The Florida Senate
BILL ANALYSIS AND FISCAL IMPACT STATEMENT
(This document is based on the provisions contained in the legislation as of the latest date listed below.)
Prepared By: The Professional Staff of the Committee on Appropriations
BILL: CS/SB 262
INTRODUCER: Military and Veterans Affairs, Space, and Domestic Security Committee and Senator
Harrell
SUBJECT: Dispensing Medicinal Drugs
DATE: April 16, 2021 REVISED:
ANALYST STAFF DIRECTOR REFERENCE ACTION
1. Brown Brown HP Favorable
2. Brown Caldwell MS Fav/CS
3. Howard Sadberry AP Favorable
Please see Section IX. for Additional Information:
COMMITTEE SUBSTITUTE - Substantial Changes
I. Summary:
CS/SB 262 amends s. 465.019, Florida Statutes, to authorize medicinal drugs to be dispensed by
a hospital that operates a Class II or Class III institutional pharmacy to a patient of the hospital’s
emergency department or a hospital inpatient upon discharge if a prescriber treating the patient in
the hospital determines that:
The medicinal drug is warranted; and
Community pharmacy services are not readily accessible to the patient, geographically or
otherwise.
If prescribing and dispensing occurs, the bill requires that a supply of the drug must be dispensed
that will last for the greater of up to 48 hours or through the end of the next business day, and
that during a declared state of emergency, a 72-hour supply may be dispensed by a hospital
located in an area affected by the emergency.
Any of these new circumstances that authorize the prescription of a controlled substance must
comply with existing regulations and restrictions on the prescribing of a controlled substance.
The bill has an insignificant fiscal impact on the Department of Health (department) that can be
absorbed within existing resources.
The bill takes effect on July 1, 2021.
BILL: CS/SB 262 Page 2
II. Present Situation:
Medicinal Prescribing and Dispensing Practitioners
There are several professions in Florida that have prescriptive authority at various levels,
including:
Allopathic physicians;
Osteopathic physicians;
Podiatrists;
Dentists;
Advanced practice registered nurses;1
Physician assistants;2 and
Pharmacists.3
A person may not dispense medicinal drugs unless licensed as a pharmacist, except that a
practitioner authorized by law to prescribe drugs may dispense medicinal drugs to patients in the
regular course of practice.4 A practitioner who dispenses medicinal drugs for human
consumption for a fee or remuneration of any kind, whether directly or indirectly, must:
Register with the professional licensing board as a dispensing practitioner and pay a board-
established fee at the time of registration and upon renewal of his or her license;
Comply with, and be subject to, all laws and rules applicable to pharmacists and pharmacies,
including, chs. 456, 499, and 893, F.S., and all applicable federal laws and federal
regulations; and
Give each patient a written prescription and, orally or in writing, advise the patient that the
prescription may be filled in the practitioner’s office or at any pharmacy, before dispensing
any drug.5
Pharmacy
The practice of pharmacy and the licensure of pharmacies are regulated under ch. 465, F.S. The
“practice of the profession of pharmacy” includes:
Compounding, dispensing, and consulting the consumer concerning the contents, therapeutic
values, and uses of any medicinal (prescription)6 drug; and
Other pharmaceutical services.7, 8
1
Section 464.012(3)(a), F.S.
2
See ss. 458.347(4)(e)4., and 459.022(4)(e)4., F.S.
3
See s. 465.186, F.S., and Fla. Admin. Code R. 64B8-36.001 (2019).
4
Section 465.0276(1)(a), F.S.
5
Section 465.0276(2)(a), (b), and (c), F.S.
6
Under s. 465.003(8), F.S., “medicinal drugs” means substances commonly known as “prescription” or “legend” drugs
required by law to be dispensed by prescription only.
7
Section 465.003(13), F.S.
8
In the context of pharmacy practice, “other pharmaceutical services” means the monitoring of the patient’s drug therapy and
assisting the patient in the management of his or her drug therapy, and includes review of the patient’s drug therapy and
communication with the patient’s prescribing health care provider as licensed under chs. 458, 459, 461, or 466, F.S., or
similar statutory provision in another jurisdiction, or such provider’s agent or such other persons as specifically authorized by
the patient, regarding the drug therapy. The “practice of the profession of pharmacy” also includes any other act, service,
operation, research, or transaction incidental to, or forming a part of, any of the foregoing acts, requiring, involving, or
BILL: CS/SB 262 Page 3
The Board of Pharmacy
The Board of Pharmacy (BOP) is created within the department and is authorized to make rules
to regulate the practice of professional pharmacy in pharmacies meeting minimum requirements
for safe practice.9 All pharmacies must obtain a permit before operating, unless exempt by law.
