Pharmacy Law & Regulations Practice
Exam| Questions with 100% Correct
Answers
The ____________ was enacted to protect employees in the workplace and reduce the
possibility of employees being injured at work. It oversees the preparation, dispensing, and
disposition of hazardous chemicals and drugs and requires that a manufacturer provide Safety
Data Sheets (SDS) to a pharmacy. - ✔ ✔ The Occupational Safety and Health Act (OSHA)
________________ Act of 1987 prohibited drug reimportation and distribution of medication
samples to anyone other than those licensed to prescribe them. - ✔ ✔ Prescription
Drug Marketing Act of 1987
Any errors made on a Form 222 cannot be corrected. This form must be retained in the
pharmacy for at least __ years. - ✔ ✔ 2
____________ prescriptions require the participation of the prescriber, pharmacy, and patient
in the iPledge program. Female patients are required to use birth control 1 month
before, during, and 1 month after therapy using this drug because of the iPledge
program. - ✔ ✔ Accutane (isotretinoin)
Do bulk medications require a beyond-use date? - ✔ ✔ no
Information required to be found on a _______ log includes the date the unit dose was
prepared, drug (generic name), medication strength, dosage form, quantity prepared,
drug manufacturer, drug manufacturer lot number, manufacturer's expiration date,
pharmacy assigned beyond use date, pharmacy lot number, pharmacy technician's initials,
and pharmacist's initials. - ✔ ✔ unit-dose log
,The Federal Food, Drug and Cosmetic Act of 1938 established a method of introducing new drug
entities into the market. Part of the process involved the submission of a _________to the
FDA from the pharmaceutical manufacturer. - ✔ ✔ New Drug Application (NDA)
The __________ requires PBMs to have a "brick and mortar pharmacy" in addition to providing
a mail-order pharmacy service. - ✔ ✔ Prescription Drug Equity Act
The __________ allows any pharmacy to participate in an insurance plan as long as it is willing
to meet the conditions of the contract. - ✔ ✔ Any Willing Provider Law
The __________ allows participants to ask a pharmacy to participate in an insurance plan, but
the pharmacy must agree to the conditions of the plan. - ✔ ✔ Freedom of Choice Law
The Sherman Antitrust Laws promote _______. - ✔ ✔ free trade
Prohibited the commerce (or interstate transportation/sale) of adulterated and misbranded
food, drink and drugs. It required that the labels not contain false information about the
drugs' strength and purity. Government pre-approval of drugs required. - ✔ ✔ Pure Food and
Drug Act of 1906
Which law defined aldulteration and misbranding? - ✔ ✔ Federal Food, Drug, and Cosmetic Act of
1938; adulteration-The alteration of any substance by the deliberate addition of a component not
ordinarily part of that substance; usually used to imply that the substance is debased as a result.
Also, preparing prescriptions under unsanitary conditions. Misbranding-a false or misleading label
on a product that may confound the consumer
http://www.fda.gov/Cosmetics/GuidanceRegulation/LawsRegulations/ucm074248.htm#Adulte
rated
The Federal Food, Drug, and Cosmetic Act of 1938 legislation created the _________ . Under
this act, new drugs MUST be proven safe for use by humans. - ✔ ✔ FDA
, This amendment prohibited the false claims regarding therapeutic effect of drugs - ✔ ✔
Sherley Amendment of 1911
This act created a classification of drugs based on
their abuse potential. These drugs were then ranked into five categories or schedules. Enforced
by the DEA. Under this act, all narcotics must be labeled "Warning: May Be Habit Forming" - ✔
✔ Comprehensive Drug Abuse Prevention and Control Act of 1970 (commonly referred to as
the Controlled Substances Act (CSA))
An _______ drug is one used to treat rare diseases when there are fewer than 200,000 cases.
