Pharmacy Law II Midterm

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1. Initial license fees are as follows, except: e. none of the above

a. $100 total for pharmacists

b. $190 total for pharmacists
c. $105 total for nuclear pharmacists
d. b & c
e. None of the above
2. An inactive license for a nuclear pharmacist may be changed to a. The pharmacist meets the CE requirements for each biennium
an active license if: the license was on inactive status

a. The pharmacist meets the CE requirements for each biennium

the license was on inactive status
b. The pharmacist submits a $25 reactivation fee
c. The pharmacist submits a $50 status fee if change is made at a
time other than license renewal
d. All of the above
e. None of the above
3. Which of the following statements are true concerning retired c. a licensee may elect retired status by submitting a written
status licensees? request with the board for retired status and pay a retired status
fee
a. must take the NAPLEX if retired for less than 5 years
b. must pay the past biennial fee only if retired for over 6 years
c. a licensee may elect retired status by submitting a written
request with the board for retired status and pay a retired status
fee
d. b & c
e. none of the above
4. An active or inactive license must be renewed by what time on b. midnight
the expiration date in order to not be put on delinquent status?

a. 5 PM
b. midnight
c. 3 PM
d. noon
5. To change a license from delinquent status to active status, a d. all of the above
licensee must:

a. submit a reactivation fee of $100

b. submit the current active status license fee or inactive status
license fee
c. meet continuing education requirements for each biennium on
inactive status
d. all of the above
e. none of the above
6. Which of the following is incorrect? d. a & b

a. the delinquent fee for a pharmacy permit is $250

b. the initial fee for a pharmacy permit is $100
c. the biennial pharmacy permit renewal fee is $200
d. a & b
e. a & c
7. Upon a licensee's first renewal of licensure: c. the licensee must complete 15 hours
of CE if license was issued 12 months
a. the licensee must complete 2 hours of board approved CE on HIV/AIDS or more after the initial licensure
b. the licensee must complete 15 hours of CE if the license was issued less than 12
months prior to the expiration date of the license
c. the licensee must complete 15 hours of CE if license was issued 12 months or more
after the initial licensure
d. a & c
8. Which of the following is (are) true? e. a & b

a. 10 hours of the required 30 hours must be live

b. presenters of a live CE seminar may receive 1 credit for each course credit hour
presented
c. if you attend a board disciplinary hearing and are required to appear before the
board, you may receive 5 hours of CE
d. a & c
e. a & b
9. Pharmacy technicians must complete the following hours of CE within the 24-month c. 20 hours
period prior to the expiration date of his or her license:

a. 12 hours
b. 30 hours
c. 20 hours
d. 54 hours
e. 24 hours
10. How many hours must be "live" for pharmacy technician biennial registration renewal? b. 4

a. 12
b. 4
c. 24
d. 20
e. 8
11. A pharmacist or technician who is a member of the Armed Forces of the U.S. in good A. on active duty
standing with the Board is exempt from all license renewal provisions if:

A. on active duty
B. engaged in pharmacy in the for profit or not for profit setting
C. A and B
D. none of the above
12. Which of the following is not a requirement of applicants for licensure by examination? D. All of the above

A. Received a degree from a school or college of pharmacy accredited by an

accrediting agency recognized and approved by the U.S. Office of Education
B. Completed an internship program provided by an accredited school or college of
pharmacy and/or a state board of pharmacy
C. Completed a board approved course not less than 2 hours on medication errors, or
completed academic course work no less than 2 hours as attested to by the Dean (if
applicant applying within 1 year following receipt of pharmacy degree)
D. All of the above
E. Only A and B
13. Which of the following is not a part of the "current" requirements for licensure by A. TOEFL score of 500 for the pencil
examination of foreign pharmacy graduates? and paper test or 173 for computer
version
A. TOEFL score of 500 for the pencil and paper test or 173 for computer version
B. 2080 hours of supervised work
C. 75% minimum score on the foreign pharmacy graduate equivalency examination
D. Score of 50 on recalibrated TSE
14. A U.S. pharmacy student or graduate must register with the Department of Health as B. False
an intern within 30 days after being employed as an intern in a pharmacy in Florida.

A. True
B. False
15. A pharmacist is ineligible to be a preceptor if his/her: D. All of the above

A. License is revoked
B. License is suspended
C. License is on probation
D. All of the above
E. A and B
16. An applicant for pharmacy intern registration must provide proof that he is either A. True
enrolled in an intern program at an accredited school or college of pharmacy by
ACPE, or has graduated from an ACPE accredited college or school of pharmacy.

