2020 Florida Law Review
FLORIDA PHARMACY LAW REVIEW 2020 EDITION©
Pharmacy Education Source, LLC and The Law Office of Peter P. Cohron
Peter P. Cohron, BSPharm, JD
petercohron@gmail.com PharmacyEducationSource@gmail.com Cell: 859-227-9089
This law review handout is based on the “black letter law,” the law necessary for you to pass the
board examination. It does not entertain various scenarios from the “real world” nor discuss anything
other than the “black letter law.” From experience and discussions with others on this issue, the following
are the topics considered to be the most important and seen most often on the Florida multi-state board
jurisprudence exam.
Some headings have been provided but that is no guarantee that everything regarding that title is
under it. Federal and state citations are added for me as I look for updates in the law before each year’s
review is produced; there has never, to my knowledge, been a question on the pharmacy law exam
requiring a citation to a specific regulation or statute.
The information on this handout reflects what will be on the law exam. Some recent changes in
the law that should not be on the exam are covered and there is a NOTE about that. You are not
examined on recent changes—these must be in effect for one year prior to their being on the MPJE.
This year’s Review (2020) has been modified as best as possible to reflect this year’s changes in
the MPJE.
Disclaimer: This review is written and has the sole goal of aiding you in passing the Florida
MPJE. This review is a “distillation” of pharmacy law; I have taken out the “legalese” to make the law
more easy to understand. Thus, it is not exact; certain parts of the law I consider unnecessary have been
reworded or omitted. This is a review for a board examination (the Florida MPJE) and should only
be used for that purpose. It should not be used or relied on as a substitute for a true copy of the
state and federal laws governing the practice of pharmacy. It is not a true copy of the Florida
Pharmacy Practice Act or the Controlled Substance Act. Keep in mind that the law changes; I have made
every effort to be up to date but do not guarantee that recent changes in the law are included.
More than 98% of persons using my materials pass the Florida MPJE on their first attempt. I
sincerely believe that knowing the contents of this law review is sufficient to pass the exam. I merely shy
away from promising you that you will score 100%. Further, I back away from guaranteeing a very high
grade as the 2016 MPJE Competency Statements were revised for the exam this year. I have reviewed
these statements and revised this review and practice exam to fit those to the best of my ability. You can
review these statements at nabp.net/programs/examination/mpje/mpje-blueprint
COPYRIGHT, January 2020 by Peter P. Cohron, BSPharm, JD. Any unauthorized use or copying of
this material subjects the person doing so to appropriate legal action.
BOARD OF PHARMACY
Board of Pharmacy
–Nine (9) members, appointed by the Governor & confirmed by state senate
2 in community practice 2 in hospital practice 3 in practice (no particular setting)
2 citizen members with no connection to pharmacy
–pharmacists must be in practice 4 years before can be appointed
–one member at least 60 years old
–4 year terms
Probable Cause Panel
–investigates and makes recommendations to full Board re: complaints made to the Board
–consists of 2 Board members (one must be a pharmacist)
–both members must vote in favor that a pharmacy law violation exists
Board Responsibilities
–protect the public
–assure competency and safe practice
Impaired Pharmacist Program
–also would likely attach to interns and techs
–requires pharmacists to report anyone in violation of rules of the BoP, including being impaired
–reporting person is shielded from civil liability 465.0165(8)
–pharmacist is evaluated, put in 72-hour observation, then referred to additional therapy
–if co-operative, BoP will take no further action against pharmacist
–after treatment, pharmacist is subject to a continuing care contract but my return to practice
–has a family care component for family members of the pharmacist
–no disciplinary action by the Board if the person
–acknowledges the impairment
–ceases or limits practice of pharmacy to a degree that addresses the impairment
–must cease practice while in detox/rehab program
–voluntarily seeks detox/rehab program
–permits detox/rehab program access to pertinent medical records
PHARMACISTS, TECHS, INTERNS
Pharmacist qualifications
–must be at least 18
–graduate of an accredited college of pharmacy
–complete a pharmacy internship
–licensed by the Board, every two (2) years
–must have passed NAPLEX, MPJE exams
–fit and competent to practice—no impairments that may affect ability to work or endanger patients
–must perform DUR and do final verification
–counsel patients if offer to counsel accepted
–obtain patient information
Continuing Education
–30 CE hours every two (2) years
–approved by the board or ACPE
–number of hours may be decreased for initial licensure
–pharmacists who vaccinate or use epinephrine must have 3 hours CE on this topic and be certified
–required 2 hours of medication errors with each biennium
–2 hours on validation of CS Rxs
–required 5 hours on risk management—may be met by attending a Board meeting where disciplinary
actions are taken
–first renewal of license—one (1) hour on HIV/AIDS
–Five (5) hours every two years may be gained through community service—one (1) hour for every 2
hours of service
–ten hours must be live, teleconference or interactive on computer
–consultant pharmacists must have 24 hours on this topic (consulting) and these do not count toward the
required 30 hours
–nuclear pharmacist must do 24 hours on that topic prior to each renewal
–keep records of CE for 2 years
Prescription Department Manager
–pharmacist licensed in FL
–every pharmacist must have one
–pharmacist may only be PDM of one pharmacy unless approved by the Board of Pharmacy
–ensures security of pharmacy
–ensures compliance with law
–notifies FL Dept of Health of any theft or substantial loss within one (1) day
–nuclear pharmacy PDM must be qualified nuclear pharmacist
–institutional pharmacy PDM must be a consultant pharmacist
–must notify Board within 10 days of change in PDM
Proof of licensure and ID
–applies to pharmacists, techs, interns
