MPJE

MPJE Worksheet
Instructions: This is meant to be a guide that covers as many possible MPJE topics as possible. Each state has different laws, and you
may find some boxes that are not addressed by your state (in which case write n/a). Always check your state board for latest
guidance.
State Florida

The Board of Pharmacy

The Florida State Board of Pharmacy is made of up of 9 members
● 7 pharmacists (2 community, 2 class II institutional/modified class II/class III, 3 any setting)
● 2 community members (not connected with the practice of pharmacy in any way)
Who are the Board Members?
All board members must be state residents, pharmacists must be in practice for at least 4 years. At
least one board member must be 60 years or older and no members may be associated with a
manufacturer or wholesaler.
Is the Board a Separate Entity or Under
Under the Florida Department of Health
Another Organization/Department?
Who Chairs the Board? Not explicitly stated how chair/vice-chair is appointed, there is also an executive director.
How Are Board Members Selected?
Appointed by the governor, confirmed by senate.
Appointment/Election?
4 years. At the end of the term, board members continue to serve until they’ve been replaced and may
How Long do Board Members Serve?
be reappointed for additional terms (no explicit limit).
How Often Does the Board Convene? The board meets six times a year..
Who Can Attend Meetings? All board meetings at which official acts are to be taken are public meetings.

Licensure Requirements
The Pharmacist
New Transfer/Reciprocity Foreign Graduate
Who Can Apply? Age 18
Application Fee? $295
30 hours
# of CE Hours for Renewal?
See: Florida Board of Pharmacy » Pharmacist- Licensing, Renewals & Information
HIV and AIDS (first renewal only) – 1 hour
Medication errors (mandatory) – 2 hours
Controlled substances (mandatory) – 2 hours
Special CE Requirements (e.g.
Human trafficking (mandatory) – 1 hour
live, compounding, preceptor,
Vaccine/Epi-pen (optional) – 3 hours
HIV, MTM, vaccinations,
Order/evaluate lab tests (optional) – 3 hours
opioid, medication safety)?
10 hours must be live (in person, teleconference, or interactive web training)

See: Florida Board of Pharmacy » Immunization Administration Certification- Licensing, Renewals & Information
If graduated > 2 years ago, must 2080 hours – 500 must be
Minimum Intern Hours? 2080 certify completion of 2080 work completed in FL as pharmacy
hours intern foreign grad
Degree/Education Required? PharmD or B.S.
NAPLEX/MPJE
MPJE (Technically NAPLEX too but English proficiency (3 options)
Examinations Required? NAPLEX/MPJE should’ve already passed that to 1. FPGEC certification
have a license in another state) 2. FPGEE + TOEFL IBT
3. FPGEE + TOEFL + TSE
Form A or Official Transcript
● Form A or Official Transcript
Form B – if graduated > 2 years
● Form B – if graduated before Form B
ago
1/1/01 Work Activity Manual
Documents (Transcript/Drug License verification – if have
● License verification – if have License verification – if have
Test/Background Check)? current health-related license in
current health-related license current health-related license in
another state
in another state another state
Record of 30 hours CE – if licensed
●
in other state > 2 years
Suspended or restricted as a result of disciplinary action:
Reinstatement Process? Comply with any board ordered requirements (may include educational courses, probation, restrictions,
reprimands)

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 Pay any required fees or fines
Note: A revoked license may not be reinstated

Reactivation of license placed on inactive status:

Pay fee for reinstatement application
Submit proof of CE – 15 hours for each year license inactive
Probation Reasons/Process? See: Disciplinary Guidelines
Biennial, $205 ($105 - consultant pharmacist or nuclear pharmacist license)
Renewal Period?
Expires September 30 of odd years
Other Pharmacist Licenses
Consultant Pharmacist Nuclear Pharmacist
Complete 200 hours formal didactic training
Complete 20-hour board approved course 500 hours training under the supervision of a licensed nuclear
24 hours CE required for renewal, in addition to 30 hours required for pharmacist
pharmacist license renewal. 24 hours CE required for renewal, in addition to 30 hours required for
See: Florida Board of Pharmacy » Consultant Pharmacist- Licensing, pharmacist license renewal.
Renewals & Information See: Florida Board of Pharmacy » Nuclear Pharmacist- Licensing,
Renewals & Information
Pharmacy Intern
New Foreign Graduate
License/Registration Required? Yes
Students currently enrolled in an accredited
college of pharmacy or have graduated from Graduates of a foreign college of pharmacy
Who Can Apply?
an accredited college of pharmacy but not yet who have been approved to sit for FPGEE
licensed as a pharmacist
Application Fee? No
Hours Required? 2080 2080 (500 must be completed in FL)
Within thirty (30) days of termination of enrollment in an intern program, or withdrawal of
registration or attendance in an accredited school or college of pharmacy, all registered
pharmacy interns shall report such change in enrollment, registration or attendance to the
Current Enrollment/Good Standing Required? Board office. The notification may include a request, including full explanation and supported
by accompanying documentation, if any, that the pharmacy intern registration not be canceled
pending the registered pharmacy intern’s re-enrollment, re-registration, or re-attendance in an
accredited intern program or accredited school or college of pharmacy.
No intern shall perform any acts relating to the filling, compounding, or dispensing of medicinal
Preceptor Required? drugs unless it is done under the direct and immediate personal supervision of a person
actively licensed to practice pharmacy in this state
Renewal Period? Pharmacy Intern license do not expire
Pharmacy Technician
New
License/Registration Required? Yes
At least 17 years old.
Who Can Apply? A registered intern may work as a pharmacy technician without paying a registration fee or
filing an application with the board to register as a pharmacy technician..
20 hours, 4 must be live
Immunization Certified: additional 2 hours of vaccine administration
# of CE Hours for Renewal?
See: Florida Board of Pharmacy » Registered Pharmacy Technician- Licensing, Renewals &
Information
HIV and AIDS (first renewal only) – 1 hour
Special CE Requirements (e.g. compounding,
Medication errors and pharmacy law– 2 hours
live, HIV, opioid, medication safety)?
Human trafficking (mandatory) – 1 hour
Application Fee? $105
Requirements? Examination, PTCB, Education? Must have completed a pharmacy technician training program approved by the board, PTCB
Drug Test? Background Check? cannot be used in lieu of a board–approved program
Biennial, $55
Renewal Period?
Expires December 31 of even years

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 The Pharmacy
The Physical Space
The prescription department of any community pharmacy permittee shall be considered closed whenever the
Specific Requirements on Who establishment is open and a pharmacist is not present and on duty
Can Access the Pharmacy? Whenever the prescription department of any community pharmacy establishment is closed, no person other
Without Pharmacist? BOP? than a pharmacist shall enter or remain in the prescription department.
Police? Authorized agents/employees of the Department or other persons authorized by law may inspect at a
reasonable hour or when the practice of the profession of pharmacy is being carried on.
Minimum Square Footage? Not specified – rule states that there should be adequate facilities (ex: shelves, cabinet, fridge) for employees to
Minimum Counter Space? safely perform the functions of the pharmacy and for orderly storage.
Counseling area should be:
Counseling Area
● Designed to maintain the confidentiality and privacy of the pharmacist/patient communication.
Requirements?
● Accessible by the patient without having to traverse a stockroom or the prescription dispensing area.
The partition or other means of enclosure shall be securely locked or padlocked and only a pharmacist shall
Security System Requirements
have the means to gain access to the prescription department.
Specifications on Alarms? Must be able to detect entry after hours and protect against theft/diversion
Connectivity
Not specified but should have equipment as is necessary to meet the needs of the professional practice of
(Phone/Fax/Internet
pharmacy
Required)?
Hard copies must be stored in a 2 or 3–file storage system
Drugs must be stored within the confines of the prescription department.
Controls may be locked up, dispersed among floor stock, or some combination of both

