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| 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 |