Professional Documents
Culture Documents
4. Applicants for a nuclear pharmacist license must complete training, including at least:
A. 84 hours on radiation physics
(64B16-26.303 Nuclear Pharmacist Licensure.
B. 20 hours on radiopharmaceutical chemistry (a) Radiation physics and instrumentation (85 hours).
C. 20 hours on radiation biology (b) Radiation protection (45 hours).
(c) Mathematics pertaining to the use and measurement of radioactivity (20 hours).
D. 20 hours on radiation protection (d) Radiation biology (20 hours).
E. All of the above (e) Radiopharmaceutical chemistry (30 hours).
(3) Such academic training programs will be submitted to the Board of Pharmacy for approval by an accredited
educational institution which operates under the auspices of or in conjunction with an accredited college of pharmacy.)
8. All of the following applies to applicants who wish to apply to become a A. Applicant may be 16 years of age
registered pharmacy technician, except:
A. Applicant may be 16 years of age
B. Applicant may be 50 years of age
(64B16-26.350 Requirements for Pharmacy Technician Registration.
C. Applicant may be 17 years of age Applicants who are at least 17 years of age may apply to become a registered pharmacy
D. Applicant may be 25 years of age technician.)
9. All foreign pharmacy graduates must complete the following number of C. 500
hours of supervised work activity within the state of Florida :
A. 200
B. 850 (4B16-26.2031 Licensure by Examination; Foreign Pharmacy Graduates.
C. 500 (2) Complete 2080 hours of supervised work activity, of which a minimum of
D. None 500 hours must be completed within the State of Florida.)
10. Which of the following is (are) a requirement(s) 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
(64B16-26.203 Licensure by Examination; Application.
B. Completed an internship program provided by an accredited school or college of pharmacy and or a Applicants who are at least 18 years of age and a recipient of a degree from a school or college of pharmacy
state board of pharmacy accredited by an accrediting agency recognized and approved by the United States Office of Education may apply to
C. Must be at least 18 years of age take the licensure examination.
D. All of the above a) Completion of an internship program provided by either an accredited school or college of pharmacy or a state
board of pharmacy or jointly by both provided that the program meets requirements of Rule 64B16-26.2032, F.A.C.)
E. Only A and B
B. 4
11. How many hours must be live for pharmacy technician biennial registration renewal?
A. 12
B. 4
C. 24
(64B16-26.103 Continuing Education Credits; Renewal.
D. 20
(f) At least four (4) of the required 20 hours must be obtained either at a live seminar, a live
E. 8
video teleconference, or through an interactive computer-based application.)
False
13. Only consultant pharmacists may order and evaluate
(64B16-26.320 Subject Matter for Continuing Education to Order and Evaluate Laboratory Tests.
laboratory tests under the provisions of section F. S. 465.0125. (1) Consultant pharmacists and pharmacists holding the Doctor of Pharmacy degree that wish to order
and evaluate laboratory tests under the provisions of Section 465.0125, F.S., shall successfully complete
True the requirements of a continuing education course set forth herein prior to such practice. Successful
False completion of the course will certify the pharmacist for this practice for two (2) years from date of
completion.)
15. 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 Tripartite Continuing Education Committee
A. Complete an 8-hour course approved by the Florida Board of Pharmacy Tripartite Continuing
Education Committee 64B16-26.300 Consultant Pharmacist Licensure.
B. Complete 40 hours of training within 3 consecutive months b) Successfully complete a consultant pharmacist course of no fewer than twelve (12) hours, sponsored by an
C. After initial licensure, must complete 24 hours of board approved CE biennially for consultant license accredited college of pharmacy located within the State of Florida, and approved by the Florida Board of Pharmacy
Tripartite Continuing Education Committee which is based on the Statement of the Competencies Required in
renewal Institutional Pharmacy Practice and subject matter set forth in Rule 64B16-26.301, F.A.C. The course shall be
D. Complete the 24 hours of CE for consultant license renewal plus 30 hours of CE for regular instructionally designed to include a cognitive test on which the applicant must score a passing grade for certification
pharmacist license renewal of successful completion of the course.
17. An inactive license for a nuclear pharmacist may be changed to an active license if:
A. The pharmacist meets the CE requirements for each biennium the license was on inactive status 64B16-26.1004 Inactive License Election; Renewal; Fees.
B. The pharmacist submits a $25 reactivation fee (3) A nuclear pharmacist licensee may elect:
C. The pharmacist submits a $50 status fee if change is made at a time other than license renewal (a) At the time of license renewal to place the nuclear pharmacist license on inactive status by submitting a written
D. All of the above request with the board for inactive status and submitting the inactive status renewal fee of $100 plus a $5 unlicensed
activity fee pursuant to Section 456.065(3), F.S.
E. None of the above (b) At the time of license renewal, if the nuclear pharmacist license is inactive, to continue the license on inactive
status by submitting a written request with the board for inactive status and submitting the inactive status renewal fee of
$100 plus a $5 unlicensed activity fee pursuant to Section 456.065(3), F.S.
(c) At the time of license renewal to change the inactive status license to active status provided the nuclear pharmacist
18. 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 ( 64B16-26.600 Tripartite Continuing Education Committee.