Pursuant to 21 CFR 1304.04(h), controlled substance prescriptions must be filed in one of the following
ways:
● Paper Prescriptions Records Option 1:
Separate Storage for ○ A file for schedule II controlled substances dispensed.
Prescription Hard Copies by ○ A file for schedules III, IV and V controlled substances dispensed.
Control? Drugs by Control? ● Paper Prescriptions Records Option 2:
○ A file for all schedule II controlled substances dispensed.
○ A file for all other drugs dispensed (non-controlled and those in schedules III, IV and V). If this method
is used, a prescription for a schedule III, IV or V drug must be made readily retrievable by use of a red
“C” stamp not less than one inch high.
Electronic records must be maintained electronically for two years from the date of their creation or receipt.
Records regarding controlled substances must be readily retrievable from all other records. Electronic records
must be easily readable or easily rendered into a format that a person can read.
Hard copies – Not Specified
Must Storage Area Be Locked Drugs must be stored within the confines of the prescription department.
for Hard Copies? Drugs? The partition or other means of enclosure shall be securely locked or padlocked and only a pharmacist shall
have the means to gain access to the prescription department.
Hard copies: storage location not explicitly stated, however, records must be either on site or produced within
Must Storage Area Be On Site 48 hours.
for Hard Copies? Drugs? Drugs: shall be stored within the confines of the prescription department of a community pharmacy, or in a
class II institutional pharmacy, within the confines of the pharmacy provided
Signage
Sign Requirement for
Must have a sign stating “Patient Consultation Area”.
Counseling?
Yes, a sign in block letters at least 1 inch in height. If open < 40 hours, must also post the information for after-
Sign Requirement for Hours?
hours access.
Sign Requirement for PIC
Not required
Change?
Whenever the pharmacy is closed or open and a pharmacist is not present and on duty, A sign with bold letters
Sign Requirement for
not less than 2 inches in width and height stating “Prescription Department Closed” must be easily visible to
Closures?
patrons.
Must display a sign in block letters at least 1 inch in height “CONSULT YOUR PHARMACIST CONCERNING THE
AVAILABILITY OF A LESS EXPENSIVE GENERICALLY EQUIVALENT DRUG AND THE REQUIREMENTS OF
FLORIDA LAW”
Other Signage Requirements?
Pharmacist is considered present and on duty during meal breaks IF a sign is posted indicating the specific
hours of the day during which meal breaks may be taken and assuring patients that a pharmacist is available for
consultation upon request

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 By January 1, 2021, the licensees or certificateholders shall post in their place of work in a conspicuous place
accessible to employees a sign at least 11 inches by 15 inches in size, printed in a clearly legible font and in at
least a 32-point type, which substantially states in English and Spanish:
“If you or someone you know is being forced to engage in an activity and cannot leave, whether it is prostitution,
housework, farm work, factory work, retail work, restaurant work, or any other activity, call the National Human
Trafficking Resource Center at 888-373-7888 or text INFO or HELP to 233-733 to access help and services.
Victims of slavery and human trafficking are protected under United States and Florida law.”
Board Notification
A pharmacy permit is nontransferable so a change in ownership constitutes the closing of the old pharmacy and
Time to Notify Board of
opening of a new pharmacy. The current permit holder must notify the board of transfer of ownership interests
Changes to Ownership?
within 15 days.
Time to Notify Board of No later than 10 days after change in designated prescription department manager (30 days for internet
Changes to PIC? pharmacies). Both incoming and outgoing managers must notify the board.
Time to Notify Board of Not specified, however, a new location requires a new inspection before opening so the board must be notified
Changes to Address? in that capacity.
Time to Notify Board of
Not specified
Changes to Hours?
Equipment
Type of Prescription Balance
No requirements
Required?
There shall be provided for the prescription department of each pharmacy:
● An adequate sink in workable condition and running water easily accessible to the prescription counter.
● Sufficient shelf, drawer or cabinet space for the neat and orderly storage of pharmaceutical stock,
prescription containers, prescription labels, the required equipment, and all other items.
● Adequate facilities for the proper storage of pharmaceuticals which require refrigeration.
● Adequate sanitation to insure the prescription department is operating under clean, sanitary, uncrowded,
and healthy conditions.
Other Equipment Required? ● The following items:
○ A current pharmacy reference compendium such as the United States Pharmacopoeia/National
Formulary, the U.S. Dispensatory, USP DI, (United States Pharmacopoeial Drug Information), the
Remington Practice of Pharmacy, Facts and Comparisons or an equivalent thereof sufficient in scope,
and a current copy of the laws and rules governing the practice of pharmacy in the State of Florida. It
shall be acceptable, in lieu of an actual hard copy, to maintain these materials in a readily available
electronic data format.
● Such other equipment as is necessary to meet the needs of the professional practice of pharmacy.
Must be under the supervision of a FL pharmacist. To qualify as a supervisor for an automated pharmacy
Special Rules on Automated system, the pharmacist need not be physically present at the site of the automated pharmacy system and may
Dispensing Cabinets? supervise the system electronically.
A record of every transaction with the automated pharmacy system shall be maintained for four (4) years.
Access
The prescription department of any community pharmacy permittee shall be considered closed whenever the
establishment is open and a pharmacist is not present and on duty
Must RPh Be On-Site for Hospital: A single dose of medicinal drugs based upon a valid physician’s drug order may also be obtained and
Access to Pharmacy? administered under the supervision of the nurse in charge consistent with good institutional practice procedures
as established by the consultant pharmacist of record and written in the policy and procedure manual which
shall be available within the pharmacy.
After Hours Dispensing
Allowed? Requirements (i.e. See above
Dispensing Cabinet?
Emergency Access to None specified, however, LTC/hospice/prisons may utilize an emergency kit within an automated pharmacy
Pharmacy Procedures? system managed by a provider pharmacy
Mail Order
Mail Allowed? (In-State to Out,
Yes a nonresident pharmacy permit is required, separate permit needed for compounded sterile products.
Out-of-State to In)
License Required for Mail to
Not specified.
Other States?
Ownership Requirements
What Are the Fees for A
$250 (+ $5 unlicensed activity fee) initially and every 2 years
Pharmacy License?
Who Can Apply? Anyone except those convicted of certain healthcare–related crimes

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 Must be RPh to Own
No
Pharmacy?
Additional Requirements for
No
Ownership?
Owners/operations managers must submit fingerprints for background check
Rules on Sales/Transfers New permit holder must perform “opening inventory” if transferring drugs (with specific requirements for
controlled substances)
Application/Fees Required? See above
How Long for Notification
Current permit holder must notify board within 15 days of transfer.
Period?
Signage Requirements? Must post a sign with business hours and a sign with new address if changing locations
Staffing Requirements
Default: 1:1
Regular dispensing (not sterile compounding): up to 6:1
RPh-Tech Ratio? Different by
Sterile compounding: up to 3:1
Setting?
Non–dispensing OR physically separate areas in dispensing pharmacies (with walls/barrier): 8:1
Immunizations: 5:1
Immunizations: 5:1
RPh-Intern Ratio? Different by
Foreign grad: 1:1
Setting?
Otherwise, unlimited
RPh-Staff (Clerk/Delivery
Driver/Cashier) Ratio? Not specified
Different by Setting?

Compounding
Is Facility Licensure Required for No licensure required for general compounding
General Compounding? Sterile A special sterile compounding permit (SSCP) OR a nonresident sterile compounding permit is required
Compounding? Exception: Modified Class II institutional permit and only making low risk/immediate use preparations
Restrictions on Compounding
In general, may only compound pursuant to a prescription or in anticipation based on prescription patterns.
Without Prescription?
Stability of Compounded
See: USP Compounding Standards and Beyond-Use Dates (BUDs)
Product?
Special Volume Requirements?
See above
Manufacturer License Required?
Must be in strict compliance with good manufacturing practices
Certification and testing clean room/hood at least every six months and whenever the device or room is
Certifications/Licensure
relocated, altered, or major service to the facility is performed.
Required?
Didactic training/assessments for personnel, gloved fingertip and media fill tests annually or semiannually
depending on risk.
Special Requirements for Patent
May not compound products that are commercially available.
Drugs? Controlled Drugs? OTC?
Dispensing Without Prescription May also compound for “office use” with some restrictions, including being registered as an outsourcing
Allowed? Which Drugs? facility. See more here.