–pharmacy MAY either post licenses where the public can view or post a list of employees and state that
licenses are available for viewing
–must wear an ID badge at work that states name and title
Immunizing Pharmacist
–active license in good standing
–certification requires one-time 20-hour class on vaccines, CPR, laws on giving vaccines
–3 hours of CE on immunizations every 2 years to be re-certified
–at least $200,000 in malpractice insurance
–vaccines to adults only
–written records of vaccines given maintained for 5 years
–must have protocol with supervisory physician licensed in FL
–immunizations must be reported to Fl SHOTS, vaccine registry
–may give all CDC recommended vaccines
–interns may give vaccines
–Intern registration is active and in good standing
–pharmacist intern ration for vaccines 1:1
–must be under pharmacist supervision
–must have attended vaccine program of at least 20 hours length
Consultant pharmacist
–must complete CP training at least 12 hours from accredited college of pharmacy
–24 additional CE hours every 2 years
–must complete 40 hours of clerkship under another consultant pharmacist, must occur within a 90 day
period, at least 60% at a consulting pharmacy/institution
–must be a consultant pharmacist at least 1 year before precepting
Nuclear pharmacist
–renew license every 2 years
–additional 24 hours CE on nuclear pharmacy every 2 years
–at least 200 hours didactic training
–at least 500 hours on the job training
Patient Counseling
–only an offer is required—counseling is required if the patient accepts the offer
–any pharmacy personnel can make the offer—only pharmacist or intern may counsel
–offer is both oral and in writing—for delivery, in writing with a phone number to call
–offer must be made even if person picking up the Rx is not the patient
–no offer or counseling required for inpatients
Lab tests
–may be ordered by consultant pharmacist or PharmD after required CE (3 hours)
Meal break
–may take up to 30 minutes
–pharmacy may remain open for up to 30 minutes
–sign must be posted as to when meal break occurs
–must be available for consultation or questions during the break
Law enforcement
–must report obtaining or attempt to obtains CS by fraud or misrepresentation to local authorities
–must do so within 24 hours
–a misdemeanor to fail to do so
Preceptor
–must be currently licensed
–cannot be on probation or have licensed suspended or revoked
–must have been in practice a minimum of two (2) years
Intern
–may transfer Rxs, including CS Rxs
–must register with Board
–no pharmacist-intern ratio, except
–may give immunizations after 20 hours approved training—for immunizations 1:1 pharmacist-intern
ratio
–currently attending accredited college of pharmacy
Technicians
–at least 17 years old
–register with Board
–approved training program, 160 hours in first 180 days of employment
–pharmacist/tech ratio is 1:6
–must wear ID badge identifying themselves as a technician—must identify oneself as a tech in all
communications
–written job description
–may perform only duties not requiring a pharmacist or her professional judgment
–20 hours CE every 2 years, 4 hours must be live, 2 hours must be on med errors
Technician CE
–20 hours every 2 years; 4 hours live
–1 hour on HIV/AIDS prior to first renewal
–2 hours on medication errors
–5 hours on risk management can be obtained by attending a Board meeting where disciplinary actions
are taken
PHARMACIES
Pharmacy Permit
–types of permits
–community retail
–each location must have a separate permit
–must have prescription drug manager named
–limited sterile compounding after Board inspection
–Class I Institutional
–nursing home
–consultant pharmacist named on permit
–no actual pharmacy on premises
–emergency kits permitted—nurse or pharmacist may restock & reseal
–may contract with a pharmacy for starter doses
–Class II Institutional
–hospital
–must have hours of operation that provide adequate services
–drugs dispensed in unit-dose packaging
–ER may dispense drugs when local pharmacies closed—properly labeled—minimum
duration or 24 hours supply
–Modified Class II
–meets all requirements of Class II except for space/equipment requirements
–free standing ER, alcohol treatment center, day surgery, correctional institution
–consultant pharmacist named on permit
–all drugs dispensed for on-site use only
–Modified Class II A—dialysis clinic, methadone clinic
–Modified Class II B—day surgery
–Special Pharmacy
–Special Limited Community—for employees of a hospital, discharge meds for patients,
ER patients
–Special Enteral and Parenteral—provides IV services and enteral services to outpatients
–Special Closed System Pharmacy—closed to the public—medications are prepared for
administration for ultimate consumer—nursing home, assisted living, at-home
–Special End Stage Renal Disease—prepares meds for dialysis
–Special Assisted Living Facility—for ALF patients only
–Special Sterile Compounding Pharmacy
–requires additional special permit
–activities supervised by FL licensed pharmacist
–Nuclear Pharmacy
–under direction of FL licensed nuclear pharmacy
–at least 150 square feet for storage, compounding, dispensing
–technicians registered with the Board may take new Rx orders
–Internet Pharmacy
–must register as Internet Pharmacy in FL if providing medications to FL residents
–must be open six days a week at least 40 hours with toll-free number on Rx label
–must have a prescription drug manager—does not have to be FL licensed
–Nonresident Pharmacy—mail order
–nonresident (out of state) pharmacies must register with FL Board if mailing or sending
Rxs into the state
–one time delivery is exempt from registration
–must be open six days a week at least 40 hours with toll-free number on Rx label
–Nonresident Sterile Compounding Pharmacy
–for patient specific Rxs only
Permits
–good for two years
–not transferable—sale of a pharmacy requires old permit be returned to the Board and new owner to
obtain new permit
–non-pharmacist may be owner
–required inspection by the Board before opening
–permits and licenses conspicuously displayed
–have and periodically update Continuous Quality Improvement Program
–written policy & procedure manual
–record of errors—summary of event, date discovered, action taken—maintain for 4 years—not
discoverable in court action
–review every three months
–expiration dates checked at least every quarter
