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E.

All of the above


1. The training program for a consultant pharmacist must include:
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 (64B16-26.301 Subject Matter for Consultant Pharmacist Training Program.
C. Formulary development, in-service education of nurses (1) Jurisprudence.
D. Maintenance of drug quality and safe storage (a) Laws and regulations, state and federal, pertaining to institutional pharmacy and health care facilities.
(b) Laws and regulations, state and federal, pertaining to the safe and controlled storage of alcohol and other related
E. All of the above substances, and relating to fire and health-hazard control.
F. A, B, and C (2) Policy and Procedures.
(a) Written procedures for outlining the medication system in effect.
1 Traditional systems

2. An active or inactive license must be renewed by what time on the B. Midnight


expiration date in order to not be put on delinquent status?
A. 5pm
B. Midnight (64B16-26.1021 Delinquent License Reversion; Reinstatement; Fees.
C. 3pm (1) An active or inactive license that is not renewed by midnight of the
D. Noon expiration date of the license shall automatically revert to delinquent status.)

D. Score of 50 on recalibrated TSE


3. Which of the following is not a part of the current requirements for licensure by
examination of foreign pharmacy graduates?
A. TOEFL score of 500 for the pencil and paper test or 173 for computer version (4B16-26.2031 Licensure by Examination; Foreign Pharmacy Graduates.
B. 2080 hours of supervised work 2. Demonstrate proficiency in the use of English by passing the Test of English as a Foreign Language
C. 75% minimum score on the foreign pharmacy graduate equivalency examination (TOEFL), which is administered by the Educational Testing Service, Inc., with a score of at least 500 for
the pencil and paper test or 173 for the computer version and by passing the Test of Spoken English
D. Score of 50 on recalibrated TSE (TSE) with a score of 45 on the recalibrated TSE; )

C. 20 hours on radiation biology

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.)

5. 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 (64B16-26.600 Tripartite Continuing Education Committee.
D. Members from colleges and schools of pharmacy in the state (1) The Tripartite Continuing Education Committee will be composed of equal representation from the Board of
E. Practicing pharmacists within the state Pharmacy, each College or School of Pharmacy in the State, and practicing pharmacists within the State. The members
F. A, C, and E of the Committee shall be selected by the Board of Pharmacy and shall serve for a period of two years. The chairman of
the committee shall be selected by the Chair of the Board.)
G. C, D, and E

6. An applicant for pharmacy intern registration must provide proof that he


is either 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. True
True
False

7. Which of the following is incorrect? D. A and B


A. The delinquent fee for a pharmacy permit is $250 (64B16-26.1022 Permit Fees.
B. The initial fee for a pharmacy permit is $100 (1) The initial permit fee for a pharmacy, as provided by Section 465.022(8)(a), F.S., shall be $250.
C. The biennial pharmacy permit renewal fee is $250 (2) The biennial permit renewal fee for a pharmacy, as provided by Section 465.022(8)(b), F.S., shall be
$250.
D. A and B (3) The change of location fee for a pharmacy, as provided by Section 465.022(8)(d), F.S., shall be $100.
E. A and C (4) The delinquent fee for a pharmacy permit, as provided by Section 465.022(8)(c), F.S., shall be $100.)

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.)

12. Which of the following is (are) true? D. A and C


A. 10 hours of the required 30 hours of pharmacist CE 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 64B16-26.103 Continuing Education Credits; Renewal.
j) The presenter of a live seminar, a live video teleconference or through an interactive computer-based application
D. A and C shall receive 1 credit for each course credit hour presented, however presenter will not receive additional credit for
E. A and B multiple same course presentations.

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.)

E. None of the above


14. Initial license fees are as follows, except:
A. $100 total for pharmacists
B. $105 total for pharmacists (64B16-26.1002 Initial License Fees.
C. $105 total for nuclear pharmacists (1) The initial license fee for a pharmacist license shall be $190 plus a $5 unlicensed activity fee pursuant to Section
456.065(3), F.S.
D. B and C (2) The initial license fee for a consultant pharmacist license shall be $50 plus a $5 unlicensed activity fee pursuant to
Section 456.065(3), F.S.
E. None of the above (3) The initial license fee for a nuclear pharmacist license shall be $50 plus a $5 unlicensed activity fee pursuant to
Section 456.065(3), F.S.
(4) The initial registration fee for a registered pharmacy technician shall be $50 plus a $5 unlicensed activity fee

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.

