Law : )

8. All of the following applies to applicants who wish to apply to become a registered pharmacy technician, except: A. Applicant may be 16 years of age B. Applicant may be 50 years of age C. Applicant may be 17 years of age D. Applicant may be 25 years of age

A. Applicant may be 16 years of age (64B16-26.350 Requirements for Pharmacy Technician Registration. Applicants who are at least 17 years of age may apply to become a registered pharmacy technician.)

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 B. Complete 40 hours of training within 3 consecutive months C. After initial licensure, must complete 24 hours of board approved CE biennially for consultant license renewal D. Complete the 24 hours of CE for consultant license renewal plus 30 hours of CE for regular pharmacist license renewal

A. Complete an 8-hour course approved by the Florida Board of Pharmacy Tripartite Continuing Education Committee 64B16-26.300 Consultant Pharmacist Licensure. b) Successfully complete a consultant pharmacist course of no fewer than twelve (12) hours, sponsored by an 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 Institutional Pharmacy Practice and subject matter set forth in Rule 64B16-26.301, F.A.C. The course shall be instructionally designed to include a cognitive test on which the applicant must score a passing grade for certification of successful completion of the course.

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 number of refills C. Data Entry D. Receiving, in a permitted nuclear pharmacy, of diagnostic orders only

A. Final verification of dosage and directions

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: A. On active duty B. Engaged in pharmacy in the for profit setting C. A and B D. None of the above

A. On active duty (64B16-26.104 Exemptions for Members of the Armed Forces; Spouses. (1) Any pharmacist or registered pharmacy technician on active duty with the Armed Forces of the United States who at 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 all license renewal provisions so long as the licensee is on active duty with the Armed Forces and for a period of six 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 shall be exempt from all license renewal provisions.)

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 B. The activities of the registered pharmacy technician during a pharmacist s meal break are not considered to be under the direct and immediate personal supervision of a pharmacist even though a pharmacist is available on the premises during the meal break to answer the technician s questions C. Registered pharmacy technicians may receive verbal prescriptions from a practitioner D. A pharmacy intern may make the final check of the completed prescription thereby assuming the complete responsibility for its preparation and accuracy

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

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 B. The pharmacist submits a $25 reactivation fee C. The pharmacist submits a $50 status fee if change is made at a time other than license renewal D. All of the above E. None of the above

A. The pharmacist meets the CE requirements for each biennium the license was on inactive status 64B16-26.1004 Inactive License Election; Renewal; Fees. (3) A nuclear pharmacist licensee may elect: (a) At the time of license renewal to place the nuclear pharmacist 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. (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 meets the continuing education requirements of Rule 64B16-26.304, F.A.C., for each biennium the license was on inactive status, and by submitting a reactivation fee of $50, and the active nuclear license renewal fee set forth in Rule 64B16-26.1003, F.A.C. (d) At a time other than license renewal to change the inactive status license to active status, provided the nuclear pharmacist licensee meets the continuing education requirements of Rule 64B16-26.304, F.A.C., for each biennium the license was on inactive status and by submitting a reactivation fee of $50, a change of status fee of $25 and the difference between the inactive status renewal fee and the active status renewal fee, if any exists.

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 B. False

A. True

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 B. False

A. True

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 B. False

A. True

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 B. False

A. True

84. Which of the following is (are) true? 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. C. A central fill pharmacy is restricted to performing centralized prescription filling, delivering, and returning for only one originating pharmacy. D. All or true

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.

11. How many hours must be live for pharmacy technician biennial registration renewal? A. 12 B. 4 C. 24 D. 20 E. 8

B. 4 (64B16-26.103 Continuing Education Credits; Renewal. (f) At least four (4) of the required 20 hours must be obtained either at a live seminar, a live video teleconference, or through an interactive computer-based application.)

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 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.

