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 Appropriations Committee on Rules
BILL: CS/SB 516
INTRODUCER: Health Policy Committee and Senator Rodriguez
SUBJECT: Emergency Refills of Insulin and Insulin-related Supplies or Equipment
DATE: February 20, 2024 REVISED:
ANALYST STAFF DIRECTOR REFERENCE ACTION
1. Rossitto-Van
Brown HP Fav/CS
Winkle
2. Gerbrandt McKnight AHS Favorable
3. Rossitto-Van
Twogood RC Favorable
Winkle
Please see Section IX. for Additional Information:
COMMITTEE SUBSTITUTE - Substantial Changes
I. Summary:
CS/SB 516 amends sections 465.0275 and 893.04, Florida Statutes, relating to emergency
prescription refills. The bill eliminates the current one-vial limit on emergency insulin refills and
expands current law on emergency insulin refills to include related supplies and equipment.
The bill authorizes pharmacists who have received a prescription refill request from a patient but
are unable to obtain an authorization from a prescriber, to dispense to the patient an emergency
refill of insulin and insulin-related supplies or equipment to treat diabetes, not to exceed three
nonconsecutive times per calendar year, as opposed to a “one-time emergency refill of one vial
of insulin” as provided under current law.
The bill has no fiscal impact on state revenues or state expenditures.
The bill takes effect on July 1, 2024.
BILL: CS/SB 516 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 pursuant to 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
Successfully 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 for biennial licensure renewal.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, regarding the drug therapy;
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. 30, 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 four 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/SB 516 Page 3
Administering 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, the Board of Osteopathic Medicine,
and the BOP.13 The formulary may only include:14
Any medicinal drug of single or multiple active ingredients in any strengths 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-infectives excluding eye and ear topical anti-infectives.
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%, benzocaine 1.4%, 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/SB 516 Page 4
Certain topical antifungal/antibacterials;
Topical anti-inflammatory preparations containing hydrocortisone not exceeding 2.5%;
Certain otic antifungal/antibacterial;
Salicylic acid 16.7% and lactic acid 16.7% in flexible collodion, to be applied to warts,
except for patients under two years of age, and those with diabetes or impaired circulation;
Vitamins with fluoride, excluding vitamins with folic acid in excess of 0.9 mg.;
Medicinal drug shampoos containing Lindane for the treatment of head lice;
Ophthalmic. Naphazoline 0.1% ophthalmic solution;
Certain histamine H2 antagonists;
Acne products; and
Topical Antiviral for herpes simplex infections of the lips.15
Emergency Prescription Refills
Section 465.0275(1), F.S., authorizes a pharmacist to dispense, if the pharmacist is unable to
readily obtain refill authorization from a prescriber, a one-time emergency refill of up to a 72-
hour supply of a prescribed medication or a one-time emergency refill of one vial of insulin to
treat diabetes. Current law however does not authorize pharmacists to dispense insulin-related
supplies or equipment as part of an emergency prescription refill.
A pharmacist may also dispense an emergency refill of up to a 30-day supply if the Governor
declares a state of emergency in areas affected by the order if:16
The prescription is not for a medicinal drug listed in Schedule II of ch. 893, F.S.;
The medication is essential to the maintenance of life or to the continuation of therapy in a
chronic condition;
In the pharmacist’s professional judgment, the interruption of therapy might reasonably
produce undesirable health consequences or may cause physical or mental discomfort;
The dispensing pharmacist creates a written order containing all the prescription required by
law and signs that order; and
The dispensing pharmacist notifies the prescriber of the emergency refill within a reasonable
time after such dispensing.
Diabetes
Diabetes is a chronic health condition that affects how the human body converts food into
energy.
The human digestive system breaks down carbohydrates consumed as food into glucose17 and
releases it into the bloodstream that increases the blood’s glucose level. Such an increase in
blood glucose should signal the pancreas to release the hormone insulin that acts as a catalyst to
allow the body’s cells to metabolize the glucose and convert it to energy, or to convert the
glucose into forms suitable for short-term or long-term storage.
15
Florida Administrative Code R. 64B16-27.220 (2023).
16
Section 465.0275(2), F.S.
17
Glucose is the simplest type of carbohydrate (chemical formula C6H12O6), and all carbohydrates consumed as food must be
broken down into glucose before the body can metabolize them.
BILL: CS/SB 516 Page 5
With diabetes, depending on the type of diabetes, the pancreas either does not make any insulin
or does not make enough insulin, or the body cannot use insulin as well as it should. When there
is not enough insulin or if cells stop responding to insulin, blood glucose levels elevate and stay
elevated for extended periods. Over time, such elevated blood glucose levels can cause serious
health problems, such as heart disease, vision loss, kidney disease, vascular disease, and other
maladies. Such outcomes are often known as long-term complications of diabetes.
Approximately 2,164,009 people in Florida have diabetes, according to the American Diabetes
Association.