Behind the Counter

Can Legend Drugs (e.g. Codeine,
See complete list here. When ordering, pharmacist must create a prescription and store in patient’s
Opium Tinctures) Be Dispensed
records. May not prescribe more than a 34-day supply and may not prescribe oral medications for
Without Prescription? Which Ones?
pregnant/nursing mothers.
Logging Requirements?
“Scheduled listed chemical products” (SLCPs) are required to be placed behind the counter or in locked
Which Drugs Are Required to Be cabinets. SLCPs include any product that may be marketed or distributed lawfully in the United States
Behind the Counter? under the Federal Food, Drug, and Cosmetic Act as a non-prescription drug, and that contains ephedrine,
pseudoephedrine, or phenylpropanolamine.
Schedule V OTC: The total quantity of controlled substance listed in Schedule V which may be sold to any
one purchaser within a given 48-hour period shall not exceed 120 milligrams of codeine, 60 milligrams
Dispensing Requirements
dihydrocodeine, 30 milligrams of ethyl morphine, or 240 milligrams of opium. A bound volume must be
(Maximum Allowed/Logging)?
maintained as a record of sale at retail of excepted compounds, mixtures, and preparations, and the
pharmacist must require suitable identification from every unknown purchaser.
It is unlawful for any person to sell or otherwise deliver hypodermic syringes, needles, or other objects
Can Syringes Be Dispensed Without
which may be used, are intended for use, or are designed for use in parenterally injecting substances into
Prescription? Logging Requirement?
the human body to any person under 18 years of age, except that hypodermic syringes, needles, or other

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 such objects may be lawfully dispensed to a person under 18 years of age by a licensed practitioner,
parent, or legal guardian or by a pharmacist pursuant to a valid prescription for same.
A person may not knowingly obtain or deliver to an individual in any retail over-the-counter sale any
nonprescription compound, mixture, or preparation containing ephedrine or related compounds in excess
of the following amounts:
● In any single day, any number of packages that contain a total of 3.6 grams of ephedrine or related
What are the Rules Around
compounds;
Pseudoephedrine? Limits?
● In any single retail, over-the-counter sale, three packages, regardless of weight, containing ephedrine
or related compounds; or
● In any 30-day period, in any number of retail, over-the-counter sales, a total of 9 grams or more of
ephedrine or related compounds.

Drug Administration
In accordance with guidelines of the Centers for Disease Control and Prevention for each recommended
immunization or vaccine, a pharmacist who is certified or a registered intern or a registered pharmacy
technician under the supervision of such pharmacist may administer the following immunizations or vaccines
to an adult within the framework of an established protocol under a supervising physician:
● Immunizations or vaccines listed in the Adult Immunization Schedule as of March 31, 2022, by the United
States Centers for Disease Control and Prevention. The board may authorize by rule additional
immunizations or vaccines as they are added to the Adult Immunization Schedule.
Can Pharmacists Administer
● Immunizations or vaccines recommended by the United States Centers for Disease Control and
Immunizations? Which Ones Can
Prevention for international travel as of March 31, 2022. The board may authorize by rule additional
They Administer?
immunizations or vaccines as they are recommended by the United States Centers for Disease Control
and Prevention for international travel.
● Immunizations or vaccines licensed for use in the United States, or which have been authorized for
emergency use, by the United States Food and Drug Administration as of March 31, 2022. The board may
authorize by rule additional immunizations or vaccines as they are so licensed or authorized.
● Immunizations or vaccines approved by the board in response to a state of emergency declared by the
Governor.
Can Pharmacists Administer
Medications? Which Ones Can Injectable antipsychotics: If part of establish protocol with physician and pharmacist attends 8–hour training
They Administer?
Is a Collaborative Practice Yes
Agreement/Other Required? See: Injectable antipsychotics and Administration of vaccines
Facility Requirements? Private Injectable antipsychotics: a facility that accommodates privacy for nondeltoid injections and conforms with
Space/Partition? state rules and regulations regarding the appropriate and safe disposal of medication and medical waste
A registered intern who administers an immunization or vaccine must be supervised by a certified pharmacist
at a ratio of one pharmacist to a maximum of five registered interns or registered pharmacy technicians, or a
combination thereof.
Other Requirements? Patient A pharmacist who is certified may administer influenza vaccines to individuals 7 years of age or older within
Age Limit? the framework of an established protocol under a supervising physician.
Any pharmacist, registered intern, or registered pharmacy technicians seeking to administer vaccines must be
certified to administer such vaccines pursuant to a certification program approved by the Board of Pharmacy
in consultation with the Board of Medicine and the Board of Osteopathic Medicine.
Are There Laws/Protections for Pharmacists may administer an Epi–pen in response to an allergic reaction, within framework of an
Emergencies (e.g. Anaphylaxis, established protocol
Overdose)? Drugs Covered? See overdose section for naloxone rules

Pharmacists’ Rights
Can Pharmacists Refuse to Fill a Narcotics specifically mentioned in rules. Pharmacist may use professional judgment in determining
Valid Prescription (e.g. Birth Control, validity – “neither a person nor a licensee shall interfere with the exercise of the pharmacist’s
Narcotics)? In What Circumstances? independent professional judgment”
Before refusing, the pharmacist shall attempt to resolve those concerns and validate the prescription by
performing the following:
● Try to obtain relevant info from patient, patient representative, or prescriber
● Must consult the patient in a private area where conversation cannot be overheard
Requirements for Refusal? ● Access the PDMP to obtain pertinent information
● If the patient is unwilling cooperate, the pharmacist is not required to attempt to validate and may
refuse
If a pharmacist has reason to believe that a prescriber is involved in the diversion of
controlled substances, the pharmacist shall report such prescriber to the Department of Health
Religious Objection? See: Conscience Protections for Health Care Providers
What Actions Can Be Taken Against No action specified for refusal to fill. Other grounds for discipline for a pharmacist license can be found
RPh License for Refusal to Fill? here.
Appeals Process on Actions? See here for general information about the court of appeals

