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 Rules
BILL: CS/CS/SB 1320
INTRODUCER: Appropriations Committee on Health and Human Services; Health Policy Committee;
and Senator Calatayud
SUBJECT: HIV Infection Prevention Drugs
DATE: February 23, 2024 REVISED:
ANALYST STAFF DIRECTOR REFERENCE ACTION
1. Rossitto-Van
Brown HP Fav/CS
Winkle
2. Gerbrandt McKnight AHS Fav/CS
3. Rossitto-Van
Twogood RC Favorable
Winkle
Please see Section IX. for Additional Information:
COMMITTEE SUBSTITUTE - Substantial Changes
I. Summary:
CS/CS/SB 1320 creates s. 465.1861, F.S., to establish an additional process under which a
pharmacist may order and dispense certain HIV drugs. The bill defines the following terms: HIV,
HIV infection prevention drug, HIV postexposure prophylaxis drug, and HIV preexposure
prophylaxis drug.
The bill authorizes a pharmacist to screen an adult for HIV exposure and provide the results to
that adult, with the advice that the patient should seek further medical consultation or treatment
from a physician, regardless of the test results.
The bill requires all pharmacies that provide adult HIV screenings have an access-to-care plan
for assisting patients in gaining access to appropriate care settings when they present to the
pharmacy for HIV screening and indicate that they lack regular access to primary care.
The bill does not have a fiscal impact on state expenditures.
The bill provides an effective date of July 1, 2024.
BILL: CS/CS/SB 1320 Page 2
II. Present Situation:
Pharmacist Licensure
Pharmacy is the third largest health profession behind nursing and medicine.1 The Board of
Pharmacy (BOP), in conjunction with the Department of Health (DOH), regulates the practice of
pharmacists under ch. 465, F.S.2 To be licensed as a pharmacist, a person must:3
Complete an application and remit an examination fee;
Be at least 18 years of age;
Hold a degree from an accredited and approved school or college of pharmacy; 4
Have completed a BOP-approved internship; and
Complete the BOP-approved examination.
A pharmacist must complete at least 30 hours of BOP-approved continuing education during
each biennial renewal period.5 Pharmacists who are certified to administer vaccines or
epinephrine auto-injections must complete a three-hour continuing education course on the safe
and effective administration of vaccines and epinephrine auto-injections as a part of the biennial
licensure renewal.6 Pharmacists who administer long-acting antipsychotic medications must
complete an approved eight-hour continuing education course as a part of the continuing
education.7
Pharmacist Scope of Practice
In Florida, the practice of the profession of pharmacy includes:8
Compounding, dispensing, and consulting concerning the contents, therapeutic values, and
uses of any 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;
Transmitting information from prescribers to their patients;
1 American Association of Colleges of Pharmacy, About AACP, available at https://www.aacp.org/about-aacp (last visited
Jan. 24, 2024).
2
Sections 465.004 and 465.005, F.S.
3
Section 465.007, F.S. The 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.
4
If the applicant has graduated from a 4-year undergraduate pharmacy program of a school or college of pharmacy located
outside the U.S., 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.
5
Section 465.009, F.S.
6
Section 465.009(6), F.S.
7
Section 465.1893, F.S.
8
Section 465.003(13), F.S.
BILL: CS/CS/SB 1320 Page 3
Administering specified vaccines to adults and influenza vaccines to persons seven years of
age or older;9
Administering epinephrine autoinjections;10 and
Administering antipsychotic medications by injection.11
A pharmacist may not alter a prescriber’s directions, diagnose or treat any disease, initiate any
drug therapy, or practice medicine or osteopathic medicine, unless permitted by law.12
Pharmacists may order and dispense drugs that are included in a formulary developed by a
committee composed of members of the Board of Medicine (BOM), the Board of Osteopathic
Medicine (BOOM), and the BOP.13 The formulary may only include:
Any medicinal drug of single or multiple active ingredients in any strength when such active
ingredients have been approved individually or in combination for over-the-counter sale by
the U.S. Food and Drug Administration (FDA);
Any medicinal drug recommended by the FDA Advisory Panel for transfer to over-the-
counter status pending approval by the FDA;
Any medicinal drug containing any antihistamine or decongestant as a single active
ingredient or in combination;
Any medicinal drug containing fluoride in any strength;
Any medicinal drug containing lindane in any strength;
Any over-the-counter proprietary drug under federal law that has been approved for
reimbursement by the Florida Medicaid Program; and
Any topical anti-infective, excluding eye and ear topical anti-infective.14
A pharmacist may order the following, within his or her professional judgment and subject to the
following conditions:
Certain oral analgesics for mild to moderate pain. The pharmacist may order these drugs for
minor pain and menstrual cramps for patients with no history of peptic ulcer disease. The
prescription is limited to a six-day supply for one treatment of:
o Magnesium salicylate/phenyltoloxamine citrate;
o Acetylsalicylic acid (zero order release, long-acting tablets);
o Choline salicylate and magnesium salicylate;
o Naproxen sodium;
o Naproxen;
o Ibuprofen;
o Phenazopyridine, for urinary pain; and
o Antipyrine 5.4 percent, benzocaine 1.4 percent, glycerin, for ear pain if clinical signs or
symptoms of tympanic membrane perforation are not present;
Anti-nausea preparations;
Certain antihistamines and decongestants;
9
See s. 465.189, F.S.