F. All of the above


16. All employer based approved registered pharmacy technician training programs must include
instruction on interpersonal relations, communications, and ethics that includes:
64B16-26.351 Standards for Approval of Registered Pharmacy Technician Training Programs.
A. Patient and caregiver communication The following objectives must be met:
B. Diversity of communications (a) Program content:
C. Ethics governing pharmacy practice 1. Introduction to pharmacy and health care systems:
D. Empathetic communications a. Confidentiality,
b. Patient rights and Health Insurance Portability and Accountability Act (HIPAA).
E. A, B, and C 2. Pharmacy law:
F. All of the above a. Federal law,
b. State law,
c State rules
A. The pharmacist meets the CE requirements for each biennium the license was on inactive status

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

without the direct and immediate personal supervision of a


(64B16-26.2032 Pharmacy Intern Registration Internship Requirements (U.S. Pharmacy
pharmacist actively licensed in this state. Students/Graduates.
True (4) No intern shall perform any acts relating to the filing, compounding, or dispensing of medicinal drugs
unless it is done under the direct and immediate personal supervision of a person actively licensed to
False practice pharmacy in this state.)

24. A U.S. pharmacy student or graduate must register with the False

Department of Health as an intern within 30 days after being


employed as an intern in a pharmacy in Florida. 964B16-26.2032 Pharmacy Intern Registration Internship Requirements (U.S. Pharmacy
Students/Graduates).
True A U.S. pharmacy student or graduate is required to be registered with the Department of
False Health as an intern before being employed as an intern in a pharmacy in Florida.)

25. A pharmacist licensed to practice pharmacy in this state who performs a


radiopharmaceutical service shall, prior to engaging in such specialized practice, be
actively licensed as a
A. Radiopharmaceutical pharmacist
B. Nuclear pharmacist
Nuclear pharmacist
C. Nuclear physicist
D. Oncology pharmacist

26. An applicant for licensure by endorsement must:


A. 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
B. Take MPJE-Florida version
C. A and B
C. A and B
D. None of the above

27. Only pharmacists holding the Doctor of Pharmacy degree who


wish to order and evaluate laboratory tests under the provisions F. S.
465.0125 must complete a three-hour initial certification course. ...
True
False

28. A pharmacy intern is:


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
D. B and C
E. All of the above

D. All of the above


29. To change a pharmacist license from delinquent status to active status, a licensee must:
A. Submit a reactivation fee of $100 (64B16-26.1021 Delinquent License Reversion; Reinstatement; Fees.
(1) An active or inactive license that is not renewed by midnight of the expiration date of the license shall automatically
B. Submit the current active status license fee or inactive status license fee revert to delinquent status.
C. Meet continuing education requirements for each biennium on inactive status (2) A pharmacist may request that a delinquent license be reinstated to active or inactive status, provided the licensee
meets the continuing education requirements of Rule 64B16-26.103, F.A.C., for each biennium the license was on inactive
D. All of the above status, and by submitting a reactivation fee of $100 plus the current fee for an active status or inactive status license set
E. None of the above forth in Rule 64B16-26.1003 or 64B16-26.1004, F.A.C.)

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

d.Statements A & C are correct


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

e. Statements A & C are correct


32. Which of the following accurately describe the FDA? •The FDA enforces the FDCA (issues guidance documents and regulations (rules)- after publishing drafts of these for
stakeholder input first)
a. It is a component of the Department of Health and Human Services •The FDA is a part of DHHS (President appoints the commissioner of the FDA, with confirmation by the Senate).
Commissioner of the FDA reports to the Secretary of DHHS.
b. Congress appoints the commissioner of the FDA •The FDA's Office of Medical Products and Tobacco which relate to drugs, biologics, medical devices, and tobacco
c. The agency issues guidance documents as well as regulations includes:
ØCenter for Drug Evaluation and Research (CDER)
d. Statements A & B are correct ØCenter for Biologics Evaluation and Research
ØCenter for Devices and Radiological Health
e. Statements A & C are correct ØCenter for Tobacco Products
ØThe Oncology Center of Excellence
ØThe Office of Special Medical Programs

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.

35. Under the law, a dietary supplement includes: e. B & C


a. A food product
b. An amino acid Definition of a dietary supplement: a product to be ingested that is intended
c. A mineral to supplement the diet, and contains one or more of the following: a vitamin,
d. A & C a mineral, an herb, botanical, amino acid, an increaser of total dietary intake,
e. B & C or a concentrate, metabolite, constituent, extract, or combo thereof

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)

40. A definition of adulteration under the DSHEA is a dietary


supplement that poses a significant or unreasonable risk of
illness or injury. a. True
a. True
b. False
41. The company marketed the cinnamon capsules by saying that
it will help to maintain blood glucose. Is this a correct dietary
supplement claim? a. True
a. True
b. False

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

45. Which of the following definitions is


are paired correctly with its class number:
a. Class I: There is reasonable probability that the product will cause serious adverse health consequences or death;
b. Class I: The product may cause temporary or medically reversible adverse health consequences, but serious

