Florida Laws Topics
Table of Contents Accessing Table of Contents How to navigate? Navigation: Tip Avoid scrolling: Tip The Board of Pharmacy The Board of Pharmacy The Pharmacist members’ requirements Pharmacy Permits Pharmacy Permits Community Permits Community Permits # 2 Institutional Class I Permits Institutional Class I Permits # 2 Institutional Class II Permits Institutional Class II Permits # 2 Institutional Class II A, B, C Permits Sterile Compounding Permits Internet Pharmacies Nonresident Pharmacies Nuclear Pharmacies Prescriptions Prescriptions Prescription Types Oral Prescriptions Facsimile Prescriptions (Part 1) Facsimile Prescriptions (Part 2) Controlled Substances' Prescriptions (Part 1) Controlled Substances' Prescriptions (Part 2) Controlled Substances' Prescriptions (Part 3) Controlled Substances' Prescriptions (Part 4) Prescription Refills Prescription Refills # 1 Prescription Refills # 2 Emergency Refills Prescription Transfers Prescription Transfers # 1 Prescription Transfers # 2 Prescription Transfers # 3 Labeling Labeling # 1 Labeling # 2 Labeling # 3 Pharmacists Registered Pharmacists # 1 Registered Pharmacists # 2 Registered Pharmacists # 3 Consultant pharmacists Pharmacy interns Pharmacy Interns # 1 Pharmacy Interns # 2 Pharmacy Technicians Pharmacy Technicians # 1 Pharmacy Technicians # 2 Pharmacy Technicians # 3 Pharmacy Technicians # 4 Pharmacy Technicians # 5 Pharmacy Technicians # 6 Continuing Education Continuing Education # 1 Continuing Education # 2 Continuing Education # 3 Continuing Education # 4 Continuing Education # 5 Prescription Drug Monitoring Program (PDMP) Prescription Drug Monitoring Program (PDMP) # 1 Prescription Drug Monitoring Program (PDMP) # 2 Prescription Drug Monitoring Program (PDMP) # 3 Prescription Drug Monitoring Program (PDMP) # 4 Drug substitutions Drug substitutions # 1 Drug substitutions # 2 Drug substitutions # 3 Drug substitutions # 4 Immunizations Ephedrine containing products Ephedrine containing products # 1 Ephedrine containing products # 2 Ephedrine containing products # 3 Ephedrine containing products # 4 Schedule V/ephedrine containing OTC drugs Schedule V/ephedrine containing OTC drugs # 1 Schedule V/ephedrine containing OTC drugs # 2 Centralized filling Remote Processing Prescriptive/dispensing Authorities Prescriptive/dispensing Authorities # 1 Prescriptive/dispensing Authorities # 2 Prescriptive/dispensing Authorities # 3 Prescriptive/dispensing Authorities # 4 Prescriptive/dispensing Authorities # 5 When to notify the Board? Recordkeeping Recordkeeping # 1 Recordkeeping # 2 Recordkeeping # 3 Recordkeeping # 4 Recordkeeping # 5 Continuous Quality Improvement (CQI) Program Patient Profiles Drug Use Review Patient Counseling Patient Counseling # 1 Patient Counseling # 2 Drug Therapy Management Ordering Lab Tests Expiration checks/outdates Pharmacists' Ordering Pharmacists' Ordering # 1 Pharmacists' Ordering # 2 Emergency Medication Kit Dispensing by ER Prescribers Timelines State Inspections Display in Pharmacies Badge Advertisement Regulations Drug Samples Resources/equipments in Pharmacies Controlled Substances Schedules Different Than Federal Laws Age Animal Control Shelters Animal Control Shelters # 1 Animal Control Shelters # 2 Animal Control Shelters # 3 Animal Control Shelters # 4 Automated Pharmacy Systems (LTCFs) Automated Pharmacy Systems (LTCFs) # 1 Automated Pharmacy Systems (LTCFs) # 2 Automated Pharmacy Systems (Retail Pharmacies) Automated Pharmacy Systems (Retail Pharmacies) # 1 Automated Pharmacy Systems (Retail Pharmacies) # 2 Recent Updates HB 831   [Effective Date: January 1, 2020] Prescription Drug Importation Programs (HB 19)   [Effective Date: July 1, 2019] Nonopioid alternatives (HB 451)   [July 1, 2019] Epidolex (CBD) a Schedule V   [May 2019] Telepharmacy laws in Florida   [January 2019] Possessing controlled substances by MLPs   [January 2019] Veterinarian possessing controlled substances   [January 2019] Possession of legend drugs (NON-CONTROLLED) rules   [January 2019] Dispensing authority changes   [January 2019] Prescribing authority changes   [January 2019] Prescriptions written by out-of-state prescribers   [January 2019] Pharmacy technicians to pharmacist ratio   [January 2019] Who can discipline pharmacists in Florida now?   [January 2019] The special condition added in license transfer requirements   [January 2019] Does FL BOP require registration of preceptors in 2019?   [January 2019] Class III Institutional Pharmacies   [October 2018] Continuing Education Requirements   [June 2018] HB 21 - Controlled Substances   [July 2018] HB 675 - Pharmacies   [July 2018] New Changes Related to Florida Board of Pharmacy   [July 2018] Pharmacists' Examination changes   [2018] Pharmacist licensure related changes   [2018] Pharmacist CE changes   [2018] Pharmacists other changes   [2018] Technicians related changes   [2018] Pharmacy-related changes   [2018] Manufacturer/Distributors related changes   [2018] Controlled substances related changes   [2018] NABP related changes   [2018] Miscellaneous changes   [2018]




