MPJE NSU Dr. Seamon 2022

April 2027, NSU COLLEGE OF PHARMACY MPJE REVIEW
2022 Matthew J. Seamon PharmD Esq.
Top 10 Hot Topics of 2022

1. Immunizations
2. Impaired Practitioner Program
3. Controlled Substance Prescribing / Acute Pain Exception / Chronic
4. Consultant Pharmacy
5. Collaborative Practice / Test and Treat
6. Tele-Pharmacy, Automation, and Technology
7. Patient Records, Consent and Confidentiality
8. Epinephrine and Naloxone
9. Pharmacist discipline
10. Institutional Class III
Top 10 Mainstays for the MPJE

1. Pharmacist/Intern/Technician Responsibilities
2. PDMP and Narcotics
3. Counseling and confidentiality
4. Controlled Substances and Legend Drugs: ordering, refills, transfers, schedules
5. Pseudoephedrine / OTC
6. Adulteration/Misbranding
7. Patient Records / Confidentiality
8. Drug label requirements (OTC/prepack/Rx/Patient Specific)
9. Prescribers / Scope of practice
10. Drug Substitution Laws
Table of Contents
Section 1 About the MPJE Page 1
Competency Statements Page 3
Section 2 Federal Pharmacy Page 8
Section 3 Controlled Substances Act Page 17
Section 4 Florida State Pharmacy Practice Page 22
Section 5 Florida Appendices Page 50
Section 6 Exam Type Questions Page 127
Section 7 Wrap and Disclaimer Page 134
Section 1 – ABOUT THE MPJE

Exam Overview
• Multistate Pharmacy Jurisprudence Exam

o Misnomer…it is a single State Exam…Your State
o Required to be a licensed pharmacist.
o Uses adaptive technology to deliver new questions based on previous answers
o Online registration
o $150.00 per examination
• Administered at Pearson VUE testing centers.
o Two forms of identification required
▪ One picture ID with signature
o Palm Vein Scan and Photograph at testing site
o Erasable note board and pen will be provided
• 2.5 hours to complete, no breaks given
o All questions answered in order, no going back after you confirm answer
o No skipping questions….Guess!
o Rich in situational questions
• 3 hour Appointment Time
o You may take a break but that time will be deducted from your examination Combines
federal- and state-specific law
• Based on a national blueprint of pharmacy jurisprudence competencies
o Questions are tailored to the specific laws in each state.
• Consists of 120 multiple-choice test questions.
• 100 questions used to calculate score (operational)
o 20 items serve as pretest questions, and do not affect the MPJE score. Those pretest
questions are dispersed throughout the examination and cannot be identified by the
candidate.
o Must answer questions in order
o Once an answer is confirmed, there is no opportunity to return to the question
o Must complete at least 107 questions to be scored
o Question Types
▪ Multiple Choice
▪ Select All That Apply (~25%)
▪ Ordered Response
▪ Controlled substance (~20%)
▪ Florida State (100%)
• Grade issued as Pass or Failed; no scaled score and no percentage reported
o If fail, must wait at least 30 days to retake.
o Rescore process available $200
o Withholding, invalidation; psychometric review may occur
• Strike 5 and you are out (may take exam MAXIMUM of 5 times and then you must move to
another state…sorry bub)
• Results available within 7 business days
• Examination does not distinguish between State and Federal law. Accordingly, answer each
question based on FL law.
• Avoid misconduct. Avoid any inkling of misconduct. Avoid any perception of misconduct
• PROHIBITED items include reference/study materials, smartphones, fitness/smart watches
handbags, purses, wallets, food beverages, any carrying bag, must have empty pockets, no
cameras, recording devices or microphones, no outerwear such as coats and hats, no weapons.
Top 10 Money Tips for the MPJE

1) Know the Exam….that is the competency statements
2) Do not walk in unprepared
3) This is absolutely a “Test of Confidence”
4) Remember this is a FLORIDA LAW EXAM
5) Not a test of how your favorite pharmacist practices
6) Not a test of how insurance companies and pbm’s operate
7) Etch-a-sketch 5 and 6. I’m serious
8) Don’t get side-tracked by the situational madness at hand. Identify the question and apply the law
9) Be prepared for Brand, generic, and schedule
10) Be a WINNER; Don’t be a loser
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Matthew J. Seamon, PharmD, Esq 04272022
Nova Southeastern University College of Pharmacy
COMPETENCY STATEMENTS
AREA 1 – PHARMACY PRACTICE (APPROXIMATELY 83% OF TEST) 100 TOTAL QUESTIONS / 83 SCORED
1.1 – Legal responsibilities of the pharmacist and other pharmacy personnel:

• 1.1.1 – Unique legal responsibilities of the pharmacist-in-charge (or equivalent), pharmacists,
interns, and pharmacy owners
o Responsibilities for inventory, loss and/or theft of prescription drugs, the
destruction/disposal of prescription drugs and the precedence of Local, State, or Federal
requirements
• 1.1.2 – Qualifications, scope of duties, and conditions for practice relating to pharmacy
technicians and all other non-pharmacist personnel
o Personnel ratios, duties, tasks, roles, and functions of non-pharmacist personnel
1.2 – Requirements for the acquisition and distribution of pharmaceutical products, including samples:
• 1.2.1 – Requirements and record keeping in relation to the ordering, acquiring, and maintenance
of all pharmaceutical products and bulk drug substances/excipients
o Legitimate suppliers, pedigrees and the maintenance of acquisition records
• 1.2.2 – Requirements for distributing pharmaceutical products and preparations, including the
content and maintenance of distribution records
o Legal possession of pharmaceutical products (including drug samples), labeling,
packaging, repackaging, compounding, and sales to practitioners
1.3 – Legal requirements that must be observed in the issuance of a prescription/drug order:
• 1.3.1 – Prescription/order requirements for pharmaceutical products and the limitations on their
respective therapeutic uses
o Products, preparations, their uses and limitations applicable to all prescribed orders for
both human and veterinary uses
• 1.3.2 – Scope of authority, scope of practice, and valid registration of all practitioners who are
authorized under law to prescribe, dispense, or administer pharmaceutical products, including
controlled substances
o Federal and State registrations, methadone programs, office-based opioid treatment
programs, regulations related to retired or deceased prescribers, internet prescribing,
limits on jurisdictional prescribing
• 1.3.3 – Conditions under which the pharmacist participates in the administration of
pharmaceutical products, or in the management of patients’ drug therapy
o Prescriptive authority, collaborative practice, consulting, counseling, medication
administration (including immunization, vaccines), ordering labs, medication therapy
management, and disease state management
• 1.3.4 – Requirements for issuing a prescription/order
o Content and format for written, telephonic voice transmission, electronic facsimile,
computer and internet, during emergency conditions, and tamper-resistant prescription
forms
• 1.3.5 – Requirements for the issuance of controlled substance prescriptions/orders
o Content and format for written, telephonic voice transmission, electronic facsimile,
computerized and internet, during emergency conditions, conditions for changing a
prescription, time limits for dispensing initial prescriptions/drug orders, and requirements
for multiple Schedule II orders
• 1.3.6 – Limits of a practitioner’s authority to authorize refills of a pharmaceutical product, including
controlled substances
1.4 – Procedures necessary to properly dispense a pharmaceutical product, including controlled
substances, pursuant to a prescription/drug order:
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• 1.4.1 – Responsibilities for determining whether prescriptions/orders were issued for a legitimate
medical purpose and within all applicable legal restrictions
o Corresponding responsibility, maximum quantities, restricted distribution systems, red
flags/automated alerts, controlled substances, valid patient prescriber relationship, and
due diligence to ensure validity of the order
• 1.4.2 – Requirements for the transfer of existing prescription/order information from one
pharmacist to another
• 1.4.3 – Conditions under which a prescription/order may be filled or refilled
o Emergency fills or refills, partial dispensing of a controlled substance, disaster or
emergency protocol, patient identification, requirement for death with dignity, medical
marijuana, and conscience /moral circumstances
• 1.4.4 – Conditions under which prospective drug use review is conducted prior to dispensing
o Patient-specific therapy and requirements for patient-specific documentation
• 1.4.5 – Conditions under which product selection is permitted or mandated
o Consent of the patient and/or prescriber, passing-on of cost savings, and appropriate
documentation
• 1.4.6 – Requirements for the labeling of pharmaceutical products and preparations dispensed
pursuant to a prescription/order
o Generic and therapeutic equivalency, formulary use, auxiliary labels, patient package
inserts, FDA medication guides, and written drug information
• 1.4.7 – Packaging requirements of pharmaceutical products, preparations, and devices to be
dispensed pursuant to a prescription/order
o Child-resistant and customized patient medication packaging
• 1.4.8 – Conditions under which a pharmaceutical product, preparation, or device may not be
dispensed
o Adulteration, misbranding, and dating
• 1.4.9 – Requirements for compounding pharmaceutical products
o Environmental controls, release checks and testing, beyond use date (BUD), initial and
ongoing training
• 1.4.10 – Requirements for emergency kits
o Supplying, maintenance, access, security, and inventory
• 1.4.11 – Conditions regarding the return and/or reuse of pharmaceutical products, preparations,
bulk drug substances/excipients, and devices
o Charitable programs, cancer or other repository programs, previously dispensed, and
from “will call” areas of pharmacies
• 1.4.12 – Procedures and requirements for systems or processes whereby a non-pharmacist may
obtain pharmaceutical products, preparations, bulk drug substances/excipients, and devices
o Pyxis (vending), after hour’s access, telepharmacies, and secure automated patient drug
retrieval centers
• 1.4.13 – Procedures and requirements for establishing and operating central processing and
central fill pharmacies
o Remote order verification
• 1.4.14 – Requirements for reporting to PMP, accessing information in a PMP and the
maintenance of security and confidentiality of information accessed in PMPs
• 1.4.15 – Requirements when informed consent must be obtained from the patient and/or a duty to
warn must be executed
o Collaborative practice and investigational drug therapy
1.5 – Conditions for making an offer to counsel or counseling appropriate patients, including the
requirements for documentation:
• 1.5.1 – Requirements to counsel or to make an offer to counsel
• 1.5.2 – Required documentation necessary for counseling
1.6 – Requirements for the distribution and/or dispensing of non-prescription pharmaceutical products,
including controlled substances:
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• 1.6.1 – Requirements for the labeling of non-prescription pharmaceutical products and devices
• 1.6.2 – Requirements for the packaging and repackaging of non-prescription pharmaceutical
products and devices
• 1.6.3 – Requirements for the distribution and/or dispensing of poisons, restricted, non-prescription
pharmaceutical products, and other restricted materials or devices
o Pseudoephedrine, dextromethorphan, emergency contraception, and behind the counter
products as appropriate
1.7 – Procedures for keeping records of information related to pharmacy practice, pharmaceutical
products and patients, including requirements for protecting patient confidentiality:
• 1.7.1 – Requirements pertaining to controlled substance inventories
• 1.7.2 – Content, maintenance, storage, and reporting requirements for records required in the
operation of a pharmacy
o Prescription filing systems, computer systems and backups, and prescription monitoring
programs
• 1.7.3 – Requirements for protecting patient confidentiality and confidential health records
o HIPAA requirements and conditions for access and use of information
1.8 – Requirements for handling hazardous materials such as described in USP:
• 1.8.1 – Requirements for appropriate disposal of hazardous materials
• 1.8.2 – Requirements for training regarding hazardous materials
o Reverse distributors, quarantine procedures, comprehensive safety programs, Material
Safety Data Sheets
• 1.8.3 – Environmental controls addressing the proper storage, handling, and disposal of
hazardous materials
o Ventilation controls, personal protective equipment, work practices, and reporting
• 1.8.4 – Methods for the compounding, dispensing and administration of hazardous materials
o All hazardous materials including sterile and non-sterile compounding
AREA 2 – LICENSURE, REGISTRATION, CERTIFICATION, AND OPERATIONAL REQUIREMENTS (APPROXIMATELY

15% OF TEST) 18 QUESTIONS TOTAL / 15 SCORED
2.1 – Qualifications, application procedure, necessary examinations, and internship for licensure,
registration, or certification of individuals engaged in the storage, distribution, and/or dispensing of
pharmaceutical products (prescription and non-prescription):
• 2.1.1 – Requirements for special or restricted licenses, registration, authorization, or certificates
o Pharmacists, pharmacist preceptors, pharmacy interns, pharmacy technicians, controlled
substance registrants, and under specialty pharmacist licenses (Nuclear, Consultant etc.)
• 2.1.2 – Standards of practice related to the practice of pharmacy
o Quality assurance programs (including peer review), changing dosage forms, therapeutic
substitution, error reporting, public health reporting requirements (such as notification of
potential terrorist event, physical abuse, and treatment for tuberculosis), and issues of
conscience and maintaining competency
• 2.1.3 – Requirements for classifications and processes of disciplinary actions that may be taken
against a registered, licensed, certified, or permitted individual
• 2.1.4 – Requirements for reporting to, and participating in, programs addressing the inability of an
individual licensed, registered, or certified by the Board to engage in the practice of pharmacy
with reasonable skill and safety
o Impairment caused by the use of alcohol, drugs, chemicals, or other materials, or mental,
physical, or psychological conditions
2.2 – Requirements and application procedure for the registration, licensure, certification, or permitting of
a practice setting or business entity:
• 2.2.1 – Requirements for registration, license, certification, or permitting of a practice setting
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o In-state pharmacies, out-of-state pharmacies, specialty pharmacies, controlled substance
registrants, wholesalers, distributors, manufacturers/repackagers, computer services
providers, and internet pharmacies
• 2.2.2 – Requirements for an inspection of a licensed, registered, certified, or permitted practice
setting
• 2.2.3 – Requirements for the renewal or reinstatement of a license, registration, certificate, or
permit of a practice setting
• 2.2.4 – Classifications and processes of disciplinary actions that may be taken against a
registered, licensed, certified, or permitted practice setting
2.3 – Operational requirements for a registered, licensed, certified, or permitted practice setting:
• 2.3.1 – Requirements for the operation of a pharmacy or practice setting that is not directly
related to the dispensing of pharmaceutical products
o Issues related to space, equipment, advertising and signage, security (including
temporary absences of the pharmacist), policies and procedures, libraries and references
(including veterinary), and the display of licenses
• 2.3.2 – Requirements for the possession, storage, and handling of pharmaceutical products,
preparations, bulk drug substances/excipients, and devices, including controlled substances
o Investigational new drugs, repackaged or resold drugs, sample pharmaceuticals, recalls,
and outdated pharmaceutical products
• 2.3.3 – Requirements for delivery of pharmaceutical products, preparations, bulk drug
substances/excipients, and devices, including controlled substances
o Issues related to identification of the person accepting delivery of a drug, use of the mail,
contract delivery, use of couriers, use of pharmacy employees, use of kiosks, secure mail
boxes, script centers, use of vacuum tubes, and use of drive-up windows
o
AREA 3 – GENERAL REGULATORY PROCESSES (APPROXIMATELY 2% OF TEST) 3 QUESTIONS TOTAL / 2 SCORED
3.1 – Application of regulations:

• 3.1.1 – Laws and rules that regulate or affect the manufacture, storage, distribution, and
dispensing of pharmaceutical products, preparations, bulk drug substances/excipients, and
devices, (prescription and non-prescription), including controlled substances
o Food, Drug, and Cosmetic Act(s) and Regulations, the Controlled Substances Act(s) and
Regulations, OBRA 90’s Title IV Requirements, Practice Acts and Rules, other statutes
and regulations, including but not limited to, dispensing of methadone, child-resistant
packaging, tamper resistant packaging, drug paraphernalia, drug samples, pharmacist
responsibilities in Medicare-certified skilled-nursing facilities, NDC numbers, and
schedules of controlled substances
Prior Test Results – Nova Southeastern University College of Pharmacy

Passing Rates All Attempts (first time attempts FTA)
2021 = All 76% (Instate 82%, Outstate 57%)
2020 = All 84% (84% FTA)
2019 = All 78% (77% FTA)
2018 = All 68% (69% FTA)
2017 = All 76% (75% FTA)
2016 = All 77% (75% FTA)
2015 = All 93% (94% FTA)
2014 = All 93% (92% FTA)
2013 = All 98%
2012 = All 98%
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Exam Resources
• Florida Pharmacy Act - FL Statute 465

o http://www.leg.state.fl.us/Statutes/index.cfm?App_mode=Display_Statute&URL=0400-
0499/0465/0465.html
o These laws will provide a general outline for your studying and the overall framework for
pharmacy practice
• Florida Board of Pharmacy Rules - 64B16
o https://www.flrules.org/gateway/Division.asp?DivID=307
o Knowledge of these rules is essential, especially 64B16-27: Pharmacy Practice
• Pharmacist Manual / Controlled Substance Act (CSA) REVISED 2020
o https://www.deadiversion.usdoj.gov/GDP/(DEA-DC-046)(EO-
DEA154)_Pharmacist_Manual.pdf
o A good number of questions (~20%) involve controlled substance law. Study this manual
comprehensively. Know this.
• Florida Comprehensive Drug Abuse Prevention and Control Act (FL Controlled Substance Act)
FL Statute 893
o http://www.leg.state.fl.us/statutes/index.cfm?App_mode=Display_Statute&URL=Ch0893/
ch0893.htm
o Try and identify differences between state and federal controlled substance law.
Carefully study 893.04: Pharmacist and Practitioner. Focus on important words with
precise legal meanings. Imagine different situations where these issues arise and how
they would influence the law
• Miscellaneous Florida Laws (much less applied and tested)
o FL Statutes 456 deals with healthcare professionals generally in FL
o FL Statutes 499 Florida’s version of the FDCA (adulteration, misbranding etc)
o FL Statutes 120 Florida’s Administrative Procedures Act – dictates procedures around
licensure
▪ 120 Not relevant for MPJE purposes
Exam Study Guides (based on Poor/Fair/Good/Very Good/Excellent rating scale)

• Florida Pharmacy Law Test by pharmacyexam.com
▪ 150 question compact disc (CD) with detailed answers.
▪ Excellent resource, priced at $70.00
• Inspection Forms - Florida Department of Health / Board of Pharmacy
▪ http://www.floridahealth.gov/licensing-and-regulation/enforcement/inspection-
program/inspection-forms.html
▪ Very good; and best of all: FREE
▪ See also: http://www.floridahealth.gov/licensing-and-regulation/counterfeit-proof-
prescription-pad-vendors/faq.html
• MPJE Florida / Help Pass Pharmacy Law by Stephen Strauss
▪ Good resource, priced at $161.65
• Florida State and Federal Pharmacy Law Guide by Rxlaw.org
▪ Comprehensive inclusion of relevant statutes; excessive information not
adequately distilled
▪ Number of test questions available
▪ Good resource Priced at $99.95
• Florida MPJE Review by Cacciatore
▪ Very similar to this review.
• Guide to Federal Pharmacy Law by Barry S Reiss and Gary D. Hall (7th Edition)
▪ Looking at the MPJE Competencies- focus your studies on Section G and
Section H. This book has exam-type questions for further review
▪ Fair resource with a number of review questions and good study tips
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• Pharmacy Law: Textbook and Review by Debra B, Feinberg 2008
▪ Available electronically through NovaCat free of charge
▪ 450 federal law review questions
▪ Fair resource
• Pronto Pass MPJE Review – Florida
▪ Poor resource priced at $137.95
How to Study & How to Test (Most Important Section In this Packet)
• Focus your study time on State materials
o Study AT LEAST ONE WEEK INTENSELY
o Study at least two-three weeks otherwise
• Remember this is a FL exam. Always rely on FL Law.
• Read the MPJE competencies every day of your studying
• Know brand and generics and schedule of controlled substances
• Know labeling and prescription requirements
• Consider every word in the question
• Read every option and reflect before selecting (select best [emphasis added] choice)
• Look for unusual facts as triggers
• Know the law and THEN use common sense to answer the question. (Use Common Sense)
• The exam contains many situational questions / scenario-based. These are challenging
• If you don’t KNOW the answer then think Policy – what would a smart law be to help provide
information and access to patients while providing them the necessary safeguards (Think
Policy)
• Do not get distracted with what you see at work or what insurance ‘dictates’. This is a state
law test. Answer based on law, not what you see or are told (Law Test, Not Insurance ‘stuff’)
• Select all apply suck (25%). Handle each selection as true-false statement
• Do not memorize statute and regulation numbers (ie 64B16 - 28.100), fees, specific
disciplinary sanctions, legislation years or names (FDCA 1938) - understand only what they
mean to practice
• Get a good night sleep the night before
• Arrive at least 30 min early.
• Be confident! This is a test of confidence! Chose the “smartest” answer confidently
and then move on.
Section 2 Remember this is a state test. The super