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 Other Settings
Long-Term Care – Class I Institutional Pharmacy
Drugs are technically not dispensed on premises, medications are dispensed by a vendor pharmacy.
Who Can Dispense/Administer The vendor pharmacy may contract with another pharmacy to provide “starter doses” to the patient until the
Medication? vendor pharmacy can dispense/deliver meds. Controlled substances may not be dispensed as a starter
dose. Not specified who may administer.
Automated Pharmacy Systems: The prescription department manager or a designee shall:
● Authorize or deny access to the data from an automated pharmacy system or to a drug stored inside the
automated pharmacy system.
● Document the training of each person who has access to the data from an automated pharmacy system
or to a drug stored inside the automated pharmacy system.
A pharmacist at the provider pharmacy shall control all operations of the automated pharmacy system and
Who Can Access Dispensing
approve release of the initial dose of a prescription or order. A subsequent dose from an approved
Units? Special Requirements?
prescription or order may be released without additional approval of a pharmacist. However, any change
made in a prescription or order shall require a new approval by a pharmacist to release the drug.
Access to controlled substances shall be limited to a pharmacist or a registered pharmacy technician
employed by the provider pharmacy or licensed personnel in the facility or institution who are authorized to
administer medication. Automated pharmacy system must prohibit simultaneous access to multiple
drugs/strengths.
The stocking or restocking of a medicinal drug in an automated pharmacy system at the remote site shall be
completed by a pharmacist or other licensed personnel.
If the automated pharmacy system uses removable cartridges or containers to store the drug, the stocking
or restocking of the cartridges or containers may occur at the provider pharmacy and be sent to the remote
Who Can Access Medications site to be loaded by personnel designated by the pharmacist if:
Without Pharmacy Staff? ● A pharmacist verifies the cartridge or container has been properly filled and labeled.
● The individual cartridge or container is transported to the remote site in a secure, tamper-evident
container.
● The automated pharmacy system uses bar code verification, electronic verification, or similar process to
assure that the cartridge or container is accurately loaded into the automated pharmacy system.
Requirements on IV Labeling for
Not specified
Dispensing Unit
All drugs must be administered from individual prescription containers to the individual patient (must be
labeled like a typical prescription).
Requirements on Unit Dose If the facility where pharmacy services are being provided maintains a medication administration record that
Labeling for Dispensing Unit includes directions for use of the medication, , a unit dose medication may be utilized if the provider
pharmacy or an automated pharmacy system identifies and records the dispensing pharmacy, the
prescription or order number, the name of the patient, and the name of the prescribing practitioner.
Requirements on Multi-
See packaging section
Dose/Repackaging
Requirements on Storage of If stored in automated pharmacy system: access to controlled substances shall be limited to a pharmacist
Controlled Medication? or a registered pharmacy technician employed by the provider pharmacy or licensed personnel in the facility
Who can Access Controlled or institution who are authorized to administer medication. Automated pharmacy system must prohibit
Medications? simultaneous access to multiple drugs/strengths. Other storage requirements not specified
Prospective review of prescription orders is not required in an emergency dispensing situation. An
automated pharmacy system may be utilized as an emergency medication kit. Must have written policies
and procedures for use. If controls are only kept for emergency purposes, does not need DEA registration.
If the automated pharmacy system is also utilized for patient specific medication storage:
Emergency Dispensing ● The emergency medication shall be stored separately from other patient medications.
Requirements? ● The record shall identify the storage location from which the medication was released.
● The record shall include the name of the medication, the patient, the prescriber, the person who
accessed the automated pharmacy system, and the date and time of the release.
Medications in the emergency kit are determined by the medical director, director of nursing, and
pharmacist.
Must have a consultant pharmacist of record who must conduct on–site drug regimen reviews once
monthly.
Automated pharmacy system records must be kept for 4 years and contain the following info:
● Name or identification of the patient or resident.
● Name, strength and dosage form of the drug product released.
● Quantity of drug released.
Record Keeping Requirements?
● Date and time of each release of a drug.
● Name of provider pharmacy.
● Prescription number or order number.
● Name of prescribing practitioner.
● Identity of the pharmacist who approved the prescription or order.
● Identity of the person to whom the drug was released.

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 Nuclear
Must be under the control of a Prescription Department Manager (PDM) that is a FL licensed nuclear
RPh Special Requirements? pharmacist (see licensing section)
Fun fact: registered technicians in a nuclear pharmacy may take down new scripts from verbal orders
The area for the storage, compounding, distribution and disposal of radiopharmaceuticals shall be adequate
to completely separate such radioactive pharmaceuticals from pharmacy areas which contain non-
radioactive medicinal drugs;
The Hot lab, storage area, and compounding and dispensing area shall be a minimum of 150 square feet.
Equipment:
● Fume hood with appropriate air sampling equipment;
● Shielded radiation containment drawing station;
● Dose calibrator;
● Well scintillation counters;
● Area rate meters;
● Geiger-Mueller (GM) Survey meters;
● Refrigerator;
● Microscope;
Facility Special Requirements? ● Syringe shields; and,
● Personnel radiation detection devices.
Supplies:
● Syringes and vials required to perform practice;
● Disposable gloves and protective lab coats;
● Appropriate supplies to ensure sterile practices for I.V. solutions;
● Appropriate supplies to perform thin layer chromotography;
● Lead transport shields for syringes and vials.
● D.O.T. Type 7A approved transport containers and other labels and supplies for shipping radioactive
materials.
● Various current references including USP-NF
It shall be acceptable, in lieu of an actual hard copy, to maintain these materials in a readily available
electronic data format.
See also: Nuclear Pharmacy Permit- Licensing, Renewals & Information
Remote
Remote order processing may be performed for Class II or Class III Institutional Pharmacies or Special
Pharmacy Permits Servicing Class I, Class II, Modified Class II, Class III, and Special ALF Permitted Facilities.
Special Licensure Requirements?
An Internet Pharmacy (i.e. mail order) uses the internet to fill/dispense and “otherwise engage in the practice
of pharmacy in this state”.
Must Pharmacy Be Located at
Not specified
Dispensing Site?
Remote order entry allowed.
Telework? From Out of State? No clear guidance regarding telework from out of state, however, an Internet Pharmacy Permit holder may be
located in or outside of Florida.
Must Pharmacist Have an In-State
If processing orders remotely for an institutional pharmacy – yes. Not specified for mail order.
License?
Central Fill Allowed? Yes; see:Centralized Prescription Filling, Delivering, and Returning
Medical Offices
Which Type of Providers Can
Not specified but a practitioner who can prescribe can dispense/administer, thus must be able to
Receive/Store Medications?
receive/store.
Administer?
Samples may not be sold, purchased, or traded
Restrictions on Drug Samples? Drug samples may only be distributed to prescribing practitioners or hospital/clinic pharmacies (at the
written request of prescriber)
A practitioner authorized by law to prescribe drugs may dispense such drugs to her or his patients in the
Can Prescribers
regular course of her or his practice in compliance with this section. May not be schedule II or III unless a
Prepare/Dispense Prescriptions?
drug sample. Must inform patient that script can be filled at a pharmacy if desired. Sterile compounding not
Controlled? Sterile Compounding?
specified.
Requirements on Subject to the Florida Drug and Cosmetic Act and Drug Abuse Prevention and Control – essentially held to
Preparation/Storage/Logging? the same standard as pharmacies
Drug Sources? Can Pharmacies Pharmacies may compound medications for office use.
Supply Offices? Wholesale drug distributors: need credentialing prior to the purchase of schedule II or III drugs
Miscellaneous
Correctional Facilities Dispensing See: Modified Class II Institutional Pharmacies
Rules Referenced in automated pharmacy systems laws.

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 If selling drugs, requires veterinary prescription drug retail establishment permit
● Sale of drug must be based on valid order written by a licensed vet
Veterinary/Animal Dispensing
● Prescription is good for 1 year
Rules
● Prohibited from possessing or selling human prescription drugs
● Vet may prescribe controlled substances, but cannot sell (patient must get at retail pharmacy)
A Special Limited Community Permit is required for any Institutional Class II Pharmacy that dispenses drugs
to employees, emergency room patients, and other patients on continuation of a course of therapy
Emergency Room/Urgent Care
Dispensing Rules However, prescribers may dispense a 48 hour supply or enough through the next business day of a medicinal
drug to any patient of an emergency department of a hospital that operates a Class II or Class III institutional
pharmacy if a pharmacy is not readily accessible
Modified Class II Institutional Pharmacies are generally restricted in scope of practice and provide short-
term or primary care treatment such as primary alcoholism treatment centers, free-standing emergency
rooms, rapid in/out surgical centers, certain county health programs, and correctional institutions.
Medications must be administered on site from either a patient–specific or bulk drug system.