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

47. Which of the following are true?


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

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

48. A prescription ordered by a pharmacist for naproxen sodium is authorized if;


A. For severe pain
B. For menstrual cramps
C. Limited to a six-day supply
D. Patient has a history of peptic ulcer disease
F. B and C
E. All of the above
F. B and C

49. A pharmacist may order and dispense:


A. Naproxen
B. Phenazopyridine
C. Antipyrine 5.4%, benzocaine 1.4%, glycerin F. B and C
F. B and C
E. A and B

50. Requirements for Patient Records:


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 D. All of the above
C. The record must include the patient s age OR date of birth
D. All of the above
51. All of the following are true concerning drug therapy management, except:
A. Is provided pursuant to a prescriber care plan
B. May entail ordering laboratory tests, interpreting laboratory values, and executing drug C. May be performed at the pharmacy
counter in front of other customers
therapy orders
C. May be performed at the pharmacy counter in front of other customers
D. All are true

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

53. Direct supervision of a registered pharmacy technician by a pharmacist means which of


the following?
A. Pharmacist is on the premises
B. Pharmacist is available to provide personal assistance, direction and approval of
delegated tasks performed
D. All of the above
C. Pharmacist is aware of delegated tasks performed
D. All of the above

54. A pharmacist must:


A. Inform a person of the retail price difference between the branded and substituted generic
prescription dispensed

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

55. All of the following apply to patient counseling, except:


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
D. A and B or incorrect
C. A and B are correct
D. A and B or incorrect

56. A pharmacist may:


A. Order oral medications for pregnant and nursing women
B. Order some medicinal drug products subject to certain terms and B. Order some medicinal drug products
limitations
C. Order injectable products subject to certain terms and limitations
D. 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

59. All registered pharmacy technicians must:


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

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

60. An institutional pharmacy must never


be in possession of a sample medicinal False
drug.
True
61. Although the USP requires the donning of gloves prior to entry into the
clean-room (when compounding sterile products), all required donning of
gloves can be performed after entry into the clean room according to
Florida pharmacy rules. True
True
False

62. Which of the following statements is incorrect?


A. Each pharmacy shall establish a Continuous Quality Improvement Program
C. Continuous Quality Improvement
B. Quality-related events include dispensing or administering a prescribed medication to
an incorrect patient or with an incorrect drug strength records are not considered peer-review
documents and are subject to discovery
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
in civil litigation and administrative
63. The negative drug formulary
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
C. Includes conjugated estrogen
D. None of the above

64. Which of the following is (are) true?


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

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

65. Compounding entails all of the following, except:


A. A professional act by a pharmacist or other practitioner authorized by law
B. Is the same as manufacturing

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

68. A registered pharmacy technician may:


A. Transfer a prescription
B. Engage in prospective drug review C. Count, weigh, measure, and pour
C. Count, weigh, measure, and pour controlled substances
D. Receive therapy or blood product procedures in a permitted nuclear controlled substances
pharmacy

69. Which of the following is (are) true?


A. Pharmacy technicians may deliver prescriptions with a final certification by the pharmacist during the pharmacist s
meal break, if a pharmacist is available on the premises during the meal break for emergency consultation
A. Pharmacy technicians may deliver prescriptions with a final
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
certification by the pharmacist during the pharmacist s meal
premises during the meal break to answer the technician s questions
C. Registered pharmacy technicians may receive verbal prescriptions from a practitioner
break, if a pharmacist is available on the premises during the
D. A pharmacy intern may make the final check of the completed prescription thereby assuming the complete
responsibility for its preparation and accuracy meal break for emergency consultation

70. A pharmacist must maintain proof of current licensure such that if


someone from the Department of Health, Board of Pharmacy, or a member
of the public requests such proof of licensure, it is readily retrievable.
True
True
False
71. The Continuous Quality Improvement Committee in a pharmacy usually consists of:
A. Pharmacy District Manager or Vice-President of Operations

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

72. A pharmacist may not continue a course of therapy with


fluoride products for a patient for more than one year.
True True
False

73. A pharmacist in a traditional community pharmacy setting


may be allowed to supervise up to six technicians, if not
engaging in sterile compounding. True
True
False

74. Which of the following is (are) true?


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 D. A and B
period
D. A and B
E. A and C

75. All pharmacists shall complete a Board-approved 2-hour


continuing education course on Validation of Prescriptions for
Controlled Substances; and every biennium thereafter. True
True
False

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

78. The delivery of a filled prescription by a community central fill


pharmacy to the ultimate consumer pursuant to a contract with an
originating pharmacy is considered dispensing per F. S. 465.003(6). B. False
A. True
B. False

79. Which of the following statements is (are) true?


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.

