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: SB 1476
INTRODUCER: Senator Brodeur
SUBJECT: Controlled Substances
DATE: April 15, 2021 REVISED:
ANALYST STAFF DIRECTOR REFERENCE ACTION
1. Erickson Jones CJ Favorable
2. Looke Brown HP Favorable
3. Erickson Phelps RC Favorable
I. Summary:
SB 1476 amends s. 893.03, F.S., which contains Florida’s controlled substance schedules, to
remove the following substance from Schedule V: a drug product in finished dosage formulation
which has been approved by the U.S. Food and Drug Administration (FDA) and which contains
cannabidiol (CBD) derived from cannabis and no more than 0.1 percent tetrahydrocannabinols.
In 2019, the Legislature placed the previously-described language in Schedule V. From that time
to the present date, the scheduling language has only applied to Epidiolex®, the first
pharmaceutical oral solution containing highly purified CBD to be approved by the FDA. It is
used for the treatment of seizures associated with two rare and severe forms of epilepsy. While
making Epidiolex® a Schedule V controlled substance was consistent with the federal
scheduling in 2019, the substance has since been descheduled by the U.S. Drug Enforcement
Administration (DEA). Therefore, the bill’s removal of the Schedule V language (and the
descheduling of Epidiolex®) would be consistent with federal descheduling action.
The bill takes effect upon becoming a law.
II. Present Situation:
Florida’s Controlled Substance Schedules
Section 893.03, F.S., classifies controlled substances into five categories, known as schedules.
These schedules regulate the manufacture, distribution, preparation, and dispensing of the
substances listed in the schedules. The most important factors in determining which schedule
may apply to a substance are the “potential for abuse”1 of the substance and whether there is a
1
Pursuant to s. 893.035(3)(a), F.S., “potential for abuse” means a substance has properties as a central nervous system
stimulant or depressant or a hallucinogen that create a substantial likelihood of the substance being: (1) used in amounts that
BILL: SB 1476 Page 2
currently accepted medical use for the substance. The controlled substance schedules are as
follows:
Schedule I substances (s. 893.03(1), F.S.) have a high potential for abuse and no currently
accepted medical use in treatment in the United States. Use of these substances under
medical supervision does not meet accepted safety standards.
Schedule II substances (s. 893.03(2), F.S.) have a high potential for abuse and a currently
accepted but severely restricted medical use in treatment in the United States. Abuse of these
substances may lead to severe psychological or physical dependence.
Schedule III substances (s. 893.03(3), F.S.) have a potential for abuse less than the Schedule I
and Schedule II substances and a currently accepted medical use in treatment in the United
States. Abuse of these substances may lead to moderate or low physical dependence or high
psychological dependence. Abuse of anabolic steroids may lead to physical damage.
Schedule IV substances (s. 893.03(4), F.S.) have a low potential for abuse relative to
Schedule III substances and a currently accepted medical use in treatment in the United
States. Abuse of these substances may lead to limited physical or psychological dependence
relative to Schedule III substances.
Schedule V substances (s. 893.03(5), F.S.) have a low potential for abuse relative to the
substances in Schedule IV and a currently accepted medical use in treatment in the United
States. Abuse of these substances may lead to limited physical or psychological dependence
relative to Schedule IV substances.
Prescribing and Dispensing a Schedule V Controlled Substance
A prescriber2 or dispenser3 of controlled substances in Florida is required to consult the state’s
Prescription Drug Monitoring Program (PDMP) system each time a controlled substance is
prescribed or dispensed to a patient age 16 or over unless a statutory exemption applies.4 A
dispenser is required to report to the PDMP each time a controlled substance, including a
controlled substance in Schedule V, is dispensed to a patient.5 Willful and knowing failure to
report the dispensing of a controlled substance is a first degree misdemeanor.6
Numerous pieces of information are required to appear on the face or written record of the
prescription for a controlled substance7 and the prescription must be retained by the prescribing
pharmacy for two years.8 There are also numerous labeling requirements relating to the container
in which a controlled substance is delivered.9 There are also limitations on filling or refilling a
create a hazard to the user’s health or the safety of the community; (2) diverted from legal channels and distributed through
illegal channels; or (3) taken on the user’s own initiative rather than on the basis of professional medical advice.