Class III Institution Pharmacies, including central distribution facilities, are affiliated with a hospital that
provide the same services that are authorized by a Class II institutional pharmacy permit. Class III
institutional pharmacies may also:
● Dispense, distribute, compound, and fill prescriptions for medicinal drugs for inpatient treatment or for
Other Facilities & Dispensing patients receiving acute and postacute hospital care at home.
Rules ● Prepare prepackaged drug products.
● Conduct other pharmaceutical services for the affiliated hospital and for entities under common control
that are each permitted under this chapter to possess medicinal drugs.
● Provide the services above to an entity under common control which holds an active health care clinic
establishment permit

See here for more information about various types of special pharmacy permits: Special Parenteral and
Enteral Permit, Special Closed System Pharmacy Permit, A Special Pharmacy – End Stage Renal Disease
(ESRD) Permit, A Special Pharmacy – Parenteral/Enteral Extended Scope Permit, Special – Assisted Living
Facility (ALF) Permit
International Drug Sources Rules Must hold an international export pharmacy permit. See restrictions here.
If being audited by a third party, the pharmacy has to the right to:
● The agency conducting the audit must give the pharmacist at least 1 week’s prior notice of the initial
audit for each audit cycle.
● An audit must be conducted by a pharmacist licensed in this state.
● Any clerical or recordkeeping error, such as a typographical error, scrivener’s error, or computer error
regarding a document or record required under the Medicaid program does not constitute a willful
violation and is not subject to criminal penalties without proof of intent to commit fraud.
● A pharmacist may use the physician’s record or other order for drugs or medicinal supplies written or
transmitted by any means of communication for purposes of validating the pharmacy record with
respect to orders or refills of a legend or narcotic drug.
PBM Rules
● A finding of an overpayment or underpayment must be based on the actual overpayment or
underpayment and may not be a projection based on the number of patients served having a similar
diagnosis or on the number of similar orders or refills for similar drugs.
● Each pharmacy shall be audited under the same standards and parameters.
● A pharmacist must be allowed at least 10 days in which to produce documentation to address any
discrepancy found during an audit.
● The period covered by an audit may not exceed 1 calendar year.
● An audit may not be scheduled during the first 5 days of any month due to the high volume of
prescriptions filled during that time.
● The audit report must be delivered to the pharmacist within 90 days after conclusion of the audit.

Records
Patient Records
Yes. The data processing system shall have the capacity to produce a daily hard-copy printout of all original
Can Records be Held Digitally?
prescriptions dispensed and refilled within 72 hours of the date on which the prescription drug orders were
Requirements for Printed Copy?
dispensed. In lieu of this printout, pharmacies may maintain a logbook of which pharmacists used the data
Other Requirements?
processing system to validate/dispense. See here for more requirements.
How Long do Controlled
Prescriptions Need to Be Held? 4 years
CII? CIII to V?
How Long do Legend
4 years
Prescriptions Need to Be Held?

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 Pharmacy records may only be released to the following parties: the patient’s legal representative, or other
Who Can Request or Receive health care practitioners involved in the patient’s treatment, except upon written authorization from the patient.
Records (Family, Others)? Any Exceptions: court subpoena in criminal/civil litigation, for research if pt’s info is de–identified, department of
Restrictions? POA? children and families in the course of an investigation, poison control for the purposes of treating a poison
episode
Reporting
Requirements for Drug Must report controlled substance dispensing to the PDMP no later than the close of the next business day. See
Monitoring Programs? controlled substance section for more info.
Concerns regarding the professional actions of a prescriber in the setting of controlled substance
Requirements for Reporting prescriptions must be reported to the FL Board of Health
Suspected Fraud/Abuse? Must report a person who attempted to or successfully obtained controlled substances fraudulently to law
enforcement within 24 hours
Requirements for Reporting Healthcare providers are required to report certain adverse events related to vaccine administration to VAERS
ADRs? Not required by Florida law but drugs reactions can be voluntarily reported to the FDA through MedWatch
Requirements for Reporting Must report to the BOP in writing within 30 days after licensee has been convicted of, entered a plea of nolo
Licensure Violations? contendere to, regardless of adjudication, a crime in any jurisdiction.
Requirements for Reporting
Not specified, however federal law requires HIPAA covered entities to report breach of PHI
Privacy Violations?
Patient Profile
Must verify the accuracy of the prescription and review the following for each new prescription/refill:
● Over-utilization or under-utilization;
What Must RPh Review on ● Therapeutic duplication;
Patient Profile Prior to ● Drug-disease contraindications;
Dispensing? REMS ● Drug-drug interactions;
Requirements? ● Incorrect drug dosage or duration of drug treatment;
● Drug-allergy interactions;
● Clinical abuse/misuse.
Specific Requirements for
See controlled substance section for PDMP reporting requirement. Otherwise, no specific requirements for
Checking
checking interactions or indication.
PDMP/Interactions/Indication?

Notes on Laws & Requirements

FD&C
Federal Food, Drug, and Cosmetic Act Established FDA
Durham-Humphrey Amendment OTC vs. Rx
Kefauver Harris Amendment Thalidomide
PPPA
Poison Prevention Packaging Act
Child-resistant packaging requirement
(PPPA)
HIPAA
Health Insurance Portability and
Privacy of identifiable health information and security of electronic PHI
Accountability Act
HITECH
Health Information Technology for
Electronic health record implementation.
Economic and Clinical Health Act
Adulterated vs. Misbranded
Adulterated See: 499.006
Misbranded See: 499.007
Recalls
Class I Recall is a situation in which there is a reasonable probability that the use of, or exposure to, a
FDA Class I Recall
violative product will cause serious adverse health consequences or death.
Class II Recall is a situation in which use of, or exposure to, a violative product may cause temporary
FDA Class II Recall or medically reversible adverse health consequences or where the probability of serious adverse
health consequences is remote.
Class III Recall is a situation in which use of, or exposure to, a violative product is not likely to cause
FDA Class III Recall
adverse health consequences.
Other Recalls Additional reading

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 Definitions/References
Red Book Drug Pricing
Orange Book Therapeutic Equivalence
Yellow Book International Travel Vaccines
Green Book Animal Drug Products
Pink Book Vaccine–Preventable Diseases
Purple Book Biological Products
USP 795 Nonsterile Compounding
USP 797 Sterile Compounding
USP 800 Hazardous Drug Handling

The Prescription
Required Fields
A written prescription for a medicinal drug issued by a health care practitioner licensed by law to
prescribe such drug must be legibly printed or typed so as to be capable of being understood by the
pharmacist filling the prescription; must contain
● the name of the prescribing practitioner,
● the name and strength of the drug prescribed, the quantity of the drug prescribed, and
● the directions for use of the drug;
● must be dated; and
● must be signed by the prescribing practitioner on the day when issued.

What Are the Required Elements for a However, a prescription that is electronically generated and transmitted must contain
Valid Prescription (ex. Name, DOB, ● the name of the prescribing practitioner,
Address, Etc.)? ● the name and strength of the drug prescribed,
● the quantity of the drug prescribed in numerical format, and
● the directions for use of the drug and
● must contain the date and an electronic signature by the prescribing practitioner only on the
day issued.

A written prescription for a controlled substance must have the

● quantity of the drug prescribed in both textual and numerical formats,
● must be dated in numerical, month/day/year format, or with the abbreviated month written
out, or the month written out in whole
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
What can RPh Correct/Change/Add to
controlled substance prescribed and a notation of the date in numerical, month/day/year format, or
Prescription (Legend/Controlled)?
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.
What can non-RPh Pharmacy Staff
Correct/Change/Add to a Prescription Not specified
(Legend/Controlled)?
A pharmacist who receives a prescription for a brand name drug shall, unless requested otherwise by
the purchaser, substitute a less expensive, generically equivalent drug product that is:
● Distributed by a business entity doing business, and subject to suit and service of legal process,
in the United States; and
● Listed in the formulary of generic and brand name drug products for the brand name drug
prescribed,
unless the prescriber writes the words “MEDICALLY NECESSARY,” in her or his own handwriting, on
the face of a written prescription; unless, in the case of an oral prescription, the prescriber expressly
What Type of Substitutions Are Allowed?
indicates to the pharmacist that the brand name drug prescribed is medically necessary; or unless, in
(Generic, Orange Book Equivalence,
the case of a prescription that is electronically generated and transmitted, the prescriber makes an
Therapeutic Substitution, Etc.)
overt act when transmitting the prescription to indicate that the brand name drug prescribed is
medically necessary.
Any pharmacist who substitutes any drug shall notify the person presenting the prescription of such
substitution, together with the existence and amount of the retail price difference between the brand
name drug and the drug substituted for it, and shall inform the person presenting the prescription that
such person may refuse the substitution.
Any pharmacist substituting a less expensive drug product shall pass on to the consumer the full
amount of the savings realized by such substitution.
Special Restrictions on Drugs/Refills? No prescription may be filled later than 1 year after written date.
Special Requirements for Prescription
See controlled substance requirements below. Special requirements not specified for legend drugs.
Pads?