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)

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). A. True B. False

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. A. True B. False

B. False

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." A. True B. False

B. False

2. An active or inactive license must be renewed by what time on the expiration date in order to not be put on delinquent status? A. 5pm B. Midnight C. 3pm D. Noon

B. Midnight (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 revert to delinquent status.)

97. An automated filling system within a pharmacy : A. Includes automated devices used solely to count medications or vacuum tube drug delivery systems. B. Must have policies and procedures that provide for the removal of expired, adulterated, misbranded or recalled drugs.

B. Must have policies and procedures that provide for the removal of expired, adulterated, misbranded or recalled drugs.

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

B. Order some medicinal drug products subject to certain terms and limitations

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 D. 54 hours E. 24 hours

C. 20 hours

4. Applicants for a nuclear pharmacist license must complete training, including at least: A. 84 hours on radiation physics B. 20 hours on radiopharmaceutical chemistry C. 20 hours on radiation biology D. 20 hours on radiation protection E. All of the above

C. 20 hours on radiation biology (64B16-26.303 Nuclear Pharmacist Licensure. (a) Radiation physics and instrumentation (85 hours). (b) Radiation protection (45 hours). (c) Mathematics pertaining to the use and measurement of radioactivity (20 hours). (d) Radiation biology (20 hours). (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.)

9. All foreign pharmacy graduates must complete the following number of hours of supervised work activity within the state of Florida : A. 200 B. 850 C. 500 D. None

C. 500 (4B16-26.2031 Licensure by Examination; Foreign Pharmacy Graduates. (2) Complete 2080 hours of supervised work activity, of which a minimum of 500 hours must be completed within the State of Florida.)

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 D. None of the above

C. A and B

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. 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 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.

C. A change in the company who leases the building where a permit is housed does not constitute a change in ownership.

22. Which of the following statements are true concerning retired status licensees? 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 C. A licensee may elect retired status by submitting a written request with the board for retired status and pay a retired status fee D. B and C E. None of the above

C. A licensee may elect retired status by submitting a written request with the board for retired status and pay a retired status fee (64B16-26.1005 Retired License Election; Renewal; Fees. (1) A licensee may elect to place his or her license on retired status. (a) At the time of license renewal, to place the license on retired status, the licensee must submit a written request with 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. (b) At a time other than license renewal, to place the license on retired status, the licensee must submit a written 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 requirements in Rule 64B16-26.103, F.A.C., and pay any renewal fees imposed on an active status licensee for all biennial licensure periods, plus the current unlicensed activity fee during which the licensee was on retired status. (2) Any pharmacist applying for an active status license who has been on retired status for 5 years or more, or if licensed elsewhere, has not been active during the past 5 years, shall as a condition of licensure, demonstrate that he or she is able to practice with the care and skill sufficient to protect the health, safety, and welfare of the public by: (a) If inactive for less than 5 years, the licensee must pass a jurisprudence examination; (b) If inactive for 5 or more years, in addition to paragraph (a), the licensee must pass the NAPLEX.)

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

C. Continuous Quality Improvement records are not considered peer-review documents and are subject to discovery in civil litigation and administrative actions.

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

C. Count, weigh, measure, and pour controlled substances

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 D. None of the above

C. Includes conjugated estrogen

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 D. Internet

C. Institutional

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 therapy orders C. May be performed at the pharmacy counter in front of other customers D. All are true

C. May be performed at the pharmacy counter in front of other customers

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 D. Every six months

C. Monthly

36. Which of the following would be correct regarding the United States Pharmacopoeia (USP)? a. The FDA publishes the USP b. The product cannot be considered a drug unless published in the USP c. It sets uniform standards for drugs d. Statements A & C are correct e. Statements A, B & C are correct

C. The USP is published by a private company. Products not in the USP/NF can be considered drugs based on the manufacturer's intent for use

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 period D. A and B E. A and C

D. A and B

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 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

D. A and B

7. Which of the following is incorrect? A. The delinquent fee for a pharmacy permit is $250 B. The initial fee for a pharmacy permit is $100 C. The biennial pharmacy permit renewal fee is $250 D. A and B E. A and C

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

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

D. A and B or incorrect

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 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

D. A and C

76. Requirements for records maintained in a data processing system consist of: A. An original prescription must be retained for not less than 4 years from date of last filling in hard copy or electronic form. 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

D. A and C

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

D. A and C 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 shall receive 1 credit for each course credit hour presented, however presenter will not receive additional credit for multiple same course presentations.

