Bill Summary – FastDemocracy

       Florida Senate - 2024                                     SB 444



       By Senator Collins





       14-00445A-24                                           2024444__
                      A bill to be entitled                      
       An act relating to pharmacy; amending s. 465.003,
       F.S.; revising the definition of the term “dispense”;
       revising the definition of the term “pharmacy” to
       include remote-site pharmacies; revising construction
       of the term “not present and on duty”; amending s.
       465.014, F.S.; authorizing registered pharmacy
       technicians to dispense medicinal drugs under certain
       circumstances; providing an exception to certain
       supervision limitations; amending s. 465.015, F.S.;
       providing applicability; exempting certain registered
       pharmacy technicians from specified prohibitions;
       creating s. 465.0198, F.S.; defining the terms
       “supervising pharmacy” and “telepharmacy”; providing
       for the permitting of remote-site pharmacies;
       requiring a licensed or consultant pharmacist to serve
       as the prescription department manager of a remote
       site pharmacy; requiring remote-site pharmacies to
       notify the Department of Health of a change in the
       pharmacy’s prescription department manager within a
       specified timeframe; providing requirements for
       remote-site pharmacies; authorizing remote-site
       pharmacies to store, hold, and dispense medicinal
       drugs; prohibiting the dispensing of Schedule II
       medications at remote-site pharmacies unless a
       pharmacist is present; requiring prescription
       department managers to visit remote-site pharmacies,
       based on a certain schedule, to perform specified
       tasks; prohibiting remote-site pharmacies from being
       open when the supervising pharmacy is closed unless a
       certain pharmacist is present or providing remote
       supervision at the remote-site pharmacy; prohibiting
       registered pharmacists from serving as prescription
       department managers for more than three remote-site
       pharmacies under certain circumstances; authorizing
       the Board of Pharmacy to adopt specified rules;
       amending s. 465.022, F.S.; exempting registered
       pharmacists serving as prescription department
       managers for remote-site pharmacies from certain
       practice limitations; providing an effective date.
        
Be It Enacted by the Legislature of the State of Florida:

       Section 1. Subsections (13) and (20) of section 465.003,
Florida Statutes, are amended to read:
       465.003 Definitions.—As used in this chapter, the term:
       (13) “Dispense” means the transfer of possession of one or
more doses of a medicinal drug by a pharmacist, or by a
registered pharmacy technician who is remotely supervised by an
offsite pharmacist, to the ultimate consumer or her or his
agent. As an element of dispensing, the pharmacist shall, prior
to the actual physical transfer, interpret and assess the
prescription order for potential adverse reactions,
interactions, and dosage regimen she or he deems appropriate in
the exercise of her or his professional judgment, and the
pharmacist shall certify that the medicinal drug called for by
the prescription is ready for transfer. The pharmacist shall
also provide counseling on proper drug usage, either orally or
in writing, if in the exercise of her or his professional
judgment counseling is necessary. The actual sales transaction
and delivery of such drug shall not be considered dispensing.
The administration shall not be considered dispensing.
       (20)(a) “Pharmacy” includes a community pharmacy, an
institutional pharmacy, a nuclear pharmacy, a special pharmacy,
and an Internet pharmacy, and a remote-site pharmacy.
       1. The term “community pharmacy” includes every location
where medicinal drugs are compounded, dispensed, stored, or sold
or where prescriptions are filled or dispensed on an outpatient
basis.
       2. The term “institutional pharmacy” includes every
location in a hospital, clinic, nursing home, dispensary,
sanitarium, extended care facility, or other facility,
hereinafter referred to as “health care institutions,” where
medicinal drugs are compounded, dispensed, stored, or sold.
       3. The term “nuclear pharmacy” includes 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 chapter 395 or the nuclear medicine facilities of such
hospitals.
       4. The term “special pharmacy” includes every location
where medicinal drugs are compounded, dispensed, stored, or sold
if such locations are not otherwise defined in this subsection.
       5. The term “Internet pharmacy” includes locations not
otherwise licensed or issued a permit under this chapter, within
or outside this state, which use the Internet to communicate
with or obtain information from consumers in this state and use
such communication or information to fill or refill
prescriptions or to dispense, distribute, or otherwise engage in
the practice of pharmacy in this state. Any act described in
this definition constitutes the practice of the profession of
pharmacy.
       6. The term “remote-site pharmacy” includes every location
where medicinal drugs are dispensed by a registered pharmacy
technician who is remotely supervised by an offsite pharmacist
acting in the capacity of a prescription department manager.
       (b) The pharmacy department of any permittee is shall be
considered closed whenever a Florida licensed pharmacist is not
present and on duty. The term “not present and on duty” may
shall not be construed to prevent any of the following:
       1. A pharmacist from exiting the prescription department
for the purposes of consulting or responding to inquiries or
providing assistance to patients or customers.
       2. A pharmacist from, attending to personal hygiene needs.
       3. A pharmacist from, or performing any other function for
which the pharmacist is responsible, provided that such
activities are conducted in a manner consistent with the
pharmacist’s responsibility to provide pharmacy services.
       4. An offsite pharmacist, acting in the capacity of a
prescription department manager, from remotely supervising a
registered pharmacy technician at a remote-site pharmacy.
       Section 2. Subsection (1) of section 465.014, Florida
Statutes, is amended to read:
       465.014 Pharmacy technician.—
       (1) A person other than a licensed pharmacist or pharmacy
intern may not engage in the practice of the profession of
pharmacy, except that a licensed pharmacist may delegate to
pharmacy technicians who are registered pursuant to this section
those duties, tasks, and functions that do not fall within the
purview of s. 465.003, and a registered pharmacy technician
operating under remote supervision of an offsite pharmacist
under s. 465.0198 may dispense medicinal drugs under such
supervision. All such delegated acts must be performed under the
direct supervision of a licensed pharmacist who is responsible
for all such acts performed by persons under his or her
supervision. A registered pharmacy technician, under the
supervision of a pharmacist, may initiate or receive
communications with a practitioner or his or her agent, on
behalf of a patient, regarding refill authorization requests. A
licensed pharmacist may not supervise more than one registered
pharmacy technician, except as provided in s. 465.0198 or unless
otherwise permitted by the guidelines adopted by the board. The
board shall establish guidelines to be followed by licensees or
permittees in determining the circumstances under which a
licensed pharmacist may supervise more than one pharmacy
technician.
       Section 3. Paragraph (b) of subsection (1) and paragraph
(b) of subsection (2) of section 465.015, Florida Statutes, are
amended to read:
       465.015 Violations and penalties.—
       (1) It is unlawful for any person to own, operate,
maintain, open, establish, conduct, or have charge of, either
alone or with another person or persons, a pharmacy:
       (b) In which a person not licensed as a pharmacist in this
state or not registered as an intern in this state or in which
an intern who is not acting under the direct and immediate
personal supervision of a licensed pharmacist fills, compounds,
or dispenses any prescription or dispenses medicinal drugs. This