10
Id.
11
Section 465.1893, F.S.
12
Section 465.003(13), F.S.
13
Section 465.186, F.S.
14
Id.
BILL: CS/CS/SB 1320 Page 4
Certain topical antifungals/antibacterials;
Topical anti-inflammatory preparations containing hydrocortisone not exceeding 2.5 percent;
Certain otic antifungal/antibacterial;
Salicylic acid 16.7 percent and lactic acid 16.7 percent in flexible collodion, to be applied to
warts, except for patients under 2 years of age, and those with diabetes or impaired
circulation;
Vitamins with fluoride, excluding vitamins with folic acid over 0.9 mg.;
Medicinal drug shampoos containing lindane for the treatment of head lice;
Ophthalmic. Naphazoline 0.1 percent ophthalmic solution;
Certain histamine H2 antagonists;
Acne products; and
Topical antiviral for herpes simplex infections of the lips.15
Collaborative Pharmacy Practice Agreements
Under s. 465.1865, F.S., a collaborative pharmacy practice agreement (CPPA) is a formal,
written agreement in which a physician licensed under ch. 458, F.S., or ch. 459, F.S., makes a
diagnosis, supervises patient care, and refers specific patients to a pharmacist under a protocol
that allows the pharmacist to provide specified patient care services for certain chronic medical
conditions for the patients specified in the agreement. A CPPA must indicate the functions
beyond the pharmacist’s typical scope of practice that may be delegated to the pharmacist by the
collaborating physician.16 Common tasks include initiating, modifying, or discontinuing
medication therapy and ordering and evaluating tests.17
Pharmacist Training for Collaborative Practice
To provide services under a CPPA, a pharmacist must be certified by the BOP. To obtain
certification a pharmacist must complete a 20-hour course approved by the BOP, in consultation
with the BOM and the BOOM, and:
Hold an active and unencumbered license to practice pharmacy;
Have a Ph.D. in pharmacy or have five years of experience as a licensed pharmacist;
Have completed the BOP-approved, 20-hour course, eight hours of which must be live or live
video conference that includes instruction in:
o Performance of patient assessments;
o Ordering, performing, and interpreting clinical and laboratory tests;
o Evaluating and managing diseases and health conditions in collaboration with other
health care practitioners; and
o Writing and entering into a CPPA.
Maintains at least $250,000 of professional liability insurance coverage; and
Has established a system to maintain patient records of patients receiving services under a
CPPA for five years from the patient’s most recent service.18
15
Fla. Admin. Code R. 64B16-27.220 (2023).
16
U.S. Center for Disease Control and Prevention, Advancing Team-Based Care Through Collaborative Practice
Agreements: A Resource and Implementation Guide for Adding Pharmacists to the Care Team, (2017), available at
https://www.cdc.gov/dhdsp/pubs/docs/CPA-Team-Based-Care.pdf (last visited Jan. 25, 2024).
17
Id.
18
Section 465.1865(2), F.S. and Fla. Admin. Code R. 64B-31.007 (2023).
