Meeting Packet - Professions and Public Health Subcommittee (March 9, 2021)

Summary

Meeting packet of the Professions and Public Health Subcommittee for Tuesday, March 9, 2021, 9:30 AM to 11:30 AM at Webster Hall (212 Knott). The committee meeting notice lists HB 1455 Regulation of Medical Marijuana by Roach. The House of Representatives staff analysis of HB 1455 says the bill limits a 35-day supply of marijuana to 15,000 mg of THC and limits potency to 10 percent THC for marijuana in a form for smoking and 60 percent THC for all other forms of marijuana products, excluding edibles. The packet closes with text that includes a prohibition on a qualified physician issuing a physician certification to a minor patient for marijuana, except for low-THC cannabis.

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Professions and Public Health
Subcommittee
Tuesday, March 9, 2021
9:30 AM – 11:30 AM
Webster Hall (212 Knott)

Meeting Packet

Chris Sprowls Will Robinson
Speaker Chair
Committee Meeting Notice
HOUSE OF REPRESENTATIVES

Professions & Public Health Subcommittee

Start Date and Time: Tuesday, March 09, 2021 09:30 am

End Date and Time: Tuesday, March 09, 2021 11:30 am

Location: Webster Hall (212 Knott)
Duration: 2.00 hrs

Consideration of the following bill(s):

HB 1455 Regulation of Medical Marijuana by Roach

This meeting will be live-streamed on https://thefloridachannel.org/. Persons who wish to attend must
register at www.myfloridahouse.gov, and pick up a pass at the Legislative Welcome Center on the 4th Floor
of the Capitol beginning one hour before the start of the meeting. Audience seating will be socially
distanced and will be available on a first-come, first-served basis. Registration closes three hours before
the meeting starts.

NOTICE FINALIZED on 03/05/2021 4:03PM by Osborne.Erin

03/05/2021 04:03:04PM Leagis ® Page 1 of 1
HB 1455
HOUSE OF REPRESENTATIVES STAFF ANALYSIS

BILL #: HB 1455 Regulation of Medical Marijuana
SPONSOR(S): Roach
TIED BILLS: IDEN./SIM. BILLS: SB 1958

REFERENCE ACTION ANALYST STAFF DIRECTOR or
BUDGET/POLICY CHIEF

1) Professions & Public Health Subcommittee McElroy McElroy

2) Health Care Appropriations Subcommittee

3) Health & Human Services Committee

SUMMARY ANALYSIS
Art. X, section 29 of the Florida Constitution, Use of Marijuana for Debilitating Medical Conditions, authorizes patients with an
enumerated debilitating medical condition to obtain medical marijuana from Medical Marijuana Treatment Centers (MMTC).
During the 2017A Special Session, the legislature implemented this constitutional provision by passing the Medical Use of
Marijuana Act.

A medical marijuana patient must obtain a physician certification from a qualified physician, who may only certify a patient for
three 70-day supply limits of marijuana not in a form for smoking and six 35-day supply limits for marijuana in a form for smoking
before issuing a new certification. A 35-day supply of marijuana in a form for smoking cannot exceed 2.5 ounces. The
Department of Health (DOH) is required to set a daily dose limit for all forms of marijuana, but has not done so, leaving the
determination of an adequate supply at the sole discretion of a qualified physician.

Delta-9-tetrahydrocannabinol (THC) is the psychoactive chemical in marijuana. The full extent of the health impact of consuming
products with high concentration of THC is unknown; however, research indicates that such use significantly increases the risk
of marijuana-associated psychosis. Studies have found daily use, especially of high-potency marijuana (over 10 percent THC),
is strongly associated with earlier onset of psychosis and the development of schizophrenia in marijuana users. Some studies
have also shown that marijuana with a THC concentration of 10 percent or less is effective for medical treatment, including the
relief of neuropathic pain and pain caused by conditions such as HIV/AIDS, multiple sclerosis, and post-traumatic surgical pain.
Currently, MMTCs produce and dispense products ranging from 0.4% THC to 100% THC.

HB 1455 limits a 35-day supply of marijuana to 15,000 mg of THC and limits the potency to 10 percent THC for marijuana in a
form for smoking and 60 percent THC for all other forms of marijuana products, excluding edibles. The bill limits the amount of
marijuana a MMTC may dispense within any 70-day period to two 35-day supplies. The bill provides an exception to the potency
limits for patients with terminal illnesses.

The bill prohibits qualified physicians from certifying medical marijuana for minors (under age 18), other than low-THC cannabis,
unless the qualified physician determines that it is the most effective treatment for the patient and a second physician, who is a
board-certified pediatrician, concurs with such determination.

The bill also prohibits a certified medical marijuana testing laboratory from having an economic interest in a MMTC and prohibits
MMTCs from employing qualified physicians or having an economic interest in qualified physicians’ practices, to align with
similar provisions in current law applicable to physicians. The bill restricts advertising by qualified physicians and expands
current MMTC advertising restrictions.

The bill requires MMTCs to recall all marijuana that fails to meet the safety and potency requirements, authorizes DOH to test
samples of all forms of marijuana from MMTCs, and immunizes DOH staff from prosecution for possessing marijuana for this
purpose.

The bill has a significant, indeterminate, negative fiscal impact on DOH and no fiscal impact upon local governments.

The bill provides an effective date of July 1, 2021, except as otherwise provided.

This document does not reflect the intent or official position of the bill sponsor or House of Representatives.
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FULL ANALYSIS

I. SUBSTANTIVE ANALYSIS

A. EFFECT OF PROPOSED CHANGES:
Background

Research on the Health Effects of THC

Although there are more than 100 cannabinoids in a marijuana plant, the two main cannabinoids are Delta-9-
tetrahydrocannabinol THC and cannabidiol (CBD). 1 THC is a mind-altering chemical that increases appetite and
reduces nausea and may also decrease pain, anxiety, and muscle control problems. 2 Though CBD may also
have an effect on the mind, it does not produce the high or sense of euphoria associated with THC. CBD has
been shown to help with anxiety, depression, reducing pain and inflammation, controlling epileptic seizures, and
possibly treating psychosis or mental disorders. 3

Marijuana has changed over time. The THC concentration in commonly cultivated marijuana plants increased
three-fold between 1995 and 2014 (4% and 12% respectively). 4 Conversely, the CBD content decreased from
.28% in 2001 to .15% in 2014. In 1995, the level of THC was 14 times higher than its CBD level. In 2014, the THC
level was 80 times the CBD level. 5 The marijuana available today is much stronger than previous versions.

