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NDC #s & FDA Recall

Pharmacy Technician

QuestionAnswer
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