19. Upon a licensee's first renewal of licensure: A. The licensee must complete 2 hours of board approved CE on HIVAIDS B. The licensee must complete 15 hours of CE if the license was issued less than 12 months prior to the expiration date of the license C. The licensee must complete 15 hours of CE if license was issued 12 months or more after the initial licensure D. A and C

D. A and C (64B16-26.103 Continuing Education Credits; Renewal. (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 Deficiency Syndrome; the modes of transmission, including transmission from a healthcare worker to a patient and the patient to the healthcare worker The initial renewal of a pharmacist license will not require completion of courses of continued professional pharmaceutical education hours if the license was issued less than 12 months prior to the expiration date of the license. If the initial renewal occurs 12 months or more after the initial licensure, then 15 hours of continued professional pharmaceutical education hours)

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 E. A and B

D. All of the above

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 C. The record must include the patient s age OR date of birth D. All of the above

D. All of the above

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 C. Pharmacist is aware of delegated tasks performed D. All of the above

D. All of the above

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 database to gather relevant information concerning the validity of the prescription D. All of the above

D. All of the above

10. Which of the following is (are) a requirement(s) of applicants for licensure by examination? A. Received a degree from a school or college of pharmacy accredited by an accrediting agency recognized and approved by the U.S. Office of Education B. Completed an internship program provided by an accredited school or college of pharmacy and or a state board of pharmacy C. Must be at least 18 years of age D. All of the above E. Only A and B

D. All of the above (64B16-26.203 Licensure by Examination; Application. Applicants who are at least 18 years of age and a recipient of a degree from a school or college of pharmacy accredited by an accrediting agency recognized and approved by the United States Office of Education may apply to take the licensure examination. 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.)

29. To change a pharmacist license from delinquent status to active status, a licensee must: A. Submit a reactivation fee of $100 B. Submit the current active status license fee or inactive status license fee C. Meet continuing education requirements for each biennium on inactive status D. All of the above E. None of the above

D. All of the above (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 revert to delinquent 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 status, and by submitting a reactivation fee of $100 plus the current fee for an active status or inactive status license set forth in Rule 64B16-26.1003 or 64B16-26.1004, F.A.C.)

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. 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

D. All of the above are true

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 E. All of the above

D. B and C

18. The Tripartite Committee oversees: A. Schools and colleges of pharmacy accreditation B. Promulgation of Board rules C. Lobbying of the state legislature on behalf of pharmacists D. Review of continuing education providers and approval of continuing education courses

D. Review of continuing education providers and approval of continuing education courses ( 64B16-26.600 Tripartite Continuing Education Committee. The Tripartite Committee shall perform an audit on each approved continuing education provider 90 days prior to the end of the biennium. The approved provider shall submit the following information for one program of the provider's choosing and one program selected by the Board

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 B. 2080 hours of supervised work C. 75% minimum score on the foreign pharmacy graduate equivalency examination D. Score of 50 on recalibrated TSE

D. Score of 50 on recalibrated TSE (4B16-26.2031 Licensure by Examination; Foreign Pharmacy Graduates. 2. Demonstrate proficiency in the use of English by passing the Test of English as a Foreign Language (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 (TSE) with a score of 45 on the recalibrated TSE; )

88. The Board recognizes all of the following types of Special Pharmacy permits; except, A. Special Parenteral/Enteral Extended Scope Permit B. Special Closed System Pharmacy Permit C. Special Limited Community Permit D. Special Institutional/Nuclear Permit E. A and D

