Phamacy Law Exam 1 new update for 2024 with latest
questions and answers
Ciminal action - CORRECT ANSWER--Wrongful action that
violates an existing statute is subject to criminal action.
-Government vs. private party
-Santions may be fines or imprisonment or both.
-Objective is to deter, punish, and rehabilitate.
Civil Action - CORRECT ANSWER--Wrongul action that violates
a statute or common law, but results in personal injury is
subject to civil action.
-Private party vs. private party
-Santions usually limited to payment of damages.
-Objective is to compensate injured party for damages
Bilogic Agents Facts - CORRECT ANSWER-Fastest growing
segment of the pharmaceutical market.
Ex. Vaccines, therapeutic proteins, monoclonal antibodies
Biosimilar - CORRECT ANSWER-No clinically meaningful
differences between the biologic product and reference
product in terms of: safety, purity, potency
,Bioequivalence - CORRECT ANSWER-No significan difference in
the rate and extent to which the active ingredient is available
at the site of action.
Biologics Price Competition and Innovation Act - CORRECT
ANSWER-This act establishes generic approval pathway for
biologics (BLA).
FDA Purple Book - CORRECT ANSWER-Biologic interchangablity
book
How are CS stored? - CORRECT ANSWER-CII stored in a locked
cabnet, CIII-V dispursed throughout the remaining.
Orange Book (FDA) - CORRECT ANSWER-List of approved drugs
that can be interchanged with generics based on therapeutic
equivalence
, 1906 Pure Food and Drug Act - CORRECT ANSWER-Prohibits
the sale and transport of adulterated or mislabeled food,
drinks and drugs.
Prohibits the mislabeling and misbranding of products.
1938 Federal Food, Drug, and Cosmetic Act - CORRECT
ANSWER-Scientific proof of *safety* before a drug could be
marketed. (Sulfonilamide disaster)
1951 Durham-Humphrey Amendment - CORRECT ANSWER-
This act made the distinction between over the counter drugs
(OTC) and legend (prescription drugs) possible. Legend drugs
should be labeled as "Caution: Federal Law prohibits
dispensing without a prescription
1962 Kefauver-Harris Amendment - CORRECT ANSWER-All
drugs made from 1938 forward must be proven safe and
EFFECTIVE. Also, the FTC now handles drug advertisements.
Stricter requirements for drug approval. Manufacturers must
now register annually, be inspected every 2 years, and report
adverse effects of drugs.
questions and answers
Ciminal action - CORRECT ANSWER--Wrongful action that
violates an existing statute is subject to criminal action.
-Government vs. private party
-Santions may be fines or imprisonment or both.
-Objective is to deter, punish, and rehabilitate.
Civil Action - CORRECT ANSWER--Wrongul action that violates
a statute or common law, but results in personal injury is
subject to civil action.
-Private party vs. private party
-Santions usually limited to payment of damages.
-Objective is to compensate injured party for damages
Bilogic Agents Facts - CORRECT ANSWER-Fastest growing
segment of the pharmaceutical market.
Ex. Vaccines, therapeutic proteins, monoclonal antibodies
Biosimilar - CORRECT ANSWER-No clinically meaningful
differences between the biologic product and reference
product in terms of: safety, purity, potency
,Bioequivalence - CORRECT ANSWER-No significan difference in
the rate and extent to which the active ingredient is available
at the site of action.
Biologics Price Competition and Innovation Act - CORRECT
ANSWER-This act establishes generic approval pathway for
biologics (BLA).
FDA Purple Book - CORRECT ANSWER-Biologic interchangablity
book
How are CS stored? - CORRECT ANSWER-CII stored in a locked
cabnet, CIII-V dispursed throughout the remaining.
Orange Book (FDA) - CORRECT ANSWER-List of approved drugs
that can be interchanged with generics based on therapeutic
equivalence
, 1906 Pure Food and Drug Act - CORRECT ANSWER-Prohibits
the sale and transport of adulterated or mislabeled food,
drinks and drugs.
Prohibits the mislabeling and misbranding of products.
1938 Federal Food, Drug, and Cosmetic Act - CORRECT
ANSWER-Scientific proof of *safety* before a drug could be
marketed. (Sulfonilamide disaster)
1951 Durham-Humphrey Amendment - CORRECT ANSWER-
This act made the distinction between over the counter drugs
(OTC) and legend (prescription drugs) possible. Legend drugs
should be labeled as "Caution: Federal Law prohibits
dispensing without a prescription
1962 Kefauver-Harris Amendment - CORRECT ANSWER-All
drugs made from 1938 forward must be proven safe and
EFFECTIVE. Also, the FTC now handles drug advertisements.
Stricter requirements for drug approval. Manufacturers must
now register annually, be inspected every 2 years, and report
adverse effects of drugs.
