PHARMACY TECHNICIAN & PHARMACY LAW EXAM – QUESTIONS AND ANSWERS | VERIFIED
AND WELL DETAILED ANSWERS | PLUS RATIONALES | GUARANTEED PASS | LATEST EXAM
UPDATE
Affordable Care Act (ACA) - CORRECT ANSWER -increases access to medical coverage and
lowers the cost of prescription drugs, particularly for older people who are more likely to
have multiple prescriptions.
Pure Food and Drug Act of 1906 - CORRECT ANSWER --was to prohibit the interstate
transportation or sale of adulterated and misbranded food and drugs. This act required that
the labels not contain false information about the drugs' strength and purity. The act,
although amended, proved unenforceable, and new legislation was later required.
Food, Drug, and Cosmetic Act of 1938 - CORRECT ANSWER -required pharmaceutical
manufacturers to file a new drug application (NDA) with each new drug before marketing.
Requires new drugs must be proven safe before marketing
United States Pharmacopeia - National Formulary. It also extended and clarified the
definitions of adulterated and misbranded drugs
There have always been laws controlling drug manufacturing. - CORRECT ANSWER -false, the
first law was created after there was 107 deaths
The Pure Food and Drug Act established the Food and Drug Administration. - CORRECT
ANSWER -false, The food, drug, and cosmetic of 1938 created the food and drug
administration
If a drug is prepared and packed in unsanitary conditions, it is considered adulterated and
not fit for sale. - CORRECT ANSWER -true
All drug labels must have information on the manufacturer and packer, but not the
distributor. - CORRECT ANSWER -False, both the manufacturer and the distributor must have
drug labels
All drug manufacturers must file a new drug application if they want to market a new drug. -
CORRECT ANSWER -True
Durham-Humphrey Amendment of 1951 - CORRECT ANSWER -Stated that drug stock
containers do not have to include "adequate directions for use" as long as they bear the
legend "Caution: Federal Law Prohibits Dispensing without Prescription.The amendment
,thus established the distinction between so-called legend, or prescription, drugs and over-
the-counter (OTC), or nonprescription, drugs.
Kefauver-Harris Amendment of 1962 - CORRECT ANSWER -requires drug manufacturers to
file with the FDA an investigational new drug application (INDA) before initiating a clinical
trial in humans. After extensive trials in which a product is proved both safe and effective,
Prescription drugs are also known as _____ drugs. - CORRECT ANSWER -legend
The Kefauver-Harris Amendment states that drugs must be safe and _____. - CORRECT
ANSWER -effective
Clinical testing on humans usually averages _____ years before reaching the market. -
CORRECT ANSWER -7-10
Prescriptions that are subject to abuse cannot be _____ without expressed consent of the
prescriber. - CORRECT ANSWER -refilled
Comprehensive Drug Abuse Prevention and Control Act of 1970 - CORRECT ANSWER -
commonly referred to as the Controlled Substances Act (CSA), was created to combat and
control drug abuse and to supersede previous federal drug abuse laws. The act classified
drugs with potential for abuse as controlled substances and ranked them into five
categories, or schedules
controlled substance - CORRECT ANSWER -is defined as a drug with a risk for abuse and
physical or psychological dependence.
Drug Enforcement Administration (DEA) - CORRECT ANSWER -is charged with enforcement
and prevention related to the abuse of controlled substances such as the many narcotic pain
medications on the market.
