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pht 101 c1p4
chapter 1 part 4
Question | Answer |
---|---|
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 |