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QuestionAnswer
The FDA requires how many phases of testing humans? 3 phases.
The main purpose of Phase 2 clinical trials is effectiveness
several hundred to several thousand people Phase 3 clinical trial generally have...
After a patent has expired for a med, other mfg may copy the drug and release it under generic name
A script to dispense Plan B is required for pt under 17yrs of age
MedWatch The FDA reporting system for adverse effects that occur from use of approved drugs
A tech could be prosecuted for misconduct if incorrectly labeled a prescription is negligence
The first digit 5 digits of the NDC is mfg
The last digit of NDC are indicative. the package size
Federal law requires pharmacies to have available for inspection Copy 3 of DEA form 222 for 2 yrs.
Which book is used for FDAs list of approved generic equivalents Orange Book
Scheduled C2 meperidine
HIPAA privacy rules are observed for PHI
Must be administered in a glass IV container Nitroglycerin
the sale of this drug is restricted by CMEA Claritin-D24
CMEA allows what max amount sold per month 15
Of all the Recalls, the most important in all involving: Dr, pharmacy, pt due to drug potential/serious harm Class 1 Recall
Accutane associated with iPLEDGE
Whom and how receives Copy 2 of DEA Form 222 it is forwarded to DEA
Exempt Narcotics are DEA Schedule C5
They are regulated for dosage units sold within 48hrs Exempt Narcotics
Federal law requires pharmacies to keep Copy 3 of DEA Form 222
MedWatch Form 3500 reports adverse reactions to drugs
Created by: coquine