HOUSE OF REPRESENTATIVES STAFF ANALYSIS
BILL #: CS/HB 493 Pharmacy
SPONSOR(S): Healthcare Regulation Subcommittee, Roach
TIED BILLS: IDEN./SIM. BILLS: SB 444
REFERENCE ACTION ANALYST STAFF DIRECTOR or
BUDGET/POLICY CHIEF
1) Healthcare Regulation Subcommittee 14 Y, 4 N, As CS DesRochers McElroy
2) Health Care Appropriations Subcommittee
3) Health & Human Services Committee
SUMMARY ANALYSIS
The Florida Pharmacy Act (Act) regulates the practice of pharmacy in Florida. The Board of Pharmacy (Board)
adopts rules to implement the provisions of the Act and sets standards of practice within the state. Any person
who operates a pharmacy in Florida must have a permit in one of the seven categories: community pharmacy,
institutional pharmacy, nuclear pharmacy, special pharmacy, internet pharmacy, nonresident sterile
compounding pharmacy, or special sterile compounding pharmacy. A pharmacist must be present and on duty
for the prescription department of a pharmacy to be considered open; however the prescription department is
not considered closed if the pharmacist briefly leaves to tend to personal needs or counsel patients.
CS/HB 493 creates a new pharmacy permit category for the operation of a remote site pharmacy. A remote-
site pharmacy is a location where a supervising pharmacist dispenses medicinal drugs, acts in the capacity of
a prescription department manager, and remotely supervises a registered pharmacy technician who handles
the sales transactions and the delivery of the drugs.
In addition to meeting all the requirements in rule and statute for permitting pharmacies, a remote pharmacy
must be jointly owned by a supervising pharmacy or operated under contract with a supervising pharmacy;
maintain a video surveillance system that records continuously 24 hours per day and retain video surveillance
recordings for at least 30 days; display a sign, visible by the public, which indicates that the facility is a remote
site pharmacy and that it is under 24-hour video surveillance; maintain a policies and procedures manual which
must be made available to the Board of Pharmacy or its agent upon request; and designate a licensed
pharmacist or consultant pharmacist as the prescription department manager responsible for oversight of the
facility.
The bill authorizes a remote-site pharmacy to store, hold, and dispense all medicinal drugs, including
proprietary drugs and controlled substances. However, a remote-site pharmacy may not dispense Schedule II
controlled substances listed in s. 893.03 unless a pharmacist is present at the remote-site pharmacy.
The prescription department manager must visit the remote-site pharmacy as often as the Board’s schedule
states. During remote site pharmacy visits, the prescription department manager must inspect the pharmacy,
address personnel matters, and provide clinical services for patients.
The bill allows a pharmacy technician to perform delegated tasks at a remote-site pharmacy under the remote
supervision of a supervising pharmacist. The bill limits the number of pharmacy technicians that a supervising
pharmacist can remotely supervise at remote-site pharmacy to six.
The bill has a significant, negative fiscal impact on DOH and no impact on local governments. See Fiscal
Analysis.
The bill provides an effective date of July 1, 2024.
This docum ent does not reflect the intent or official position of the bill sponsor or House of Representatives .
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FULL ANALYSIS
I. SUBSTANTIVE ANALYSIS
A. EFFECT OF PROPOSED CHANGES:
Background
Pharmacy Regulation
The Florida Pharmacy Act (act) regulates the practice of pharmacy in Florida and contains the minimum
requirements for safe practice.1 The Board of Pharmacy (Board) is tasked with adopting rules to
implement the provisions of the act and setting standards of practice within the state.2 Any person who
operates a pharmacy in Florida must have a permit, and as of June 30, 2023, there were 10,901
permitted pharmacies in the state.3 The following permits are issued by the Department of Health
(DOH):
Community pharmacy – A permit is required for each location where medicinal drugs are
compounded, dispensed, stored, or sold or where prescriptions are filled or dispensed on an
outpatient basis.4
Institutional pharmacy – A permit is required for every location in a hospital, clinic, nursing
home, dispensary, sanitarium, extended care facility, or other facility where medicinal drugs are
compounded, dispensed, stored, or sold.5
Nuclear pharmacy – A permit is required for every location where radioactive drugs and
chemicals within the classification of medicinal drugs are compounded, dispensed, stored, or
sold. The term “nuclear pharmacy” does not include hospitals licensed under ch. 395, F.S., or
the nuclear medicine facilities of such hospitals. 6
Special pharmacy – A permit is required for every location where medicinal drugs are
compounded, dispensed, stored, or sold if the location does not otherwise meet an applicable
pharmacy definition in s. 465.003, F.S.7
Internet pharmacy – A permit is required for a location not otherwise licensed or issued a permit
under this chapter, within or outside this state, which uses the Internet to communicate with or
obtain information from consumers in this state to fill or refill prescriptions or to dispense,
distribute, or otherwise practice pharmacy in this state.8
Nonresident sterile compounding pharmacy – A permit is required for a registered nonresident
pharmacy or an outsourcing facility to ship, mail, deliver, or dispense, in any manner, a
compounded sterile product into this state.9
Special sterile compounding – A separate permit is required for a pharmacy holding an active
pharmacy permit that engages in sterile compounding. 10
A pharmacy must pass an on-site inspection for a permit to be issued,11 and the permit is valid only for
the name and address to which it is issued.12
1 Chapter 465, F.S.
2
Sections 465.005, 465.0155, and 465.022, F.S.