E. All of the above


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

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

82. Which of the following is (are) false?


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.

D. All of the above are true


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

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

G. All of the above


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

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.

F. All of the above


B. Under common ownership
C. Utilize a common database
D. A and C
E. A and B
F. All of the above

87. Compounding records must contain a complete formula for


the compounded product maintained in a readily retrievable
form including methodology and necessary equipment. A. True
A. True
B. False

88. The Board recognizes all of the following types of Special Pharmacy permits; except,
A. Special Parenteral/Enteral Extended Scope Permit

D. Special Institutional/Nuclear Permit


B. Special Closed System Pharmacy Permit
C. Special Limited Community Permit
D. Special Institutional/Nuclear Permit
E. A and D

89. An automated pharmacy system may be used in a pharmacy if:


A. The system has the ability to comply with product recalls.
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.
E. All of the above
D. B and C
E. All of the above

90. The consultation area of a pharmacy may consist of


designated private counter space with a sign bearing Patient
Consultation Area, or words that are substantially similar. A. True
A. True
B. False
91. Which of the following statements is false?
A. A permit is valid only for the name and address to which it is issued. The name must be that which appears on
B. A permit can only be issued to a single
entity at a single location, which may
purchase and sales invoices.
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.
include an area 2 miles from the central
location of the permit. (See 64B16-28.113)
92. A customized patient medication package label must include:
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
E. All of the above
D. A and C
E. All of the above

93. When an establishment is open, the pharmacy department of a community 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."
B. False
A. True
B. False

94. Which of the following is (are) true?


A. A pharmacy ceasing or terminating professional and business activities may notify the board verbally and does not
need to return the permit to the Board of Pharmacy. C. A change in the company who leases the
B. If a pharmacy is sold to a different person or business (change in identity), the new owner may operate under the first
pharmacy owners permit.
C. A change in the company who leases the building where a permit is housed does not constitute a change in building where a permit is housed does not
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. constitute a change in ownership.

95. Which of the following is false?


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

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

97. An automated filling system within a pharmacy :


A. Includes automated devices used solely to count medications B. Must have policies and procedures that
or vacuum tube drug delivery systems. provide for the removal of expired,
B. Must have policies and procedures that provide for the
removal of expired, adulterated, misbranded or recalled drugs.
adulterated, misbranded or recalled drugs.
98. Which statement(s) is (are) true?
A. A Closed System Pharmacy Permit dispenses medicinal drugs utilizing closed system delivery systems to facilities
where prescriptions are individually prepared for the ultimate consumer including nursing homes, jails, ALFs (Adult
Congregate Living Facilities), ICF-IIDs (Intermediate Care Facilities-Developmentally Delayed (individuals with
Intellectual Disabilities), or other custodial care facilities when defined by ACHA rules and which the Board may
approve.

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

99. All applicants for a nonresident sterile compounding permit must


have and present a current and satisfactory inspection report. (Note:
See 64B16-32.015 to answer this question, transferred out of 64B16-
28) A. True
A. True
B. False

100. Which of the following is (are) true?


A. A sterile products and parenteral -enteral compounding pharmacy shall obtain a special sterile products and
parenteral- enteral compounding pharmacy permit.
B. A special sterile products and parenteral-enteral compounding pharmacy shall provide telephone accessibility to its
pharmacist(s) for its patients at all hours.
C. Products provided by a special sterile products and parenteral-enteral compounding pharmacy are limited to
parenteral therapy, parenteral nutrition, jejunostomy feeding and sterile irrigation, cytotoxic or antineoplastic agents,
and sterile products such as injectables and eye drops.
F. All are true
D. All cytotoxins must be compounded in a certified vertical laminar air flow hood or certified mobile isolation
chamber.
E. All are false
F. All are true
101. An employed inspector of an Inspection Entity seeking approval to become an Approved Inspection Entity for
registered nonresident sterile compounding pharmacies must: (Note: See 64B16-32.015 to answer this question,
transferred out of 64B16-28)

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,

B. Only controlled substance medications stored


A. The system may be used by a provider pharmacy to provide pharmacy services to a long term care facility,
hospice, or a state correctional institution.
B. Only controlled substance medications stored in an automated pharmacy system shall be considered owned by the

in an automated pharmacy system shall be


provider pharmacy.
C. A pharmacist at the provider pharmacy shall control all operations of the automated pharmacy system and approve
release of the initial dose of a prescription or order.
D. A record of every transaction must be maintained for four years.
E. A provider pharmacy may utilize one DEA registration to include multiple automated pharmacy systems located at considered owned by the provider pharmacy.
one address.