The Tripartite Committee shall perform an audit on each approved continuing education provider 90 days
D. Review of continuing education providers and approval of continuing prior to the end of the biennium. The approved provider shall submit the following information for one
education courses program of the provider's choosing and one program selected by the Board
D. A and C
19. Upon a licensee's first renewal of licensure:
A. The licensee must complete 2 hours of board approved CE on HIVAIDS (64B16-26.103 Continuing Education Credits; Renewal.
B. The licensee must complete 15 hours of CE if the license was issued less than 12 months (a) Upon a licensee's first renewal of licensure, the licensee must document the completion of one (1) hour of board
approved continuing education which includes the topics of Human Immunodeficiency Virus and Acquired Immune
prior to the expiration date of the license Deficiency Syndrome; the modes of transmission, including transmission from a healthcare worker to a patient and the
C. The licensee must complete 15 hours of CE if license was issued 12 months or more after patient to the healthcare worker
The initial renewal of a pharmacist license will not require completion of courses of continued professional
the initial licensure pharmaceutical education hours if the license was issued less than 12 months prior to the expiration date of the license.
D. A and C If the initial renewal occurs 12 months or more after the initial licensure, then 15 hours of continued professional
pharmaceutical education hours)
A. On active duty
20. A pharmacist or technician who is a member of the Armed Forces of the U.S. in good
standing with the Board is exempt from all license renewal provisions if:
(64B16-26.104 Exemptions for Members of the Armed Forces; Spouses.
A. On active duty (1) Any pharmacist or registered pharmacy technician on active duty with the Armed Forces of the United States who at
B. Engaged in pharmacy in the for profit setting the time of becoming a member of the Armed Forces of the United States was in good standing with the Board and was
entitled to practice the profession of pharmacy or registered as a pharmacy technician in Florida shall be exempt from
C. A and B all license renewal provisions so long as the licensee is on active duty with the Armed Forces and for a period of six
D. None of the above months after discharge so long as the licensee is not engaged in the practice of pharmacy in the private sector for
profit.
(2) A pharmacist or registered pharmacy technician who is a spouse of a member of the Armed Forces of the United
States and who was caused to be absent from the State of Florida because of the spouse's duties with the Armed Forces
21. A pharmacist is ineligible to be a preceptor if his/her:
A. License is revoked
B. License is suspended
C. License is on probation D. All of the above
D. All of the above
E. A and B
C. A licensee may elect retired status by submitting a written request with the board for retired status and pay a retired
22. Which of the following statements are true concerning retired status licensees? status fee
A. Must take the NAPLEX if retired for less than 5 years
B. Must pay the past biennial fees, only if retired for over 6 years (64B16-26.1005 Retired License Election; Renewal; Fees.
(1) A licensee may elect to place his or her license on retired status.
C. A licensee may elect retired status by submitting a written request with the board for (a) At the time of license renewal, to place the license on retired status, the licensee must submit a written request with
retired status and pay a retired status fee the board for retired status and submit the retired status fee of $50.00 pursuant to Section 456.036(4)(b), F.S., and the
current unlicensed activity fee.
D. B and C (b) At a time other than license renewal, to place the license on retired status, the licensee must submit a written
E. None of the above request to the Board for the retired status plus submit the retired status fee of $50.00 pursuant to Section 456.036(4)(b),
F.S., plus a change of status fee of $25.00, plus the current unlicensed activity fee.
(c) Before the license of a retired status licensee is reactivated the licensee must meet the continuing education
23. Interns may fill, compound, and dispense medicinal drugs False
24. A U.S. pharmacy student or graduate must register with the False
30. Pharmacy technicians must complete the following hours of CE within the 24-month
period prior to the expiration date of his or her license:
A. 12 hours
B. 30 hours
C. 20 hours
C. 20 hours
D. 54 hours
E. 24 hours
31. Which of the following accurately describe(s) the 1938 FDCA?
a. The catalyst for the law was the sulfanilamide elixir event
33. The most important distinguishing factor in whether a product is a drug c. Whether the manufacturer intends the product to treat a disease
or not is:
It is the supplier's intended use of a product (or claim) that determines whether the
a. Whether it is a chemical entity
product is a "drug" or something else.
b. Whether the product is safe and effective
A drug is a chemical or nonchemical entity intended for use with diseases or that affects
c. Whether the manufacturer intends the product to treat a disease the structure or function of the body. Foods are specifically excluded from this latter part
d. The motivation or intent of the person taking the product (part (C)) of the "drug" definition. However
34. A manufacturer of catsup (ketchup) advertised that its particular brand of catsup c. The catsup is likely both a food and a drug
would effectively treat gouty arthritis. Which of the following would be correct:
a. The catsup is likely a food
b. The catsup is likely a drug A food and a drug. A drug because of the "treatment of a
c. The catsup is likely both a food and a drug disease" claim made by the manufacturer. A food because
d. The catsup is likely neither a food nor a drug
ketchup is made from tomatoes.
