PCOL 310 Exam Questions And Accurate
Answers 2024-2025
Federal Food, Drug, and Cosmetic Act of 1938 - ANSWER -Mandatory for manufacturers
to demonstrate safety of new drugs before they are marketed
-FDA allowed to inspect manufacturing facility
-Defined the following key terms: drug, device, cosmetics and labeling
Durham-Humphrey Amendment of 1951 - ANSWER differentiates prescription from
non-prescription
Kefauver-Harris Amendment of 1962 - ANSWER -Since then, the manufacturer was
compelled to show that a certain drug product is effective before making it available in
the market. Also, should serious adverse effects occur, the same must be reported to
the FDA.
-required that evidence of effectiveness be based upon 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
"food" - ANSWER - articles used for food or drink for man or other animals
- chewing gum
articles used as 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 distinction 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
"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 Appearance of written material on the container holding the product
and, if any, on the outside container or wrapper
labeling - ANSWER All labels and other written, printed or graphic matter upon any
container or wrapper or accompanying any container or wrapper or product Includes:
, -package insert
-drug advertisement
-promotional materials
-information in publications (PDR)
GMP - ANSWER set of regulations that establishes minimum requirements for the
methods, facilities, or controls used in the manufacture, processing, packaging, or
holding of a drug product
Nonprescription drug labeling requirements - ANSWER - Drug must bear the name and
place of business of the manufacturer
- Display panel
- labels have detailed usage and warning information so consumers can properly
choose and use the products
Principal Display Panel (PDP)- ANSWER the panel of a label that is most likely to be
displayed, presented, shown, or examined by the end user
NDC number:
1234-5678-90 - ANSWER -1234=Manufacturer
-5678=drug
-90=package
seizure - ANSWER the physical isolation of a drug while FDA or state agency files civil
lawsuit
recall - ANSWER the correction or removal, and notification to the company, of a
product that is in violation of the law
Drug Approval Process (1-5) - ANSWER *drug developed*
Answers 2024-2025
Federal Food, Drug, and Cosmetic Act of 1938 - ANSWER -Mandatory for manufacturers
to demonstrate safety of new drugs before they are marketed
-FDA allowed to inspect manufacturing facility
-Defined the following key terms: drug, device, cosmetics and labeling
Durham-Humphrey Amendment of 1951 - ANSWER differentiates prescription from
non-prescription
Kefauver-Harris Amendment of 1962 - ANSWER -Since then, the manufacturer was
compelled to show that a certain drug product is effective before making it available in
the market. Also, should serious adverse effects occur, the same must be reported to
the FDA.
-required that evidence of effectiveness be based upon 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
"food" - ANSWER - articles used for food or drink for man or other animals
- chewing gum
articles used as 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 distinction 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
"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 Appearance of written material on the container holding the product
and, if any, on the outside container or wrapper
labeling - ANSWER All labels and other written, printed or graphic matter upon any
container or wrapper or accompanying any container or wrapper or product Includes:
, -package insert
-drug advertisement
-promotional materials
-information in publications (PDR)
GMP - ANSWER set of regulations that establishes minimum requirements for the
methods, facilities, or controls used in the manufacture, processing, packaging, or
holding of a drug product
Nonprescription drug labeling requirements - ANSWER - Drug must bear the name and
place of business of the manufacturer
- Display panel
- labels have detailed usage and warning information so consumers can properly
choose and use the products
Principal Display Panel (PDP)- ANSWER the panel of a label that is most likely to be
displayed, presented, shown, or examined by the end user
NDC number:
1234-5678-90 - ANSWER -1234=Manufacturer
-5678=drug
-90=package
seizure - ANSWER the physical isolation of a drug while FDA or state agency files civil
lawsuit
recall - ANSWER the correction or removal, and notification to the company, of a
product that is in violation of the law
Drug Approval Process (1-5) - ANSWER *drug developed*
