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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 ...

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  • October 20, 2024
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  • 2024/2025
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©SIRJOEL EXAM SOLUTIONS
12/3/2024 11:27AM



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


Durham-Humphrey Amendment of 1951 - answer✔distinguishes prescription from non-

prescription


Kefauver-Harris Amendment of 1962 - answer✔-required that manufacturers prove the

effectiveness of drug products before they go on the market, and report any serious side effects

-required that evidence of effectiveness be based on adequate and well-controlled clinical studies

conducted by qualified experts

-gave FDA 180 days to approve a new drug application


Orphan Drug Act of 1983 - answer✔-drugs intended to treat rare diseases and conditions


-provides pharmaceutical manufacturers tax and licensing incentives to develop them

, ©SIRJOEL EXAM SOLUTIONS
12/3/2024 11:27AM


"food" - answer✔- articles used for food or drink for man or other animals


- chewing gum

- articles used for components of any such article.


"drug" - answer✔- Articles recognized in the official USP/NF or Homeopathic Pharmacopoeia,

or any supplement to any of them

- Articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in

man or other animals

- Articles other than food intended to affect the structure or function of the body of man or other

animals




(no destinction b/w prescription vs. non-prescription & human vs. animal)


"cosmetic" - answer✔- articles intended to be rubbed, poured, sprinkled, or sprayed on,

introduced into, or otherwise applied to the human body or any part thereof for cleansing,

beautifying, promoting attractiveness, or altering the appearance

- articles intended for use as a component of any such articles; except that such term shall not

include soap

, ©SIRJOEL EXAM SOLUTIONS
12/3/2024 11:27AM


"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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