104. Modified Class II Institutional Pharmacies, Type B:


A. Provide pharmacy services in facilities that have a formulary of 15 or less medicinal drugs, excluding those in an
emergency box, which are stored in bulk.
B. Provide pharmacy services in facilities where drugs are stored in patient specific form and which have an expanded

...
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

108. Which of the following is (are) true?


A. Medications determined to be low risk override medications which are medications with a low risk of drug allergy,
drug interaction, dosing error, or adverse patient outcome may be removed from a decentralized automated
medication system only after a pharmacist reviews the order or status of the patient.

...
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.

109. Minimum requirements for a nuclear pharmacy include:


A. Handbook of Injectable Drugs by the American Society of Hospital Pharmacists.
B. Geiger-Mueller Survey meters
C. Well scintillation counters
D. A and B
...
E. B and C
F. All of the above

110. Which of the following is (are) true?


A. A Special Sterile Compounding permit is required for a Special Parenteral-Enteral or Special Parenteral-Enteral
Extended Scope pharmacy if the pharmacy has no other pharmacy permit and is not registered as an outsourcing
facility.
B. A Special-Limited Community permit must be obtained by a Class II or Class III Institutional pharmacy that dispenses
to employees, medical staff and their dependents, and emergency room patients.
C. Patients of the hospital who are under a continuous course of therapy may receive up to a 7-day supply of
medication, if medication is not a multi-dose medicinal drug, with a Special Limited Community Permit.
...
.
D. There are no labeling requirements for multi-dose medicinal drugs dispensed to discharged patients of a hospital
pursuant to a special-limited community pharmacy permit.
E. B and D
111. A starter dose pharmacy :
A. Transmits a starter dose prescription to the vendor pharmacy.
B. Has written authorization from a prescribing practitioner to act as the practitioner s
agent.
C. Dispenses a medicinal drug pursuant to a starter dose prescription for a patient in a
...
Class I Institutional or a Modified Class II B facility.
D. None of the above

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

114. An automated medication system


A. Is designed to distribute medications or package medications.
B. Is decentralized if it is located in a pharmacy department.
C. Is centralized if located outside of a pharmacy but within the same ...
institution.
D. A and B

115. A Special-ALF permit requires:


A. Medicinal drugs to be maintained in individual prescription containers for the individual patients.
B. Is an optional license for Assisted Living Facilities that wish to provide medications via unit dose
packaging.
C. Drugs may not be dispensed on the premises.
...
D. A and B
E. All of the above

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

102. An adulterated drug or device:


A. Meets the requirements of the USP-NF
B. Is prepared under conditions where it could have been contaminated with filth

...
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

105. Phenylalanine restricted formula and non-exempted


formulas of ephedrine may be dispensed without a prescription
True ...
False
106. Wholesale distributor facilities located within this State shall report all transactions involving
controlled substances, and wholesale distributor facilities located outside this state shall report all
distributions to entities in this state. When must this report be submitted?
A. Every 3 months by the 20th
B. Monthly by the 20th of the next month
...
C. Once a year on December 31st
D. Every 2 years

107. A drug requiring a prescription is considered misbranded if it


is refilled without the authorization of a practitioner.
True ...
False

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

109. All of the following apply to drug samples, except:


A. They may not be sold
B. They are also referred to as a starter packs or starter stocks
C. They may only be distributed in response to a written request
D. They may be distributed to pharmacies of hospitals or to pharmacies of other health
...
care entities at the written request of a practitioner authorized by law to prescribe such
drugs

110. If from the outward appearance of a person he or she is


presumably 20 years of age, proof of age from the purchaser of
dextromethorphan (OTC) is not necessary. ...
True
False

111. An establishment where prescription drugs are held must:


A. Be of suitable size
B. Be free from infestation by insects, rodents, birds, or vermin of any kind
C. Must have a quarantine area for outdated drugs ...
D. A and B
E. All of the Above

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

113. A manufacturer or distributor may not hold, distribute, or dispose of any


complimentary drugs or drug samples in this state without obtaining a:
A. A third party logistics provider permit
B. A retail pharmacy drug wholesale distributor permit ...
C. A complimentary drug distributor permit
D. None of the above

114. A manufacturer, distributor, or retailer may not knowingly or


willfully sell a finished product containing dextromethorphan
(OTC) to a person younger than 18 years of age. ...
True
False

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

117. Which of the following represents a wholesale distribution under 499.003?


A. A distribution of a prescription drug among hospitals under common control
B. The distribution by a wholesaler (such as McKesson, Cardinal Health, or AmerisourceBergen) to a local
retail pharmacy
C. The distribution of minimal quantities of prescription drugs by a licensed retail pharmacy to a licensed
...
practitioner for office use in compliance with chapter 465
D. Transportation by a common carrier when the carrier does not take ownership of the prescription drug