Florida Pharmacy Laws



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PreMPJE Florida Laws




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The Board of Pharmacy

Florida Chapter 465.004

  • Members are appointed by Governor
  • Members are confirmed by Senate
  • Term-length4-year
  • Total members 9 members
  • Pharmacist members 7 members
  • Required experience by pharmacist members At least 4 years (in Florida)
  • Public members 2 members
  • Public members' type Not connected to pharmacy
  • Age restriction One member must be at least 60 years-old
  • Limited to how many terms? Two terms (full)

The Pharmacist members’ requirements

Florida Chapter 465.004


  • TWO community practitioners

  • TWO from class II institutional or modified class II institutional

  • THREE must be licensed irrespective of practice setting

Pharmacy Permits

  • Community Pharmacies
  • Institutional Class I Permits
  • Institutional Class II Permits
  • Institutional Class II A, B, C Permits
  • Sterile Compounding Permits
  • Internet Pharmacies
  • Nonresident Pharmacies
  • Nuclear Pharmacies

Community Permits

Florida Chapter 465.018


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Community Permits (slide # 2)

Florida Chapter 465.018


  • In which situations is a pharmacist not present but on duty?

    ⇛ Leave pharmacy for consultation
    ⇛ For personal hygiene

  • Any condition for above situation?

    Yes, post sign "The pharmacy department is closed"

  • Is a manager required?

    Yes

  • Can they perform limited sterile compounding?

    Yes

Institutional Class I Permits

Florida Chapter 465.019


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Continued on next slide...

Institutional Class I Permits (Slide # 2)

Florida Chapter 465.019


  • Can a manager manage more than one pharmacy?

    Not allowed (64B16-28.501)

  • Can a consultant pharmacist manage more than one pharmacy?

    Yes (64B16-28.501)

Continued on next slide...

Institutional Class II Permits

Florida Chapter 465.019


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Institutional Class II Permits

Florida Chapter 465.019


  • Is a consultant pharmacist of Record required?

    Yes (64B16-28.501)

  • Can the pharmacy dispense more than one dose at a time?

    No, only unit dose packages

Institutional Class II A, B, C Permits

Florida Admin. Code 64B16-28.702


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Sterile Compounding Permits

[465.0158, 64B16-27.797, 64B16-28.802, 64B16-28.820, 64B16-28.860]


  • Do nonresident pharmacies require this permit for such compounding?

    YES (465.0158)

  • Do instate pharmacies require a permit for such compounding?

    Yes (64B16-28.802)

Internet Pharmacies

[465.0158, 64B16-27.797, 64B16-28.802, 64B16-28.820, 64B16-28.860]


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Nonresident Pharmacies


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Nuclear Pharmacies


  • Space Requirements

    150 square feet

  • an a technician accept a new verbal prescription?

    Yes (ONLY working in a nuclear pharmacy)

Prescriptions

FL Chapter 465.003.14


“Prescription” includes any order for drugs or medicinal supplies written or transmitted by any means of communication by a duly licensed practitioner authorized by the laws of the state to prescribe such drugs or medicinal supplies and intended to be dispensed by a pharmacist.

Prescription Types


  • Oral Prescriptions

  • Facsimile Prescriptions

  • Controlled Substances Prescriptions

Oral Prescriptions

Florida Chapter 64B16.27.103


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Facsimile Prescriptions (Part 1)

Chapter 465.035 & 64B16-27.1003


  • Is faxing a prescription allowed?

    Yes

  • Is the patient's approval needed?

    Yes, choice of the pharmacy should not be restricted either

  • Is it allowed for non-controlled drugs?

    Yes

Facsimile Prescriptions (Part 2)

Chapter 465.035 & 64B16-27.1003


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DEA

Controlled Substances' Prescriptions (Part 1)

Chapter 456.42, 893.04, 893.04, 893.065, 893.02

Is it allowed to accept a verbal or a faxed prescription?
Yes (schedule II only in emergency)

Are there any rules on prescription blanks?
Yes (see below)

Is it allowed to write more than one drug on the blank?
Not for different schedules
One form for the same scheduled drugs

Is it allowed to write a non-controlled drug on a blank?
Not allowed

Should quantity be worded?
Yes (MUST have textual and numbered)

DEA

Controlled Substances' Prescriptions (Part 2)

Chapter 456.42, 893.04, 893.04, 893.065, 893.02

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DEA
Chad Madden (Unsplash)

Controlled Substances' Prescriptions (Part 3)

Chapter 456.42, 893.04, 893.04, 893.065, 893.02

Minimum required prescription elements:

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DEA
Chad Madden (Unsplash)

Controlled Substances' Prescriptions (Part 4)

Chapter 456.42, 893.04, 893.04, 893.065, 893.02

Record on the prescription after dispensing:

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Prescriptions' Refills

F. A. C. 64B16-27.211


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Prescriptions' Refills (Part # 2)

F. A. C. 64B16-27.211


  • Refills validity on Schedule III to V

    SIX months

  • Schedule II prescription validity

    ONE year

Emergency Refills

Chapter 465.0275


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Prescription Transfer

Chapter 465.026, 64B16-27.103, 64B16-27.105, 465.0266


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DEA

Prescription Transfer (Part # 2)

Chapter 465.026, 64B16-27.103, 64B16-27.105, 465.0266

The transferring pharmacy should write:
• The name of pharmacy
• The name of drug
• Original amount dispensed
• Original dispensing date
• Number of remaining refills

DEA

Prescription Transfer (Part # 3)

Chapter 465.026, 64B16-27.103, 64B16-27.105, 465.0266

The original pharmacy should note:
• The name of pharmacy
• The name of the pharmacist
• date of transfer
• Cancel the prescription

LABELING

F.A.C. 64B16-28.108


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DEA

LABELING (Part # 2)

F.A.C. 64B16-28.108

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DEA

LABELING (Part # 3)

F.A.C. 64B16-28.108

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REGISTERED PHARMACISTS (Part # 1)

F.A.C. 64B16-26.203


  • How can you become one?


