PCOL 310 Exam Questions With Correct
Answers
Federal Food, Drug, and Cosmetic Act of 1938 - answer-Required manufacturers demonstrate
safety of new drugs prior to marketing
-Allowed FDA to inspect manufacturing facilities
-Defined the following key terms: drug, device, cosmetics and labeling
...
"dietary supplement" - answer✔product taken by mouth that is intended to supplement the diet
and that contains one or more "dietary ingredients." The "dietary ingredients" in these products
may include:
-vitamins
-minerals
-herbs/botanicals
-amino acids
"device" - answer✔- an instrument, apparatus, implement, machine, contrivance, implant, in
vitro reagent, or other similar or related article, including any component, part, or accessory
- intended to diagnose or treat diseases
label - answer✔Display of written material on the product's container and on the outside
container or wrapper, if any
labeling - answer✔All labels and other written, printed, or graphic matter on any container or
wrapper or material accompanying the product Includes:
-package insert
-drug advertisement
-promotional materials
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