Question | Answer |
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 |
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