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 Fax Prescriptions
Requirements for Type of Fax Machine? None specified
No; “Prescription” includes any order for drugs or medicinal supplies written or transmitted by any
Can Patients Fax Their Prescription? means of communication by a duly licensed practitioner authorized by the laws of the state to
Prescribers from Outside Their Practice? prescribe such drugs or medicinal supplies and intended to be dispensed by a pharmacist. The term
also includes an orally transmitted order by the lawfully designated agent of such practitioner.
CIII – CV allowed with no restrictions.
CII – Allowed for LTC/hospice or narcotics may be faxed and should be retained as the original
What Controlled Schedules are Allowed? prescription
Allowed in anticipation of a prescription for compounding, but need original hard copy prior to
dispensing
Electronic Rx
May not interfere with patient’s ability to choose a pharmacy
May not use any means or permit any other person to use any means to influence or attempt to
influence, through economic incentives or otherwise, the prescribing decision of a prescribing
Requirements for Electronic Prescribing? practitioner or his or her agent at the point of care, including, but not limited to, means such as
advertising, instant messaging, pop-up ads, and similar means triggered by or in specific response to
the input, selection, or act of a prescribing practitioner or his or her agent in prescribing a certain
medicinal drug or directing a patient to a certain pharmacy.
Requirements for
Certification/Technology? Refer to: PART 1311 - Subpart C - Electronic Prescriptions
A prescription that is electronically generated and transmitted must contain
● the name of the prescribing practitioner,
● the name and strength of the drug prescribed,
Required Fields on Electronic
● the quantity of the drug prescribed in numerical format, and
Prescriptions?
● the directions for use of the drug and
● must contain the date and an electronic signature by the prescribing practitioner only on the day
issued.
What Control Schedules Are Allowed? All
Can RPh Make Changes to Electronic
Not specified
Prescriptions?
The term prescription also includes an order written or transmitted by a practitioner licensed to
Can Electronic Prescriptions Be practice in a jurisdiction other than this state, but only if the pharmacist called upon to dispense such
Transmitted Across State Lines? order determines, in the exercise of her or his professional judgment, that the order is valid and
necessary for the treatment of a chronic or recurrent illness.
Phone Rx
What Information Must Be Provided? Not specified, assumed the same items as a written prescription.
Who Can Phone in Prescriptions
Any lawfully designated agent of the physician
(Prescriber, Staff, Receptionist)?
Can Interns Receive New Prescriptions
Yes
Via Phone/Voicemail? Refills?
Can Technicians Receive New
Prescriptions Via Phone/Voicemail? No
Refills?
Can Clerks/Cashiers/Others Receive
New Prescriptions Via No
Phone/Voicemail? Refills?
Transfer Rx
Prior to dispensing any transferred prescription, the dispensing pharmacist must, either verbally or by
any electronic means, do all of the following:
● Advise the patient that the prescription on file at the other pharmacy must be canceled before it
may be filled or refilled.
● Determine that the prescription is valid and on file at the other pharmacy and that the prescription
may be filled or refilled, as requested, in accordance with the prescriber’s intent expressed on the
What Information Must Be Provided? prescription.
● Notify the pharmacist or pharmacy where the prescription is on file that the prescription must be
canceled.
● Record in writing, or by any electronic means, the prescription order, the name of the pharmacy at
which the prescription was on file, the prescription number, the name of the drug and the original
amount dispensed, the date of original dispensing, and the number of remaining authorized
refills.

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 ● Obtain the consent of the prescriber to the refilling of the prescription when the prescription, in
the dispensing pharmacist’s professional judgment, so requires. Any interference with the
professional judgment of the dispensing pharmacist by any pharmacist or pharmacy permittee,
or its agents or employees, shall be grounds for discipline.
Upon receipt of a prescription transfer request, if the pharmacist is satisfied in her or his professional
judgment that the request is valid, or if the request has been validated by any electronic means, the
pharmacist or pharmacy must do all of the following:
● Transfer the information required by paragraph (1)(d) accurately and completely.
● Record on the prescription, or by any electronic means, the requesting pharmacy and pharmacist
and the date of request.
● Cancel the prescription on file by electronic means or by recording the word “void” on the
prescription record. No further prescription information shall be given or medication dispensed
pursuant to the original prescription.
Can Interns Transfer Prescriptions? Not specifically specified, assumed yes, under the direct supervision of a pharmacist
Can Technicians Transfer Prescriptions? No
How Many Fills Can Be Transferred? Not specified
Florida pharmacy must verify that the person/entity involved in the transfer is a licensed
Any Specific Rules for Out-Of-State?
pharmacist/pharmacy in the other state
Packaging
Prescription:
● Name/address of pharmacy
● Date of dispensing
● Prescription number
● Name of patient, or if for a pet, name of owner and species of animal
● Name of prescriber
● Name of drug dispensed (except if prescriber specifically requests for name to be omitted)
● Directions for use
● Beyond–use–date
● If controlled substances, a warning that it is a crime to transfer the drug to another person

Repackaged product or a multiple unit prepackaged drug product:

● Brand or generic name
● Strength
● Dosage form
● Name of the manufacturer
Information Required on Label? (List the
● Expiration date
Data Elements)
● Lot number (either manufacturer’s or number assigned by packager)
A medicinal drug dispensed in a unit dose system by a pharmacist shall be accompanied by labeling.
The requirement will be satisfied if, to the extent not included on the label, the unit dose system
indicates clearly the name of the resident or patient, the prescription number or other means utilized
for readily retrieving the medication order, the directions for use, and the prescriber’s name.

Customized patient medication package (AKA Pillpack):

● Name, address and telephone number of pharmacy
● Rx number for package AND separate serial number for each drug dispensed
● Date of preparation
● Patient’s name
● Name of prescriber
● Directions for use and any required cautionary statements
● Storage instructions
● Name, strength, quantity and physical description of each drug product
● Beyond–use–date
OTC Label Requirements See: CFR - Code of Federal Regulations Title 21
Child Safety Cap Requirements See: Poison Prevention Packaging Act
Prescriptions: Either 1 year from dispensing or manufacturer expiration if sooner
Expiration/By-Use Date?
Customized patient medication package: 120 days or manufacturer’s expiration if sooner
Prescriber
Special Authority or Restrictions by Type
of Provider? (Dentists, Optometrists, See Prescribers Table Below
Etc.)
Counseling
Upon receipt of a new or refill prescription, the pharmacist shall ensure that a verbal and printed offer
Requirements for Counseling
to counsel is made to the patient or the patient’s agent when present. If the delivery of the drugs to

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 the patient or the patient’s agent is not made at the pharmacy the offer shall be in writing and shall
provide for toll-free telephone access to the pharmacist.
If the patient does not refuse such counseling, the pharmacist, or the pharmacy intern, acting under
the direct and immediate personal supervision of a licensed pharmacist, shall review the patient’s
record and personally discuss matters which will enhance or optimize drug therapy with each patient
or agent of such patient. Such discussion shall be in person, whenever practicable, by toll-free
telephonic communication, or by an interactive audio and digital image format, and shall include
appropriate elements of patient counseling. Such elements may include, in the professional judgment
of the pharmacist, the following:
● The name and description of the drug;
● The dosage form, dose, route of administration, and duration of drug therapy;
● Intended use of the drug and expected action (if indicated by the prescribing health care
Required Topics to Cover practitioner);
● Special directions and precautions for preparation, administration, and use by the patient;
● Common severe side or adverse effects or interactions and therapeutic contraindications that
may be encountered, including their avoidance, and the action required if they occur;
● Techniques for self-monitoring drug therapy;
● Proper storage;
● Prescription refill information;
● Action to be taken in the event of a missed dose;
● The potential for physical dependence, addiction, misuse, or abuse; and
● Pharmacist comments relevant to the individual’s drug therapy, including any other information
peculiar to the specific patient or drug.
Disposal/Donation
Long–term care facility: controlled substance waste must be documented and witnessed by 2 of
following – consultant pharmacist, director of nursing, facility administrator, law enforcement,
Special Disposal Requirements? physician/nurse/NP/pharmacist employed by facility

