-LAWWhich of the following is TRUE regarding Schedule II drugs?

Have a low potential for abuse

Have a high potential for abuse
Have a moderate potential for abuse
Have no medical use in the U.S.
Which of the following is not true in regards to the sale of hypodermic needles
in Kentucky?
A. They cannot be displayed where customers have access to them
B. Intended use of the syringes must be recorded
C. May be exchanged at pharmacies according to the Clean Needle Act
D. Law enforcement officials may inspect sales records
In Kentucky, prescriptions for Schedule II substances:
A. Must be kept in a separate file
B. May be kept with other Scheduled prescriptions
C. Must be kept with Schedule III prescriptions
D. May be kept with non-controlled substance prescriptions if marked with a red
"C-II
The advertising of Rx only drugs is regulated by which of the following?
A. The Federal Trade Commission
B. The FDA
C. The Interstate Commerce Commission
D. The attorney General of the USA
What percentage of the controlled substance does dispensed each year may be tran
sferred to another pharmacy without requiring registration as a wholesaler?
A. 5%
B. 10%
C. 15%
D. 20%
Which of the following is TRUE regarding the definition of a "drug"?
A. Distinguishes legal or lawful drugs from illicit drugs
B. Differentiates between Rx only and OTC drugs
C. Includes devices intended for diagnosis of disease
D. Includes certain food
A label mixup of two potent drugs is an example of which class of drug recall?
A. I
B. II
C. III
D. IV
According to federal and state regulations, Schedule II prescriptions must be wh
ich of the following?
A. Signed by the prescriber
B. Signed by an agent of the prescriber
C. Written only in ink
D. Typewritten

A product that violates the Poison Prevention Packaging Act is classed as which
of the following?
A. Adultered
B. Misbranded

C. Expired
D. Counterfeit
Record-keeping requirements for sale of OTC
he following except:
A. The separate registry must show the name
B. The separate registry must show the name
C. The separate registry must show the name
D. The separate registry must show the name
f the product

Schedule V products include all of t

and address of the purchaser
and quantity of the product sold
or initials of the pharmacist
of the manufacturer or distributor o

According to the Controlled Substance Act and Regulations, an individual practit

ioner is?
A. An individual licensed to prescribe or dispense controlled substances in the
course of professional practice
B. Not required to keep records of C-II to C-V drugs dispensed
C. Permitted to order controlled drugs for office use by means of a prescription
D. Not required to have a DEA registration
According to federal law, the authority to place or remove substances from Sched
ules is granted to which of the following?
A. The Attorney General of the US
B. The Commissioner of the FDA
C. The secretary of Health and Human Services
D. The Director of the FBI
Prior to
A. Proof
B. Proof
C. Proof
D. Proof

1962, which of the following was required by the FDC Act?

of safety only
of safety and efficacy
of manufacturer s location
that a drug was made in the USA

The FDCA authorizes the FDA to switch drugs from Rx only to OTC status if:
A. A manufacturer requests the switch by submitting a supplemental application t
o its approved NDA
B. The FDA amends an OTC monograph to include the product
C. A federal judge issues a writ of mandamus
D. Either A or B above
Which of the following statements concerning Schedule II drugs is TRUE?
A. The amount dispensed on an emergency oral Rx is limited to a three day supply
B. A pharmacy has 72 hours to complete a partially filled C-II prescription
C. Hospital physicians may not order C-II drugs w/o a DEA registration
D. A pharmacist must refuse to fill a C-II Rx from a podiatrist.
The advertising of OTC drugs is regulated by which of the following?
A. The FDA
B. The Federal Trade Commission
C. The Department of Justice
D. The Department of the Treasury
A drug may be considered "new" if changes occur in which of the following?
A. Indications of use
B. Route of administration
C. Packaging
D. Duration of action
Which of the following concerning written controlled drug prescriptions in Kentu
cky is False?

A.
B.
C.
D.

The order must be on a security prescription blank

The pre-printed name of the drug may appear on the blank
Only one drug is permitted per blank
The prescription must signed and dated on date of issue

Which of the following is not a provision of the Kefauver-Harris Amendment to th

e FDCA?
A. It requires proof of safety and efficacy of a drug
B. It transferred jurisdiction over Rx drug advertising to the Federal Trade Com
mission
C. It requires a positive act of approval of a drug by the FDA prior to marketin
g
D. It requires informed consent of research subjects and reporting of adverse re
actions during testing.
When a medication is to be considered for switching from Rx to ORC status, what
is one of the factors examined by the FDA?
A. Safety for patients
B. Savings to the parent company
C. The impact on Medicaid
D. The impact on Medicare
E. The impact on noninsured consumers
Explanation: The FDA has not historically considered any aspect of financial imp
act when looking at an Rx to OTC switch, the agency examines safety, efficacy, l
abeling, and occasionally a few other issues such as public opinion.
Rx
A.
B.
C.
D.
E.

drug package inserts include all of the following except.

adverse reactions
contraindications
symptoms and treatment of overdoses
average wholesale price
date of the most recent revision of the labeling

A pharmacy has been compounding a psoriasis cream in 30g jars based upon prescri
ptions written by physicians in a dermatology clinic. Under which of the followi
ng circumstances could the pharmacy also dispense the jars?
A. For patients of other prescribers based upon written prescriptions
B. To be original clinic for dispensing by the dermatologists
C. To other pharmacies provided they provide a written purchase order
D. There are no circumstances which permit the pharmacy to dispense the jars
A dietary supplement must contain an additional statement on the labeling if the
manufacturer makes a claim of benefit for a particular condition. What statemen
t, must be included?
A. Warning: The safety of this product has not been determined
B. This product is not intended for children
C. This statement has not been evaluated by the FDA. This product is not intende
d to diagnose, treat, cure or prevent any disease
D. Caution: Transfer of this medication to another person is prohibited
What is the FDA's attitude about the need for patient counseling prior to sale o
f the majority of nonprescription products?
A. The patient does not need to speak to anyone
B. The patient must consult a convenience store owner before purchase
C. The patient must consult a pharmacist before purchase
D. The patient must consult a pharmacy clerk before purchase
E. The patient must consult a physician before purchase

Explanation: The FDA believes that patients are fully capable of making their ow
n nonprescription product choices, unless the label specifically directs them to
contact a pharmacist or physician.
Which of the following is the established name of a drug?
A. Brand name
B. Generic name
C. Trademark name
D. International chemical name
In
A.
B.
C.
D.