A. True
B. False
17. All foreign pharmacy graduates "must" complete the following number of hours of C. 500
supervised work activity "within the state of Florida":

A. 200
B. 850
C. 500
D. None
18. An applicant for licensure by endorsement must: F. All of the above

A. Be at least 18 years of age

B. Complete 2 years of active practice within the last 5 years of application or have
successfully completed an internship meeting the requirements of Section 465.007 (1)
(c) within the immediately preceding 2 years
C. Complete a Board approved course of 2 hours on medication errors that cover root-
cause analysis, error reduction and prevention, and patient safety
D. Take MPJE-Florida version
E. A, B, and C
F. All of the above
19. For Consultant Pharmacist licensure, a pharmacist must do all of the following, except: A. Complete an 8-hour course approved
by the Florida Board of Pharmacy
A. Complete an 8-hour course approved by the Florida Board of Pharmacy Tripartite Tripartite Continuing Education
Continuing Education Committee Committee
B. Complete 40 hours of training within 3 consecutive months
C. After initial licensure, must complete 24 hours of board approved CE biennially for
consultant license renewal
D. Complete the 24 hours of CE for consultant license renewal plus 30 hours of CE for
regular pharmacist license renewal
20. The training program for a consultant pharmacist must include: E. All of the above

A. Policies and procedures pertaining to traditional systems and unit dose systems
B. Maintenance of records related to medication errors, recalls, controlled substances, and alcohol
inventory
C. Formulary development, in-service education of nurses
D. Maintenance of drug quality and safe storage
E. All of the above
F. A,B and C
21. A pharmacist licensed to practice pharmacy in this state who performs a radiopharmaceutical service shall, B. Nuclear
prior to engaging in such specialized practice, be actively licensed as a... pharmacist

A. Radiopharmaceutical pharmacist
B. Nuclear pharmacist
C. Nuclear physicist
D. Oncology pharmacist
22. Applicants for a nuclear pharmacist license must complete training, including at least: C. 20 hours on
radiation biology
A. 84 hours on radiation physics
B. 20 hours on radiopharmaceutical chemistry
C. 20 hours on radiation biology
D. 20 hours on radiation protection
E. All of the above
23. Only consultant pharmacists may order and evaluate laboratory tests under the provisions of section F. S. B. False
465.0125.

A. True
B. False
24. Only pharmacists holding the Doctor of Pharmacy degree who wish to order and evaluate laboratory tests B. False
under the provisions F. S. 465.0125 must complete a three-hour initial certification course.

A. True
B. False
25. All of the following applies to applicants who wish to apply to become a registered pharmacy technician, A. Applicant may
except: be 16 years of age

A. Applicant may be 16 years of age

B. Applicant may be 50 years of age
C. Applicant may be 17 years of age
D. Applicant may be 25 years of age
26. All employer based approved registered pharmacy technician training programs must include instruction F. All of the above
on interpersonal relations, communications, and ethics that includes:

A. Patient and caregiver communication

B. Diversity of communications
C. Ethics governing pharmacy practice
D. Empathetic communications
E. A, B, and C
F. All of the above
27. A pharmacy intern is: D. B and C

A. Required to be registered with the DEA as an intern

B. Required to be registered before being employed as an intern in a pharmacy
in Florida
C. May be enrolled at an accredited college or school of pharmacy or be a
graduate of an accredited college or school and not yet licensed in the state
D. B and C
E. All of the above
28. Interns may fill, compound, and dispense medicinal drugs without the direct and B. False
immediate personal supervision of a pharmacist actively licensed in this state.

A. True
B. False
29. The Tripartite Committee consists of: G. C, D, and E

A. Members of the Board of Medicine

B. Members of the Board of Nursing
C. Members of the Board of Pharmacy
D. Members from colleges and schools of pharmacy in the state
E. Practicing pharmacists within the state
F. A, C, and E
G. C, D, and E
30. The Tripartite Committee oversees: D. Review of continuing education providers
and approval of continuing education courses
A. Schools and colleges of pharmacy accreditation
B. Promulgation of Board rules
C. Lobbying of the state legislature on behalf of pharmacists
D. Review of continuing education providers and approval of continuing
education courses
31. All registered pharmacy technicians must: E. All of the above

A. Verbally identify themselves as a registered technician over the telephone

and in other forms of communication
B. Maintain proof of current licensure, but such licensure does not need to be
readily retrievable upon request by a customer
C. Identify themselves as a registered technician by wearing a badge or
monogrammed smock showing their name and that he/she is a pharmacy
technician
D. A and C
E. All of the above
32. A pharmacist may not continue a course of therapy with fluoride products for a A. True
patient for more than one year.