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

119. The Drug Wholesale Distributor Advisory Council consists of:


A. One person who is employed by a permitted medical gas manufacturer or medical gas wholesale
distributor and who has been recommended by the Compressed Gas Association
B. One person who is a member of the Board of Nursing
C. One person who is employed by a retail pharmacy chain in this state
...
D. A and B
E. A and C

120. A cancer drug may not be accepted or dispensed under the


Cancer Drug Donation Program if the drug bears an expiration date
that is less than 6 months after the date the drug was donated. ...
True
False

121. The Durham-Humphrey Amendment:


a. exempted prescription labels dispensed by pharmacies from many of the
label requirements imposed by law on manufacturers
b. categorized drugs as either prescription or over the counter ...
c. legalized prescription refills if authorized
d. All of these are correct.

122. Which of the following is not required to be included on the label of a


dispensed drug under the FDCA?
a. The dispenser name and address
b. The prescription serial number ...
c. The drug name
d. The prescriber name

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.

125. Medication Guides (MedGuides):


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
126. Pharmacists are required to dispense Medication Guides (MedGuides):
a. for all prescription drugs
b. for prescription drugs the FDA has determined require MedGuides
c. for prescription drugs that, in the pharmacist's professional judgment, ...
require MedGuides
d. for oral contraceptives

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.

129. The Drug Supply Chain Security Act:


a. preempts state pedigree laws
b. requires pharmacies to quarantine, investigate, and notify the FDA of
suspect products ...
c. requires pharmacies to receive a transaction history with the drug product
d. All of these are correct.

130. Tax-free alcohol may be used by:


a. hospital pharmacies for compounding medications for inpatients
b. hospital pharmacies for compounding medications for outpatients
c. community pharmacies for compounding medications for patients ...
d. outpatient charity clinics for compounding medications for patients,
provided they charge the patients for the compound

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.

132. Which of the following statements are true?


A. Records of controlled substances shall show: the date of receipt, name and address of the person from whom
received, kind and quantity of controlled substances received
B. The records of all controlled substances sold, administered, dispensed or otherwise disposed of shall show: the date
of selling, administering, or dispensing; name and address of the person to whom or for whose use, or the owner and
species of animal for which, sold, administered or dispensed; and the kind and quantity of the controlled substances
sold, administered or dispensed
C. Every inventory or record required in 893, including prescription records, may be maintained with any and all
...
other records of registrant and do not have to be readily retrievable from the ordinary business records of the
registrant.
D. Law enforcement officers must obtain a subpoena, court order, or search warrant in order to obtain access to or
copies of controlled substance records
E Any compound mixture or preparation described in Schedule V may be distributed at retail without a prescription

133. A prescription for a controlled substance may not be issued on the


same prescription blank with another prescription for a controlled substance
that is named or described in a different schedule or with another
prescription for a medicinal drug that is not a controlled substance. ...
A. True
B. False

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

137. Which of the following statements is


(are) true concerning when acts of ...
dispensing and
or administering controlled substances are exempt from reporting under the prescription drug monitoring program?
A. Only when a health care practitioner administers a controlled substance directly to a patient in an amount adequate
to treat the patient during that particular treatment session is administration exempt

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

D. All acts of administration of a controlled substance are exempt


E A and C

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

139. Which of the following represents a list of Schedule II medications?


A. Methaqualone, Methoxy-PCP ((Methoxyphenyl)cyclohexylpiperidine),
alpha-PVP (Flakka)
B. Oxycodone, Hydrocodone, Raw Opium, Phencyclidine
C. Benzphetamine, Testosterone cypionate, Dronabinol, Ketamine
...
D. Bromazepam, Delorazepam, Carisoprodol, Butorphanol tartrate,
Triazolam

140. Which of the following definitions found in 893 is true?


A. Cultivating means the transfer of possession of one or more doses of a medicinal drug by a pharmacist or other
licensed professional to the ultimate consumer.

