PN2002 PACKAGED DEAL 2026 ACTUAL EXAM
PAPER QUESTIONS WITH SOLUTIONS GRADED
A+
◉ 1938 Food, Drug and Cosmetic Act (FDCA).
Answer: This act requires that manufacture prove a new drug is safe
for human consumption.
Toxicological studies - done on animals.
Clinical trials - done on humans.
Gave rise to the Food and Drug Administration.
Manufacturer must submit New Drug Application (NDA) to FDA.
◉ 1951 Durham-Humphrey Amendment.
Answer: This act distinguishes legend drugs (prescription) from the
over the counter drugs (OTC). This act requires companies to label
legend drugs: "Caution: Federal law prohibits dispensing without a
prescription". Refills may only be authorized by the subscriber.
◉ 1962 Kefauver-Harris Amendment.
Answer: Required drugs be effective for the purpose they were
marketed for. Written in response to Thalidomide incident in
Europe.
, ◉ 1970 Comprehensive Drug Abuse Prevention and Control Act
(Controlled Substance Act - CSA).
Answer: Purpose is to regulate manufacture and sale of Narcotics.
Drug Enforcement Agency (DEA) was formed. Introduced a stair
step schedule for narcotics based on their abuse potential. Schedule
I drugs have the highest abuse potential and Schedule V drugs have
the lowest abuse potential.
DEA Form 222 - to buy
DEA Form 224 - to sell
◉ 1970 Poison Prevention Packaging Act.
Answer: This act required childproof packaging on most drugs
dispensed in a pharmacy. Drugs that are exempt from this act are
drugs used in emergency situations, such as nitroglycerin (Nitrostat
SL), birth control pills, inhalers, ointments and creams.
◉ 1972 Drug Listing Act.
Answer: Authorized the FDA to compile a list of all legal drugs for
sale in the US. Assigned a unique identifier to all drugs called the
National Drug Code (NDC) 12 digit code. Leading zero on the ones
with only 4 digits in first sequence.
◉ 1983 Orphan Drug Act.
Answer: Created to promote the research and development of drugs
needed for the treatment of rare diseases. (less than 200,000)
PAPER QUESTIONS WITH SOLUTIONS GRADED
A+
◉ 1938 Food, Drug and Cosmetic Act (FDCA).
Answer: This act requires that manufacture prove a new drug is safe
for human consumption.
Toxicological studies - done on animals.
Clinical trials - done on humans.
Gave rise to the Food and Drug Administration.
Manufacturer must submit New Drug Application (NDA) to FDA.
◉ 1951 Durham-Humphrey Amendment.
Answer: This act distinguishes legend drugs (prescription) from the
over the counter drugs (OTC). This act requires companies to label
legend drugs: "Caution: Federal law prohibits dispensing without a
prescription". Refills may only be authorized by the subscriber.
◉ 1962 Kefauver-Harris Amendment.
Answer: Required drugs be effective for the purpose they were
marketed for. Written in response to Thalidomide incident in
Europe.
, ◉ 1970 Comprehensive Drug Abuse Prevention and Control Act
(Controlled Substance Act - CSA).
Answer: Purpose is to regulate manufacture and sale of Narcotics.
Drug Enforcement Agency (DEA) was formed. Introduced a stair
step schedule for narcotics based on their abuse potential. Schedule
I drugs have the highest abuse potential and Schedule V drugs have
the lowest abuse potential.
DEA Form 222 - to buy
DEA Form 224 - to sell
◉ 1970 Poison Prevention Packaging Act.
Answer: This act required childproof packaging on most drugs
dispensed in a pharmacy. Drugs that are exempt from this act are
drugs used in emergency situations, such as nitroglycerin (Nitrostat
SL), birth control pills, inhalers, ointments and creams.
◉ 1972 Drug Listing Act.
Answer: Authorized the FDA to compile a list of all legal drugs for
sale in the US. Assigned a unique identifier to all drugs called the
National Drug Code (NDC) 12 digit code. Leading zero on the ones
with only 4 digits in first sequence.
◉ 1983 Orphan Drug Act.
Answer: Created to promote the research and development of drugs
needed for the treatment of rare diseases. (less than 200,000)