36. Which of the following would be correct regarding the United States Pharmacopoeia
(USP)?
a. The FDA publishes the USP
C. The USP is published by a private company.
b. The product cannot be considered a drug unless published in the USP Products not in the USP/NF can be considered
c. It sets uniform standards for drugs
d. Statements A & C are correct drugs based on the manufacturer's intent for use
e. Statements A, B & C are correct
37. Based on the following scenario, which drug Act was put in place due to rare
conditions affecting less than 200,000 Americans?
a. Prescription Drug Marketing Act of 1987
b. FDA Safety and Innovation Act of 2012
c. Orphan Drug Act of 1983
c. Orphan Drug Act of 1983
d. Drug Quality and Security Act of 2013 (DQSA)
e. The 21st Century Cures Act of 1983
38. Which act mandates informed consent for research subjects in clinical investigations like for
Xenazzine marketing purposes?
a. Clinical design trial are not needed for rare diseases
c. Kefauver-Harris Amendment of 1962 to
ensure that current good manufacturing
b. The Kefauver-Harris Amendment Act of 1962 which was also implemented to directly reduce drug
counterfeiting
c. Kefauver-Harris Amendment of 1962 to ensure that current good manufacturing practices are
established.
d. Orphan Drug Act of 1983
practices are established.
39. The development of Xenazine (tetrabenazine) was put forth to treat a rare disease called Huntington Disease
affecting less than 200,000 Americans. Prior to putting the drug out on the market, limited clinical trials were rapidly
put into play until Xenazine was proven safe and effective to be further approved by the FDA. Post marketing clinical a. Current Good Manufacturing Practices (CGMP)
b. Food and Drug Administration Amendments Act (FDAAA)
studies were also put in place to assess risks.
A new drug as described in the scenario above must comply with the following (Select all that apply):
a. Current Good Manufacturing Practices (CGMP)
b. Food and Drug Administration Amendments Act (FDAAA) c. Kefauver-Harris Amendment of 1962
c. Kefauver-Harris Amendment of 1962
d. Food, Drug, and Cosmetic Act (FDCA) of 1938 d. Food, Drug, and Cosmetic Act (FDCA) of 1938
e. Resource Conservation and Recovery Act (RCRA)
42. The Dietary Supplement and Health Education Act of 1994 states which of the
following?
a. The FDA cannot require premarket approval for dietary supplements
b. Forces the FDA to regulate dietary supplements more as foods than drugs
c. Products must comply with CGMP standards
e. All of the above
d. Can only be removed from the market only if deemed unsafe
e. All of the above
43. Which of the following are true regarding FDCA PenaltiesViolations (SATA):
a. Nearly every violation of the FDCA constitutes adulteration, misbranding, or both.
b. First time violators of the FDCA, shall be imprisoned for no more than 1 year, fined no more than $1,000, or both, as
long as this violation was unintentional
abce
c. If a second violation (or if an act with intent to defraud or mislead), violators can get up to 3 years and fined up to
$10,000.
d. Selling a penicillin-containing product labeled as a cephalosporin, is not a violation, as long as it is done
unintentionally
e. FDA will excuse pharmacist here if he acted in good faith and cooperates in FDA investigations under Sec 303(c) of
FDCA
44. The following are true regarding Current Good Manufacturing Practices (CGMP) except:
a. CGMP is a set of regulations that set a minimum requirement for methods, facilities, or controls used in the
manufacture, processing, and packaging, or holding of a drug product.
b. CGMP are applicable to manufacturers (including those not registered with the FDA), as well as all pharmacies,
ac
especially when pharmacy engages in activity considered manufacturing or pharmacy is registered as an outsourcing
facility.
c. Noncompliance with CGMP could result in a lawsuit against manufacturer and a declaration that the drugs are
adulterated
d. All of the above
e. None of the above
a
consequences are remote
c. Class II: The product is not likely to cause adverse health consequences.
d. Class III: There is reasonable probability that the product will cause serious adverse health consequences or death;
e. Class IV: The product will, without a doubt, cause patient death(s)
f. All of the above
g. None of the above
46. Delegateable tasks which a registered pharmacy technician can perform are all of the
following, except:
A. Final verification of dosage and directions
B. Initiation of communication to confirm a patient s name, medication, directions, or
A. Final verification of dosage and
number of refills
C. Data Entry
directions
D. Receiving, in a permitted nuclear pharmacy, of diagnostic orders only
E. B and C
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
52. Prospective drug use review entails a review of which of the following?
A. Medicaid prescription data
B. Clinical abuse/misuse
C. Therapeutic duplication
D. Drug-allergy interaction
F. B, C, and D
E. All of the above
F. B, C, and D
E. A and C
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
57. Under 64B16-27.230, pharmacists may order fluoride for which of the following patients
who have 0.6 ppm and over of fluoride in their drinking water?
E. None of the above
A. Ages 0-6 months
B. Ages 6-16 years
C. Ages 6 months-3 years
D. A and B (1) The fluoride content of drinking water
E. None of the above
does not exceed 0.5 ppm.
