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pht 101 c1p4

chapter 1 part 4

QuestionAnswer
The U. S. legal system regulates the manufacture, sale, and use of drugs
State and federal laws govern the development, prescribing, and dispensing of drugs
In 1906 was the First attempt by U.S. government to regulate the sale of drugs or substances that affect the body
In 1927 was the formation of Food, Drug, and Insecticide Administration
In 1930, the F D & I Name changed to FDA
In 1938 was the Passage of Food, Drug, and Cosmetic Act
All new drugs were to be proved safe before being marketed
With New Drug Application (NDA), in 1951, Durham-Humphrey Amendment was formed
Legend drug are sold by prescription, “Rx only”
The fda Regulates both legend and OTC drugs
The fda Regulates medical and radiological devices, food, cosmetics, biologics, and veterinary drugs
The fda Does not test drugs
Companies seeking to market drugs must test and submit evidence to the FDA that the drugs are safe and clinically effective
FDA requires that medication guides are to be distributed to patients when certain drugs are dispensed
Medication guides should come From retail pharmacies or upon discharge from the hospital
Many retail computer systems print the medication guide automatically when the drug label is printed
Some medication guides prepared for entire classes of drugs
Other medication guides are prepared for specific drugs
Medication guides must be given to patients at all dispensing for about 300 drugs
Make sure patient receives proper medication guide
Techs Can put guide together with the drug for pharmacist when pharmacist verifies the drug
Techs can Offer patients counseling by pharmacist
FDA requires the manufacturer of a new drug to provide evidence of the drug’s safety and effectiveness
New Drug Application (NDA) Specifies the proposed labeling
The N D A Documents the drug’s development and testing
The N D A Details manufacturing, processing, packaging
Created by: moekah
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