paragraph does not apply to any person who owns, operates,
maintains, opens, establishes, conducts, or has charge of a
remote-site pharmacy under s. 465.0198.
       (2) It is unlawful for any person:
       (b) To fill, compound, or dispense prescriptions or to
dispense medicinal drugs if such person does not hold an active
license as a pharmacist in this state, is not registered as an
intern in this state, or is an intern not acting under the
direct and immediate personal supervision of a licensed
pharmacist, or is not a registered pharmacy technician at a
remote-site pharmacy who is acting under remote supervision of a
licensed pharmacist pursuant to s. 465.0198.
       Section 4. Section 465.0198, Florida Statutes, is created
to read:
       465.0198 Remote-site pharmacy permits.—
       (1) As used in this section, the term:
       (a) “Supervising pharmacy” means a pharmacy licensed in
this state which employs or contracts with a pharmacist licensed
in this state who remotely supervises a registered pharmacy
technician at a remote-site pharmacy at a ratio of one
pharmacist to up to six registered pharmacy technicians.
       (b) “Telepharmacy” means the practice of pharmacy by a
pharmacist located in this state using telecommunications or
other automations and technologies to provide or supervise the
provision of pharmacy services to patients and their agents who
are located at sites other than where the pharmacist is located,
including dispensing of prescriptions to and counseling of
patients.
       (2) Any person desiring a permit to operate a remote-site
pharmacy must apply to the department. If the board certifies
that the application complies with the laws and rules of the
board, the department must issue the permit. A permit may not be
issued unless a licensed pharmacist or consultant pharmacist is
designated as the prescription department manager responsible
for the oversight of the remote-site pharmacy. The permittee
must notify the department within 10 days after any change of
the prescription department manager.
       (3) A remote-site pharmacy must comply with all of the
following:
       (a) Be jointly owned by or operated under a contract with a
supervising pharmacy.
       (b) Maintain a video surveillance system that records
continuously 24 hours per day and retain video surveillance
recordings for at least 30 days.
       (c) Display a sign visible to the public indicating that
the location is a remote-site pharmacy and that the facility is
under 24-hour video surveillance.
       (d) Maintain a policies and procedures manual, which must
be made available to the board or its agent upon request and
must include, but need not be limited to, all of the following:
       1. A description of how the pharmacy will comply with
federal and state laws and rules.
       2. The procedures for supervising the remote-site pharmacy
and counseling its patients.
       3. The procedures for reviewing the prescription drug
inventory and drug records maintained by the remote-site
pharmacy.
       4. The policies and procedures for providing security
adequate to protect the confidentiality and integrity of patient
information.
       5. The written plan for recovery from an event that
interrupts or prevents the prescription department manager from
supervising the remote-site pharmacy’s operation.
       6. The procedures for use of the state prescription drug
monitoring program by the prescription department manager before
he or she may authorize the dispensing of any controlled
substance.
       7. The procedures for maintaining a perpetual inventory of
the controlled substances listed in Schedule II of s. 893.03.
       8. The specific duties, tasks, and functions that
registered pharmacy technicians are authorized to perform at the
remote-site pharmacy.
       (4) A remote-site pharmacy may store, hold, or dispense any
medicinal drug, 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.
       (5) The prescription department manager must visit the
remote-site pharmacy, based on a schedule determined by the
board, to inspect the pharmacy, address personnel matters, and
provide clinical services for patients.
       (6) A remote-site pharmacy may not be open when the
supervising pharmacy is closed, unless a pharmacist employed by
or under contract with the supervising pharmacy, or a pharmacy
under contract with the supervising pharmacy, is present at the
remote-site pharmacy or is providing remote supervision as
required under this section.
       (7) A registered pharmacist may not serve as the
prescription department manager for more than three remote-site
pharmacies that are under common control of the same supervising
pharmacy, at a ratio of one pharmacist to up to six registered
pharmacy technicians at each remote-site pharmacy.
       (8) The board may adopt rules as necessary to specify
additional criteria for a remote-site pharmacy. Any additional
criteria adopted by the board must be limited to rules
concerning one or more of the following:
       (a) Application requirements.
       (b) Structural and equipment requirements.
       (c) Training requirements.
       (d) Inventory recordkeeping and storage requirements.
       Section 5. Paragraph (c) of subsection (11) of section
465.022, Florida Statutes, is amended to read:
       465.022 Pharmacies; general requirements; fees.—
       (11) A permittee must notify the department of the identity
of the prescription department manager within 10 days after
employment. The prescription department manager must comply with
the following requirements:
       (c) A registered pharmacist may not serve as the
prescription department manager in more than one location,
except as authorized under s. 465.0198, unless approved by the
board.
       Section 6. This act shall take effect July 1, 2024.
Statutes affected: 
S 444 Filed: 465.014, 465.022