See here for more info

Patient Waste/Disposal? See: Where and How to Dispose of Unused Medicines
The Cancer Drug Donation Program facilitates donation of cancer drugs and supplies to eligible
patients
“Prescription Drug Donation Repository Program”:A repository may dispense an eligible donation to a
state resident who is indigent, uninsured, or underinsured, and who has a valid prescription for such
donation, as applicable.
The following entities may participate as a repository:
● A health care practitioner’s office.
● A pharmacy.
● A hospital with a closed drug delivery system.
● A nursing home facility with a closed drug delivery system.
Donations? ● A free clinic or nonprofit health clinic that is licensed or permitted to dispense medicinal drugs in
the state.
The following entities may donate prescription drugs or supplies to a repository under the program:
● Nursing home facilities with closed drug delivery systems.
● Hospices that have maintained control of a patient’s prescription drugs.
● Hospitals with closed drug delivery systems.
● Pharmacies.
● Drug manufacturers or wholesale distributors.
● Medical device manufacturers or suppliers.
● Prescribers who receive prescription drugs or supplies directly from a drug manufacturer,
wholesale distributor, or pharmacy.
Drug Take-Back Days? DEA sponsored take–back days occur twice yearly
Are Returns Allowed? The following acts constitute grounds for denial of a license or disciplinary action:
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
Can Returns be Dispensed? 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.

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 Controlled Substances
Note: Review List of Drugs by Schedule at https://www.deadiversion.usdoj.gov/schedules/orangebook/c_cs_alpha.pdf
Prescriptions – See here for laws for this section
Counterfeit–proof prescription pad produced by an approved vendor with the following requirements:
● The background color must be blue or green and resist reproduction
● The pad or blank must be printed on artificial watermarked paper
● Must have a unique tracking number
Special Prescription Pad ● Must resist erasures and alterations
Requirements? ● The word “void” or “illegal” must appear on any photocopy
● The preprinted name, address and category of professional licensure of the prescribing practitioner or the
name and address of the healthcare facility
● Must have space for DEA number (may either be pre–printed or handwritten)
● Must have a place to indicate if the prescription is for the treatment of pain other than acute pain
Sale of schedule V drug over the counter under the following conditions:
● Only allowed to be sold under the Federal Food, Drug, and Cosmetic Act (ex: codeine–containing products
but not lacosamide).
● Cannot be amphetamine drug or sympathomimetic amine drug
● Must contain one or more active medicinal ingredients not having depressant or stimulant effect on the
central nervous system
State Specific Restrictions?
● Must be sold by a pharmacist
● Must be over the age of 18 (under age 18 needs Rx)
● The total quantity of controlled substance listed in Schedule V which may be sold to any one purchaser
within a given 48-hour period shall not exceed 120 milligrams of codeine, 60 milligrams dihydrocodeine, 30
milligrams of ethyl morphine, or 240 milligrams of opium
Schedule III opioid prescribing: limited to 14-day supply for surgical pain
The term also includes an order written or transmitted by a practitioner licensed to practice in a jurisdiction
Out-of-State or Out-of-Country
other than this state, but only if the pharmacist called upon to dispense such order determines, in the exercise
Allowed? Restrictions by
of her or his professional judgment, that the order is valid and necessary for the treatment of a chronic or
Control Schedule?
recurrent illness.
Separate Registration
DEA registration required to prescribe
Required for Prescribing?
Separate Registration
DEA registration required to dispense
Required for Dispensing?
PDMP must be consulted prior to prescribing and prior to dispensing ANY controlled substance (except a non–
opioid CV)
For each controlled substance dispensed to a patient in this state, the following information must be reported
by the dispenser to the system as soon thereafter as possible but no later than the close of the next business
day after the day the controlled substance is dispensed unless an extension or exemption is approved by the
department:
● The name of the prescribing practitioner, the practitioner’s federal Drug Enforcement Administration
registration number, the practitioner’s National Provider Identification or other appropriate identifier, and
the date of the prescription.
● The date the prescription was filled and the method of payment, such as cash by an individual, insurance
coverage through a third party, or Medicaid payment. This paragraph does not authorize the department to
include individual credit card numbers or other account numbers in the system.
● The full name, address, telephone number, and date of birth of the person for whom the prescription was
written.
● The name, national drug code, quantity, and strength of the controlled substance dispensed.
PDMP Requirements? ● The full name, federal Drug Enforcement Administration registration number, State of Florida Department of
Health issued pharmacy permit number, and address of the pharmacy or other location from which the
controlled substance was dispensed. If the controlled substance was dispensed by a practitioner other
than a pharmacist, the practitioner’s full name, address, federal Drug Enforcement Administration
registration number, State of Florida Department of Health issued license number, and National Provider
Identification.
● Whether the drug was dispensed as an initial prescription or a refill, and the number of refills ordered.
● The name of the individual picking up the controlled substance prescription and type and issuer of the
identification provided.
● Other appropriate identifying information as determined by department rule.

The following acts of administration or dispensing are exempt from the reporting requirements of this
subsection:
● All acts of administration of a controlled substance.
● The dispensing of a controlled substance in the health care system of the Department of Corrections.
● The dispensing of a controlled substance to a person under the age of 16.

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 CII: written or electronic, with exceptions for fax (see above), phone/verbal limited to an emergency 72–hour
supply
CIII – CV: no restrictions
Rules on Phone, Fax or Any controlled substance listed in Schedule III or Schedule IV may be dispensed by a pharmacist upon an oral
Electronic? 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.
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.
State-Specific Control
In general, aligns with federal schedule. See Florida Statute 893.03
Schedules (e.g. Schedule VI)?
How Long Is the Prescription CII: Not specified, however no prescription may be filled beyond one year after written date
Valid? CIII–CV: 6 months
For the treatment of acute pain, a prescription for an opioid drug listed as a Schedule II controlled substance
may not exceed a 3-day supply, except that up to a 7-day supply may be prescribed if:
● The prescriber, in his or her professional judgment, believes that more than a 3-day supply of such an opioid
is medically necessary to treat the patient’s pain as an acute medical condition;
Days Supply Restrictions? ● The prescriber indicates “ACUTE PAIN EXCEPTION” on the prescription; and
● The prescriber adequately documents in the patient’s medical records the acute medical condition and lack
of alternative treatment options that justify deviation from the 3-day supply limit established in this
subsection.
CIII only: 30-day supply IF verbal prescription
CII: no refills
Refills Allowed?
CIII–CV: 5 refills allowed, up to a total of 6-month supply (including original)
Fill-By Dates Allowed? Yes, for a total of 90 days
Postdating Allowed? The written prescription must be dated and signed by the prescribing practitioner on the day when issued.
CII: Partial fills must be completed within 72 hours (or 60 days for LTC patients)
Partial Fills Allowed?
CIII–CV: Yes (as long as total dispensed does not exceed 6 months)
CII: need verbal authorization to fill an emergency 72–hour supply
Emergency Fill Requirements?
CIII–CV: 72–hour emergency supply allowed without prescriber authorization
DEA
Every pharmacy that dispenses a controlled substance must be registered with the DEA. A state license must be
What are the Licensure
obtained.
Requirements?
Federal agencies are exempt from the state license requirement.
The requirement of registration is waived for any official of the U.S. Army, Navy, Marine Corps, Air Force, Coast
Who Must Apply? Guard, Public Health Service, or Bureau of Prisons who is authorized to prescribe, dispense, or administer, but
not to procure or purchase, controlled substances in the course of his/her official duties.
DEA Form 224 – Retail Pharmacy, Hospital/Clinic, Practitioner, Teaching Institution, or Mid-Level Practitioner
DEA Form 225 – Manufacturer, Distributor, Researcher, Canine Handler, Analytical Laboratory, Importer,
Application Requirements? Exporter
DEA Form 363 – Narcotic Treatment Programs
DEA Form 510 – Domestic Chemical
The DATA Waiver has been removed as of January 2023 thus the following no longer applies:
The Unique Identification Number (UIN) or “X” number authorized a DEA registered, Qualified Practitioner (e.g.,
a physician) under the Drug Addiction Treatment Act of 2000 or Qualifying Other Practitioner (i.e., nurse
When Does the DEA No. Have
practitioner, physician’s assistant, clinical nurse specialists, certified registered nurse anesthetists, or certified
an ‘X’?
nurse midwives) under the Comprehensive Addiction and Recovery Act of 2016 and the SUPPORT for Patients
and Communities Act of 2018, to prescribe schedule III-V narcotic controlled substances approved by the Food
and Drug Administration specifically for maintenance and detoxification treatment.
Two letters followed by seven numbers.
● First letter:
o A, B, F is a full practitioner. X is a full practitioner with buprenorphine privileges.
o M is a mid-level practitioner
● Second letter:
How Do You Validate a DEA
o First letter of prescriber’s last name
Number?
● Math
o Step one: 1st, 3rd, and 5th numbers are added together.
o Step two: 2nd, 4th, and 6th numbers are added together and multiplied by two.
o Step three: Add the sum from step one and two together
o The 7th number of the DEA number should equal the last digit of the number obtained in step three
What Is Required for
See: PART 1311 - Subpart C - Electronic Prescriptions
Electronic Use?
Renewal Cost? Frequency? $888, must be renewed every 3 years.
License Update Process? Complete DEA Form 224a online