This is true whether opening a new establishment or simply changing locations or owners.10
The Practice of Pharmacy
Florida law recognizes seven types of pharmacies as eligible for various operating permits to be
issued by the department:
Community pharmacy;11
Institutional pharmacy;12
Nuclear pharmacy;13
Special pharmacy;14
Internet pharmacy;15
Non-resident sterile compounding pharmacy;16 and
Special sterile compounding pharmacy.17
Institutional Pharmacies
An “institutional pharmacy” includes any pharmacy located in a health care institution, that
includes a hospital, clinic, nursing home, dispensary, sanitarium, extended care facility, or other
facility where medicinal drugs are compounded, dispensed, stored, or sold.18 Institutional
pharmacy permits are required for any pharmacy located in any health care institution.19
employing the science or art of any branch of the pharmaceutical profession, study, or training, expressly permits a
pharmacist to transmit information from persons authorized to prescribe medicinal drugs to their patients, and includes the
administration of vaccines to adults. See s. 465.003(13), F.S.
9
See ss. 465.002, and 465.0155, F.S.
10
Fla. Admin. Code R. 64B16-28.100(1) (2019).
11
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. See ss. 465.003(11)(a)1. and 465.018, F.S.
12
See ss. 465.003(11)(a)2., and 465.019, F.S.
13
The term “nuclear pharmacy” includes every location where radioactive drugs and chemicals within the classification of
medicinal drugs are compounded, dispensed, stored, or sold, but does not include hospitals licensed under ch. 395, F.S., or
the nuclear medicine facilities of such hospitals. See ss. 465.003(11)(a)3. and 465.0193, F.S.
14
The term “special pharmacy” includes every location where medicinal drugs are compounded, dispensed, stored, or sold if
such locations are not otherwise defined by law. See ss. 465.003(11)(a)4. and 465.0196, F.S.
15
The term “internet pharmacy” includes locations not otherwise licensed or issued a permit under ch. 465, F.S., whether or
not in Florida, 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. See ss. 465.003(11)(a)5. and 465.0197, F.S.
16
The term “nonresident sterile compounding pharmacy” includes a pharmacy that ships, mails, delivers, or dispenses, in any
manner, a compounded sterile product into Florida, and a nonresident pharmacy registered under s. 465.0156, F.S., or an
outsourcing facility, must hold a nonresident sterile compounding permit. See s. 465.0158(1), F.S.
17
See Fla. Admin. Code R. 64B16-28.100 and 64B16-28.802 (2019). An outsourcing facility is considered a pharmacy and
must hold a special sterile compounding permit if it engages in sterile compounding.
18
Section 465.003(11)(a)2., F.S.
19
Fla. Admin. Code R. 64B16-28.100(3) (2019).
BILL: CS/SB 262 Page 4
All institutional pharmacies must designate a consultant pharmacist20 who is responsible for
maintaining all drug records required by law, and for establishing drug handling procedures for
the safe handling and storage of drugs. The consultant pharmacist may also be responsible for
ordering and evaluating any laboratory or clinical tests when these tests are necessary.21 These
laboratory or clinical tests may be ordered only for patients residing in a nursing home, when
authorized by the facility’s medical director. The consultant pharmacist must complete additional
training and demonstrate additional qualifications in the practice of institutional pharmacy, as
required by the BOP, and be licensed as a registered pharmacist.22, 23
Currently, there are four types of institutional pharmacy permits issued by the BOP to
institutional pharmacies: Institutional Class I, Class II, Modified Class II, and Class III.24
Institutional Class I Pharmacy
A Class I institutional pharmacy is an institutional pharmacy that all medicinal drugs are
administered from individual prescription containers to an individual patient and that medicinal
drugs are not dispensed on the premises, except that licensed nursing homes25 may purchase
medical oxygen for administration to residents.26
Institutional Class II Pharmacy
A Class II institutional pharmacy is a pharmacy that employs the services of a registered
pharmacist or pharmacists who, in practicing institutional pharmacy, provide dispensing and
consulting services on the premises to patients of the institution, for use on the premises of the
institution.27 A Class II institutional pharmacy is required to be open sufficient hours to meet the
needs of the hospital facility.28 The consultant pharmacist of record is responsible for
establishing a written policy and procedure manual.29 An institutional Class II pharmacy may
elect to participate in the Cancer Drug Donation Program within the Department of Business and
Professional Regulation.30
20
See ss. 465.003(11), and 465.0125, F.S.
21
Id.
22
Section 465.0125, F.S.