F. None of the above
58. Orthosis means which of the following medical devices?
A. Specialized utensils
B. Finger splints means any medical device used to provide support, correction, or alleviation of neuromuscular or musculoskeletal
dysfunction, disease, injury, or deformity but does not include the following assistive technology devices: upper
C. Wheelchair seating extremity adaptive equipment used to facilitate the activities of daily living, including specialized utensils, combs, and
D. Arch supports brushes; finger splints; wheelchair seating and equipment that is an integral part of the wheelchair and not worn by the
patient; elastic abdominal supports that do not have metal or plastic reinforcing stays; nontherapeutic arch supports;
E. All of the above nontherapeutic accommodative inlays and nontherapeutic accommodative footwear, regardless of method of
F. None of the above manufacture; unmodified, over-the-counter nontherapeutic shoes; prefabricated nontherapeutic foot care products;
durable medical equipment such as canes, crutches, or walkers; dental appliances; or devices implanted into the body
by a physician For purposes of this subsection "accommodative" means designed with the primary goal of conforming
D. A and C
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
F. B and C
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
F. B and D
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
66. Paying rent to a facility (as defined in Section 408.032 (7), F. S.) for space
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. True
True
False
67. Before a pharmacist can refuse to fill a controlled substance prescription 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
D. All of the above
database to gather relevant information concerning the validity of the prescription
D. All of the above
E. A and C
B. Produce Department Manager
C. Registered Pharmacy Interns and Registered Pharmacy Technicians
D. All of the above
E. A and C
76. Requirements for records maintained in a data processing system consist of:
A. An original prescription must be retained for not less than 4 years from date of last filling in hard copy or electronic
form.
D. A and C
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
77. The consultant pharmacist of record at a Class I, Class II, Modified Class II, 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
C. Monthly
D. Every six months
80. 64B16-28 requires that each applicant for a pharmacy permit must attach the
applicant's written policies and 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
A. True
B. False
81. When a pharmacy closes and transfers its prescriptions to another
pharmacy, the transfer 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. B. False
A. True
B. False
83. Which of the following pharmacy permittees must notify the board within 10 days of any change in prescription
department manager, consultant pharmacist of record, or nuclear pharmacist of record? (See also, F.S. 465 and 64B16-
32)
F. A, B, and C
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
84. Which of the following is (are) true? B. . Acceptable methods for destroying unusable controlled
substances in pharmacies (except Institutional Class I s) are: (1)
A. Controlled substances dispensed to patients at a nursing home may be returned to the pharmacy if unused.
B. Acceptable methods for destroying unusable controlled substances in pharmacies (except Institutional Class I s) are:
(1) Use of a DEA-41 form, plus witnesses to the actual destruction of the product; or (2) Shipment of product to a reverse
distributor for destruction in conformity with federal guidelines. Use of a DEA-41 form, plus witnesses to the actual destruction of
C. A central fill pharmacy is restricted to performing centralized prescription filling, delivering, and returning for only
one originating pharmacy. the product; or (2) Shipment of product to a reverse distributor
D. All or true
for destruction in conformity with federal guidelines.
85. Each container of medicinal drugs dispensed shall have a label or shall be accompanied by labeling. The label
affixed to each container dispensed to a patient shall contain:
A. An Expiration or Beyond-Use date
86. In order for a pharmacy to perform prescription drug processing for other pharmacies, all
pharmacies must be:
A. Properly licensed or registered in this state or another state.
88. The Board recognizes all of the following types of Special Pharmacy permits; except,
A. Special Parenteral/Enteral Extended Scope Permit
D. A and B
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
96. A Special Parenteral Enteral Extended Scope permit is required for pharmacies to
compound patient specific enteral parenteral preparations in conjunction with which type
of pharmacy permit?
A. Nuclear
B. Community
C. Institutional
C. Institutional
D. Internet
B. A prescription department manager of a closed system pharmacy may also be the department manager of any other
E. A and C
type of pharmacy permit, but not if the permit is within the premises of a community pharmacy permit.
C. An End Stage Renal Disease Pharmacy is limited in scope to dispensing products and supplies related to chronic
kidney failure for self-administration at the person's home or specified address .These products are limited to those
enumerated in 64B16-28 850
E. B and C
A. Hold an active license to practice pharmacy in Florida.
B. May not have disciplinary history related to the practice of a health profession within 5 years prior to the approval
request.
C. Must never have been disciplined in an offense related to compounding.
D. A and B
E. B and C
102. Which of the following is (are) true for Class II and Class III Institutional pharmacies?
A. Medications must be administered to patients by hospital personnel from the original container, or from a container
prepared by a Florida pharmacist.
B. Class II and Class III Institutional pharmacies may not contract with a Special Parenteral-Enteral Extended Scope
pharmacy for pharmacy services.
C. Medicinal drugs may be dispensed by Class II and Class III Institutional pharmacies to outpatients without a
community pharmacy permit.
D. If a community pharmacy is not readily accessible and a medication is warranted, an Emergency Department of a
F. A and D
hospital may dispense up to a 24-hour supply (or the minimal dispensable quantity) of medication to a patient of the
Emergency Department.
E. A and B
F. A and D
103. All of the following are true concerning an automated pharmacy system; except,
...
drug formulary.
C. Provide pharmacy services in facilities where drugs are stored in patient specific form and in bulk form and which
have an expanded drug formulary.
D. Allows for only administration of medicinal drugs to patients for use on the premises of the institution.
E. B and D
F. C and D
105. Which Modified Class II Institutional pharmacy requires proof of use record sheets for
both controlled and non-controlled substance medications?
...