3 Department of Health, 2024 Agency Legislative Bill Analysis for House Bill 493, (Nov. 20, 2023), on file with the Healthcare Regulation
Subcommittee.
4 Sections 465.003(20)(a)1. and 465.018, F.S.
5 Sections 465.003(20)(a)2. and 465.019, F.S.
6 Sections 465.003(20)(a)3. and 465.0193, F.S.
7 Sections 465.003(20)(a)4. and 465.0196, F.S.
8 Sections 465.003(20)(a)5. and 465.0197, F.S.
9 Section 465.0158, F.S.
10 Rules 64B16-28.100 and 64B16-28.802, F.A.C. An outsourcing facility is considered a pharmacy and need to hold a special sterile
compounding permit if it engages in sterile compounding.
11 Id.
12 Rule 64B16-28.100, F.A.C.
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Regulation of Pharmacists and Pharmacy Technicians
Pharmacists
Licensure Requirements
A pharmacist is a person who is licensed under the act to practice the profession of pharmacy. 13 To be
licensed as a pharmacist in Florida, a person must: 14
Be at least 18 years of age;
Complete an application and remit an examination fee;
Hold a degree from an accredited and approved school or college of pharmacy; 15
Have completed a Board-approved internship; and
Successfully complete the Board-approved examination.
During each biennial licensure renewal cycle, a pharmacist must complete at least 30 hours of Board-
approved continuing education.16 If a pharmacist is certified to administer vaccines or epinephrine, the
pharmacist must complete a 3-hour continuing education course on the safe and effective
administration of vaccines and epinephrine autoinjections as a part of the biennial licensure renewal. 17
Scope of Practice
The practice of the profession of pharmacy includes:18
Compounding,19 dispensing, and consulting concerning contents, therapeutic values, and uses
of a medicinal drug;
Consulting concerning therapeutic values and interactions of patent or proprietary preparations;
Monitoring a patient’s drug therapy and assisting the patient in the management of his or her
drug therapy, including the review of the patient’s drug therapy and communication with the
patient’s prescribing health care provider or other persons specifically authorized by the patient,
regarding the drug therapy;
Transmitting information from prescribers to their patients;
Administering vaccines to adults;20
Administering epinephrine injections;21 and
Administering antipsychotic medications by injection. 22
Pharmacists are specifically prohibited from altering a prescriber’s directions, diagnosing or treating any
disease, initiating any drug therapy, and practicing medicine or osteopathic medicine, unless permitted
by law.23
13 Section 465.003(19), F.S.
14 Section 465.007, F.S. DOH may also issue a license by endorsement to a pharmacist who is licensed in another state upon meeting
the applicable requirements set forth in law and rule. See s. 465.0075, F.S.
15 If the applicant has graduated from a 4-year undergraduate pharmacy program of a school or college of pharmacy located outside
the United States, the applicant must demonstrate proficiency in English, pass the Board -approved Foreign Pharmacy Graduate
Equivalency Examination, and complete a minimum of 500 hours in a supervised work activity program within Florida under the
supervision of a DOH-licensed pharmacist.
16
Section 465.009, F.S.
17 Section 465.009(6), F.S.
18 Section 465.003(22), F.S.
19 Rule 64B16-27.700, F.A.C., defines compounding a professional act by a pharmacist incorporating i ngredients to create a finished
product for dispensing to a patient or to a practitioner for administration to a patient. The American Pharmacists Associatio n, citing the
U.S. Pharmacopeia Convention (USP) defines compounding as “the preparation, mixing, a ssembling, altering, packaging, and labeling
of a drug, drug-delivery device, or device in accordance with a licensed practitioner's prescription, medication order, or initiative based
on the practitioner/patient/ pharmacist/compounder relationship in the course of professional practice.” See
https://www.pharmacist.com/Practice/Patient-Care-Services/Compounding/Compounding-FAQs (last visited Jan. 21, 2024).