Pharmacy requirements
–adequate drug information resources for the services being provided
–MAY advertise drugs & prices (but not CS)
–pharmacists, techs, interns must have ID badges that IDs their position
–conspicuous sign regarding generic substitution
–signs hung conspicuously re: Medicaid
–sink with hot & cold water
–refrigerator
–sufficient space for amount of work being done
–clean and sanitary
–quarantine area
–patient consultation area near prescription department
Hours of operation
–must be open minimum of 20 hours per week
–if less than 40 hours per week, posted hours with info on after-hours availability
64B16-28.140 Computers in Pharmacies
–prescriptions shall be reduced to writing if not already in writing and retained for four (4) years
–computer shall be able to show patients record back at least 4 years
–records must indicate which tech/pharmacist dealt with each Rx
–any loss of records must be reported to Board within ten (10) days
–daily hardcopy printout shall be printed within 72 hours—CS Rxs shall be listed separately from nonCS—shall be signed by pharmacist within 7 days
–record shall include
Rx number dispensing date patient name prescriber name/address, DEA if CS
quantity Drug name, strength quantity date of issue # refills dispensed by
date
–records available for inspection within 48 hours
64B16-28.141 Automated Pharmacy System in Community Setting
–pharmacy must have policy and procedure manual
–security that prevents unauthorized access
–protect patient confidentiality
–able to ID all pharmacists, techs and interns involved with system
–stocking & filling process that records product, lot #, expiration date
–stocking is by a FL pharmacist r if filled at a repackaging center by authorized personnel & then verified
by FL pharmacist
–system must have 2 separate verifications
–records shall include
Patient name drug name, strength, dosage form quantity date/time of dispensing
Pharmacy name Rx number prescriber name pharmacist name
Name of person to whom drug was released
465.0235 Automated Pharmacy System in LTCF, Hospice, or Correctional Facility
–drugs and devices considered part of pharmacy inventory
–FL pharmacist must develop policies by which drugs are stocked and that system is functioning safely
and securely
–label requirements
APS identifier directions for use dispensing pharmacy Rx number
Patient name prescriber name
Recommended reference materials
–USP DI
–a copy of FL pharmacy laws
–medical dictionary
–USP/or NF
–PDR
–Facts and Comparisons
–American Drug Index
21 CFR 1301 A pharmacy that is a DEA registrant may not employ any person who has been convicted
of a felony related to controlled substances unless the DEA issues a waiver. Waivers are specific to each
employer and each employee.
Compounding (also see below in Misc section)
–written record for each batch compounded
Date compounded control number recipe/formula quantity
Package size name of manufacturer of raw materials patient name
Pharmacist/tech ID
Inspections
–done by Dept of Health
–performed only during business hours
–inspected twice during first year of operation
–inspected yearly, if no discipline or issues for three (3) most recent years, then inspections go to every
two (2) years
–may not view patient Rx records without a warrant
–may not seize materials or drugs without a subpoena
Medicaid Audits of Pharmacies
–agency doing audit must give at least one (1) week notice of initial audit
–must be conducted by a FL-licensed pharmacist
–typos, clerical errors, etc not subject to criminal action without proof of intent to commit fraud
–audit may not exceed one (1) calendar year
–audit may not be scheduled during first five (5) days of the month
–audit report must be sent to pharmacy within 90 days of end of audit
–final audit report must be sent to pharmacy within six (6) months of receipt of preliminary audit report
Central Fill Pharmacy
–no dealings with the public
–fills prescriptions presented to or sent to another pharmacy
–sends Rx back to original pharmacy for dispensing to the public
–must have contract with original pharmacy
–may fill CS Rxs but no oral C-II emergency Rxs
Common database
–two or more pharmacies sharing the same database
–common ownership
–records must ID which pharmacist filled each Rx and at what location
–one pharmacist may not override the professional judgment of another
Internet Pharmacies
–shall have a FL pharmacy permit
–shall have regular hours with 40 hours per week & 6 days a week
–tollfree telephone number
–FL shall be kept aware of location, owner, and pharmacy manager
Closing a Pharmacy
–notify Board, preferably 2-3 weeks before
Date pharmacy will close name/address of entity getting Rx files/drugs
–return pharmacy permit to Board within 10 days of closing
–place conspicuous sign that informs patients of where Rx files have been sent
–return DEA registration and DEA order forms to DEA
–destroy all unused pharmacy labels
–remove all signage indicating that a pharmacy was at this location
–complete inventory—copy of CS inventory sent to the Board
Temporary closure
–pharmacy closed and locked
–all pharmacy personnel outside the prescription area
–sign posted “Prescription Department Closed” in letters at least 2 inches high
–a pharmacy is NOT closed if a pharmacist has stepped out temporarily for a usual and customary
activity—counseling, meals, restroom
Recordkeeping 64B16-28.140
–Rx records must be maintained for four (4) years
–Medicaid/Medicare records ten (10) years
–must be readily retrievable—can be printed out within 72 hours of request
–summary record of CS dispensed in last sixty (60) days must be made available to authorized police
powers within 72 hours
–pharmacist must sign daily printout within 7 days of dispensing
–pharmacist must sign daily logbook acknowledging having worked that day/shift
–computerized pharmacies must have back-up system which must be backed up at least weekly
–prescription drug manager and owner responsible for records
PRESCRIPTIONS
A prescription must be for a legitimate medical purpose. Corresponding Responsibility—the
pharmacist has equal liability as the prescriber for dispensing a prescription that would be dangerous to
the patient
A prescription may be prepared by an agent of the prescriber (nurse, receptionist, etc) including all
information on the prescription except the signature.