Some studies have shown that marijuana with a THC concentration of 10% or less is effective for medical
treatment, including the relief of neuropathic pain and pain caused by conditions such as HIV/AIDS, multiple
sclerosis, post-traumatic surgical pain. 6 Studies on the use of marijuana for pain relief found that marijuana
cigarettes with a THC concentration between 2% and 10% THC provided sufficient pain relief, 7 with one study
finding that medium-dose marijuana cigarettes with 3.5% THC were as effective as higher dosed marijuana
cigarettes at 7% THC. 8

A 2014 New England Journal of Medicine study warned that long-term marijuana use can lead to addiction and
that adolescents are more vulnerable to adverse long-term outcomes from marijuana use. 9 Specifically, the study
found that, as compared with persons who begin to use marijuana in adulthood, those who begin in adolescence
are approximately 2 to 4 times as likely to have symptoms of marijuana dependence within 2 years after first
use. 10 The study also found that marijuana-based treatments with THC may have irreversible effects on brain
development in adolescents as the brain’s endocannabinoid system undergoes development in childhood and
adolescence. 11

1 U.S. Department of Health & Human Services, National Center for Complementary and Integrative Health, Cannabis (Marijuana) and

Cannabinoids: What You Need To Know, available at https://www.nccih.nih.gov/health/cannabis-marijuana-and-cannabinoids-what-
you-need-to-know (last visited February 9, 2021).
2 Healthline, CBD vs. THC: What’s the Difference?, https://www.healthline.com/health/cbd-vs-thc (last visited February 16, 2021).
3 Id.
4 U.S. Surgeon General’s Advisory: Marijuana Use and the Developing Brain, https://www.hhs.gov/surgeongeneral/reports-and-

publications/addiction-and-substance-misuse/advisory-on-marijuana-use-and-developing-brain/index.html (last visited February 8,
2021).
5 ElSohly, M.A., Mehmedic, Z., Foster, S., Gon, C., Chandra, S. and Church, J.C. Changes in Cannabis Potency Over the Last 2

Decades (1995-2014): Analysis of Current Data in the United States, Biological Psychiatry. April 1, 2016; 79(7):613-619.
6 Igor Grant,1 J. Hampton Atkinson, Ben Gouaux, and Barth Wilsey. Medical Marijuana: Clearing Away the Smoke. Open Neurol J.

2012; 6: 18–25. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3358713/; Ellis RJ, Toperoff W, Vaida F, et al. Smoked
Medicinal Cannabis for Neuropathic Pain in HIV: A Randomized, Crossover Clinical Trial, Neuropsychopharmacology, 2009; 34(3):672-
680, available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3066045/ (last viewed on March 6, 2021); Abrams DI, Jay CA, Shade
SB, et al. Cannabis in Painful HIV-associated Sensory Neuropathy: A Randomized Placebo-controlled Trial. Neurology. 2007;
68(7):515-521 available at https://pubmed.ncbi.nlm.nih.gov/17296917/ (last viewed on March 6, 2021); Wilsey B, Marcotte T, Tsodikov
A, et al. A Randomized, Placebo-controlled, Crossover Trial of Cannabis Cigarettes in Neuropathic Pain, J Pain. 2008;9(6):506-521,
available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4968043/ (last viewed on March 6, 2021); Wallace M, Schulteis G, Atkinson
JH, et al. Dose-dependent Effects of Smoked Cannabis on Capsaicin-induced Pain and Hyperalgesia in Healthy Volunteers.
Anesthesiology. 2007; 107(5):785–96, available at https://pubs.asahq.org/anesthesiology/article/107/5/785/7080/Dose-dependent-
Effects-of-Smoked-Cannabis-on (last viewed on March 6, 2021).
7 Id.
8 Wilsey B, Marcotte T, Tsodikov A, et al. A Randomized, Placebo-controlled, Crossover Trial of Cannabis Cigarettes in Neuropathic

Pain. J Pain. 2008; 9(6):506–21, available at https://pubmed.ncbi.nlm.nih.gov/18403272/ (last viewed on March 6, 2021).
9 Volkow, N.D., Baler, R.D., Compton, W.M. and Weiss, S.R., Adverse Health Effects of Marijuana Use, NEW ENG. J. MED., June 5,

2014, available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4827335/ (last viewed on March 6, 2021).
10 Id.
11 Id.

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Heavy use of marijuana by adolescents is associated with impairments in attention, learning, memory, poor
grades, high drop rates and I.Q. reduction. 12 Though the full extent of the health impact of consuming products
with high concentration of THC is unknown, research indicates that use of such products significantly increases
the risk of marijuana-associated psychosis, 13 regardless of age at first use or the type of marijuana used. 14 A
2019 European study showed that the use of high-potency marijuana (over 10% THC) only modestly increased
the odds of a psychotic disorder compared to never using it; however, individuals who started using high-potency
marijuana by age 15 showed a doubling of risk. 15 The European study also found that daily use of high-potency
cannabis increased the risk of psychotic disorder nearly five times compared with never having used marijuana. 16

Another study found that frequent use of marijuana or use of marijuana with high THC potency increased the risk
of schizophrenia six-fold. 17 According to a literature review of studies on the impact of marijuana use on mental
health published in the Journal of the American Medical Association Psychiatry, there is strong physiological and
epidemiological evidence supporting a link between marijuana use and schizophrenia. 18 High doses of THC can
cause acute, transient, dose-dependent psychosis, which are schizophrenia-like symptoms. 19 Additionally,
prospective, longitudinal, and epidemiological studies have consistently found an association between marijuana
use and schizophrenia in which marijuana use precedes psychosis, independent of alcohol consumption, and
even after removing or controlling for those individuals who had used other drugs. 20

Even though marijuana use may have been discontinued long before the onset of psychosis, studies have found
that the age at which marijuana use begins appears to correlate with the age of onset of psychosis, which
suggests that early marijuana use plays a role in initiating psychosis that is independent of actual use. 21 Overall,
studies have found that the association between marijuana use and chronic psychosis (including a schizophrenia
diagnosis) is stronger in those individuals who have had heavy or frequent marijuana use, use marijuana during
adolescence, or use marijuana with high THC potency. 22

While studies have not shown that marijuana use alone is either necessary or sufficient for the development of
schizophrenia, studies suggests that marijuana use may initiate the emergence of a lasting psychotic illness in
some individuals, especially those with a genetic vulnerability to develop a psychotic illness. 23

12 See footnote 9; see also The Influence of Marijuana Use on Neurocognitive Functioning in Adolescents, Schweinsburg AD, Brown

SA, Tapert SF, Curr Drug Abuse Rev. 2008;1(1):99-111, available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2825218/ (last
viewed on March 6, 2021).
13 Robin Murray, Harriet Quigley, Diego Quattrone, Amir Englund and Marta Di Forti, Traditional Marijuana, High-Potency Cannabis and

Cannabinoids: Increasing Risk for Psychosis, World Psychiatry, 2016 Oct; 15(3): 195–204, available at
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5032490/ (last viewed February 18, 2021).
14 Di Forti et al. The Contribution of Cannabis Use to Variation in the Incidence of Psychotic Disorder Across Europe (EU-GEI): A

Multicenter Case-control Study. Lancet Psychiatry. 2019; 6:427-36, available at https://www.thelancet.com/article/S2215-
0366(19)30048-3/fulltext (last viewed on March 6, 2021); High-Potency Cannabis and Incident Psychosis: Correcting the Causal
Assumption, The Lancet, Volume 6, Issue 6, June 2019, available at https://www.thelancet.com/journals/lanpsy/article/PIIS2215-
0366(19)30174-9/fulltext (last viewed March 7, 2021); High-Potency Cannabis and Incident Psychosis: Correcting the Causal
Assumption – Author’s Reply, The Lancet, Volume 6, Issue 6, June 2019available at
https://www.thelancet.com/journals/lanpsy/article/PIIS2215-0366(19)30176-2/fulltext (last viewed March 7, 2021).
15 Id. at 430.
16 Id. at 431. The odds were lower for those who use low-potency marijuana daily.
17 Nora D. Volkow, MD; James M. Swanson, PhD; A. Eden Evins, MD; Lynn E. DeLisi, MD; Madeline H. Meier, PhD;

Raul Gonzalez, PhD; Michael A. P. Bloomfield, MRCPsych; H. Valerie Curran, PhD; Ruben Baler, PhD., Effects of Cannabis Use on
Human Behavior, Including Cognition, Motivation, and Psychosis: A Review. JAMA Psychiatry. 2016; 73(3):292-297, available at
https://www.yellowbrickprogram.com/ArticlePDF/Cannabis-and-Behavior-JAMA.pdf (last viewed February 16, 2021).
18 Id.
19 Id.
20 Id.
21 Id.
22 Id.
23 Id.

