuse prevention and control act
1970- more restrictions with prescriptive authority
Food and Drug Administration Modernization Act
1997- allowed for an easier time to get generic drugs through the market
Class I drugs
No accepted medical use, highest potential for abuse, severe physical or psychological dependence.
Ex- Heroin
Class II drugs
Accepted medical use, high potential for abuse, severe physical or psychological dependence
EX- methadone, oxycodone
Class III drugs
Accepted medical use, potential for abuse is less than CI or CII, and physical or psychological dependence is limited.
Class IV drugs
Accepted medical use, low potential for abuse, physical and psychological dependence is limited
Class V drugs
Accepted medical use, lower potential for abuse, and physical or psychological dependence is limited
Over the counter - OTC
Drugs deemed safe enough for use by layperson in self treatment of simple conditions
Prescriptions-RX
Drugs that are considered useful only after experts diagnosis are too dangerous for use in self medication.
Preformation Studies
Define physical and chemical properties
Formulation studies
Develop Proposed product or dosage form
Preclinical
Cell culture and animal studies. Determine drug safety and effectiveness.
Black box warning
Warnings that appear on rx medications informing patients of serious side effects.