21 CFR 1306.03 A prescription may be communicated to an RPh by an employee or agent of the
practitioner
Refills
–non-CS drugs may be refilled up to one year from date of issue
–C-II-no refills
–C-III thru C-V—up to five refills within six months from date of issue
Emergency fill
–up to 72 hour supply
–one-time only
–unable to reach provider
–not a C-II
–drug is essential to maintenance of life—interference with therapy would have serious detrimental effect
–pharmacist must write Rx for the drug
–provider must be notified of emergency fill within a reasonable time
State of emergency fill
–pharmacist may dispense up to a 30 day supply
–only in counties affected by the emergency
–other than days supply, same rules as above
Expiration date on patient Rx bottles
–one year from date of issue unless manufacturer’s expiration date is less than one year
Out of state prescriptions
–Rx must be valid—must make reasonable effort to ensure this
–prescriber must be licensed in state of prescription’s origin
–must be for chronic condition—acute illnesses should be addressed in state of origin
Transfers of prescriptions
C-IIs may not be transferred.
C-III-Vs may only be transferred once unless the pharmacies doing the transfer electronically
share a real-time, on-line database (ie, within a chain) then may transfer up to the maximum # of refills
permitted by law and by prescriber. 21 CFR 1306.25. Since this is federal law, this means transferring to
another state by realtime online database is NOT a transfer unless that state’s law forbids it
Legend drugs may be transferred for as many times as the prescription may be refilled.
Real time computer transfers within a chain do not require a telephone call and a prescription
being refilled at different locations from real time on-line computers does NOT constitute a transfer.
Otherwise, the pharmacist transferring the prescription must call the pharmacist to which the prescription
is being transferred.
On all prescriptions transferred out of it, record the name of the pharmacist, date, name and
address of pharmacy receiving the prescription, DEA number if the prescription is for a controlled
substance. The receiving pharmacy must get the same information along with the original date and last
date of fill, date of issue, # of refills remaining and original number of refills authorized.
Transfers may be by fax or electronic transfer if ALL of the necessary information is provided in
the faxed materials.
Transfer records must be kept for 5 yrs
Non controlled substance Rxs can be transferred in or out by an intern. CS transfers must be by a
pharmacist
CS Rxs that are on-hold cannot be transferred unless they were sent electronically (e-prescribed)
Return of Prescription Drugs
–unit dose or customized medications may be re-used if seal intact
–unclaimed prescriptions (filled in the waiting bins) may be put back into stock based on the expiration
date on the Rx label
Patient Counseling 64B16-27.820
–an OFFER to counsel must be made by any pharmacy personnel on all new Rxs and every refill
–only pharmacist or intern may counsel
–offer may be verbal or in writing
–counseling points
Name/description of medication dosage form, dose, route of administration, duration
Intended use refill info proper storage expected action of drug
Special directions, if any techniques for self-monitoring
What to do in case of missed dose common adverse effects, therapeutic contraindications
–Patient Medication Information Sources
–Patient Package Insert
–Medication Guide
–Consumer Medication Information—info usually provided by dispensing pharmacy as required
by law
–NOT required for institutionalized or hospital patients
Patient Consultation Space 64B16-28.1035
–pharmacy shall provide patient consultation space
–must be outside restricted pharmacy area
–away from usual customer traffic area
–sign with “Patient Consultation Area”
Patient Records 64B16-27.800
–medication records must extend back four (4) years
–make a reasonable to get the following
Patient name DOB gender drug/food allergies address/telephone
Chronic disease states OTC drugs
Samples
–only to practitioner’s own patients
–no payment or fee of any kind permitted
–no C-II or C-III drugs
–should be in manufacturer’s labeled bottle—if not, must have a label with
Prescriber name patient name drug name/strength date directions for use
–institutional pharmacies may have samples upon written request of prescriber
–community pharmacies may have samples upon written request of prescriber
–pharmacies may NOT request samples
PRESCRIPTION DRUGS
“RX ONLY” This is the designation that must be on all prescription drug containers (stock bottles) from
the manufacturer or repacked. If this is missing, the drug is misbranded—see below
Solid dosage forms must be clearly & prominently marked with a symbol, number, word (ie, drug or
company name) that allows identification of drug, unless impractical
NDC code
–eleven digits in 3 segments 5-4-2 (if one missing place a “0” at beginning of that segment)
–identifies the drug
–first five digits = manufacturer
–second four digits = drug
–last two digits = package size
–required on stock bottle but not required on patient bottle label
A drug is adulterated if it is filthy, putrid, decomposed, contaminated (drug or container), poisonous,
wrong strength, labeled as a compendium drug but fails to meet compendium standards, mixed or packed
in a manner that reduces its quality or strength
A drug is misbranded if its labeling is false or misleading, if the package fails to have on it information
required by law (ie, name and place of business of manufacturer and distributor), if such labeling is not as
prominently displayed as required by law, if the name on the label is not in an official compendium, if
there is no “Warning–May Be Habit Forming” for certain controlled substances, if there inadequate
instructions for use, dangerous to the health when used as prescribed on the label, if offered for sale as an
imitation of or using the name of another drug, etc
Safety caps are required on all prescription bottles except Nitroglycerin sublingual tablets–you want the
patient to be able to get to these quickly. A blanket request by a patient for non-safety tops is OK, but a
blanket request by a physician is not. A request by a physician for a single prescription to have nonsafety caps is OK.
–a childproof cap is one that a five-year old child cannot remove in five minutes
Drug recalls
FDA can only request a recall, but can seize products if a recall request is refused.