majority of content will be covered in state
Federal Pharmacy Law material. This is provided primarily as a
basis or framework for state materials
Statutory Law
1890 Sherman Antitrust Act
• Outlaws agreements that restrain trade
o attempts to monopolize, chain-store price discrimination, price fixing, predatory pricing,
bundling products and services, deceptive trade practices, mergers which lessen
competition are all illegal
1938 Federal Food Drug and Cosmetic Act
• No adulterated or misbranded drugs in interstate commerce
o Adulteration – (may be) gross/filthy/putrid, no follow-cGMP
▪ Think inside the pill
o Misbranded – improperly labeled, not FDA registered establishment, no follow
REMS/PPPA, improper advertising
▪ Think outside the bottle
• Must disclose ingredients on label
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• Drug must be proven safe before marketing
• Authorizes FDA inspection of manufacturers and distributors
1944 Public Health Service Act (PHSA)
• Biologic drugs (monoclonal/interleukins/etc) approved under a BLA (not an NDA)
• Biologics reviewed for purity, potency, and safety
1951 Durham-Humphrey Labeling Amendments to FDCA
• Allows refills of prescriptions
• Establishes Rx and OTC drug categories
o OTC drugs must be labeled with adequate directions for use (drug facts label)
▪ Pregnancy and breast-feeding warning
▪ Calcium, Sodium, Magnesium, Potassium content
▪ Domestic contact information to receive ADR report
▪ OTC drugs approved under OTC monograph or NDA
o OTC Labels must include drug name and strength, directions for use, expiration
date, lot number, warnings, name and address of manufacturer [NDC not required]
o Rx drugs labeled with adequate information for use (package insert)
▪ Approved under NDA or grandfathered in pre-1938
▪ Currently require information on “Pregnancy”, “Lactation”, and “Females and
Males of Reproductive Potential”
• Note Pregnancy Ratings no longer in use (ie ABCDX)
o Unit dose drugs labeling requirements
▪ Generic name (or brand not both), strength, dosage form, expiration date (1
year or manufacturer if earlier), lot number, business name of packager,
quantity, Rx Only and Habit Forming warning, if applicable
▪ Directions for use not required on dose, but stored retrievably
1962 Kefauver-Harris Drug Efficacy Amendments to FDCA Act
• Drugs must be proven effective before marketing
• Creates NDA and SNDA
o Phase I, Phase II, Phase III research
o Studies require informed consent and IRB approval
o 505(b)(2) Paper NDA may be used where there is extensive data to support a use.
No clinical data is required.
• IND required to test new drug in humans
o FDA has 30 days to issue “clinical hold” or else study can proceed
• Mandates Informed Consent in Clinical research
• Adverse Drug Reactions including clinical studies must be reported to FDA
o ADRs are reported using MedWatch Form
▪ Manufacturers required to report. Healthcare professionals and patients
report voluntarily.
• All drug labels to contain brand and generic name
• Advertising of drugs FDA-Rx, FTC-OTC
• Establishes cGMP requirements (Current Good Manufacturing Practices)
o Each manufacturer must register each facility with the FDA and are required to be
inspected every two years. If a facility is not registered than all drugs manufactured
from the facility are misbranded. If the facility fails to comply with standards of
strength, quality, or purity s a product the drug is deemed adulterated
o Pharmacies that compound large amounts of drug not based on individual
prescriptions must register with the FDA as a manufacturer and meet cGMP
requirements. Pharmacies that compound drugs based on individual prescriptions
are not considered manufacturers and do not need follow cGMP
• Compounded Drug Products under the FDCA are allowed for individually identifiable patients
by a licensed pharmacist in a State-licensed pharmacy and are EXEMPT from the
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requirements of 1) current good manufacturing practice (CGMP) 2) labeling with adequate
directions for and 3) FDA approval prior to marketing
1970 Controlled Substances Act (see following section)
1970 Poison Prevention Packaging Act
• Pharmacy must dispense drugs using child-resistant containers (with exceptions)
o Exceptions found at http://www.cpsc.gov/cpscpub/pubs/384.pdf
o All drugs to be dispensed/sold in child-proof resistant containers with exceptions:
▪ PANS-E/Pains-E “don’t be a Pans-E, use child proof containers” except:
• Provera, Prednisone / Amorphous cholestyramine/ isosorbide
diNitrate/sublingual nitroglycerine, sexy birth controls/ Erythromycin,
Effervescent aspirin, Effervescent acetaminophen
• Patient may make blanket request for non-child resistant containers (oral request okay)
• Physician may request individual prescriptions be dispensed in non-child resistant containers
o Cannot make blanket requests for all prescriptions for a patient
• Pharmacist can’t unilaterally decide to dispense prescriptions in non-child resistant container
• Enforced by the Consumer Product Safety Commission (CPSC)
• Use of reversible caps is acceptable
• Cannot reuse plastic containers (glass is okay, must use new tops each fill)
• Hospitals pharmacists exempt from requirement
• Manufacturers containers must be compliant
o may market one size for in non-compliant packaging with labeling requirement
1982 Federal Anti-Tampering Act
• Illegal to tamper with over-the-counter drug products
• OTC Drugs must be sold in tamper-resistant packaging-if breached provides evidence of
tampering
o Label must indicate tamper-resistant features
o Exceptions include dermatologicals, dentifrice, insulin, and lozenge products
1982 Orphan Drug Act
• Provides incentives for companies to develop drugs for rare (Orphan) diseases
o Orphan disease defined as <200,00 patients or no reasonable expectation to recoup
development costs
• Must still submit NDA and follow FDA rigorous drug approval process
• Orphan drug designates status not approval for marketing
1982 Federal False Claims Act
• Not allowed to falsely bill Medicare/Medicaid
• Allows whistleblowers to collect up to 25% of government award
1984 Hatch-Waxman Amendment to FDCA, aka Drug Price Competition and Patent-Term Restoration
Act
• Establishes an abbreviated drug approval process for generic drugs (ANDA) based on
bioequivalence
• Provides added patent term equal to drug development review period by FDA
• Establishes the Orange Book which lists all FDA approved drug products and cross-references
generic drugs that can be substituted for brand drugs
o AB rated drugs can be substituted
o BX/BC/BE rated drugs cannot be substituted
1986 National Childhood Vaccine Injury Act
• Many reports involving vaccines must be reported using VAERS form. (any conditions on the
Reportable Events Table, those listed in the manufacturer's package insert, and clinically
significant or unexpected events). Pharmacists in FL can vaccinate selectively
1987 Prescription Drug Marketing Act
• Prohibits sale/trade/purchase of drug samples
• Requires states such as FL to license drug wholesalers
• Prohibits the sale/purchase/trade/or counterfeiting of any pharmaceutical coupon
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• No importation of drugs except by original Manufacturer
o Patients cannot bring/order foreign drugs into this country
▪ FDA inspectors exercise enforcement discretion for personal use
o the product must be for personal use (a 90-day supply or less, and not
for resale);
o intended for a serious condition for which effective treatment may not be
available domestically
o no commercialization or promotion to U.S. residents
o drug poses no unreasonable risk; and
o patient affirms in writing it is for the patient's own use and provides
doctor’s contact information
o FDA will not routinely search personal baggage
• Importation of Active Pharmaceutical Ingredients (bulk substances) legal only if:
o Intended for compounding and meets the requirements of 503A FDCA or
o Has an approved drug application (NDA/ANDA/NADA/ANADA/IND) or
o Used in an approved OTC monograph drug
• Allows use of starter packs
• Requires prescription drugs to bear the legend Rx Only
o Any drug without legend is considered misbranded
1990 The Omnibus Budget Reconciliation Act (OBRA 90)
• States required to mandate pharmacists to conduct prospective drug use reviews and counsel all
Medicaid patients for reimbursement
1992 Prescription Drug User Fee Act
• Manufacturers must pay a user fee along with each drug that is marketed, facility that
manufacturers drugs, and each application for approval (reauthorized every five years)
o Money is used to hire drug reviewers and facilitate the drug approval process
o FDA promises that 90% of Priority drugs will be reviewed within 6 months and 90% of
Standard (me too) drugs will be reviewed within 10 months
1994 Dietary Supplement Health and Education Act
• Allows dietary supplements to be categorized as food. Must be marketed to promote existing
good health
• Dietary supplements not required to be proven safe or effective, must follow cGMP, puts
limitations on providing published information along with products, FTC regulates advertising
• Products must be orally formulated only. Any disease claim makes the dietary supplement a drug
and requires manufacturer to submit NDA
1996 FDA Export Reform and Enhancement Act
• Allows export of FDA approved drugs if labeled to meet other country requirements
• Allows export of unapproved drugs if used for clinical investigation
• API-active pharmaceutical ingredient may be imported only if part of an FDA approved application
or will be used for compounding (no bulk manufacturing)
1996 Health Insurance Portability and Accountability Act (HIPAA)
• Pharmacies that bill electronically must limit disclosure of patient health information (PHI) to
amount “minimally necessary”
• Pharmacy employees may not use or disclose health information except for treatment, payment,
regular health care operations
o May provide to patients upon request (verbal okay)
• All pharmacy personnel must be trained about HIPAA
• Pharmacy must have procedures and safeguards in place to ensure privacy
o Pharmacy must appoint a responsible individual to ensure safeguards and procedures
are followed
• Patients must be notified of their rights and how information may be used
o Patients typically sign away rights of HIPAA
• Patients have rights to inspect and correct medical records
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• Only provide patient information to patient or legal representative (if minor, parent okay)
o Patients may authorize friends and family to pick-up medication
o May leave messages on answering machines as long as don’t disclose PHI
• Requires patients to authorize use of PHI for marketing
• Pharmacy has 30 days to provide patient records to patient upon requests
o 60 days to correct any errors
1997 FDA Modernization Act – Manufacturer friendly set of drug laws
• Allows for fast-track approval of life-saving drugs
o Surrogate endpoints acceptable, must provide post-marketing confirmation study
• Allows drug manufacturers to provide off-label sales information if requested by physician
• Permits manufacturers to provide economic information and formulary support
• Affirms pharmacist right to compound certain drugs based on individual prescriptions
• Allows drugs to receive an additional 6 month patent term if manufacturer submits data on
pediatrics
2000 Drug Addiction Treatment Act (DATA 2000)
• Allows authorized physicians to treat drug addiction with buprenorphine (Subutex/Subuxone) in
office-based practice whereby pharmacist dispense drugs
o 100 patient limit per physician year one (275 patients thereafter)
• Authorized physician unique provider number staring with X
• Treatment requires completion of a number of FDA Forms (patient consent, responsibility
statement, application for approval of use)
Methadone is used for pain and opioid addiction
o Pain use is treated like any CII narcotic.
▪ Methadone 40 mg tabs/disks indicated for addiction only. Not approved for pain
o If used for opioid addiction, patient MUST be used as part of DEA registered program
(DEA Form 363)
▪ Three-day exception rule - methadone may be administered to addict by
physician while making arrangements. Also, may be ordered in a hospital
incidental to surgery or acute medical care outside of program
2003 Medicare Prescription Drug Improvement and Modernization Act (Medicare Part D)
• Provides prescription drug coverage to Medicare patients (>65 yo, disabled, ESRD) with copays
and donut hole
o Excludes weight loss, fertility, cosmetic, hair growth, bzd/barbiturates, OTC, cold and
cough relief
• Reimburses pharmacists for Medication Therapy Management of Medicare patients
• Imposes on pharmacists and technicians to receive annual training on fraud, waste, and abuse
and pharmacies to have written policies and procedures to address such
2005 Combat Methamphetamine Act (+ 2008 Methamphetamine Production Prevention Act)
• Restricts pharmacy sales of pseudoephedrine (PSE)
o 3.6 grams per person per day (#146, pseudoephdrine HCl 30 mg)
o 9 grams of PSE per person per 30 day period (#366, pseudoephdrine HCl 30 mg)
o Mail order 7.5 grams of PSE per person 30 day period (#305, pseudoephdrine HCl 30
mg)
o See http://www.deadiversion.usdoj.gov/pubs/manuals/pharm2/appendix/appdx_g.htm for
quantity limits
• All solid dosage forms of PSE must be sold in blister packs with no more than 2 doses/blister
• All PSE is placed behind the counter, or secured in pharmacy
• All purchasers must furnish picture ID (see exception immediately below)
• Retailers must maintain logbook of transactions at least two years
o Products packaged for individual sale that contain less than 60 mg of pseudoephedrine
are exempt from the logbook and ID requirements – ie Travel Size
• All pharmacy personnel selling PSE must have training and self-certification
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• In FL, Must be at least 18 years of age to buy PSE [Pseudoephedrine], must show ID, and sign
log
o Pharmacies that sell <72 grams / 30 days and lacks the technology e-recordkeep may
seek exemption from reporting to STATE
• In FL, Must be 18 years of age to purchase Dextromethorphan – still available OTC, no quantity
limits; must show proof of age
2006 Dietary Supplement and Nonprescription Drug Consumer Protection Act
• Requires manufacturers to report serious ADRs to FDA for OTC and dietary supplements
2007 FDA Amendments Act – Drug laws focused on drug safety
• Establishes risk evaluation and mitigation strategies (REMS) for drugs with important health risks
o Manufacturers to provide FDA approved medication guides, communication plans,
elements to assure safe use, and implementation systems as determined by FDA
• Requires all prescription drugs to have Side Effects Statement
o Call your Doctor or FDA if Side Effects somewhere on bottle/cap/paper
• Companies may pay review fee to FDA for review of DTCA prior to dissemination
2008 Ryan Haight Online Pharmacy Consumer Protection Act – Amendment to CSA
• Prohibits internet prescriptions for controlled substances without in-person medical evaluation
o Online survey’s not sufficient to fill a prescription
• Online pharmacies must obtain modified DEA registration, have special website disclosure
(statement of compliance) and DEA (monthly) reporting (if surpass threshold) requirements
o Statement of Compliance: In accordance with the Controlled Substances Act and the
DEA regulations, this online pharmacy has made the notifications to the DEA
Administrator required by 21 U.S.C. § 831 and 21 C.F.R. § 1304.40.”
2009 Family Smoking Prevention and Tobacco Act
• Grants limited authority to FDA involving tobacco (from ATF)
• Bans flavored cigarettes
• Requires cigarette companies to disclose all ingredients, prohibits youth-focused marketing
2010 Biologics Price Competition and Innovation Act
• Establishes a generic approval pathway for biologics (BLA). Generics are called BIOSIMILARS
2012 Generic Drug User Fee Act (GDUFA) – charges Fees for Generic Drug manufacturers for ANDA
and to market generally
2012 Food and Drug Administration Safety and Innovation Act (FDASIA)
• Improves FDA’s inspection authority and the drug supply by expediting inspections
• Creates incentives to encourage the development of products for antibiotic-resistant infections
• Expands the scope of products that qualify for accelerated approval, creates a new “breakthrough
therapy” program - drugs that treats a serious or life-threatening condition and preliminary clinical
evidence indicates that the drug may demonstrate substantial improvement on a clinically
significant endpoint(s) over available therapies gives Fast Track review benefits
• Legislatively address the current drug shortage problem by broadening the scope of the early
notification requirement, manufacturers are required to report discontinuances to FDA regardless
of cause, mandates reporting of shortages of biological products, and requires FDA to issue a
non-compliance letter to manufacturers who fail to comply with the drug shortage notification
2013 Drug Quality and Security Act (DQSA)/ 2014 Compounding Quality Act
• Expands the framework for 503A and 503B Compounding Pharmacies and increases FDA
oversight
o 503A are traditional compounding pharmacies based on individual prescriptions
▪ Drug may be used for compounding if 1) is an FDA approved drug OR have a
USP/NF monograph or 3) appear on FDA good (positive) list AND is 4) not on
the FDA bad (negative) list including difficult to compound list
▪ In compliance with USP only (not cGMP)
▪ No office use compounding
o 503B are based on large batch compounding approaching manufacturing (outsourcing
facilities) of drugs that are used for “office use” for purchase by a healthcare system
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▪ Must be in compliance with cGMP and USP
▪ Labeling per the Drug Quality and Security Act (see below DQSA)
▪ Must be under the direct supervision of a pharmacist; must meet cGMPS
▪ Products must be labeled “compounded drug” and “not for resale”
• Must include Name, Address, and Phone # of outsourcing facility
▪ Must report products compounded to FDA
▪ Facility must report adverse events
▪ Open to FDA Inspection
• Dispensers must:
o confirm that trading partners (manufacturers, repackagers, wholesale distributors,
dispensers, and third-party logistics providers) are authorized under federal law
o maintain lot-level product tracing information—namely, transaction information, history,
and statements—for 6 years
o establish systems for verification and handling of suspect or illegitimate products
2016 Comprehensive Addition and Recovery Act (CARA)
• nurse practitioners and physician’s assistants to administer, prescribe, and dispense narcotics in
office-based opioid treatment programs
o increases the patient limit for office-based treatment from 30 to 100 (first year) and 275
thereafter
• Expand the availability of naloxone to law enforcement agencies and other first responders
2017 FDA Reauthorization act
• Incorporates patient experience data in drug development
2020 PREP ACT
• Authorizes pharmacists to order and administer FDA authorized Covid-19 tests
• Authorizes pharmacists, interns, and technicians to order and administer, and interns to
administer, childhood vaccines (ages 3 – 18)
• Authorizes pharmacists to order and administer, and interns to administer, COVID vaccines
• Authorizes pharmacy technicians and interns (further clarifies interns) to administer both
childhood vaccines and COVID vaccine
• Authorizes pharmacists and pharmacy interns/student pharmacists who have licenses that are
inactive, expired, or lapsed in the past 5 years to prescribe, dispense, and/or administer COVID
vaccines (based on previous PREP Act authority) provided the licensee was in good standing
before inactivity, expiration, or lapse
Miscellaneous Law
Social Security Act
• Skilled nursing facilities must provide “pharmaceutical services” including procedures that assure
the accurate acquiring, receiving, dispensing, and administering of all drugs and biologicals to
meet the needs of each resident
o must be provided in a timely manner that avoids discomfort or endangers the patients
health and safety
• Facilities must employ or obtain the services of a licensed pharmacist who - Provides consultation
on all aspects of the provision of pharmacy services in the facility
• Must have policies on drug related issues
• A licensed pharmacist must review each resident’s medication regimen at least once a month
Case Law
• Plan B OTC (Tummino v. Hamburg/FDA 2013)
o Plan B now available OTC without any-point of sale or age restrictions. Sell like any
OTC
o Note FL has no law that requires pharmacists to dispense contraception or any other
drug against their religious/moral opposition.
• Overtime Pay not Required (De Jesus-Rentas v. Baxter Pharmacy, 2005)
o Pharmacists are considered professionals, not entitled to overtime pay under the FLSA
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Federal Rules and Regulations
Drug Recalls involve a firm's voluntary removal or correction of a marketed product in violation of a law
• Class I: a situation in which there is a reasonable probability that the use of or exposure to a
violative product will cause serious adverse health consequences or death.
• Class II: a situation in which use of or exposure to a violative product may cause temporary or
medically reversible adverse health consequences or where the probability of serious adverse
health consequences is remote.
• Class III: a situation in which use of or exposure to a violative product is not likely to cause
adverse health consequences.
• Each recall must have a ‘Recall Strategy’
o Depth of recall to three potential levels (consumer, retail, wholesale) and must
have an effectiveness check to verify communication is successful
o Firm responsible for promptly notifying each of its affected direct accounts
about the recall.
▪ Format, content, and extent should be commensurate with the hazard
and strategy
▪ Accomplished by telegrams, mailgrams, or first class letters
conspicuously marked, in bold red type, on the letter and the envelope
“drug recall".
• Letter and the envelope should be marked "urgent" for class I
and class II recalls.
• Identify product, size, lot number(s), code(s) or serial
number(s)
• Explain concisely the recall
• Provide specific instructions on what should be done with
respect to the recalled products
o Recalls can be initiated by manufacturer or government (FDA/State Board of
Health)
o Pharmacists do not have a duty to contact patients about a recalled drug if the
drug has already been dispensed
Federal labeling requirements on select products or else considered misbranded
• Glandular preparations
o No scientific evidence
• Isoproterenol
o Severe paradoxical bronchoconstriction
• OTC sore throat lozenges/troches
o If severe or persistent call physician, may be severe
• Ipecac
o Call for professional advice before using
• Nonoxynol 9
o Does not protect against HIV
• Phenindione
o Causes agranulocytosis and hepatitis
• “Contains FD&C Yellow No. 5 (tartrazine) as a color additive”
o Further warning statement required in precautions section of package insert
• “Contains FD&C Yellow No. 6 as a color additive”
• “Phenylketonurics: Contains Phenlalanine ___mg
o Aspartame containing drugs
• “Contains sulfite…”
• Systemic antibiotics, “to reduce the development of resistance, use only in proven or strongly
suspected
• Alcohol and OTC internal analgesics/antipyretics
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o Advises consumers with a history of heavy alcohol use to consult a physician
o 3 or more drinks per day
o APA - Liver damage
o NSAIDs - Internal bleeding
o Combination - Liver damage and Stomach bleeding
• Phytondione (Vitamin K) oral and injectable are prescription-only.
• Isotretinoin - iPledge program utilized, required registration for wholesalers, prescribers,
pharmacies dispensing and all male and female patients, 30 day supply only, females must use
two methods of birth control, one month prior to one month after therapy, two negative pregnancy
tests prior to initiation of therapy
• Thalidomide – STEPS program developed to minimize fetal exposure of drug, restricted
distribution, restrictions involve men and women, prescribers must be in program as well
Tablet Imprints required when possible. Under both Federal and State law, all tablets dispensed must
have a unique imprint/identifier that in conjunction with the product’s size, shape, and color, permits the
unique identification of the drug product and the manufacturer
– Exemptions include compounded medications, radiopharmaceuticals, investigational drugs,
and any product whose size or physical characteristics make imprinting unfeasible or
impossible
National Drug Codes (NDC) serve as a universal (unique) product identifier for human drugs
o Every distinct drug, package has a unique ten digit, three segment number (11 digit HIPPAA
standard)
1) Manufacturer or Labeler 2) Drug Product 3) Package Size
• 4-4-2, 5-3-2, or 5-4-1 configurations
o Use is currently voluntary, used by insurance and pharmacies to process claims
• Not Required to be on a drug label
o Presence of a NDC number does not denote FDA approval
Definitions
Misbranding (FL Statute 499.007)
• Label is false or misleading
• Label missing
o “Established Name” of the drug
o Each active drug ingredient listed
o Quantity of container ingredients
o Adequate information for use (Rx drugs only)
o name or location of manufacturer (packer or distributor)
o Words, statements, information as required by law conspicuously and prominently
displayed
▪ Prescription drugs required to contain Rx only
• OTC labeling lacks adequate directions for use, adequate warnings, or address/phone number of
manufacturer to report serious adverse effects
• Drug made in a nonregistered establishment
• Failure to include contact information to report adverse drug reactions
• Prescription drug promoted in violation of advertising provisions, lacking: established name of the
drug, strength of the drug, brief summary requirement
• Drug is not in accordance with USP/NF specifications or offered for sale under the name of
another drug
• Misrepresents to be a recognized drug
• Packed in violation of PPPA/FATA
• Not in compliance with REMS
• Health-endangering when used as prescribed
• Lacking precautionary statement for drugs subject to deterioration
• Wrong lot number
Adulteration (FL Statute 499.006)
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• Contains any filthy, putrid, or decomposed substance
• Contains an unapproved / unsafe color additive (from list)
• Exposed to any unsanitary condition where it may have been contaminated
• Involving substandard cGMPS
• Mixed or substituted with another product to reduce its strength
• Strength, quality, purity, not meeting compendia standards
o If no standard exists, differing from strength, quality, purity indicated
o Positron Emission Tomography compounded drug does not meet compounding
standards
• Used in substitution of another substance
• Container is composed of any poisonous or deleterious substance which may render the contents
injurious to health
Remember this is a closed-loop system.
From manufacture of precursor chemicals
Section 3 thru administration or dispensing to the
patient, each controlled substance dosage is
Federal Controlled documented and tightly controlled. Consult
Substance Law the Pharmacist Manual (2020) in detail for
MPJE. Florida Law Tests 893 of the State
Statues
Federal Controlled Substances Act
• Five schedules of drugs based on medical use, potential for abuse and dependence
• CI
o High potential for abuse, have no currently accepted medical use in treatment in the United
States, and there is a lack of accepted safety for use of the drug or other substance under
medical supervision.
o May not be prescribed, administered, or dispensed for medical use.
▪ May order/use for research and investigational use
o Order using DEA 222 / CSOS
• CII
o No refills
o No transfers
o Sequential filling of multiple Rx’s acceptable as long as each rx is written on a different blank,
actual date of prescribing is written (no post-date), must contain information on earliest date
to fill, and 90 day limit max in total.
o Oral Rx not permitted
▪ Exceptions 1) emergency (immediate administration of the drug is necessary for
proper treatment of patient, no alternative treatment is available, and it's not possible
for the prescriber to provide a written Rx, amount limited to emergency, pharmacist
writes Rx (“authorization for emergency dispensing) and attaches the original when it
arrives, must get written Rx (or postmark) within 7 days)
o Facsimile Rx not permitted
▪ Exceptions 1) Home infusion/IV if narcotic compounded for pain 2) Residents of
LTCF 3) State licensed Hospice Facility
o Partial fill allowed within 72 hours. Must mark on prescription face amount dispensed. If no
complete order within 72 hrs must contact prescriber and void remaining amount.
o LTCF partial fills permitted. Prescription valid for only 60 days from date written. Each partial
fill, the pharmacist must document date of fill, quantity dispensed and remaining quantity and
sign
o Pharmacist may not change any “Essential Element” on Rx (eg Drug, Patient, Signature,
Date)
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▪ May change address, quantity, strength, directions with authorization, always use
proper judgment
▪ Note the DEA has issued conflicting guidance as to what constitutes “Essential
Element” so you may find differing view.
o Orders require Form 222 / CSOS
▪ Single Sheet 222
• Completed in typewritten or permanent marking
• One drug per line
• Defective forms cannot be filled by supplier. Must void and re-executed
o Very minor errors, like spelling errors not voidable
• Stolen forms should be reported to DEA immediately
• Also used to move CII from pharmacy to pharmacy or pharmacy to
wholesaler
• Remember closed-loop system.
▪ Form 222 can also be used by pharmacy to ship drug to Reverse Distributor who
disposes of drug using Form 41
• CIII-CIV
o Five refills in six months from date written
o 1 transfer permitted
▪ If sharing a common (chain) database may transfer as many times as needed
▪ Note Pharmacy Interns Can Transfer Controlled Substances Prescriptions (definition
of a pharmacist under 21 CFR)
o Cannot transfer prescription that has not been filled [however DEA currently working to revise
this]. May only transfer refill
o Prescriptions may be written, verbal, or electronic
o Partial fills permitted. Any amount may be filled as long as total quantity or six month
duration is not violated. Note: Partial Fills are not considered Refills!
o Pharmacist may make any changes with consultation from prescriber
o No special order form, although orders must be kept readily retrievable
o Codeine combination 90mg/dose
o CV
o No limit on refills (Florida 6 month expiration)!
o 1 transfer permitted
▪ If sharing a common (chain) database may ‘transfer’ as many times as needed
o Most are available without prescription and indicated as cough or antidiarrheal
o Lyrica (pregabalin) requires prescription – may have more than 5 refills!
o cough preparations with less than 200 milligrams of codeine or per 100 milliliters (Robitussin
AC), Lomotil, Motofen, Lyrica, Parepectolin
o Dispensing OTC drug must be done by PHARMACIST
▪ 8 oz max opium containing product / 4 oz codeine per 48 hours
▪ Purchaser must be 18 years old; furnish ID if not known, document transaction in
bound record-book
• Include name and address of the purchaser, the name and quantity of
controlled substance purchased, the date of each purchase, and the name or
initials of the pharmacist who dispensed the drug
▪ Central fill pharmacies may not dispense CV’s at the retail level to a purchaser
o Prescriptions may be written, verbal, or electronic
o Partial fills permitted. Any amount may be filled as long as total quantity or six month
duration is not violated. Note: Partial Fills are not considered Refills!
o Pharmacist may make any changes with consultation from prescriber
o No special order form, although orders must be kept readily retrievable
o SLCPS – Schedule listed Chemical products: used in manufacture of Meth
o Ephedrine, pseudoephedrine, phenlypropanolamine
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• Sellers must self-certify to DEA through the computer that 1) Employees have been
trained 2) Records of the training are being maintained 3) sales limits are being enforced
4) Products are being stored behind the counter or in a locked cabinet AND 5) A written
or electronic logbook is being maintained.
• List 1 Chemicals - drugs involved in the manufacture of a controlled substance
o Ephedrine, Pseudoephedrine, Ergonovine, Iodine, Sasfrole, Piperidine
• List 2 Chemicals - solvents used in the manufacture of a controlled substance
o Acetone, HCl, K/NA-Permanganate
• Electronic prescribing of Controlled Substances permitted; including CII
o Pharmacy system must be suited
o Prescriber system must be suited using double security measures
• Inventory requirements: Every Two Years (see table)
o CII – exact
o CIII-CV – estimated unless container holds more than 1000 units which requires an exact
count
• Prescriptions may be filed in one of TWO methods. C2’s must be stored separately
1) Three separate files
i. CII
ii. CIII-CV
iii. Non-Controls
2) Two separate files (CIII-CV Stamp)
i. CII
ii. CIII-CV + non-Controls Red “C” Stamp >1 in lower right corner on controls
• Controlled substances may be stored in one of three methods in the pharmacy

1) Stored in locked container
2) Dispersed throughout the pharmacy
3) Combination of 1 and 2
o No requirement for CII’s to be locked up; they can be dispersed among inventory. Goal is to
make it difficult to steal all at once!
• Prescription Requirements: Default to FL law (11/15 points)
• Label Requirements: Default to FL law (9/11 points)
o Hospitals do not need to follow label requirements as these are orders not prescriptions
• Filled prescriptions for controlled substances are permitted to be mailed via common carrier
(UPS/FedEx, USPS)
o Package should be unmarked regarding contents
o Pharmacist cannot mail Controlled Substances prescriptions out of the United States. This is
considered illegal Export.
• Theft or significant loss
o Notify DEA and local police
o Complete DEA Form 106
• Pharmacy may use reverse distributor to dispose controlled substances
o For schedule II controlled substances, the reverse distributor must issue an official order form
(DEA Form 222) or the electronic equivalent to the pharmacy.
o For schedules III-V controlled substances pharmacy must maintain a record of distribution that
lists the drug name, dosage form, strength, quantity, and date transferred.
o The DEA registered reverse distributor who will destroy the controlled substances is responsible
for submitting a DEA Form 41 (Registrants Inventory of Drugs Surrendered) to the DEA when the
controlled substances have been destroyed. A DEA Form 41 should not be used to record the
transfer of controlled substances between the pharmacy and the reverse distributor disposing of
the drugs.
• Breakage, damage, spillage of recoverable or destruction of controlled substances must be
reported to DEA on a DEA Form 41 (Registrants Inventory of Drugs Surrendered).
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o Drug may also be disposed of through shipment to a reverse distributor
o Any drug spilled/broken/damaged non-recoverable, pharmacist must document the
circumstances of the breakage in their inventory records. Two individuals who witnessed the
breakage must sign the inventory records, indicating what they witnessed.
• States determine who is entitled to prescribe controlled substances; must register with DEA
o In FL, midlevel practitioners are authorized to prescribe controlled substances (PA and
ARNP)
o Optometrists can prescribe Tylenol with Codeine #3 and Tramadol as the only controls (plus
other non-controlled drugs such as oral antibiotics)
o 3 day max for antibiotics, antivirals and controlled substances
o Require DEA and state registration
o Cannot delegate authority to another, although an agent can phone in prescription at request
of registrant (ie receptionist) including emergency prescriptions of CII
• Military personnel authorized to prescribe controlled substances (Army, Navy, Marine Corps, Air
Force, Coast Guard, Public Health Service, or Bureau of Prison) do not need a DEA registration
number to prescribe in their official duty
o Must provide Military Service Number in lieu of DEA number.
o Prescriptions written in official duty may be filled by community pharmacy off base even
without DEA number
• Hospital interns and residents so authorized to prescribe controlled substances do not need a DEA
registration number to prescribe while in their scope of employment
o Must provide Hospital DEA number and individual physician’s internal hospital code
o Prescriptions may be filled by outside community pharmacy using Hospital’s DEA number
• Central fill of controlled substance prescriptions is permitted in FL
o Prescription information may be transmitted by fax or electronically to central fill pharmacy
o Local pharmacy must write date, pharmacist transmitting, and “Central Fill” on face of
prescription along with the central fill pharmacy’s name, address and DEA number.
o Central fill pharmacy fills the prescription and ships drug to local pharmacy for dispensing and
counseling
o Both pharmacies must be registered with DEA and store records for FOUR years from date
of last fill.
o May NOT fill Schedule II in EMERGENCY SITUATIONS; use local pharmacy only
[21CFR1306.11]
• DEA Registered Pharmacy may keep an Emergency Kit, containing controlled substances in a LTCF
that is not registered with the DEA.
o Security safeguards must be in place
o Must maintain inventory and records
Executing 222 (21 CFR 1305)
o DEA is a one page order form (no longer triplicate).
o Electronic signatures are allowed
• Supplier can endorse form to another, if unable to complete order
• Each form must be signed and dated by a person authorized to sign or granted power of attorney
from registrant (wide leeway in who/how many are granted power of attorneys)
Calculating DEA Number- e.g. BS1212125 (Be prepared to do this on exam)
✓ A valid DEA number consists of 2 letters, 6 digits, and 1 check digit.
✓ The first letter is a code identifying the type of registrant (currently in use: A/B/F/G/M) [note: X is
required to dispense buprenorphine for detox and maintenance but not pain]
o M for midlevel practitioner only
o P/R starting letter is for manufacturer/distributor, exporter, narcotic treatment program
✓ The second letter is the first letter of the registrant's last name.
Step 1: add the first, third, and fifth digits of the DEA number (1+1+1)
Step 2: add the second, fourth, and sixth digits of the DEA number (2+2+2)
Step 3: multiply the result of Step 2 by two (6 x 2)
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Step 4: add the result of Step 1 to the result of Step 3 (3+12)
Then, the last digit of this sum must be the same as the last digit of the DEA number.
CII CIII-CV
Refills No refills allowed 5 within 6 months from date
written (CV-unlimited refills)
Transfer of prescription between No transfers permitted 1 allowed (may transfer
pharmacies additional times to the maximum
if within same common
database)
Transfer of bulk drugs between Requires 222 Requires complete invoice
registrants (ie pharmacies)
Oral Rx allowed In case of emergency only Yes
Facsimile Rx allowed Fax may be received in Facsimile acceptable under
preparation, but original hard- Federal Law – check State Law
copy required to dispense (see • Florida Fax is okay as
exception) long as it is tracked to
• Narcotic compounded prescriber
for direct administration
to patient
• LTCF/Hospice Patients
Electronic Rx Allowed Yes, if meet applicable security Yes, if meet applicable security
requirements requirements
Partial Fills allowed Yes: (remainder required within Yes, no restrictions as long as
72 hrs) within total quantity and six
-Yes, for terminally ill patients month limitation
and LTCF patients. Pharmacist
must mark “Terminally Ill” or
“LTCF Patient”
Maximum quantity No limit - pharmacist judgment No limit – pharmacist judgment
Expiration date No expiration (FL law imposes 1 Six months from date written
year expiration on all Rx)
Inventory Exact count Estimated count unless
container holds more than 1000
units which requires an exact
count
Inventory Requirements Initial inventory required, every two years thereafter.
Drug name, strength, dosage form, number of units in each
container, and number of containers (written, typewritten, or printed,
kept on site and include inventory date and time: opening or close of
business). Inventory is mandated, flexibility in who inventories
allowed
Ordering Form 222 / CSOS No special form used, Standard
Invoice okay
All order forms must be readily retrievable and stored for 2 years
onsite at place of business
Theft or significant loss Report to DEA Form 106 Report to DEA Form 106
Any pharmacy that transfers more than five percent of its inventory must register as distributor
(Five Percent Rule)
DEA Form Intent Additional
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41 Document disposal and destruction of Not used for breakage or spillage
scheduled drugs if drug is non-recoverable
106 Unusual or excessive loss, disappearance, or What constitutes unusual or
theft excessive loss is pharmacist
judgment
222 Order CI and CII Can be completed electronically -
CSOS
224 New Application for Retail Pharmacy, Pharmacies are registered not
Hospital/Clinic, Practitioner, Teaching pharmacists
Institution, or Mid-Level Practitioner
224a Renewal Application for Retail Pharmacy, Renewal application due every
Hospital/Clinic, Practitioner, Teaching three years
Institution, or Mid-Level Practitioner.
224b Affidavit for Chain Renewal Renew license for chain
pharmacy operating under single
registration
224C Application for Modification of Registration for
Online Pharmacies
225 New Application for Manufacturer, Distributor, Manufacturers and distributors of
Researcher, Analytical Laboratory, Importer, controlled substances (Ortho,
Exporter McKesson). Valid 12 months
363 New Application for Narcotic Treatment Methadone maintenance and
Programs detoxification programs
510 New Application for Domestic Chemical Business involved with precursor
chemicals used in the
manufacture of controlled
substances
Known brand, generic, and schedule of most common controlled substances