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Marijuana for Medical Use

Article X, section 29 of the Florida Constitution, Use of Marijuana for Debilitating Medical Conditions, authorizes
patients with any of the following debilitating medical conditions to obtain medical marijuana from Medical
Marijuana Treatment Centers (MMTC):

• Cancer
• Epilepsy
• Glaucoma
• Positive status for human immunodeficiency virus
• Acquired immune deficiency syndrome
• Post-traumatic stress disorder
• Amyotrophic lateral sclerosis
• Crohn’s disease
• Parkinson’s disease
• Multiple sclerosis
• Medical conditions of the same kind or class as or comparable to those enumerated above

The legislature executed this constitutional provision by passing the Medical Use of Marijuana Act (Act) of 2017,
implemented by the Department of Health (DOH). 24

The medical use of marijuana is permitted in any form except for marijuana seeds and commercially produced
food items that do not meet the definition of edibles 25 in the Act. 26 MMTCs are authorized to produce edibles if
they obtain a food establishment permit from the Florida Department of Agriculture and Consumer Services
(DACS) before production and comply with the Florida Food Safety Act. 27 Each MMTC is also required to provide
at least one low-THC cannabis product. 28

Physician and Patient Requirements

Under current law, to obtain marijuana for medical use from a MMTC, and maintain the immunity from criminal
prosecution granted by the Constitution, the patient must obtain a physician certification from a qualified
physician 29 and an identification card from DOH. As of February 26, 2021, there are 2,630 qualified physicians
and 497,068 patients with an active identification card. 30

To certify a patient for medical use of marijuana, a qualified physician must determine that the patient has a
qualifying medical condition and that medical marijuana would likely outweigh the health risks to the patient. The
qualified physician must obtain the informed consent of the patient using a standardized form created by rule by
the Board of Medicine and the Board of Osteopathic Medicine. 31

Adequate Supply and Supply Limits

The Florida Constitution requires DOH to define an amount of marijuana that could reasonably be presumed to be
an adequate supply for a qualifying patient’s medical use. The Act executes this provision by defining time
increments for certifying and dispensing marijuana: A qualified physician may only certify a patient for three 70-
day supply limits of marijuana not in a form for smoking and six 35-day supply limits for marijuana in a form for

24 S. 381.986, F.S (2017).
25 Edibles are commercially produced food items made with marijuana oil, but no other form of marijuana, that are produced and

dispensed by MMTCs and must only be in the forms of lozenges, gelatins, baked goods, chocolates, or drink powders. See s.
381.986(1)(d), F.S. and R. 64ER20-35, F.A.C.
26 S. 381.986(1)(j), F.S.
27 S. 381.986(8)(e)8., F.S.
28 S. 381.986(8), F.S. Low-THC cannabis is defined as a plant of the genus Cannabis, the dried flowers of which contain 0.8 % or less

of tetrahydrocannabinol and more than 10 % 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. See s. 381.986(1)(e), F.S.
29 To certify patients for medical use of marijuana, a physician must hold an active, unrestricted license as an allopathic physician under

chapter 458 or as an osteopathic physician under chapter 459 and comply with certain physician education requirements. See ss.
381.986(1)m, F.S. and 381.986(3)(a), F.S.
30 Department of Health, Office of Medical Marijuana Use Weekly Updates, Feb. 26, 20201, available at https://s27415.pcdn.co/wp-

content/uploads/ommu_updates/2021/022621-OMMU-Update.pdf (last visited Mar. 2, 2021).
31 S. 381.986(4)(a)8., F.S.

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smoking 32, and requires the physician to recertify the patient every 30 weeks. In addition, the Act gives additional
guidance to DOH in complying with the constitutional directive, by requiring DOH to
set a daily dose amount limit and use the daily dose amount limit to calculate a 70-day supply of marijuana. In
2019, when the Act was amended to allow medical use of marijuana in a form for smoking, it also set the 35-day
supply of marijuana in a form for smoking (flower) of up to 2.5 ounces. 33 Current law does not have supply limits
for other products.

Consistent with the Constitution, the Act allows a qualified physician to request an exception from DOH from the
daily dose amount limit 34, and the requested amount is deemed approved if DOH fails to approve or deny the
request within 14 days. 35 The qualified physician must submit the following to DOH when requesting an
exception: 36

• The qualified patient's qualifying medical condition;
• The dosage and route of administration that was insufficient to provide relief to the qualified patient;
• A description of how the patient will benefit from an increased daily dose amount;
• The minimum daily dose amount of marijuana that would be sufficient for the treatment of the qualified
patient's qualifying medical condition; and
• The qualified patient’s records, upon the request of DOH.

To date, DOH has not set a daily dose limit amount by rule. Therefore, other than marijuana in a form for
smoking, the amount of marijuana certified and dispensed for a 70-day supply is at the sole discretion of a
qualified physician. According to the 2021 Physician Certification Pattern Review Panel 37 Report, the average
daily dose for the various routes of administration, once outliers are removed, are as follows. 38

Product Milligrams THC
Edible 175 mg
Inhalation 225 mg
Oral 197 mg
Sublingual 189 mg
Suppository 194 mg
Topical 148 mg

The report identifies the top 5 qualified physicians with the highest average daily doses per route of
administration. The daily doses of this group range from approximately 1,600 mg of THC to approximately 43,000
mg of THC or a range of 56,000 mg of THC to 5 million mg of THC over a 35-day period. 39 The report also shows
that the greatest number of certifications were issued by a small percentage of qualified physicians, a ratio that
has been increasing since 2019: 40

• 2019: 41% of certifications were issued by 4% of qualified physicians;
• 2020: 61% of certifications were issued by 9% of qualified physicians; and
• 2021: 71% of certifications were issued by 12% of qualified physicians.

Currently, 33 state have medical marijuana programs. Of these, 18 states limit the supply of THC a patient may
obtain over a set period of timer their medical marijuana programs. Some states list a single, cumulative amount,
without specifying or differentiating between different products, as follows. 41

32 S. 381.986(4)(f), F.S.
33 S. 381.986(8)(e)16.b., F.S.
34 S. 381.986(4)(f), F.S.
35 Id.
36 Id.
37 The Physician Certification Pattern Review Panel is required to review all physician certifications submitted to the medical marijuana

use registry; track and report the number of physician certifications and the qualifying medical conditions, dosage, supply amount, and
form of marijuana certified; report the data both by individual qualified physician and in the aggregate, by county, and statewide; and
submit an annual report of its findings and recommendations to the Governor, the President of the Senate, and the Speaker of the
House of Representatives.
38 Physician Certification Pattern Review 2021 Annual Report, Physician Certification Pattern Review Panel, January 2021, available at

https://flboardofmedicine.gov/pdfs/Physician-Certification-Pattern-Review-2021-Annual-Report.pdf (last visited March 6, 2021).
39 Id.
40 Id.
41 New Jersey-N.J.A.C. 8:64–10.6; Vermont-18 V.S.A. § 4474b; D.C.-D.C. Mun. Regs. Tit. 22-C, § 5608; Nevada-NAC 453A.704;