Class I recall–reasonable possibility of death or serious adverse effects—this is the only type of
recall where drugs must be gotten back from the patient
Class II recall–risk is remote or effects are temporary or reversible
Class III recall–unlikely to cause adverse health consequences
Outdated, expired, recalled drugs
–authorized personnel must check pharmacy stock at least every four (4) months
–drugs must be quarantined until returned or destroyed
–an expiration date that only states month & year means the LAST day of that month
Label requirements
Stock bottle: brand name (if a brand drug) generic name strength quantity
Ingredients per tablet, capsule, tsp, tbsp. manufacturer name & address expiration # Lot #
package insert storage temperature requirements C with roman numeral if controlled
Required warnings (eg, “May be habit forming”) NDC #
Rx bottle label: pharmacy name, address & telephone number Rx serial number Patient name
drug name & strength quantity instructions for use
Date filled Rx expiration date Pharmacist name or initials prescriber name
Original fill date Refill information
OTC label: drug name generic and brand if brand name quantity strength
Lot # expiration # common warnings/adverse effects directions for use
Manufacturer name and address storage requirements
Specialty drugs
Thalidomide—prescriber must be specially certified (Prescriber Enrollment Form)
–patient must be enrolled in program
–prescriber must counsel on risks v benefits
–Rx limited to 28 day supply
Accutane and generics
–patient and prescriber must be enrolled in iPledge program
–pharmacy must get on-line with patient iPledge number for clearance to fill Rx
–females must have pregnancy test
–if Rx not picked up within 7 days (females who can get pregnant) or 30 days (males and females
who cannot get pregnant, Rx is void
–up to 30 day supply, no refills
–if sexually active, females must use two forms of birth control
Plan B
–no age restriction on purchase
–available OTC
–no ID required
Fluoride treatment
–pharmacist can order if patient does not have fluoride in water
–up to one (1) year treatment
–may not switch brands during treatment time
Anorexiant drugs
–first time fills may not be called in—refills can be
–patient and physician must have face-to-face encounter before prescribing
Advertising
–pharmacies may advertise
–may not advertise anything about CS
Investigational drugs—important point here to get patient’s informed written consent
Medication guides—some prescription drugs may only be dispensed with a medication guide that
informs the patient of known dangers that may not be common. EG, estrogens, misoprostol, Accutane
Hazardous Drugs—see the presentation that can be found on hazardous drugs—it says “KY” but is a
good review for ALL states: http://pharmacy.ky.gov/Documents/USP%20800%20Presentation.pdf
–any drug that exhibits one of the following:
Teratogenicity carcinogenicity reproductive toxicity organ toxicity genetotoxicity
Examples: antineoplastics estrogen progesterone fluconazole testosterone
–must be handled with personal protection equipment (PPE)
–employees must be trained in the handling and care
Manufacturer responsibility
–a pedigree paper must be supplied to person receiving the drug
–copies maintained at pharmacy and warehouse
–makes drug traceable from manufacturer to pharmacy
–not required for veterinary drugs, drop shipments
GENERIC SUBSTITUTION
When a pharmacy receives a prescription for a BRAND name drug, the pharmacist SHALL substitute a
generic drug unless prohibited
–applies only to community pharmacy
–must be less expensive
–must be equivalent drug
–patient is to be told that substitution occurred—has right to refuse
–written “Medically Necessary” means no substitution
–sign must be prominently displayed CONSULT YOUR PHARMACIST CONCERNING THE
AVAILABILITY OF A LESS EXPENSIVE GENERICALLY EQUIVALENT DRUG AND THE
REQUIREMENTS OF FLORIDA LAW
–label must state generic name—may not do brand name followed by the word generic (Tenormin
generic)
Positive Formulary
–drugs deemed appropriate by FL for generic substitution
Negative Formulary
–FL Board may create a formulary of drugs that may NOT be substituted
–currently
Digitoxin conjugated estrogens dicumarol chlorpromazine
Theophylline (controlled release forms) pancrealipase (oral forms)
Erythromycin base
ORANGE BOOK CODES
AA – No bioequivalence problems in conventional dosage
forms
AB – Meets necessary bioequivalence requirements
AB1 – Meets bioequivalence requirement to AB1 rated
reference drug
AB2 – Meets bioequivalence requirement to AB2 rated
reference drug
AB3 – Meets bioequivalence requirement to AB3 rated
reference drug
AB4 – Meets bioequivalence requirement to AB4 rated
reference drug
AN – Solution or powder for aerosolization
AO Injectable oil solution
AP Injectable aqueous solution
AT Topical product
BC Controlled-release tablet, capsule, or injectable
BD Documented bioequivalence problem
BE Enteric coated oral dosage form
BN Product in aerosol-nebulizer delivery system
BP Potential bioequivalence problem
BR Suppository or enema for systemic use
BS Testing standards are insufficient for determination
BT Topical product with bioequivalence issues
BX Insufficient data to confirm bioequivalence
B* Requires further FDA investigation and review
EE This entry has been evaluated by the FDA, but a rating
is not available for this labeler’s product
ZZ FDA Standard with no orange book code
CONTROLLED SUBSTANCES
CSA criteria for designating a drug a CS
–actual or relative potential for abuse
–state of current scientific knowledge
–risk to public health
–immediate precursor to CS
–history and current pattern of abuse
Schedule or C-I C-II
High potential for abuse High potential for abuse
No accepted medical use Accepted medical use
Abuse may lead to severe dependence
C-III
Potential for abuse less than C-I or C-II
Accepted medical use
Abuse may lead to moderate to low physical or high psychological dependence
C-IV
Low potential for abuse relative to C-III
Accepted medical use
Abuse may lead to limited physical or psychological abuse relative to C-III
C-V
Accepted medical use
Low potential for abuse relative to C-IV
Abuse may lead to limited physical/psychological dependence relative to C-IV
Commercial containers (stock bottles) of controlled substances must have a symbol on the label
indicating the bottle contains a controlled substance. “C-II, C-III, C-IV, C-V”
Form 222s are for ordering C-II prescription medications.
BROWN copy—supplier
GREEN copy—DEA (sent to DEA by supplier after order is filled)
BLUE copy—retained at pharmacy
DEA order forms (#222)
–must retain all executed (signed) forms on the premises;
–unexecuted forms may be stored at an off-site location.
–one drug per line
–forms are numbered sequentially
–Voided or defective forms must be retained.
–Lost or stolen forms must be reported.