    1. Study and pass the exam
    2. Endorse
    3. Foreign graduates (pass exams)

  • Minimum required age

    18-year old

DEA

REGISTERED PHARMACISTS (Part # 2)

F.A.C. 64B16-26.203

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DEA

REGISTERED PHARMACISTS (Part # 3)

F.A.C. 64B16-26.203

Endorsement conditions:
• Must pass NAPLEX (or passed in last 3 years)
• Must be actively practicing (2 out of 5 preceding years)
• Two-year internship (2080 hours)
• Passed MPJE
• Other state's license in good standing
(Reference: 465.0075; 64B16-26.204)

CONSULTANT PHARMACISTS

Chapter 465.0125, 64B16-26.300-302


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PHARMACY INTERNS (Part # 1)


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PHARMACY INTERNS (Part # 2)


  • In which academic year does the board recognize internship credit?

    First professional year

  • Are interns required to be registered?

    Yes

  • Are preceptors required to be registered?

    No

  • Are training sites required to be registered?

    No

PHARMACY TECHNICIANS (Part # 1) (imaging from here)

Chapter 465.014, 465.015, 465.019, 465.0196, 465.0197, 64B16-26.103, 64B16-26.350, 64B16-26.351, 64B16-26.355, 64B16-27.100, 64B16-27.410, 64B16-27.420, 64B16-27.430, 64B16-27.440


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PHARMACY TECHNICIANS (Part # 2)

Chapter 465.014, 465.015, 465.019, 465.0196, 465.0197, 64B16-26.103, 64B16-26.350, 64B16-26.351, 64B16-26.355, 64B16-27.100, 64B16-27.410, 64B16-27.420, 64B16-27.430, 64B16-27.440


  • Are they required to be licensed?

    No

  • Are they required to be registered?

    Yes

  • Are they required to be certified?

    No

  • Can they take a new verbal prescription?

    No

PHARMACY TECHNICIANS (Part # 3)

Chapter 465.014, 465.015, 465.019, 465.0196, 465.0197, 64B16-26.103, 64B16-26.350, 64B16-26.351, 64B16-26.355, 64B16-27.100, 64B16-27.410, 64B16-27.420, 64B16-27.430, 64B16-27.440


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PHARMACY TECHNICIANS (Part # 4)

Chapter 465.014, 465.015, 465.019, 465.0196, 465.0197, 64B16-26.103, 64B16-26.350, 64B16-26.351, 64B16-26.355, 64B16-27.100, 64B16-27.410, 64B16-27.420, 64B16-27.430, 64B16-27.440


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PHARMACY TECHNICIANS (Part # 5)

Chapter 465.014, 465.015, 465.019, 465.0196, 465.0197, 64B16-26.103, 64B16-26.350, 64B16-26.351, 64B16-26.355, 64B16-27.100, 64B16-27.410, 64B16-27.420, 64B16-27.430, 64B16-27.440


  • Can they fill drugs in automated medication systems?

    Yes

  • Can they contact a patient for his/her information?

    Yes

PHARMACY TECHNICIANS (Part # 6)

Chapter 465.014, 465.015, 465.019, 465.0196, 465.0197, 64B16-26.103, 64B16-26.350, 64B16-26.351, 64B16-26.355, 64B16-27.100, 64B16-27.410, 64B16-27.420, 64B16-27.430, 64B16-27.440


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CONTINUING EDUCATION (Part # 1)

Chapter 465.009, 64B16-26.103, 64B16-26.200, 64B16-26.6012, 64B16-26.603


  • Renewal period

    Every TWO years

  • Total hours (for pharmacists)

    30 hours

  • Live hours (for pharmacists)

    10 hours

  • Live hours can be

    1. Live
    2. Video based
    3. Computer based

CONTINUING EDUCATION (Part # 2)

Chapter 465.009, 64B16-26.103, 64B16-26.200, 64B16-26.6012, 64B16-26.603


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CONTINUING EDUCATION (Part # 3)

Chapter 465.009, 64B16-26.103, 64B16-26.200, 64B16-26.6012, 64B16-26.603


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CONTINUING EDUCATION (Part # 4)

Chapter 465.009, 64B16-26.103, 64B16-26.200, 64B16-26.6012, 64B16-26.603


  • Who audits CE providers?

    Tripartite Continuing Education Committees
    Consists of:
    1. A representative from the Board
    2. Each college or school of pharmacy
    3. A practicing pharmacist

  • Board meetings credit?

    5 hours for EIGHT hours of meeting

CONTINUING EDUCATION (Part # 5)

Chapter 465.009, 64B16-26.103, 64B16-26.200, 64B16-26.6012, 64B16-26.603


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PRESCRIPTION DRUG MONITORING PROGRAM (Part # 1)

Chapter 893.055


  • Which drugs are covered?

    Schedule II, III, IV (NOT schedule V)

  • Reporting interval

    Within 7 days

  • Who should report?