Maine-22 M.R.S.A. § 2430-C; Arkansas-Ark. Admin. Code 006.02.7-14; Arizona- A.R.S. Title 36, Ch. 28.1; Illinois-8 Ill. Adm. Code
1000.420; Massachusetts-935 CMR 501.001; Missouri-19 CSR 30-95.030; New Hampshire-N.H. Rev. Stat. § 126-X:2; Delaware-16
Del. C. § 4902A; Maryland- COMAR 10.62.01.01; Hawaii- Haw. Admin. Rules (HAR) § 11-850-92.
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35-Day Dose Limit
State
(mg THC) 42
New Jersey 11,310 mg
Vermont 11,310 mg
D.C. 22,166 mg
Nevada 25,000 mg
Maine 28,300 mg
Arkansas 30,298 mg
Arizona 30,298 mg
Illinois 30,298 mg
Massachusetts 30,298 mg
Missouri 32,625 mg
New Hampshire 33,935 mg
Delaware 36,358 mg
Maryland 42,000 mg
Hawaii 45,250 mg
Some states differentiate between products or types of products. North Dakota, for example, limits the supply to
2,333 mg of “usable marijuana” and 4,667 mg of concentrate or product (in 35 days), while Montana limits infused
products to 4,667 mg and concentrates to 46,667 mg (in 35 days). 43

Potency Limits

Current law does not regulate the THC potency of medical marijuana. THC potency levels vary greatly based
upon the product. On the low end are balms, body oil, capsules, suppositories and tinctures which contain no
more than 5% THC and on the high end there is powder which is 95% to 100% THC. 44 Marijuana concentrates 45
comprise the majority of product types available under the program and contain THC levels ranging from 60% to
90%. 46 Whole flower marijuana, whose THC content is limited by genetics, has a THC potency range of 10% to
28%. 47

Florida THC Potency Ranges 48
Product Low High
Balm 0.4% 0.9%
Body Oil 0.7% 1.2%
Capsule 0.5% 3.0%
Suppository 1.3% 3.0%
Oil (tincture) 1.3% 5.0%
Flower 10% 28%
Transdermal Patch 11% 90%
Concentrate 49 60% 90%
Powder 95% 100%

42 States have marijuana supply limits that vary in measurements, ounces versus milligrams, and the number of days allotted for such

supply. For comparative purposes, this analysis converts all supply limits to milligrams, assumes 17% THC potency and establishes a
daily dose using the formula established by the Colorado Department of Revenue. Marijuana Equivalency in Portion and Dosage,
Colorado Department of Revenue, August 2015, available at
https://www.colorado.gov/pacific/sites/default/files/MED%20Equivalency_Final%2008102015.pdf (last viewed on March 7, 2021).
43 Id. North Dakota-NDCC 19-24.1-01;Montana-MCA 50-46-319
44 See Christopher K. Ferguson, Director, OMMU, OMMU: Medical Marijuana Program Update, prepared for Florida Legislature, Feb.

2021, and Presentation to the Professions and Public Health Subcommittee on Feb. 16, 2021, slide 26.
48 Id.
49 This includes crumble, rosin, RSO, sauce, shatter, wax, inhaler, kief, vaporizer cartridge and vaporizer disposable products.

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Other state medical marijuana programs limit potency. However, the methods and product focus vary significantly,
making comparison difficult. For example, California imposes milligram-based limits on topicals, concentrates
and orally-dissolving edibles, while Delaware imposes a percentage-based cap on oils. 50 Several states limit
potency by percentage of THC in the product. New Jersey imposes a 10 percent cap on all products. 51 North
Dakota, Oregon and Michigan all impose a 6% cap on topicals. 52 Ohio imposes a 23-35 percent cap on flower,
and a 70% cap on all other products. 53

Florida law does not impose potency limits on medical marijuana products. Current law does define servings of
edibles by THC milligram amounts: each edible product may contain up to 200 mg of THC and each single
serving portion of an edible may contain up to 10 mg. of THC, with a variance of up to 15 percent of the THC limit
per product or single serving portion. 54 These are serving increments, not supply limits or daily doses.

Testing

Presently, processed marijuana products must be tested for contaminants that are harmful for human
consumption and to ensure that products meet the THC and CBD potency requirements. 55 The DOH must adopt
rules determining what contaminants must be tested for and at what levels such contaminants are unsafe for
human consumption, as well as rules for treatment of marijuana products that fail the safety and potency
requirements. 56

Current law also requires the DACS to assist the DOH in developing rules for testing edibles. 57 It further
authorizes the DOH to select random samples of edible products available for purchase for testing to determine
whether the THC and CBD potency level on the label is accurate and whether the edible is safe for human
consumption. Edibles that fail to meet the safety and potency requirements must be recalled along with all edibles
made from the same batch of marijuana. 58

Each MMTC is required to contract with a certified marijuana testing laboratory (CMTL) to test processed
marijuana before it is dispensed. 59 Testing results must indicate that the low-THC cannabis meets the statutory
definition; THC potency meets statutory requirements; THC and CBD are labelled accurately; and the marijuana
is safe for human consumption and free from contaminants that are unsafe for human consumption. 60

The Office of Medical Marijuana Use (OMMU), housed within the DOH, licenses and regulates CMTLs in the state
of Florida. To qualify, a laboratory must have a DOH-approved accreditation or certification by a DOH-approved
accreditation or certification body, and must meet additional requirements specific to marijuana testing
established by DOH in rule. 61 As of March 2021, the OMMU has certified the following CMTLs: 62

• AccuScience Laboratories
• ACS Laboratory
• Green Scientific
• Kaycha Labs Davie
• Kaycha Labs Gainesville
• Modern Canna Labs

47 Id.
48 Id.
49 This includes crumble, rosin, RSO, sauce, shatter, wax, inhaler, kief, vaporizer cartridge and vaporizer disposable products.
50 California-17 CCR § 40315; Delaware- 16 Del. C. § 4902A.
51 The rule expressly prohibiting any medical product to have a THC potency greater than 10% was repealed. However, N.J.A.C. 8:64–

10.6(c)5. currently provides that each package of medicinal marijuana that an alternative treatment center prepares to dispense must
have a label that contains “[t]he cannabinoid profile of the medicinal marijuana contained within the package, including THC level not to
exceed 10 percent.”
52 North Dakota- NDCC 19-24.1-01; Oregon-OAR 333-007-0220; Michigan- M.C.L.A. 333.26421.
53 Ohio- OAC 3796:3-2-07.
54 S. 381.986(8)(e)8., F.S.
55 S. 381.986(8)(e)11.d., F.S.
56 Id.
57 Id.
58 Id.
59 Id.
60 Id.
61 S. 381.988, F.S.
62 OMMU: Certified Marijuana Testing Laboratories, https://knowthefactsmmj.com/cmtl/ (last visited Mar. 2, 2021).

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Conflicts of Interest

Currently, a MMTC, and any individual or entity who directly or indirectly owns, controls, or holds with power to
vote 5 percent or more of the voting shares of a medical marijuana treatment center, may not acquire direct or
indirect ownership or control of any voting shares or other form of ownership of any other MMTC. 63 A MMTC may
also not own or control a CMTL. 64

There is no prohibition against a MMTC employing a qualified physician or having a direct or indirect economical
interest in a qualified physicians’ practice or for a CMTL from having a direct or indirect economical interest in a
MMTC.

Advertising

MMTCs are currently prohibited from engaging in advertising that is visible to members of the public from any
street, sidewalk, park, or other public place, except they may: 65

o All advertisements are approved by the DOH;
o An advertisement’s content does not specifically target individuals under the age of 18;
o An advertisement is not an unsolicited pop-up advertisement; and
o Any opt-in marketing includes an easy and permanent opt-out feature.

These regulations do not address radio or television advertisements.

Current law does not address advertising by a qualified physician with respect to his or her practice relating to
marijuana for medical use.

Effect of Proposed Changes

The bill’s provisions have two different effective dates, to allow sufficient time for the medical marijuana industry to
come into compliance with certain provisions.