A. True
B. False
33. A pharmacist may: B. Order some medicinal drug products
subject to certain terms and limitations
A. Order oral medications for pregnant and nursing women
B. Order some medicinal drug products subject to certain terms and limitations
C. Order injectable products
D. A and C
34. A pharmacist may order and dispense: D. All of the above

A. Naproxen
B. Phenazopyridine
C. Antipyrine 5.4%, benzocaine 1.4%, glycerin
D. All of the above
E. A and B
35. Which of the following is (are) true? F. B and C

A. Registered pharmacy technicians may accept oral prescriptions if

done under the supervision of a pharmacist
B. A pharmacist may prepare a copy of a prescription or read a
prescription concerning treatment of a person or animal
C. A pharmacy intern, under the direct supervision of a pharmacist, may
accept an oral prescription
D. All of the above
E. A and C
F. B and C
36. Before a pharmacist can refuse to fill a controlled substance prescription D. All of the above
based solely upon a concern with the prescription s validity, the
pharmacist shall attempt to validate the prescription by,

A. Communicating with the patient or the patient s representative to

acquire relevant information
B. Communicating with the prescriber or the prescriber s agent to acquire
relevant information
C. In lieu of A or B, but not both, the pharmacist may access the
Prescription Drug Monitoring Program s database to gather relevant
information concerning the validity of the prescription
D. All of the above
37. Paying rent to a facility (as defined in Section 408.032 (7), F. S.) for space A. True
that is not used or is unusable or paying a rental rate for space that is
significantly greater than the usual and customary rental rate for similar
space would justify discipline against a pharmacist or permittee.

A. True
B. False
38. Which of the following is (are) true? A. Pharmacy technicians may deliver prescriptions
with a final certification by the pharmacist during the
A. Pharmacy technicians may deliver prescriptions with a final pharmacist s meal break, if a pharmacist is available
certification by the pharmacist during the pharmacist s meal break, if a on the premises during the meal break for emergency
pharmacist is available on the premises during the meal break for consultation
emergency consultation
B. The activities of the registered pharmacy technician during a
pharmacist s meal break are not considered to be under the direct and
immediate personal supervision of a pharmacist even though a pharmacist
is available on the premises during the meal break to answer the
technician s questions
C. Registered pharmacy technicians may receive verbal prescriptions
from a practitioner
D. A pharmacy intern may make the final check of the completed
prescription thereby assuming the complete responsibility for its
preparation and accuracy
39. Under 64B16-27.230, pharmacists may order fluoride for which of the following patients who E. None of the above
have 0.6 ppm and over of fluoride in their drinking water?

A. Ages 0-6 months

B. Ages 6-16 years
C. Ages 6 months-3 years
D. A and B
E. None of the above
40. A pharmacist must: E. A and C

A. Inform a person of the retail price difference between the branded and substituted generic
prescription dispensed
B. Call patient within two days to notify him that a generic substituted drug has been
dispensed
C. Inform a person that he (the pharmacist ) will substitute a generic for a brand product, prior
to the delivery of the prescription
D. A and B
E. A and C
41. A pharmacist must maintain proof of current licensure such that if someone from the A. True
Department of Health, Board of Pharmacy, or a member of the public requests such proof of
licensure, it is readily retrievable.

A. True
B. False
42. A pharmacist in a traditional community pharmacy setting may be allowed to supervise up to A. True
six technicians, if not engaging in sterile compounding.

A. True
B. False
43. Which of the following is (are) true? D. A and B

A. No prescription may be filled or refilled in excess of one year from the date of the original
prescription in the State of Florida
B. No prescription for a CII may be refilled
C. A prescription for CIII, CIV, or CV medications may be filled or refilled six times over a one-
year period
D. A and B
E. A and C
44. All of the following are true concerning drug therapy management, except: C. May be performed at the
pharmacy counter in front of
A. Is provided pursuant to a prescriber care plan other customers
B. May entail ordering laboratory tests, interpreting laboratory values, and executing drug
therapy orders
C. May be performed at the pharmacy counter in front of other customers
D. All are true
45. Prospective drug use review entails a review of which of the F. B, C, and D
following?

A. Medicaid prescription data

B. Clinical abuse/misuse
C. Therapeutic duplication
D. Drug-allergy interaction
E. All of the above
F. B, C, and D
46. The Continuous Quality Improvement Committee in a pharmacy C. Registered Pharmacy Interns and Registered Pharmacy
usually consists of: Technicians

A. Pharmacy District Manager or Vice-President of Operations

B. Produce Department Manager
C. Registered Pharmacy Interns and Registered Pharmacy
Technicians
D. All of the above
E. A and C
47. All pharmacists shall complete a Board-approved 2-hour continuing A. True
education course on Validation of Prescriptions for Controlled
Substances; and every biennium thereafter.

A. True
B. False
48. Orthosis means which of the following medical devices? F. None of the above

A. Specialized utensils
B. Finger splints
C. Wheelchair seating
D. Arch supports
E. All of the above
F. None of the above
49. An institutional pharmacy must never be in possession of a sample B. False
medicinal drug.