–If the person filling out a Form-222 makes an error and sees this, he should void the form and start a
new one. If a form with a line error is sent to the distributor, the distributor may supply to the pharmacy
all the drugs on all the lines correctly filled out, but must send a form to the pharmacy and the DEA
explaining why the line error was not filled.
–Requesting party sends the DEA Form 222 to the supplier, sending brown & green copy.
–When an order is received, the date and number of units received must be documented on copy 3,
which is retained at the pharmacy when the order is sent. Pharmacist receiving the order must sign
The Power of Attorney (the person who signs the Form 222) form to purchase controlled substances
must be on file before the designated POA signs any DEA forms. If there is a change in POA, the
revocation must also be kept on file. The POA need not be the PIC or even a pharmacist. How many
POAs can a pharmacy have? Unlimited
CSOS—electronic version of Form 222 for ordering C-IIs online
–enroll with DEA and get CSOS certificate
–supplier notifies DEA within 48 hours
Ordering Freedom: CSOS transactions are the only allowance for electronic ordering of Schedule I
and II controlled substances, but may also be used for Schedule III-V substances. Additionally, CSOS
has no line item limit for a single order.
Faster Transactions: CSOS certificates contain the same identification information as DEA Form
222, which allows for timely and accurate validation by the supplier. Faster transactions allow for justin-time ordering and smaller inventories.
Accurate Orders: CSOS reduces the number of ordering errors.
DEA Form 106 reports theft of CS theft or loss must now be reported to DEA and police
–significant loss must be reported within ten (10) days
DEA Form 41 form for outdated (expired) drugs—drugs being destroyed must be witnessed by
prescription drug manager (and Dept Inspector) who must also sign Form 41
Bienniel inventory of controlled substances.
–This inventory is required at least every two years.
–C-II drugs are listed separately and must be counted exactly.
–C-III-V may be estimated unless the container has 1000 or more units.
–The inventory must be for all drugs on hand, ie, in the possession or control of the pharmacy—this
includes filled Rx in the waiting bins.
–The inventory must be done before opening or after closing and must be signed by the person
conducting the inventory.
–any complete CS inventory for any reason (sale of pharmacy, change of PIC) that meets these
conditions pushes back the DEA required date
A new drug added to any schedule must be inventoried within 30 days
CS Rxs
–my be written or oral (for an oral C-II, it must be an emergency)
–may be faxed
–an agent of the prescriber may prepare the Rx but the prescriber must sign
–records retained for two (2) years from date of last fill
–required info on written Rx
Prescriber signature direction for use date of issue quantity
Prescriber name, address, DEA # patient name, address drug name, strength
–required info on Rx patient bottle
Pharmacy name, address prescriber name date filled patient name
Drug name directions for use expiration date “Caution: federal law
prohibits…” statement (not required for C-V)
–for a practitioner’s office supply, an Rx is not allowed—must use an invoice and Form-222
–must exercise professional judgment in filling
–refusal to fill must be based on a concern not addressed by the prescriber or issue seen on PDMP
–pattern of refusing to fill CS Rxs out of fear of prosecution is in itself a violation
–must report within one (1) day fraudulent, forged, altered Rxs
C-II
–may not be refilled
–expires 1 year from date of issue
–prescribing limits
–3 day supply for acute pain
–may be increased to 7 day supply if prescriber believes it medically necessary
–90 day supply max
–exceptions for terminally ill, cancer, palliative care, severe trauma
–quantity in both letters and numbers
–may do oral emergency prescription
–may not be transmitted to central fill pharmacy
–immediate use necessary for proper medical treatment
–no appropriate alternative treatment
–not reasonably able to provide written Rx
–prescriber to provide written Rx within 7 calendar days—notify DEA if not provided
–limit 72 hour supply
–faxes not permitted
Partial Fills
–may partial fill up to 72 hour supply if unable to supply full quantity
–note partial on face of Rx
–remainder must be picked up within 72 hours
–if not picked up, notify prescriber
–LTCF or terminally ill patient
–note on face of Rx “LTCF” or “terminally ill”
–partials up to full quantity authorized
–partials stop after 60 days from date of issue
Changes to C-II that are NOT allowed
–prescriber signature
–patient name
–drug name, except for generic substitution
Post dating 21 CFR 1306.05(a) the DEA ruled that prescribers could write more than one prescription
for the same patient for the same drug. All Rxs had to be dated the date of issue. Other than the Rx
which could be filled that day the other Rx(s) could have a “Do Not Fill Until …” with a later date on it
–in FL, may not exceed a 90 day supply
C-III thru C-V
–up to 5 refills within six months from date of issue
–may be written, oral, faxed or electronic
–oral Rxs may not have refills
–C-III may only be up to 30 days supply if sent orally
–may be transferred ONE time—exception for shared common database
–pharmacist or intern may transfer CS Rxs
Partial Fills
–partial fills up to total quantity authorized
–partials stop after 180 days from date of issue
–partial fills are not refills
C-V OTC
–sale must be OK’d by a pharmacist but another person may conduct transaction
–pharmacist must determine medical need
–buyer must be 18
–ID required if not known to the pharmacist
–no more than 240 mls (48 dosage units) every 48 hours of opium containing product
–no more than 120 mls (24 dosage units) every 48 hours of codeine containing product
–record book that contains
date of purchase buyer name/address pharmacist ID
Name of product quantity
–keep records for two (2) years
Pharmacist responsibility
–if patient is not known to pharmacist, must see ID
–if there are concerns about the CS Rx—verify with prescriber—if unable to reach BUT considers Rx
legitimate, dispense 72 hour supply
CS RX prescription blank
–standardized counterfeit-proof pad
–vender must be approved by Dept of Health
–must be signed by prescriber
–blue or green
–must resist reproduction—either “void” or “illegal” must appear on reproduction or photocopy
–unique tracking ID number
–printed on artificial watermarked paper which has unique alphabetic prefix, date of printing, & batch