A. Type A
B. Type B
C. Type C
D. All of the above
106. A _______ ________ describes a community pharmacy or special closed system pharmacy
which has a contract to dispense a medicinal drug to a patient in a facility holding a Class
I Institutional permit or Modified Class II B permit.
A. Starter-dose pharmacy
B. Vendor pharmacy
...
C. Leading-dose pharmacy
D. None of the above
107. Two minimum requirements for the special permit of a sterile products
and parenteral-enteral compounding pharmacy are: (1) a horizontal and-or
vertical laminar airflow hood and (2) the Handbook of Injectable Drugs by
the American Society of Hospital Pharmacists. ...
A. True
B. False
...
B. The consultant pharmacist of record is responsible for maintaining policies and procedures related to maintaining
patient services when the automated medication system is inoperable.
C. A pharmacist must perform prospective drug use review and approve each medication order prior to administration
of an override medication, a low risk override medication or a physician controlled medication.
D. Record keeping for automated medication systems include maintenance of any report or analysis generated as part
of the quality assurance program for 60 days only.
112. Any employed inspector of an Approved Inspection Entity must have a minimum of 4
years of experience in the practice of sterile compounding, at least 2 of which must be
...
obtained through the active practice of only low risk sterile compounding. (Note: See
64B16-32.015 to answer this question, transferred out of 64B16-28)
A. True
B. False
113. A pharmacist may perform remote medication order processing for a Class II or Class III Institutional
Pharmacy, or Special Pharmacy servicing a Class I, Class II, Modified Class II, Class III, or Special ALF
permitted facility from a remote location if the pharmacist is licensed in Florida and is an employee of
the pharmacy, or if not an employee, the pharmacist (or entity employing the pharmacist) has a written
agreement or contract with the facility.
...
A. True
B. False
116. A wholesale distributor must assess orders for more than _______ unit doses of any one
controlled substance in any one month to determine whether the purchase is reasonable.
...
A. 7,500
B. 10,000
C. 2,000
D. 5,000
...
C. Is a drug or device for which the expiration date has passed
D. Is a prescription drug for which the required transaction history, transaction information, or transaction
statement is nonexistent, fraudulent, or incomplete
E. A, B, and D
F. B, C, and D
103. The Florida Right to Try Act covers dispensing requirements for:
A. Investigational drugs prior to clinical phases of drug trials (i.e., during animal studies).
...
B. Investigational drugs that have completed phase 1 of clinical trials
C. Investigational biologicals or devices that have completed phase 1 of clinical trials
D. B and C only
E. All of the above
104. A retail pharmacy which has wholesale distribution activity in excess of 30% of its
total annual purchases of prescription drugs must obtain which permit?
...
A. Prescription drug wholesale distributor permit
B. Retail pharmacy drug wholesale distributor permit
C. Restricted prescription drug distributor permit
D. Prescription drug manufacturer permit
108. Except for those persons exempted from the definition of manufacturer in F.S. 499.003,
the state of Florida requires the biennial registration of any drug, device, or cosmetic by
any person who manufactures, packages, repackages, labels, or relabels a drug, device, or
cosmetic in this state. However, the department may not register any product that does not
comply with the Federal Food, Drug, and Cosmetic Act.
...
True
False
112. Which of the following is true concerning the Cancer Drug Donation Program?
A. The program includes controlled substances listed in F.S. 893.03
B. The program does not include drugs used to treat the side effects of prescription drugs used to treat
...
cancer
C. Cancer drugs may be donated to a specific patient, and may be resold by the program
D. A dispenser of donated cancer drugs or supplies may not submit a claim or otherwise seek
reimbursement from any public or private third-party payor for donated cancer drugs or supplies
dispensed under the program
115. All of the following are permits required in the state of Florida, except
A. Health care clinic establishment permit
B. Over-the-counter drug manufacturer permit
C. Restricted prescription drug distributor permit
D. Nonresident prescription drug repackager permit
...
E. A and B
F. All of the above are required
116. Under F.S. 499.003:
A. A contraband prescription drug is an adulterated drug; a counterfeit drug; and a drug for which a transaction
history, transaction information, or transaction statement does not exist, is forged, is counterfeit, is falsely created or
contains altered, false, or misrepresented matter.
B. Department means the Department of Health
C. A counterfeit drug, device, or cosmetic bears the unauthorized trademark, trade name, or other identifying mark,
imprint, device, or likeness of another manufacturer, processor, packer, or distributor
D. Medical gas means any liquefied or vaporized gas that is over-the-counter
...
E. One definition of a new drug is a drug that is not generally recognized as safe and effective for use under the
conditions prescribed, recommended, or suggested in the labeling
F. A, B, C, and D
G. A, C, and E
118. A wholesale distributor may not distribute controlled substances to an entity if any
criminal history record check for any person associated with the entity shows that the
person has been convicted of, or entered a plea of guilty or nolo contender to,
regardless of adjudication, a crime in any jurisdiction related to controlled substances, the
practice of pharmacy, or the dispensing of medicinal drugs.
...
True
False
123. A dentist issued a prescription to a 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
124. Which statement regarding patient 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 judgment as to whether a PPI should be dispensed to a
patient.