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 The DEA allows reinstatement of an expired registration for one calendar month after the expiration date. If the
Reinstatement Process? expiration date is not renewed within that calendar month, an application for a new DEA registration will be
required.
● Form 222 - ordering controlled substances
When to Use DEA Forms?
● Form 106 - theft or loss of controlled substances
(222, 41, 106)
● Form 41 - destruction of controlled substances (expiration, spillage, breakage, etc.)
Schedules I-II
A purchaser must prepare and execute a DEA Form 222 by use of a typewriter, computer printer, pen, or indelible
pencil. Only one item may be entered on each numbered line. The number of lines completed must be noted on
that form at the bottom of the form, in the space provided. The purchaser should record the name and address
of the supplier. Only one supplier may be listed on any form. The supplier's DEA registration number may be
entered by the purchaser or the supplier. If the purchaser does not have this information then the supplier
should ensure it is on the form. The purchaser must make a copy of the original DEA Form 222 for its records
and then submit the original to the supplier. The purchaser does not have the option of retaining the original.
The copy retained by the purchaser may be in paper or electronic form. Each DEA Form 222 must be signed and
dated by a person authorized to sign a registration application or a person granted power of attorney. The name
of the purchaser, if different from the individual signing the DEA Form 222, must also be inserted in the
signature space.
When the items are received, the purchaser must document on the purchaser’s copy the actual number of
commercial or bulk containers received and the date received. The purchaser must retain a copy of each
executed DEA Form 222 and all copies of unaccepted or defective forms with each statement attached. DEA
Forms 222 must be maintained separately from all other records of the registrant. DEA Forms 222 are required
to be kept available for inspection for a period of two years.
Required Information on
Invoices? Schedules III-V
The registrant must keep a receipt (invoice or packing slip) on which it records the date the drugs were received
and confirm that the order is accurate. Such receipts must also contain the following information:
● The name of the substance;
● Each finished form and the number of units or volume of finished form in each commercial container;
● The number of units of finished forms and/or commercial containers acquired from other persons,
including the date of and number of units and/or commercial containers in each acquisition to inventory
and the name, address, and registration number of the person from whom the units were acquired;
● The number of commercial containers distributed to other persons, including the date of and number of
containers in each reduction from inventory, and the name, address, and registration number of the person
to whom the containers were distributed;
● The number of units of finished forms and/or commercial containers distributed or disposed of in any other
manner by the registrant including the date and manner of distribution or disposal, the name, address, and
registration number of the person to whom distributed, and the quantity in finished form distributed or
disposed.
In addition, these receipts must be maintained either separately from all other records of the registrant or in
such form that the information required is readily retrievable from the ordinary business records of the
registrant
Overdose/Dependence
Under a standing order, pharmacists can dispense naloxone to a patient or caregiver (friend/family or person in
position to have recurring contact with a person at risk of overdose)
Rules on Naloxone
Pharmacists may possess, store, and administer naloxone
Administration
Pharmacists who administer naloxone in good faith are immune from criminal and civil liability and are not
subject to discipline from the board of pharmacy
The DATA Waiver has been removed as of January 2023 thus the following no longer applies:
The practitioner is required to include the UIN on all prescriptions when prescribing FDA approved schedules III,
Rules on Suboxone
IV, or V narcotic controlled drugs for use in maintenance or detoxification treatment. The listing of the UIN on a
Administration
prescription is in addition to all other information required on a valid prescription to include the practitioner’s
DEA registration number.

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 Prescribing Authority (Mark/Note If Allowed to Prescribe)
Type of Provider Schedule I Schedule II Schedule III Schedule IV Schedule V Legend/OTC Methadone
Physician Yes Yes Yes Yes Yes Yes†

Dentist Yes Yes Yes Yes Yes Yes (for pain)†

Optometrist No Yes Yes Yes Yes No

Podiatrist Yes Yes Yes Yes Yes Yes (for pain)†

Veterinarian Yes Yes Yes Yes Yes Yes (for pain)†

Psychologist No No No No No No

Psychiatrist Yes Yes Yes Yes Yes Yes†

Physician Assistant Yes* Yes* Yes Yes Yes Yes (for pain)†

Nurse Practitioner Yes* Yes* Yes Yes Yes Yes (for pain)†

Registered Nurse No No No No No No

Chiropractor No No No No No No

Midwife No No No No No No

Physical Therapist No No No No No No

Pharmacist No No No No Yes‡ No

Other ()
*Advanced practice nurses: must have masters or doctorate in nursing to prescribe or dispense controlled substances
(CII limited to 7-day supply). Only psychiatric nurses may prescribe psychotropic controlled substances, CII restriction
does not apply in this case.

*Physician Assistants: A physician may delegate authority to prescribe any medication not listed in formulary. Similar
restrictions as advanced practice nurses, may not prescribe longer than 7-days of C-II medications, or longer than 14-
day supply of psychiatric controlled substances for children < 18.

†No special Drug Enforcement Agency (DEA) registration is required to prescribe methadone for pain, and no special
Special Notes on
restrictions exist for the prescribing of methadone for pain. However, it is a good practice to write "for pain" on
Prescribing Authority
methadone prescription issued to treat pain
(e.g. Classes Allowed
by Provider Type)
Optometrists: May only prescribe/administer pursuant to limited formulary after completing 20-hour course and
passing subsequent examination. May not provide a prescription for more than a 72–hour supply of tramadol, Tylenol
#3, acetazolamide, or methazolamide without consulting a licensed medical or osteopathic physician. See link for oral
formulary and list of topical medication formulary.

‡ Pharmacists: See here for terms and conditions for pharmacists who are allowed to prescribe.

Dentists: may prescribe drugs limited to scope of practice. For example, would be reasonable to prescribe short course
of oxycodone, not reasonable to prescribe oral contraception.

Refills/Length of Validity (By Control Schedule)

Schedule Schedule I Schedule II Schedule III Schedule IV Schedule V Legend/OTC Methadone
# of Refills Allowed 0 5 5 5 N/A 0

How Long is Rx Valid 1 year 6 months 6 months 6 months 1 year 1 year

Medical Marijuana
“Qualified patient” means a resident of this state who has been added to the medical marijuana use registry by a
Dispensing Requirements qualified physician to receive marijuana or a marijuana delivery device for a medical use and who has a qualified
patient identification card.
Specific requirements regarding licensure, applicable medical conditions, days supply, operating hours,
Special Requirements
packaging and transport, and penalties can be found here

© tl;dr pharmacy llc. All Rights Reserved