number
–place to indicate NONACUTE PAIN and ACUTE PAIN EXCEPTION
–can have multiples Rxs per blank but must be in the same class
–not transferable
DEA registration
–two letters followed by seven numerals
–required to prescribe, manufacture, wholesale, or dispense CS
–separate for each physical location
–kept at location address on registration—must be available for inspection
Storage of CS drugs
–C-II through C-V
–can be stored together in a secure, locked cabinet
–may be spread throughout the entire pharmacy inventory
CS-II Rx blank
–only one Rx per blank
–non-CS drugs cannot be on these blanks
Emergency Refill
–one-time only
–up to a 72 hour supply
–C-III through C-V
Refusing to fill a CS Rx
–attempt to validate
–speak to the provider/prescriber
–access PDMP
–any refusal to cooperate with pharmacist is basis for refusal
–if any suspicion of diversion, report prescriber to Dept of Health and DEA
E-Rxs
–CS Rxs transmitted electronically are legal
–prescriber must ID themselves by using TWO of the following
Password biometric ID `specific info unique to prescriber
Prescription Drug Monitoring Program
–required of all dispensers of CS
–must report daily
–for C-II through C-V not required for non-opioid C-V)
–exemptions
Dept of Corrections patients under 16 hospitals/institutions
Correctional facilities 72 hour emergency dispensings
–required reporting info
Date of issue prescriber name & identifier (DEA, NPI) date issued payment method
Patient name, address, DOB, telephone # drug name, strength, quantity, NDC #
Pharmacy name, DEA #, pharmacy permit #, address first fill or refill
Name of person picking up and ID
–prescriber and dispenser MUST check PDMP –if unable to do so, may only dispense a 72 hour supply
Record of CS kept electronically for the previous 60 days must be available within 72 hours for any party
authorized to make such a request
Mailing a controlled substance is legal. The medicine in the mailing package must be properly labeled,
but the mailing package must be free of markings that indicate the contents of the package.
Transfer of CS
–Form 222 if C-II transferred
–invoice with date, transferor name, transferee name, drug name & strength, quantity, DEA numbers of
both parties
–if more than 5% of annual CS inventory is transferred to another party, the pharmacy must obtain a
distributor’s license
Pseudoephedrine, ephedrine, etc
–buyer must be at least 18 years, must show government-issued photo ID
–daily limit 3.6 grams
–monthly limit 9 grams
–pharmacies must do self-certification in training employees as to rules for selling these products
–these products are stored behind the Rx counter
Needles/syringes
–may not sell to a minor without a prescription
–each city or county makes up its own rules for sell
Dextromethorphan
–available OTC
–buyer must be at least 18
–no quantity limit
Naloxone/opioid antagonist
–required to be prescribed if an opioid is prescribed for traumatic injury
–may dispense nasal or auto-injector pursuant to standing order
Medical Marijuana
–Charlotte’s Web Law
–permits use of > 10% CBD, < 0.8% THC
–patients must be listed in state registry
–patient must be FL resident
–physician orders the marijuana—no prescriptions—NO pharmacy involvement
Special veterinary drugs
–carfentanil, etorphine, diprenorphine
–prescribed only by a vet
–MUST be stored in a safe, secure locked cabinet
–must be ordered separately, cannot have other drugs on the Form 222
PRACTITIONERS
Prescribers
–MD/DO physician
–ARNP advanced registered nurse practitioner
–PA physician assistant
–DVM veterinarian
–DDS/DMD dentist
–DPM podiatrist
–OD optometrist
Hospital interns and residents
–may prescribe CS
–use institution’s DEA number plus internal hospital code
ARNP/PA prescribing
• Prescriptions for Schedule II controlled substances are limited to a 7-day supply, except
for psychiatric medications prescribed by a psychiatric nurse.
• Psychiatric medications for patients younger than 18 years old may only be prescribed by a
psychiatric nurse.
• An ARNP must have a master’s degree or doctorate to prescribe controlled substances
• ARNPs and Pas may prescribe controlled substances under existing supervision and protocol
requirements, and subject to a formulary to be developed by a committee under the Board of
Nursing
Veterinarians
–may prescribe accordingly for animals
–may prescribe human products for animals
Optometrists
–must take 20 hour course to be able to prescribe oral agents
–cannot prescribe more than a 72 hour supply without a physician approval
. Tramadol hydrochloride Acetaminophen 300 mg with No. 3 codeine phosphate 30 mg.
(b) The following antibiotics or their generic or therapeutic equivalents:
Amoxicillin with/without clavulanic acid. Azithromycin Erythromycin.
Dicloxacillin Doxycycline/Tetracycline Keflex Minocycline.
© The following antivirals or their generic or therapeutic equivalents:
Acyclovir Famciclovir Valacyclovir.
(d) The following oral anti-glaucoma agents or their generic or therapeutic equivalents, which may
not be administered or prescribed for more than 72 hours:
Acetazolamide Methazolamide
Dentists
–may prescribe accordingly for conditions of the teeth and mouth
Podiatrists
–may prescribe accordingly for conditions for the ankle and foot
Death of a prescriber
–refills remain valid and can be filled
Physician dispensing
–mut register with the state
–must allow patients to choose between a prescription and physician dispensing
–must meet all pharmacy requirements for storage, safety, recordkeeping—open to inspection
–may only dispense C-IV and C-V
–samples are not considered physician dispensing
MISCELLANEOUS
Drug Addiction Treatment Act Title XXXV Section 3502
–allows qualified physicians to treat opioid addiction in their office
–special DEA # starts with ’X’ Rxs for opioid addiction must have BOTH the DEA and x-DEA
numbers
–limit 100 patients after a year of such type of practice—as of 2016 this number can be increased with a
DEA waiver to 275
–may write for suboxone, subutex (buprenorphine) or other C-III thru C-V
–MD, DO, nurse practitioner and physician assistants may write for buprenorphine products once
properly registered
–methadone must be administered on-site, no prescriptions—methadone 40mg for addiction
only—however, a hospitalist or attending may temporarily prescribe for a hospitalized addict without an
X-DEA number
Compounding is under the auspices of the USP 795 (non-sterile) and USP 797 (sterile) regulations
–special area set aside for compounding—no other pharmacy business may occur there without
permission from the Board
–compounding OTC products is NOT allowed.