D. Special Institutional/Nuclear Permit

54. A pharmacist must: A. Inform a person of the retail price difference between the branded and substituted generic prescription dispensed B. Call patient within two days to notify him that a generic substituted drug has been dispensed C. Inform a person that he (the pharmacist) will substitute a generic for a brand product, prior to the delivery of the prescription D. A and B E. A and C

E. A and C

71. The Continuous Quality Improvement Committee in a pharmacy usually consists of: A. Pharmacy District Manager or Vice-President of Operations B. Produce Department Manager C. Registered Pharmacy Interns and Registered Pharmacy Technicians D. All of the above E. A and C

E. A and C

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 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. D. A and B E. A and C

E. A and C

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. 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

E. All of the above

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. D. B and C E. All of the above

E. All of the above

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 D. A and C E. All of the above

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 C. Formulary development, in-service education of nurses D. Maintenance of drug quality and safe storage E. All of the above F. A, B, and C

E. All of the above (64B16-26.301 Subject Matter for Consultant Pharmacist Training Program. (1) Jurisprudence. (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 substances, and relating to fire and health-hazard control. (2) Policy and Procedures. (a) Written procedures for outlining the medication system in effect. 1. Traditional systems. 2. Unit-dose systems. a. Centralized. b. Decentralized. c. Automated medication systems. 3. Routine and emergency use of drugs. 4. After hours procedure for medication dispensing. 5. Managing drug shortages. (b) Record keeping and reports. 1. Controlled substance control and record-of-usage. 2. Alcohol inventory and record-of-usage. 3. Patient drug use control and records. a. Recalls. b. Medication use evaluation. c. Medication errors. 4. Drug charges, methods, accountability, and reports. 5. Statistical reports of usage, volume, etc. (3) Administrative Responsibilities. (a) Fiscal Control. 1. Perpetual and traditional inventory systems. 2. Application of EDP techniques. (b) Personnel Management, orientation and training. (c) Intra-professional relations pertaining to medication use. (d) Inter-professional relations with other members of the institutional health care team. 1. Pharmacy & Therapeutic Committee. a. Rational drug therapy; review of medication use and prescribing. b. Formulary development - evaluation, appraisal, selection, procurement, storage, distribution, medication safety, criteria for use development and safety. c. Automatic stop orders on potent and dangerous drugs. d. Controls on storage and use of investigational drugs. 2. In-service education of nurses and other health-related personnel. 3. Infectious Disease Committee. (4) Professional Responsibilities. (a) Drug information retrieval and methods of dispersal. (b) Development of pharmacy practice. (c) Development of an IV Admixture service. (d) Procedures to enhance medication safety. 1. Availability of equipment, technique, etc., to prepare special dosage forms for pediatric and geriatric patients. 2. Preparation of sterile dosage forms. 3. Proper writing, transcribing and initiating and/or transferring patient medication orders; development of physician's chart order copy system. 4. Safety of patient self-medication and control of drugs at bedside. 5. Reporting and trending adverse drug reactions. 6. Screening for potential drug interactions. 7. Development and maintenance of up-to-date emergency kits. (e) Maintain drug quality and safe storage. 1. Procedures for eliminating out-dated drugs. 2. Requirements for safe and appropriate storage conditions. (f) Maintain drug identity. 1. Procedures for labeling, transferring of bulk medications, etc. 2. Manufacturing and packaging procedures. 3. Pre-packaging control and supervision. (5) The Institutional Environment. (a) The institution's pharmacy function and purpose. (b) Interdepartmental relationships important to the institutional pharmacy. (c) Understanding of scope of service and in-patient care mission of the institution. (d) Special training with respect to the operation of nursing homes and Extended Care Facilities (ECF)/pharmacy relationship and special procurement procedures. (6) Nuclear pharmacy. (a) Procurement. (b) Compounding. (c) Quality control procedures. (d) Dispensing. (e) Distribution. (f) Basic radiation protection and practices. (g) Consultation and education to the nuclear medicine community; including patients, pharmacists, other health professionals, and the general public. (h) Research and development of new formulations. (i) Record keeping. (j) Reporting adverse drug reactions and medication errors. (k) Screening for potential drug interaction.)