Schedule 1 Marijuana, ecstasy, heroin, LSD, Peyote, Salvia, Peyote (allowed in Native American
Church ceremony)
Schedule 2 Dilaudid, Demerol, Oxycontin, Sublimaze, Dexedrine, Ritalin, Vicodin (hydrocodone
with APA), Pentobarbital, MS Contin, Codeine straight, Amphetanine, Tylox, Codeine,
Hydrocodone straight, Cocaine, PCP
Schedule 3 Buprenorphine, Anabolic Steroids – Oxandrin, Testosterone, ketamine, Didrex,
Suboxone, Tylenol with Codeine, Fiorinal, (Fioricet is non-controlled)) [DEA in process
working to make all butalbital CIII; on exam Foriricet is not scheduled currently ]
Rule of three Generally, the quantities are evenly divisible by 3 (not typically morphine and opium)
Codeine 90 mg dose (or <1.8 g / 100 ml), Hydrocodone 15 mg dose (or < 300 mg/ 100 ml)
Schedule 4 Benzodiazepines, Sonata (Zaleplon), Lunesta, Soma, Tramadol, Butorphanol,
Daridorexant (Quiviviq)
Schedule 5 Lyrica (requires Rx), Robitussin AC, Phenergan with Codeine, Epidolex No longer CV
Rule of Five Generally, the quantities are evenly divisible by 5
<200 mg codeine/ 100 ml, <100 mg opium/ 100 ml, <2.5 mg diphenoxylate
Section 4
Florida State Pharmacy Laws
Permits Types
Community pharmacy (Independent/Chain Retail Drug Stores)
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• Pharmacy where medicinal drugs are compounded, dispensed, stored, sold, filled or
dispensed on an outpatient basis.
• Typical independent or chain drug store
o Each store must have its own permit
• Must have a prescription drug manager of record named
o May only be manager of one pharmacy at a time (exceptions may be granted)
o Must notify state within 10 days of relinquishing responsibility
• May do limited sterile compounding if properly equipped and inspected by Board
• Community Pharmacy may use off-site automated pharmacy system to dispense
o but must be under supervision ad control of the pharmacy
o must provide live, real-time patient counseling
o must be indoor in a convenient location
o May not have controlled substances
o Labeling and recordkeeping requirements
o Must ensure confidentiality of personal health information
o Detailed policy and procedures including removing expired drugs, accuracy
testing, accessible individuals, cleanliness,
• May use automated pharmacy system [robots/drug cabinets] to fill prescriptions
• Comply with required label requirements (9/11)
o PDM grants access and is responsible for Manual to include security / policies
and procedures / compliance with continuous quality improvement program /
records to identify personnel involved with dispensing
o Must have system to deal with drug recalls and isolate affected lots under
continuous use
o Non-pharmacist service employee may access the system not under the direct
supervision if the system employs technology that will prevent access to areas of
the dispensing cabinet where drugs are stored
Class I Institutional Pharmacy (Nursing Home)
• “A pharmacy in which all medicinal drugs are administered from individual prescription
containers to the individual patient and in which medicinal drugs are not dispensed on the
premises”
o Typical nursing home
• Does not have a pharmacy on premises: no dispensing on premises permitted
• Drugs must be securely stored available only to appropriate licensed staff
• Must have a consultant pharmacist of record named
o must provide written, on-site consultation (drug regimen review) at least once a
month
• “Vendor Pharmacy” that provides medications to the nursing home may contract with a
“Starter dose Pharmacy” to provide “starter doses” to the patient until the Vendor
pharmacy can dispense/deliver the meds.
o Each pharmacy must have policies and procedures and maintain records for four
years
▪ Controlled substances not allowed
• Long Term Care / Hospice / Prisons may have an Automated Pharmacy System on site
which provides medications (prescribed by a physician and verified by the provider
pharmacist) to be administered to the resident patients
o Drugs are considered inventory of the pharmacy that services the automated
system
o Drugs delivered by the automated system are considered dispensed by the
pharmacy maintaining the automated system
o Pharmacist can remotely monitor the automated system and does not need to be
on-site
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o System must adhere to recordkeeping requirements (4 years dispensing records,
etc), security requirements (locked, etc) and labeling requirements.
o May include controlled substances
• May have an emergency medication kit for residents
o Drugs selection determined by Medical Director, Director of Nursing and
Pharmacist. Must have written policies and procedures for use. Kit must be sealed
and all contents labeled. If seal is broken must reseal by next business day.
Inventory log must be atttached to kit.
o Doctors prescribe emergency medicine which is administered by nurse/physician.
Pharmacy (Consultant) oversees recordkeeping and inventory, ensures valid
prescription subsequentyly written and restocks inventory.
▪ Facility may have controls but does not have to be DEA-registered
o Intermediate Care Facility for Developmentally Disabled (ICF)
▪ May possess up to five controlled drugs (with up to three doses of each
for 60 beds or less (and an additional three doses for each 60 beds
subsequent)
▪ Nurse or pharmacist has to inventory, replace, and reseal
Class II Institutional Pharmacy (Hospital)
• “A pharmacy that employs the services of a registered pharmacist or pharmacists who, in
practicing institutional pharmacy, provide dispensing and consulting services on the
premises to patients of that institution, for use on the premises of that institution”
• Must have consultant pharmacist of record named
• Typical hospital pharmacy / Institution has pharmacy onsite
o Drugs must be dispensed in unit-dose packages
o Typically has a formulary system approved by medical staff
o Required to have operating hours sufficient to provide adequate and quality
services
o Considered closed whenever pharmacist no present and on duty
▪ Must lock the pharmacy to prevent access from non-pharmacists
• May use decentralized automated filling systems (Pyxis/Omnicell/Acudose) [64B16-
28.605] Class II and Class III
o Drugs may be distributed [not considered dispensed] by an automated system to
an individual authorized to administer medications to patient
▪ Pharmacist must perform prospective drug use review and approve each
medication order prior to administration
▪ Bar code type verification system required to access
• May include controlled substances
o Consultant of record responsible to maintaining a record of each transaction or
operation, controlling access to the system, and maintaining policies and
procedures, quality assurance program, and security oversight
▪ Multidisciplinary Committee (MD/RN/PharmD/Etc) required and makes
recommendations subject to Consultant Pharmacist of Record
o Stocking may be pharmacist/intern/or technician
o 60 day recordkeeping requirement for daily stocking, outputs, and transaction
records non-controls [controlled substance transaction records maintained four
years]
o CPOE (Computer Provider [physician] Order Entry) may be used whereby
pharmacist then verifies the prescription
▪ Some meds may be ordered and directly distributed by physician without
oversight of pharmacist
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• Pharmacists in a Class II/III (also Modified/ALF) may remotely enter orders for patients
[offsite]
o Typically (offsite contacted) FL pharmacist enters order and automated unit
dispenses drugs for administration
▪ Pharmacist must have access to relevant patient data
o Hospital must have policy and procedure manual detailing privacy,
responsibilities, how to contact pharmacist, etc…
o Recordkeeping requirement of 4 years of every person who performed a
processing function
• ER Prescribers may dispense drugs for outpatient use.
o Smallest duration necessary or 24 hrs.
o Only if drug is warranted and community pharmacy services are not available
o Records must be made by prescriber and maintained by Consultant Pharmacist
o Drug must be properly labeled
▪ Controlled Substances okay to dispense
• May apply for a Special Pharmacy – Limited Community license to dispense remaining
multi-dose medications used in the hospital (topical, creams, insulin, eye drops, etc) at
discharge (saves the patients money re-ordering these medications)
• Prescription Drug Donation Repository Program (465.1902). Pharmacies may serve as
an authorized repository program for charitable donations. Sources of donation may
include nursing homes, hospices, pharmacies, manufacturers, wholesalers, prescribers.
Drug must be in proper condition (not adulterated, not misbranded) and unexpired (w/in
after 3 months of donation) . Drop boxes prohibited. Must give to pharmacist who signs
and inspection record. Must maintain inventory and update DOH to new donations
o Pharmacy may dispense to indigent / uninisured underinsured Florida resident
patients. Patients notified of donation
o Can sell donated drugs
• Cancer Drug Donation Program (499.029 for more information) Hospital pharmacy may
accept donated cancer drugs and supplies from eligible donors, inspects the donated
cancer drugs and supplies for authenticity and dispenses the cancer drugs and supplies
to eligible patients.
o Hospital must complete and submit a Notice of Participation form
o May charge the recipient of the drug or supply a handling fee of no more than
300 percent of the Medicaid dispensing fee or no more than $15, whichever is
less for each cancer drug or supply dispensed
o Drugs must remain in their original sealed container or in a tamper-evident unit-
dose packaging. Never in actual possession of patient
o May not be accepted or dispensed if there is less than six months remaining until
the expiration date.
o Controlled substances are not eligible for donation.
o Eligible patients uninsured and do not qualify for third-party insurance coverage,
Medicaid, or any other state or federal assistance programs
• May use remote medication order processing if pharmacist has necessary patient
information (including modified Class II)
Class III Institutional Pharmacy (Central Distribution Pharmacies associated with a Hospital / Integrated
Network of Pharmacies ie Holy Cow Heath Systems)
• Must maintain a pharmacist of record, maintain policies and procedures (manual)
• Permitted pharmacy may dispense, distribute, compound, or fill prescriptions for prepare
prepackaged drug products; and conduct other pharmaceutical services
• If dispending to patients of the hospital, must have a community permit
• Must be under common control of the hospital pharmacy (Class II Institutional Permit)
• Prescribers in the ER may dispense drugs directly to patients from emergency
department (records required); 48 hr max; may also provide outpatient prescriptions
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o Patient Name and address
o Drug strength and name
o Quantity
o Directions for use
o Prescriber/Dispenser name and DEA if controlled substance
o Only and documented reason that community pharmacy services not available
Label of drug must meet outpatient labeling requirements
• Required to have operating hours sufficient to provide adequate and quality services
Modified Class II Institutional Pharmacy
• Pharmacies that meet all the requirements for a Class II permit, except space and
equipment requirements (typically primary alcoholism treatment centers, free-standing
emergency rooms, rapid in/out surgical centers, certain county health programs, and
correctional institutions)
• Must have consultant pharmacist of record named
o Consultant must provide written, on-site consultation (drug regimen review) at
least once a month
• All drugs dispensed must be for on-site use only
• Consultant pharmacist must provide written protocols and a policy and procedure manual
Modified Class II A, eg Methadone clinic, dialysis center
• Formulary limited to 15 drugs or less
• <10 Modified Class II registrations
• Must not have large stock bottles of controlled substances (>100 dosages)
Modified Class II B, eg Surgical Center
• No formulary limitations, drugs can be stored in bulk or unit-dose
• >90% of Modified Class II registrations
Modified Class II C
• No drugs can be stored in bulk
• None currently registered in FL
Special Pharmacy (all must have consultant pharmacist of record)
Special-Limited Community
• Pharmacy services provided to employees and dependents for personal use, patients of
a hospital (Institutional Class II permit) under a continuation of a course of therapy,
Patients in the emergency room
• Hospital pharmacy practicing under a continuation of a course of therapy using multi-
dose medicinal drugs (see above section on Class II Pharmacies)
Special-Parenteral and Enteral
• provides parenteral (IV), enteral, and cytotoxic pharmacy services to outpatients
Special-Closed System Pharmacy
• Not open to the public.
• Prescriptions are individually prepared for dispensing utilizing closed delivery systems to
facilities where prescriptions are individually prepared for the ultimate consumer,
including nursing homes, jails, Assisted Living Facilities (ALF’s), Intermediate Care
Facility/Mentally Retarded (ICF-MR’s) or other custodial care facilities
• May share location with an establishment that hold community permit
Special-End Stage Renal Disease
• Provides dialysis products and supplies to persons with chronic kidney failure for self-
administration at the person’s home or specified address
Special-ALF
• Assisted Living Facilities providing a drug delivery system utilizing medicinal drugs
provided in unit dose packaging
• Drugs not dispensed on premises
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• Consultant of record must provide written, on-site consultation (drug regimen review) at
least once a month
o Subject to FL State BOP inspection
Special Sterile Compounding Permit (SSCP)
• Special permit, which is required before any permitted pharmacy may engage in the preparation
of compounding sterile products.
o not required for 1) Stand-alone Special Parenteral/Enteral pharmacies; 2) Special
Parenteral/Enteral Extended Scope pharmacies; 3) pharmacies that only perform non-
sterile compounding; and 4) non-resident pharmacies
o Available also for “Outsourcing Facilities;” update with board if register as Outsourcing
Facility
• requires Special Sterile Compounding Pharmacies to be under the professional supervision of the
PDM or Consultant Pharmacist of Record licensed in the State of Florida. A Florida licensed
pharmacist shall perform compounding and dispensing of medicinal drugs
• Compounding must be in strict compliance with the State Standards (64B16-27.700 and 27.797)
of Good Manufacturing Practices
• If also compound, dispense patient-specific prescriptions, must register as a Hospital (Institutional
Class II) or Community Pharmacy as well
• Modified Class II permits may compound low risk meds without SSCP Permit
OUTSOURCING PHARMACY- OUT OF STATE Nonresident Sterile Compounding Permits
• Out of state Outsourcing Facilities must register with the Florida Board of Pharmacy as a non-
resident Special Sterile Compounding Pharmacy
Internet Pharmacy Permit
• In state or out of state pharmacy which uses the Internet to communicate to FL patients or fill
prescriptions for FL patients
o Must always maintain an active pharmacy and DEA registration if dispensing controls
• Required to register as an Internet Pharmacy in FL
• Pharmacy must be open, ie accessible at least six days a week and 40 hours a week, with a toll-
free telephone number that is listed on the label of each prescription bottle filled (doesn’t need to
be 24/7/365)
• Must designate a licensed prescription drug manager
o PDM does not need be licensed in FL
o PDM must notify state within 30 days of relinquishing responsibility
• Requirement of permit is to protect FL patients and ensure a legitimate and competent practice
Nonresident Pharmacy Permit (eg Mail Order)
• Any out of state pharmacy that ships, mails, delivers, or advertises it fills prescription medications
to patients in FL must register as a nonresident pharmacy
o Must always maintain an active pharmacy license and DEA registration if dispensing
controls. Notify Board within 30 days if change name, corporate officer, or PDM
pharmacist.
▪ If mail only one-time delivery to FL, exempt from registration
• All Non-Sterile Products shipped to FL must register Nonresident Sterile
o If providing sterile products in FL, must ALSO register as nonresident Sterile
Compounding Pharmacy (see below)
• No need to register if dispensing isolated transactions (one patient, one time in FL)
• Pharmacy must be open, ie accessible at least six days a week and 40 hours a week, with a toll-
free telephone number that is listed on the label of each prescription bottle filled (doesn’t need to
be 24/7/365)
• Requirement of permit is to protect FL patients and ensure nonresident pharmacy is legitimate
and competent
• Subject to Inspection from FL (Department of Helath/BOP) cost charged to Non-resident
Pharmacy
• Mail Order Pharmacies out of state must register as non-resident pharmacies.
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• Nonresident Sterile Compounding Permit required to ship, mail, deliver, or dispense any sterile
products into the state
o Also applies to FDA Licensed Outsourcing Facility; they must have permit
Nonresident Sterile Compounding Permits
• May ship/compound ONLY FOR PATIENT SPECIFIC PRESCRIPTIONS
o If non-resident state does not inspect, the non-resident pharmacy may request an
inspection from FL BOP or may contract with an approved entity to conduct the
inspection, with the cost to the non-resident permitee
o Must comply with FL and non-resident state sterile compounding requirements
International Export Pharmacy Permit (contingent upon Federal authorization)
• Allows foreign country to ship drugs into the United States (export) = Save Money for FL
Consumers
o Only Countries with Agreement
o Pharmacy Must be licensed in the country of exportation and have current inspection
approved (w/in 6 months of initial application, or 1 year of renewal)
o Drugs must be USP Quality
Nuclear Pharmacy
• Requires the practice of a FL licensed nuclear pharmacist to be named Prescription Department
Manager (PDM)
o Must notify state within 10 days of relinquishing responsibility
• Must have a secured radioactive storage and decay area
o The Hot lab, storage area, and compounding and dispensing area shall be a minimum of
150 square feet (surprisingly tested)
• Must have full spectrum of supplies (syringes, gloves, protective labcoat) and equipment (hood,
shield, scintillation counter, etc)
• Registered technicians employed only in a nuclear pharmacy may write new prescriptions from a
prescriber’s oral prescription
Animal Control Shelter Pharmacy (Modified Class II) NOT TESTED
• Provides for purchase of sodium pento-barbital and sodium pento-barbital with lidocaine for
animal euthanasia
Miscellaneous Permits Issued in FL
• The following must have a permit to operate in FL:
(a) A prescription drug manufacturer;
(b) A prescription drug repackager;
(c) A nonresident prescription drug manufacturer;
(d) A prescription drug wholesale distributor;
(e) An out-of-state prescription drug wholesale distributor;
(f) A retail pharmacy drug wholesale distributor;
(g) A restricted prescription drug distributor;
(h) A complimentary drug distributor;
(i) A freight forwarder;
(j) A veterinary prescription drug retail establishment;
(k) A veterinary prescription drug wholesale distributor;
(l) A limited prescription drug veterinary wholesale distributor;
(m) A medical oxygen retail establishment;
(n) A compressed medical gas wholesale distributor;
(o) A compressed medical gas manufacturer;
(p) An over-the-counter drug manufacturer;
(q) A device manufacturer;
(r) A cosmetic manufacturer;
(s) A third party logistics provider; or
(t) A health care clinic establishment.
Permits Generally
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• Permits are not transferrable; meaning can’t just sign over the pharmacy. New owner must
complete full application and be approved by BOP
o Renewable every two years
o Each applicant with a 5% or greater financial interest in the pharmacy seeking a permit
must submit a signed affidavit disclosing any 5% or greater interest in any permitted
pharmacy in the past 5 years that has closed voluntarily or involuntarily, has voluntarily
relinquished its permit, has had its permit suspended or revoked, or has had an injunction
issued against it by a regulatory agency.
o Applications must include written policies and procedures for preventing controlled
substance dispensing based on fraudulent representations or invalid practitioner-patient
relationships.
• Community pharmacy permit required in FL, to dispense controlled substances listed in Schedule
II or Schedule III
• Pharmacist / Non-Pharmacist may own/permit a pharmacy
o No Medicaid or other healthcare fraud or criminal activity
▪ Fingerprint, application, and background check
o Must be 18 years of age (all entities)
• Onsite Inspection must occur before a permit is issued (initial, change of ownership or change of
address)
o written policies and procedures for preventing controlled substance dispensing based on
fraudulent representations or invalid practitioner-patient relationships must be provided
o Permit must be issued before DEA will register
• Must have sufficient drug information resources necessary to operate pharmacy
• Permits and licenses must be conspicuously displayed
• Individuals must be readily identifiable by license through name badges (Tech/Intern/RPh)
• May advertise drugs and prices
o No controlled substance advertising permitted (can provide drug pricing)
o No advertise ephedrine (salts/isomers) drugs for stimulation, mental alertness, weight
loss, appetite control, energy, non-FDA approved indications
• Must not have any expired drugs in the pharmacy
o Formally recommended to check expiration dates every four months (three times a
year) and remove expired drugs immediately (ALL outdated, damaged, deteriorated,
expired, beyond use, adulterated and misbranded drugs MUST be removed/quarantined
from stock - immediately)
o Policy and Procedure Manual must include procedures for storage and removal to ensure
drugs are high quality and provide patients instructions on reporting concerns
• Maintain Continuous Quality Improvement Program to deal with errors
o Requires a written policy and procedure manual. Must take proactive steps towards
improvement.
o Must conduct reviews at least every three months (quarterly) and consider how staffing
levels, workflow, and technology contributed to the error.
o There must be a record/database of errors.
▪ Each incident must be documented/summarized by the pharmacist that first
become aware of the matter on the initial date notified and include a description
of the event that is sufficient to permit categorization and analysis. Must also
include a description of the remedial measures instituted. Reports must be
maintained for four years. Reports are not discoverable in court. However
summaries may be reviewed by State Department of Health as long as names
and identities are stricken.
• May use Robotics for Dispensing; Automated Filling Systems [64B16-28.607/608] to fill, label and
seal medications for dispensing
o System provides for a verification process
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▪ Pharmacist does not need to manually verify prescription if proper safeguards in
place and policy is strictly adhered to
o Pharmacist/Intern/ or Technician can stock
o Audit trail of all action recordkeeping for four years
o Detailed policy and procedure manual required
o May use automated system in long term care facility / hospice facilities
▪ Each site having controlled substances MUST be individually DEA registered
(sites having only emergency kits do not require a DEA registration)
• Must hang sign informing of the National Human Trafficking Resource Center / Phone Number
• Must hang sign regarding generic substitution (all pharmacies)
• If have website must provide link to state health information
• Medicaid provider pharmacies required to post two signs, Important Notice to Medicaid
Recipients, and Aviso Importante a Recipientes de Medicaid in a conspicuous location that is
visible to recipients. The signs inform recipients of a toll-free number that can be called if the
prescription is denied and the pharmacy failed to provide the denial information and an Important
Information About Your Florida Medicaid Prescription Drug Benefits
• Must substitute generic drugs unless 1) patient requests otherwise 2) prescriber mandates
“Medically Necessary” or 3) drug is on negative formulary.
o Must give patient right to refuse, inform patient of substitution and price difference
o Must pass full savings on to patient
▪ Handwritten Rx-medically necessary handwritten
▪ Verbal Rx-expressly indicates medically necessary
▪ Electronic Rx-overt act indicates medically necessary
If by chance brand costs less than generic…dispense brand! Always try to save
patients money is a good answer on the exam!
• Institutional Pharmacy (Nursing Home) pharmacist may substitute therapeutically equivalent drug
if on formulary and agreed upon by protocol. However pharmacist MUST NOT substitute if
prescriber indicates NO THERAPEUTIC SUBSTITUTION.
• Samples not allowed in community pharmacy. Samples only allowed in Class II institutional
pharmacy (Hospital Pharmacies) upon written request of prescriber. Drugs held in pharmacy to
be used by institution – not just the prescriber
o Physician offices may keep drug samples subject to storage and recordkeeping
requirements
• Each pharmacy must name a PDM or Consultant of Record and must notify the board of any
change in this status within 10 days
• Each pharmacy is typically granted only a single permit
o Hospitals may also have a permit for an on-site community pharmacy
o Rare exceptions may be granted, ie Community Pharmacy also granted Special
Parenteral/Enteral permit
• If permit is revoked or suspended, business MUST close, all signs removed
o Suspended license maximum 1 (one) year
• Drugs must only be stored in the pharmacy area
o Hospitals may also store drugs in areas deemed necessary to treat (Surgical Units/ER)
▪ Must be delineated in policies and procedures manual
o Nursing homes may store secure, available only to appropriate licensed staff
• Destruction of controlled substances require execution of DEA Form 41
o witnessed and signed by the prescription department manager and Department inspector
(no DEA prior approval required) OR two licensed individuals (MD/DO, RN, RPh, Law
Enforcement)
▪ Form must be mailed to DEA at least two weeks before proposed date and
approved by them
o Also may use DEA registered reverse distributors using form 222/41 respectively
• Destruction / Unused Controlled Substances in Nursing homes – No returns
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o Whereby controlled substances have been dispensed and not used must NOT be
returned to the pharmacy. They must locked and stored by the nursing home and then
destroyed (64B16-28.303 Destruction of Controlled Substances)
▪ Must record drug name, strength/dosage form,. quantity, patient name,
prescriptiopn number, institution’s name
– Permittee to complete DEA Form 41 with DEA letter describing destruction at least two
weeks prior. DEA must grant approval prior to destruction
– Destruction to be witnessed by two persons who are either a consultant pharmacist,
director of nursing, facility administrator, physicain, midlevel practitioner, or other
pharmacist of the facility, or sworn law enformcemt officer → must sign document, and
Pharmacy
• Regulation of Daily Operating Hours (64B16-28.1081 Regulation of Daily Operating Hours)
• Pharmacy must be open a minimum 20 hours a week
o If not yet open, must tell Board no commencing operation, within 14 days of
receiving permit and then tell Board within 2 days of opening. Sign must be hung
before opening block letters one inch noting not yet open, no prescriptions filled.
• Required to have a sign in block letters at least one inch must state hours of operation in
unobstructed view, either at front door or by pharmacy providing hours
o If pharmacy is open less than 40 hours per week must post specific hours of
operation, information on afterhours access and have policies for transferring a
prescription and emergency refills.
• Must have working sink, running water, sufficient shelving to maintain a clean/organized practice,
refrigeration for drugs, sanitation, a print or electronic drug information, a print or electronic copy
of FL drug laws, quarantine area for defective drugs, and anything else typically relied upon for
your particular practice. Must be clean and orderly
• Must have a patient consultation area directly next to pharmacy
• Must have a sign that indicates “Patient Consultation Area” or something equivalent
• Note there is no size requirement for this sign
• Must place notice in customer area and link on website to AHCA health information
• Only pharmacies can advertise or display Rx, Apothecary, Pharmacy, etc.
• If pharmacist is “not present and on duty,” pharmacy considered closed!
• Whenever a pharmacy is closed, it must be locked so that no non-pharmacist can enter
• Sign in block letters at least two inches, prominently displayed, that states exactly
“Prescription Department Closed”
• Not present and on duty means that the pharmacist is away from the pharmacy doing any
non-job related activity
o Pharmacist may leave to counsel patients, take a meal break and attend to
personal hygiene, and do other job responsibilities (ie take out garbage, etc.)
• Pedigree Papers- Each drug wholesaler of prescription drugs must provide a pedigree paper to
the pharmacy who receives the drug
o Pharmacy and Wholesaler maintain copies
▪ Often wholesaler maintains pharmacy’s copies as well – which is fine
o No pedigree papers for veterinary drugs and drop shipments
• Central Fill Pharmacies are permitted in FL (64B16-28.450)
• Patient drops off prescription at local pharmacy (licensed in FL) who then transmits to
Central Fill (licensed in FL) Pharmacy (fax/electronic transmission) under contract or
same owner
• This central fill pharmacy then fills the prescription and mails to local pharmacy who then
dispenses to patient.
• Central fill pharmacies may fill prescriptions for controlled substances on behalf of retail
pharmacies with which they have a contractual agreement
• Label includes both central (simple code okay) and local pharmacy name and address
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• All records must be maintained by both pharmacies for 4 year period
• Each pharmacy must maintain policy and procedure manual detailing each’s roles
• Central fill may ship directly to patient: pharmacies are under contract/same ownership,
both pharmacies have pharmacist available at least 40 hours per week to consult, both
pharmacies have toll-free phone, NON-CONTROLLED SUBSTANCES DIRECTLY
o Class II Central Pharmacy may not ship directly to patient
o Central Fill to Patient directly is NOT considered dispensing
• Central fill does not have to offer to counsel
• Central fill pharmacy does not need private patient consultation area on premises,
“prescription department closed” sign, and may be open only as many hours as needed
to provide patients timely filling of prescriptions.
• Common databases are permitted in FL
• All pharmacies accessing must be properly licensed and under common ownership
o Database owner must have written policy and procedure manual
• Must maintain records of all pharmacist activity
o Each pharmacist must maintain right to exercise professional judgment
o No pharmacist is responsible for errors of another pharmacist not under direct,
personal supervision.
• IF ONLY process drugs for other pharmacies and do not compound, dispense, store or
sell drugs, THEN do not require sink, running water, refrigeration, patient consultation
area, signs, and daily operating hours
• Closing of a pharmacy must follow procedures
• Prior to closing, must notify Board of Pharmacy of closing, return permit, and advise to
where prescriptions will be transferred
• Upon closing, must physically deliver the prescription files to a pharmacy operating within
reasonable proximity and provide a means by which to advise the public of the new
location of their prescription files, receiving pharmacy must keep files separate and not
commingle
• May transfer drug to another pharmacy transfer drug to other pharmacy
o Provide Board date of transfer, name, address, DEA# of two pharmacies,
complete inventory of controlled substances
• Close-out inventory, including controlled-substances must occur
• Permit NOT transferable
o Change of ownership of business entity (corporation, etc) does not necessitate
new permit unless identity of business entity changes
• Biosimilars Pharmacist can substitute a ‘biosimilar’ for a ‘biological product’ if there is an FDA
approved product listed in the Purple Book. [BOP must publish the list on its website as well]. FL
pharmacist must notify patient of substitute/price savings and keep record for two (2) years. If
prescriber expresses a preference against substitution in writing, verbally, or electronically then
the pharmacist must not substitute. Patient has right to refuse substitute {like a generic drug}
• FL Medical Marijuana Constitutional Amendment (passed Nov 2016)
Titled: Use of Marijuana for Debilitating Medical Conditions
• Not dispensed by a pharmacist or from a pharmacy
o Only from state assigned licensed treatment centers / use of delivery services okay
• Patient must have a documented qualifying condition by a qualified physician and be enrolled
in state registry
o Full time and seasonal patients allowed – must have a state address
o Must be used on private property in FL.
o Caregivers permitted access
• Death with Dignity / Florida does NOT provide a framework for physician assisted suicide. No
prescribing or dispensing is permitted otherwise subject to criminal prosecution
• Only Pharmacy may sell poisons (see 859.04 for list)
o Must be labeled with pharmacy name and address and the word “Poison”
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▪ Must make seller aware of poisonous characteristics and ensure legitimate
use if unusual quantity
• Sale of syringes in FL is based on city/county ordinances which vary from requiring Rx to OTC.
However, must never sell syringes to a minor without a prescription under FL law.
• Oxygen (499 Florida Statutes) – a pharmacy may sell and deliver oxygen with a prescription.
Otherwise one has to obtain a medical oxygen retail establishment permit in Florida [Not in
Blueprint – Not Tested]
• Pharmacy MUST be open to inspection all reasonable hours (Medicaid/Board of Pharmacy/State
Health Department/Insurance companies)
• May not view patient’s prescription records or other confidential data without a warrant
• May not take any physical materials (evidence) without consent or a subpoena
• All pharmacies must be inspected onsite for new permit (initial, change of owner or
address)
• State Pharmacy Inspections twice during the first year of operation
o Minimum of 1 inspection per year thereafter
o Passed inspection for three years without discipline inspected every two years
o If fail inspection or disciplined during previous 2 years inspected annually until
passed inspections for most current three years
• Medicaid Audits Specifically
• Must be conducted by a FL licensed pharmacist
• Must give at least 7 days advanced calendar notice
o Not allowed during first five days of month
• Audit period max most recent one year
• Audit Rights (see 465.1885) of PBM’s
• 7 day advanced calendar notice
o Not allowed during first three days of the month without Pharmacist’s consent
• Limited to 24 months after claim is submitted
• Audit that requires professional judgment must be conducted by a pharmacist
• Audit may be reviewed, corrected by pharmacy
COMPOUNDING
• Drugs (OTC and Rx) may be COMPOUNDED in FL pharmacy – differentiate from manufacturers
who need manufacturing license in State and FDA approval to manufacture drugs
o Must be in anticipation of prescriptions based on routine, regularly observed prescribing
patterns, preparation pursuant to a prescription of drugs which is not commercially
available, preparation of commercially available products from bulk when the prescribing
practitioner has prescribed the compounded product on a per prescription basis and the
patient has been made aware of the compounding, not be on FDA list of drugs removed
or withdrawn for safety reason
▪ Labeling requirements:
o The name, address, and phone number of the compounding pharmacy;
o The name and strength of the preparation of a list of active ingredients
and strengths;
o The pharmacy’s lot number and beyond use-date;
o The quantity or amount in the container; (note non-compounded drugs
are exempt from labeling quantity)
o The appropriate ancillary instructions such as storage instructions,
cautionary statements, or hazardous drug warning labels were
appropriate; and
o The statement “For Institutional or Office Use Only – Not for Resale,” or if
the drug is provided to a veterinarian the statement “Compounded Drug.”
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▪ Recordkeeping requirements (4 years)
o The name, address and phone number of the practitioner ordering the
compounded drug for office use and the date of the order;
o The name, strength, and quantity of the compounded drug provided,
including the number of containers and quantity in each;
o The date the drug was compounded;
o The date the compounded drug was provided to the practitioner;
o The lot number and beyond use date.
o Non-Sterile Compounding should use ‘Good Manufacturing Practices’ as defined by USP
795. USP 795 is NOT law
o May compound limited amounts for “Office Use” (see 64B16-27.700)
▪ Must register as an Outsourcing Facility with the FDA
o Central fill pharmacy may compound for another pharmacy with agreement
Sterile Compounding permitted subject to USP 797 compliance (64B16.27.797)
• This section incorporates USP 797 Guidelines into law (Pharmaceutical Compounding Sterile-
Sterile Preparations). Also USP 71 (sterility tests), USP 85 (Bacterial Endotoxins Test) and USP
731 (Loss on Drying) are now FL Law.
o ABC Required: Anteroom (ISO 8 or better [lower]), Buffer Room (ISO 7 or
better)/Compounding Room (ISO 5 or better involving uni-directional HEPA-filtered air).
Lower the ISO, the more sterile the area.
o ISO 7 Buffer and Anteroom must supply at least 30 Air Changes per hour
(AC/PH)
o Facilities must be tested twice a year minimum for sterility and air particle count
o Chemotherapy must be compounded in a dedicated hood in a negative pressure
room or biological safety hood. Needleless, splash free devices should be used
to minimize exposure of drug molecules to the environment.
o Ceiling Tiles inlaid with polymer and caulking if not ISO Class 7 or better
o Expiration dates (Beyond Use Dating is the terminology now used that you can’t begin
infusing anything Beyond the Date of expiration): Low risk compounding (48 hrs room
temp, 14 days cold , 45 days frozen). Medium Risk (30 hrs room temp, 9 days cold, 45
days frozen) High risk compounding (24 hrs room temp, 3 days cold , 45 days frozen)
o A site can extend date beyond these standard times if you have your own data to prove
your technique is effective for that period of time – cannot use literature to extend date –
only your own proof of effectiveness.
▪ Low risk- aseptic manipulations entirely within ISO 5 or better hoods; combining 3
or less sterile products into a single bag/vial. Technically, you have 3 entries into
the vial or bag – not 3 separate products. So if you need to enter the IV bag twice
to place the entire dose of reconstituted drug, then you only have one more entry
before you move to medium risk
▪ Medium risk – combining more than three (3) commercial sterile drug products and
those requiring complex manipulations and/or preparation methods. Must use
ISO 5 or less - same technicality – it really is 3 entries into the IV container, not 3
separate drug products
▪ High risk- non-sterile ingredients, lack effective antimicrobial preservatives, sterile
surfaces. Must use ISO 5 or less
▪ Immediate use in emergency (ie Code) discard in 1 hour if administration has not
begun (good for 24 hours once hung)
o Require a policy and procedures manual, adequately skilled, educated, instructed, and
trained personnel, must be USP Chapter 797 Compliant, requires a proper designated
area, specified anteroom and clean room, appropriate environmental control devices,
disposal containers, environmental controls, documented, ongoing QA control program.
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▪ All compounding personnel are required to demonstrate competency by completing
a media-filled test that represents low-level compounding annually the testing
becomes more demanding if a pharmacist or technician is going to prepare high
risk products – more frequent tests (I think twice a year), different tests (sterilizing
a non-sterile product) for high risk
New USP <797> Official December 2019:
Minimum Requirements (Based on USP 797 Proposed Requirements)
Item Frequency Competency Assessment Method
Core Hand Hygiene Initially and then at Visually observed (by qualified person)
Competencies least every 6 months
Garbing Initially and then at Visually observed (by qualified person)
least every 6 months
INITIAL-Gloved Initial testing (3 times) Initially done 3 separate times. Each
fingertip and time must be done after performing a
thumb separate and complete hand hygiene
sampling and full garbing procedure. Successful
completion is defined as zero CFU for
initial. Must be performed on donned
sterile gloves in a ISO 7 buffer room or
segregated compounding area.
*** After initial, every 6 Must be done after media fill test.
SUBSEQUENT - months in conjunction Successful completion is defined as ≤ 3
Gloved with media-fill testing CFU (total from both hands). Must be
fingertip and performed on donned sterile gloves
thumb inside an ISO 5 PEC.
sampling
Media fill test Initial qualification, Use the most difficult and challenging
and then every 6 compounding procedures and
months in conjunction processing conditions encountered by
with gloved fingertip the person during a work shift. (most
and thumb sampling. manipulations, most complex flow of
materials, longest time to compound,
size of batch). Replace all components
with soybean-casein digest media.
Failure is indicated by visible turbidity or
other visual manifestations of growth in
one or more container-closure units on
or before the end of incubation period.
• Employee or student cannot work in IV room until they have passed all of their
tests, including the media-filled test which takes 2 weeks
▪ Must complete aseptic hand-washing and wear (don) appropriate garb
• Must remove personal outer garments, cosmetics, jewelry, piercings,
and artificial nails before entering buffer area
• Wear shoe covers/head and facial hair covers/face masks/hand
wash/gown and sleeve/antispectic hand wash/sterile powder-free gloves.
Must use sterile isopropyl alcohol
o Require a policy and procedures manual, adequately skilled, educated,
instructed, and trained personnel, must be USP Chapter 797 Compliant, requires
a proper designated area, specified anteroom and clean room, appropriate
environmental control devices, disposal containers, environmental controls,
documented, ongoing QA control program.
o Lyphophilized products must be compounded under ISO 5 laminar air flow at all times
o Closed System Vial Transfer Devices (CSTD) may be used in a compounding pharmacy
ISO Class 5 hood and less than 40 doses per month
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oChemotherapy compounding requires VERTICAL laminar hood (Class II) with negative
pressure and adequate protections including splash free devices. Chemo spill kit must
be readily available
USP 800 Not yet active rule in FL
• Establishes standards for handling hazardous drugs (HD) to promote patient safety,
worker safety, and environmental protection
o Hazardous drugs include antineoplastic and other products listed with the
National Institute for Occupational Safety and Health (NIOSH Compounding,
dispensing, storage, handling, disposal, training interns and technicians
regarding quarantine, publication and accessibility of Material Safety Data
Sheets, use of reverse distributors, etc
• Requires hazardous NON-STERILE compounding to be performed in a negative
pressure room with at least 12 Air Changes Per Hour (ACPH) that is externally vented
(room air vented outside) Hoods can be vented outside or passed through redundant
HEPA
PHARMACY AND RECORDKEEPING (64B16-28.140)
• Prescription and dispensing records must be stored for at least four years in FL (10 years under
CMS (Medicaid/Medicare))
• May use an electronic imaging recordkeeping system is able to capture both sides of a
prescription
• Pharmacy must record each prescription filled in a data processing unit [Dispensing Records]
• Maintain record for at least four years
• Have capacity to produce a daily hard-copy printout within 72 hours.
o Prescription #, date dispensing, Patient Name, Prescriber Name, drug name and
strength [manufacturer of generic / or brand name], quantity dispensed, initials of
dispensing pharmacist [or other unique identifier]
o Must also have access to patient address, prescriber address and DEA if
controlled substance, quantity prescribed if different from quantity dispensed,
date prescription written [if different from date dispensed] and total number of
refills authorized
o Any significant loss of data MUST be reported to Board in writing within 10 days
of discovery
• Each individual pharmacist who dispenses or refills drugs shall verify that the data
indicated on the daily hard-copy printout is correct, by dating and signing such document
within seven days from the date of dispensing
• Each pharmacy must maintain a log book in which each individual pharmacist shall sign a
statement each day, attesting to the fact that the information entered into the data
processing system that day has been reviewed by him or her and is correct as entered,
stored for at least four years
o Must date and sign in the same manner as signing a check or legal document
• Pharmacy must maintain patient records (four years) and they must be immediately retrievable
• Must provide patient examination/dispensing records to patients upon request in a timely
manner
• Full name, address, and telephone number, age or date of birth, and gender, list of all
new and refill prescriptions over preceding four years, pharmacist clinical comments
o Must make reasonable efforts to obtain allergies, chronic diseases, and current
medications
• Hard copy or a computerized record must be maintained for at least Four years
• Records should not be provided without consent
• May provide records without consent to: provides caring for patient, upon court order
(subpoena), for research/statistical purposes (must be de-identified data), poison control
centers for treatment purposes, to department of children and family services
investigating abuse, neglect of children and adults. Pharmacist’s lawyer if concerned
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about malpractice or administrative action, department of health’s written request
investigations
• Pharmacy must seek to notify patients in writing or publish in newspaper if closing or
moving locations for them to where records will be held
• Pharmacy must maintain a back-up recordkeeping system
• Back-up system on disk, tape or other electronic medium.
• Must be backed-up on a regular basis, at least weekly
• Must report to the Board in writing any significant loss of data within 10 days of discovery
• In case of emergency, ie Hurricane the pharmacy must have an auxiliary procedure to ensure
proper refilling.
• All of the appropriate data shall be retained for on-line data entry as soon as the system
is available for use again.
COMPOUNDED prescriptions have specific recordkeeping requirements
• USP requires a Master Formulation Record and a Compounding Record for each
preparation
o Date of compounding, traceable control number, complete formula maintained in
a readily accessible format, pharmacist / technician signature or initials (preparer
and verifier), manufacturer, expiration and lot # of materials used (name and
quantity of all ingredients used), quantity in units of finished product, package
size and number of units prepared, name of the patient who received the
particular compounded product, beyond use date.
o Must be stored for four (4) years
• The prescription department manager and the permit holder are responsible for the proper
maintenance of such records and responsible that such data processing system can produce the
records outlined in this section and that such system is in compliance with this subsection
• Medicaid / Medicare recordkeeping 10 years
Controlled Substance Recordkeeping (Florida law now requires records maintained for 4 years)
• Pharmacy must maintain a computerized record of controlled substance prescriptions dispensed
• Hard copy printout summary of such record, covering the previous 60 day period, shall be
made available within 72 hours following a request for it by authorized law enforcement
• Date / Patient name and address (+ species) / Drug name and Quantity / Prescriber
• Biennial complete and accurate inventory
• Date may vary by no more than 6 months from the biennial date that would otherwise
apply
• Any member of the pharmacy team can inventory
• Records of all controls lost, destroyed or stolen including name, quantity, and date for four years
• All records must be readily retrievable from other business records and retained for at least four
years
Dispensing Controlled Substances in FL (64B16-27.831)
• Pharmacists should use sound judgment and fill prescriptions for legitimate medical purpose in
the usual course of professional practice
• If there are any concerns about the use/abuse/legitimacy of a controlled substance prescription,
the pharmacist SHALL:
o Consult PDMP and initiate communication with patient to address concerns
o Require Picture ID and make copy or document ID if patient is unknown. If no ID still must
confirm identity
o If the pharmacist’s concerns cannot be resolved, the pharmacist should not fill the
prescription
o If the pharmacist has concerns about the professional actions of the prescriber the
pharmacist MUST report said concerns to the FL Board of Health
Dispensing Practitioners
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• In FL, physicians and other prescribers (including midlevel practitioners) may register as
dispensing practitioners, allowing them to dispense drugs on premises (similar to veterinarians)
• May not dispense CII or CIII drugs (may dispense CIV’s and CV’s)
o May dispense associated with surgical procedure (14 day supply max), ‘approved’ clinical
trial, methadone per 3 day rule (3 day supply may be dispensed), buprenorphine for
detox and maintenance
o Label must include date of delivery, directions for use, name and address of prescriber,
name of the patient, and transfer warning
• Must comply with same pharmacy rules, including open to inspection
• Must allow patients options to fill elsewhere, including a pharmacy
• Use of drug samples is not included in this section and does NOT require registration as
dispensing practitioner
Pharmacist Responsibilities [Major concept on exam is differentiating responsibilities between
pharmacist/interns and technicians]
• Must be licensed
o 18 years of age, pass NAPLEX (75%) and MPJE (75%), meet internship requirements
o License renewal every two years
▪ If licensed in FL for 50 years or more, lifetime license issued, no fee required
o US Foreign graduates may licensure through endorsement
• Must be fit and competent to practice
o Cannot be intoxicated or have any physical or mental impairment which threatens safety
of patients
• Must report any fraudulent prescriptions to law enforcement. Must also report any theft or
significant loss of controlled substances to local law enforcement within 24 hrs
• Responsible for the final check of prescriptions (Not interns)
o Initial or sign the prescription face and write date filled
• Must conduct prospective drug use review (check suitability of prescription) for each prescription
filled and take the necessary steps to ensure safe practice
• Must counsel patients on medication if requested
• Must be present and on duty while working
• Pharmacists must wear a visible identification badge or monogramed smock with name and title
(Registered Pharmacist)
• Must make drug pricing readily available upon request
• May take a 30 min meal break while keeping pharmacy open
o Must post prominently a sign in the pharmacy indicating the specific hours of the day
during which meal breaks may be taken
o Pharmacist remains directly and immediately available to patients during such meal
breaks
o Technicians remain under the direct and immediate supervision of the pharmacist on
break and the pharmacist must certify all prescriptions after the meal break
• Sign the daily prescription log affirming they are responsible for the prescriptions filled
• Use professional judgment and establish validity of all prescriptions and obtain “satisfactory
patient information” if unknown
o Mail order prescriptions exempt if covered by insurance
• Direct and immediate responsibility over all interns and technicians and accept full responsibility
o May delegate responsibilities to technicians and interns while assuming ultimate
supervision and complete responsibility while conducting continuing review of their work.
▪ May monitor use technology to assist
• Dispense a one-time 72 hr emergency refill if prescriber unavailable, including controlled
substances
o Essentially any drug other than a CII can be refilled. Pharmacist must create a record and
contact the physician “within a reasonable time”
o One vial of insulin okay, in lieu of 72 hour supply
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o Pharmacy interns or technicians cannot be delegated authority to dispense this
o State of Emergency by Executive Order of Florida Governor (ie Hurricane) pharmacist
may dispense 30 day emergency prescription refill supply
• Pharmacists can order fluoride treatments if patients do not have fluoride supplement in their
water. Maximum one year of therapy. Must not switch fluoride brands.
• Ultimately responsible for compounding medications
o Interpret and identify all incoming orders, mix or be physically present and give direction to
the registered pharmacy technician
• Only pharmacist can use title pharmacist, druggist, etc
• May immunize for influenza, shingles pneumococcal and all vaccinations listed by the CDC
schedule including international travel vaccines with proper credentialing including Meningococcal
B and Zoster Vaccine recombinant (adjuvanted).
o Under protocol with physician only (conditions, categories, terms, scope, etc)
o Interns can also immunize 1:1 supervision of a pharmacist (1:5 in starting July 1st 2022)
o Complete board approved/certified 20 hrs minimum education including CPR training,
epinephrine, reimbursement procedures, reporting to VAERS
▪ Pharmacist may administer epinephrine if necessary per protocol
▪ 3 hr CE course biannually
o Maintain $200,000 of professional liability insurance
o Maintain record for 5 years
o May administer influenza to children 7 years of age and older
o Other immunizations may be authorized under Florida State of Emergency (ie hurricane,
epidemic)
o Covid Emergency Order allows pharmacists/interns/technicians to immunize pediatrics 3