Schedule I - CORRECT ANSWER -highest potential for abuse
for research only; must have license to obtain; no accepted medical use in the United States
heroin, lysergic acid diethylamide (LSD)
Schedule II - CORRECT ANSWER -high possibility of abuse, which can lead to severe
psychological or physical dependence
dispensing severely restricted; cannot be prescribed by telephone except in an emergency;
no refills on prescriptions
Schedule III - CORRECT ANSWER -less potential for abuse and addiction than C-II
prescriptions can be refilled up to five times within 6 months if authorized by physician
benzphetamine, phendimetrazine, ketamine, anabolic steroids, acetaminophen with codeine
combination products
, Schedule IV - CORRECT ANSWER -lower abuse potential than C-II and C-III; associated with
limited physical or psychological dependence
same as for Schedule III
benzodiazepines, meprobamate,
phenobarbital
Schedule V - CORRECT ANSWER -lowest abuse potential
some sold without a prescription depending on state law; if so, purchaser must be over 18
and is required to sign log and show driver's license
liquid codeine combination cough preparations, diphenoxylate/atropine
DEA 222 form - CORRECT ANSWER -This form provides the record of any Schedule II
substances sold or delivered to another DEA-registered dispenser
perpetual inventory record - CORRECT ANSWER -is a method of maintaining ongoing
accountability for Schedule II medications on a tablet-by-tablet (or other dosage form) basis.
Poison Prevention Packaging Act of 1970 - CORRECT ANSWER -This act is enforced by the
Consumer Product Safety Commission and requires that most over-the-counter (OTC) and
prescription drugs be packaged in a child-resistant container that cannot be opened by 80%
of children under 5 but can be opened by 90% of adults.
Exceptions to the Requirement for Child-Resistant Containers - CORRECT ANSWER -nhalation
aerosols (ProAir, Proventil HFA)
methylprednisolone (Medrol) tablets with no more than 85 mg per package
oral contraceptives to be taken cyclically, in manufacturer's dispensing packages
potassium supplements in unit dosage form
powdered anhydrous cholestyramine or colestipol
prednisone tablets with no more than 105 mg per package
sublingual nitroglycerin (tablets to be taken by dissolving beneath the tongue)
Drug Listing Act of 1972 - CORRECT ANSWER -gives the FDA the authority to compile a list of
currently marketed drugs. Under the act, each new drug is assigned a unique and
permanent product code, known as a National Drug Code (NDC), consisting of 11 characters
that identify the manufacturer or distributor, the drug formulation, and the size and type of
its packaging.
The 10- to 11-character NDC number is made up of the following parts - CORRECT ANSWER -
a four- or five-digit labeler code, identifying the manufacturer or distributor of the drug
AND WELL DETAILED ANSWERS | PLUS RATIONALES | GUARANTEED PASS | LATEST EXAM
UPDATE
Affordable Care Act (ACA) - CORRECT ANSWER -increases access to medical coverage and
lowers the cost of prescription drugs, particularly for older people who are more likely to
have multiple prescriptions.
Pure Food and Drug Act of 1906 - CORRECT ANSWER --was to prohibit the interstate
transportation or sale of adulterated and misbranded food and drugs. This act required that
the labels not contain false information about the drugs' strength and purity. The act,
although amended, proved unenforceable, and new legislation was later required.
Food, Drug, and Cosmetic Act of 1938 - CORRECT ANSWER -required pharmaceutical
manufacturers to file a new drug application (NDA) with each new drug before marketing.
Requires new drugs must be proven safe before marketing
United States Pharmacopeia - National Formulary. It also extended and clarified the
definitions of adulterated and misbranded drugs
There have always been laws controlling drug manufacturing. - CORRECT ANSWER -false, the
first law was created after there was 107 deaths
The Pure Food and Drug Act established the Food and Drug Administration. - CORRECT
ANSWER -false, The food, drug, and cosmetic of 1938 created the food and drug
administration
If a drug is prepared and packed in unsanitary conditions, it is considered adulterated and
not fit for sale. - CORRECT ANSWER -true
All drug labels must have information on the manufacturer and packer, but not the
distributor. - CORRECT ANSWER -False, both the manufacturer and the distributor must have
drug labels
All drug manufacturers must file a new drug application if they want to market a new drug. -
CORRECT ANSWER -True
Durham-Humphrey Amendment of 1951 - CORRECT ANSWER -Stated that drug stock
containers do not have to include "adequate directions for use" as long as they bear the
legend "Caution: Federal Law Prohibits Dispensing without Prescription.The amendment
,thus established the distinction between so-called legend, or prescription, drugs and over-
the-counter (OTC), or nonprescription, drugs.