BILL: CS/CS/SB 1320 Page 5
Required Contents of CPPA
The terms and conditions of the CPPA must be appropriate to the pharmacist’s training, and the
services delegated to the pharmacist must be within the collaborating physician’s scope of
practice. A copy of the certification received from the BOP must be included as an attachment to
the CPPA. A CPPA must include the following:
The name of the collaborating physician’s patient(s) for whom a pharmacist may provide
services;
Each chronic health condition to be collaboratively managed;
The specific medicinal drug(s) to be managed for each patient;
Material terms defined as those terms enumerated in s. 465.1865(3)(a), F.S.;
Circumstances under which the pharmacist may order or perform and evaluate laboratory or
clinical tests;
Conditions and events in which the pharmacist must notify the collaborating physician and
the manner and timeframe in which notification must occur;
The start and end dates of the CPPA and termination procedures, including procedures for
patient notification and medical records transfers;
A statement that the CPPA may be terminated, in writing, by either party at any time; and
In the event of an addendum to the material terms of an existing CPPA, a copy of the
addendum and the initial agreement.
A CPPA will automatically terminate two years after execution if not renewed. The pharmacist,
along with the collaborating physician, must maintain the CPPA on file at his or her practice
location and must make the CPPA available to the DOH or BOP upon request or inspection. A
pharmacist who enters into a CPPA must submit a copy of the signed agreement to the BOP
before the agreement may be implemented.19
Allowable Chronic Health Conditions for Pharmacist CPPAs
CPPAs in Florida allow a pharmacist to provide specific patient care services for the following
chronic health conditions:
Anti-coagulation management;
Arthritis;
Asthma;
Chronic obstructive pulmonary disease (COPD);
HIV or acquired immune deficiency syndrome (AIDS);
Hyperlipidemia;
Hypertension;
Nicotine dependence;
Obesity;
Opioid use disorder;
Type 2 diabetes;
Hepatitis C; and
19
Section 465.1865(3), F.S. and Fla. Admin. Code R. 64B-31.003 (2023).
BILL: CS/CS/SB 1320 Page 6
Any other chronic condition adopted in rule by the BOP, in consultation with the BOM and
the BOOM.20
Prohibited Acts Regarding a CPPA
A pharmacist may not:
Modify or discontinue medicinal drugs prescribed by a health care practitioner with whom he
or she does not have a CPPA; or
Enter into a CPPA while acting as a pharmacy employee without the written approval of the
owner of the pharmacy.
A physician may not delegate the authority to initiate or prescribe a controlled substance listed in
s. 893.03, F.S. or 21 U.S.C. s. 812, to a pharmacist.
Continuing Education
A pharmacist who practices under a CPPA must complete an eight-hour continuing education
(CE) course approved by the BOP that addresses CPPA-related issues each biennial licensure
renewal, in addition to the CE requirements under s. 465.009, F.S. A pharmacist wishing to
maintain CPPA certification must submit confirmation of having completed such course when
applying for licensure renewal. A pharmacist who fails to complete this CE is prohibited from
practicing under a CPPA.
CPPAs in Effect
According to the DOH 2022-2023 Annual Report there are 39,337 licensed pharmacists in
Florida.21 There are 120 pharmacists certified to provide care under a CPPA. There are 37
pharmacists and 37 physicians actively engaged in collaborative practice. The BOP has received
97 CPPAs, 47 of which contain more than one chronic health condition that can be
collaboratively managed.22 The list below illustrates the composition of chronic conditions
treated by CPPA as of March 31, 2023.23
20
Section 465.1865, F.S. and Fla. Admin. Code R. 64B-31.005 (2023). The statute provides for arthritis, asthma, COPD,
Type 2 diabetes, HIV/AIDS, and obesity. The other items in the list (anti-coagulation management, hyperlipidemia,
hypertension, nicotine dependence, opioid use disorder, and hepatitis C) were added under BOP rule.
21
Florida Department of Health, Division of Medical Quality Assurance, Annual Report and Long-Range Plan, Fiscal Year
2022-2023, at pg. 4, available at https://www.floridahealth.gov/licensing-and-regulation/reports-and-publications/annual-
reports.html (last visited Jan. 26, 2024).
22
Florida Department of Health, Division of Medical Quality Assurance, Pharmacy Collaborative Practice Agreements,
Report to Senate Health Policy Committee, Aug, 1, 2023, (on file with the senate Committee on Health Policy). While the
number of participating pharmacists and physicians are identical, this does not represent a one-to-one ratio; a pharmacist may
have multiple agreements with more than one physician just as multiple physicians may have multiple agreements with more
than one pharmacist.
23
Id.
BILL: CS/CS/SB 1320 Page 7
Condition Count
Anti-Coagulation Management ................. 48
Arthritis 46
Asthma ...................................................... 46
COPD 46
HIV/AIDS ................................................. 85
Hyperlipi