years of age and older
• May dispense epinephrine auto-injectors to authorized entity (restaurant, camp, theme parks,
sports arenas)
• May dispense naloxone auto inject (Narcan) or intranasal under “pharmacist order” or
“nonpatient specific standing order” starting July 1st 2022 under protocol with a physician
• May administer a long-acting antipsychotic within a collaborative practice (standing) agreement
with a prescribing physician
o Must have a privacy room for non-deltoid injections and pharmacist to complete required
8 hour CE approved by statewide pharmacist association
• Fill out of state/ out of jurisdiction (country) prescriptions only if 1) valid order 2) licensed
prescriber in that state/jurisdiction and 3) for chronic or recurrent condition only.
o Acute diseases should be attended to in the state or country that it arises in
• Must comply with Standards of Practice for Filling Controlled Substances (see 64B16-27.831),
that is to use sound professional judgment
o Goal is for the pharmacist to dispense valid prescriptions. Habit of failing to fill valid
prescriptions out of fear is a violation of the rules
o There must exist a valid doctor patient relationship and a legitimate medical purpose
▪ True belief in indication / patient truly in need of medication
o Fill prescriptions for pain (narcotics) only if valid
▪ If the pharmacist has any questions about said validity the pharmacist must 1)
verify with doctor and 2) if patient is unknown, photocopy identification or
document on back of prescription
o May reject the filling of a controlled substance prescription only after pharmacist:
▪ First tries and communicate and rectify the concern with the patient and the
prescriber’s office OR
▪ Checks the PDMP Database (e-Forsce)
o Must report to Department of Health if suspect physician is involved with illegal diversion
o Communication between pharmacist and patient should not be overheard by others
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• Must report to State Department of Health any concerns that a prescriber is involved in diversion
• Must report any fraudulent attempts to obtain scheduled drugs within one business day to county
police or first degree misdemeanor
• Selling drugs (NON controls) without a prescription or a license is a third degree felony
• Ensure patient-physician relationship still exists and prescription is valid
o If a physician dies after the original prescription is written and refills remain, they should
be viewed as valid refills and refilled accordingly
• Prescription Department Manager is responsible CQI Programs, Recordkeeping, Automation
(QA/Security/Recordkeeping), Closing, Inspection, Compliance with the full law. Named on
permit application, and fingerprinted. Notify board within 10 days if changed.
o Rule: can only be PDM for one location only, unless otherwise approved by Board (if
show close proximity and limited workload)
• May Refuse to Fill a Prescription if concerned with validity of the prescription. But MUST
address the concern:
o Initiate communication with patient (or patient’s representative), initiate communication
with the prescriber, consult the PDMP
• Duty to Notify Patients in person about adverse incidents that result in SERIOUS HARM to the
patient. Does not constitute an admission or acknowledgment of guilt (456.0575)
• License to be immediately suspended if guilty/no contest of sex/trafficking felony/default on
student loan/positive drug test/Medicaid fraud/
Patient Counseling
• In FL, for every prescription, there must be an offer to counsel verbally and in writing. (Note that
anyone can make the offer, but only the pharmacist or intern under the direct and immediate
personal supervision can counsel).
o For drug delivery services, the offer shall be in writing and shall provide for toll-free
telephone access to the pharmacist
o No states requirement about log-book and documentation
o “The Pharmacists shall also provide counseling….if in the exercise of her or his
professional judgment, counseling is necessary”
o Patient may refuse counseling
• Pharmacist/Intern counsel on whatever is most important to the patient/situation. Nothing specific
required. Likely counsel on storage, drug name and duration, intended use, refill information,
physical dependence, addiction, misuse and abuse, especially involving controlled substances
• Counseling not required for inpatients of a hospital or institution where other licensed health care
practitioners are authorized to administer the drug(s) and not required if refused
• If a person picks up a prescription for another you must still offer to counsel
• Patient counseling may be done in person, telephonically, or via an interactive audio-digital image
format
Continuing Education Requirements (all pharmacists)
• 30 hours ACPE approved CE every two years (30 CE credits = 3 CEU)
o First time renewal to include 1 hr HIV/AIDS (FL), Each renewal 2 hours Medication Errors
o 10 of 30 hours live seminar, video teleconference, or through an interactive computer-
based application
• If first renewal is <12 months after licensure need five hours (1 HIV/AIDS, 2
med errors and 2 controlled substances)
• Between 12 and 24 months 15 hours required (5 live, 1 HIV/AIDS, 2 med
errors and 2 controlled substances)
• By January 1st 2020 must complete
o May acquire 5 credits (in Risk Management) attending all day Board meeting, 5 credits
volunteer services to indigent, 5 credits / post graduate professional semester credit
o Retain documents for 2 years after license renewed
o By January 2021 must complete approved 1-hr ce course on human trafficking and post
notice of trafficking. ”If you or someone you know…” in registered pharmacy
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• Pharmacist must complete a mandatory 2-hour CE on Controlled Substances (validation and
counseling) each cycle (counts toward the 30 hours)
• Board of Pharmacy may require disciplinary coursework for misfilles
o Laws and Rules must be at least 12 hrs / Med Errors (QRE) must be at least 8 hrs
• No need to maintain hard copies of CE completion, but instead must report CE through Board
portal. Board of Pharmacy no longer conducting audits for CE credits as they are instead
reviewed in electronic tracking system
FL Pharmacist can order/dispense from limited formulary without a prescription (Pharmacist only class of
drugs), although practically speaking this is non-existent (outdated)
• No injectables, pregnant patients or nursing mothers, recommended dose and duration only (34 d
max), must create a prescription, maintain patient profile and store for at least FOUR years
including chief complaint (in patients own words). Formulary in Appendix (see 64B16-27.220)
• Records must be protected under HIPAA
Dispense Pharmacist-only Narcotics
• Schedule V only, Adult patient only (18 years of age minimum), proof of identification required
(even if patient known), bound volume must be maintained as a record
• Dose not to exceed 120 milligrams of codeine [60 milligrams dihydrocodeine, 30 milligrams of
ethyl morphine,] or 240 milligrams of opium within 48 hrs
• Pharmacist may withhold sale at discretion if believe purpose is abuse
Impaired Practitioners (Drugs/Alcohol/Mental/Physical (DAMP) condition) (see 456.076)
• Florida has an impaired practitioner programs for pharmacists (interns and technicians also) (and
other licensed healthcare providers)
• Complaints involving DAMP impairment will not be subject to disciplinary action (ie loss of
licensure) if the Probable Cause Panel/Board of Pharmacy (PCP/BOP) determines the
pharmacist, working with a state-approved impairment consultant:
o Acknowledges the impairment
o Voluntarily enrolls in an approved-treatment program
o Withdrawals or limits scope of practice as determined by consultant
o Makes available pertinent medical records to consultant
• Upon fulfilling the requirements of the program, the pharmacist may return back to practice
unrestricted as long as no other complaints have been filed.
o No practice while in program
• Pharmacist pays own expenses
• If there is no complaint a pharmacist may still join the program without oversight by PCP or BOP.
Must withdraw from practice
• If pharmacist does not comply with the program, such facts will be disclosed to the board for
action (ie suspension, etc…)
• Reports to Department of Health will undergo a probable cause panel to establish preliminary
requisite
Consultant Pharmacists
• Each Institutional Pharmacy MUST have a pharmacist of record
o May hire other consultants to do work, although ultimate responsibility remains with
consultant of record
o Consultant of record must notify Board within 10 days of relinquishing responsibility
• Requires successful completion of a Consultant Pharmacist course of at least 20 hours
sponsored by an accredited college of pharmacy located within the State of Florida, and
approved by the Florida Board of Pharmacy
• Must obtain 24 CE credits every two years approved for consultant in addition (12 + 12) to the 30
required of all pharmacusts (54 credits total every two years)
Consultant Pharmacists may provide ‘Medication Management Services’ in the institutional healthcare
system (Medical Director/Physician/Dentist/Podiatrist) under a Collaborative Practice Agreements
• Prescriber Care Plan is written by MD/DO/PA/Podiatrist/Dentist/ Medical Director
• There must be ‘private, distinct, and partitioned’ area
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• Continuous quality improvement required
• Includes such things as “order laboratory tests, interpret laboratory values ordered for a patient,
execute (new and changes to) drug therapy orders for a patient, and notify the prescriber”
• Pharmacist must be registered consultant pharmacist in FL
Collaborative Practice Agreements and Chronic Care Therapy (465.1865)

• Must be certified with Board of Pharmacy
• In, FL under collaborative practice agreements (Called Prescriber Care Plans), pharmacist in
ambulatory care and community practice may treat chronic (NO ACUTE) conditions listed with a
prescribing physician:
o Arthritis, asthma, COPD, T2DM, HIV, Obesity, Hyperlipidemia, Hypertension, Anti-Coag,
Smoking Cessation/Nicotine Dependence, Opioid Use Disorder (#11)
• Requires written DETAILED protocol (called the Prescriber Care Plan) with information on
responsibility, timing, drugs, diseases, tests, etc preapproved by Board
o May be terminated by either party at any time
o Involves MD/DO only
o No controlled substances by pharmacist under agreement
o Pharmacy Owner must approve employee
• Requires PharmD or BSPharm plus 5 years experience, $250,000 liability insurance, must
maintain records for at least five years, complete a program at least 20 hours and then must also
complete 8 hours ce annually in addition to relating to collaborative practice
Test and Treat Programs for Minor Ailments (465.1895)

• Must be certified with Board of Pharmacy
• In FL, pharmacists may Test and treat minor ailments within the pharmacists, NEW scope of
practice UNDER ESTABLISHED PROTOCOL OF A PHYSICIAN, preapproved by Board;
community and ambulatory settings
• Test: order labs, perform physical , ie nasal swab testing,
• Treat, non-chronic conditions, acute such as flu, strep, lice, athlete’s foot/ringworm, and minor
uncomplicated infections, ie skin, hair, nails, etc.
o Treat only with formulary of FDA approved drugs (no off label use)
• Requires certification by the BOP in conjunction with BOM, complete a program at least 20 hours
and approved 3 hr CE on minor, non-chronic conditions each renewal in addition to / 2 years,
minimum $250,000 liability insurance and maintain records for at least five years
• Requires written DETAILED protocol with information on responsibility, timing, drugs, diseases,
tests, etc
• Must post visible sign advising patients to seek follow-up care with primary care physician
• DOES NOT APPLY TO OTC drugs, which a pharmacist can recommend under basic scope of
practice
• Pharmacists must report public health diseases to Board if found
• Must deliver patient records within 5 days of a patient request
Nuclear Pharmacist
• Must renew their license every two years
• Must receive at least 24 hrs approved continuing education credit for nuclear pharmacy every two
years
o Cannot be applied towards the required 30 general hours required of all pharmacists
o Must complete 200 hour approved didactic coursework
o Must complete 500 hours on the job training
o If trained in nuclear pharmacy more than 7 years ago, must have documented at least
1080 hours of nuclear practice in last seven years
Interns
• MAY NOT provide final check of the completed prescription
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o Only the pharmacist assumes the complete responsibility for its preparation and accuracy
• Function under the “direct and immediate personal supervision” of a licensed pharmacist
• Unlimited number per pharmacist allowed
o Foreign pharmacy graduates must be 1:1 ration of pharmacist:intern
• May give copies and transfers
o Must fill a prescription before it can be transferred, meaning a pharmacy that has a script
on file cannot simply transfer the prescription. It must be filled and then transferred.
o Interns may transfer controlled substance prescriptions
o (remember technicians may not transfer ANY prescriptions)
• Interns must wear a visible identification badge or monogramed smock with name and title
(Registered Pharmacy Intern)
• May immunize adults under the direct and immediate supervision of a certified immunizing
pharmacist (1:1 Ratio on immunizations)
o Must complete 20 hours board approved coursework
o Registration fee waived for interns
• Must be currently enrolled and attending an accredited pharmacy school
• Must register with State, demonstrate proof of enrollment or graduation from accredited school of
pharmacy
o Must notify state board of pharmacy within 30 days of graduation or withdrawal from
program. May request maintenance of intern license if plan to re-enroll.
• Interns with documented 2080 hours completed are eligible for lilcensure
o Can not use more than 50 hrs per week when in school or 60 hours per week after
graduation toward the 2080 requirement
Technicians
• Function under the “direct supervision” of a pharmacist who is “readily and immediately available”
o Technology is okay. Technicians must be in Same physical location OR real-time, two-
way technology is employed
• 1:1 technician to pharmacist ratio DEFAULT
o However, this ratio may be increased with written approval from Board of Pharmacy
• Request must include brief description of the workflow include operating hours of
pharmacy, number of pharmacists/interns/and technicians.
• Up to 3:1 ratio allowed for sterile compounding
• Up to 6:1 ratio allowed for regular dispensing, not involving with sterile
compounding
• Up to 8:1 ratio allowed for non-dispensing pharmacies (no sterile
compounding) and dispensing pharmacies where their drugs are not
dispensed (‘Physically Separate Areas’ with walls or a barrier)
• Must be registered
o Complete application, pay fee, must be at least 17 years of age, provide proof of Board
approved training program (proposed 160 hours within 6 months)
• Disciplined pharmacist ineligible to be registered
• Interns can work as technicians without registering
• Do not have to register while in technician school
• Must complete 20 hours of CE required biennially
o 4 hours live, 2 hours med errors / pharmacy law
• Pharmacy must have written job descriptions for technicians as well as policies and procedures in
pharmacy, signed by the technicians.
o Must be signed within 90 days of hire
o Ensure each technician is knowledgeable and work requests do not exceed the written
job description/policy/procedure.
o includes information on 12 items defined in rule (this manual must be maintained at the
pharmacy)
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o Prescription Department Manager must maintain documentation of appropriate training,
such as certification, attendance logs, and quiz scores
• May administer vaccines and immunizations to ADULTS with six hours approved training
effective July 1st 2022 (1:5 ratio approved)
• Technicians must wear a visible identification badge or monogramed smock with name and title
(Registered Pharmacy Technician) and identity themselves in all communications as technicians
• Pharmacists may delegate certain tasks to technicians (Registered Technicians including
Technicians In Training). Pharmacist must have Direct Supervision meaning can provide
personal assistance. This includes the use of Technology (ie video or audio)
Pharmacy technicians MAY NOT (64B16-27.420): NON-DELEGABLE ACTS:
o Receive new non written prescriptions or receive any change in the medication, strength, or
directions of an existing prescription;
o Interpret a prescription or medication order for therapeutic acceptability and appropriateness;
o Conduct final verification of dosage and directions;
o Engage in prospective drug review;
o Monitor prescription usage;
o Override clinical alerts without first notifying the pharmacist;
o Transfer a prescription;
o Prepare a copy of a prescription or read a prescription to any person for purposes of
providing reference concerning treatment of the person or animal for whom the prescription
was written;
o Engage in patient counseling;
o Receive therapy or blood product procedures in a permitted nuclear pharmacy, or
o Engage in any other act that requires the exercise of a pharmacist’s professional judgment.
Delegable Acts: Acts which are NOT based on the technicians own judgment or discretion. The
pharmacist MAY delegate these tasks to the pharmacy technician. Should be stated in the policies and
procedures manual
Pharmacy technicians MAY (64B16-27.420): DELEGABLE ACTS:
o Data entry;
o Labeling of preparations and prescriptions;
o Retrieval of prescription files, patient files and profiles, and other similar records
pertaining to the practice of pharmacy;
o The counting, weighing, measuring, and pouring of prescription medication or stock
legend drugs and controlled substance
o Filling of an automated medication system (under the direct supervision of a pharmacist)
o The initiation of communication to confirm the patient’s name, medication, strength,
quantity, directions, number of refills, and date of last refill;
o The initiation of communication with a prescribing practitioner or their agents to obtain
clarification on missing or illegible dates, prescriber name, brand or generic preference,
quantity, license numbers or DEA registration numbers;
o The acceptance of authorization to dispense medications pursuant to a prescribing
practitioner’s authorization to fill an existing prescription that has no refills remaining (refill
authorization);
o The receiving, in a permitted nuclear pharmacy, of diagnostic orders only;
o Assisting in preparing parenteral and bulk solutions or assisting in any act involving
sterile compounding
o Organizing of or participating in continuous quality improvement related events,
meetings, or presentations;
o Participation in a monitoring program to remove deteriorated pharmaceuticals to a
quarantine area; and
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o While under the direct supervision of the pharmacist, performance of any other
mechanical, technical or administrative tasks which do not themselves constitute practice
of the profession of pharmacy.
o A registered pharmacy technician, under the supervision of a pharmacist, may initiate or
receive communications with a practitioner or his or her agent, on behalf of a patient,
regarding refill authorization request
Prescribers
o In FL, the following may prescribe (including controlled substances), limited to scope of practice:
o Dentists (DDS, DMD)
o Physicians (MD / DO)
o Podiatrists (DPM)
o Veterinarians (DVM)
o Optometrists (OD) (OcularTopical and Systemic drugs per formulary (see Formulary
463.0055) – some analgesics, antibiotics, antivirals, and antiglaucomas
o Only control substance allowed is Tylenol 3 with Codeine. Must have complete
additional training to prescribe oral medications (ie 20 hour course) and DEA
registration to prescribe control substances
o Physician Assistants (PA), Nurse Practitioners (ARNP)
▪ May prescribe controlled substances 7 day max CII narcotics
• PA: Schedule II Psychiatric Mental Health 14 days max to children
under 18
▪ ARNP: Psychiatric Nurse only prescribe CII mental health drugs to children
under 18
▪ PA prescriptions must have supervising physician’s name on prescription
o Physicians cannot self-prescribe controlled substances in FL (Medical Rule); may prescribe for
family friend within scope of practice. Must document in chart. Should never pre-sign
prescription blanks
o All prescribers of Controlled Substances MUST complete a 2 hour program approved by
statewide association of physicians each biennial renewal period (every two years)
o All state prescribers must complete a One Hour State approved course on Human Trafficking
o In FL, the following (may prescribe under statute but very narrowly construed and thus practically
should be viewed as) unable to prescribe:
o Chiropractors
o Pharmacist
o Naturopaths (pre 1959)
o In FL, the following are never able to prescribe:
o Anesthesiologist Assistants, Doctors of Oriental Medicine, Nurses, Respiratory
Therapists, Psychologists
o Active Military Physician not licensed in Florida to practice, may be issued a ‘Temporary’ license
in FL to practice in non-military setting for six months
o No “Office Use” of Controlled substances allowed to be prescribed or dispensed
o Must write prescription legibly (Unique FL law)
o All controlled substance prescriptions must have copies in the patients’ Medical Record
o FL allows compassionate use/ investigational use of a non-approved drug for a patient who has
given informed consent and has documentation from the prescribing physician has a terminal
illness, that is expected death within 1 year
o Patient consent required. ‘Reasonable’ Cost to be established between
manufacturer and patient.
Prescriptions
• In FL all prescriptions [under an electronic health record] should be electronic
o Exceptions where written may be permissible include prescriber reasonably determines it
would be impractical as to delay care, practitioner and dispenser are the same, research
protocol, hospice or nursing home facility, to allow patient to cost-compare among local
pharmacies, or physician has been granted a waiver [lots of loopholes ].
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o E-script software must not include any sponsorship or advertisements intended to
influence choice; may include formulary pricing information however
• Florida prescriptions expire in one year from date written
o CIII-CV expire in 6 months per Controlled Substance Law
• All prescriptions must be based upon a valid practitioner-patient relationship that includes a
documented patient evaluation, including history and a physical examination adequate to establish
the diagnosis for which any drug is prescribed and any other requirement. This is interpreted as
physician must be in active practice, accessible conventional communications. Important note,
Florida law has no rules defining valid prescription per se.
• FL maintains a Negative drug formulary- the following generic drugs cannot be substituted for a
brand drug prescribed
1. Digitoxin (note this is NOT digoxin)
2. Conjugated Estrogen (ie Premarin, Cenesta, Enjuvia)
3. Dicumarol (note this is NOT warfarin)
4. Solid Oral Dosages of Chlorpromazine (Can substitute syrup, injection, and suppository)
5. Controlled Release Theophylline (Can substitute immediate release formulations)
6. Oral Pancrelipase
✓ Any drug that has all A-rated generics are not permitted to be included on FL’s Negative
Drug Formulary
Note that absence of levothyroxine, warfarin and digoxin which have been removed over the years
• All controlled substance prescriptions require counterfeit-resistant, vendor-approved blanks
including vendor nunber-date-batch (seriel) number
o Veterinary drugs exempt from requirement to use counterfeit-resistant pads
o Not transferrable from physican to physican
• Physicians may not prescribe Controlled Substances using telehealth in an outpatient setting
(Hospice , Nurisng Home, Hospital okay). May prescribe psychiatric controls.
FL Prescribing CII’s (456.44)
• Prescribing Controlled Substances CII ACUTE PAIN in FL
o 3 day rule for CII’s, maximum allowed UNLESS:
o 7 day supply if prescription states Acute Pain Exception
▪ Necessary deviation from three days and documented in medical record
• Prescribing Controlled Substances CII CHRONIC PAIN in FL
o No max duration or quantity
o Must state Non Acute Pain on Prescription
• Patients with severe trauma injury (> score of 9) having CII’s must be prescribed emergency
opioid antagonist naloxone (Narcan) concurrently
• Different prescriptions required for different drug classes/scheduled. Cannot prescribe drugs from
different schedules on same prescription blank
• Prescribers must discuss non-opiod options with patients when prescribing opiates (CII) including
options and pros and cons
o Must provide state mandated pamphlet electronically or paper format
o Exemptions include hospice, hospital critical care and ER
Prescription Orders must be legible and contain the following (11 + refills /15 points)
1. Date of issue
▪ Controlled substances: numerical month/day/year (or month/abbreviated written)
2. Patient’s full name (owner’s name plus species of the animal if controlled substance)
3. Patients address (controlled substances)
4. Practitioner’s name
5. Practitioners address
6. Drug name
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7. Drug strength
8. Dosage form
9. Quantity prescribed (in numeric (#30) and textual (thirty) for controlled substances)
▪ Number of refills (if any) authorized
10. Directions for use
11. Manual signature of prescriber (stamp not okay)
Remember all controlled substance prescriptions must be on vendor approved counterfeit resistant pads
Patients have right to bring prescriptions (including e-scripts) to ANY pharmacy of choice
Controlled prescriptions in Florida, Pharmacist must
12. Practitioners DEA registration
13. Initial the prescription
14. Write date filled
15. Note the prescription number
All dispensed outpatient prescriptions must be LABELED/LABELING with the following (9/11) items - [See
64B16-28.108]
1. Name of pharmacy
2. Address of pharmacy
3. Date of dispensing.
4. Serial (prescription) number.
5. Name of the patient (or if the patient is an animal, the name of the owner and the species
of animal)
6. Name of the prescriber.
7. Name of the drug dispensed (except where the prescribing practitioner specifically
requests that the name to be withheld).
8. Directions for use.
9. Expiration date (FL uses a 1 year beyond use date (discard aftyer date / do not use after
date) from date filled or manufacturers expiration date if earlier)
* note what is NOT REQUIRED on the label – patient address, date prescription was
written, address of prescriber, quantity, dosage form, number of refills remaining,
formulation, telephone number of the pharmacy, Manufacturer contact information
Controlled Substances must also include:
10. Date of initial fill if a refill
11. Cautionary statement required under Federal Law (Caution: Federal law prohibits the
transfer of this drug to any person other than the patient for whom it was
prescribed) [CII-CIV Only]
If the prescription only includes the quantity numerically (not textually) or the date numerically (not textually),
the pharmacist can still dispense without physician verification IF there is a prescription record on file for
the patient
Repackaged drugs must be labeled with (R-E-P-A-C-K 6 Requirement)
1. Brand or generic name.
2. Strength.
3. Dosage form.
4. Name of the manufacturer.
5. Expiration date.
6. Lot number:
a. Manufacturer’s lot number, or
b. Number assigned by the dispenser or repackager which references the
manufacturer’s lot number.
o Prepacking in Class II pharmacy / Community pharmacy must follow documented
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procedures as set up be Consultant Pharmacist on Record / Prescription Department
Manager
• Customized Patient Medication Packages (Med Paks, Multi-dose packs, Pill Packs, Blister
Packs)
o Must obtain patient consent prior to dispensing
o Label with name, address, and telephone # of pharmacy, prescription # for the pack and
each individual drug within the pack, date prepared, patient name, name of each
prescriber, directions for use and any cautionary statements required, storage
instructions, name strength quantity and physical description of each drug, beyond use
date no more than 60 days from date of preparation
• Florida permits a one-time 72 hr emergency refill if prescriber unavailable, including controlled
substances
o Essentially any drug other than a CII can be refilled as law is written. Pharmacist must
create a record and contact the physician as soon as possible
• Standards for the Prescription of Obesity Drugs (64B8-9.012): All Prescriptions for weight loss
drugs must be in writing signed by the prescribing physician. Initial prescriptions may not be called
into the pharmacy. Refills may be phoned in. Physician must meet personally with patient and
may only prescribe FDA approved drugs. Note this is a a medical rule, not a pharmacy rule so
unlikely to be tested on MPJE.
• Pharmacists and Interns may give copies and transfers to another pharmacy
o Taking Transfer/Copy
▪ Dispensing pharmacist must tell patient the prescription at other
pharmacy is now cancelled, establish legitimate prescription with
valid refill(s) (including pharmacy/pharmacist is licensed), record
the prescription, the name of the copying pharmacy, the
prescription number, the drug, the original amount dispensed,
the date of original dispensing, and number of remaining refills.
o Giving Transfer/Copying
▪ Pharmacist must determine valid request, provide the
prescription, the name of the pharmacy, the prescription number,
the drug, the original amount dispensed, the date of original
dispensing, and number of remaining refills. Pharmacist must
record the transferring pharmacy name, pharmacist, and date of
request and cancel the electronic prescription (or void written
prescription).
o Interns may give/take transfers for Controlled Substances under State
and Federal law
o If prescription is not dispensed within a reasonable time, the transferring
pharmacy should contact the copying pharmacy and the prescription
should be revalidated through the same process, as described above.
o May dispense generic even if brand was originally filled
▪ Unless prohibited by negative formulary or “Medically
Necessary”
• Drug Returns - Dispensed prescriptions may not be returned to stock and must
never be redispensed. The pharmacist may wish to give credit or a refund but
cannot comingle any drug because the quality cannot be assured.
o Unused unit-dose medications dispensed to inpatients and properly
labeled may be returned to the pharmacy for redispensing.
▪ Nursing homes, hospitals, short-term primary care treatment
centers
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o Pharmacist must maintain appropriate records for any unused or
returned medicinal drugs.
o Drugs dispensed but returned in a Closed delivery system (unit
dose/customized medication packages) may be returned to stock if is
individually sealed and labelled)
▪ Unclaimed prescriptions may be stored in pharmacy and reused, subject to 1 year beyond use
date from date originally filled or manufacturer’s expiration date
• Patient Medication Information Sources (3 types) provided with prescriptions dispensed
o Medication Guide is considered part of the Drug labeling
• Required for certain drugs the FDA determines has risks that need to be provided to
patients
• Currently about 200 drugs have a Medication Guide required
• If required and do not provide, drug is misbranded
o Patient Package Insert (PPI) is considered part of the drug labeling
• Required for all estrogens and oral contraceptives
– Outpatient: Required with each prescription
– Inpatient: Provided before first dose and every 30 days thereafter
• Other products may Voluntarily seek approval to provide these to patients.
• Approved by the FDA
o Brochures/Pamphlets/Leaflets/ Consumer medication information (CMI) is the pharmacy drug
information provided by pharmacies with dispensed drugs
• Required under law to be provided for every prescription dispensed
• Are not FDA reviewed/approved and not part of the drugs labeling
• If no provide, no liable for misbranding
• Students may carry epinephrine auto injectors in FL school with written authorization from
physician and parent/guardian. School nurse must be informed and work with student to develop
an overall emergency health plan annually.
Florida Prescription Drug Monitoring Program of Controlled Substances (PDMP E-FORSCE)

• Dispensing CII-CV drugs are reported to the States Prescription Drug Monitoring Program
• CV non-opioids are not reported
• Pharmacist and Physician MUST consult for patients 16 yo and older
• Pharmacist dispensing of controls monitored; as well as physician prescribing of controls
• Attempts to minimize diversion of controlled substances
• Program called E-FORCSE
• Within 1 days of dispensing using ASAP Standards, pharmacy must report:
• Doctors Name, DEA#, Date Rx written
• Pharmacy’s name, address, DEA#, Date Rx filled and method of payment,
NPI
• Full name, address and DOB of patient
• National drug code, quantity, and strength of controlled substance
dispensed.
• Name of individual picking up controlled substance
• State Department of Health to issue Patient “Advisory Report” to pharmacist and physician
upon request for Rx history – summary of reported information for a patient
• Not reported: hospitals, nursing homes, correctional facilities, ambulatory surgical centers,
hospices, intermediate care facilities for the developmentally disabled, correctional facilities,
emergency rooms, patients under the age of 16, one-time doses, 72-hour emergency refills,
and patients directly administered controlled substances by a physician
• Compounded drugs are included (ie reportable) in database
• It is illegal in FL for a person to possess prescription drugs without a valid
prescription. Florida law recognizes that there are limited instances where the possession of
prescription drugs without a valid prescription is warranted. The department is authorized to
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issue letters of exemption in such cases for certain qualified persons for lawful research,
teaching, or testing, and not for resale.
• Information (name, doctor, address, phone number) is confidential (even insurance plan) and
is to be disclosed only for legitimate requests using a verification process to healthcare
workers, attorney general (not a regular lawyer), medical examiner, impaired practitioner
program when authorized by the Impaired practitioner, legal healthcare surrogate
FL Board of Pharmacy
• Job is to protect the public (FL patients) not the pharmacists or the profession
• Composed of 9 members, appointed by the Governor, confirmed by the Senate
o 7 licensed pharmacist members, state residents, representative of various practice
settings, in practice for at least 4 years, at least 1 member must be at least 60 years of
age
▪ 2 Community/outpatient pharmacy representative
▪ 2 Class II institutional Pharmacy /Modified Class II / Class III
▪ 3 members open requirement
o 2 community members, state residents, not pharmacists, no connection to the profession,
drug wholesales or pharmaceutical manufactures
• Members serve 4 year terms
• May discipline pharmacists who deviate from law/rule
o Sanctions may include fine, suspension, revocation
o See table below…examples of violations include, , failing any drug test subjects the
pharmacist to suspension or restriction of the license to practice, etc
o Default on student loan no longer a violation since Covid
• Probable Cause panel investigates rule violations or complaints to determine if there is sufficient
cause to bring before the full board. Meets as often as necessary
o Composed of two members of the Board of Pharmacy, one of which must be a
pharmacist (usually chair)
o Double affirmative (positive) vote required to find probable cause exists that a violation
has occurred
• Florda Parent’s Bill of Rights: pharmacist must obtain parent’s signed consent when providing
services to a child
Section 5
Florida Pharmacy Law Appendices
Differences between Federal and FL Pharmacy Laws
Florida State Law Federal Law
Expiration date Schedule II prescriptions expire 1 year from the date of No expiration generally
on CII’s the original prescription. on Schedule II
Rule 64B16-27.211 Prescription Refills. prescriptions.
60 days from date

issued for LTC patients
and Terminal Illness
21 CFR 1306.13
Patient A verbal and printed offer to counsel must be made for OBRA-90 requires
counseling all outpatient prescriptions including new or refill counseling be offered to
requirements prescriptions. If the drug is not delivered directly to the Medicaid patients only.
patient (or agent), the offer shall be in writing and
provide for toll-free telephone access to the pharmacist.
No such requirement for inpatient prescriptions.
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Rule 64B16-27.820 Patient Counseling.
CII Emergency limited to a 72-hour supply. limited to amount

Prescriptions – 893.04.(1).(f). adequate to treat the
Verbal patient during the
emergency period
Written format the date on controlled substance prescriptions must be No requirement exists
on controlled written out in abbreviated month (Jan 1, 2011) and for how date should be
substance quantity must be provided in both numbers (30) and written or for how
prescriptions letters (thirty). Pharmacist may write the information in quantity must be
after verifying with prescriber. If prescriber is provided on controlled
unavailable, then the pharmacist may dispense the substance prescriptions
controlled substance but may insist that the person to
whom the controlled substance is dispensed provide
valid photographic identification. If a prescription
includes a numerical notation of the quantity of the
controlled substance or date, but does not include the
quantity or date written out in textual format, the
pharmacist may dispense the controlled substance
without verification by the prescriber of the quantity or
date if the pharmacy previously dispensed another
prescription for the person to whom the prescription was
written
893.04(2).(d).
Legible Yes. Prescription be legibly written or typed; that No requirements

prescription law the quantity of the drug must be written in numerical
and textual format; that the date of
the prescription must be written in textual letters (e.g.
July 1, 2003); and that the
practitioner must sign the prescription on the day it is
issued.
§ 456.42
Multiple drugs Each blank must only have drugs from same class No restriction
on same blank prescribed.
Oral Oral prescriptions for Schedule III medications are No restriction for oral
Prescriptions for limited to a 30 day supply including refills Schedule III
CIII prescriptions are
described
Checking The pharmacist must write his/her initials and the date There is no requirement
prescriptions for filled on the face of all controlled substance that the initials of the
Controlled prescriptions pharmacist filling the
Substances
prescription and the date
filled be written on the
face of the prescription
Tamper Counterfeit resistant prescription pads for Schedule II, All written Medicaid
resistant pad III, IV drugs are required [veterinary prescriptions are outpatient prescriptions
requirements exempt] must be written on
tamper-resistant pads
Counterfeit pads contain:
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– Preprinted physician’s name, address,
and category of licensure
– Security features
• background green or blue and
resist reproduction.
• The blank must be printed on
watermarked paper.
• The blank must resist erasures
and alterations.
• The word ‘void” or “illegal” to
appear on any photocopy or
reproduction
893.065
Prescribers of Florida authorizes Federal law allows
Controlled • Physicians (MD and DO) states to determine
Substances • Dentists which practitioners can
• Podiatrists prescribe. Midlevel
• Veterinarians practitioners (NP/PA)
Midlevel Practitioners authorized under protocol with may be authorized under
exception. state law, but Florida
• Seven day max CII (except for psychiatric nurse prohibits.
prescribing psychiatric CII which has no limit.
Patient must be 18 years or older)
• Optometrist can only prescribe Tylenol #3
Codeine
Note that theoretically an out of state DEA licensed
midlevel practitioner may write a valid prescription in FL
if “necessary for the continuation of treatment of a
chronic or recurrent illness”
Salvia Schedule Schedule I Not scheduled
Amount of CV Lower Higher
Available
without
prescription
Recordkeeping Requirements in Florida