Effective July 1, 2022

Supply and Potency Limits

HB 1455 limits the 35-day supply of marijuana that a qualified physician may certify to 15,000 mg of THC and
limits the potency a qualified physician may certify for marijuana in a form for smoking to 10 percent THC and 60
percent THC in the final product for all other forms of marijuana, excluding edibles. Similarly, the bill limits the
amount of marijuana a MMTC may dispense within any 70-day period to two 35-day supplies and prohibits
MMTCs from dispensing marijuana with potency greater than 10 percent THC for smokeable marijuana and 60
percent THC in the final product for all other forms of marijuana, excluding edibles. The bill provides an exception
to the potency limits for terminal patients.

The bill prohibits qualified physicians from certifying qualified patients under the age of 18 for marijuana, other
than low-THC cannabis, unless the qualified physician determines that it is the most effective treatment for the
patient and a second physician, who is a board-certified pediatrician, concurs with such determination.
marijuana, excluding edibles, unless the qualified physician certifies that the qualified patient is terminally ill.

Effective July 1, 2021

Testing

63 S. 381.986(8)(e)2., F.S.
64 S. 381.988(1)(a).
65 S. 381.986(8)(h), F.S.

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The bill requires MMTCs to test all forms of its marijuana, not only processed marijuana, to ensure that it meets
safety and potency requirements before it is dispensed. The bill requires MMTCs to recall all forms of marijuana
that fail to meet the safety and potency requirements, rather than only edibles.

The bill authorizes the DOH to select available samples of all forms of marijuana available in a cultivation facility,
processing facility, or for purchase for testing to determine that the marijuana is safe for human consumption and
that the THC and CBD potency level on the label is accurate or to verify medical marijuana testing laboratory
results. The bill also authorizes the DOH to sample marijuana delivery devices from a dispensing facility to
determine that the marijuana delivery device is safe for use by qualified patients. The bill permits the DOH,
including employees acting within the scope of their employment, to acquire, possess, test, transport, and lawfully
dispose of marijuana.

Conflicts of Interest

The bill prohibits MMTCs and certain other individuals and entities from employing qualified physicians or having
direct or indirect economic interests in qualified physician practices or medical marijuana testing laboratories. This
aligns with the reverse provisions in current law (prohibiting a qualified physician from having an economic
interest in a MMTC). The bill also prohibits a CMTL from having a direct or indirect economic interest in, or
financial relationship with, a MMTC.

Advertising

With respect to his or her practice relating to marijuana for medical use, the bill prohibits a qualified physician
from engaging in radio or television advertising and other specified advertising, except he or she may:

• Have a sign on the outside or hanging in the window of the premises which identifies the dispensary by
the licensee’s business name, a department-approved trade name, or a department-approved logo, as
long as the trade name and logo does not contain wording or images commonly associated with
marketing targeted toward children or which promote the recreational use of marijuana; and
• Engage in Internet advertising and marketing under the following conditions:
o All advertisements are approved by the DOH;
o An advertisement’s content does not specifically target individuals under the age of 18;
o An advertisement is not an unsolicited pop-up advertisement; and
o Any opt-in marketing includes an easy and permanent opt-out feature.

The bill expands advertising requirements for MMTCs to include prohibitions against radio and television
advertising so that the advertising restrictions for MMTCS are identical to those for qualified physicians.

The bill provides an effective date of July 1, 2021, except as otherwise provided.

B. SECTION DIRECTORY:
Section 1: Amends s. 381.986, F.S., relating to medical use of marijuana.
Section 2: Amends s. 381.986, F.S., relating to medical use of marijuana.
Section 3: Amends s. 381.988, F.S., relating to medical marijuana testing laboratories; marijuana tests
conducted by a certified laboratory.
Section 4: Provides an effective date of July 1, 2021, except as otherwise provided.

II. FISCAL ANALYSIS & ECONOMIC IMPACT STATEMENT

A. FISCAL IMPACT ON STATE GOVERNMENT:

1. Revenues:
None.

2. Expenditures:
The bill has a significant, indeterminate negative fiscal impact on DOH related to IT system enhancements.

B. FISCAL IMPACT ON LOCAL GOVERNMENTS:

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1. Revenues:
None.

2. Expenditures:
None.

C. DIRECT ECONOMIC IMPACT ON PRIVATE SECTOR:
MMTCs may experience costs associated with complying with the THC limits for marijuana established by the bill.

D. FISCAL COMMENTS:
None.

III. COMMENTS

A. CONSTITUTIONAL ISSUES:

1. Applicability of Municipality/County Mandates Provision:
Not Applicable. This bill does not appear to affect county or municipal governments.

2. Other:
None.

B. RULE-MAKING AUTHORITY:
Current law currently provides the DOH sufficient rulemaking authority to implement the bill.

C. DRAFTING ISSUES OR OTHER COMMENTS:
None.

IV. AMENDMENTS/ COMMITTEE SUBSTITUTE CHANGES

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C. DRAFTING ISSUES OR OTHER COMMENTS:
None.

IV. AMENDMENTS/ COMMITTEE SUBSTITUTE CHANGES

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F L O R I D A H O U S E O F R E P R E S E N T A T I V E S

HB 1455 2021

1 A bill to be entitled
2 An act relating to the regulation of medical
3 marijuana; amending s. 381.986, F.S.; providing a
4 definition; prohibiting qualified physicians from
5 engaging in certain advertising for their practices
6 relating to marijuana for medical use; providing
7 exceptions; prohibiting medical marijuana treatment
8 centers and certain other individuals and entities
9 from employing qualified physicians or having direct
10 or indirect economic interests in qualified physician
11 practices and medical marijuana testing laboratories;
12 revising a provision relating to the potency of
13 tetrahydrocannabinol in edibles dispensed by a medical
14 marijuana treatment center; authorizing the Department
15 of Health to select samples of marijuana available in
16 certain facilities for testing for specified purposes;
17 authorizing the department to sample marijuana
18 delivery devices from a dispensing facility to
19 determine safety; requiring that a medical marijuana
20 treatment center recall all marijuana, rather than
21 only edibles, under certain circumstances; revising
22 advertising requirements for medical marijuana
23 treatment centers to prohibit radio and television
24 advertising; authorizing the department and certain
25 employees to acquire, possess, test, transport, and

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26 dispose of marijuana; prohibiting a qualified
27 physician from issuing a physician certification to a
28 minor patient for marijuana, except for low-THC
29 cannabis; providing an exception; revising the supply
30 limits of marijuana for which a physician
31 certification may be issued; limiting the potency of
32 tetrahydrocannabinol in such supply; prohibiting a
33 qualified physician from certifying a certain potency
34 of tetrahydrocannabinol in marijuana; providing an
35 exception; prohibiting a medical marijuana treatment
36 center from dispensing a certain daily supply within a
37 specified period to conform to changes made by the
38 act; prohibiting a medical marijuana treatment center
39 from dispensing marijuana that exceeds a certain
40 potency of tetrahydrocannabinol; providing an
41 exception; amending s. 381.988, F.S.; prohibiting a
42 certified medical marijuana testing laboratory from
43 having an economic interest in or financial
44 relationship with a medical marijuana treatment
45 center; providing construction; authorizing the
46 department and certain employees to acquire, possess,
47 test, transport, and dispose of marijuana; providing
48 effective dates.
49
50 Be It Enacted by the Legislature of the State of Florida:

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51
52 Section 1. Paragraphs (l) through (o) of subsection (1) of
53 section 381.986, Florida Statutes, are redesignated as
54 paragraphs (m) through (p), respectively, paragraph (a) of
55 subsection (3) and paragraphs (e) and (h) of subsection (8) are
56 amended, and a new paragraph (l) is added to subsection (1),
57 paragraph (d) is added to subsection (3), and paragraph (i) is
58 added to subsection (14) of that section, to read:
59 381.986 Medical use of marijuana.—
60 (1) DEFINITIONS.—As used in this section, the term:
61 (l) "Potency" means the relative strength of cannabinoids,
62 and the total amount, in milligrams, of tetrahydrocannabinol as
63 the sum of delta-9-tetrahydrocannabinol plus (0.877 multiplied
64 by tetrahydrocannabinolic acid plus delta-8-
65 tetrahydrocannabinol) and cannabidiol as the sum of cannabidiol
66 plus (0.877 multiplied by cannabidiolic acid) in the final
67 product dispensed to a patient or caregiver.
68 (3) QUALIFIED PHYSICIANS AND MEDICAL DIRECTORS.—
69 (a) Before being approved as a qualified physician, as
70 defined in paragraph (1)(m), and before each license renewal, a
71 physician must successfully complete a 2-hour course and
72 subsequent examination offered by the Florida Medical
73 Association or the Florida Osteopathic Medical Association which
74 encompass the requirements of this section and any rules adopted
75 hereunder. The course and examination shall be administered at

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76 least annually and may be offered in a distance learning format,
77 including an electronic, online format that is available upon
78 request. The price of the course may not exceed $500. A
79 physician who has met the physician education requirements of
80 former s. 381.986(4), Florida Statutes 2016, before June 23,
81 2017, shall be deemed to be in compliance with this paragraph
82 from June 23, 2017, until 90 days after the course and
83 examination required by this paragraph become available.
84 (d) With respect to his or her practice relating to
85 marijuana for medical use under this section, a qualified
86 physician may not engage in radio or television advertising or
87 advertising that is visible to members of the public from any
88 street, sidewalk, park, or other public place, except:
89 1. The qualified physician's practice may have a sign that
90 is affixed to the outside or hanging in the window of the
91 premises which identifies the qualified physician, a department-
92 approved practice name, or a department-approved logo. A
93 qualified physician's practice name and logo may not contain
94 wording or images commonly associated with marketing targeted
95 toward children or which promote the recreational use of
96 marijuana.
97 2. A qualified physician may engage in Internet
98 advertising and marketing for his or her practice under the
99 following conditions:
100 a. All advertisements must be approved by the department.

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101 b. An advertisement may not have any content that
102 specifically targets individuals under the age of 18, including
103 cartoon characters or similar images.
104 c. An advertisement may not be an unsolicited pop-up
105 advertisement.
106 d. Opt-in marketing must include an easy and permanent
107 opt-out feature.
108 (8) MEDICAL MARIJUANA TREATMENT CENTERS.—
109 (e) A licensed medical marijuana treatment center shall
110 cultivate, process, transport, and dispense marijuana for
111 medical use. A licensed medical marijuana treatment center may
112 not contract for services directly related to the cultivation,
113 processing, and dispensing of marijuana or marijuana delivery
114 devices, except that a medical marijuana treatment center
115 licensed pursuant to subparagraph (a)1. may contract with a
116 single entity for the cultivation, processing, transporting, and
117 dispensing of marijuana and marijuana delivery devices. A
118 licensed medical marijuana treatment center must, at all times,
119 maintain compliance with the criteria demonstrated and
120 representations made in the initial application and the criteria
121 established in this subsection. Upon request, the department may
122 grant a medical marijuana treatment center a variance from the
123 representations made in the initial application. Consideration
124 of such a request shall be based upon the individual facts and
125 circumstances surrounding the request. A variance may not be

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126 granted unless the requesting medical marijuana treatment center
127 can demonstrate to the department that it has a proposed
128 alternative to the specific representation made in its
129 application which fulfills the same or a similar purpose as the
130 specific representation in a way that the department can
131 reasonably determine will not be a lower standard than the
132 specific representation in the application. A variance may not
133 be granted from the requirements in subparagraph 2. and
134 subparagraphs (b)1. and 2.
135 1. A licensed medical marijuana treatment center may
136 transfer ownership to an individual or entity who meets the
137 requirements of this section. A publicly traded corporation or
138 publicly traded company that meets the requirements of this
139 section is not precluded from ownership of a medical marijuana
140 treatment center. To accommodate a change in ownership:
141 a. The licensed medical marijuana treatment center shall
142 notify the department in writing at least 60 days before the
143 anticipated date of the change of ownership.
144 b. The individual or entity applying for initial licensure
145 due to a change of ownership must submit an application that
146 must be received by the department at least 60 days before the
147 date of change of ownership.
148 c. Upon receipt of an application for a license, the
149 department shall examine the application and, within 30 days
150 after receipt, notify the applicant in writing of any apparent

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151 errors or omissions and request any additional information
152 required.
153 d. Requested information omitted from an application for
154 licensure must be filed with the department within 21 days after
155 the department's request for omitted information or the
156 application shall be deemed incomplete and shall be withdrawn
157 from further consideration and the fees shall be forfeited.
158
159 Within 30 days after the receipt of a complete application, the
160 department shall approve or deny the application.
161 2. A medical marijuana treatment center, and any
162 individual or entity who directly or indirectly owns, controls,
163 or holds with power to vote 5 percent or more of the voting
164 shares of a medical marijuana treatment center, may not acquire
165 direct or indirect ownership or control of any voting shares or
166 other form of ownership of any other medical marijuana treatment
167 center.
168 3. A medical marijuana treatment center and any individual
169 or entity that directly or indirectly owns, controls, or holds
170 with power to vote 5 percent or more of the voting shares of a
171 medical marijuana treatment center may not employ a qualified
172 physician or have any direct or indirect economic interest in a
173 qualified physician's practice or a marijuana testing
174 laboratory.
175 4.3. A medical marijuana treatment center may not enter

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176 into any form of profit-sharing arrangement with the property
177 owner or lessor of any of its facilities where cultivation,
178 processing, storing, or dispensing of marijuana and marijuana
179 delivery devices occurs.
180 5.4. All employees of a medical marijuana treatment center
181 must be 21 years of age or older and have passed a background
182 screening pursuant to subsection (9).
183 6.5. Each medical marijuana treatment center must adopt
184 and enforce policies and procedures to ensure employees and
185 volunteers receive training on the legal requirements to
186 dispense marijuana to qualified patients.
187 7.6. When growing marijuana, a medical marijuana treatment
188 center:
189 a. May use pesticides determined by the department, after
190 consultation with the Department of Agriculture and Consumer
191 Services, to be safely applied to plants intended for human
192 consumption, but may not use pesticides designated as
193 restricted-use pesticides pursuant to s. 487.042.
194 b. Must grow marijuana within an enclosed structure and in
195 a room separate from any other plant.
196 c. Must inspect seeds and growing plants for plant pests
197 that endanger or threaten the horticultural and agricultural
198 interests of the state in accordance with chapter 581 and any
199 rules adopted thereunder.
200 d. Must perform fumigation or treatment of plants, or

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201 remove and destroy infested or infected plants, in accordance
202 with chapter 581 and any rules adopted thereunder.
203 8.7. Each medical marijuana treatment center must produce
204 and make available for purchase at least one low-THC cannabis
205 product.
206 9.8. A medical marijuana treatment center that produces
207 edibles must hold a permit to operate as a food establishment
208 pursuant to chapter 500, the Florida Food Safety Act, and must
209 comply with all the requirements for food establishments
210 pursuant to chapter 500 and any rules adopted thereunder.
211 Edibles may not contain more than 200 milligrams of
212 tetrahydrocannabinol, and a single serving portion of an edible
213 may not exceed 10 milligrams of tetrahydrocannabinol. Edibles
214 may have a potency variance of no greater than 15 percent of the
215 10 milligrams of tetrahydrocannabinol per single serving limit
216 or 15 percent of the 200 milligrams of tetrahydrocannabinol per
217 product limit. Edibles may not be attractive to children; be
218 manufactured in the shape of humans, cartoons, or animals; be
219 manufactured in a form that bears any reasonable resemblance to
220 products available for consumption as commercially available
221 candy; or contain any color additives. To discourage consumption
222 of edibles by children, the department shall determine by rule
223 any shapes, forms, and ingredients allowed and prohibited for
224 edibles. Medical marijuana treatment centers may not begin
225 processing or dispensing edibles until after the effective date