    Dispensers

  • Other names

    E-FORCSE

PRESCRIPTION DRUG MONITORING PROGRAM (Part # 2)

Chapter 893.055


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PRESCRIPTION DRUG MONITORING PROGRAM (Part # 3)

Chapter 893.055


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PRESCRIPTION DRUG MONITORING PROGRAM (Part # 4)

Chapter 893.055


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DRUG SUBSTITUTIONS (Part # 1)

Chapter 465.0251-.0252, 64B16-27.500, 64B16-27.520, 64B16-27.530


  • How to prevent these substitutions?

    The words "Medically Necessary"

  • Is it required to pass the cost of savings to patients?

    Yes

  • The generic drug pricing

    It should be cheaper than the brand

DRUG SUBSTITUTIONS (Part # 2)

Chapter 465.0251-.0252, 64B16-27.500, 64B16-27.520, 64B16-27.530


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DRUG SUBSTITUTIONS (Part # 3)

Chapter 465.0251-.0252, 64B16-27.500, 64B16-27.520, 64B16-27.530


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DRUG SUBSTITUTIONS (Part # 4)

Chapter 465.0251-.0252, 64B16-27.500, 64B16-27.520, 64B16-27.530


  • Negative formulary drugs:

    1. Digitoxin
    2. Dicumarol
    3. Chlorpromazine (sold oral dosage forms only)
    4. Conjugated estrogens
    5. Theophylline (controlled release)
    6. Pancrelipase (oral dosage forms)

  • Can a patient request negative formulary drug to be substituted to generic one?

    NO

IMMUNIZATIONS

Chapter 465.189; 64B16-26.1031, 64B16-26.1032


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EPHEDRINE CONTAINING OTC PRODUCTS (Part # 1)


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EPHEDRINE CONTAINING OTC PRODUCTS (Part # 2)


  • Is it required to report to registry electronically?

    Yes

  • OTC Single transaction sale limit

    Three packages regardless of weight

  • OTC Daily sales limit

    3.6 grams

EPHEDRINE CONTAINING OTC PRODUCTS (Part # 3)


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EPHEDRINE CONTAINING OTC PRODUCTS (Part # 4)


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SCHEDULE V/EPHEDRINE CONTAING OTC DRUGS (Part # 1)


  • Minimum age

    18-year old

  • Limit on codeine

    120 mg of codeine

  • Limit on dihydrocodeine

    60 mg

SCHEDULE V/EPHEDRINE CONTAING OTC DRUGS (Part # 2)


  • Limit on ethylmorphine

    30 mg

  • Limit on opium

    240 mg

  • Time limits on above drugs

    48-hour only

CENTRALIZED FILLING

Chapter 465.0265, 465.0266, 64B16-28.450, 64B16-28.451


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REMOTE PROCESSING

Chapter 64B16-28.606, 664B16-28.607


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PRESCRIPTIVE/DISPENSING AUTHORITIES (Part # 1)


  • Can a prescriber self-prescribe?

    No (for controlled substances)

  • Are the allowed to write, "Office Use" prescriptions to obtain controlled substances?

    No

  • Are the allowed to write, "Office Use" for compounded products for their patients?

    Yes

  • Can a nurse practitioner prescribe controlled substances?

    YES (effective January, 2017)
    (C-II to V)

PRESCRIPTIVE/DISPENSING AUTHORITIES (Part # 2)


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PRESCRIPTIVE/DISPENSING AUTHORITIES (Part # 3)


  • Clinical nurse specialists

    None

  • Homeopathic doctors

    Not licensed

  • Optometrists

    Independent but limited
    (C-III to IV – APAP w/codeine, tramadol only)

  • Emergency medical technician paramedic

    None

PRESCRIPTIVE/DISPENSING AUTHORITIES (Part # 4)


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PRESCRIPTIVE/DISPENSING AUTHORITIES (Part # 5)


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WHEN TO NOTIFY THE BOARD?


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RECORDKEEPING (Part # 1)

F.A.C. 64B16-28.140, 21 C.F.R. Sec. 1304.04


  • Prescriptions

    FOUR years (465.022 12(b))

  • Computerized system backup

    Weekly

  • When to report if any loss of data

    Immediately

RECORDKEEPING (Part # 2)

F.A.C. 64B16-28.140, 21 C.F.R. Sec. 1304.04


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RECORDKEEPING (Part # 3)

F.A.C. 64B16-28.140, 21 C.F.R. Sec. 1304.04


  • Print-outs of new and refills

    Daily

  • Daily hardcopy

    Within 72 hours

  • Daily logs (dated and signed)

    within 7 days date/sign by all pharmacists

  • Electronic data related to drug usage

    Able to produce audit for the preceding 4 years

RECORDKEEPING (Part # 4)

F.A.C. 64B16-28.140, 21 C.F.R. Sec. 1304.04


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RECORDKEEPING (Part # 5)

F.A.C. 64B16-28.140, 21 C.F.R. Sec. 1304.04


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CONTINUOUS QUALITY IMPROVEMENT (CQI)

F. A. C. 64B16-28.140


  • Who can join?

    Pharmacy staff, interns, technicians,
    clerical staff, or any other person

  • How often?

    Every THREE months

  • How long the records should be kept?

    Two years

PATIENT PROFILES

F.A.C. 64B16-17.800


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DRUG USE REVIEW

F. A. C. 64B16-27.810


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PATIENT COUNSELING (Part # 1)

F. A. C. 64B16-27.820


  • How must it be made?

    Verbal
    AND printed

  • When?

    New prescriptions
    Refills

  • If medications are being delivered, then what?

    Provide a toll-free telephone access

PATIENT COUNSELING (Part # 2)

F. A. C. 64B16-27.820


  • Who can do it?