Prescription record Four years from date of last dispensing 465.022 12 (b)
Controlled substance inventory Conducted every two years 893.07(1)(a)
Inventory records Maintained for at least four years 893.07(4)(a)(b)
Pharmacy permits Expire every odd years on Feb 28th
Immunization records Maintain for at least five years 465.189(3)
Patient records for pharmacist-only drug Four years 64B16-27.210
orders
Patient records for prescription drugs Four years from date of last entry 465.022 12 (b)
dispensed
Compounded drugs ordered by Four years 64B16-27.700
practitioners for office use
Pharmacy Continuous Quality Four years 64B16-27.300
Improvement Program summarizations
Dispensing logbook Four years 64B16-28.140
Starter Dose prescription Records Four years 64B16-28.503
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Class II Institutional Pharmacy reports / Four years 64B16-28.605
analysis generated as part of the quality
assurance program
Class II Institutional Pharmacy Four years 64B16-28.605
transaction records from the automated
medication system for all controlled
substances dispensed or distributed
Class II Institutional Pharmacy reports / Four years 64B16-28.605
databases related to access to the
system or any change in the access to
the system or to medications
Class II Institutional Pharmacy remote Four years 64B16-28.606
medication order records that identify the
name, initials, or identification code of
each person who performed a
processing function for every medication
order.
Automated pharmacy system Four years 64B16-28.607
transactions for Long Term Care,
Hospice, and Prisons
Drug Samples records of distribution, Three years 499. 028
destruction, or return to the manufacturer
or distributor, thefts or significant losses
of drug samples, and of all requests
made under for drug samples.
Wholesale records The longer of two years following the 499.0121
disposition of the drug or three years
from the creation of the record
Prescription drug distributions Four years 465.022
Records and sales of ether by Five years 499.66
manufacturers, distributors, and dealers
465.016 Pharmacist Disciplinary actions.—

(1) The following acts constitute grounds for denial of a license or disciplinary action,
(a) Obtaining a license by misrepresentation or fraud or through an error of the
department or the board.
(b) Procuring or attempting to procure a license for any other person by making or
causing to be made any false representation.
(c) Permitting any person not licensed as a pharmacist in this state or not registered as
an intern in this state, or permitting a registered intern who is not acting under the direct
and immediate personal supervision of a licensed pharmacist, to fill, compound, or
dispense any prescriptions in a pharmacy owned and operated by such pharmacist or in
a pharmacy where such pharmacist is employed or on duty.
(d) Being unfit or incompetent to practice pharmacy by reason of:
1. Habitual intoxication.
2. The misuse or abuse of any medicinal drug appearing in any schedule controlled
substance
3. Any abnormal physical or mental condition which threatens the safety of persons to
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whom she or he might sell or dispense prescriptions, drugs, or medical supplies or for
whom she or he might manufacture, prepare, or package, or supervise the manufacturing,
preparation, or packaging of, prescriptions, drugs, or medical supplies.
(e) Adulteration
(f) Having been convicted or found guilty, regardless of adjudication, in a court of this
state or other jurisdiction, of a crime which directly relates to the ability to practice
pharmacy or to the practice of pharmacy. A plea of nolo contendere constitutes a
conviction for purposes of this provision.
(g) Using in the compounding of a prescription, or furnishing upon prescription, an
ingredient or article different in any manner from the ingredient or article prescribed,
except as authorized in s. 465.019(6) or s. 465.025.
(h) Having been disciplined by a regulatory agency in another state for any offense that
would constitute a violation of this chapter.
(i) Compounding, dispensing, or distributing a legend drug, including any controlled
substance, other than in the course of the professional practice of pharmacy. For
purposes of this paragraph, it shall be legally presumed that the compounding,
dispensing, or distributing of legend drugs in excessive or inappropriate quantities is not
in the best interests of the patient and is not in the course of the professional practice of
pharmacy.
(j) Making or filing a report or record which the licensee knows to be false, intentionally
or negligently failing to file a report or record required by federal or state law, willfully
impeding or obstructing such filing, or inducing another person to do so. Such reports or
records include only those which the licensee is required to make or file in her or his
capacity as a licensed pharmacist.
(k) Failing to make prescription fee or price information readily available by failing to
provide such information upon request and upon the presentation of a prescription for
pricing or dispensing. Nothing in this section shall be construed to prohibit the quotation
of price information on a prescription drug to a potential consumer by telephone.
(l) Placing in the stock of any pharmacy any part of any prescription compounded or
dispensed which is returned by a patient; however, in a hospital, nursing home,
correctional facility, or extended care facility in which unit-dose medication is dispensed
to inpatients, each dose being individually sealed and the individual unit dose or unit-dose
system labeled with the name of the drug, dosage strength, manufacturer’s control
number, and expiration date, if any, the unused unit dose of medication may be returned
to the pharmacy for redispensing. Each pharmacist shall maintain appropriate records for
any unused or returned medicinal drugs.
(m) Being unable to practice pharmacy with reasonable skill and safety by reason of
illness, use of drugs, narcotics, chemicals, or any other type of material or as a result of
any mental or physical condition. A pharmacist affected under this paragraph shall at
reasonable intervals be afforded an opportunity to demonstrate that she or he can resume
the competent practice of pharmacy with reasonable skill and safety to her or his
customers.
(n) Violating a rule of the board or department or violating an order of the board or
department previously entered in a disciplinary hearing.
(o) Failing to report to the department any licensee under chapter 458 or under chapter
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459 who the pharmacist knows has violated the grounds for disciplinary action set out in
the law under which that person is licensed and who provides health care services in a
facility licensed under chapter 395, or a health maintenance organization certificated
under part I of chapter 641, in which the pharmacist also provides services. However, a
person who the licensee knows is unable to practice medicine or osteopathic medicine
with reasonable skill and safety to patients by reason of illness or use of alcohol, drugs,
narcotics, chemicals, or any other type of material, or as a result of a mental or physical
condition, may be reported to a consultant operating an impaired practitioner program as
described in s. 456.076 rather than to the department.
(p) Failing to notify the Board of Pharmacy in writing within 20 days of the
commencement or cessation of the practice of the profession of pharmacy in Florida when
such commencement or cessation of the practice of the profession of pharmacy in Florida
was a result of a pending or completed disciplinary action or investigation in another
jurisdiction.
(q) Using or releasing a patient’s records except as authorized by this chapter and
chapter 456.
(r) Violating any provision of this chapter or chapter 456, or any rules adopted pursuant
thereto.
(s) Dispensing any medicinal drug based upon a communication that purports to be a
prescription as defined by s. 465.003(14) or s. 893.02 when the pharmacist knows or has
reason to believe that the purported prescription is not based upon a valid practitioner-
patient relationship.
(t) Committing an error or omission during the performance of a specific function of
prescription drug processing, which includes, for purposes of this paragraph:
1. Receiving, interpreting, or clarifying a prescription.
2. Entering prescription data into the pharmacy’s record.
3. Verifying or validating a prescription.
4. Performing pharmaceutical calculations.
5. Performing prospective drug review as defined by the board.
6. Obtaining refill and substitution authorizations.
7. Interpreting or acting on clinical data.
8. Performing therapeutic interventions.
9. Providing drug information concerning a patient’s prescription.
10. Providing patient counseling.
(2) The board may enter an order denying licensure or imposing any of the penalties in
s. 456.072(2) against any applicant for licensure or licensee who is found guilty of violating
any provision of subsection (1) of this section or who is found guilty of violating any
provision of s. 456.072(1).
(3) The board shall not reinstate the license of a pharmacist, or cause a license to be
issued to a person it has deemed unqualified, until such time as it is satisfied that she or
he has complied with all the terms and conditions set forth in the final order and that such
person is capable of safely engaging in the practice of pharmacy.
(4) The board shall by rule establish guidelines for the disposition of disciplinary cases
involving specific types of violations. Such guidelines may include minimum and
maximum fines, periods of supervision or probation, or conditions of probation or
55 | P a g e
reissuance of a license.
History.—ss. 1, 7, ch. 79-226; ss. 13, 15, 24, 25, 30, 34, 62, ch. 80-406; s. 324, ch. 81-
259; ss. 2, 3, ch. 81-318; s. 3, ch. 83-101; s. 37, ch. 83-216; ss. 32, 119, ch. 83-329; s. 1,
ch. 84-364; ss. 26, 27, ch. 86-256; s. 41, ch. 88-1; s. 20, ch. 88-277; s. 2, ch. 89-77; s.
59, ch. 91-137; s. 6, ch. 91-156; s. 4, ch. 91-429; s. 45, ch. 92-149; s. 32, ch. 95-144; s.
244, ch. 97-103; s. 91, ch. 97-264; s. 119, ch. 99-397; s. 126, ch. 2000-160; s. 33, ch.
2001-277; s. 3, ch. 2004-387; s. 10, ch. 2005-240; s. 5, ch. 2008-184; s. 11, ch. 2011-
141; s. 20, ch. 2016-145; s. 16, ch. 2017-41.
Minor Pharmacy Violations (64B16-30.002)

(1) The Board sets forth the following guidelines for use by Department investigators
when a licensee is in noncompliance of an initial offense of a minor violation. The Board
deems the following violations, depending upon severity, to be consistent with section
456.073(3), F.S.
(a) Outdated pharmaceuticals – rule 64B16-28.110, F.A.C.
(b) Failure to meet regulation of daily operating hours – rule 64B16-28.404, F.A.C.
(c) Generic substitution sign not displayed – section 465.025(7), F.S.
(d) Information required on controlled substance prescriptions: practitioner’s address,
practitioner’s DEA registration number, patient’s address – section 893.04, F.S.
(e) Failure to have certified by dispensing pharmacists the daily hard-copy printout or daily
log – paragraph 64B16-28.140(3)(c) or (e), F.A.C.
(f) Failure to have pharmacy minimally equipped i.e. references, compounding
equipment, and a current copy of the laws and rules governing the practice of pharmacy
in the State of Florida – rule 64B16-28.107, F.A.C.
(g) Failure to properly identify pharmacy technicians – rule 64B16-27.410, F.A.C.
(h) Results of P&E quality assurance program not documented or available for inspection
– paragraph 64B16-28.820(3)(d), F.A.C.
(i) Improper storage of legend drugs – rule 64B16-28.120, F.A.C.
(j) Improper documentation of destruction of controlled substances – rules 64B16-28.301,
64B16-28.303, F.A.C.
(k) Consultant pharmacist’s monthly reports not current or available for inspection – rule
64B16-28.501, subsection 64B16-28.702(2), F.A.C.
(l) Controlled substance prescription labels lack transfer crime warning labeling –
paragraph 64B16-28.502(2)(c), F.A.C.
(m) Failure to maintain proof of licensure, display licenses/registrations or notices, or to
properly identify pharmacy staff – rule 64B16-27.100, F.A.C.
(n) Failure to have a continuously designated Prescription Department Manager or
Consultant Pharamcist of Record, if the gap between designations is less than fifteen (15)
business days – rules 64B16-27.450 and 64B16-28.501, F.A.C.
(2) The Department’s investigator may issue a Notice of Deficiencies when the above
conditions occur and the requirements of section 456.073(3), F.S., are met. In such cases
licensees shall correct the violation and respond to the investigator on forms provided by
the Department and with other evidence of compliance as may be necessary, within 30
days, to certify current compliance. Failure to do so shall subject the licensee to further
proceedings.
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Rulemaking Authority 456.073(3), 465.005 FS. Law Implemented 456.073(3) FS.
History–New 11-12-90, Formerly 21S-17.002, 21S-30.002, 61F10-30.002, 59X-30.002,
Amended 12-9-98, 8-26-02, 11-7-17, 7-11-18.
Citations Pharmacist/Pharmacy (64B16-30.003)

(a) Practicing pharmacy as an inactive licensee. Fine based on length of time in practice
(Section 465.015(2)(b), F.S.) while inactive; $200/month or $5,000
maximum (penalty will require licensee to
renew license or cease practice).
(b) Operating a pharmacy with an inactive permit. $500 per month to a maximum of $5000
(Section 465.015(1)(a), F.S.) (penalty will require permittee to renew
permit or cease practice).
(c) First time failure to complete the required continuing
education during the biennial licensure period.
(Section 456.072(3)(a), F.S.
Failure to complete less than 10 hours $500
Failure to complete 10 or more hours $1,000
In addition, licensees shall take two additional hours of continuing education for each of the continuing education
deficiencies. Said hours shall not count for continuing education renewal requirements for the next biennium.
(d) Failure to timely pay a fine or costs imposed by a final order. $500 per month late to a maximum of
$5,000 (penalty will require permittee
or licensee to also pay the original fine
and/or costs).
(e) Failure to display any sign, license or permit required by $500
statute or rule.
(f) Failure to have any reference material required by statute or $500
rule available.
(g) Failure to notify the board of a change in a prescription Fine based on the length of time prior
department manager or consultant pharmacist. to notifying board. $200 a month to
(Rule 64B16-27.450 or 64B16-28.501, F.A.C.) $5,000 maximum.
(h) Using in the compounding of a prescription, or furnishing $250 fine, Completion of an approved
upon prescription, an ingredient or article different in any CE course in the prevention of
manner from the ingredient or article prescribed, except as medication errors of no less than 8
authorized in section 465.019(6) or 465.025, F.S.; or dispensing hours.
a medication with dosage instructions different in any way than
prescribed, provided that the medication was not used or
ingested.
(Section 465.016(1)(g), F.S.)
(i) Tendering a check payable to the Board of Pharmacy or to $100 fine plus payment of the check
the Department of Health that is dishonored by the Institution within 30 days.
upon which it is drawn.
(j) Failing to comply with the Educational course requirements $500
for Human immunodeficiency virus and Aquired immune
deficiency syndrome (HIV/AIDS), or medical errors.
(Section 465.033(1), F.S.)
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(k) Failure to correct Minor violation as listed in rule 64B16- $250
30.002, F.A.C.
(l) First time failure to report controlled substance dispensing $100
information to the Prescription Drug Monitoring Program
Controlled Substance Dispensing Information Electronic
System.
(Section 893.055(3)(a), F.S.)
(m) First time (initial) failure to consult the Prescription Drug $100
Monitoring Program Controlled Substance Dispensing
Information Electronic System prior to dispensing a controlled
substance.
(Section 893.055(8), F.S.)
(n) Failure to request photo of other verification of identity prior $100
to dispensing a controlled substance to a person not known.
(Section 465.0155(2), F.S.)
(o) Failure to inform customers of less expensive drug when $100
cost sharing obligation to customer exceeds retail price.
(Section 465.0244(2), F.S.)
(p) Failure to comply with pharmacist to registered pharmacist $250
technician ratio for activities not involving sterile
compounding; no injury to patient/customer.
(Rule 64B16-27.410(5) or (6), F.A.C.)
(q) Failure to remove from active stock and properly quarantine $250
outdated prescription drugs.
(Section 499.006(9) through 499.005(2), F.S.)
(Section 499.0121(5)(a)2., F.S.)
(Rule 64B16-28.110, F.A.C.)
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Disciplinary Guidelines Pharmacist/Pharmacy 64B16-30.001

OUT-OF-STATE TELEHEALTH
VIOLATION FLORIDA LICENSE PENALTY RANGE PROVIDER PENALTY RANGE
SECOND AND SECOND AND
SUBSEQUENT FIRST SUBSEQUENT
FIRST VIOLATION VIOLATIONS VIOLATION VIOLATIONS
(a) Obtaining a license
or permit by
misrepresentation,
fraud, or error.
(Section
465.016(1)(a), F.S.);
and
(Section
465.023(1)(a), F.S.)
1. By MIN: $10,000 fine for MIN: $10,000 fine for each MIN: MIN: Revocation;
misrepresentation or each count and count and Revocation; Revocation;
fraud. Revocation;
MAX: $10,000 fine for MAX: $10,000 fine for each MAX: MAX: Revocation.
each count and count and Revocation. Revocation.
Revocation.
2. By error of the MIN: Revocation; MIN: Revocation; MIN: MIN: Revocation;
Department or Board Revocation;
on original application
or renewal. MAX: Revocation. MAX: Revocation MAX: MAX: Revocation
Revocation
(b) Procuring or MIN: $10,000 fine for MIN: $10,000 fine for each MIN: MIN: Revocation;
attempting to procure a each count and count and Revocation; Revocation;
license or permit for Revocation;
another person by false
representation. MAX: $10,000 fine for MAX: $10,000 fine for each MAX: MAX: Revocation.
(Section each count and count and Revocation. Revocation.
465.016(1)(b), F.S.); Revocation.
and
(Section
465.023(1)(b), F.S.)
(c) Permitting any MIN: $2,500 fine and 12- MIN: $5,000 fine and one (1) MIN: MIN: Suspension and
unlicensed persons or hour Laws & Rules course year suspension followed by Suspension and a corrective action
unsupervised or Multistate Pharmacy one (1) year of probation; a corrective plan;
registered interns to Jurisprudence Exam action plan
fill, compound, or (MPJE); including, at a
dispense any minimum,
prescriptions. completion of a
(Section 12-hour Laws &
465.016(1)(c), F.S.) Rules course or
MPJE;
MAX: $5,000 fine and one MAX: $10,000 fine and MAX: One (1) MAX: Revocation.
(1) year suspension Revocation. year suspension
followed by one (1) year of and a corrective
probation. action plan as
outlined above.
(d) Being unfit or MIN: Suspension until MIN: Suspension until MIN: MIN: Suspension and
incompetent to licensee is able to licensee is able to demonstrate Suspension and a corrective action
practice pharmacy by demonstrate the ability to the ability to practice with a corrective plan, including, at a
reason of habitual practice with reasonable reasonable skill and safety action plan, minimum, that the
intoxication, medicinal skill and safety; followed by one (1) year of including, at a provider is able to
drug abuse, or probation; minimum, that demonstrate the
physical or mental the provider is ability to practice
condition that able to with reasonable skill
threatens public demonstrate the and safety;
safety. ability to
(Sections practice with
465.016(1)(d), and reasonable skill
(m), F.S.) and safety;
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MAX: Revocation. MAX: Revocation. MAX: MAX: Revocation.
Revocation.
(e) Violating laws
governing the practice
of pharmacy.
(Section
465.016(1)(e), F.S.);
(Section
465.023(1)(c), F.S.)
1. Chapter 465, F.S.:
a. Failure to properly MIN: $250 fine, one (1) MIN: $5,000 fine and one (1) MIN: MIN: One (1) year
supervise registered year of probation, and 12- year suspension followed by Suspension and suspension and a
pharmacy technician. hour Laws and Rules one (1) year of probation; a corrective corrective action plan;
(Section 465.014, F.S.) course or MPJE; action plan
including, at a
minimum, a 12-
hour Laws and
Rules course or
MPJE;
MAX: Revocation.
MAX: $1,000 fine and one MAX: Revocation. MAX: One (1)
(1) year suspension year suspension
outlined above.
b. Operating a MIN: $500 fine per month MIN: Revocation; MIN: MIN: Revocation;
pharmacy that is not (up to $5,000 fine), 12- Reprimand;
registered. hour Laws and Rules
(Section course or MPJE, and
465.015(1)(a), F.S.) permittee must renew
permit, obtain new permit,
or cease operation;
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MAX: Revocation. MAX: $10,000 fine, MAX: MAX: Revocation
revocation, referral to State Revocation. and, if appropriate,
Attorney’s Office for criminal referral for criminal
prosecution. prosecution.
c. Operating a MIN: $5,000 fine, 12-hour MIN: $10,000 fine, one (1) MIN: MIN: One (1) year
pharmacy where an Laws and Rules course or year suspension followed by Suspension and suspension and a
unlicensed, MPJE, and one (1) year of one (1) year of probation; a corrective corrective action plan;
unregistered, or probation; action plan;
unsupervised person MAX: Revocation.
practices pharmacy. MAX: Revocation. MAX: Revocation. MAX:
(Section Revocation.
465.015(1)(b), F.S.)
d. Making a false or MIN: $10,000 fine; MIN: $10,000 fine and MIN: MIN: Revocation;
fraudulent statement to Revocation; Reprimand;
the board.
(Section MAX: $10,000 fine and MAX: $10,000 fine and MAX: MAX: Revocation.
465.015(2)(a), F.S.) Revocation. revocation. Revocation.
e. Filling or MIN: $500 fine per month MIN: $10,000 fine and one MIN: MIN: One (1) year
compounding while inactive (up to (1) year suspension; Reprimand; suspension and a
prescriptions, or $6,000); corrective action plan;
dispensing medicinal
drugs, without an MAX: Revocation.
active license. MAX: $10,000 fine and MAX: Revocation. MAX:
(Section one (1) year suspension Revocation.
465.015(2)(b), F.S.) followed by one (1) year of
probation;
f. Selling or MIN: $1,500 fine; MIN: $5,000 fine and one (1) MIN: MIN: Suspension and
dispensing drugs year suspension followed by Reprimand; a corrective action
without a prescription. one (1) year of probation; plan;
(Section
465.015(2)(c), F.S.) MAX: $5,000 fine and one MAX: Revocation. MAX: MAX: Revocation.
(1) year of probation. Suspension and
a corrective
action plan.
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g. Selling samples or
complimentary drugs.
(Section
465.015(2)(d), F.S.)
(I) Non-scheduled MIN: $1,500 fine and (1) MIN: $5,000 fine and one (1) MIN: MIN: Suspension and
legend drugs. year of probation; year suspension followed by Suspension and a corrective action
one (1) year of probation; a corrective plan;
action plan;
MAX: $5,000 fine and one MAX: Revocation. MAX: One (1) MAX: Revocation.
(1) year suspension. year suspension
and a corrective
action plan.
(II) Scheduled MIN: $5,000 fine and one MIN: $10,000 fine and one MIN: MIN: One (1) year
(controlled substances) (1) year of probation; (1) year suspension followed Suspension and suspension and a
legend by one (1) year of probation; a corrective corrective action plan;
drugs. action plan;
MAX: Revocation.
MAX: Revocation. MAX: Revocation. MAX:
Revocation.
h. Failure to notify the
board of, or failure to
have, a prescription
department manager or
a supervising, a
responsible, or a
consultant pharmacist.
(Sections 465.0157,
465.018, 465.019,
465.0193, 465.0196, or
465.0197, and
465.022(10), or (11),
F.S.)
(I) Failure to notify of MIN: $500 fine each MIN: $500 fine each month MIN: MIN: One (1) year
64 | P a g e
change. month licensee fails to licensee fails to notify the Reprimand; suspension and a
(Section 465.022(10), notify the Board Board (maximum $7,500) and corrective action plan;
or (11), F.S.) (maximum $5,000); one (1) year probation;
MAX: Revocation.
MAX: One (1) year of MAX: $10,000 fine and one MAX:
probation and $7,500 fine. (1) year suspension followed Suspension and
by one (1) year of probation. a corrective
action plan.
(II) Failure to have MIN: $750 fine per month MIN: $2,000 fine per month MIN: MIN: Reprimand;
prescription practicing without a practicing without a Reprimand;
department manager or prescription department prescription department
a supervising, a manager (maximum of manager (maximum of
responsible, or a $6,000); $10,000); and one (1) year of
consultant pharmacist probation;
of record.
MAX: One (1) year MAX: $10,000 fine and two MAX: One (1) MAX: Revocation.
suspension and a fine of (2) year suspension followed year suspension
$7,500. by two (2) years of probation. and a corrective
action plan.
i. Failure to comply MIN: $500 fine and 12- MIN: $2,500 fine, 12-hour MIN: MIN: Suspension and
with substitution of hour Laws & Rules course Laws & Rules course or Suspension and a corrective action
legend drug or MPJE; MPJE, and one (1) year of a corrective plan including, at a
requirements. probation; action plan minimum,
(Sections 465.025(2), including, at a completion of a 12-
(3), and (4), F.S.) minimum, hour Laws and Rules
completion of a course or MPJE;
12-hour Laws
and Rules
course or MPJE;
MAX: One (1)

MAX: $2,200 fine and one MAX: $10,000 fine and one year suspension MAX: Revocation.
(1) year of probation. (1) year suspension followed and a corrective
by one (1) year of probation. action plan as
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outlined above.
j. Failure to follow MIN: $1,000 fine and 12- MIN: $2,500 fine, 12-hour MIN: MIN: Suspension and
negative formulary hour Laws & Rules course Laws & Rules course or Suspension and a corrective action
requirements. or MPJE; MPJE, and one (1) year of a corrective plan including, at a
(Section 465.025(6), probation; action plan minimum,
F.S.); including, at a completion of a 12-
(Rule 64B16-27.500, minimum, hour Laws and Rules
F.A.C.) completion of a course or MPJE;
12-hour Laws
and Rules
course or MPJE;
MAX: One (1)

outlined above.
k. Failure to follow MIN: $500 fine; MIN: $2,500 fine and one (1) MIN: MIN: Suspension and
emergency year of probation; Reprimand; a corrective action
prescription plan;
requirements.
(Section 465.0275, MAX: $2,500 fine and one MAX: $5,000 fine and one (1) MAX: MAX: One (1) year
F.S.) (1) year of probation. year suspension followed by Suspension and suspension and a
one (1) year of probation. a corrective corrective action plan.
action plan.
l. Engage in prohibited MIN: $1,500 fine and 12- MIN: $5,000 fine, 12-hour MIN: MIN: Suspension and
rebate scheme. hour Laws & Rules course Laws & Rules course or Suspension and a corrective action
(Section 465.185, F.S.) or MPJE; MPJE, and one (1) year a corrective plan including, at a
suspension followed by one action plan minimum,
(1) year of probation; including, at a completion of a 12-
minimum, hour Laws and Rules
completion of a course or MPJE;
12-hour Laws
and Rules
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course or MPJE;
MAX: One (1)

MAX: $5,000 fine and one MAX: Revocation. year suspension MAX: Revocation.
(1) year of probation. and a corrective
action plan as
outlined above.
m. Failure to comply
with pharmacist
dispensing
requirements.
(Section 465.186, F.S.)
(I) Failure to follow MIN: $500 fine; MIN: $1,000 fine and one (1) MIN: MIN: Suspension and
procedure, but year of probation; Reprimand; a corrective action
dispense drug plan;
appearing on
formulary. MAX: $1,000 fine and one MAX: Suspension of right to MAX: MAX: One (1) year
(Section 465.186(3), (1) year of probation. dispense. Suspension and suspension and a
F.S.); a corrective corrective action plan.
(Rule 64B16-27.210, action plan.
F.A.C.)
(II) Dispensing drug MIN: $1,500 fine and 12- MIN: $5,000 fine and one (1) MIN: MIN: Suspension and
not on the formulary. hour Laws & Rules course year of probation; Suspension and a corrective action
(Section 465.186(2), or MPJE; a corrective plan;
F.S.); action plan
(Rules 64B16-27.220, including, at a
.230, F.A.C.) minimum,
completion of a
12-hour Laws
and Rules
course or MPJE;
MAX: One (1)

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outlined above.
n. Failure to timely
report fraudulent
obtaining or attempted
obtaining of controlled
substances from a
pharmacy.
(Section 465.015(3),
F.S.)
(I) Failure to timely MIN: $500 fine and 12- MIN: $1,000 fine and one (1) MIN: MIN: Suspension and
report. hour Laws & Rules course year of probation; Suspension and a corrective action
or MPJE; a corrective plan;
action plan
including, at a
minimum,
completion of a
12-hour Laws
and Rules
course or MPJE;
MAX: One (1)

outlined above.
(II) Failure to report. MIN: $1,000 fine and one MIN: $5,000 fine and one (1) MIN: MIN: Suspension and
(1) year of probation; year suspension followed by Suspension and a corrective action
one (1) year of probation; a corrective plan;
action plan;
(1) year suspension. year suspension
68 | P a g e
and a corrective
action plan.
o. Violation of MIN: $500 fine and 12- MIN: $1,000 fine and one (1) MIN: MIN: Suspension and
facsimile prescription hour Laws & Rules course year of probation; Suspension and a corrective action
requirements. or MPJE; a corrective plan;
(Section 465.035, F.S.) action plan
including, at a
minimum,
completion of a
12-hour Laws
and Rules
course or MPJE;
MAX: One (1)

MAX: $1,000 fine and one MAX: $5,000 fine and one (1) year suspension MAX: Revocation.
(1) year of probation. year suspension followed by and a corrective
one (1) year of probation; action plan as
outlined above.
p. Violation of
requirements for
administration of
vaccines and
epinephrine auto
injection.
(Section 465.189,
F.S.); and; (Section
465.009(6)(a), F.S.)
(I) Administration MIN: $2,500 fine and 12- MIN: $5,000 fine and one (1) MIN: MIN: Suspension and
with failure to enter hour Laws & Rules course year of probation; Suspension and a corrective action
into a written protocol. or MPJE; a corrective plan;
action plan
including, at a
minimum,
completion of a
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12-hour Laws
and Rules
course or MPJE;
MAX: One (1)

by one (1) year of probation; action plan as
outlined above.
(II) Administration MIN: $500 fine and MIN: $1,000 fine and MIN: MIN: Suspension and
with failure to suspension until insured; suspension until insured, Suspension and a corrective action
maintain proper followed by one (1) year of a corrective plan including, at a
insurance. probation; action plan minimum, becoming
including, at a insured;
minimum,
becoming
insured;
MAX: $1,000 fine and MAX: $10,000 fine and one MAX: One (1) MAX: Revocation.
suspension until insured (1) year suspension followed year suspension
followed by one (1) of year by one (1) year of probation. and a corrective
outlined above.
(III) Administration MIN: $500 fine; MIN: $1,000 fine and one (1) MIN: MIN: Suspension and
with failure to year of probation; Reprimand; a corrective action
maintain and make plan;
available patient
records. MAX: $1,000 fine and one MAX: $5,000 fine and one (1) MAX: MAX: Revocation.
(1) year of probation. year suspension followed by Suspension and
one (1) year of probation. a corrective
action plan.
(IV) Uncertified MIN: $5,000 fine and one MIN: $7,500 fine and MIN: MIN: Suspension and
administration of (1) year of probation; suspension of license until Suspension and a corrective action
vaccine. receipt of immunization a corrective plan;
70 | P a g e
certification; action plan;
(1) year suspension of year suspension
license. and a corrective
action plan.
(V) Failure to submit MIN: $500 fine; MIN: $1,000 fine and one (1) MIN: MIN: Suspension and
copy of protocol or year of probation; Reprimand; a corrective action
written agreement to plan;
the board.
MAX: $1,000 fine and one MAX: $5,000 fine and one (1) MAX: MAX: Revocation.
action plan.
q. Failure to request MIN: $500 fine and 12- MIN: $1,000 fine and one (1) MIN: MIN: Suspension and
photo or other hour Laws & Rules course year of probation; Suspension and a corrective action
verification of identity or MPJE; a corrective plan;
prior to dispensing a action plan
controlled substance to including, at a
a person not known. minimum,
(Section 465.0155(2), completion of a
F.S.) 12-hour Laws
and Rules
course or MPJE;
MAX: One (1)

one (1) year of probation. action plan as
outlined above.
r. Failure to inform MIN: $500 fine and 12- MIN: $1,000 fine and one (1) MIN: MIN: Suspension and
customers of less hour Laws & Rules course year of probation; Suspension and a corrective action
expensive drug when or MPJE; a corrective plan including, at a
cost sharing obligation action plan minimum, one (1)
71 | P a g e
to customer exceeds including, at a year suspension of
retail price. minimum, dispensing rights;
(Section 465.0244(2), completion of a
F.S.) 12-hour Laws
and Rules
course or MPJE;
MAX: One (1)

(1) year of probation. year suspension of dispensing and a corrective
rights followed by one (1) action plan as
year of probation. outlined above.
2. Chapter 499, F.S.:
a. Adulteration or
misbranding of a drug.
(Sections 499.005(2),
and (3) F.S.); (Section
499.006, F.S.); and
(Section 499.007, F.S.)
(I) Adulteration of a MIN: $1,000 fine and 12- MIN: $5,000 fine and one (1) MIN: MIN: Suspension and
drug. hour Laws & Rules course year suspension followed by Suspension and a corrective action
(Section 499.005(2), or MPJE; one (1) year of probation; a corrective plan;
F.S.); and (Section action plan
499.006, F.S.) including, at a
minimum,
completion of a
12-hour Laws
and Rules
course or MPJE;
MAX: One (1)

MAX: $5,000 fine and one MAX: Revocation. year suspension MAX: Revocation.
(1) year of probation. and a corrective
action plan as
72 | P a g e
outlined above.
(II) Receipt or delivery MIN: $1,000 fine and 12- MIN: $5,000 fine and one (1) MIN: MIN: Suspension and
of any drug that is hour Laws & Rules course year of probation; Suspension and a corrective action
adulterated or or MPJE; a corrective plan;
misbranded. action plan
(Section 499.005(3), including, at a
F.S.) minimum,
completion of a
12-hour Laws
and Rules
course or MPJE;
MAX: One (1)

outlined above.
(III) Incomplete or MIN: $250 fine and 12- MIN: $2,500 fine and one (1) MIN: MIN: Suspension and
inaccurate labeling. hour Laws & Rules course year of probation; Suspension and a corrective action
(Section 499.007, or MPJE; a corrective plan;
F.S.); action plan
(Rule 64B16-28.108, including, at a
F.A.C.) minimum,
completion of a
12-hour Laws
and Rules
course or MPJE;
MAX: One (1)

MAX: $2,500 and one (1) MAX: $5,000 fine and one (1) year suspension MAX: Revocation.
year of probation. year suspension followed by and a corrective
outlined above.
73 | P a g e
(IV) Fraudulent MIN: $10,000 fine and one MIN: $10,000 fine and two MIN: One (1) MIN: Two (2) year
misbranding of legend (1) year suspension (2) year suspension followed year suspension suspension and a
drugs. followed by one (1) year of by two (2) years of probation; and a corrective corrective action plan;
(Section 499.007, F.S.) probation; action plan;
MAX: Revocation.
MAX: Two (2) year MAX: Revocation. MAX: Two (2)
suspension. year suspension
and a corrective
action plan.
b. Failure to obtain a MIN: $500 fine per month MIN: $10,000 fine (penalty MIN: MIN: One (1) year
permit or registration to a maximum of $5,000 will require permittee to Suspension and suspension and a
or operating without a (penalty will require obtain permit, renew permit, a corrective corrective action plan
valid permit when it is permittee to obtain permit, or cease practice); action plan including, at a
required. renew permit, or cease including, at a minimum, the
(Section 499.005(22), practice); minimum, the provider to obtain
F.S.) provider to permit, renew permit,
obtain permit, or cease practicing;
renew permit, or
cease
practicing;
MAX: $10,000 fine and MAX: Revocation. MAX: One (1) MAX: Revocation.
one (1) year of probation. year suspension
and a corrective
action plan as
outlined above.
c. Prescription drug MIN: $500 fine and 12- MIN: $5,000 fine and one (1) MIN: MIN: One (1) year
transaction violations. hour Laws & Rules course year suspension followed by Suspension and suspension and a
(Section 499.005(28), or MPJE; one (1) year of probation; a corrective corrective action plan;
F.S.); and (Section action plan
499.0051, F.S.) including, at a
minimum,
completion of a
12-hour Laws
74 | P a g e
and Rules
course or MPJE;
MAX: One (1) MAX: Revocation.