127. What is the source of legal authority for pharmacists to engage in drug
product substitution?
a. The FDCA
b. State law ...
c. The Orange Book
d. Professional judgment
128. Pursuant to the Prescription Drug Marketing Act, a prescriber can receive samples from
a manufacturer by means of:
...
a. a written request on a proper form each time the prescriber wants samples
b. a standing written request for samples
c. a verbal request from the manufacturer's representative
d. The manufacturer can supply the samples without request.
131. Pursuant to the Poison Prevention Packaging Act, a community pharmacy may:
a. dispense a non-child-resistant container if, in the pharmacist's professional judgment, it
is appropriate
b. dispense a non-child-resistant container upon a patient's request, but only if the request
is in writing
...
c. reuse a child-resistant container if it is threaded plastic
d. All of these are correct.
134. In terms of controlled substances in F. S. 893, "potential for abuse" means substances
that may affect the central nervous system as a:
A. Stimulant
B. Hallucinogen
C. Depressant
...
D. A and B
E. All of the above
135. The Florida requirements for the sale of ephedrine, pseudoephedrine, and phenylpropanolamine (i.e., ephedrine or
related compounds) are as follows:
A. Products must be displayed and offered for retail sale behind a checkout counter or other location not accessible to
...
the general public
B. Purchaser must be at least 18 years of age
C. May sell up to three packages in any single retail over-the-counter sale
D. A total of up to 3.6 grams of ephedrine or related compounds may be sold in any single day
E. A, B, and D
F. All of the above
136. A certified optometrist licensed under chapter 463 may not
administer or prescribe a Schedule I or Schedule II controlled
substance listed in s. 893.03. ...
A. True
B. False
B. Only when a pharmacist or health care practitioner administers a controlled substance to a patient or resident of a
hospital, nursing home, ambulatory surgical center, hospice, or immediate care facility for the developmentally
disabled is administration exempt ...
C. Exemption applies when a practitioner administers or dispenses a controlled substance in the Department of
Corrections; or when administering or dispensing a controlled substance to a person under 16 years of age
138. What information must be on the "label" affixed on a controlled substance prescription bottle?
A. A clear, concise warning that it is a crime to transfer the controlled substance to any person other than the patient
for whom prescribed
...
B. The date on which the prescription was filled
C. The name of the prescribing practitioner
D. The name of the patient for whom, or the owner and species of the animal for which, the controlled substance is
prescribed
E. A, B, and D
F. All of the above
...
B. Dispense means the actual, constructive, or attempted transfer from one person to another of a controlled substance.
C. Administer or administration means the direct application of a controlled substance, whether by injection, inhalation,
ingestion, or any other means, to the body of a person or animal.
D. Deliver or delivery means the preparation of any soil or hydroponic medium for the planting of a controlled
substance or the tending and care or harvesting of a controlled substance.
141. Each time a controlled substance is dispensed to a patient in this state, information
concerning the controlled substance must be reported by the dispenser to the
prescription drug monitoring program system as soon thereafter as possible, but not more
than 30 days after the date the controlled substance is dispensed unless an exemption or
extension is approved by the department.
...
A. True
B. False
142. What information must appear on the face of a prescription or written record for a controlled substance?
A. The initials of the pharmacist filling the prescription and the date filled.
B. The full name and address of the prescribing practitioner and the practitioner's federal controlled substance registry
...
number
C. If the prescription is for an animal, the species of the animal
D. The name of the controlled substance prescribed and the strength, quantity, and directions for use
E. A, B, and D
F. All of the above
...
B. The date and time of the transaction
C. The name, date of birth, address, and photo identification number of the purchaser, as well as the type
of identification and the government of issuance
D. A and B
E. All of the above
147. For each controlled substance dispensed to a patient in this state, the following information must be reported by the
dispenser to the prescription drug monitoring program system, except...
A. Prescribing practitioner's name, DEA no., NPI (or other appropriate identifier), date of prescription
B. Full name, address, telephone number, and date of birth of the person for whom the prescription was written
acetaminophen?
A. Percocet
B. Alprazolam ...
C. Ibuprofen
D. Propranolol
149. Which of the following represents the limits of a controlled substance considered a
schedule V when included in a compound, mixture or preparation which includes one or
more active ingredients that are not controlled substances?
A. Not more than 200mg of dihydrocodeine per 100ml or per 100gm
B. Not more than 200mg of diphenoxylate per 100ml or per 100gm
...
C. Not more than 200mg of codeine per 100ml or per 100gm
D. Not more than 200mg of opium per 100ml or per 100gm
...
B. Naphthoylpyrroles-that may begin with JWH and end with (1-napthoyl)pyrrole.
C. Naphthylindole carboxamides and Naphthylindazole carboxamides-that may begin with N-Napthalen
and end with 3-carboxamide.
D. Substituted Phenethylamines-that may begin with 2C and end with 2,5-dimethoxyphenethylamine.
function claim
B. Not likely make the product a drug because of the solvent proclamation
of the label
C. Not likely make the product of a drug if it has been commonly used for ...
this purpose
D. Likely make the product a drug because this is a disease claim
4. The FDA rated a new drug product as P4 for the purposes of the NDA process. This
means that the drug product is a new:
...