    Pharmacists
    Pharmacy interns
    NOTE: pharmacy technicians can only
    OFFER (but not provide)

  • It is NOT required if

    • A patient refuses it
    • A patient is an inpatient

MEDICATION THERAPY MANAGEMENT

F. A. C. 64B16-27.830


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ORDERING LAB TESTS

F. A. C. 64B16.320, 465.0125, 64B16-27.120


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EXPIRATION CHECKS/OUTDATES

F. A. C. 64B16-28.110, 465.0255


  • How often to check this?

    Every 4 months (whole inventory)

  • What could be the maximum expiration date on outpatient drugs?

    ONE year or less

PHARMACISTS' ORDERING (Part # 1)

F. A. C. 465.186; 64B16-27.210 - .230


  • Can a pharmacist issue a prescription for allowed drugs?

    Yes

  • Can a pharmacist write refills on the prescriptions?

    No

PHARMACISTS’ ORDERING (Part # 2)

F. A. C. 465.186; 64B16-27.210 - .230


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EMERGENCY MEDICATION KIT


  • Who selects the drugs for the kit?

    Medical Director
    Director of Nursing
    Pharmacist

  • When should it be resealed, if it is opened?

    By next business day

  • Are controlled substances allowed in it?

    Yes

  • If yes, how many?

    • Up to FIVE for 60 beds or less
    • Additional THREE doses per each 60 beds

DISPENSING BY ER PRESCRIBERS


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TIMELINES


  • Pharmacy permit renewal

    Every TWO years

  • Pharmacists’ licenses renewal

    Every TWO years

  • Pharmacists’ licenses expiration

    September 30th of every other year

  • Pharmacy technicians’ license renewal

    Every TWO years

STATE INSPECTIONS


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DISPLAY IN PHARMACIES


  • What?

    Permit
    Licenses of employees

  • Signs

    - Patient consultation area
    - Operation hours
    - Prescription Department Closed sign if needed

BADGE


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ADVERTISEMENT REGULATIONS


  • What can be advertised by a pharmacy?

    1. Drugs
    2. Prices

  • What CANNOT be advertised?

    • Controlled substances advertising
    • Non-FDA approved use of ephedrine

DRUG SAMPLES


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RESOURCES/EQUIPMENTS IN PHARMACIES


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CONTROLLED SUBSTANCES DIFFERENT THAN FEDERAL LAWS


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AGE


  • What is the age requirement to license as a pharmacist?

    At least 18-year old

  • What is the age requirement to purchase ephedrine containing products?

    At least 18-year old

  • Who is exempt from paying the biennial renewal fee for a license?

    A person who has been licensed as a pharmacist in FL 50 years or more

  • Age requirement to purchase a Schedule V OTC drugs:

    At least 18-year old

ANIMAL CONTROL SHELTERS (Part # 1)

64B16-29.001 - .005


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ANIMAL CONTROL SHELTERS (Part # 2)

64B16-29.001 - .005


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ANIMAL CONTROL SHELTERS (Part # 3)

64B16-29.001 - .005


  • How often these facilities are being inspected?

    Not less than TWICE a year

  • Recordkeeping (administration records)

    For FOUR years

  • Loss of records data shall be reported within

    10 days

  • Minimum storage requirements of drugs and DEA form 222s:

    All drugs shall be kept in a securely locked cabinet
    with a locked storage room

ANIMAL CONTROL SHELTERS (Part # 4)

64B16-29.001 - .005


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AUTOMATED PHARMACY SYSTEMS (LTCFs) (Part # 1)

Fl Chap. 465.0235


  • Is it allowed in LTCFs or hospices?

    Yes, a pharmacy may provide such services.

  • Does the system need to be located at the same location as the pharmacy?

    No, it is not required

  • Does the supervising pharmacist have to present at the site of the system?

    No, it is not required but he/she has to make sure that the machine is properly restocked.

AUTOMATED PHARMACY SYSTEMS (LTCFs) (Part # 2)

Fl Chap. 465.0235


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AUTOMATED PHARMACY SYSTEMS (Community pharmacies) (Part # 1)

F. A. C. 64B16-28.141


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AUTOMATED PHARMACY SYSTEMS (Community pharmacies) (Part # 2)

F. A. C. 64B16-28.141


  • The system CAN do:

    • Storing medications
    • Packaging medications
    • Dispensing medications
    • Distribution of medications
    • Collecting, controlling and maintaining
    all transactions information

  • The system CANNOT do:

    • Compounding
    • Administration





Law Updates/Changes



Please refer to the next slides for laws updates in Florida



PreMPJE Florida Laws




Copyrighted    2019 PreMPJE.com


HB 831

Effective Date: January 1, 2020

The law relocates language regarding electronic prescribing from existing section 456.43, Florida Statutes, to section 456.42, Florida Statutes, and repeals section 456.43, Florida Statutes, on January 1, 2021. The law requires prescribers to generate and transmit all prescription electronically, except when electronic prescribing is unavailable due to a temporary electrical or technological failure. In such instances, written prescriptions may be used, which must meet the requirements under current section 456.43, Florida Statutes.

Reference:
Read more at https://www.flsenate.gov/Session/Bill/2019/831/BillText/er/PDF



Prescription Drug Importation Programs (HB 19)

Effective Date: July 1, 2019

The law establishes two programs to safely import FDA-approved prescription drugs into Florida: The Canadian Importation Program and the International Drug Importation Program. The Department is responsible for the creation of and inspection of new permits for an international export pharmacy. Additionally, the law creates eligibility criteria for the types of prescription drugs to be imported, the importation process, safety standards, distribution requirements, and penalties for violations of the established program. Federal approval is required before the programs may begin.