Under the 1983 ______ Drug Act, drug manufacturers are provided tax incentives for research,
approval, and marketing of medications & provided exclusive licenses to make these drugs for
a period of time. - ✔ ✔ orphan
This act changes legend requirement to
read "Rx Only" instead of the statement "Caution: Federal Law prohibits dispensing without a
prescription" - ✔ ✔ 1997 FDA Modernization Act
The FDA is responsible for the annual publishing (available online) of "Approved Drug Products
with Therapeutic Equivalence Evaluations," better known as the "FDA ____ Book." This
reference is used in pharmacy primarily to make sure that generic products can be
safely substituted for brand name products. - ✔ ✔ Orange
The ___________ Act required a prescription for opium-containing products - ✔ ✔ Harrison
Narcotic Act
This agency regulates the dispensing of radio-pharmaceuticals. - ✔ ✔ Nuclear
Regulatory Commission (NRC)
Anabolic Steroids are classified as a Schedule _____ controlled substance under the Anabolic
Steroid Control Act of 1990 - ✔ ✔ III
Exam| Questions with 100% Correct
Answers
The ____________ was enacted to protect employees in the workplace and reduce the
possibility of employees being injured at work. It oversees the preparation, dispensing, and
disposition of hazardous chemicals and drugs and requires that a manufacturer provide Safety
Data Sheets (SDS) to a pharmacy. - ✔ ✔ The Occupational Safety and Health Act (OSHA)
________________ Act of 1987 prohibited drug reimportation and distribution of medication
samples to anyone other than those licensed to prescribe them. - ✔ ✔ Prescription
Drug Marketing Act of 1987
Any errors made on a Form 222 cannot be corrected. This form must be retained in the
pharmacy for at least __ years. - ✔ ✔ 2
____________ prescriptions require the participation of the prescriber, pharmacy, and patient
in the iPledge program. Female patients are required to use birth control 1 month
before, during, and 1 month after therapy using this drug because of the iPledge
program. - ✔ ✔ Accutane (isotretinoin)
Do bulk medications require a beyond-use date? - ✔ ✔ no
Information required to be found on a _______ log includes the date the unit dose was
prepared, drug (generic name), medication strength, dosage form, quantity prepared,
drug manufacturer, drug manufacturer lot number, manufacturer's expiration date,
pharmacy assigned beyond use date, pharmacy lot number, pharmacy technician's initials,
and pharmacist's initials. - ✔ ✔ unit-dose log
,The Federal Food, Drug and Cosmetic Act of 1938 established a method of introducing new drug
entities into the market. Part of the process involved the submission of a _________to the
FDA from the pharmaceutical manufacturer. - ✔ ✔ New Drug Application (NDA)
The __________ requires PBMs to have a "brick and mortar pharmacy" in addition to providing
a mail-order pharmacy service. - ✔ ✔ Prescription Drug Equity Act
The __________ allows any pharmacy to participate in an insurance plan as long as it is willing
to meet the conditions of the contract. - ✔ ✔ Any Willing Provider Law
The __________ allows participants to ask a pharmacy to participate in an insurance plan, but
the pharmacy must agree to the conditions of the plan. - ✔ ✔ Freedom of Choice Law
The Sherman Antitrust Laws promote _______. - ✔ ✔ free trade
Prohibited the commerce (or interstate transportation/sale) of adulterated and misbranded
food, drink and drugs. It required that the labels not contain false information about the
drugs' strength and purity. Government pre-approval of drugs required. - ✔ ✔ Pure Food and
Drug Act of 1906
Which law defined aldulteration and misbranding? - ✔ ✔ Federal Food, Drug, and Cosmetic Act of
1938; adulteration-The alteration of any substance by the deliberate addition of a component not
ordinarily part of that substance; usually used to imply that the substance is debased as a result.
Also, preparing prescriptions under unsanitary conditions. Misbranding-a false or misleading label
on a product that may confound the consumer
http://www.fda.gov/Cosmetics/GuidanceRegulation/LawsRegulations/ucm074248.htm#Adulte
rated
The Federal Food, Drug, and Cosmetic Act of 1938 legislation created the _________ . Under
this act, new drugs MUST be proven safe for use by humans. - ✔ ✔ FDA
, This amendment prohibited the false claims regarding therapeutic effect of drugs - ✔ ✔
Sherley Amendment of 1911
This act created a classification of drugs based on
their abuse potential. These drugs were then ranked into five categories or schedules. Enforced
by the DEA. Under this act, all narcotics must be labeled "Warning: May Be Habit Forming" - ✔
✔ Comprehensive Drug Abuse Prevention and Control Act of 1970 (commonly referred to as
the Controlled Substances Act (CSA))
An _______ drug is one used to treat rare diseases when there are fewer than 200,000 cases.
Under the 1983 ______ Drug Act, drug manufacturers are provided tax incentives for research,
approval, and marketing of medications & provided exclusive licenses to make these drugs for
a period of time. - ✔ ✔ orphan
This act changes legend requirement to
read "Rx Only" instead of the statement "Caution: Federal Law prohibits dispensing without a
prescription" - ✔ ✔ 1997 FDA Modernization Act
The FDA is responsible for the annual publishing (available online) of "Approved Drug Products
with Therapeutic Equivalence Evaluations," better known as the "FDA ____ Book." This
reference is used in pharmacy primarily to make sure that generic products can be
safely substituted for brand name products. - ✔ ✔ Orange
The ___________ Act required a prescription for opium-containing products - ✔ ✔ Harrison
Narcotic Act
This agency regulates the dispensing of radio-pharmaceuticals. - ✔ ✔ Nuclear
Regulatory Commission (NRC)
Anabolic Steroids are classified as a Schedule _____ controlled substance under the Anabolic
Steroid Control Act of 1990 - ✔ ✔ III