2
A “prescriber” is a prescribing physician, prescribing practitioner, or other prescribing health care practitioner authorized by
the laws of this state to order controlled substances. Section 893.055(1)(k), F.S.
3
A “dispenser” is a dispensing health care practitioner, pharmacy, or pharmacist licensed to dispense controlled substances in
or into this state. Section 893.055(1)(e), F.S.
4
Section 893.055(8), F.S.
5
Section 893.055(3), F.S. Schedule I substances are not included because, by definition, a Schedule I substance has no
accepted medical use, and therefore, is not prescribed or dispensed.
6
Section 893.055(9), F.S. A first degree misdemeanor is punishable by up to one year in county jail and a fine of up to
$1,000. Sections 775.082 and 775.083, F.S.
7
Section 893.04(1)(c), F.S.
8
Section 893.04(1)(d), F.S.
9
Section 893.04(1)(d), F.S.
BILL: SB 1476 Page 3
prescription for a controlled substance: no more than five times within a period of six months
after the date on which the prescription was written unless the prescription is renewed by a
practitioner.10
Punishment of Prohibited Drug Acts Involving Cannabis and Schedule V Controlled
Substances
Cannabis is a Schedule I controlled substance.11 Schedule I is the most restrictive controlled
substance schedule. Section 893.13, F.S., in part, punishes unlawful possession, sale, purchase,
manufacture, delivery, and importation of a Schedule I controlled substance. Simple possession
of 20 grams or less of cannabis is a first degree misdemeanor,12 and simple possession of more
than 20 grams of cannabis is a third degree felony.13 Purchase, or possession with intent to
purchase, cannabis is a third degree felony.14 Delivery, without consideration, of 20 grams or less
of cannabis is a first degree misdemeanor.15 Generally, it is a third degree felony to deliver, sell,
manufacture, import, or possess with the intent to sell, manufacture, or deliver cannabis.16
Section 893.135, F.S., punishes drug trafficking. Trafficking in significant quantities of cannabis
is a first degree felony, which is subject to a three, seven, or 15-year mandatory minimum term
and mandatory fine based on the quantity of cannabis trafficked.17
Schedule V is the least restrictive controlled substance schedule. Section 893.13, F.S., in part,
punishes unlawful possession, sale, purchase, manufacture, delivery, and importation of a
Schedule V controlled substance. Simple possession of a Schedule V controlled substance is a
second degree misdemeanor.18 Purchase, or possession with intent to purchase, a Schedule V
controlled substance is a first degree misdemeanor.19 Generally, it is a first degree misdemeanor
to deliver, sell, manufacture, import, or possess with the intent to sell, manufacture, or deliver a
Schedule V controlled substance.20 Drug trafficking offenses in s. 893.135, F.S., do not apply to
Schedule V controlled substances.21
10
Section 893.04(1)(g), F.S.
11
Section 893.03(1)(c)7., F.S.
12
Section 893.13(6)(b), F.S.
13
Section 893.13(6)(a), F.S. A third degree felony is punishable by up to five years in state prison and a fine of up to $5,000.
Sections 775.082 and 775.083, F.S.
14
Section 893.13(2)(a)2., F.S.
15
Section 893.13(3), F.S.
16
Section 893.13(1)(a)2. and (5)(b), F.S.
17
Section 893.135(1)(a), F.S. A first degree felony is generally punishable by up to 30 years in state prison and a fine of up to
$10,000. Sections 775.082 and 775.083, F.S.