A. True
B. False
50. Which of the following statements is incorrect? C. Continuous Quality Improvement records are not
considered peer-review documents and are subject to
A. Each pharmacy shall establish a Continuous Quality discovery in civil litigation and administrative actions.
Improvement Program
B. Quality-related events include dispensing or administering a
prescribed medication to an incorrect patient or with an incorrect
drug strength
C. Continuous Quality Improvement records are not considered
peer-review documents and are subject to discovery in civil
litigation and administrative actions.
D. All are true
51. Requirements for Patient Records: D. All of the above

A. The patient record must be maintained for at least 4 years from the date of the last entry in the
profile
B. The record must include the patient s gender
C. The record must include the patient s age OR date of birth
D. All of the above
52. A registered pharmacy technician may: C. Count, weigh,
measure, and pour
A. Transfer a prescription controlled substances
B. Engage in prospective drug review
C. Count, weigh, measure, and pour controlled substances
D. Receive therapy or blood product procedures in a permitted nuclear pharmacy
53. Which of the following are true? E. B and C

A. Pharmacists may knowingly place into stock any prescription returned to the pharmacy by customers
B. The Board, generally, shall not register a prescription department manager as the manager of more
than one pharmacy
C. Offering or providing cash, or goods, or entertainment (including, money, food or decorations) to a
health facility in exchange for favorable consideration in obtaining or maintaining the business of the
facility justifies discipline against a pharmacist or permittee
D. A and B
E. B and C
54. The negative drug formulary C. Includes
conjugated estrogen
A. Allows for the generic substitution of drugs on the list by a pharmacist without physician approval
B. Is determined by the Board of Pharmacy and the Board of Nursing
C. Includes conjugated estrogen
D. None of the above
55. Direct supervision of a registered pharmacy technician by a pharmacist means which of the following? D. All of the above

A. Pharmacist is on the premises

B. Pharmacist is available to provide personal assistance, direction and approval of delegated tasks
performed
C. Pharmacist is aware of delegated tasks performed
D. All of the above
56. A prescription ordered by a pharmacist for naproxen sodium is authorized if; F. B and C

A. For severe pain

B. For menstrual cramps
C. Limited to a six-day supply
D. Patient has a history of peptic ulcer disease
E. All of the above
F. B and C
57. Compounding entails all of the following, except: F. B and D

A. A professional act by a pharmacist or other practitioner authorized by law

B. Is the same as manufacturing
C. The incorporation of ingredients to create a finished product for dispensing to a patient or for administration
by a practitioner
D. The preparation of drugs or devices for sale or transfer to pharmacists, practitioners, or entities for purposes
of dispensing or distribution
E. B and C
F. B and D
58. Although the USP requires the donning of gloves prior to entry into the clean-room (when compounding sterile A. True
products), all required donning of gloves can be performed after entry into the clean room according to Florida
pharmacy rules.

A. True
B. False
59. All of the following apply to patient counseling, except: D. A and B
are incorrect
A. A pharmacist must counsel a patient or a patient s agent even when the patient or agent refuses
consultation
B. A pharmacist, or a pharmacy technician acting under the direct and immediate supervision of a licensed
pharmacist, shall counsel a patient if the patient does not refuse such counseling
C. A and B are correct
D. A and B are incorrect
60. Delegable tasks which a registered pharmacy technician can perform are all of the following, except: A. Final
verification of
A. Final verification of dosage and directions dosage and
B. Initiation of communication to confirm a patient s name, medication, directions, or number of refills directions
C. Data Entry
D. Receiving, in a permitted nuclear pharmacy, of diagnostic orders only
61. The consultation area of a pharmacy may consist of designated private counter space with a sign bearing A. True
Patient Consultation Area, or words that are substantially similar.

A. True
B. False
62. Requirements for records maintained in a data processing system consist of: D.A and C

A.An original prescription must be retained for not less than 4 years from date of last filling in hard copy or
electronic form.
B.A pharmacy does not need to maintain a backup copy of information stored in the data processing system.
C.The data processing system shall have the capacity to produce a daily hard copy print out of all original
prescriptions dispensed and refilled; or the pharmacy shall maintain a log book wherein each individual
pharmacist attests to the fact that the information in the data processing system has been reviewed and is
correct.
D.A and C
E.B and C
63. Each container of medicinal drugs dispensed shall have a label or shall be G.All of the above
accompanied by labeling. The label affixed to each container dispensed to
a patient shall contain:

A.An Expiration or Beyond-Use date

B.A warning that it is a crime to transfer the drug to another person, if a
controlled substance.
C.Name of the prescriber
D.Directions for use
E.Serial number
F.C, D, and E
G.All of the above
64. The consultant pharmacist of record at a Class I, Class II, Modified Class II, C.Monthly
or Class III Institution shall conduct a Drug Regimen Review, inspect the
facility, and prepare a written report to be filed at the permitted facility at
least:

A.Once yearly
B.Every three months
C.Monthly
D.Every six months
65. Which of the following is false? D.A and B

A.A prescription department of a community pharmacy permittee must

open for a minimum of 40 hours per week.
B.A sign in block letters not more than ½ inch in height must provide
prescription department hours open each day and be located at the back
of the store or near the photo department.
C.Any person receiving a community pharmacy permit pursuant to Section
465.018 F.S. shall be open a minimum of 20 hours/week.
D.A and B
E.All are false
66. Which of the following statements is false? B.A permit can only be issued to a single entity at a
single location, which may include an area 2 miles
A.A permit is valid only for the name and address to which it is issued. The from the central location of the permit. (See 64B16-
name must be that which appears on purchase and sales invoices. 28.113)
B.A permit can only be issued to a single entity at a single location, which
may include an area 2 miles from the central location of the permit. (See
64B16-28.113)
C.An onsite inspection must be passed before a new permit is issued,
whether the permit is based on an initial application, change of ownership,
or address change.
D.A Community Pharmacy Permit is required for every location where
medicinal drugs are compounded, dispensed, stored, or sold or where
prescriptions are filled or dispensed on an outpatient basis.
67. Compounding records must contain a complete formula for the A. True
compounded product maintained in a readily retrievable form including
methodology and necessary equipment.

A. True
B. False
68. Which of the following is (are) true? C.A change in the company who
leases the building where a permit is
A.A pharmacy ceasing or terminating professional and business activities may notify the housed does not constitute a change
board verbally and does not need to return the permit to the Board of Pharmacy. in ownership.
B.If a pharmacy is sold to a different person or business (change in identity), the new
owner may operate under the first pharmacy owner s permit.
C.A change in the company who leases the building where a permit is housed does not
constitute a change in ownership.
D.Medicinal drugs may not be transferred to a new owner upon the change of ownership
of a pharmacy or upon the closing of a pharmacy.
69. When a pharmacy closes and transfers its prescriptions to another pharmacy, the transfer B. False
of controlled substances in Schedule II does not require the use of a DEA 222 form. And,
all unused forms may be shredded at the pharmacy.

A. True
B. False
70. The Board recognizes all of the following types of Special Pharmacy permits; except, D.Special Institutional/Nuclear
Permit
A.Special Parenteral/Enteral Extended Scope Permit
B.Special Closed System Pharmacy Permit
C.Special Limited Community Permit
D.Special Institutional/Nuclear Permit
E.A and D
71. Which of the following is (are) false? D.All of the above are true

A.Special closed system pharmacy permittees provide dispensing of medications to

ultimate consumers in nursing homes, jails, ALFs, and Intermediate Care Facilities for the
Developmentally Delayed or custodial facilities defined by AHCA rules, but not to in-
patients in a hospital.
B.Generally, each pharmacy must be inspected by the Department once a year; however,
if a pharmacy passes inspection and has no discipline during the most current three years,
the pharmacy shall be inspected every two years.
C.Prescription departments must have an adequate sink and running water; sufficient
shelf, drawer or cabinet space; adequate sanitation; and current pharmacy reference
compendium (which may be in electronic data format ).
D.All of the above are true
E.A and C
72. Which of the following is (are) true? B.Acceptable methods for destroying unusable
controlled substances in pharmacies (except
A.Controlled substances dispensed to patients at a nursing home may be Institutional Class I s) are: (1) Use of a DEA-41 form,
returned to the pharmacy if unused. plus witnesses to the actual destruction of the
B.Acceptable methods for destroying unusable controlled substances in product; or (2) Shipment of product to a reverse
pharmacies (except Institutional Class I s) are: (1) Use of a DEA-41 form, distributor for destruction in conformity with federal
plus witnesses to the actual destruction of the product; or (2) Shipment of guidelines
product to a reverse distributor for destruction in conformity with federal
guidelines.
C.A central fill pharmacy is restricted to performing centralized
prescription filling, delivering, and returning for only one originating
pharmacy.
D.All or true
73. A customized patient medication package label must include: E.All of the above

A.The name, strength, quantity and physical description of each drug

product.
B.A beyond use date no more than 60 days from the date of preparation
of the package, but no later than any appropriate beyond use date for
any medicinal drug included in the package.
C.Storage Instructions
D.A and C
E.All of the above
74. Which of the following statements is (are) true? E.All of the above

A.Under no circumstances will pharmaceuticals or devices which bear upon

the container an expiration date which has been reached be sold or
dispensed to the public.
B.Each pharmacy at a minimum interval of four months, shall remove all
deteriorated and expired pharmaceuticals.
C.Generally, patients may not return prescriptions to a pharmacy, but
closed drug delivery systems which use unit dose or customized patient
medication packages may allow for unused meds to be returned to the
pharmacy for redispensing if package is individually sealed and each unit
dose is clearly labeled with the name of the drug, dosage strength,
manufacturer s control number, and expiration date, if any.
D.A and C
E.All of the above
75. When an establishment is open, the pharmacy department of a community B. False
pharmacy permittee shall be considered closed when a pharmacist is not
present and on duty; and a sign with bold letters not less than one (1) inch
in width and height, shall be displayed in a prominent place in the
prescription department and shall contain the following language:
"Prescription Department Closed."