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226 of the rule. The department shall also adopt sanitation rules
227 providing the standards and requirements for the storage,
228 display, or dispensing of edibles.
229 10.9. Within 12 months after licensure, a medical
230 marijuana treatment center must demonstrate to the department
231 that all of its processing facilities have passed a Food Safety
232 Good Manufacturing Practices, such as Global Food Safety
233 Initiative or equivalent, inspection by a nationally accredited
234 certifying body. A medical marijuana treatment center must
235 immediately stop processing at any facility which fails to pass
236 this inspection until it demonstrates to the department that
237 such facility has met this requirement.
238 11.10. A medical marijuana treatment center that produces
239 prerolled marijuana cigarettes may not use wrapping paper made
240 with tobacco or hemp.
241 12.11. When processing marijuana, a medical marijuana
242 treatment center must:
243 a. Process the marijuana within an enclosed structure and
244 in a room separate from other plants or products.
245 b. Comply with department rules when processing marijuana
246 with hydrocarbon solvents or other solvents or gases exhibiting
247 potential toxicity to humans. The department shall determine by
248 rule the requirements for medical marijuana treatment centers to
249 use such solvents or gases exhibiting potential toxicity to
250 humans.

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251 c. Comply with federal and state laws and regulations and
252 department rules for solid and liquid wastes. The department
253 shall determine by rule procedures for the storage, handling,
254 transportation, management, and disposal of solid and liquid
255 waste generated during marijuana production and processing. The
256 Department of Environmental Protection shall assist the
257 department in developing such rules.
258 13.d. A medical marijuana treatment center must test the
259 processed marijuana using a medical marijuana testing laboratory
260 before it is dispensed. Results must be verified and signed by
261 two medical marijuana treatment center employees. Before
262 dispensing, the medical marijuana treatment center must
263 determine that the test results indicate that low-THC cannabis
264 meets the definition of low-THC cannabis, the concentration of
265 tetrahydrocannabinol meets the potency requirements of this
266 section, the labeling of the concentration of
267 tetrahydrocannabinol and cannabidiol is accurate, and all
268 marijuana is safe for human consumption and free from
269 contaminants that are unsafe for human consumption. The
270 department shall determine by rule which contaminants must be
271 tested for and the maximum levels of each contaminant which are
272 safe for human consumption. The Department of Agriculture and
273 Consumer Services shall assist the department in developing the
274 testing requirements for contaminants that are unsafe for human
275 consumption in edibles. The department shall also determine by

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276 rule the procedures for the treatment of marijuana that fails to
277 meet the testing requirements of this section, s. 381.988, or
278 department rule. The department may select samples of marijuana
279 a random sample from edibles available in a cultivation
280 facility, processing facility, or for purchase in a dispensing
281 facility which shall be tested by the department to determine
282 that the marijuana edible meets the potency requirements of this
283 section, is safe for human consumption, and the labeling of the
284 tetrahydrocannabinol and cannabidiol concentration is accurate
285 or to verify medical marijuana testing laboratory results. The
286 department may also sample marijuana delivery devices from a
287 dispensing facility to determine that the marijuana delivery
288 device is safe for use by qualified patients. A medical
289 marijuana treatment center may not require payment from the
290 department for the sample. A medical marijuana treatment center
291 must recall all marijuana which fails edibles, including all
292 edibles made from the same batch of marijuana, which fail to
293 meet the potency requirements of this section, which is are
294 unsafe for human consumption, or for which the labeling of the
295 tetrahydrocannabinol and cannabidiol concentration is
296 inaccurate. The medical marijuana treatment center must retain
297 records of all testing and samples of each homogenous batch of
298 marijuana for at least 9 months. The medical marijuana treatment
299 center must contract with a marijuana testing laboratory to
300 perform audits on the medical marijuana treatment center's

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301 standard operating procedures, testing records, and samples and
302 provide the results to the department to confirm that the
303 marijuana or low-THC cannabis meets the requirements of this
304 section and that the marijuana or low-THC cannabis is safe for
305 human consumption. A medical marijuana treatment center shall
306 reserve two processed samples from each batch and retain such
307 samples for at least 9 months for the purpose of such audits. A
308 medical marijuana treatment center may use a laboratory that has
309 not been certified by the department under s. 381.988 until such
310 time as at least one laboratory holds the required
311 certification, but in no event later than July 1, 2018.
312 14. When packaging marijuana, a medical marijuana
313 treatment center must:
314 a.e. Package the marijuana in compliance with the United
315 States Poison Prevention Packaging Act of 1970, 15 U.S.C. ss.
316 1471 et seq.
317 b.f. Package the marijuana in a receptacle that has a
318 firmly affixed and legible label stating the following
319 information:
320 (I) The marijuana or low-THC cannabis meets the
321 requirements of subparagraph 13 sub-subparagraph d.
322 (II) The name of the medical marijuana treatment center
323 from which the marijuana originates.
324 (III) The batch number and harvest number from which the
325 marijuana originates and the date dispensed.

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326 (IV) The name of the physician who issued the physician
327 certification.
328 (V) The name of the patient.
329 (VI) The product name, if applicable, and dosage form,
330 including concentration of tetrahydrocannabinol and cannabidiol.
331 The product name may not contain wording commonly associated
332 with products marketed by or to children.
333 (VII) The recommended dose.
334 (VIII) A warning that it is illegal to transfer medical
335 marijuana to another person.
336 (IX) A marijuana universal symbol developed by the
337 department.
338 15.12. The medical marijuana treatment center shall
339 include in each package a patient package insert with
340 information on the specific product dispensed related to:
341 a. Clinical pharmacology.
342 b. Indications and use.
343 c. Dosage and administration.
344 d. Dosage forms and strengths.
345 e. Contraindications.
346 f. Warnings and precautions.
347 g. Adverse reactions.
348 16.13. In addition to the packaging and labeling
349 requirements specified in subparagraphs 14. and 15., 11. and
350 12., marijuana in a form for smoking must be packaged in a

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351 sealed receptacle with a legible and prominent warning to keep
352 away from children and a warning that states marijuana smoke
353 contains carcinogens and may negatively affect health. Such
354 receptacles for marijuana in a form for smoking must be plain,
355 opaque, and white without depictions of the product or images
356 other than the medical marijuana treatment center's department-
357 approved logo and the marijuana universal symbol.
358 17.14. The department shall adopt rules to regulate the
359 types, appearance, and labeling of marijuana delivery devices
360 dispensed from a medical marijuana treatment center. The rules
361 must require marijuana delivery devices to have an appearance
362 consistent with medical use.
363 18.15. Each edible shall be individually sealed in plain,
364 opaque wrapping marked only with the marijuana universal symbol.
365 Where practical, each edible shall be marked with the marijuana
366 universal symbol. In addition to the packaging and labeling
367 requirements in subparagraphs 14. and 15. 11. and 12., edible
368 receptacles must be plain, opaque, and white without depictions
369 of the product or images other than the medical marijuana
370 treatment center's department-approved logo and the marijuana
371 universal symbol. The receptacle must also include a list of all
372 the edible's ingredients, storage instructions, an expiration
373 date, a legible and prominent warning to keep away from children
374 and pets, and a warning that the edible has not been produced or
375 inspected pursuant to federal food safety laws.