23
As required by Fla. Admin. Code R. 64B16-28.501(1), (2), and (3) (2019), the consultant pharmacist must also “conduct
Drug Regimen Reviews required by Federal or State law, inspect the facility and prepare a written report to be filed at the
permitted facility at least monthly, . . . monitor the facility system for providing medication administration records and
physician order sheets to ensure that the most current record of medications is available for the monthly drug regimen review,
and may utilize additional consultant pharmacists to assist in this review and in the monthly facility inspection.” A licensed
consultant pharmacist may “remotely access a facility or pharmacy’s electronic database from outside the facility or
pharmacy to conduct any services additional or supplemental to regular drug regimen reviews, subject to the pharmacy or
facility establishing policies and procedures to ensure the security and privacy of confidential patient records, including
compliance with applicable Federal HIPAA regulations.” The BOP must be notified in writing within ten days of any change
in the consultant pharmacist of record, pursuant to Fla. Admin. Code R. 64B16-28.501(1)(b) (2019).
24
Section 465.019, F.S.
25
See part II, ch. 400, F.S., relating to nursing homes.
26
Section 465.019(2)(a), F.S.
27
See s. 465.019(2)(b), F.S. Exceptions apply when there is a state of emergency and for single doses of a drug ordered by
physicians in limited circumstances.
28
Fla. Admin. Code R. 64B16-28.603 (2019).
29
Section 465.019(5), F.S.
30
See s. 499.029, F.S., relating to the Cancer Drug Donation Program Act.
BILL: CS/SB 262 Page 5
Modified Institutional Class II Pharmacy Permits
Modified Institutional Class II pharmacies are institutional pharmacies in short-term, primary
care treatment centers that meet all the requirements for a Class II permit, except space and
equipment requirements.31 Modified Class II Institutional pharmacies are designated as Type A,
Type B, and Type C according to the specialized type of the medicinal drug delivery system
utilized at the facility, either a patient-specific or bulk drug system, and the quantity of the
medicinal drug formulary at the facility.32
All Modified Class II institutional pharmacies must be under the control and supervision of a
certified consultant pharmacist. The consultant pharmacist of record is responsible for
developing and maintaining a current policy and procedure manual. The permittee must make
available the policy and procedure manual to the appropriate state or federal agencies upon
inspection.33
Institutional Class III Pharmacies
Class III institutional pharmacies are pharmacies, including central distribution facilities, that are
affiliated with a hospital that provide the same services authorized by a Class II institutional
pharmacy permit. Class III institutional pharmacies may also:
Dispense, distribute, compound, and fill prescriptions for medicinal drugs;
Prepare prepackaged drug products;
Conduct other pharmaceutical services for the affiliated hospital and for entities under
common control that are each permitted under ch. 465, F.S., to possess medicinal drugs; and
Provide the services in Class I institutional pharmacies, Class II institutional pharmacies, and
Modified Class II institutional pharmacies that hold an active health care clinic establishment
permit.34, 35
A Class III institutional pharmacy must also maintain policies and procedures addressing the
following:
The consultant pharmacist responsible for pharmaceutical services;
31
Section 465.019(2)(c), F.S.
32
Fla. Admin. Code R. 64B16-28.702(2) (2019). Modified Class II Institutional Pharmacies provide the following pharmacy
services: (1) Type “A” Modified Class II Institutional Pharmacies provide pharmacy services in a facility which has a
formulary of not more than 15 medicinal drugs, excluding those medicinal drugs contained in an emergency box, and in
which the medicinal drugs are stored in bulk and in which the consultant pharmacist provides on-site consultations not less
than once every month, unless otherwise directed by the BOP after review of the policy and procedure manual; (2) Type “B”
Modified Class II Institutional Pharmacies provide pharmacy services in a facility in which medicinal drugs are stored in the
facility in patient specific form and in bulk form and which has an expanded drug formulary, and in which the consultant
pharmacist provides on-site consultations not less than once per month, unless otherwise directed by the BOP after review of
the policy and procedure manual; and (3) Type “C” Modified Class II Institutional Pharmacies provide pharmacy services in
a facility in which medicinal drugs are stored in the facility in patient specific form and which has an expanded drug
formulary, and in which the consultant pharmacist provides onsite consultations not less than once per month, unless
otherwise directed by the BOP after review of the policy and procedure manual.
33
See Florida Board of Pharmacy, Institutional Pharmacy Permit, available at
http://floridaspharmacy.gov/licensing/institutional-pharmacy-permit/ (last visited March 19, 2021).
34
Section 465.019(2)(d)1., F.S.
35
See s. 499.01(2)(r), F.S.
BILL: CS/SB 262 Page 6
Safe practices for the preparation, dispensing, prepackaging, distribution, and transportation
of medicinal drugs and prepackaged drug products;
Recordkeeping to monitor the movement, distribution, and transportation of medicinal drugs
and prepackaged drug products;
Recordkeeping of pharmacy staff responsible for each step in the preparation, dispensing,
prepackaging, transportation, and distribution of medicinal drugs and prepackaged drug
products; and
Medicinal drugs and prepackage