MAX: $5,000 fine and one MAX: Revocation. year suspension
(1) year suspension and a corrective
followed by one (1) year of action plan as
probation. outlined above.
d. Recordkeeping MIN: $500 fine and 12- MIN: $1,000 fine and one (1) MIN: MIN: Suspension and
requirement. hour Laws & Rules course year of probation; Suspension and a corrective action
(Section 499.0121, or MPJE; a corrective plan;
F.S.); and (Sections action plan
499.005(18), and (19), including, at a
F.S.) minimum,
completion of a
12-hour Laws
and Rules
course or MPJE;
MAX: One (1)

outlined above.
e. Storage of drugs. MIN: $500 fine and 12- MIN: $1,000 fine and one (1) MIN: MIN: Suspension and
(Section 499.0121, hour Laws & Rules course year of probation; Suspension and a corrective action
F.S.) or MPJE; a corrective plan;
action plan
including, at a
minimum,
completion of a
12-hour Laws
and Rules
course or MPJE;
75 | P a g e
MAX: One (1)
outlined above.
3. Chapter 893, F.S.
(Controlled
Substances):
a. Filling a written or MIN: $1,500 fine and 12- MIN: $5,000 fine and one (1) MIN: MIN: Suspension and
oral prescription for hour Laws & Rules course year of probation; Suspension and a corrective action
controlled substances or MPJE; a corrective plan;
that does not meet the action plan
requirements of including, at a
Chapter 893, F.S. minimum,
(Sections 893.04(1)(a), completion of a
(b), and (c), F.S.) 12-hour Laws
and Rules
course or MPJE;
MAX: One (1)

outlined above.
b. Failing to retain MIN: $1,000 fine and 12- MIN: $5,000 fine and one (1) MIN: MIN: Suspension and
prescription records hour Laws & Rules course year of probation; Suspension and a corrective action
for two (2) years. or MPJE; a corrective plan;
(Section 893.04(1)(d), action plan
F.S.) including, at a
minimum,
completion of a
12-hour Laws
and Rules
76 | P a g e
course or MPJE;
MAX: One (1)

outlined above.
c. Failing to MIN: $250 fine and 12- MIN: $2,500 fine and (1) year MIN: MIN: One (1) year
appropriately label. hour Laws & Rules course probation; Suspension and suspension and a
(Section 893.04(1)(e), or MPJE; a corrective corrective action plan;
F.S.) action plan
including, at a
minimum,
completion of a
12-hour Laws
and Rules
course or MPJE;
MAX: One (1) MAX: Revocation.

MAX: $2,500 fine and one MAX: $10,000 fine and one year suspension
outlined above.
d. Dispensing a MIN: $5,000 fine and one MIN: $10,000 fine and one MIN: MIN: One (1) year
Schedule II drug (1) year of probation; (1) year suspension followed Suspension and suspension and a
inappropriately with a by one (1) year of probation; a corrective corrective action plan;
non-written action plan;
prescription. MAX: Revocation.
(Section 893.04(1)(f), MAX: $10,000 fine and MAX: Revocation. MAX: One (1)
F.S.) one (1) year suspension year suspension
probation. action plan.
e. Inappropriate MIN: $1,750 fine and one MIN: $5,000 fine and one (1) MIN: MIN: One (1) year
refilling of Schedule (1) year of probation; year suspension; Suspension and suspension;
77 | P a g e
III, IV, or V drugs. a corrective
(Section 893.04(1)(g), action plan;
F.S.); and (Section MAX: $10,000 fine and one
893.04(2)(e), F.S.) MAX: $5,000 fine and one (1) year suspension followed MAX: One (1) MAX: Revocation.
(1) year suspension. by one (1) year of probation. year suspension
and corrective
action plan.
f. Receiving controlled MIN: $2,500 fine; MIN: $5,000 fine and one (1) MIN: MIN: Suspension and
substances without an year of probation; Reprimand; a corrective action
appropriate order plan;
form.
(Section 893.06(1), MAX: $5,000 fine and one MAX: $10,000 fine and one MAX: MAX: Revocation.
F.S.) (1) year of probation. (1) year suspension followed Suspension and
action plan.
g. Possession of MIN: $2,500 fine and one MIN: $5,000 fine and one (1) MIN: MIN: One (1) year
controlled substances (1) year of probation; year suspension followed by Suspension and suspension and a
outside the regular one (1) year of probation; a corrective corrective action plan;
course of business, action plan;
occupation, MAX: Revocation.
profession, MAX: $5,000 fine and one MAX: Revocation. MAX: One (1)
employment, or duty. (1) year suspension. year suspension
(Section 893.06(2), and a corrective
F.S.) action plan.
h. Failure to take a MIN: $1,000 fine and 12- MIN: $2,500 fine and one (1) MIN: MIN: Suspension and
biennial inventory. hour Laws & Rules course year of probation; Suspension and a corrective action
(Sections 893.07(1)(a), or MPJE; a corrective plan;
(2), (3), (4), and (5), action plan
F.S.) including, at a
minimum,
completion of a
12-hour Laws
and Rules
course or MPJE;
78 | P a g e
MAX: One (1)
outlined above.
i. Failure to maintain a MIN: $1,000 fine and 12- MIN: $5,000 fine and two (2) MIN: MIN: Suspension and
complete and accurate hour Laws & Rules course years of probation; Suspension and a corrective action
record of controlled or MPJE; a corrective plan;
substances. action plan
(Sections including, at a
893.07(1)(b), (2), (3), minimum,
(4), and (5), F.S.) completion of a
12-hour Laws
and Rules
course or MPJE;
MAX: One (1)

outlined above.
j. Dispensing Schedule MIN: $5,000 fine and one MIN: $10,000 fine and one MIN: MIN: One (1) year
V controlled (1) year of probation; (1) year suspension followed Suspension and suspension and a
substances in other by one (1) year of probation; a corrective corrective action plan;
than good faith. action plan;
(Section 893.08(3)(b), MAX: Revocation.
F.S.) MAX: $10,000 fine and MAX: Revocation. MAX: One (1)
one (1) year suspension year suspension
k. Inappropriate MIN: $1,500 fine, 12-hour MIN: $5,000 fine and one (1) MIN: MIN: One (1) year
selling of Schedule V Laws and Rules course or year suspension followed by Suspension and suspension;
controlled substance. MPJE and one (1) year of one (1) year of probation; a corrective
79 | P a g e
(Section 893.08(3)(c), probation; action plan;
F.S.)
Revocation
l. Unlawful possession MIN: $5,000 fine and one MIN: $10,000 fine and two MIN: MIN: One (1) year
of controlled (1) year suspension (2) year suspension followed Suspension and suspension and a
substance. followed by one (1) year of by two (2) years of probation; a corrective corrective action plan;
(Section 893.13, F.S.) probation; action plan;
MAX: Revocation.
Revocation.
m. Failure to report MIN: $1,000 fine and 12- MIN: $5,000 fine and one (1) MIN: MIN: Suspension and
information regarding hour Laws & Rules course year of probation; Suspension and a corrective action
dispensed controlled or MPJE; a corrective plan;
substances to the action plan
Prescription Drug including, at a
Monitoring Program minimum, 12-
Controlled Substance hour Laws &
Dispensing Rules course or
Information Electronic MPJE;
System.
(Section 893.055(3), MAX: $5,000 fine and one MAX: $10,000 fine and one MAX: One (1) MAX: Revocation.
F.S.) (1) year of probation. (1) year suspension followed year suspension
by one (1) year of probation. and a corrective
action plan as
outlined above.
n. Failure to consult the MIN: $1,000 fine and 12- MIN: $5,000 fine and one (1) MIN: MIN: Suspension and
Prescription Drug hour Laws & Rules course year of probation; Suspension and a corrective action
Monitoring Program or MPJE; a corrective plan;
Controlled Substance action plan
Dispensing including, at a
Information Electronic minimum, a 12-
System prior to hour Laws &
dispensing a controlled Rules course or
80 | P a g e
substance. MPJE;
(Section 893.055(8),
F.S.) MAX: $5,000 fine and one MAX: $10,000 fine and one MAX: One (1) MAX: Revocation.
(1) year of probation. (1) year suspension followed year suspension
action plan as
outlined above.
o. Failure to maintain
confidentiality of
information obtained
from the Prescription
Drug Monitoring
Program Controlled
Substance Dispensing
Information Electronic
System.
(Section 893.0551(6),
F.S.)
(I) Knowing violation. MIN: $5,000 fine and one MIN: $10,000 fine and one MIN: MIN: One (1) year
(1) year of probation; (1) year suspension followed Suspension and suspension and a
by one (1) year of probation; a corrective corrective action plan;
action plan;
MAX: Revocation.
MAX: $10,000 fine and MAX: Revocation. MAX: One (1)
one (1) year suspension. year suspension
and a corrective
action plan.
(II) Negligent MIN: Reprimand; MIN: $1,000 fine and one (1) MIN: MIN: Suspension and
violation. year of probation; Reprimand; a corrective action
plan;
MAX: $500 fine and 12- MAX: $2,500 fine and one (1) MAX: MAX: One (1) year
hour Laws & Rules course year suspension. Suspension and suspension and a
or MPJE. a corrective corrective action plan.
81 | P a g e
action plan
including, at a
minimum, a 12-
hour Laws &
Rules course or
MPJE.
4. Violation of Federal MIN: $1,000 fine and one MIN: $10,000 fine and one MIN: MIN: One (1) year
Drug Abuse Act 21 (1) year of probation; (1) year suspension followed Suspension and suspension and a
U.S.C. 821 et seq. by one (1) year of probation; a corrective corrective action plan;
(Manufacture, action plan;
Distribution, and MAX: Revocation.
Dispensing of MAX: $2,000 fine and one MAX: Revocation. MAX: One (1)
Controlled (1) year suspension. year suspension
Substances.) and a corrective
action plan.
5. Violation of Food MIN: $5,000 fine and one MIN: $7,500 fine and two (2) MIN: One (1) MIN: Two (2) year
and Drug Act 21 (1) year suspension year suspension followed by year suspension and a
U.S.C. 301 – 392. followed by one (1) year of two (2) years of probation; suspension; corrective action plan;
probation;
MAX: Revocation.
Revocation
(f) Criminal
conviction related to
Pharmacy.
(Section 465.016(1)(f),
F.S.)
1. Misdemeanor. MIN: $1,000 fine; MIN: $5,000 fine and one (1) MIN: MIN: Suspension and
year of probation; Reprimand; a corrective action
plan;
MAX: $5,000 fine and one MAX: $10,000 fine and one MAX: MAX: Revocation.
(1) year of probation. (1) year suspension followed Suspension and
82 | P a g e
action plan.
2. Felony. MIN: $5,000 fine and one MIN: $10,000 fine and two MIN: One (1) MIN: Two (2) year
(1) year suspension (2) year suspension followed year suspension suspension and a
followed by two (2) years by three (3) years of and a corrective corrective action plan;
of probation; probation; action plan;
MAX: Revocation.
Revocation.
(g) Using in the MIN (without ingestion or MIN: (without ingestion or MIN: MIN: Suspension and
compounding of a harm): Reprimand, harm) $500 fine, complete a Suspension and a corrective action
prescription, or submission of an Board approved eight (8) hour a corrective plan including, at a
furnishing upon improvement action plan, CE course directly related to action plan minimum, complete a
prescription, an and complete a Board the violation at issue, and two including, at a Board approved eight
ingredient or article approved eight (8) hour (2) years of probation; minimum, (8) hour CE course
different in any CE course directly related MIN (with ingestion or complete a directly related to the
manner from the to the violation at issue; harm); $1,000 fine complete a Board approved violation at issue;
ingredient or article MIN: (with ingestion) Board approved eight (8) hour eight (8) hour
prescribed, except as $500 fine, submission of CE course directly related to CE course
authorized in Section an improvement action the violation at issue, and two directly related
465.019(6), or plan, and complete a (2) years of probation; to the violation
465.025, F.S. Board approved eight (8) at issue;
(Section hour CE course directly
465.016(1)(g), F.S.); related to the violation at
or, compounding, issue; MAX (without ingestion or
dispensing or harm) $2,500 fine and one (1)
distributing legend MAX (with or without year suspension followed by MAX: One (1) MAX: Revocation.
drugs outside ingestion or harm): $1,000 two (2) years of probation; year suspension
professional practice fine and one (1) year of MAX (with harm): and a corrective
of pharmacy. probation. Revocation. action plan as
(Section 465.016(1)(i), outlined above.
F.S.)
(h) Filing a false report
or failing to file a
report required by law.
83 | P a g e
(Section 465.016(1)(j),
F.S.)
1. Knowing violation. MIN: $5,000 fine and one MIN: $10,000 fine and one MIN: MIN: One (1) year
(1) year of probation; (1) year suspension followed Suspension and suspension and a
by one (1) year of probation; a corrective corrective action plan;
action plan;
MAX: Revocation.
one (1) year suspension. year suspension
and a corrective
action plan.
2. Negligent violation. MIN: Reprimand; MIN: $1,000 fine and one (1) MIN: MIN: Suspension and
plan;
MAX: $500 fine and 12- MAX: $5,000 fine and one (1) MAX: MAX: One (1) year
hour Laws & Rules course year suspension. Suspension and suspension and a
or MPJE. a corrective corrective action plan.
action plan
including, at a
minimum, a 12-
hour Laws &
Rules course or
MPJE.
(i) Failure to make MIN: $250 fine and 12- MIN: $5,000 fine and one (1) MIN: MIN: Suspension and
prescription price hour Laws & Rules course year of probation; Suspension and a corrective action
information available. or MPJE; a corrective plan;
(Section action plan
465.016(1)(k), F.S.) including, at a
minimum, a 12-
hour Laws &
Rules course or
MPJE;
84 | P a g e
MAX: $1,000 fine and one MAX: $10,000 fine and one MAX: One (1) MAX: One (1) year
(1) year of probation. (1) month suspension year suspension suspension and a
followed by two (2) years of and a corrective corrective action plan.
outlined above.
(j) Improperly placing MIN: $1,000 fine; MIN: $3,000 fine and one (1) MIN: MIN: Suspension and
returned drugs into the year of probation; Reprimand; a corrective action
stock of a pharmacy. plan;
(Section 465.016(1)(l),
F.S.) MAX: $1,500 fine and one MAX: $5,000 fine and one (1) MAX: MAX: One (1) year
(1) year of probation. year suspension. Suspension and suspension and a
a corrective corrective action plan.
action plan.
(k) Violating a rule or
order of the Board or
Department.
(Section
465.016(1)(n), F.S.)
1. Rules of Board of
Pharmacy.
a. Rules 64B16-28.101 MIN: $500 fine and 12- MIN: $2,000 fine and one (1) MIN: MIN: Suspension and
to 64B16-28.1035, hour Laws & Rules course year of probation; Suspension and a corrective action
F.A.C. or MPJE; a corrective plan;
Rule 64B16-27.100, action plan
F.A.C. including, at a
Rule 64B16-28.109, minimum, a 12-
F.A.C. hour Laws &
Rule 64B16-27.103, Rules course or
F.A.C. MPJE;
Rule 64B16-27.104,
F.A.C. MAX: $1,000 fine and one MAX: $5,000 fine and one (1) MAX: One (1) MAX: One (1) year
Rule 64B16-26.400, (1) year of probation. year suspension. year suspension suspension and a
F.A.C. and a corrective corrective action plan.
Rule 64B16-26.2032 action plan as
85 | P a g e
F.A.C. outlined above.
Rule 64B16-28.1081,
F.A.C.
Rule 64B16-27.105,
F.A.C.
Rule 64B16-27.211,
F.A.C.
Rule 64B16-28.113,
F.A.C.
Rule 64B16-28.2021,
F.A.C.
Rule 64B16-28.603,
F.A.C.
b. Sink and running MIN: $250 fine and MIN: $2,000 fine and MIN: MIN: Suspension and
water, sufficient space, suspension until suspension until compliance; Suspension and a corrective action
refrigeration, compliance; a corrective plan including, at a
sanitation, equipment. action plan minimum,
(Rule 64B16-28.102, including, at a compliance;
F.A.C.) minimum,
compliance;
suspension until year suspension
compliance. and a corrective
action plan as
outlined above.
c. Knowingly MIN: $5,000 fine, and one MIN: $10,000 fine, and one MIN: One (1) MIN: One (1) year
purchase, sell, possess, (1) year suspension (1) year suspension followed year suspension suspension and a
or distribute followed by one (1) year of by one (1) year of probation; and a corrective corrective action plan;
counterfeit drugs. probation; action plan;
(Section 499.005(8), MAX: Revocation.
F.S.) MAX: Revocation. MAX: Revocation. MAX:
Revocation.
d. Failure to remove MIN: $500 fine for failure Min: $2,500 fine for failure to MIN: MIN: Suspension and
86 | P a g e
outdated to remove, $1,000 fine for remove, $5,000 fine for Reprimand; a corrective action
pharmaceuticals from dispensing; dispensing, and one (1) year plan;
active stock or of probation;
dispensing of same.
(Rule 64B16-28.110, MAX: $2,500 fine, and MAX: $10,000 fine and one MAX: MAX: Revocation.
F.A.C.) one (1) year probation. (1) year suspension followed Suspension and
by one (1) year of probation a corrective
for failure to remove and action plan.
revocation for dispensing.
e. Violation of MIN: $500 fine and 12- MIN: $5,000 fine and one (1) MIN: MIN: Suspension and
destruction of hour Laws & Rules course year of probation; Suspension and a corrective action
controlled substances. or MPJE; a corrective plan;
(Rules 64B16-28.301 action plan
and 64B16-28.303, including, at a
F.A.C.) minimum, a 12-
hour Laws &
Rules course or
MPJE;
MAX: $5,000 fine and one MAX: $10,000 fine and one MAX: One (1) MAX: Revocation.
action plan as
outlined above.
f. Serving as MIN: $500 fine per month MIN: $500 fine per month up MIN: MIN: One (1) year
consultant pharmacist up to $5,000 fine (fine to $7,500 fine (fine based Reprimand; suspension and a
without being licensed based upon the length of upon the length of time the corrective action plan;
as a consultant time the person is serving person is serving as a
pharmacist. as a consultant without consultant without being
(Rule 64B16-26.300, being licensed as a licensed as a consultant
F.A.C.) consultant pharmacist); pharmacist) and one (1) year
suspension followed by one
(1) year of probation;
MAX: Revocation.
87 | P a g e
MAX: $500 fine per MAX: Revocation. MAX:
month up to $7,500 fine Suspension and
(fine based upon the length a corrective
of time the person is action plan.
serving as a consultant
without being licensed as a
consultant pharmacist) and
one (1) year of probation.
g. Violation of MIN: $1,000 fine and 12- MIN: $5,000 fine and one (1) MIN: MIN: Suspension and
requirements for hour Laws & Rules course year of probation; Suspension and a corrective action
records maintained in a or MPJE and 8-hour CE a corrective plan;
data processing course in record keeping; action plan
system. including, at a
(Rule 64B16-28.140, minimum, a 12-
F.A.C.) hour Laws &
Rules course or
MPJE and 8-
hours CE course
in record
keeping;
action plan as
outlined above.
h. Failure to properly MIN: $1,000 fine and 12- MIN: $5,000 fine and one (1) MIN: MIN: Suspension and
store legend drugs. hour Laws & Rules course year of probation; Suspension and a corrective action
(Rule 64B16-28.120, or MPJE; a corrective plan;
F.A.C.) action plan
including, at a
minimum, a 12-
hour Laws &
Rules course or
88 | P a g e
MPJE;
action plan as
outlined above.
i. Practicing nuclear MIN: $500 fine per month MIN: $500 fine per month up MIN: MIN: One (1) year
pharmacy without up to $5,000 fine (fine to $10,000 fine. (fine based Reprimand; suspension;
being licensed as a based upon the length of upon the length of time the
nuclear pharmacist. time the person is person is practicing without
(Rule 64B16-26.303, practicing without being being licensed as a nuclear
F.A.C.) licensed as a nuclear pharmacist) and one (1) year
pharmacist); suspension;
MAX: $500 fine per MAX: Revocation. MAX: MAX: Revocation.

month up to $10,000 fine. Suspension and
(fine based upon the length a corrective
of time the person is action plan.
practicing without being
licensed as a nuclear
pharmacist) and one-year
of probation.
j. Failure to follow MIN: $1,000 fine, and one MIN: $5,000 fine and one (1) MIN: MIN: One (1) year
technical requirements (1) year of probation; year suspension followed by Suspension and suspension and a
for nuclear pharmacy. one (1) year of probation; a corrective corrective action plan;
(Rules 64B16-28.901 action plan;
and 64B16-28.902, MAX: Revocation.
F.A.C.) MAX: $2,500 fine and one MAX: Revocation. MAX: One (1)
k. Failure to properly MIN: Revocation. MIN: Revocation. MIN: MIN: Revocation;
transfer prescription Revocation;
89 | P a g e
files and medicinal
drugs when closing MAX: Revocation. MAX: Revocation, MAX: MAX: Revocation.
pharmacy. Revocation
(Rules 64B16-28.202
and 64B16-28.203,
F.A.C.)
l. Failure to complete
the required
continuing education
during the biennial
licensure period.
(Rule 64B16-26.103,
F.A.C.)
(I) Failure to complete MIN: $500 fine and MIN: $1,500 fine and N/A N/A
less than ten (10) suspension until suspension until completed;
hours. completed;
MAX: $1,500 fine and MAX: $3,000 fine and

suspension until suspension until completed.
completed.
(II) Failure to complete MIN: $1,000 fine, take MIN: $2,500 fine, suspension N/A N/A
ten (10) or more hours. two (2) additional hours of until deficiency and penalty
continuing education for units are completed, and take
each of the continuing two (2) additional hours of
education deficiencies. continuing education for each
Said hours shall not count of the continuing education
for continuing education deficiencies. Said hours shall
renewal requirements for not count for continuing
the next biennium; education renewal
requirements for the next
biennium;
MAX: $2,500 fine and two MAX: $5,000 fine,

(2) additional hours of suspension until deficiency
90 | P a g e
continuing education per and penalty units are
missing hour as outlined completed and two (2)
above. additional hours of continuing
education per missing hour as
outlined above.
m. Failure to practice
in accordance with
established practice
standards.
(Rules 64B16-27.1001
and 64B16-27.104,
F.A.C.)
(I) Pharmacist. MIN: $500 fine and 12- MIN: $2,500 fine and one (1) MIN: MIN: One (1) year
hour Laws & Rules course year suspension followed by Suspension and suspension and a
or MPJE; one (1) year of probation; a corrective corrective action plan;
action plan
including, at a
minimum, a 12-
hour Laws &
Rules course or
MPJE;
MAX: Revocation.
MAX: $1,000 fine and one MAX: $10,000 fine and MAX: One (1)
(1) year of probation. revocation. year suspension
and a corrective
action plan as
outlined above.
(II) Pharmacy Intern. MIN: $250 fine and 12- MIN: $1,000 fine and one (1) MIN: MIN: One (1) year
hour Laws & Rules course year suspension followed by Suspension and suspension and a
or MPJE; one (1) year of probation; a corrective corrective action plan;
action plan
including, at a
minimum, a 12-
hour Laws &
91 | P a g e
Rules course or
MPJE;
MAX: Revocation.
MAX: $500 fine and one MAX: $5,000 fine and MAX: One (1)
with a
corrective
action plan as
outlined above.
(III) Permittee. MIN: $500 fine and 12- MIN: $2,500 and one (1) year MIN: MIN: One (1) year
hour Laws & Rules course suspension followed by one Suspension and suspension and a
or MPJE; (1) year of probation; a corrective corrective action plan;
action plan
including, at a
minimum, a 12-
hour Laws &
Rules course or
MPJE;
MAX: Revocation.
with a
corrective
action plan as
outlined above.
n. Failure to have or MIN: $500 and 12-hour MIN: $2,500 fine and MIN: MIN: Suspension and
maintain current Laws & Rules course or suspension of license/permit Suspension and a corrective action
policies and MPJE; until current policies and a corrective plan including, at a
procedures for procedures are in place; action plan minimum, current
automated pharmacy including, at a policies and
system or central fill minimum, a 12- procedures are in
pharmacy. hour Laws & place;
(Rules 64B16-28.141 Rules course or
and 64B16-28.450, MPJE;
92 | P a g e
F.A.C.)
MAX: $1,000 fine and MAX: $5,000 fine and one (1) MAX: One (1) MAX: Revocation.
suspension of year suspension followed by year suspension
license/permit until one (1) year of probation. with a
current policies and corrective
procedures are in place. action plan
including, at a
minimum,
current policies
and procedures
are in place.
o. Failure to have or MIN: $500 fine and 12- MIN: $2,500 fine and MIN: MIN: Suspension and
maintain standards for hour Laws & Rules course suspension of license until Suspension and a corrective action
an institutional or MJPE; policies and procedures are in a corrective plan including, at a
pharmacy. place; action plan minimum, current
(Rules 64B16-28.602, including, at a policies and
64B16-28.6021, minimum, a 12- procedures are in
64B16-28.605, 64B16- hour Laws & place;
28.606, 64B16-28.702, Rules course or
F.A.C.) MPJE;
MAX: $2,500 fine and MAX: $5,000 fine and MAX: One (1) MAX: Revocation.
suspension of revocation. year suspension
license/permit until with a
including, at a
minimum,
current policies
and procedures
are in place.
p. Failure to have or MIN: $500 fine and 12- MIN: $2,500 fine and MIN: MIN: Suspension and
maintain standards for hour Laws & Rules course suspension of license until Suspension and a corrective action
a special pharmacy. or MJPE; policies and procedures are in a corrective plan including, at a
93 | P a g e
(Rules 64B16-28.800, place; action plan minimum, current
64B16-28.810, 64B16- including, at a policies and
28.820, 64B16-28.850, minimum, a 12- procedures are in
64B16-28.860, 64B16- hour Laws & place;
28.870, F.A.C.) Rules course or
MJPE;
including, at a
minimum,
current policies
and procedures
are in place.
q. Failure to maintain MIN: $500 fine and 12- MIN: $2,500 fine and MIN: MIN: Suspension and
standards for animal hour Laws & Rules course suspension of license until Suspension and a corrective action
control shelters. or MJPE. policies and procedures are in a corrective plan including, at a
(Rule Chapter 64B16- place; action plan minimum, current
29, F.A.C.) including, at a policies and
minimum, a 12- procedures are in
hour Laws & place;
Rules course or
MJPE;
including, at a
minimum,
94 | P a g e
current policies
and procedures
are in place.
r. Failure to comply MIN: (without ingestion MIN: (without ingestion or MIN: MIN: Suspension and
with Board’s rule on or harm): $250 fine and harm) $500 fine and complete Suspension and a corrective action
patient counseling. complete approved CE approved CE course in the a corrective plan including, at a
(Rules 64B16-27.800, course in the prevention of prevention of medication action plan minimum,
64B16-27.810, 64B16- medication errors of no errors of no less than eight (8) including, at a completion of an
27.820, F.A.C.) less than eight (8) hours; hours; minimum, approved CE course
MIN: (with ingestion) MIN: (with ingestion) $1,000 completion of in the prevention of
$500 fine and complete fine and complete approved an approved CE medication errors of
approved CE course in the CE course in the prevention of course in the no less than eight (8)
prevention of medication medication errors of no less prevention of hours;
errors of no less than eight than eight (8) hours, and one medication
(8) hours; (1) year of probation; errors of no less
than eight (8)
hours;
MAX: (with or with MAX: (without ingestion or MAX: One (1) MAX: Revocation.
ingestion or harm): $1,000 harm) $10,000 fine, and one year suspension
fine and (1) year of (1) year suspension followed with a
probation. by one year of probation; corrective
MAX: (with ingestion or action plan as
harm) Revocation. outlined above.
s. Standards of
practice for
compounding CSPs.
(Rules 64B16-27.700
and 64B16-27.797,
F.A.C.)
(I) No harm. MIN: $500 fine, 12-hour MIN: $2,500 fine and one (1) MIN: MIN: One (1) year
Laws & Rules course, and year suspension followed by Suspension and suspension and a
course governing sterile one (1) year of probation; a corrective corrective action plan;
compounds; action plan
95 | P a g e
including, at a
minimum, a 12-
hour Laws &
Rules course,
and course
governing
sterile
compounds;
MAX: Revocation.
with a
corrective
action plan as
outlined above.
(II) Harm. MIN: $2,000 fine, one (1) MIN: $10,000 fine, and one MIN: MIN: Revocation;
year of probation, course (1) year suspension followed Suspension and
governing sterile by one (1) year of probation; a corrective
compounds and 12-hour action plan
Laws & Rules course; including, at a
minimum, a 12-
hour Laws &
Rules course
and course
governing
sterile
compounds;
MAX: Revocation. MAX: $10,000 fine and MAX: MAX: Revocation

revocation. Revocation
2. Violation of an order MIN: $2,500 fine and one MIN: $5,000 fine and MIN: MIN: Suspension and
of the Board or (1) year of probation; suspension until compliance Suspension and a corrective action
Department previously with order; a corrective plan including, at a
entered in a action plan; minimum,
96 | P a g e
disciplinary hearing. compliance with
order;
compliance with order. and a corrective
action plan
including, at a
minimum,
compliance
with order.
(l) License disciplined MIN: (Administrative MIN: Same penalty as MIN: MIN: Reprimand;
by another jurisdiction related offense or offense imposed in other jurisdiction Reprimand;
for an offense that not impacting patients or as closely as possible to
would constitute a directly) Reprimand; penalties set forth in Florida
violation of this MIN: (All other offenses) Statutes;
chapter. Same penalty as imposed
(Sections in other jurisdiction or as
465.016(1)(h) and closely as possible to
465.023(1)(e), F.S.) penalties set forth in
Florida Statutes;
MAX: $5,000 fine and MAX: $10,000 fine and MAX: MAX: Revocation.
same penalty as imposed revocation. Revocation. (Discipline shall be as
in other jurisdiction or as (Discipline shall close as possible to
closely as possible to be as close as the penalty imposed
penalties set forth in possible to the in other jurisdiction.)
Florida Statutes. penalty imposed
in other
jurisdiction.)
(m) Failing to report to MIN: $500 fine and 12- MIN: $1,500 fine, one (1) MIN: MIN: Suspension and
the Department any hour Laws & Rules course year of probation, and 12- Suspension and a corrective action
Chapter 458 or 459, or MJPE; hour Laws & Rules course or a corrective plan including, at a
F.S., licensee MJPE; action plan minimum, a 12-hour
97 | P a g e
violation. including, at a Laws & Rules course
(Section minimum, a 12- or MPJE;
465.016(1)(o), F.S.) hour Laws &
Rules course or
MPJE;
MAX: $1,500 fine and one MAX: $5,000 fine and one (1) MAX: One (1) MAX: One (1) year
(1) year of probation. year of suspension. year suspension suspension and a
and a corrective corrective action plan
action plan as including, at a
outlined above. minimum, a 12-hour
Laws & Rules course
or MPJE.
(n) Abandoning or MIN: Revocation; MIN: Revocation; MIN: MIN: Revocation;
allowing permit to Revocation;
become null and void
after notice of MAX: Revocation. MAX: Revocation. MAX: MAX: Revocation.
disciplinary Revocation.
proceedings.
(Section 465.018(3),
F.S.)
(o) Failing to notify the MIN: $500 fine and 12- MIN: $2,000 fine and one (1) MIN: MIN: Suspension and
Board of hour Laws & Rules course year of probation; Suspension and a corrective action
commencement or or MJPE; a corrective plan;
cessation of practice action plan
due to discipline in including, at a
another jurisdiction. minimum, a 12-
(Section hour Laws &
465.016(1)(p), F.S.) Rules course or
MPJE;
MAX: $2,000 fine and one MAX: $5,000 fine and one (1) MAX: One (1) MAX: Revocation.
(1) year of probation. year suspension followed by year suspension
one (1) year of probation. and a corrective
98 | P a g e
action plan as
outlined above.
(p) Using or releasing MIN: $1,000 fine and 12- MIN: $2,500 fine and one (1) MIN: MIN: One (1) year
patient records hour Laws & Rules course year suspension followed by Suspension and suspension and a
improperly. or MJPE; one (1) year of probation; a corrective corrective action plan;
465.016(1)(q), F.S.) including, at a
minimum, a 12-
hour Laws &
Rules course or
MPJE;
MAX: Revocation.
MAX: $2,500 fine and one MAX: Revocation. MAX: One (1)
outlined above.
(q) Knowingly, or with
reason to believe,
dispensing based on
purported prescription
where patient-
prescriber relationship
is invalid.
(Sections
465.016(1)(s) and
465.023(1)(h), F.S.)
1. Reason to believe. MIN: $2,000 fine, 12-hour MIN: $2,500 fine and one (1) MIN: MIN: One (1) year
Laws & Rules course or year suspension followed by Suspension and suspension and a
MJPE, and one (1) year of one (1) year of probation; a corrective corrective action plan;
probation; action plan
including, at a
minimum, a 12-
hour Laws &
99 | P a g e
Rules course or
MJPE;
MAX: Revocation.
MAX: $2,500 fine and one MAX: revocation. MAX: One (1)
followed by one (1) year of with a
probation. corrective
action plan as
outlined above.
2. Knowingly. MIN: $5,000 fine, 12-hour MIN: Revocation; MIN: One (1) MIN: Revocation;
Laws & Rules Course or year suspension
MPJE, and one (1) year and a corrective
suspension; action plan
including, at a
minimum, a 12-
hour Laws &
Rules course or
MJPE;