Kefauver-Harris Amendment of 1962 - CORRECT ANSWER -requires drug manufacturers to
file with the FDA an investigational new drug application (INDA) before initiating a clinical
trial in humans. After extensive trials in which a product is proved both safe and effective,
Prescription drugs are also known as _____ drugs. - CORRECT ANSWER -legend
The Kefauver-Harris Amendment states that drugs must be safe and _____. - CORRECT
ANSWER -effective
Clinical testing on humans usually averages _____ years before reaching the market. -
CORRECT ANSWER -7-10
Prescriptions that are subject to abuse cannot be _____ without expressed consent of the
prescriber. - CORRECT ANSWER -refilled
Comprehensive Drug Abuse Prevention and Control Act of 1970 - CORRECT ANSWER -
commonly referred to as the Controlled Substances Act (CSA), was created to combat and
control drug abuse and to supersede previous federal drug abuse laws. The act classified
drugs with potential for abuse as controlled substances and ranked them into five
categories, or schedules
controlled substance - CORRECT ANSWER -is defined as a drug with a risk for abuse and
physical or psychological dependence.
Drug Enforcement Administration (DEA) - CORRECT ANSWER -is charged with enforcement
and prevention related to the abuse of controlled substances such as the many narcotic pain
medications on the market.
Schedule I - CORRECT ANSWER -highest potential for abuse
for research only; must have license to obtain; no accepted medical use in the United States
heroin, lysergic acid diethylamide (LSD)
Schedule II - CORRECT ANSWER -high possibility of abuse, which can lead to severe
psychological or physical dependence
dispensing severely restricted; cannot be prescribed by telephone except in an emergency;
no refills on prescriptions
Schedule III - CORRECT ANSWER -less potential for abuse and addiction than C-II
prescriptions can be refilled up to five times within 6 months if authorized by physician
benzphetamine, phendimetrazine, ketamine, anabolic steroids, acetaminophen with codeine
combination products
, Schedule IV - CORRECT ANSWER -lower abuse potential than C-II and C-III; associated with
limited physical or psychological dependence
same as for Schedule III
benzodiazepines, meprobamate,
phenobarbital
Schedule V - CORRECT ANSWER -lowest abuse potential
some sold without a prescription depending on state law; if so, purchaser must be over 18
and is required to sign log and show driver's license
liquid codeine combination cough preparations, diphenoxylate/atropine
DEA 222 form - CORRECT ANSWER -This form provides the record of any Schedule II
substances sold or delivered to another DEA-registered dispenser
perpetual inventory record - CORRECT ANSWER -is a method of maintaining ongoing
accountability for Schedule II medications on a tablet-by-tablet (or other dosage form) basis.
Poison Prevention Packaging Act of 1970 - CORRECT ANSWER -This act is enforced by the
Consumer Product Safety Commission and requires that most over-the-counter (OTC) and
prescription drugs be packaged in a child-resistant container that cannot be opened by 80%
of children under 5 but can be opened by 90% of adults.
Exceptions to the Requirement for Child-Resistant Containers - CORRECT ANSWER -nhalation
aerosols (ProAir, Proventil HFA)
methylprednisolone (Medrol) tablets with no more than 85 mg per package
oral contraceptives to be taken cyclically, in manufacturer's dispensing packages
potassium supplements in unit dosage form
powdered anhydrous cholestyramine or colestipol
prednisone tablets with no more than 105 mg per package
sublingual nitroglycerin (tablets to be taken by dissolving beneath the tongue)
Drug Listing Act of 1972 - CORRECT ANSWER -gives the FDA the authority to compile a list of
currently marketed drugs. Under the act, each new drug is assigned a unique and
permanent product code, known as a National Drug Code (NDC), consisting of 11 characters
that identify the manufacturer or distributor, the drug formulation, and the size and type of
its packaging.
The 10- to 11-character NDC number is made up of the following parts - CORRECT ANSWER -
a four- or five-digit labeler code, identifying the manufacturer or distributor of the drug