18
Section 893.13(6)(d), F.S. A second degree misdemeanor is punishable by up to 60 days in county jail and a fine of up to
$500. Sections 775.082 and 775.083, F.S.
19
Section 893.13(2)(a)3., F.S.
20
Section 893.13(1)(a)3. and (5)(c), F.S.
21
See s. 893.135(1)(a)-(n), F.S.
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Scheduling of Epidiolex®
Epidiolex® is an oral solution developed by GW Pharmaceuticals (GW).22 According to GW,
Epidiolex® is “a pharmaceutical formulation of highly purified cannabidiol (CBD)[.]”23 CBD is
“a chemical constituent of the cannabis plant (commonly referred to as marijuana).”24 “However,
CBD does not cause intoxication or euphoria (the ‘high’) that comes from tetrahydrocannabinol
(THC).”25
In June of 2018, the FDA announced that it approved Epidiolex® for the treatment of seizures
associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet
syndrome, in patients two years of age and older.26 Epidiolex® “is the first FDA-approved drug
that contains a purified drug substance derived from marijuana.”27
On September 28, 2018, the DEA rescheduled Epidiolex® from Schedule I to Schedule V of the
federal Controlled Substance Act (CSA).28 Because Epidiolex® was approved by the FDA, the
DEA determined it has a currently accepted medical use in treatment in the United States, and no
longer met criteria for placement in Schedule I of the CSA.29 Epidiolex® was a Schedule I
substance under federal law because it contains CBD, a chemical component of the cannabis
plant, which is a Schedule I controlled substance.30
22
EPIDIOLEX® (cannabidiol) Oral Solution – the First FDA-approved Plant-derived Cannabinoid Medicine – Now
Available by Prescription in the U.S., Press Release (Nov. 1, 2018), GW Pharmaceuticals, Ltd., available at
http://ir.gwpharm.com/news-releases/news-release-details/epidiolexr-cannabidiol-oral-solution-first-fda-approved-plant (last
visited March 25, 2021). According to GW, Epidiolex® “will be marketed in the U.S. by its subsidiary, Greenwich
Biosciences.” Id.
23
FDA-approved drug Epidiolex placed in schedule V of Controlled Substance Act, Press Release (Sept. 27, 2018), U.S.
Drug Enforcement Administration, available at https://www.dea.gov/press-releases/2018/09/27/fda-approved-drug-
epidiolex-placed-schedule-v-controlled-substance-act (last visited March 25, 2021).
24
Id.
25
FDA approves first drug comprised of an active ingredient derived from marijuana to treat rare, severe forms of epilepsy,
News Release (June 25, 2018), U.S. Food and Drug Administration, available at
https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm611046.htm (last visited March 25, 2021).
26
Id.
27
Id.
28
Schedules of Controlled Substances: Placement in Schedule V of Certain FDA-Approved Drugs Containing Cannabidiol;
Corresponding Change to Permit Requirements, 83 FR 48950 (Sept. 28, 2018), available at
https://www.federalregister.gov/documents/2018/09/28/2018-21121/schedules-of-controlled-substances-placement-in-
schedule-v-of-certain-fda-approved-drugs-containing (last visited March 25, 2021). The U.S. Department of Health and
Human Services advised the DEA “that it found the Epidiolex formulation to have a very low potential for abuse[.]” Id. The
federal Controlled Substance Act is codified at 21 U.S.C. ss. 801-978.
29
Id.
30
Id.
BILL: SB 1476 Page 5
On October 31, 2018, former Florida Attorney General Pam Bondi, pursuant to her emergency
scheduling authority under s. 893.0355, F.S.,31 rescheduled Epidiolex® from Schedule I of the
Florida controlled substance schedules (s. 893.03, F.S.) to Schedule V of the schedules.32
In 2019, the Legislature placed the following language in Schedule V: “a drug product in
finished dosage formulation which has been approved by the U.S. Food and Drug Administration
(FDA) and which contains cannabidiol (CBD) derived from cannabis and no more than 0.1
percent tetrahydrocannabinols.”33 From that time to the present date, the scheduling language has
only applied to Epidiolex®.
