Questions:Law
A drug product is assumed to be free of contamination, due to what legislation? Ans: The
Federal Food, Drug, and Cosmetic Act
Childprrof packaging would be required on
A: A bottle of children's aspirin sold over the counter
B: A bottle of VIagra
C: A bottle of Celebrex dispensed to an elderly, arthritic person
D: Both A and B Ans: D: Both A and B
Which of the following would be expemt from mandatory childproof packaging?
A. A narcotic analgesic such as oxydone
B:A "prednisone pacl"
C:A "memory" dispense package of contraceptives containing <26 mf of conjugated estrogens
D: Both B and C Ans: D: Both B and C
The FOod, Drug,a nd Cosmetic Act Provides for documentation for the safety and efficacy of
drugs by reviewing
what? Ans: Data from clinical trials and animal studies.
In order for a drug to be sold over the counter it must what? Ans: have a low abuse potential,
must be low in strength to help prevent over dosage, and it must be approved by the FDA
A drug classified as Schedule I would have what? Ans: no therapeurtic benefit
An example of a Schedule II drug would be? Ans: Morphine and Meperidine
A prescription for Xanax (alprazolam) might be Ans: written on a regular prescription forma dn
notated with a red "C" before filing
Mandatory patient counseling is required with what? Ans: with all new and refill prescriptions
The words "this medication is intended for use only by the person for who it was prescribed"
might be found on a drug label. This would be termed as what? Ans: a transfer warning
The label on a drug sold over the counter must carry what? Ans: instructions for use and dosage,
contraindications and warnings, and pediatric dosage or contraindications
A bottle of ibuprofen in labeled as follows: Motrin 800mg tablets. The manufacturer is guilty of
what? Ans: mislabeling