Kentucky, who may prevent drug product selection (substitution)?

Only the patient
Only the prescriber
Either the patient or the prescriber
Either the patient or insurance company

If
od
A.
B.
C.
D.

a Kentucky pharmacist fails to renew his/her license for any consecutive peri
up to 5 years, he/she is required to do which of the following?
Satisfy the CE requirements only
Pay all fees and penalties and satisfy CE requirements
Pass the MPJE only
Pass an examination before the Board and the MPJE

Which of the following is true?

A. Schedule II prescriptions cannot be refilled
B. Schedule III, IV, and V prescriptions can be refilled anytime
C. A DEA number is required only for Schedule II prescription
D. Schedule II prescriptions can be refilled as long as there is a valid reason
E. A DEA number is not required for storing controlled substances of any schedul
e
While the proprietary name of a drug is chosen by the manufacturer, its generic
name is assigned and approved by which of the following organizations?
A. USP
B. AMA
C. APhA
D. FDA
E. USAN
Explanation: The United Adopted Names (USAN) Council is the official organizatio
n that approves the generic name of a drug. The USP, AMA, and APhA are all spons
ors of the generic names. The FDA approves the proposed proprietary name
Why does the Federal Government has authority to regulate controlled drugs?
A. Because of the Interstate Commerce Clause of the US Constitution
B. By virtue of Presidential Executive Order
C. Because of the Congressional power of tax
D. Because of the Federal Police Powers
Which of the following statements is FALSE concerning Schedule V codeine cough p
reparations?
A. If permitted by state law, a purchaser may not obtain more than 120ml in 48hr
s
B. The product may not contain more than 200mg of codeine per 100ml
C. The purchaser must be at least 18 years of age
D. If permitted by state law, a purchaser may not obtain more than 120ml in 24hr
s
Under provision of the Controlled Substances Act, who is EXEMPT from individual
registration?
A. Pharmacies

B.
C.
D.
E.

Pharmacists
Drug wholesalers
Hospitals
Veterinarians

You receive an Rx which requires you to add 15g of codeine to Elixir of Benadryl
and qs to 240ml. Which Schedule would the prescription fall in?
A. II
B. III
C. IV
D. V
The purpose of any drug laws and regulations as they pertain to good manufacturi
ng practices is to ensure
A. Efficacy
B. Potency
C. Profit
D. Purity
E. Safety
When ordering multiple C-II prescriptions for the same drug and the same patient
on the same day, the total quantity ordered by the prescriber may not exceed a
how many day supply?
A. 30
B. 60
C. 90
D. 120
What is a pharmacist required to do upon receiving the written follow-up prescri
ption to an emergency oral prescription for a C-II drug?
A. Keep the written follow-up Rx and send the written emergency oral Rx to the D
EA
B. Throw away the emergency oral Rx
C. Place the written follow-up Rx in the controlled Rx file
D. Attach the written follow-up Rx to the written emergency oral Rx and file bot
h in the controlled Rx file.
In conducting an inventory for controlled substances, an estimated count may be
taken for which schedule of drugs as long as the contents of the container does
not exceed 1000 tablets?
A. II and III
B. III-V
C. IV only
D. V only
Every pharmacy in the US must re-register with the DEA how often?
A. Annually
B. Every two years
C. Every three years
D. Every five years
A faxed prescription for a Schedule II drug is permitted in which of the followi
ng cases?
A. The order is to be compounded for direct administration to a patient by injec
tion or intraspinal infusion
B. The order is for a resident of a long term care facility (LTCF)
C. The order is for a patient in a hospice licensed by a state
D. All of the above
Which of the following designations is given to a medication that is proven to c
ause birth defects in either human or animal studies?

A.
B.
C.
D.
E.

Category
Category
Category
Category
Category

A
B
C
D
X

When ordering multiple C-II prescriptions for the same drug and the same patient
on the same day, the total quantity ordered by the prescriber may not exceed ho
w many day supply?
A. 30
B. 60
C. 90
D. 120
The FDCA authorizes the FDA to switch drugs from Rx only to OTC status if:
A. A manufacturer requests the switch by submitting a supplemental application
to its approved NDA
B. The FDA amends an OTC monograph to include the product
C. A federal judge issues a write or mandamus
D. Either A or B above
Prior to 1962, which of the following was required by the FDC Act?
A. Proof of safety only
B. Proof of safety and efficacy
C. Proof of manufacturer s location
D. Proof that a drug was made in the USA
In Kentucky, all prescription records shall be maintained for a period of how ma
ny years?
A. 2
B. 3
C. 4
D. 5
In Kentucky, rules concerning
ich of the following?
A.
B.
C. A preceptor may supervise
of an intern receiving credit
rvising interns as part of an
D.

preceptors include all of the following, EXCEPT wh

not more than 2 interns at a time for the purpose

for pharmacy practice experience, except when supe
academic experience program.

A schedule V drug product may contain not more than ____ of codeine per 100 ml o
r 100 grams in combination with at least one non-narcotic active ingredient.
A. 100mg
B. 200mg
C. 900mg
D.1800mg