A. True
B. False
76. Which of the following pharmacy permittees must notify the board within 10 days of any change in prescription F.A, B,
department manager, consultant pharmacist of record, or nuclear pharmacist of record? (See also, F.S. 465 and 64B16- and C
32)

A.Community Pharmacy
B.Institutional Pharmacy
C.Nuclear Pharmacy and Special Pharmacies
D.Internet Pharmacy
E.All of the Above
F.A, B, and C
77. The delivery of a filled prescription by a community central fill pharmacy to the ultimate consumer pursuant to a B.
contract with an originating pharmacy is considered dispensing per F. S. 465.003(6). False

A. True
B. False
78. 64B16-28 requires that each applicant for a pharmacy permit must attach the applicant's written policies and A. True
procedures for preventing controlled substance dispensing based on fraudulent representations or invalid
practitioner-patient relationships. This manual must provide provisions to identify the characteristics of a forged or
altered prescription.

A. True
B. False
79. An automated pharmacy system may be used in a pharmacy if: E.All
of the
A.The system has the ability to comply with product recalls. above
B.The system has a method for identifying all registered pharmacy interns and technicians involved in the dispensing
process.
C.The system will utilize a method to ensure security, such as optic scanning or electronic passwords.
D.B and C
E.All of the above
80. In order for a pharmacy to perform prescription drug processing for other pharmacies, all pharmacies must be: F.All of
the
A.Properly licensed or registered in this state or another state. above
B.Under common ownership
C.Utilize a common database
D.A and C
E.A and B
F.All of the above
81. The Durham-Humphrey Amendment: D. All
of
A. Exempted prescription labels dispensed by pharmacies from many of the label requirements imposed by law on these
manufacturers are
B. Categorized drugs as either prescription or over the counter correct
C. Legalized prescription refills if authorized
D. All of these are correct
82. Which of the following is not required C. The drug name
to be included on the label of a
dispensed drug under the FDCA? Federal law does not require it, but the state of Florida does. Prescription label
requirements in the state of Florida include: name, initials, or license # of dispensing
A. The dispenser name and address pharmacist, expiration date of the drug if any, drugs name and strength, address of the
B. The prescription serial number patient, name of the manufacturer or distributor, and the lot or control number.
C. The drug name
D. The prescriber name
83. A dentist issued a prescription to a C. Invalid, because the dentist has exceeded the scope of practice under state law
patient for a statin drug for the
purpose of reducing the patient's
cholesterol level. This prescription is:

A. Valid, because a dentist has

prescriptive authority under state law
B. Valid, because a dentist has
prescriptive authority under federal
law
C. Invalid, because the dentist has
exceeded the scope of practice under
state law
D. Invalid, because the dentist has
exceeded the scope of practice under
federal law
84. Which statement regarding patient A. They must be included for new prescriptions and refills
package inserts (PPIs) is correct,
assuming the drug is one for which a
PPI is required?

A. They must be included for new

prescriptions and refills
B. They must be given to an inpatient
prior to the administration of the first
dose and for each subsequent dose
administered
C. A hospital physician can decide
whether an inpatient should receive a
PPI
D. A pharmacy may exercise
professional judgement as to whether
a PPI should be dispensed to a patient
85. Medication Guides (MedGuides): A. Must be distributed when required, to avoid an FDCA misbranding charge