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 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

E. B and C

14. Initial license fees are as follows, except: A. $100 total for pharmacists B. $105 total for pharmacists C. $105 total for nuclear pharmacists D. B and C E. None of the above

E. None of the above (64B16-26.1002 Initial License Fees. (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. (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. (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 pursuant to Section 456.065(3), F.S.)

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? A. Ages 0-6 months B. Ages 6-16 years C. Ages 6 months-3 years D. A and B E. None of the above

E. None of the above (1) The fluoride content of drinking water does not exceed 0.5 ppm.

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) 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

F. A, B, and C

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. 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

F. All are true

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

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: A. Patient and caregiver communication B. Diversity of communications C. Ethics governing pharmacy practice D. Empathetic communications E. A, B, and C F. All of the above

F. All of the above 64B16-26.351 Standards for Approval of Registered Pharmacy Technician Training Programs. The following objectives must be met: (a) Program content: 1. Introduction to pharmacy and health care systems: a. Confidentiality, b. Patient rights and Health Insurance Portability and Accountability Act (HIPAA). 2. Pharmacy law: a. Federal law, b. State law, c. State rules, d. Pharmacy technician rules and law. 3. Pharmaceutical-medical terminology, abbreviations, and symbols: a. Medication safety and error prevention, b. Prescriptions and medication orders. 4. Records management and inventory control: a. Pharmaceutical supplies, b. Medication labeling, c. Medication packaging and storage, d. Controlled substances, e. Adjudication and billing. 5. Interpersonal relations, communications, and ethics: a. Diversity of communications, b. Empathetic communications, c. Ethics governing pharmacy practice, d. Patient and caregiver communication. 6. Pharmaceutical calculations. (b) Materials and Methods. Evidence satisfactory to the Board shall be presented that: 1. Learning experiences and teaching methods are appropriate to meet the content stated above. 2. Time allotted for each activity shall be sufficient for the participant to meet the objectives. 3. Principles of adult education are utilized in determining teaching strategies and learning activities

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 E. All of the above F. B and C

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 E. A and B

F. B and C

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 animal C. A pharmacy intern, under the direct supervision of a pharmacist, may accept an oral prescription D. All of the above E. A and C F. B and C

F. B and 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 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

F. B and D

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 E. All of the above F. B, C, and D

F. B, C, and D

58. Orthosis means which of the following medical devices? A. Specialized utensils B. Finger splints C. Wheelchair seating D. Arch supports E. All of the above F. None of the above

F. None of the above 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 extremity adaptive equipment used to facilitate the activities of daily living, including specialized utensils, combs, and 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; nontherapeutic accommodative inlays and nontherapeutic accommodative footwear, regardless of method of 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 to the individual's anatomy, "inlay" means any removable material upon which the foot directly rests inside the shoe and which may be an integral design component of the shoe, and "musculoskeletal" and "neuromuscular" mean the systems of the body providing support and movement and include the skeletal, muscular, circulatory, nervous, and integumentary systems

60. An institutional pharmacy must never be in possession of a sample medicinal drug. True False

False

23. Interns may fill, compound, and dispense medicinal drugs without the direct and immediate personal supervision of a pharmacist actively licensed in this state. True False

False (64B16-26.2032 Pharmacy Intern Registration Internship Requirements (U.S. Pharmacy Students/Graduates. (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 practice pharmacy in this state.)

24. A U.S. pharmacy student or graduate must register with the Department of Health as an intern within 30 days after being employed as an intern in a pharmacy in Florida. True False

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

13. Only consultant pharmacists may order and evaluate laboratory tests under the provisions of section F. S. 465.0125. True False

False (64B16-26.320 Subject Matter for Continuing Education to Order and Evaluate Laboratory Tests. (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 the requirements of a continuing education course set forth herein prior to such practice. Successful completion of the course will certify the pharmacist for this practice for two (2) years from date of completion.)