A. Molecular entry and offers only minor improvements over existing drug therapies
B. Molecular entry and is more safe or effective than other drugs currently used
C. Combination of drugs and is more safe or effective than other drugs currently used
D. Combination of drugs and offers only minor improvements over existing drug therapies
5. The 21st Century Cures Act has affected the new drug approval process
by encouraging the:
A. Consideration of novel clinical trial designs
B. Incorporation of real world evidence ...
C. Consideration of patient experience data
D. All of these are correct
7. CGMPs:
A. Do not apply to dietary supplements
B. Do not apply to generic drugs
C. Are a set of regulations establishing requirements for manufacturing ...
methods, facilities, ad controls
D. All of these are correct
11. Repezidid (fct) is marketed as an OTC drug in 300 mg strength, and as a prescription in the 600 mg
strength. The reason for the difference is that:
...
A. All of the indications for the 600 mg strength are labeled with adequate directions for use
B. All of the indications for the 300 mg strength are labeled with adequate directions for use
C. All of the indications for the 300 mg strength are labeled with adequate information for use
D. The 300 mg strength is less toxic and safer
12. The FDA approved Femstripril (fct) in 2014. How could Femstripril
become a "new drug"?
A. The manufacturer adding a new indication to its labeling
B. The manufacturer changes the enteric coating ...
C. The manufacturer changes the recommended dosage
D. All of these are correct
...
predominance
B. Misbranded if its labeling has not been approved by the FDA prior to marketing
C. Adulterated if it is a hair dye that contains coal tar irritant
D. All of these are correct
1. Which statement regarding patient package inserts (PPIS) is correct, assuming that 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 for 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
...
the prescriber, and, if confirmed, dispense the drug without further consideration
C. Yes, it is legal under the FDCA. However, the pharmacist should confirm the prescription accuracy with
the prescriber, and, if confirmed, exercise professional judgement regarding the reasonableness of the
risk in deciding whether to dispense the prescription
D. No, it's not legal to use Angelica in this manner and the pharmacist should not dispense it
5. You want to use Casey to fill Anna's prescription because it is $100 cheaper for her because she has no insurance.
You look up the Orange Book rating of Angelica with Casey. The Orange Book confirms a rating of Casey as BD to
Angelica. How would you describe this situation?
...
A. The BD rating provides you with the information that the products are therapeutically equivalent
B. The Orange Book is not necessary to consult for products that contain the same active ingredient in the same dosage
form
C. The BD rating provides you with the information that the products are not therapeutically equivalent
D. The Orange Book ratings are not used to assist pharmacists when substituting generally equivalent drug products
7. Bonus question: Drug product P is the original patented drug product. Drug products X,
Y, and Z are generic drug products to the P. The Orange Book classifies X as A related to
P. It classifies drugs Y and Z as B rated to P. Which statement is correct?
A. X, Y, and Z are therapeutically equivalent to P
B. Y and Z are therapeutically equivalent to one another
...
C. P and X are therapeutically equivalent to one another
D. Y and Z are therapeutically equivalent, and P and X are therapeutically equivalent
10. Bonus question: A hospital has excess inventory of drug products. Local community pharmacies would
like to purchase the excess inventory since they can buy the products for less from the hospital than
from the wholesaler. The hospital:
A. Can sell inventory to the pharmacies, provided it charged the same amount at the wholesaler
B. Call sell inventory to the pharmacies, for emergency reasons to alleviate a temporary shortage
...
C. Call sell inventory to the pharmacies, without restriction
D. Cannot sell inventory to the pharmacies
12. A drug with a high potential for abuse, and that has no current medical
use in treatment in the US, is defined as __ under the CSA.
A. Marijuana
B. Codeine ...
C. Amobarbital
D. Secobarbital
13. Dispensing under the CSA includes:
A. Administering a controlled substance
B. Prescribing a controlled substance ...
C. Dispensing a controlled substance
D. All of these are correct
14. John owns a pharmacy that has just been bought out by another pharmacy. The inventory may:
A. Be transferred without notifying the DEA
...
B. Not be transferred, and must either be returned to the supplier or destroyed
C. Be transferred if prior notice is given to the DEA and the DEA sends notice approving the transfer
D. Be transferred if prior notice is given to the DEA and the DEA does not send notice that the transfer
may not occur
18. The pharmacist at Friendly Pharmacy receives a prescription for Methadone. The patient
informs the pharmacist that it is to help detoxify him from a drug addiction. Can the
pharmacist legally fill the prescription?
A. Yes. Methadone is approved for addicts
B. Yes. There are no CSA restrictions regarding methadone
...
C. No. Methadone is a schedule I drug and is only allowed to be used in research
D. No. Methadone may only be dispensed from the pharmacy for analgesic purposes
22. Under federal law, methadone may be legally dispensed from a community pharmacy
as prescribed by a physician within the regular course of medical practices for what
purpose?
A. As an analgesic
B. As an analgesic and antitussive
...
C. As an analgesic, antitussive, and for the maintenance and detoxification of addicts
D. Any purpose the prescriber decides
23. Each place of business or professional practice where
controlled substances are manufactured, distributed, or
dispensed requires a separate registration. ...
A. True
B. False
1. Dr. Jones is a new dentist in town. He asks the pharmacist at Friendly Pharmacy if he can obtain Ativan, a schedule IV
anti-anxiety drug, to use on his patients in the office prior to procedures. Dr. Jones would like to write a prescription for
office use. Is this allowable?
