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NDC #s & FDA Recall
Pharmacy Technician
| Question | Answer |
|---|---|
| Every NDC number has how many segments? | 3 |
| Which segment of NDA number string identifies the drug's manufacturer? This number is unique to the maker or repackager of the product | First Segment |
| Which segment of DNA number string identifies the product? This number is unique to the formulation and strength of the product. | Second Segment |
| Which segment of NDA number string identifies the Packaging? This number is unique to the size and quantity of the product | Third Segment |
| What are the 2 stages in New Drug Initial Development? | The first is Pre-Clinical (Animal Testing), and the 2nd stages is Investigational New Drug Review (IND). |
| In this phase of New Drug Clinical Trials, a small number of healthy volunteers try safely tolerated dosages. This phase identifies major side effects, with an emphasis on safety and maximum tolerated dosages. | Phase I |
| Which phase of the New Drug Clinical Trials includes many volunteers (100-300), with an emphasis on drugs effect against what it's designed to treat, comparing patients. | Phase II |
| Which phase of the New Drug Clinical Trials includes many volunteers (300-3000) with an emphasis on the drugs overall effect. Effects are compared with patients unknowingly taking placebos, study of different populations and different dosages. | Phase III |
| Which phase in the New Drug Clinical Trials has ongoing/post approval trials, with health care professionals reporting any adverse findings. This phase lasts as long as the drug is on the market. | Phase IV (New Drug Post Approval Trials) |
| How long is the process to admit a new drug? | 12-15 years |
| Which FDA Recall Class is used in a case where there is a probability that the use to a violative product will cause severe health consequences or death. | Class I |
| Which FDA Recall Class is used where use of violative product may cause temporary health problems and the probability of serious health consequences is remote. | Class II |
| Which FDA Recall Class is used where the use of a violative product is NOT likely to cause adverse health consequenses, but has violated some FDA regulation? | Class III |
| This is appropriate when a product has a minor violation that would not be subject to FDA legal action; the manufacturer must remove product from the market or correct the violation. | FDA Market Withdrawal |
| This is used for medical apparatus equipment when a medical device may present a risk or substantial harm. | FDA Medical Device Safety Alert |
Created by:
sham13
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