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 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

G. All of the above

5. The Tripartite Committee consists of: A. Members of the Board of Medicine B. Members of the Board of Nursing C. Members of the Board of Pharmacy D. Members from colleges and schools of pharmacy in the state E. Practicing pharmacists within the state F. A, C, and E G. C, D, and E

G. C, D, and E (64B16-26.600 Tripartite Continuing Education Committee. (1) The Tripartite Continuing Education Committee will be composed of equal representation from the Board of Pharmacy, each College or School of Pharmacy in the State, and practicing pharmacists within the State. The members 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.)

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 C. Nuclear physicist D. Oncology pharmacist

Nuclear pharmacist

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 False

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 False

True

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 False

True

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 False

True

72. A pharmacist may not continue a course of therapy with fluoride products for a patient for more than one year. True False

True

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 False

True

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 False

True

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 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

a

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 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 d. Food, Drug, and Cosmetic Act (FDCA) of 1938 e. Resource Conservation and Recovery Act (RCRA)

a. Current Good Manufacturing Practices (CGMP) b. Food and Drug Administration Amendments Act (FDAAA) c. Kefauver-Harris Amendment of 1962 d. Food, Drug, and Cosmetic Act (FDCA) of 1938

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 b. False

a. True

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 b. False

a. True

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 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

abce

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, 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

ac

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 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

c. Kefauver-Harris Amendment of 1962 to ensure that current good manufacturing practices are established.

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 d. Drug Quality and Security Act of 2013 (DQSA) e. The 21st Century Cures Act of 1983

c. Orphan Drug Act of 1983

34. A manufacturer of catsup (ketchup) advertised that its particular brand of catsup 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 c. The catsup is likely both a food and a drug d. The catsup is likely neither a food nor a drug

c. The catsup is likely both a food and a drug A food and a drug. A drug because of the "treatment of a disease" claim made by the manufacturer. A food because ketchup is made from tomatoes.

33. The most important distinguishing factor in whether a product is a drug or not is: a. Whether it is a chemical entity b. Whether the product is safe and effective c. Whether the manufacturer intends the product to treat a disease d. The motivation or intent of the person taking the product

c. Whether the manufacturer intends the product to treat a disease It is the supplier's intended use of a product (or claim) that determines whether the product is a "drug" or something else. A drug is a chemical or nonchemical entity intended for use with diseases or that affects the structure or function of the body. Foods are specifically excluded from this latter part (part (C)) of the "drug" definition. However

31. Which of the following accurately describe(s) the 1938 FDCA? a. The catalyst for the law was the sulfanilamide elixir event b. The law required that new drugs must be proven safe and effective prior to marketing c. The law grandfathered drugs marketed prior to 1938 d. Statements A & C are correct e. Statements A,B & C are correct

d.Statements A & C are correct

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 d. Can only be removed from the market only if deemed unsafe e. All of the above

e. All of the above

35. Under the law, a dietary supplement includes: a. A food product b. An amino acid c. A mineral d. A & C e. B & C

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

32. Which of the following accurately describe the FDA? a. It is a component of the Department of Health and Human Services b. Congress appoints the commissioner of the FDA c. The agency issues guidance documents as well as regulations d. Statements A & B are correct e. Statements A & C are correct

e. Statements A & C are correct •The FDA enforces the FDCA (issues guidance documents and regulations (rules)- after publishing drafts of these for stakeholder input first) •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. •The FDA's Office of Medical Products and Tobacco which relate to drugs, biologics, medical devices, and tobacco includes: ØCenter for Drug Evaluation and Research (CDER) ØCenter for Biologics Evaluation and Research ØCenter for Devices and Radiological Health ØCenter for Tobacco Products ØThe Oncology Center of Excellence ØThe Office of Special Medical Programs ØThe Patient Affairs Staff