–Pharmacies may compound “ahead” or prepare compounded products that would be expected to be sold
within a reasonable amount of time
–compounding pharmacists & techs mist have initial and ongoing training
▪ — Pharmacies must be classified as Category 1 and Category 2 – based primarily on the conditions
under which they are made and the time within which they will be used. Category 1 compounding
sterile preparations (CSPs) have a shorter maximum beyond use date (BUD), while Category 2
CSPs have a longer maximum BUD, based on several factors, such as sterility considerations. The
revised chapter describes all the applicable standards for Category 1 and 2 CSPs.
–facilities inspected and tested at least 2 times per year
–chemo is prepared in a dedicated vertical laminar airflow hood area in negative pressure room
–low risk
–ISO-5 or better
–no more than 3 sticks into a single vial or bag
–medium risk
–ISO-5 or less
–no more than 3 sticks into a single vial or bag
–high risk
–ISO-5 or less
▪ Beyond Use Dating:
▪ Non-aqueous formulations; No later than the time remaining
until the earliest expiration date of any active pharmaceutical
ingredient or 6 months, whichever is earlier.
▪ Water-containing oral formulations: No later than 14 days
when stored at controlled cold temps
▪ Water-containing topical/dermal and mucosal liquid and
semisolid formulations: No later than 30 days
▪ Low risk—48 hours room temp, 14 days refrigerated, 45 days
frozen
▪ Medium risk—30 hours room temp, 9 days refrigerated, 45
days frozen
▪ High risk—24 hours room temp, 3 days refrigerated, 45 days
frozen
▪ Master formulations & Compounding Records on file—a recipe book—all master formulae must
be kept on file
▪ Recordkeeping requirements
Compounding date control number compounding pharmacist/tech ID
Package size quantity of ingredients units compounded patient name
Rx formula manufacturer of ingredients
Patient counseling on all NEW prescriptions
HIPAA—the law requiring stricter confidentiality
HIPAA 3 main exemptions:
–communication with patient
–communication with other healthcare practitioners providing care to the patient
–billing, esp electronically
–all pharmacy employees must have HIPAA training, as do any non-employees who have access to the
pharmacy (“business associates”)
— Pharmacy personnel should have codes for logging on and off computer stations
–there must be a Notice of Privacy Practices supplied to each customer
–the NPP notifies the patient that his/her information will be kept confidential and what
the patient can/should if he/she believes there has been a non-exempted disclosure
–service may not be refused if customer refuses to acknowledge receipt of NPP
–the NPP must name a Privacy Officer and his address/phone number supplied on the
NPP
–there must be an accounting of all non-exempted disclosures of PHI—this and all
HIPAA records must be maintained for 6 years
–customers can view their own PHI when they request and can ask that it be modified
Poisons
–must have pharmacy name and address on label
–label must have word “Poison”
–buyer made aware of dangers
–determine legitimate use if large quantity
Laws
Sherman Antitrust Act 1890—prohibits agreements, contracts, etc that restrain trade, mergers that
decrease competition
Pure Food and Drug Act 1906 led to creation of FDA, certain drugs had to be accurately labeled with
dose and contents
Food Drug & Cosmetic Act 1938 FDA to provide regulation to ensure safety of food, drugs, etc
Humphrey-Durham Amendment 1951 classified drugs as “prescription only” and OTC
Kefauver-Harris Amendment 1962 manufacturers must prove a drug is both safe and effective
Controlled Substance Act 1970 see “Controlled Substances” above
Federal Anti-Tampering Act 1982 a response to the Tylenol poisonings –created tamper-resistant
packaging
SUMMARY
WHAT YOU DO NOT NEED TO KNOW
• Citations for statutes and regulations. If present, those are for reference to update this review
• Most states have questions from the Food, Drug and Cosmetic Act but do not ask questions about
food or cosmetics, unless there is a relation to drugs
• Dates—even though the date of enactment is under the Laws section above, the MPJE does not
ask for dates as to when laws when into effect
• Chemical names per se are usually not questioned on the MPJE, though there may be some in
conjunction with a question re: compounding
• Until settled between the states and the FDA, questions regarding USP 795 and 797 should not
refer to the proposed 2019 updates
STUDY HINTS
• The exam will have 120 questions, 100 scored and 20 pre-test. You have 2.5 hours to complete
• Know dates: when does a license expire, what dates cover obtaining CE, etc.
• Know time periods: how often is a license/permit good before it requires renewal, how long may
a store be closed before the Board may seize the drugs, etc.
• Be prepared for K-type questions: use my practice exams and if you make your own, formulate
this type of question
• Know your insulins: Rx vs OTC
• Knowing my materials is not enough–be able to apply them. Fair amount of analysis required on
the MPJE, not just regurgitation.
What federal law you need is in my materials.
Want to give feedback on how this MPJE prep course is doing? PES would love to hear back from you.
Applicants for licensure are reminded that NAPLEX has you sign a form that states you will NOT discuss
what you saw on the MPJE. Pharmacy Law Source fully supports preserving and protecting NAPLEX’s
product and integrity. Feedback should therefore be limited to general comments such as “You could do
more on generic substitution” or “You need more detail on technicians.” Do NOT quote actual questions
you had or seek to re-create.