Revocation.
(r) Committing an MIN (without ingestion or MIN (without ingestion or MIN: MIN: One (1) year
error or omission harm): $250 fine, harm): $500 fine and Suspension and suspension and a
during prescription complete approved CE complete approved CE course a corrective corrective action plan
drug processing. course in the prevention of in the prevention of action plan including, at a
(Section 465.016(1)(t), medication errors of no medication errors of no less including, at a minimum,
F.S.) less than eight (8) hours than eight (8) hours, and two minimum, completion of an
and submission of an (2) years of probation; completion of approved CE course
improvement action plan; MIN (with ingestion) $1,000 an approved CE in the prevention of
MIN (with ingestion) $500 fine, complete approved CE course in the medication errors of
fine, complete approved course as outlined above, and prevention of no less than eight (8)
CE course in the two (2) years of probation; medication hours;
prevention of medication MAX (without ingestion or errors of no less
errors of no less than eight harm); $5,000 fine, and one than eight (8)
100 | P a g e
(8) hours and submission (1) year suspension followed hours;
of an improvement action by one (1) year of probation.
plan;
MAX (with or without MAX (with ingestion or MAX: One (1) MAX: Revocation.
ingestion or harm): $1,000 harm): Revocation. year suspension
fine and one (1) year of with a
probation. continuing
action plan as
outlined above.
(s) Guilty of a felony MIN: $1,000 fine and 12- MIN: $5,000 fine and one (1) MIN: MIN: Suspension and
involving moral hour Laws & Rules course year suspension followed by Suspension and a corrective action
turpitude. or MJPE; one (1) year of probation; a corrective plan;
465.023(1)(d), F.S.) including, at a
minimum, a 12-
hour Laws &
Rules course or
MPJE;
(1) year of probation. year suspension
with a
continuing
action plan as
outlined above.
(t) Guilty of a crime MIN: Revocation, or in the MIN: Revocation, or in the MIN: MIN: Revocation;
related to health care case of application for case of application for Revocation;
fraud. licensure, denial of licensure, denial of license;
(Section license;
465.023(1)(g), F.S.)
MAX: Revocation and a MAX: $10,000 fine and MAX: MAX: Revocation.
fine of $10,000. Revocation. Revocation.
(u) Violating Section
101 | P a g e
456.072, F.S.
(Section 465.016(1)(r),
F.S.)
1. Making misleading, MIN: $2,500 fine and one MIN: Revocation; MIN: MIN: Revocation;
deceptive, or (1) year of probation; Suspension and
fraudulent a corrective
representation in or action plan;
related to the practice
of the licensee’s MAX: $5,000 fine and one MAX: $10,000 fine and MAX: One (1) MAX: Revocation
profession. (1) year suspension revocation. year suspension
(Section followed by one (1) year and a corrective
456.072(1)(a), F.S.) probation. action plan.
2. Intentionally MIN: $2,500 fine and one MIN: $5,000 fine and one (1) MIN: MIN: One (1) year
violating any rule (1) year of probation; year suspension followed by Suspension and suspension and a
adopted by the Board one (1) year probation; a corrective corrective action plan;
or the Department. action plan;
(Section MAX: Revocation.
456.072(1)(b), F.S.) MAX: $5,000 fine and one MAX: revocation. MAX: One (1)
followed by one (1) year and a corrective
3. Being convicted or
found guilty of, or
entering a plea of
guilty or nolo
contendere to,
regardless of
adjudication, a crime
in any jurisdiction
which relates to the
practice of, or the
ability to practice, a
licensee’s profession.
(Section
102 | P a g e
456.072(1)(c), F.S.)
a. Misdemeanor. MIN: $1,000 fine; MIN: $2,500 fine and one (1) MIN: MIN: Suspension and
plan;
MAX: $2,500 fine and one MAX: $5,000 fine and one (1) MAX: MAX: Revocation.
action plan.
b. Felony. MIN: $3,000 fine and one MIN: $5,000 fine and one (1) MIN: MIN: One (1) year
(1) year of probation; year suspension followed by Suspension and suspension and a
one (1) year probation; a corrective corrective action plan;
action plan;
MAX: Revocation.
MAX: $5,000 fine and one MAX: revocation. MAX: One (1)
followed by one (1) year and a corrective
4. Failing to comply MIN: $500 fine and MIN: $2,500 fine and MIN: MIN: One (1) year
with the educational suspension until suspension until compliant; Suspension and suspension and a
course requirements compliant; a corrective corrective action plan
for human action plan which includes, at a
immunodeficiency which includes, minimum, becoming
virus and acquired at a minimum, compliant;
immune deficiency becoming
syndrome, or medical compliant;
errors.
(Section MAX: $1,000 fine and MAX: $5,000 fine and MAX: One (1) MAX: Revocation.
456.072(1)(e), F.S.) suspension until suspension until compliant. year suspension
(Rules 64B16- compliant. and a corrective
26.103(1)(c) and action plan as
64B16-26.103(4)(e), outlined above.
F.A.C.)
103 | P a g e
5. Having a license or MIN: (Administrative MIN: Same penalty as MIN: Discipline MIN: Discipline as
the authority to related offense or offense imposed in the other as close as close as possible to
practice the regulated not impacting patients jurisdiction or as closely as possible to the the discipline
profession revoked, directly) Reprimand; possible to penalties for discipline imposed in the other
suspended, or MIN: (All other offenses) similar violation; imposed in the jurisdiction;
otherwise acted Same penalty as imposed other
against, including the in the other jurisdiction or jurisdiction;
denial of licensure, by as closely as possible to
the licensing authority penalties for similar
of any jurisdiction, violation;
including its agencies MAX:
or subdivisions, for a MAX: $2,500 fine and MAX: $10,000 fine and Revocation. MAX: Revocation.
violation that would same penalty as imposed revocation.
constitute a violation in the other jurisdiction or
under Florida law. as closely as possible to
(Section 456.072(1)(f), penalties for similar
F.S.) violation.
6. Having been found MIN: $3,000 fine; MIN: $5,000 fine and one (1) MIN: MIN: One (1) year
liable in a civil year suspension followed by Reprimand; suspension and a
proceeding for one (1) year probation; corrective action plan;
knowingly filing a
false report or MAX: Revocation.
complaint with the MAX: $5,000 fine and one MAX: revocation. MAX: One (1)
Department against (1) year suspension year suspension
another licensee. followed by one (1) year of and a corrective
(Section probation. action plan.
456.072(1)(g), F.S.)
7. Attempting to MIN: Revocation or denial MIN: Revocation or denial of MIN: MIN: Revocation;
obtain, obtaining, or of license application; license application; Revocation;
renewing a license to
practice a profession MAX: $10,000 fine and
by bribery, by Revocation or denial of MAX: $10,000 fine and MAX: MAX: Revocation.
fraudulent license application. revocation or denial of license Revocation.
misrepresentation, or application.
104 | P a g e
through an error of the
Department or the
Board.
(Section
456.072(1)(h), F.S.)
8. Except as provided MIN: $500 fine and 12- MIN: $5,000 fine and one (1) MIN: MIN: Suspension and
in Section 465.016, hour Laws & Rules course year suspension followed by Suspension and a corrective action
F.S., failing to report to or MJPE; one (1) year of probation; a corrective plan including, at a
the Department any action plan minimum, a 12-hour
person who the including, at a Laws & Rules course
licensee knows is in minimum, a 12- or MPJE;
violation of Chapter hour Laws &
456, F.S., the chapter Rules course or
regulating the alleged MPJE;
violator, or the rules of
the Department or the MAX: $1,500 fine, and MAX: Revocation. MAX: One (1) MAX: Revocation.
Board. one (1) year suspension year suspension
(Section 456.072(1)(i), followed by one (1) year of and a corrective
F.S.) probation. action plan as
outlined above.
9. Aiding, assisting, MIN: $2,000 fine and 12- MIN: $5,000 fine and one (1) MIN: MIN: One (1) year
procuring, employing, hour Laws & Rules course year suspension followed by Suspension and suspension and a
or advising any or MJPE; one (1) year of probation; a corrective corrective action plan;
unlicensed person or action plan
entity to practice a including, at a
profession contrary to minimum, a 12-
Chapter 456, F.S., the hour Laws &
chapter regulating the Rules course or
profession, or the rules MPJE;
of the Department or MAX: Revocation.
the Board. MAX: $2,500 fine and one MAX: revocation. MAX: One (1)
(Section 456.072(1)(j), (1) year of probation. year suspension
F.S.) and a corrective
action plan as
105 | P a g e
outlined above.
10. Failing to perform MIN: $2,000 fine and MIN: $5,000 fine and one (1) MIN: MIN: One (1) year
any statutory or legal suspension until year suspension followed by Suspension and suspension and a
obligation placed upon compliant; one (1) year of probation; a corrective corrective action plan;
a licensee. action plan
(Section which includes,
456.072(1)(k), F.S.) at a minimum,
becoming
compliant;
MAX: Revocation.
MAX: $2,500 fine and MAX: revocation. MAX: One (1)
compliant. and a corrective
action plan as
outlined above.
11. Making or filing a
report which the
licensee knows to be
false, intentionally or
negligently failing to
file a report or record
required by state or
federal law, or
willfully impeding or
obstructing another
person to do so.
(Section 456.072(1)(l),
F.S.)
a. Knowingly filing a MIN: $5,000 fine and one MIN: $10,000 fine and one MIN: MIN: One (1) year
false report or willful (1) year of probation; (1) year suspension followed Suspension and suspension and a
obstruction. by one (1) year of probation; a corrective corrective action plan;
action plan;
MAX: Revocation.
106 | P a g e
b. Negligently failing MIN: $2,500 fine; MIN: $5,000 fine and one (1) MIN: MIN: Suspension and
to file a report or year of probation; Reprimand; a corrective action
record. plan;
MAX: $5,000 fine. MAX: $5,000 fine and one (1) MAX: MAX: Revocation.
year suspension followed by Suspension and
action plan.
12. Making deceptive, MIN: $5,000 fine and one MIN: $10,000 fine and one MIN: MIN: One (1) year
untrue, or fraudulent (1) year of probation; (1) year suspension followed Suspension and suspension and a
representations in or by one (1) year of probation; a corrective corrective action plan;
related to the practice action plan;
of a profession or MAX: Revocation.
employing a trick or a MAX: $10,000 fine and MAX: Revocation. MAX: One (1)
scheme in or related to one (1) year suspension year suspension
the practice of a followed by one (1) year of and a corrective
profession. probation. action plan.
(Section
456.072(1)(m), F.S.)
13. Exercising MIN: $3,000 fine; MIN: $5,000 fine and one (1) MIN: MIN: One (1) year
influence on the year suspension followed by Reprimand; suspension and a
patient or client for the one (1) year of probation; corrective action plan;
purpose of financial
gain of the licensee or MAX: Revocation.
a third party. MAX: $5,000 fine and one MAX: revocation. MAX: One (1)
(Section (1) year suspension year suspension
456.072(1)(n), F.S.) followed by one (1) year of and a corrective
14. Practicing or MIN: $2,000 fine and one MIN: $5,000 fine and one (1) MIN: MIN: One (1) year
offering to practice (1) year of probation; year suspension followed by Suspension and suspension and a
beyond the scope one (1) year of probation; a corrective corrective action plan;
107 | P a g e
permitted by law or action plan;
accepting and MAX: Revocation.
performing MAX: $5,000 fine and one MAX: revocation. MAX: One (1)
professional (1) year suspension year suspension
responsibilities the followed by one (1) year and a corrective
licensee knows, or has probation. action plan.
reason to know, the
licensee is not
competent to perform.
(Section
456.072(1)(o), F.S.)
15. Delegating or MIN: $2,000 fine and one MIN: $5,000 fine and one (1) MIN: MIN: One (1) year
contracting for the (1) year of probation; year suspension followed by Suspension and suspension and a
performance of one (1) year of probation; a corrective corrective action plan;
professional action plan;
responsibilities by a MAX: Revocation.
person when the MAX: $5,000 fine and one MAX: revocation. MAX: One (1)
licensee delegating or (1) year suspension year suspension
contracting for followed by one (1) year of and a corrective
performance of such probation. action plan.
responsibilities knows,
or has reason to know,
such person is not
qualified by training,
experience, and
authorization when
required to perform
them.
(Section
456.072(1)(p), F.S.)
16. Violating any MIN: $1,000 fine and 12- MIN: $5,000 fine and one (1) MIN: MIN: One (1) year
provision of Chapter hour Laws & Rules course year suspension followed by Suspension and suspension and a
456, F.S., the or MPJE; one (1) year of probation; a corrective corrective action plan;
applicable professional action plan
108 | P a g e
practice act, a rule of including, at a
the Department or the minimum, a 12-
Board, or a lawful hour Laws &
order of the Rules course or
Department or the MPJE;
Board, or failing to MAX: Revocation.
comply with a lawfully MAX: $5,000 fine and one MAX: revocation. MAX: One (1)
issued subpoena of the (1) year of probation. year suspension
Department. and a corrective
(Sections action plan as
456.072(1)(dd), and outlined above.
456.072(1)(q), F.S.)
17. Improperly MIN: $2,500 fine and one MIN: $5,000 fine and one (1) MIN: MIN: One (1) year
interfering with an (1) year of probation; year suspension followed by Suspension and suspension and a
investigation or one (1) year of probation; a corrective corrective action plan;
inspection authorized action plan;
by statute, or with any MAX: Revocation.
disciplinary MAX: $5,000 fine and one MAX: revocation. MAX: One (1)
proceeding. (1) year suspension year suspension
(Section 456.072(1)(r), followed by one (1) year of and a corrective
F.S.) probation. action plan.
18. Engaging or MIN: Revocation; MIN: Revocation; MIN: MIN: Revocation;
attempting to engage Revocation;
in sexual misconduct
as defined and MAX: $10,000 fine and MAX: $10,000 fine and MAX: MAX: Revocation.
prohibited in Section Revocation. revocation. Revocation.
456.063(1), F.S.
(Section
456.072(1)(v), F.S.)
19. Being unable to MIN: $500 fine, MIN: $1,000 fine, one (1) MIN: MIN: One (1) year
practice with suspension until safe to year suspension followed by Suspension and suspension and a
reasonable skill and practice with reasonable suspension until safe to a corrective corrective action plan
safety by reason of skill and safety; practice with reasonable skill action plan including, at a
illness or use of and safety; including, at a minimum,
109 | P a g e
alcohol, drugs, minimum, demonstration of the
narcotics, chemicals, demonstration ability to practice
or as a result of any of the ability to with reasonable skill
mental or physical practice with and safety;
condition. reasonable skill
(Section and safety;
456.072(1)(z), F.S.)
revocation. revocation. year suspension
and a corrective
action plan as
outlined above.
20. Failing to report to MIN: $1,000 fine; MIN: $5,000 fine and one (1) MIN: MIN: One (1) year
the Board, or the year suspension followed by Reprimand; suspension and a
Department if there is one (1) year of probation; corrective action plan;
no Board, in writing
within 30 days after the MAX: Revocation.
licensee has been MAX: $5,000 fine and one MAX: revocation. MAX: One (1)
convicted or found (1) year of probation. year suspension
guilty of, or entered a and a corrective
plea of nolo action plan.
contendere to,
regardless of
adjudication, a crime
in any jurisdiction.
(Section
456.072(1)(x), F.S.)
21. Testing positive for MIN: $500 fine, MIN: $1,000 fine, suspension MIN: MIN: Suspension and
any drug, as defined in suspension until safe to until safe to practice with Suspension and a corrective action
Section 112.0455, practice with reasonable reasonable skill and safety; a corrective plan including, at a
F.S., on any confirmed skill and safety; action plan minimum,
pre-employment or including, at a demonstration of the
employer ordered drug minimum, ability to practice
screening when the demonstration with reasonable skill
110 | P a g e
practitioner does not of the ability to and safety;
have a lawful practice with
prescription and reasonable skill
legitimate medical and safety;
reason for using such
drug. MAX: $2,500 fine and MAX: $2,500 fine and MAX: MAX: Revocation.
(Section revocation. revocation. Revocation.
456.072(1)(aa), F.S.)
22. Being terminated MIN: Suspension until MIN: Revocation; MIN: MIN: Revocation;
from, or failing to successful completion or Suspension and
successfully complete, receipt of written a corrective
an impaired confirmation of action plan
practitioner treatment compliance with ongoing including, at a
program. treatment; minimum,
(Section written
456.072(1)(hh), F.S.) confirmation of
compliance
with ongoing
treatment;
MAX: Revocation. MAX: $10,000 fine and MAX: MAX: Revocation.

revocation Revocation.
23. Being convicted of, MIN: Revocation, or in the MIN: Revocation or in the MIN: MIN: Revocation;
or entering a plea of case of application for case of application for Revocation;
guilty or nolo licensure, denial of licensure, denial of license;
contendere to, any license;
misdemeanor or
felony, regardless of MAX: $10,000 fine and MAX: $10,000 fine and MAX: MAX: Revocation.
adjudication, under 18 revocation, or in the case revocation, or in the case of Revocation.
U.S.C. s. 669, ss. 285- of application for application for licensure,
287, s. 371, s. 1001, s. licensure, denial of denial of license.
1035, s. 1341, s. 1343, license.
s. 1347, s. 1349, or s.
1518, or 42 U.S.C. ss.
111 | P a g e
1320a-7b, relating to
the Medicaid program.
(Section
456.072(1)(ii), F.S.)
24. Failing to remit the MIN: $500 fine; MIN: $2,500 and suspension MIN: MIN: Suspension and
sum owed to the state until amount owed is remitted Reprimand; a corrective action
for overpayment from followed by one (1) year of plan including, at a
the Medicaid program probation; minimum, remitting
pursuant to a final the amount owed;
order, judgment, or
settlement. MAX: $2,500 fine, MAX: revocation. MAX: MAX: Revocation.
(Section suspension until amount Suspension and
456.072(1)(jj), F.S.) owed is remitted. a corrective
action plan
including, at a
minimum,
remitting the
amount owed.
25. Being terminated MIN: $10,000 fine and one MIN: $10,000 fine and two MIN: MIN: Two (2) year
from the state (1) year of probation; (2) year suspension followed Suspension and suspension and a
Medicaid program by one (1) year probation; a corrective corrective action plan;
pursuant to Section action plan;
409.913, F.S., any MAX: Revocation.
other state Medicaid MAX: Revocation. MAX: Revocation. MAX:
program, or the federal Revocation.
Medicare program, as
a result of fraud and
abuse unless eligibility
to participate in the
program from which
the practitioner was
terminated has been
restored.
(Section
112 | P a g e
456.072(1)(kk), F.S.)
26. Being convicted of, MIN: Revocation, or in the MIN: Revocation or in the MIN: MIN: Revocation;
or entering a plea of case of application for case of application for Revocation;
guilty or nolo licensure, denial of licensure, denial of license;
contendere to, any license;
misdemeanor or
felony, regardless of MAX: $10,000 fine and MAX: $10,000 fine and MAX: MAX: Revocation.
adjudication, a crime revocation, or in the case revocation, or in the case of Revocation.
in any jurisdiction of application for application for licensure,
which relates to health licensure, denial of denial of license.
care fraud. license.
(Section
456.072(1)(ll), F.S.)
27. Willfully failing to MIN: Reprimand and a MIN: $500 fine and one (1) MIN: MIN: Suspension and
comply with Section fine of $250; year of probation; Reprimand; corrective action plan;
627.64194 or 641.513,
F.S., with such MAX: Revocation.
frequency as to MAX: $500 fine and one MAX: $1,000 fine and one (1) MAX:
indicate a general (1) year of probation. year suspension followed by Suspension and
business practice. one (1) year of probation. corrective
(Section action plan.
456.072(1)(oo), F.S.)
(v) Violation of
Section 828.055, F.S.
by a permitted county
or municipal animal
control agency or
humane society.
(Section 828.055, F.S.)
1. Using drugs for MIN: Reprimand and a MIN: $500 fine and one (1) MIN: MIN: One (1) year
animal euthanasia for $250 fine; year suspension followed by Reprimand; suspension and
an improper use. one (1) year of probation; corrective action plan;
(Section
828.055(3)(a), F.S.) MAX: Revocation.
113 | P a g e
MAX: $500 fine and one MAX: Revocation. MAX: One (1)
followed by one (1) year of and corrective
2. Failing to take MIN: Reprimand and a MIN: $500 fine and one (1) MIN: MIN: One (1) year
reasonable precautions $250 fine; year suspension followed by Reprimand; suspension and a
against misuse, theft, one (1) year probation; corrective action plan;
loss, or diversion.
828.055(3)(b), F.S.) MAX: $500 fine and one MAX: Revocation. MAX: One (1)
3. Failing to detect or MIN: Reprimand, $500 MIN: $1,000 fine and one (1) MIN: MIN: One (1) year
to report a significant fine, and one (1) year of year suspension followed by Suspension and suspension and a
loss, theft, or inventory probation; two (2) years of probation; a corrective corrective action plan;
shortage of drugs. action plan;
828.055(3)(c), F.S.) MAX: $1,000 fine, and MAX: Revocation. MAX: One (1)
followed by two (2) years and a corrective
of probation. action plan.
4. Failing to follow the MIN: Reprimand and a MIN: $500 fine and one (1) MIN: MIN: One (1) year
rules of the Board $250 fine; year suspension followed by Reprimand; suspension and a
regarding proper one (1) year probation; corrective action plan;
storage and handling
of drugs. MAX: Revocation.
(Section MAX: $500 fine and one MAX: Revocation. MAX: One (1)
828.055(3)(d), F.S.) (1) year suspension year suspension
5. Violating any MIN: Reprimand and a MIN: $500 fine and one (1) MIN: MIN: One (1) year
provision of Section $250 fine; year suspension followed by Reprimand; suspension and a
828.055, Chapters 465, one (1) year of probation; corrective action plan;
114 | P a g e
and 499, F.S., or any
rule adopted under MAX: Revocation.
those chapters. MAX: $500 fine and one MAX: Revocation. MAX: One (1)
(Section (1) year suspension year suspension
828.055(3)(e), F.S.) followed by one (1) year of and a corrective
(w) Failure to display N/A N/A MIN: MIN: Suspension and
hyperlink on telehealth Reprimand; a corrective action
registrant’s website. plan;
(Section 456.47(4)(c),
F.S. MAX: MAX: Revocation.
Suspension and
a corrective
action plan.
(x) Opening an office N/A N/A MIN: MIN: One (1) year
in Florida or providing Suspension and suspension and a
in-person healthcare a corrective corrective action plan;
services to patients in action plan;
Florida. MAX: Revocation.
(Section 456.47(4)(f), MAX:
F.S.) Revocation.
(y) Failure to notify the N/A N/A MIN: MIN: Suspension and
applicable board, or Reprimand; a corrective action
the department if there plan;
is no board, of any
adverse actions taken MAX: MAX: Revocation
against his or her Suspension and
license. a corrective
(Section action plan.
456.47(4)(i)1., F.S.)
(z) Has restrictions N/A N/A MIN: MIN: Reprimand;
placed on or Reprimand;
disciplinary action
taken against his or her MAX: MAX: Revocation.
115 | P a g e
license in any state or Revocation. (Discipline shall be as
jurisdiction. (Discipline shall close as possible to
(Section be as close as the penalty imposed
456.47(4)(i)2., F.S.) possible to the in other jurisdiction.)
penalty imposed
in other
jurisdiction.).
(aa) Violates any of the N/A N/A MIN: MIN: Suspension and
requirements of Reprimand; a corrective action
Section 456.47, F.S. plan;
(Section
456.47(4)(i)3., F.S.) MAX: One (1) MAX: Revocation.
year suspension
and a corrective
action plan.
(bb) Failure to comply MIN: Reprimand and a MIN: $1,000 fine and six (6) MIN: MIN: Suspension and
with the parental $250 fine; month suspension followed Reprimand; a corrective action
consent requirements by one (1) year of probation; plan;
of Section 1014.06,
F.S. MAX: $500 fine and one MAX: Revocation. MAX: MAX: Revocation.
(Section (1) year of probation. Suspension and
456.072(1)(rr), F.S.) a corrective
action plan.
(cc) Being convicted MIN: $10,000 fine and MIN: $10,000 fine and MIN: MIN: Revocation;
or found guilty of, Revocation; Revocation; Revocation;
entering a plea of
guilty or nolo MAX: $10,000 fine and MAX: $10,000 fine and MAX: MAX: Revocation.
contendere to, or Revocation. Revocation. Revocation.
committing or
attempting, soliciting,
or conspiring to
commit an act that
would constitute a
violation of any of the
116 | P a g e
offenses listed in
Section 456.074(5),
F.S.
(Section
456.072(1)(ss), F.S.
117 | P a g e
456.072 Grounds for discipline; penalties; enforcement; All Health care

Professionals Licensed in FL
http://www.leg.state.fl.us/statutes/index.cfm?App_mode=Display_Statute&Search_Strin
g=&URL=0400-0499/0456/Sections/0456.072.html
(1) The following acts shall constitute grounds for which the disciplinary actions
specified in subsection (2) may be taken:
(a) Making misleading, deceptive, or fraudulent representations in or related to the
practice of the licensee’s profession.
(b) Intentionally violating any rule adopted by the board or the department, as
appropriate.
(c) Being convicted or found guilty of, or entering a plea of guilty or nolo contendere to,
regardless of adjudication, a crime in any jurisdiction which relates to the practice of, or
the ability to practice, a licensee’s profession.
(d) Using a Class III or a Class IV laser device or product, as defined by federal
regulations, without having complied with the rules adopted under s. 501.122(2)
governing the registration of the devices.
(e) Failing to comply with the educational course requirements for human
immunodeficiency virus and acquired immune deficiency syndrome.
(f) Having a license or the authority to practice any regulated profession revoked,
suspended, or otherwise acted against, including the denial of licensure, by the licensing
authority of any jurisdiction, including its agencies or subdivisions, for a violation that
would constitute a violation under Florida law. The licensing authority’s acceptance of a
relinquishment of licensure, stipulation, consent order, or other settlement, offered in
response to or in anticipation of the filing of charges against the license, shall be
construed as action against the license.
(g) Having been found liable in a civil proceeding for knowingly filing a false report or
complaint with the department against another licensee.
(h) Attempting to obtain, obtaining, or renewing a license to practice a profession by
bribery, by fraudulent misrepresentation, or through an error of the department or the
board.
(i) Except as provided in s. 465.016, failing to report to the department any person who
the licensee knows is in violation of this chapter, the chapter regulating the alleged
violator, or the rules of the department or the board. However, a person who the licensee
knows is unable to practice with reasonable skill and safety to patients by reason of illness
or use of alcohol, drugs, narcotics, chemicals, or any other type of material, or as a result
of a mental or physical condition, may be reported to a consultant operating an impaired
practitioner program as described in s. 456.076 rather than to the department.
(j) Aiding, assisting, procuring, employing, or advising any unlicensed person or entity
to practice a profession contrary to this chapter, the chapter regulating the profession, or
the rules of the department or the board.
(k) Failing to perform any statutory or legal obligation placed upon a licensee. For
purposes of this section, failing to repay a student loan issued or guaranteed by the state
or the Federal Government in accordance with the terms of the loan is not considered a
failure to perform a statutory or legal obligation. Fines collected shall be deposited into
the Medical Quality Assurance Trust Fund.
(l) Making or filing a report which the licensee knows to be false, intentionally or
negligently failing to file a report or record required by state or federal law, or willfully
impeding or obstructing another person to do so. Such reports or records shall include
only those that are signed in the capacity of a licensee.
(m) Making deceptive, untrue, or fraudulent representations in or related to the practice
of a profession or employing a trick or scheme in or related to the practice of a profession.
(n) Exercising influence on the patient or client for the purpose of financial gain of the
licensee or a third party.
(o) Practicing or offering to practice beyond the scope permitted by law or accepting
and performing professional responsibilities the licensee knows, or has reason to know,
the licensee is not competent to perform.
(p) Delegating or contracting for the performance of professional responsibilities by a
person when the licensee delegating or contracting for performance of the responsibilities
knows, or has reason to know, the person is not qualified by training, experience, and
authorization when required to perform them.
(q) Violating a lawful order of the department or the board, or failing to comply with a
lawfully issued subpoena of the department.
(r) Improperly interfering with an investigation or inspection authorized by statute, or
with any disciplinary proceeding.
(s) Failing to comply with the educational course requirements for domestic violence.
(t) Failing to identify through written notice, which may include the wearing of a name
tag, or orally to a patient the type of license under which the practitioner is practicing. Any
advertisement for health care services naming the practitioner must identify the type of
license the practitioner holds. This paragraph does not apply to a practitioner while the
practitioner is providing services in a facility licensed under chapter 394, chapter 395,
chapter 400, or chapter 429. Each board, or the department where there is no board, is
authorized by rule to determine how its practitioners may comply with this disclosure
requirement.
(u) Failing to comply with the requirements of ss. 381.026 and 381.0261 to provide
patients with information about their patient rights and how to file a patient complaint.
(v) Engaging or attempting to engage in sexual misconduct as defined and prohibited in
s. 456.063(1).
(w) Failing to comply with the requirements for profiling and credentialing, including, but
not limited to, failing to provide initial information, failing to timely provide updated
information, or making misleading, untrue, deceptive, or fraudulent representations on a
profile, credentialing, or initial or renewal licensure application.
(x) Failing to report to the board, or the department if there is no board, in writing within
30 days after the licensee has been convicted or found guilty of, or entered a plea of nolo
contendere to, regardless of adjudication, a crime in any jurisdiction. Convictions,
findings, adjudications, and pleas entered into prior to the enactment of this paragraph
must be reported in writing to the board, or department if there is no board, on or before
October 1, 1999.
(y) Using information about people involved in motor vehicle accidents which has been
derived from accident reports made by law enforcement officers or persons involved in
accidents under s. 316.066, or using information published in a newspaper or other news
119 | P a g e
publication or through a radio or television broadcast that has used information gained
from such reports, for the purposes of commercial or any other solicitation whatsoever of
the people involved in the accidents.
(z) Being unable to practice with reasonable skill and safety to patients by reason of
illness or use of alcohol, drugs, narcotics, chemicals, or any other type of material or as
a result of any mental or physical condition. In enforcing this paragraph, the department
shall have, upon a finding of the State Surgeon General or the State Surgeon General’s
designee that probable cause exists to believe that the licensee is unable to practice
because of the reasons stated in this paragraph, the authority to issue an order to compel
a licensee to submit to a mental or physical examination by physicians designated by the
department. If the licensee refuses to comply with the order, the department’s order
directing the examination may be enforced by filing a petition for enforcement in the circuit
court where the licensee resides or does business. The department shall be entitled to
the summary procedure provided in s. 51.011. A licensee or certificateholder affected
under this paragraph shall at reasonable intervals be afforded an opportunity to
demonstrate that he or she can resume the competent practice of his or her profession
with reasonable skill and safety to patients.
(aa) Testing positive for any drug, as defined in s. 112.0455, on any confirmed
preemployment or employer-ordered drug screening when the practitioner does not have
a lawful prescription and legitimate medical reason for using the drug.
(bb) Performing or attempting to perform health care services on the wrong patient, a
wrong-site procedure, a wrong procedure, or an unauthorized procedure or a procedure
that is medically unnecessary or otherwise unrelated to the patient’s diagnosis or medical
condition. For the purposes of this paragraph, performing or attempting to perform health
care services includes the preparation of the patient.
(cc) Leaving a foreign body in a patient, such as a sponge, clamp, forceps, surgical
needle, or other paraphernalia commonly used in surgical, examination, or other
diagnostic procedures. For the purposes of this paragraph, it shall be legally presumed
that retention of a foreign body is not in the best interest of the patient and is not within
the standard of care of the profession, regardless of the intent of the professional.
(dd) Violating any provision of this chapter, the applicable practice act, or any rules
adopted pursuant thereto.
(ee) With respect to making a personal injury protection claim as required by s. 627.736,
intentionally submitting a claim, statement, or bill that has been “upcoded” as defined in
s. 627.732.
(ff) With respect to making a personal injury protection claim as required by s. 627.736,
intentionally submitting a claim, statement, or bill for payment of services that were not
rendered.
(gg) Engaging in a pattern of practice when prescribing medicinal drugs or controlled
substances which demonstrates a lack of reasonable skill or safety to patients, a violation
of this chapter or ss. 893.055 and 893.0551, a violation of the applicable practice act, or
a violation of any rules adopted under this chapter or the applicable practice act of the
prescribing practitioner. Notwithstanding s. 456.073(13), the department may initiate an
investigation and establish such a pattern from billing records, data, or any other
information obtained by the department.
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(hh) Being terminated from an impaired practitioner program that is overseen by a
consultant as described in s. 456.076, for failure to comply, without good cause, with the
terms of the monitoring or participant contract entered into by the licensee, or for not
successfully completing any drug treatment or alcohol treatment program.
(ii) Being convicted of, or entering a plea of guilty or nolo contendere to, any
misdemeanor or felony, regardless of adjudication, under 18 U.S.C. s. 669, ss. 285-287,
s. 371, s. 1001, s. 1035, s. 1341, s. 1343, s. 1347, s. 1349, or s. 1518, or 42 U.S.C. ss.
1320a-7b, relating to the Medicaid program.
(jj) Failing to remit the sum owed to the state for an overpayment from the Medicaid
program pursuant to a final order, judgment, or stipulation or settlement.
(kk) Being terminated from the state Medicaid program pursuant to s. 409.913, any
other state Medicaid program, or the federal Medicare program, unless eligibility to
participate in the program from which the practitioner was terminated has been restored.
(ll) Being convicted of, or entering a plea of guilty or nolo contendere to, any
misdemeanor or felony, regardless of adjudication, a crime in any jurisdiction which
relates to health care fraud.
(mm) Failure to comply with controlled substance prescribing requirements of s. 456.44.
(nn) Violating any of the provisions of s. 790.338.
(oo) Willfully failing to comply with s. 627.64194 or s. 641.513 with such frequency as
to indicate a general business practice.
(pp) Providing information, including written documentation, indicating that a person has
a disability or supporting a person’s need for an emotional support animal under s. 760.27
without personal knowledge of the person’s disability or disability-related need for the
specific emotional support animal.
(qq) Intentionally implanting a patient or causing a patient to be implanted with a human
embryo without the recipient’s consent to the use of that human embryo, or inseminating
a patient or causing a patient to be inseminated with the human reproductive material, as
defined in s. 784.086, of a donor without the recipient’s consent to the use of human
reproductive material from that donor.
(rr) Failure to comply with the parental consent requirements of s. 1014.06.
(ss) Being convicted or found guilty of; entering a plea of guilty or nolo contendere to,
regardless of adjudication; or committing or attempting, soliciting, or conspiring to commit
an act that would constitute a violation of any of the offenses listed in s. 456.074(5) or a
similar offense in another jurisdiction.
(2) When the board, or the department when there is no board, finds any person guilty
of the grounds set forth in subsection (1) or of any grounds set forth in the applicable
practice act, including conduct constituting a substantial violation of subsection (1) or a
violation of the applicable practice act which occurred prior to obtaining a license, it may
enter an order imposing one or more of the following penalties:
(a) Refusal to certify, or to certify with restrictions, an application for a license.
(b) Suspension or permanent revocation of a license.
(c) Restriction of practice or license, including, but not limited to, restricting the licensee
from practicing in certain settings, restricting the licensee to work only under designated
conditions or in certain settings, restricting the licensee from performing or providing
designated clinical and administrative services, restricting the licensee from practicing
121 | P a g e
more than a designated number of hours, or any other restriction found to be necessary
for the protection of the public health, safety, and welfare.
(d) Imposition of an administrative fine not to exceed $10,000 for each count or separate
offense. If the violation is for fraud or making a false or fraudulent representation, the
board, or the department if there is no board, must impose a fine of $10,000 per count or
offense.
(e) Issuance of a reprimand or letter of concern.
(f) Placement of the licensee on probation for a period of time and subject to such
conditions as the board, or the department when there is no board, may specify. Those
conditions may include, but are not limited to, requiring the licensee to undergo treatment,
attend continuing education courses, submit to be reexamined, work under the
supervision of another licensee, or satisfy any terms which are reasonably tailored to the
violations found.
(g) Corrective action.
(h) Imposition of an administrative fine in accordance with s. 381.0261 for violations
regarding patient rights.
(i) Refund of fees billed and collected from the patient or a third party on behalf of the
patient.
(j) Requirement that the practitioner undergo remedial education.
In determining what action is appropriate, the board, or department when there is no
board, must first consider what sanctions are necessary to protect the public or to
compensate the patient. Only after those sanctions have been imposed may the
disciplining authority consider and include in the order requirements designed to
rehabilitate the practitioner. All costs associated with compliance with orders issued under
this subsection are the obligation of the practitioner.
(3)(a) Notwithstanding subsection (2), if the ground for disciplinary action is the first-time
failure of the licensee to satisfy continuing education requirements established by the
board, or by the department if there is no board, the board or department, as applicable,
shall issue a citation in accordance with s. 456.077 and assess a fine, as determined by
the board or department by rule. In addition, for each hour of continuing education not
completed or completed late, the board or department, as applicable, may require the
licensee to take 1 additional hour of continuing education for each hour not completed or
completed late.
(b) Notwithstanding subsection (2), if the ground for disciplinary action is the first-time
violation of a practice act for unprofessional conduct, as used in ss. 464.018(1)(h),
467.203(1)(f), 468.365(1)(f), and 478.52(1)(f), and no actual harm to the patient occurred,
the board or department, as applicable, shall issue a citation in accordance with s.
456.077 and assess a penalty as determined by rule of the board or department.
(4) In addition to any other discipline imposed through final order, or citation, entered on
or after July 1, 2001, under this section or discipline imposed through final order, or
citation, entered on or after July 1, 2001, for a violation of any practice act, the board, or
the department when there is no board, shall assess costs related to the investigation
and prosecution of the case. The costs related to the investigation and prosecution
include, but are not limited to, salaries and benefits of personnel, costs related to the time
122 | P a g e
spent by the attorney and other personnel working on the case, and any other expenses
incurred by the department for the case. The board, or the department when there is no
board, shall determine the amount of costs to be assessed after its consideration of an
affidavit of itemized costs and any written objections thereto. In any case where the board
or the department imposes a fine or assessment and the fine or assessment is not paid
within a reasonable time, the reasonable time to be prescribed in the rules of the board,
or the department when there is no board, or in the order assessing the fines or costs,
the department or the Department of Legal Affairs may contract for the collection of, or
bring a civil action to recover, the fine or assessment.
(5) In addition to, or in lieu of, any other remedy or criminal prosecution, the department
may file a proceeding in the name of the state seeking issuance of an injunction or a writ
of mandamus against any person who violates any of the provisions of this chapter, or
any provision of law with respect to professions regulated by the department, or any board
therein, or the rules adopted pursuant thereto.
(6) If the board, or the department when there is no board, determines that revocation
of a license is the appropriate penalty, the revocation shall be permanent. However, the
board may establish by rule requirements for reapplication by applicants whose licenses
have been permanently revoked. The requirements may include, but are not limited to,
satisfying current requirements for an initial license.
(7) Notwithstanding subsection (2), upon a finding that a physician has prescribed or
dispensed a controlled substance, or caused a controlled substance to be prescribed or
dispensed, in a manner that violates the standard of practice set forth in s. 458.331(1)(q)
or (t), s. 459.015(1)(t) or (x), s. 461.013(1)(o) or (s), or s. 466.028(1)(p) or (x), or that an
advanced practice registered nurse has prescribed or dispensed a controlled substance,
or caused a controlled substance to be prescribed or dispensed, in a manner that violates
the standard of practice set forth in s. 464.018(1)(n) or (p)6., the physician or advanced
practice registered nurse shall be suspended for a period of not less than 6 months and
pay a fine of not less than $10,000 per count. Repeated violations shall result in increased
penalties.
(8) The purpose of this section is to facilitate uniform discipline for those actions made
punishable under this section and, to this end, a reference to this section constitutes a
general reference under the doctrine of incorporation by reference.
History.—s. 69, ch. 97-261; s. 84, ch. 99-397; s. 90, ch. 2000-160; s. 26, ch. 2000-318;
s. 71, ch. 2001-277; s. 2, ch. 2002-254; s. 6, ch. 2003-411; s. 19, ch. 2003-416; s. 10, ch.
2004-344; s. 1, ch. 2005-240; s. 2, ch. 2006-207; s. 111, ch. 2007-5; s. 64, ch. 2008-6; s.
25, ch. 2009-223; s. 3, ch. 2011-112; s. 1, ch. 2011-141; s. 8, ch. 2016-222; ss. 5, 23, ch.
2016-224; s. 6, ch. 2017-41; s. 2, ch. 2018-13; s. 47, ch. 2018-106; s. 1, ch. 2020-31; s.
4, ch. 2020-76; s. 3, ch. 2020-125; s. 15, ch. 2020-160; s. 1, ch. 2021-190; s. 9, ch. 2021-
199.
Note.—Former s. 455.624.
893.04 Drug Abuse Prevention and Control Pharmacist and practitioner.—