20 See s. 465.189, F.S.
21 Id.
22 Section 465.1893, F.S.
23 Supra note 18.
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Only a pharmacist or registered intern may:24
Supervise or be responsible for the controlled substance inventory;
Receive verbal prescriptions from a prescriber;
Interpret and identify prescription contents;
Engage in consultation with a health care practitioner regarding the interpretation of a
prescription and date in a patient’s profile record;
Engage in professional communication with health care practitioners;
Advise or consult with a patient, both as to the prescription and the patient profile record; and
Perform certain duties related to the preparation of parenteral and bulk solutions.
Pharmacists must perform the final check of a completed prescription, thereby assuming complete
responsibility for its preparation and accuracy.25 A pharmacist must be personally available at the time
of dispensing.26 A prescription department is considered closed if a Florida-licensed pharmacist is not
present and on duty unless the pharmacist leaves the prescription department to: 27
Consult, respond to inquiries, or provide assistance to customers or patients;
Attend to personal hygiene needs; or
Perform functions for which the pharmacist is responsible provided that such activities are
performed in a manner that is consistent with the pharmacist’s responsibility to provide
pharmacy services.
Prescription Department Managers
Each community pharmacy must have designate a licensed pharmacist as a prescription department
manager.28 The prescription drug manager is responsible for maintaining all drug records, providing for
the security of the prescription department, and ensuring that the all regulations of the practice of the
profession of pharmacy are followed.29 A pharmacist may only serve as the prescription department
manager of one pharmacy.30 However, the Board may grant an exception based on circumstances,
such as the proximity of the pharmacies and the workload of the pharmacist.
Pharmacy Technicians
Registration Requirements
Pharmacy technicians assist pharmacists in dispensing medications and are accountable to a
supervising pharmacist who is legally responsible for the care and safety of the patients served. 31 A
person must register with DOH to practice as a pharmacy technician. To register, an individual must: 32
Be at least 17 years of age;
Submit an application and remit an application fee; and
Complete a Board-approved pharmacy technician training program.33
24 Rule 64B16-27.1001(1)-(2), F.A.C. Section 465.003(12), F.S., defines a pharmacy intern as a person who is currently registered in,
and attending, or is a graduate of a duly accredited college or school of pharmacy and is properly registered with DOH. The American
Pharmacist Association, citing the U.S.
25 Rule 64B16-27.1001(3), F.A.C.
26 Rule 64B16-27.1001(4), F.A.C.
27 Section 465.003(20)(b), F.S.
28 Rules 64B16-27.104 and 64B16-27.450, F.A.C.
29 Id.
30 Id.
31 Pharmacy Technician Certification Board, Pharmacy Technicians, available at https://www.ptcb.org/who-we-serve/pharmacy-
technicians#.Wj1PsGyouUk (last visited on Jan. 21, 2024).
32 Section 465.014(2), F.S.
33 An individual is exempt from the training program if he or she was registered as a pharmacy technician before January 1, 2011 , and
either worked as a pharmacy technician at least 1,500 hours under a licensed pharmacists or received certification from an a ccredited
pharmacy technician program.
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The pharmacy technician must renew the registration biennially. For each renewal cycle, a pharmacy
technician must complete 20 continuing education hours, 4 of which must be live. 34
Pharmacy Technician Training Programs
A pharmacy technician may only be registered with DOH if he or she completes a Board-approved
training program. These include pre-approved training programs that were accredited on or before
December 1, 2018, by certain accreditation entities, such as the Accreditation Council on Pharmacy
Education, as well as pharmacy technician training programs provided by a branch of the United
States Armed Forces whose curriculum was developed on or before June 1, 2018. 35
The Board may review and approve other training programs that do not meet the criteria for pre-
approval. Such programs must be licensed by the Commission for Independent Education or
equivalent licensing authority or be within the public school system of this state, and offer a course of
study that includes:36
Introduction to pharmacy and health care systems;
Confidentiality;
Patient rights and the Health Insurance Portability and Accountability Act (HIPAA);
Relevant federal and state law;
Pharmaceutical topics, including medical terminology, abbreviations, and symbols; medication
safety and error prevention; and prescriptions and medication orders;
Records management and inventory control, including pharmaceutical supplies, medication
labeling, medication packaging and storage, controlled substances, and adjudication and
billing;
Interpersonal relations and ethics, including diversity of communications, empathetic
communications, ethics governing pharmacy practice, patient and caregiver communications;
and
Pharmaceutical calculations.
The training program must provide the Board with educational and professional background of its
faculty.37 A licensed pharmacist or registered pharmacy technician with appropriate expertise must be
involved with planning and instruction and must supervise learning experiences. 38
The Board may also review and approve employer-based pharmacy technician training programs. An
employer-based program must be offered by a Florida-permitted pharmacy, or affiliated group of
pharmacies under common ownership. 39 The program must consist of 160 hours of training over a
period of no more than 6 months and may only be provided to the employees of that pharmacy.40 The
employer-based training program must:41
Meet the s