In 2020, the DEA removed Epidiolex® from Schedule V and descheduled it entirely, meaning
Epidiolex® is no longer subject to the federal CSA.34 Epidiolex® remains a Schedule V
controlled substance in Florida’s controlled substance schedules until or unless the Legislature
removes the scheduling language applicable to Epidiolex®.
“Low-THC Cannabis” and Epidiolex®
The Compassionate Medical Cannabis Act of 201435 legalized “low-THC cannabis,” a low THC
and high CBD form of cannabis,36 for medical use37 by patients suffering from cancer, epilepsy,
and certain other specified medical conditions.38
A “low-THC cannabis” product obtained from a medical marijuana treatment center is not an
FDA-approved CBD product. As previously described, Epidiolex® is the only CBD product that
is currently approved by the FDA. Further, Epidiolex® is prescribed by a physician. A “low-
31
Section 893.0355(2), F.S., delegates to the Attorney General the authority to adopt rules rescheduling specified substances
to a less controlled schedule, or deleting specified substances from a schedule, upon a finding that reduced control of such
substances is in the public interest. Rulemaking under s. 893.0355, F.S., must be in accordance with the procedural
requirements of ch. 120, F.S., including the emergency rule provisions found in s. 120.54, F.S., except that s. 120.54(7), F.S.
(petition to initiate rulemaking), does not apply. Section 893.0355(4), F.S.
32
The text of Emergency Rule 2ER18-1 available at https://www.flrules.org/gateway/notice_Files.asp?ID=21109642 (last
visited March 25, 2021).
33
Section 893.03(5)(d), F.S.
34
See Implementation of the Agriculture Improvement Act of 2018 (interim final rule), Drug Enforcement Administration, 85
FR 51639 (Aug. 21, 2020), available at https://www.federalregister.gov/documents/2020/08/21/2020-17356/implementation-
of-the-agriculture-improvement-act-of-2018 (last visited March 25, 2021). The interim final rule, in part, removed “from
control in schedule V under 21 CFR 1308.15(f) a “drug product in finished dosage formulation that has been approved by the
U.S. Food and Drug Administration that contains cannabidiol (2-[1R-3-methyl-6R-(1-methylethenyl)-2-cyclohexen-1-yl]-5-
pentyl-1,3-benzenediol) derived from cannabis and no more than 0.1% (w/w) residual tetrahydrocannabinols.” Id. “…
[I]nterim final rules are considered final rules that carry the force and effect of law.” Todd Gravey, A Brief Overview of
Rulemaking and Judicial Review (March 27, 2017), Congressional Research Service, at p. 9 and n. 79 (citing Career College
Ass’n v. Riley, 74 F.3d 1265 (D.C. Cir. 1996)), available at https://fas.org/sgp/crs/misc/R41546.pdf. (last visited March 25,
2021). See also prescription information for Epidiolex® (on file with the Senate Committee on Criminal Justice).
35
See ch. 2014-157, Laws of Fla., and s. 381.986, F.S.
36
“Low-THC cannabis” means a plant of the genus Cannabis, the dried flowers of which contain 0.8 percent or less of
tetrahydrocannabinol and more than 10 percent of cannabidiol weight for weight; the seeds thereof; the resin extracted from
any part of such plant; or any compound, manufacture, salt, derivative, mixture, or preparation of such plant or its seeds or
resin that is dispensed from a medical marijuana treatment center. Section 381.986(1)(e), F.S.
37
With specified exceptions, “medical use” means the acquisition, possession, use, delivery, transfer, or administration of
marijuana authorized by a physician certification. Section 381.986(1)(j), F.S.
38
Section 381.986(2), F.S.
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THC cannabis” product is not prescribed. In addition to ot