...
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

143. Manufacture means the preparation, compounding, packaging, or


labeling of a controlled substance by a practitioner or pharmacist as an
incident to his or her administering or delivering of a controlled substance in
the course of professional practice. ...
A. True
B. False

144. The total quantity of controlled substance listed in Schedule V which


may be sold to any one purchaser within a given 48-hour period shall not
exceed 200mg of codeine, 120mg of dihydrocodeine, 60mg of
ethylmorphine, or 480mg of opium. ...
A. True
B. False
145. The electronic recordkeeping system for retail sale of ephedrine and related compounds shall
record:
A. The number of packages purchased

...
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

146. Which of the following statements are true?


A. A pharmacist may not dispense more than a 30-day supply of a Schedule III substance upon an oral prescription
issued in this state
B. A pharmacist may dispense a Schedule II prescription in an emergency situation, as defined by regulation of the
Department of Health, upon an oral prescription for up to a 72-hour supply
C. A pharmacist may dispense a one-time emergency refill of up to a 72-hour supply for any medicinal drug other than
a Schedule II, or up to one vial of insulin to treat diabetes mellitus, in compliance with 465.0275
D. If a prescription includes a numerical notation of the quantity of the controlled substance or date, but does not
...
include the quantity or date written out in textual format, the pharmacist may "not" dispense the controlled substance
under any circumstance and must hand the prescription back to the patient.
E. A, B, and C
F. 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

C. Name, NDC, quantity, and strength of the controlled substance dispensed


D. Name, address, DEA no., state of Florida Department of Health issued pharmacy permit number, and address of the
...
pharmacy or other location from which the controlled substance was dispensed (if a dispensing non-pharmacist
practitioner- report practitioner's name, address, DEA no., NPI no., and license no.)
E. The credit card number of the person paying for the prescription

148. Which drug may be written on the


...
same prescription blank as hydrocodone

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

150. A listed precursor chemical is a chemical that may be used


as a solvent, reagent, or catalyst in manufacturing a controlled
substance in violation of chapter 893. ...
A. True
B. False

151. All of the following are Synthetic Cannabinoids, except


A. Tetrahydrocannabinols-that may begin with JWH and end with tetrahydrobenzo[c]chromene.

...
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.

152. "Ecstasy" (or MDMA) is characterized as which of the following?


A. A Substituted Cathinone (bath salt)
B. A Substituted Tryptamine ...
C. A Substituted Phenethylamine
D. A Substituted Phenylcyclohexylamine

153. Common Schedule I drugs include all of the following, except:


A. Heroine
B. Methadone ...
C. LSD
D. Cathinone
1. Which amendment to the FDCA clarified and strengthened the FDA's
authority over large-scale sterile compounding pharmacies?
A. The Kefauver-Harris Amendment
B. The Drug Quality and Security ...
C. The Food and Drug Administration Modernization Act
D. The Food and Drug Administration Amendments Act

2. A manufacturer of an industrial solvent promoted that when its product


was applied to the skin it would cure eczema, but proclaimed on the label
that the product was a solvent, not a drug. The FDA investigated whether
the product should be considered as a drug. Regarding the claim to cure ...
eczema, the manufacturer's claim would:
A. Not likely make the product a drug because this is a structure

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

3. The FDCA defines a new drug as a drug:


A. That has not been generally recorded by experts as safe and effective for
the use recommended in the labeling
B. Whose labeling has been changed to reflect stronger warnings ...
C. That has been approved by the FDA within the past five years
D. That was marketed after 1906

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

6. Which of the following statements about drug recalls is correct?


A. Manufacturers are responsible for notifying the FDA, not pharmacies
B. The FDA is responsible for notifying pharmacies
C. Pharmacists are responsible for knowing that a product has been recalled
...
D. Class III recalls are the most serious

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

8. Phase IV studies are:


A. Performed at the manufacturer's discretion, and the FDA has no authority to mandate
them
B. Required by the FDA for any drug
C. Required by the FDA to assess serious risks when adverse event reporting or
...
surveillance is not sufficient
D. Required for drugs marketed after 1997

9. A medical device manufacturer has invented a revolutionary new artificial hip


replacement and wats to market it. Which of the following statements is correct?
A. This would likely by a class II device (it is a class III device)
B. The device would not require pre-market approval
C. If marketed and serious injury occurs, the manufacturer must report this to the FDA
...
D. The device would be considered a custom device and exempt from many of the device
requirements
10. The label of a drug product not listed in the USP states that the drug is
0.25 mg. in actuality, the product strength is 0.50 mg. this product is:
A. Adulterated
B. Misbranded ...
C. Both adulterated and misbranded
D. Neither adulterated nor misbranded

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

13. Pharmacies may provide the MedWatch number to patients?


A. Through verbal counseling
B. On the pharmacy's website ...
C. As part of the written drug information provided to the patient
D. All of these are correct

14. A device-user facility:


A. Includes hospitals
B. Includes nursing homes
C. Must submit reports or death or serious injury related to a product to the ...
FDA
D. All of these are correct

15. A cosmetic product is:


A. Misbranded if its labeling fails to include a list of its ingredients in descending order of

...
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

16. A drug product is considered adulterated if:


A. It contains industrial oil imparted from a machine on the manufacturing line
B. It is pure, but the plant is in violation of the CGMP
C. It is pure, but the container used to package it have the potential to contaminate it
...
D. All of these are correct