Reference:
Read more at https://www.flsenate.gov/Session/Bill/2019/19/BillText/er/PDF



Nonopioid alternatives (HB 451)

July 1, 2019

Creates section 456.44 (7), Florida Statutes, requiring the Department to develop and publish on its website an education pamphlet regarding the use of nonopioid alternatives for the treatment of pain.

Reference:
Read more at https://www.flsenate.gov/Session/Bill/2019/451/BillText/er/PDF



Epidolex (CBD) a Schedule V

May 2019

Creates section 893.03 (5) (d), Florida Statutes, to make Epidolex (CBD) a Schedule V drug and mirror the federal law.

Reference:
Read more at https://www.flsenate.gov/Session/Bill/2019/7107/BillText/er/PDF



Telepharmacy laws in Florida

January 2019

Telepharmacy specific laws or rules are not addressed in Florida.

However, per F.S. 465.035, it is lawful for a pharmacy to dispense medicinal drugs, including controlled substances, based on reception of an electronic facsimile of the original prescription if certain conditions met.

Section 465.0235 provides that a pharmacy may provide pharmacy services to an LTCF or hospice or a state correctional institution through the use of an automated pharmacy system that need not be located at the same location as the pharmacy.

Reference:
Read more at https://floridaspharmacy.gov/latest-news/



Possessing controlled substances by MLPs

January 2019

Telepharmacy specific laws or rules are not addressed in Florida.

PAs, APRNs, clinical nurse specialists, and nurse practitioners may possess controlled substances now.

However, midwives are not allowed to possess controlled substances.

Reference:
Read more at https://floridaspharmacy.gov/latest-news/



Veterinarian possessing controlled substances

January 2019

Veterinarians may possess controlled substances if they hold a valid DEA registration.

Reference:
Read more at https://floridaspharmacy.gov/latest-news/



Possession of legend drugs (NON-CONTROLLED) rules

January 2019

Nurse practitioners, clinical nurse specialists and nurse midwives are allowed to possess non-controlled legend drugs.

Reference:
Read more at https://floridaspharmacy.gov/latest-news/



Dispensing authority changes

January 2019

A practitioner may dispense drugs, but the practitioner must be registered with the FL BOP. However, they may not dispense Schedule II or III drugs. There is some exemption to this rule. Please read the Sec. 465.0276.

Reference:
Read more at https://floridaspharmacy.gov/latest-news/



Prescribing authority changes

January 2019

Clinical nurse specialists have now the dependent prescribing authority.

Advanced registered nurse practitioner (ARNP) title is changed to Advanced Practice Registered Nurse (APRN) effective 1st October 2018.

Clinical nurse specialists (CNS) also became APRNs as of the above date.

Now, a license is required to practice midwifery in Florida.

Certified Nurse Midwives (CNMs) are APRNs and they are also licensed by the board of nursing.

APRNs may prescribe, dispense, order, and administer controlled substances, but only under a supervising physician.

APRNs may prescribe or dispense controlled substances only if the APRN has graduated from a program leading to a master's or doctoral degree in a clinical nursing specialty area with training in specialized practitioner skills.

PAs now prescribe controlled substances. However, prescribing of Schedule II drugs are limited to a seven-day supply and restricts prescribing psychiatric mental health controlled substances for children under the age of 18 years.

APRNs and PAs are required to collect three hours of continuing education on the safe and effective prescribing of controlled medications biennially.

Optometrists may prescribe all topical drugs and limited oral medication as described in Sec. 463.0055 of the Florida Optometry Practice Act.

Reference:
Read more at https://floridaspharmacy.gov/latest-news/



Prescriptions written by out-of-state prescribers

January 2019

Out-of-state prescribers written prescriptions for non-controlled substances and CONTROLLED substances are valid in Florida. However, a prescription order IS NOT valid if it is based on an online questionnaire.

Reference:
Read more at https://floridaspharmacy.gov/latest-news/



Pharmacy technicians to pharmacist ratio

January 2019

Rule 64B16-27.410 outlines the acceptable as follows:

  • Three to one (3:1) ratio: a pharmacy or a pharmacist engaged in sterile compounding shall not exceed a ratio of up to three registered technicians to one pharmacist.
  • Six to one (6:1) ratio: a pharmacy or a pharmacist may allow a supervision ratio of up to six registered technicians to one pharmacist as long as the pharmacy or pharmacist is not engaged in sterile compounding.
  • Eight to one (8:1) ratio: for non-dispensing pharmacists and the pharmacists must not be involved in sterile compounding.
  • Eight to one (8:1) ratio: for a pharmacy which dispenses drugs in any physical separate area of the pharmacy from which medicinal drugs are not dispensed. A "physically separate area" is a part of the pharmacy which is separated by a permanent wall or other barriers which restricts access between the two areas.

Reference:
Read more at https://floridaspharmacy.gov/latest-news/



Who can discipline pharmacists in Florida now?

January 2019

FL Department of Health could discipline pharmacists now. Also, FL BOP cand discipline pharmacists too.

Reference:
Read more at https://floridaspharmacy.gov/latest-news/



The special condition added in license transfer requirements

January 2019

The graduates of foreign schools must need to present FPGEC certification.

Reference:
Read more at https://floridaspharmacy.gov/latest-news/



Does FL BOP require registration of preceptors in 2019?

January 2019

Yes, the board approval required now.

Reference:
Read more at https://floridaspharmacy.gov/latest-news/



Class III Institutional Pharmacies

October 2018

Class III institutional pharmacy permits were created for hospital-affiliated institutional pharmacies, including central distribution facilities that provide the same services authorized by a Class II permit.