Types of Diabetes
There are three main types of diabetes: Type 1, Type 2, and gestational diabetes.
Type 1 Diabetes
Type 1 diabetes is thought to be caused by an autoimmune reaction in which the body’s immune
system attacks and destroys the cells in the pancreas that normally produce insulin.
Approximately 5 to 10 percent of the people with diabetes have Type 1. Symptoms of Type 1
often develop quickly. It is usually diagnosed in children, teens, and young adults. Someone with
Type 1 diabetes must take insulin, usually through subcutaneous injection, on a regular basis to
survive, usually one or more times per day. Currently, Type 1 diabetes can be neither prevented
nor cured.18
Type 2 Diabetes
With Type 2 diabetes, the body does not use insulin well and cannot keep blood glucose at
normal levels. About 90 to 95 percent of people with diabetes have Type 2. It develops over
many years and is usually diagnosed in overweight, middle-aged adults, although it can
sometimes manifest in adolescents and young adults. Type 2 diabetes can often be prevented or
delayed, or even eliminated altogether, with healthy lifestyle changes, such as losing weight,
eating healthy food, and exercising regularly.19 Type 2 diabetes is usually treated with oral
medications but can require insulin injections in some cases.
Gestational Diabetes
Gestational diabetes develops in pregnant women who have never had diabetes. In pregnant
women with gestational diabetes, the baby could be at higher risk for health problems.
Gestational diabetes usually goes away after the baby is born. However, it correlates to a higher
risk for Type 2 diabetes later in life. A baby delivered by a woman with gestational diabetes is
more likely to become obese as a child or teen and to develop Type 2 diabetes later in life.20
18
Centers for Disease Control and Prevention, What Is Diabetes?, available at:
https://www.cdc.gov/diabetes/basics/diabetes.html (last visited Jan. 30, 2024).
19
Id.
20
Id.
BILL: CS/SB 516 Page 6
Managing Diabetes
In order for Type 1 or Type 2 diabetics to avoid long-term complications, or for a pregnant
woman with gestational diabetes to mitigate the effects of that condition, blood glucose levels
must be managed to stay as close to normal ranges as possible.
A widely accepted “normal” level of blood glucose is 100 milligrams of glucose per deciliter
(mg/dL) of whole blood, although normal levels may vary. A normal fasting blood glucose level
for someone without diabetes is 70 to 99 mg/dL.21
Testing blood glucose levels is key to managing diabetes. Years of elevated blood glucose levels
can lead to diabetes’ costly and disabling long-term complications, while levels that are too low
(hypoglycemia) can be dangerous in an immediate sense and can lead to disorientation, unusual
confusion, unconsciousness, grand mal seizure, brain damage, or death.
Medications and Supplies
Insulin
All Type 1 diabetics and some Type 2 diabetics require insulin to be artificially introduced into
the diabetic’s body. Different types of insulin work at different speeds, and each lasts for
different lengths of time. A patient may need to use more than one type of insulin such as long-
acting and short-acting. Insulin may be administered in a number of ways. Common options
include a needle and syringe, insulin pen, or insulin pump.22 Inhalers and insulin jet injectors are
less common ways to take insulin. Artificial pancreas systems are now approved by the U.S.
Food and Drug Administration (FDA).23
Medication Delivery Devices
Needle and Syringe
Insulin injections using a needle and syringe are a common way to receive insulin. Some people
with diabetes who take insulin need two to four injections a day to keep their blood glucose in
their target range. Others can take a single dose.24
Pen
An insulin pen looks like an oversized writing pen but has a needle for its point. Some insulin
pens come filled with insulin and are disposable. Others have room for an insulin cartridge that is
inserted and replace after use. Many people find insulin pens easier to use, but pens might be
more expensive than needles and syringes. Different pen types have features that can help with
21
Cleveland Clinic, Blood Glucose (Sugar) Test, available at: https://my.clevelandclinic.org/health/diagnostics/12363-blood-
glucose-test (last visited Jan. 30, 2024).
22
U.S. Department of Health and Human Services, National Institute of Diabetes and digestive and Kidney Diseases, Type I
Diabetes, available at https://www.niddk.nih.gov/health-information/diabetes/overview/what-is-diabetes/type-1-
diabetes#medicines (last visited Jan. 30, 2024).
23
U.S. Department of Health and Human Services, National Institute of Diabetes and digestive and Kidney Diseases, Insulin,
Medicines, & Other Diabetes Treatments, available at https://www.niddk.nih.gov/health-
information/diabetes/overview/insulin-medicines-treatments#waystotakeinsulin (last visited Jan. 30, 2024).
24
Id.
BILL: CS/SB 516 Page 7
injections. Some reusable pens have a memory function, which can recall dose amounts and
timing. Other “connected” insulin pens can be programmed to calculate insulin doses and
provide downloadable data reports, which can help health care practitioners adjust insulin
doses.25
Pump
An insulin pum