A. Must be distributed when required,

to avoid an FDCA misbranding charge
B. Replaced PPIs
C. May be replaced by a pharmacy's
CMI
D. Are mandatory the first time a
patient receives a new drug
86. Pharmacists are required to dispense Medication Guides (MedGuides): B. For prescription
drugs the FDA has
A. For all prescription drugs determined require
B. For prescription drugs the FDA has determined require MedGuides MedGuides
C. For prescription drugs that, in the pharmacist's professional judgement, require MedGuides
D. For oral contraceptives
87. A.G. wants to market the product as a drug. However, she has heard that dietary supplements are I. Articles intended
subject to less regulation and can potentially get to market sooner. Pursuant to the Food, Drug, and for the use in the
Cosmetic Act, you tell her that the definition of "drug" includes: diagnosis, cure,
mitigation, treatment
I. Articles intended for the use in the diagnosis, cure, mitigation, treatment or prevention of a disease or prevention of a
II. Articles intended to affect the structure of any function of the body disease
III. Products intended to supplement the diet II. Articles intended to
affect the structure of
any function of the
bod
88. A.G. knows that as a botanical product, she may put her product on the market as a dietary supplement, A. The manufacturer
but she decides that more money can be made if she markets the product as a drug to treat psoriasis. must apply for an
She asks you about the NDA process. As you consult with her, which of the following would be correct investigational new
regarding the new drug application (NDA) process? drug application prior
to clinical testing.
A. The manufacturer must apply for an investigational new drug application prior to clinical testing.
B. Phase I testing does not involve human testing
C. If the FDA terminates the testing of a drug, the company has a right of either appeal or judicial
review.
D. Statements A & B are correct
E. Statements A & C are correct
89. A.G. knows that CGMP will apply to her product. While explaining this requirement to her, which of the C. It is a set of
following would be correct regarding the CGMP? regulations
establishing
A. It does not apply to dietary supplements requirements for
B. It does not apply to generic drugs manufacturing
C. It is a set of regulations establishing requirements for manufacturing methods, facilities and controls methods, facilities
D. Statements A & C are correct and controls
E. Statements B & C are correct
90. A.G. starts a pharmaceutical company in Tallahassee and names it Striker Labs. She hires you as Vice- D. Statements A & B
President of regulatory affairs. She markets her newly discovered drug as Venom (Resvericortisone are correct
HCl). FDA approval was issued in 2016 for psoriasis only. Venom could become a new drug under which
of the following condition(s).

A. If Striker Labs markets the drug for an indication not contained on the label.
B. If Striker Labs changes the coating of Venom tablets
C. If the patent expires on Venom tablets
D. Statements A & B are correct
E. Statements A, B & C are correct
91. Striker Labs is a blockbuster drug. A.G. receives many awards and is now a billionaire. However, her A. The products are
chief operating officer, Millicent Hater makes an anonymous telephone to the FDA and states that the adulterated
Striker Labs facility is filled with mold. The FDA inspects the Striker facility and finds it not to be in
compliance with sanitary standards. An assay of the Venom products, however, showed them to be pure.
Which of the following would be correct:

A. The products are adulterated

B. The plant is adulterated but not the products
92. Venom comes in a 0.25mg tablet. The drug product's label states that the drug is 0.25 mg and this is sent to a D. Both
CVS in town. The pharmacist at the CVS, a friend of A.G., asks her whether the 0.25 mg has changed colors. adulterated or
A.G. goes to her plant the next day to look at the product. The color is red, but the 0.25 mg tablet should be misbranded
blue. She requests that the product be tested. The tests show that the product is actually 0.5 mg (a new
proposed mg strength, not yet released). This product is:

A. Adulterated
B. Misbranded
C. Neither adulterated or misbranded
D. Both adulterated or misbranded
93. A.G. consults with you. She wants to know what the FDA can do to her if she does nothing with the information I. Institute
she has learned. You state that the FDA has the following enforcement authority over violators of the FDCA: criminal
proceedings
I. Institute criminal proceedings II. Issue
II. Issue warning letters warning letters
III. Seek injunctive actions III. Seek
IV. Seize products injunctive
actions
IV. Seize
products
94. A.G. decides to recall Venom. Which of the following would be correct regarding drug recalls: D. Statements
A & C are
A. Manufacturers are responsible for notifying pharmacies correct
B. The FDA is responsible for notifying pharmacies
C. Pharmacists are responsible for knowing a product has been recalled
D. Statements A & C are correct
E. Statements B & C are correct
95. It is now December 2017. A.G. learns that many physicians are utilizing Venom for headaches. A.G. is worried E. Statements
about having to go through the entire NDA process again. You note that the Drug Price Competition & Patent A, B & C are
Term Restoration Act may apply, which accomplished which of the following: correct

A. Allowed generic drug manufacturers to file ANDAs instead of NDAs

B. Allowed innovator drug manufacturers patent extensions
C. Allowed market exclusivity to innovator drug manufacturers for new indications
D. Statements A & B are correct
E. Statements A, B & C are correct
96. Seminoles Corp. learns that the patent on Venom will expire in January 2018. The company wants to make a B.
generic of Venom. Seminoles Corp.'s President meets you at a dinner party. He asks you what a "theoretical" Bioequivalence
company might need to prove to get a generic approved by the FDA. You remember this class and that under and
that Drug Price Competition and Patent Term Restoration Act generic drugs must prove which of the following acceptable
(best answer): manufacturing
methods
A. Bioequivalence
B. Bioequivalence and acceptable manufacturing methods
C. Bioequivalence, acceptable manufacturing methods and safety and efficacy
D. Bioequivalence, safety and efficacy
97. Resvericortisone HCl is the established name of Venom and is notated in the USP as E. The pharmacy's product would
containing 0.25 mg of the active ingredient per tablet. A local pharmacy produces be considered adulterated and
resvericortisone with 0.125 mg of active ingredient per tablet per a physician's order. Which misbranded, unless the labeling
of the following would be the best answer indicates 0.125 mg