Class III Institutional permitees may:

  • Dispense, distribute, compound, and fill prescriptions for medicinal drugs.
  • Prepare prepackaged drug products.
  • Conduct other pharmaceutical services for the affiliated hospital and for entities under common control that are each permitted under Chapter 465, F.S., to possess medicinal drugs.
  • Provide the aforementioned services to an entity under common control that holds an active health care clinic establishment permit as required under Chapter 499, F.S.


Please visit the Board of Pharmacy Resources page to download the application form for the Class III Pharmacy and Change of Permit Association for the Class III Pharmacy.

Reference:
Read more at https://floridaspharmacy.gov/latest-news/class-iii-institutional-pharmacies/



Continuing Education Requirements

June 2018

Validation and Counseling of Prescriptions for Controlled Substances and Opioids: MANDATORY CE

Rule 64B16-27.831(6), Florida Administrative Code, related to "Standards of Practice for the Filling of Controlled Substance Prescriptions; Electronic Prescribing; Mandatory Continuing Education" has been amended, with an effective date of June 14, 2018. This rule now provides that all licensed pharmacists shall complete a Board-approved 2-hour continuing education course, on the "Validation and Counseling of Prescriptions for Controlled Substances and Opioids", during the biennium ending on September 30, 2019. This 2-hour course shall be taken every biennium thereafter.

The "Validation and Counseling of Prescriptions for Controlled Substances and Opioids" course shall count towards the mandatory 30 hours of CE required for licensure renewal, and all newly licensed pharmacists must complete the required course before the end of the first biennial renewal period. A licensee who completes the mandated "Validation and Counseling of Prescriptions for Controlled Substances and Opioids" course between October 1, 2017 and July 1, 2018, shall be deemed to have complied with this subsection for the biennium ending on September 30, 2019.

After August 1, 2018, any CE course offered on this subject, by a Board-approved CE provider, must contain the new CE requirements contained within Rule 64B16-27.831, F.A.C., in order for the licensee to obtain credit for the course during the current biennium ending on September 30, 2019.

If you have any additional questions, please contact the Florida Board of Pharmacy Office at (850)245-4292, or via e-mail at: MQA.Pharmacy@flhealth.gov.

Reference:
Read more at https://www.flrules.org/gateway/RuleNo.asp?title=PHARMACY PRACTICE&ID=64B16-27.831



HB 21 - Controlled Substances

July 2018

Creates section 456.0301, Florida Statutes, requiring practitioners to complete a specified board-approved continuing education course to prescribe controlled substances. The bill defines "acute pain" and establishes prescribing guidelines and grounds for disciplinary action if not followed. It limits opioid prescriptions for the treatment of acute pain to a specified period under certain circumstances and requires health care practitioners to check the prescription drug monitoring program (PDMP) database prior to prescribing or dispensing a controlled substance.

Additionally, the bill requires pain management clinics with an exemption from registration under section 458.3265 or 459.0137, Florida Statutes, to register their exemption with the Department of Health with no fee, and specifies a new certificate is required if a change of address occurs.

If you'd like to view all 2018 bills impacting health care professions, please go to www.flhealthsource.gov/2018-bills

Reference:
Read more at https://www.flhealthsource.gov/2018-bills



HB 675 - Pharmacies

July 2018

Expands the eligibility for a membership seat on the Board of Pharmacy. Establishes and provides requirements for Class III institutional pharmacies and adds these pharmacies to those authorized to dispense prepackaged drug products.

Reference:
Read more at https://www.flhealthsource.gov/2018-bills



New Changes Related to Florida Board of Pharmacy

July 2018

  • The community pharmacist member must be in active practice.
  • The board members are limited to two terms (consecutive).
  • No member may serve for more than the remaining portion of a previous member's unexpired term.

Reference:
Read more at https://floridaspharmacy.gov/latest-news/



Pharmacists' Examination changes

2018

The validity period for a NAPLEX Score Transfer is THREE years now.

Reference:
Read more at https://floridaspharmacy.gov/latest-news/



Pharmacist licensure related changes

2018

  • The board does not issue temporary pharmacist licenses.
  • The board accepts licensure transfer from California only if the pharmacist passed the NAPLEX after January 1, 2004.
  • The Department of Health disciplines pharmacists now.

Reference:
Read more at https://floridaspharmacy.gov/latest-news/



Pharmacist CE changes

2018

  • Total: 30 hours every two years required.
  • Live: 10 hours
  • Medication error related: 2 hours
  • Validation of controlled substances related: 2 hours
  • If the license was issued less than 12 months prior to the expiration date of the license, then CEs are NOT required.
  • If the license was issued more than 12 months prior to the expiration date of the license, then 15 hours of CEs are required.
  • HIV/AIDS: 1 hour (ONLY for the first renewal)
  • 24 hours of consultant pharmacist coursework required for a consultant license every two years.
  • Carry-over is not allowed.

Reference:
Read more at https://floridaspharmacy.gov/latest-news/



Pharmacists other changes

2018

  • Pharmacists may administer Zoster vaccines (Adjuvanted, recombinant).
  • A pharmacist seeking to administer a long-acting antipsychotic medication by injection must complete an 8-hour continuing education course [F.S. 465.1893 (2)(a)]
  • A registered intern who administers an immunization or vaccine under this subsection must be supervised by a certified pharmacist at a ratio of one pharmacist to one registered intern. [Ch. 465.189 (1)]

Reference:
Read more at https://floridaspharmacy.gov/latest-news/



Technicians related changes

2018

  • They are required to be licensed and certified (NOT registered).
  • They must identify themselves as "registered pharmacy technicians" when communicating on the phone [FAC 64B16-27.100 (2)]

Reference:
Read more at https://floridaspharmacy.gov/latest-news/



Pharmacy-related changes

2018

  • The pharmacy may display the license or registration of each pharmacy employee [But it is NOT REQUIRED anymore].
  • Any pharmacy engaged in sterile compounding must obtain a special sterile compounding permit by filing an application on form DH-MQA 1270
  • VPP Accreditation is RECOGNIZED (but not REQUIRED).
  • The Practice of Telepharmacy is allowed in Florida now.
  • The FL Board does NOT require compliance with USP Chapter <795> for nonsterile preparation or Chapter <800> for Hazardous Drugs.
  • However, the Board REQUIRES compliance with USP Chapter <797> for sterile preparations.