(1) A pharmacist, in good faith and in the course of professional practice only, may
dispense controlled substances upon a written, oral, or electronic prescription of a
practitioner, under the following conditions:
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(a) Oral prescriptions must be promptly reduced to writing by the pharmacist or recorded
electronically if permitted by federal law.
(b) The written prescription must be dated and signed by the prescribing practitioner on
the day when issued.
(c) There shall appear on the face of the prescription or written record thereof for the
controlled substance the following information:
1. The full name and address of the person for whom, or the owner of the animal for
which, the controlled substance is dispensed.
2. The full name and address of the prescribing practitioner and the practitioner’s federal
controlled substance registry number shall be printed thereon.
3. If the prescription is for an animal, the species of animal for which the controlled
substance is prescribed.
4. The name of the controlled substance prescribed and the strength, quantity, and
directions for use thereof.
5. The number of the prescription, as recorded in the prescription files of the pharmacy in
which it is filled.
6. The initials of the pharmacist filling the prescription and the date filled.
(d) The prescription shall be retained on file by the proprietor of the pharmacy in which it
is filled for a period of 2 years.
(e) Affixed to the original container in which a controlled substance is delivered upon a
prescription or authorized refill thereof, as hereinafter provided, there shall be a label
bearing the following information:
1. The name and address of the pharmacy from which such controlled substance was
dispensed.
2. The date on which the prescription for such controlled substance was filled.
3. The number of such prescription, as recorded in the prescription files of the pharmacy in
which it is filled.
4. The name of the prescribing practitioner.
5. The name of the patient for whom, or of the owner and species of the animal for which,
the controlled substance is prescribed.
6. The directions for the use of the controlled substance prescribed in the prescription.
7. A clear, concise warning that it is a crime to transfer the controlled substance to any
person other than the patient for whom prescribed.
(f) A prescription for a controlled substance listed in Schedule II may be dispensed only
upon a written or electronic prescription of a practitioner, except that in an emergency
situation, as defined by regulation of the Department of Health, such controlled substance
may be dispensed upon oral prescription but is limited to a 72-hour supply. A prescription
for a controlled substance listed in Schedule II may not be refilled.
(g) A prescription for a controlled substance listed in Schedule III, Schedule IV, or
Schedule V may not be filled or refilled more than five times within a period of 6 months
after the date on which the prescription was written unless the prescription is renewed by a
practitioner.
(2)(a) A pharmacist may not dispense a controlled substance listed in Schedule II,
Schedule III, or Schedule IV to any patient or patient’s agent without first determining, in
the exercise of her or his professional judgment, that the prescription is valid. The
pharmacist may dispense the controlled substance, in the exercise of her or his professional
judgment, when the pharmacist or pharmacist’s agent has obtained satisfactory patient
information from the patient or the patient’s agent.
(b) 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
124 | P a g e
for the prescription dispensed by mail if the pharmacist has obtained the patient’s
identification through the patient’s prescription benefit plan.
(c) Any controlled substance listed in Schedule III or Schedule IV may be dispensed by a
pharmacist upon an oral prescription if, before filling the prescription, the pharmacist
reduces it to writing or records the prescription electronically if permitted by federal law.
Such prescriptions must contain the date of the oral authorization.
(d) Each prescription written by a practitioner in this state for a controlled substance listed
in Schedule II, Schedule III, or Schedule IV must include a written and a numerical notation
of the quantity of the controlled substance prescribed and a notation of the date in
numerical, month/day/year format, or with the abbreviated month written out, or the
month written out in whole. A pharmacist may, upon verification by the prescriber,
document any information required by this paragraph. If the prescriber is not available to
verify a prescription, the pharmacist may dispense the controlled substance, but may insist
that the person to whom the controlled substance is dispensed provide valid photographic
identification. If a prescription includes a numerical notation of the quantity of the controlled
substance or date, but does not include the quantity or date written out in textual format,
the pharmacist may dispense the controlled substance without verification by the prescriber
of the quantity or date if the pharmacy previously dispensed another prescription for the
person to whom the prescription was written.
(e) A pharmacist may not dispense more than a 30-day supply of a controlled substance
listed in Schedule III upon an oral prescription issued in this state.
(f) A pharmacist may not knowingly dispense a prescription that has been forged for a
controlled substance listed in Schedule II, Schedule III, or Schedule IV.
(3) Notwithstanding subsection (1), a pharmacist may dispense a one-time emergency
refill of up to a 72-hour supply of the prescribed medication for any medicinal drug other
than a medicinal drug listed in Schedule II, or up to one vial of insulin to treat diabetes
mellitus, in compliance with s. 465.0275.
(4) 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. Such controlled substances may be sold only upon an order form,
when such an order form is required for sale by the drug abuse laws of the United States or
this state, or regulations pursuant thereto.
History.—s. 4, ch. 73-331; s. 2, ch. 75-18; s. 12, ch. 79-12; s. 2, ch. 90-2; s. 1436, ch. 97-
102; s. 301, ch. 99-8; s. 2, ch. 2007-156; s. 5, ch. 2009-202; s. 5, ch. 2014-113; s. 6, ch.
2016-145; s. 35, ch. 2016-230; s. 9, ch. 2018-13.
Medicinal Drugs Which May Be Ordered by Pharmacists in Florida (64B16-27.220)

A Pharmacist may order and dispense from the following formulary, within their professional judgment,
subject to the stated conditions.
(1) Oral analgesics for mild to moderate pain. The pharmacist may order these drugs for minor pain
and menstrual cramps for patients with no history of peptic ulcer disease. The prescription shall be limited
to a six (6) day supply for one treatment. If appropriate, the prescription shall be labeled to be taken with
food or milk.
(a) Magnesium salicylate/phenyltoloxamine citrate.
(b) Acetylsalicylic acid (Zero order release, long acting tablets).
(c) Choline salicylate and magnesium salicylate.
(d) Naproxen sodium.
(e) Naproxen.
(f) Ibuprofen.
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(2) Urinary analgesics. Phenazopyridine, not exceeding a two (2) day supply. The prescriptions shall
be labeled about the tendency to discolor urine. If appropriate, the prescription shall be labeled to be taken
after meals.
(3) Otic analgesics. Antipyrine 5.4%, benzocaine 1.4%, glycerin, if clinical signs or symptions of
tympanic membrane perforation do not exist. The product shall be labeled for use in the ear only.
(4) Anti-nausea preparations.
(a) Meclizine up to 25 mg., except for a patient currently using a central nervous system (CNS)
depressant. The prescription shall be labeled to advise the patient of drowsiness and to caution against
concomitant use with alcohol or other depressants.
(b) Scopolamine not exceeding 1.5 mg. per dermal patch. Patient shall be warned to seek appropriate
medical attention if eye pain, redness or decreased vision develops.
(5) Antihistamines and decongestants. The following, including their salts, either as a single ingredient
product or in combination, including nasal decongestants, may be ordered for a patient above 6 years of
age.
(a) Antihistamines. The pharmacist shall warn the patient that an antihistamine should not be used by
patients with bronchial asthma or other lower respiratory symptoms, glaucoma, cardiovascular disorders,
hypertension, prostate conditions and urinary retention. An antihistamine shall be labeled to advise the
patient of drowsiness and caution against the concomitant use with alcohol or other depressants.
1. Diphenhydramine.
2. Carbinoxamine.
3. Pyrilamine.
4. Dexchlorpheniramine.
5. Brompheniramine.
(b) Decongestants. The pharmacist shall not order an oral decongestant for use by a patient with
coronary artery disease, angina, hyperthyroidism, diabetes, glaucoma, prostate conditions, hypertension,
or a patient currently using a monoamine oxidase inhibitor.
1. Phenylephrine.
2. Azatadine.
(6) Topical antifungal/antibacterials. The pharmacist shall warn the patient that any of the products
should not be used near deep or puncture wounds and contact with eyes or mucous membranes should
be avoided. Iodochlorhydroxyquin preparations shall be labeled with staining potential.
(a) Iodochlorhydroxyquin with 0.5% Hydrocortisone (not exceeding 20 grams).
(b) Haloprogin 1%.
(c) Clotrimazole topical cream and lotion.
(d) Erythromycin topical.
(7) Topical anti-inflammatory. The pharmacist shall warn the patient that hydrocortisone should not be
used on bacterial infections, viral infections, fungal infections, or by patients with impaired circulation. The
prescription shall be labeled to advise the patient to avoid contact with eyes, mucous membranes or broken
skin. Preparations containing hydrocortisone not exceeding 2.5%.
(8) Otic antifungal/antibacterial. Acetic acid 2% in aluminum acetate solution which shall be labeled for
use in ears only.
(9) Keratolytics. Salicylic acid 16.7% and lactic acid 16.7% in flexible collodion, to be applied to warts,
except for patients under two (2) years of age, and those with diabetes or impaired circulation. Prescriptions
shall be labeled to avoid contact with normal skin, eyes and mucous membranes.
(10) Vitamins with fluoride. (This does not include vitamins with folic acid in excess of 0.9 mg.)
(11) Medicinal drug shampoos containing Lindane. The pharmacist shall:
(a) Limit the order to the treatment of head lice only;
(b) Order no more than four (4) ounces per person; and
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(c) Provide the patient with the appropriate instructions and precautions for use.
(12) Ophthalmics. Naphazoline 0.1% ophthalmic solution.
(13) Histamine H2 antagonists. The pharrmacist shall advise the patient to seek medical attention if
symptom persist longer than 14 days while using the medication or if stools darken or contain blood.
(a) Cimetidine.
(b) Famotidine.
(c) Ranitidine HC1.
(14) Acne products. Benzoyl Peroxide. The prescription shall be labeled to advise the patient to avoid
use on the eye, eyelid, or mucous membranes.
(15) Topical Antiviral.
(a) Acyclovir ointment may be ordered for the treatment of herpes simplex infections of the lips.
(b) Penciclovir.
Try and pinpoint the rule/law that shows why each

correct answer is right and why each incorrect answer
Section 6 is wrong. Pick out 20 rules of law or MPJE
Competencies that you think might be tested and write
Exam Type Questions one or two questions for each.
From MPJE Blueprint
Multiple-choice Item Format

How many total CPE hours are required to be completed upon the second renewal of a pharmacists
license in this jurisdiction?
A. 15
B. 20
C. 25
D. 30
E. 40
Multiple-response Item Format

Which of the following medications are classified as Schedule II controlled substances in this jurisdiction?
(Select ALL that apply.)
□A. Strattera
□B. Lisdexamfetamine
□C. Meprobamate
□D. Amphetamine
□E. Dexmethylphenidate
Ordered-response Item Format

Place the following in the order in which they would expire according to federal regulations, starting with
the earliest.(ALL options must be used.)
Unordered Options Ordered Response
A partially filled methylphenidate
prescription for a
patient not in an LTCF
A phoned-in, emergency oxycodone
prescription
A written bupropion prescription
An electronic alprazolam prescription
127 | P a g e
A partially filled morphine prescription for a
patient in an LTCF
1. Which of the following may prescribe Oxycodone in Florida for back surgery (select all that apply)?
a) *Nurse Practitioner
b) *Physician Assistant
c) *Physician
d) Podiatrist
e) Chiropractor
2. Can a prescription be written for Xanax, Soma, Lorcet and Vicodin on the same prescription blank?
a) Yes, multiple controlled substances may be written on the same prescription blank
b) Yes, as long as the pharmacist documents that therapy is valid and a patient-prescriber
relationship exists
c) No. Lorcet and Vicodin are the same drug and this is considered therapeutic duplication.
d) *No, different schedules of controlled substances require different prescription blanks
3. What is the check digit in Dr. Matthew’s DEA number AM123456?_______(*3)
4. An Ophthalmologist prescribes oxycodone 30 mg #180 for headache. The pharmacist should:

a) *Fill the prescription if the pharmacist determines this is a valid prescription
b) Fill the prescription only if oxycodone is indicated for headache
c) Not fill the prescription as midlevel practitioners in FL cannot prescribe controlled substances
d) Not fill the prescription as Ophthalmology is the practice of medicine involving the eye
5. How long does an immunizing pharmacist in FL have to maintain patient records in FL?
a) 1 year
b) 2 years
c) 3 years
d) 4 years
e) *None of the above
6. A patient brings in a 90 day prescription for Methadone for shoulder injury. The prescription reads
Non Acute Pain. The prescription is:
a) Not valid as non-acute pain prescription is limited to 7 days in FL
b) Not-valid as methadone may be prescribed only if the patient is registered with a methadone
clinic and is subject to 3 day max
c) Valid as methadone may be prescribed for non-acute pain as long as the patient has a bona-fide
doctor-patient relationship
d) Valid as methadone maybe be prescribed up to a maximum of 90 days
7. A young man enters your pharmacy and wants to purchase 90 tablets of Pseudoephedrine (PSE).
You should instruct him:
a) PSE is now a schedule I controlled substance and it is against the law to sell
b) The maximum allowable sale is 36 tablets
c) That a valid driver’s license is required to purchase the product
d) *That the age limit to purchase PSE is 18 years of age
8. If a controlled substance prescription is for an animal, which of the following is required on the
prescription?
a) Name of the physician
b) Species of animal
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c) Name of the owner
d) *All of the above
9. A young woman requests that her elderly mother receive all prescriptions (blanket request) in a non
child resistant containers. The pharmacist should:
a) comply with the request as the woman is looking out for her mother
b) *comply with the request as long as the woman is the official caregiver of the elderly woman
c) not comply with the request because a blanket request for non child resistant containers is illegal
d) not comply with the request because only the prescribing physician can make blanket requests
for dispensing in non-child resistant containers
10. A pharmacist while verifying a prescription medication spills coffee in the Stock Container of HCTZ
(25 mg). The technician empties the bottle in order to clean it out, mixing it with another bottle of
HCTZ (50 mg) by accident; The technician then fills a prescription for HCTZ 25 mg using both tablets.
The prescription is:
a) Adulterated
b) Misbranded
c) *Adulterate and Misbranded
d) Neither Adulterated or Misbranded
11. When transferring a prescription, the pharmacist must do all of the following except:
a) Advise the patient that the prescription on file at the other pharmacy will be canceled
b) Determine that the prescription is still valid
c) *Notify the doctor who wrote the prescription that it will be transferred
d) Notify the pharmacy where the prescription is currently filled that it will be canceled
12. A home infusion pharmacy receives a fax for an IV Morphine Sulfate order. Which of the following
statements is correct?
a) The pharmacist should not fill the order unless the patient is in hospice
b) The pharmacist may pre fill the order but must receive the actual written order to dispense the
drug
c) The pharmacist should wait to receive the actual written order before preparing the IV
d) *The pharmacist should fill the order as the fax will serve as the actual prescription
13. A hospital pharmacy technician properly garbed adds sterile water as a diluent in a vial of a tobramycin
under ISO 5 conditions for immediate use. The product when stored at room temperature should be
labeled with a beyond use date of:
a) 1 hour
b) *48 hours
c) 14 days
d) 45 days
14. As owner of a community pharmacy you decide to open a new business, a nursing home. You apply
for a Class I institutional Pharmacy permit, along with the other required permits. The Board of
Pharmacy should rule:
a) A pharmacist cannot own both a community pharmacy and Class I institutional pharmacy and reject
the application
b) The application may be approved as long as a pharmacist owner applying is named the pharmacist
consultant of record
c) The application is rejected because there is a significant conflict of interest and potential for illegal
kickbacks because the community pharmacy will provide drugs to the nursing home
d) *None of the above
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15. A woman calls your institutional pharmacy wanting to return a prescription for oxycodone for her
father in a LTCF that died earlier that day. What should the pharmacist do?
a) Accept the return since the patient was in a LTCF
b) Accept the return since the drug is a CII
c) Not accept the return since the patient died
d) *Not accept the return because the drug was dispensed
e) two of the above answers are correct
16. The Pharmacist makes a final check on a prescription for Ativan and the technician files the
medication in alphabetical order while it awaits to be picked up by the patient. Three weeks later
you find out the patient died, the medication was never picked up, and the medication is still filed
away in alphabetical order. What should the pharmacist do with the unclaimed prescription?
a) Destroy the medication using DEA Form 41
b) Return the drug to a reverse distributor because it cannot be returned to stock or else the drug
will be misbranded
c) Dispense to the doctor for "office use" to use for another patient subject to six month expiration
from date originally written
d) Contact the State Medical Examiner, confirm patient death and then return to stock using the
manufacturer's expiration date
e) *Return to stock subject to a 12 month beyond use date from date originally filled
17. An initial prescription for Belviq with three refills was recently filled. The patient returns to the
pharmacy requesting a refill, but the patient reports the prescribing physician is now deceased. The
pharmacist should
a) Fill the prescription as valid refills exist
b) Fill the prescription because at the time of the prescription the physician’s license was active
c) *Not fill the prescription because the physicians’ DEA# is now invalid
d) Not fill the prescription because controlled substances cannot have more than one refill
18. You open a pharmacy on Wall Street in FL and decide to use a central fill pharmacy upstate to fill the
prescriptions. Which of the following pharmacies is required to counsel the patient on a prescription
for lorazepam.
a) The central fill pharmacy only
b) The central pharmacy and Wall Street Pharmacy
c) *Wall Street Pharmacy only
d) Neither pharmacy is required to counsel the patient
e) Central fill pharmacies cannot fill prescriptions for controlled substances
19. A pharmacist is called from a community pharmacy across the street asking to borrow one bottle of
oxycodone 10 mg. The pharmacist should respond (select all that apply):
a) Florida State law prohibits this type of transaction
b) The Controlled Substances Act prohibits this type of transaction
c) *I can fulfill this request as long as it is less than 5% of my yearly transfer
d) *Please execute a DEA 222 whereby I act as a supplier
e) I can simply loan the drug to you as long as you pay the AWP
f) If this is for a patient, then I am unable, as I can only loan for ‘Office Use’
20. Which of the following are able to access a closed pharmacy after hours (select all that apply)
a) Licensed Intern
b) *Licensed Pharmacist
c) Store Manager (non-pharmacist)
d) Licensed Technician
e) Licensed Physician
f) Community Board of Pharmacy Member
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g) Contracted software support person
21. The registrant of a DEA license in a community pharmacy wishes to have his wife order stock of
methadone for pain patients. Choose the best response:
a) The wife may order methadone only if it in tablet form
b) The wife may order methadone only if she a licensed pharmacist
c) The wife may order methadone only if she has a valid DEA registration
d) *The wife may order methadone only if she has been granted power of attorney
22. A pharmacist receives a prescription for Magic Mouthwash. The pharmacist compounds the drug
using Milk of Magnesia (OTC), Diphenhydramine (OTC), Lidocaine (Rx) and Nystatin (Rx). Which of
the following labels would be correct
a) Magic Mouthwash
b) Lidocaine and Nystatin
c) *Milk of Magnesia, Diphenhydramine, Lidocaine, and Nystatin
d) Magic Mouthwash, Lidocaine and Nystatin
23. Bob’s Big Boy Pharmacy (BBBRx) in Grand Rapids, Michigan has an website that promotes a free t-
shirt with all new prescriptions. A patient in Florida decides to use BBBRx to fill her Jardiance
(empagliflozin) Prescription. Which of the following is correct:
a) BBBRx cannot lawfully fill the prescription as it is physically located outside of FL
b) BBBRx cannot lawfully fill the prescription because out of state pharmacies cannot fill
prescriptions for Controlled Substances
c) *BBBRx can lawfully fill the prescription as long as they register with the State of FL, are open at
least six days per week
d) BBBRx can lawfully fill the prescription as long as they have a FL Consultant of Record on Staff
and mail the prescription certified, return-receipt
24. How many years is a community pharmacy permit good for?

a) *2 years
b) 3 years
c) 4 years
d) Indefinitely as long as it continues to pass inspection
25. Which of the following must register with the DEA to prescribe controlled substances (Select all that
apply)?
a) Hospital physician assistant prescribing Marinol upon discharge
b) Hospital physician prescribing oxycodone for a post-surgical patient
c) Hospital physician prescribing brexanolone for inpatient treatment
d) *Veterans Affairs physician prescribing Sonata for a patient in a private sleep clinic
e) Veterans Affairs nurse practitioner prescribing Lorcet for migraine
f) Veterans Affairs physician prescribing Suboxone for a veteran with addiction problems
26. A pharmacist may be sanctioned for which of the following [select all that apply]
a) *Failure to make Vicodin drug pricing available upon request
b) *Guilty of solicitation of sex / Prostitution
c) *Failure to offer patient counseling in writing
d) *Selling drug samples
e) *Blackmailing a patient for financial gain
f) *Failure to retain CE documents
g) *Unable to practice safely due to Glaucoma
h) *Failure to maintain proper insurance
i) Failure to pay back student loans
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27. A Nursing Home patient needs diazepam injection to treat a seizure. The nurse on staff accesses the
Emergency Medicine Kit. Which of the following is correct?
a) The Nurse must be registered with the DEA to administer the injection.
b) *The seal must be resealed within the next business day.
c) The pharmacy on-site must have a written prescription for diazepam from the hospital director
before the seal can be broken.
d) The consultant pharmacist of record must report the drug usage to the DEA using a Form 41 within
seven business days.
e) a and b only
f) a and b and c only
28. Which of the following is required on the drug label for a drug?
a) Address of the pharmacy
b) Prescription (Serial) Number
c) Expiration Date/Beyond Use Date
d) Date of dispensing
e) Quantity of the drug dispensed
f) *a through d only
29. Which of the following can a registered technician do, under the direct and immediate supervision of a
pharmacist
a) *Enter an order
b) Counsel a patient on a prescription drug refill
c) *Conduct CII inventory
d) Interpret a prescription order for appropriateness
e) *Initiate communications with a prescriber for omitted quantity of a prescription order
f) Independently override clinical alerts
30. A pharmacist in a hospital pharmacy is supervising her technicians via a video monitoring system.
How many technicians can be supervised at the same time if they are performing sterile
compounding?
a) 0 as video monitoring is prohibited
b) 1
c) *3
d) 4
e) 6
f) 8
g) As many as the pharmacist do with “certain confidence”
31. You are a staff pharmacist at Wolverine Pharmacy and your intern seems to have symptoms of
alcoholism. You should:
a) Recommend the intern contact the for Board of Pharmacy for assistance while continuing to work
as an intern
b) *Recommend the intern contact the state impaired practitioner program and immediately cease
practice
c) Recommend the intern contact the Pharmacy Manager onsite and file for work social security
disability
d) Immediately fire the intern and hire another intern without alcoholism problem
32. A patient comes to the pharmacy to pick up lancet device for diabetes blood glucose monitoring. As
the pharmacist is eating lunch, she does not offer to counsel the patient. The pharmacist:
a) Is in violation of the law because all patients with diabetes must be counseled monthly
b) Is in violation of the law because all patients must be counseled orally and in writing
c) *Not in violation of the law because lancet devices are not a prescription item
132 | P a g e
d) Not in violation of the law as lunch is an exemption from counseling patients
33. Florida Pharmacist gets a prescription from a physician in Barbados for atorvastatin. The Florida
pharmacist should:
a) Not fill the prescription as the prescriber is not licensed in FL
b) Not fill the prescription as the drug is for a chronic condition
c) Fill the prescription as written if the patient is a Florida resident
d) *Fill the prescription as written if the patient has high cholesterol
34. FL Pharmacist Manager gets terminated for selling adulterated drugs. The pharmacy owner must
alert the (select all that apply):
a) DEA within 24 hrs
b) BOP within 14 days
c) FDA within 10 days
d) Third party pharmacy benefit managers within 3 business days
e) *none of the above
35. A patient calls FL Pharmacy to see if an e-script was sent for morphine IR for “Acute Pain”. The
patient asks the pharmacist to mail the drug as the patient has cracked ribs and cannot drive. The FL
pharmacist should:
a) Not mail the drug if it wont arrive within 3 days
b) Not mail the drug as CII’s cannot be sent via mail
c) Not mail the drug as e-scripts for morphine are not valid
d) Not mail the drug if the patient has not other pain relief
e) * None of the above
36. A patient comes to FL Pharmacy requesting copies of their dispensing records. The pharmacist:
a) *must comply within 30 days
b) must comply within 24 hrs
c) must comply if patient has third party insurance
d) must comply with consent of the prescribing physician
37. On January 1st 2022 a FL community pharmacist dispenses Atorvastatin from a stock bottle with an
expiration date of 5/2025. The pharmacist should label the drug with:
a) Expiration date of 5/1/2025
b) Expiration date of 12/31/23
c) *Beyond use date of 12/31/22
d) Beyond use date of 5/31/25
38. Florida pharmacy may store which of the following Controlled Substance Records off-site from the
pharmacy (select all that apply)
a) Dispensing Records
b) Inventory
c) Executed 222 forms
d) *Financial Records
e) *Shipping information
39. Place the following in order of the number of refills permissible, starting with the least.(ALL options
must be used)

Soma
Vicodin
Byetta
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Lyrica
40. Place the following in the order in how long they must be maintained, starting with the shortest
duration.(ALL options must be used.)
DEA Ordering Records
FL Prescription Records
FL immunization Records
Pseudoephedrine Sales Records
Continuous Quality Improvement Program
Records
Section 7
Wrap-Up and Disclaimer
This is a working draft for instructional use only. No actual exam content was used in the preparation of
this review. The information contained herein is not guaranteed for accuracy and contains discrepancies.
No representations or warranties are given on the material attached. Note, the law is subject to extensive
interpretation and Board rulings prevail. Please forgive any errors or omissions. Nothing in this document
should be considered legal advice or establishing any attorney-client relationship. The author requests that
either during or after your studying you send comments on the relevance and quality of this review (no
Exam Content) and/or the examination to Matthew Seamon at mseamon@nova.edu.
Thank you to Dr. David Mastropietro PhD, BS Pharm for his guidance with information on pharmacy
compounding and sterile product preparation.
Good luck!
Last actual update April 27, 2022
134 | P a g e

MPJE NSU Dr. Seamon 2022

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April 2027, NSU COLLEGE OF PHARMACY MPJE REVIEW

2022 Matthew J. Seamon PharmD Esq.

Top 10 Hot Topics of 2022

Top 10 Mainstays for the MPJE

Section 1 – ABOUT THE MPJE

• Multistate Pharmacy Jurisprudence Exam

Top 10 Money Tips for the MPJE

1.1 – Legal responsibilities of the pharmacist and other pharmacy personnel:

AREA 2 – LICENSURE, REGISTRATION, CERTIFICATION, AND OPERATIONAL REQUIREMENTS (APPROXIMATELY

3.1 – Application of regulations:

Prior Test Results – Nova Southeastern University College of Pharmacy

• Florida Pharmacy Act - FL Statute 465

Exam Study Guides (based on Poor/Fair/Good/Very Good/Excellent rating scale)

Section 2 Remember this is a state test. The super

• Controlled substances may be stored in one of three methods in the pharmacy

DEA Form Intent Additional

Known brand, generic, and schedule of most common controlled substances

o Covid Emergency Order allows pharmacists/interns/technicians to immunize pediatrics 3

Collaborative Practice Agreements and Chronic Care Therapy (465.1865)

Test and Treat Programs for Minor Ailments (465.1895)

Florida Prescription Drug Monitoring Program of Controlled Substances (PDMP E-FORSCE)

60 days from date

CII Emergency limited to a 72-hour supply. limited to amount

Legible Yes. Prescription be legibly written or typed; that No requirements

Recordkeeping Requirements in Florida

465.016 Pharmacist Disciplinary actions.—

Minor Pharmacy Violations (64B16-30.002)

Citations Pharmacist/Pharmacy (64B16-30.003)

Disciplinary Guidelines Pharmacist/Pharmacy 64B16-30.001

MAX: One (1)

MAX: One (1)

MAX: One (1)

MAX: One (1)

MAX: One (1)

MAX: One (1)

MAX: One (1)

MAX: One (1)

MAX: One (1)

MAX: One (1)

MAX: One (1)

MAX: One (1)

MAX: One (1) MAX: Revocation.

MAX: One (1)

MAX: One (1)

MAX: One (1)

MAX: One (1) MAX: Revocation.

MAX: One (1)

MAX: $500 fine per MAX: Revocation. MAX: MAX: Revocation.

MAX: $1,500 fine and MAX: $3,000 fine and

MAX: $2,500 fine and two MAX: $5,000 fine,

MAX: Revocation. MAX: $10,000 fine and MAX: MAX: Revocation

MAX: Revocation. MAX: Revocation. MAX: MAX: Revocation.

MAX: Revocation. MAX: $10,000 fine and MAX: MAX: Revocation.

456.072 Grounds for discipline; penalties; enforcement; All Health care

893.04 Drug Abuse Prevention and Control Pharmacist and practitioner.—

Medicinal Drugs Which May Be Ordered by Pharmacists in Florida (64B16-27.220)

Try and pinpoint the rule/law that shows why each

Multiple-choice Item Format

Multiple-response Item Format

Ordered-response Item Format

3. What is the check digit in Dr. Matthew’s DEA number AM123456?_______(*3)

4. An Ophthalmologist prescribes oxycodone 30 mg #180 for headache. The pharmacist should:

24. How many years is a community pharmacy permit good for?

Unordered Options Ordered Response