A. The pharmacy's product would be considered adulterated

B. The pharmacy's product would be considered misbranded, unless the labeling indicated
0.125 mg
C. The pharmacy's product would be considered adulterated unless the labeling indicates
0.125 mg
D. The pharmacy's product would be considered adulterated and misbranded
E. The pharmacy's product would be considered adulterated and misbranded, unless the
labeling indicates 0.125 mg
98. Which of the following accurately describe the FDA? E. Statements A & C are correct

A. It is a component of the Department of Health and Human Services

B. Congress appoints the commissioner of the FDA
C. The agency issues guidance documents as well as regulations
D. Statements A & B are correct
E. Statements A & C are correct
99. The most important distinguishing factor in whether a product is a drug or not is: C. Whether the manufacturer
intends the product to treat a
A. Whether it is a chemical entity disease
B. Whether the product is safe and effective
C. Whether the manufacturer intends the product to treat a disease
D. The motivation or intent of the person taking the product
100. A manufacturer of catsup (ketchup) advertised that its particular brand of catsup would C. The catsup is likely both a
effectively treat gouty arthritis. Which of the following would be correct: food and a drug
A. The catsup is likely a food
B. The catsup is likely a drug
C. The catsup is likely both a food and a drug
D. The catsup is likely neither a food nor a drug
101. Under the law, a dietary supplement includes: E. B & C

A. A food product
B. An amino acid
C. A mineral
D. A & C
E. B & C
102. Which of the following would be correct regarding the United States Pharmacopoeia (USP)? C. It sets uniform standards for
drugs
A. The FDA publishes the USP
B. A product cannot be considered a drug unless published in the USP
C. It sets uniform standards for drugs
D. Statements A & C are correct
E. Statements A, B & C are correct
103. Which of the following accurately D. Statements A & C are correc
describe(s) the 1938 FDCA?

A. The catalyst for the law was the

sulfanilamide elixir event
B. The law required that new drugs must
be proven safe and effective prior to
marketing
C. The law grandfathered drugs
marketed prior to 1938
D. Statements A & C are correct
E. Statements A, B & C are correct
104. Class III recall applied to products not likely to cause adverse health consequences
105. What are the identifiers of the three Example NDC 1234-6789-00
segments of an NDC? 1234 - a code that identifies the manufacturer or distributor
6789 - code that identifies a specific strength, dosage form, and formulation for a
particular firm
00 - code which identifies package size and type of drug
106. Misbranding A false or misleading label on a product that may confound the consumer
107. Tamper resistant package One having an indicator or barrier to entry which, if breached or missing, can
reasonably be expected to provide visible evidence to consumers that tampering has
occurred
108. Black box warning An identifier required by the FDA in the package insert of on the box notifying when the
drug may lead to death or serious injury
109. Class I recall When there is a reasonable probability that the product will cause serious, adverse
health consequences or death
110. What is required to be listed on the 1) Active ingredient, dosage unit and quantity per dosage unit
Drug Facts panel for nonprescription 2) Purpose
drug labeling? 3) Uses
4) Warnings
5) Directions
6) Other information
7) Inactive ingredients
8) Questions? Or Questions and Comments with telephone number
111. What is required for the labeling of a 1) Established name of the drug
unit dose drug? 2) Quantity of active ingredient in each unit
3) Expiry date
4) Lot or control number
5) Name/place of business of the manufacturer, packer or distributor
6) Any statements required by a compendia if an official drug
112. Pregnancy Category B Animal studies have failed to demonstrate a risk to the fetus, but there are not studies in
women. Use "only if clearly needed"

Subject in studies: Animal

113. Pregnancy Category X Studies in animals or humans clearly demonstrates fetal risk, and that risk outweighs in
potential benefit of the drug. Must state: "may cause fetal harm when administered to a
pregnant women."

Study subjects: human or animals

114. Seizure Term used to describe when the FDA physically steps in and stops the distribution of a
drug or product
115. Describe the important points of Sec 502 The name and quantity of each active drug must be clearly labeled in alphabetic
which discusses ingredient labeling on order on the drug
packaging
116. Define cGMP A set of regulations that establishes minimum requirements for the methods, facilities
or controls used in the manufacture, processing, packaging or holding of a drug
product
117. How does the FDA define a drug is an If it is..1) identical in shape, size and color 2) similar or virtually identical in gross
imitation appearance 3) similar in effect to controlled substances