Reference:
Read more at https://floridaspharmacy.gov/latest-news/



Manufacturer/Distributors related changes

2018

  • Florida licenses device manufacturers, it is managed by FL Department of Business & Professional Regulation.
  • Florida licenses device dispensers that are not pharmacies (managed by FL Department of Business & Professional Regulation).
  • Florida issue a license to virtual manufacturers.

Reference:
Read more at https://floridaspharmacy.gov/latest-news/



Controlled substances related changes

2018

  • Destruction of the controlled substance shall be witnessed by at least two (2) of the following individuals: (a) Consultant pharmacist; (b) Director of nursing (c) Facility administrator; (d) A licensed physician, mid-level practitioner, nurse, or another pharmacist employed by or under contract or written agreement with the facility, or (e) A sworn law enforcement officer.
  • Starter Dose Prescriptions for Patients in Class I or Modified II B Institutional Facilities do not include prescriptions for controlled substances.
  • Each time a controlled substance is dispensed to an individual, the controlled substance shall be reported to the department through the system as soon thereafter as possible, but no later than the close of the next business day after the day the controlled substance is dispensed. [F.S. 893.055 (4)]
  • Each written prescription prescribed by a practitioner in this state for a controlled substance listed in Schedule II, Schedule III, or Schedule IV must include both a written and a numerical notation of the quantity of the controlled substance prescribed [Ch. 893.04 (2)(d)]
  • The total quantity of controlled substance listed in Schedule V which may be sold to anyone purchaser within a given 48-hour period shall not exceed 120 milligrams of codeine, 60 milligrams dihydrocodeine, 30 milligrams of ethylmorphine, or 240 milligrams of opium [Ch. 893.08 (3)(c)]
  • Schedule II drugs may be dispensed upon oral prescription but is limited to a 72-hour supply. [Ch. 893.04 (1)(f)]
  • Any pharmacist who dispenses by mail a controlled substance listed in Schedule II, Schedule III, or Schedule IV is exempt from the requirement to obtain suitable identification for the prescription dispensed by mail if the pharmacist has obtained the patient's identification through the patient's prescription benefit plan. [Ch. 893.04(2)(b)]
  • A pharmacist may not dispense more than a 30-day supply of a controlled substance listed in Schedule III upon an oral prescription [Ch. 893.04 (2)(e)]
  • The legal owner of any stock of controlled substances in a pharmacy, upon discontinuance of dealing in controlled substances, may sell said stock to a manufacturer, wholesaler, or pharmacy. [Ch. 893.04 (4)]
  • Non-pharmacy practitioners (e.g., physicians, dentists) are NOT permitted to dispense Schedule II and III medications. [Ch. 465.0276(1)(b)]
  • A product containing not more than 200 milligrams of codeine per 100 milliliters could be sold at retail by a pharmacist without a prescription. [Ch. 893.03 (5)(a)]
  • carisoprodol is classified as a Schedule IV drug. [Ch. 893.03 (4)(iii)]
  • The inventory may be prepared on the regular physical inventory date which is nearest to, and does not vary by more than 6 months from, the biennial date that would otherwise apply [Ch. 893.07 (1)(a)]

Reference:
Read more at https://floridaspharmacy.gov/latest-news/



NABP related changes

2018

So far, Florida does not collect NABP e-Profile IDs for pharmacists, technicians or pharmacies.

Reference:
Read more at https://floridaspharmacy.gov/latest-news/



Miscellaneous changes

2018

  • FL Dept. of Health may contract Physician, ARNPs, Osteopath to operate an approved impaired practtioner program. [Ch. 456.076 (2)(a)]
  • In a Class I, Class II, Modified Class II, or Special ALF settings, medications dispensed to a patient may be returned to the pharmacy for future redispensing [NOT community pharmacies or nuclear pharmacies] [64B16-28.118 (1)]
  • "Remote Medication Order Processing" includes any of the following activities performed for a Class II Institutional Pharmacy or for Special Pharmacy Permits servicing Class I, Class II, Modified Class II, and Special ALF permitted facilities from a remote location. [FAC 64B16-28.606]
  • The Special Sterile Compounding Permit is not required for a Type B Modified Class II Institutional Pharmacy that compounds low-risk level sterile preparations for immediate use. [FAC 64B16-28.802 (6)].
  • The consultant pharmacist of record shall conduct Drug Regimen Reviews as required by Federal or State law, inspect the facility, and prepare a written report to be filed at the permitted facility at least monthly. [FAC 64B16-28.870 (3)(d)]
  • A manufacturer, distributor, or retailer, or its employees and representatives, may not knowingly or willfully sell a finished drug product containing any quantity of dextromethorphan to a person younger than 18 years of age. [Ch. 499.036 (2)(a)]
  • The prescription number is also required on the label. See 893.04 (1)(e)

Reference:
Read more at https://floridaspharmacy.gov/latest-news/