17. The Epedited Access Pathway (EAP) best applies to:


A. Drugs
B. Devices ...
C. Dietary supplements
D. Cosmetics

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

2. Pharmacists are required to dispense Medication Guides (MedGuides):


A. For all prescription drugs
B. For prescription drugs the FDA has determined require MedGuides
C. For presccription drugs that, in the pharmacist's professional judgement, ...
require MedGuides
D. For oral contraceptives
3. Angelica is indicated for estrogen only. Is it legal to use Angelica as prescribed for birth control?
A. Yes, it is legal under the FDCA and the pharmacist should dispense it
B. Yes, it is legal under the FDCA. However, the pharmacist should confirm the prescription accuracy with

...
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

4. 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 judgement

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

6. Which statement is correct, pursuant to the Orange Book?


A. Drugs rated BX have been proved as not bioequivalent
B. Substitution of a B rated product violates the FDCA
C. Bioequivalent drugs are presumed to be therapeutically equivalent ...
D. Pharmaceutically-equivalent drugs are presumed therapeutically
equivalent

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

8. What does the FDCA specify about prescribing prescription drugs?


A. They may be prescribed by practitioners licensed by law
B. Which practitioner may be licensed by law to prescribe (e.g., physicians,
dentists, etc) (state law, not federal law) ...
C. The scope of the prescriptive authority of a practitioner (state law)
D. All of these are correct

9. Under the Drug Quality and Security Act's regulations, an entity


compounding and dispensing sterile products:
A. Must register as an "outsourcing facility" with the FDA
B. Must register as a manufacturer with the FDA ...
C. May register as an "outsourcing facility" with the FDA
D. May register either with the FDA or the state board as a "compounder"

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

11. The maximum amount of codeine that can be contained in a Schedule V


cough syrup is:
A. 100 mg per 100 mL
B. 50 mg per 100 mL ...
C. 200 mg per 100 mL
D. 1800 mg per 100 mL

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

15. Opioid treatment programs:


A. Are regulated to the FDA
B. Are authorized to engage in detoxification but not maintenance treatment
C. Includes only the drugs LAAM, methadone, buprenorphine and ...
buprenorphine-naloxone for treatment
D. May treat no more than 30 addicts at one time

16. Which statement regarding pseudoephedrine (PSE) products is correct?


A. PSA is listed as a CV under federal law
B. Retail pharmacies are permitted to sell a maximum of 3.6 g of PSE to a
single purchaser per day under federal law ...
C. Only pharmacies are permitted to sell PSE products under federal law
D. State laws are often less strict regarding PSE products

17. Under the CSA, individuals practitioners:


A. Must store all scheduled drugs in securely locked, substantially constructed cabinets
B. Only need to store schedule I drugs in securely locked, substantially constructed
cabinets
C. Only need to store schedule I and II drugs in securely locked, substantially
...
constructed cabinets
D. Are not required to store scheduled drugs

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

19. Which of the following must register with the DEA?


A. A pharmacy dispensing controlled substances
B. A distributor of controlled substances ...
C. A physician prescribing controlled substances
D. All of these are correct

20. Under CSA pharmacy security requirements, a pharmacy:


A. Must store CII drugs in a securely locked cabinet
B. Must disperse CII drugs throughout the inventory
C. May either store CII drugs in a securely locked cabinet or disperse CII ...
drugs throughout the inventory
D. Must store CII, CIII, and CIV drugs in a securely locked cabinet

21. The DATA 2000 waiver ID will begin with:


A. A
B. B ...
C. D
D. X

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

2. The corresponding responsibility doctrine requires that the prescriber:


A. Correspond with the pharmacist prior to selecting any controlled drugs for a patient
B. Correspond with other practitioners that the patient sees prior to prescribing any
controlled drugs for a patient
C. And pharmacist keep corresponding documentation regarding a patient's controlled
...
drugs
D. And pharmacists assure the proper prescribing and dispensing of controlled substances

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

6. John Johnson is a physician's assistance authorized by the state he is licensed in to


prescribe certain controlled substances. What is an acceptable DEA number for John?

...
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

12. During a controlled substances inventory, which medications require an


exact count?
A. A 100 count bottle of hydrocodone with acetaminophen
B. A 1000 count bottle of lorazepam ...
C. A 500 mL bottle of a schedule V cough syrup
D. A box of 20 diazepam suppositories

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

14. Who may order CII drugs under the law?


A. Any person working for the pharmacy
B. Any pharmacist employed at the pharmacy
C. Any person named on a power of an attorney form executed between ...
the DEA registrant and the named person
D. Any pharmacist or pharmacy manager

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

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