...
A. Yes. Practitioners have no restrictions in writing controlled substance prescriptions for office use
B. Yes. Dr. Jones is an individual practitioner under the law and is permitted to obtain schedule III-V medications in this
manner
C. No. Dr. Jones is a dentist and not a physician, and therefore is unable to obtain Ativan in his manner for office use
D. No. pharmacies are restricted from filling controlled substance prescriptions written for office use
3. Harry Smith lives in a long-term care facility. The prescriber faxed to pharmacist Phil a prescription for Oxycontin
(schedule II) for 90 pills. Harry's insurance will only pay for 30 pills at a time. Can pharmacist Phil fill the prescription
for 30 pills at a time until all 90 are dispensed?
...
A. Yes; however, all the tablets must be filled within 60 days from the date that the prescription was issued
B. Yes; however, Mr. Smith must also be diagnosed as a terminally ill patient
C. Yes; however, pharmacist Phil must obtain a new written prescription for his records each time he fills another 30
pills
D. No, if Harry decides to get less than 90 tablets, he cannot obtain the remainder because schedule II drugs cannot
have refills
4. Pharmacist Phil receives a call from a chain pharmacy located in a different state. Mrs. Neely is on vacation and
would life to transfer her prescription for Ativan (schedule IV), for which has three refills remaining. The state
pharmacist Phil is in and the state Mrs. Neely is visiting follow the same CSA restrictions regarding transferring
controlled substances. Can pharmacist Phil legally transfer the prescription?
A. No. the CSA prohibits controlled drugs prescriptions from being transferred to a different state
B. No. the CSA prohibits transferring any controlled substances
C. Yes. The CSA allows Mrs. Neely to transfer her controlled prescription to another state this time and then back to
Phil's pharmacy for the next fill
...
D. Yes. The CSA allows Mrs. Neely to transfer her controlled prescription this one time only
5. Bling pharmacy called Zing Pharmacy requesting a transfer of a C-III Rx to Bling for a patient. The prescription has
two refills remaining. Which statement is correct (assume that Bling and Zing do not share common electronic files)?
A The Zing pharmacist at Zing can instruct the technician to verbally convey the required prescription to Bling
...
A. JJ4354433
B. AJ5354434
C. MJ6354435 (PA always start with M, "mid- level practitioner")
D. BJ3354433
7. A pharmacist received a prescription for 500 oxycodone tablets with the directions that the patient
was to significantly taper down the dosage over the next four weeks. The pharmacist called the
prescriber, who informed the pharmacist that the patient is an addict and that the prescriber is trying to
...
detoxify the patient. Which statement is correct?
A. This prescription is not for a legitimate medical purpose and should not be dispensed
B. This prescription is for a legitimate medical purpose and should be dispensed
C. This prescription is valid if prescribed under DATA
D. This prescription is valid if the prescriber works at a registered narcotic treatment program
8. A faxed prescription for any CII from the prescriber to the pharmacy is
acceptable in place of the original for which situation?
A. Any situation
B. A resident of a skilled nursing facility ...
C. An emergency situation
D. For terminally ill patients
9. A prescriber would like a patient to be able to obtain a three-month supply of a CII without having to return to the
office for new written prescriptions during the time frame. Which are the legal options for the patient and the
prescriber, assuming legitimacy is not an issue?
...
A. The prescriber can issue one CII prescription for a 3-month supply
B. The prescriber can issue three preparations, each for a 30 day-supply. Each prescription except the first would
specify the earliest date upon which the prescription can be filled
C. The prescriber can issue an electronic prescription for CII medication at any required time interval without the
patient having to come to the office
D. All of these are correct
10. A pharmacy received a prescription for a C-III medication. The medication strength was not indicated
on the prescription. Which statement is correct?
A. The pharmacist may legally add it without contacting the prescriber
...
B. The pharmacist may legally add it after contacting the prescriber and documenting that the prescriber
and documenting that the prescriber agreed to the strength
C. The prescription is not valid and cannot be dispensed
D. The prescription is not valid and cannot be dispensed; however, the pharmacist may contact the
prescriber and executed
11. Pharmacist Phil fills a new written prescription and two refills for Tylenol #3 - a
schedule III controlled substance. A couple months later, Phil learns from
...
A. Yes, Phil violated the CSA when he filled the refills
B. Yes, but only if Phil knew that the refills were not authorized
C. No, Phil does not have a duty to be alert for altered prescriptions
D. No, pharmacists are exempt from violating the CSA in circumstances such as this
13. Which copy of the DEA 222 form does the supplier forward to the DEA?
A. Copy 1 (brown; Mckesson)
B. Copy 2 (green; sent to the DEA)
C. Copy 3 (blue; pharmacists keep)
...
D. Copy 4
15. Which statement regarding a pharmacy reporting lost or stolen controlled substances
is accurate?
A. The pharmacy must report to the theft of the DEA, but not the loss
B. The pharmacy must report all stolen and lost medications to the DEA
C. The pharmacy must report any losses to the DEA, but may report the theft to either the
...
police or the DEA
D. The pharmacy must report thefts to the DEA and any losses that were significant