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376 19.16. When dispensing marijuana or a marijuana delivery
377 device, a medical marijuana treatment center:
378 a. May dispense any active, valid order for low-THC
379 cannabis, medical cannabis and cannabis delivery devices issued
380 pursuant to former s. 381.986, Florida Statutes 2016, which was
381 entered into the medical marijuana use registry before July 1,
382 2017.
383 b. May not dispense more than a 70-day supply of marijuana
384 within any 70-day period to a qualified patient or caregiver.
385 May not dispense more than one 35-day supply of marijuana in a
386 form for smoking within any 35-day period to a qualified patient
387 or caregiver. A 35-day supply of marijuana in a form for smoking
388 may not exceed 2.5 ounces unless an exception to this amount is
389 approved by the department pursuant to paragraph (4)(f).
390 c. Must have the medical marijuana treatment center's
391 employee who dispenses the marijuana or a marijuana delivery
392 device enter into the medical marijuana use registry his or her
393 name or unique employee identifier.
394 d. Must verify that the qualified patient and the
395 caregiver, if applicable, each have an active registration in
396 the medical marijuana use registry and an active and valid
397 medical marijuana use registry identification card, the amount
398 and type of marijuana dispensed matches the physician
399 certification in the medical marijuana use registry for that
400 qualified patient, and the physician certification has not

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401 already been filled.
402 e. May not dispense marijuana to a qualified patient who
403 is younger than 18 years of age. If the qualified patient is
404 younger than 18 years of age, marijuana may only be dispensed to
405 the qualified patient's caregiver.
406 f. May not dispense or sell any other type of cannabis,
407 alcohol, or illicit drug-related product, including pipes or
408 wrapping papers made with tobacco or hemp, other than a
409 marijuana delivery device required for the medical use of
410 marijuana and which is specified in a physician certification.
411 g. Must, upon dispensing the marijuana or marijuana
412 delivery device, record in the registry the date, time,
413 quantity, and form of marijuana dispensed; the type of marijuana
414 delivery device dispensed; and the name and medical marijuana
415 use registry identification number of the qualified patient or
416 caregiver to whom the marijuana delivery device was dispensed.
417 h. Must ensure that patient records are not visible to
418 anyone other than the qualified patient, his or her caregiver,
419 and authorized medical marijuana treatment center employees.
420 (h) A medical marijuana treatment center may not engage in
421 radio or television advertising or advertising that is visible
422 to members of the public from any street, sidewalk, park, or
423 other public place, except:
424 1. The dispensing location of a medical marijuana
425 treatment center may have a sign that is affixed to the outside

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426 or hanging in the window of the premises which identifies the
427 dispensary by the licensee's business name, a department-
428 approved trade name, or a department-approved logo. A medical
429 marijuana treatment center's trade name and logo may not contain
430 wording or images commonly associated with marketing targeted
431 toward children or which promote recreational use of marijuana.
432 2. A medical marijuana treatment center may engage in
433 Internet advertising and marketing under the following
434 conditions:
435 a. All advertisements must be approved by the department.
436 b. An advertisement may not have any content that
437 specifically targets individuals under the age of 18, including
438 cartoon characters or similar images.
439 c. An advertisement may not be an unsolicited pop-up
440 advertisement.
441 d. Opt-in marketing must include an easy and permanent
442 opt-out feature.
443 (14) EXCEPTIONS TO OTHER LAWS.—
444 (i) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or
445 any other provision of law, but subject to the requirements of
446 this section, the department, including an employee of the
447 department acting within the scope of his or her employment, may
448 acquire, possess, test, transport, and lawfully dispose of
449 marijuana as provided in this section.
450 Section 2. Effective July 1, 2022, paragraphs (g) through

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451 (k) of subsection (4) of s. 381.986, Florida Statutes, are
452 redesignated as paragraphs (h) through (l), respectively,
453 paragraphs (a), (d), and (f) of that subsection, paragraph (e)
454 of subsection (8), and paragraph (a) of subsection (14) are
455 amended, and a new paragraph (g) is added to subsection (4) of
456 that section, to read:
457 381.986 Medical use of marijuana.—
458 (4) PHYSICIAN CERTIFICATION.—
459 (a) A qualified physician may issue a physician
460 certification only if the qualified physician:
461 1. Conducted a physical examination while physically
462 present in the same room as the patient and a full assessment of
463 the medical history of the patient.
464 2. Diagnosed the patient with at least one qualifying
465 medical condition.
466 3. Determined that the medical use of marijuana would
467 likely outweigh the potential health risks for the patient, and
468 such determination must be documented in the patient's medical
469 record. If a patient is younger than 18 years of age, a second
470 physician must concur with this determination, and such
471 concurrence must be documented in the patient's medical record.
472 4. Determined whether the patient is pregnant and
473 documented such determination in the patient's medical record. A
474 physician may not issue a physician certification, except for
475 low-THC cannabis, to a patient who is pregnant.

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476 5. Reviewed the patient's controlled drug prescription
477 history in the prescription drug monitoring program database
478 established pursuant to s. 893.055.
479 6. Reviews the medical marijuana use registry and
480 confirmed that the patient does not have an active physician
481 certification from another qualified physician.
482 7. Registers as the issuer of the physician certification
483 for the named qualified patient on the medical marijuana use
484 registry in an electronic manner determined by the department,
485 and:
486 a. Enters into the registry the contents of the physician
487 certification, including the patient's qualifying condition and
488 the dosage not to exceed the daily dose amount determined by the
489 department, the amount and forms of marijuana authorized for the
490 patient, and any types of marijuana delivery devices needed by
491 the patient for the medical use of marijuana.
492 b. Updates the registry within 7 days after any change is
493 made to the original physician certification to reflect such
494 change.
495 c. Deactivates the registration of the qualified patient
496 and the patient's caregiver when the physician no longer
497 recommends the medical use of marijuana for the patient.
498 8. Obtains the voluntary and informed written consent of
499 the patient for medical use of marijuana each time the qualified
500 physician issues a physician certification for the patient,

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501 which shall be maintained in the patient's medical record. The
502 patient, or the patient's parent or legal guardian if the
503 patient is a minor, must sign the informed consent acknowledging
504 that the qualified physician has sufficiently explained its
505 content. The qualified physician must use a standardized
506 informed consent form adopted in rule by the Board of Medicine
507 and the Board of Osteopathic Medicine, which must include, at a
508 minimum, information related to:
509 a. The Federal Government's classification of marijuana as
510 a Schedule I controlled substance.
511 b. The approval and oversight status of marijuana by the
512 Food and Drug Administration.
513 c. The current state of research on the efficacy of
514 marijuana to treat the qualifying conditions set forth in this
515 section.
516 d. The potential for addiction.
517 e. The potential effect that marijuana may have on a
518 patient's coordination, motor skills, and cognition, including a
519 warning against operating heavy machinery, operating a motor
520 vehicle, or engaging in activities that require a person to be
521 alert or respond quickly.
522 f. The potential side effects of marijuana use, including
523 the negative health risks associated with smoking marijuana.
524 g. The risks, benefits, and drug interactions of
525 marijuana.

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526 h. That the patient's de-identified health information
527 contained in the physician certification and medical marijuana
528 use registry may be used for research purposes.
529 (d) A qualified physician may not issue a physician
530 certification to a patient under 18 years of age for marijuana,
531 except for low-THC cannabis, unless the qualified physician
532 determines that marijuana other than low-THC cannabis is the
533 most effective treatment for the patient and a second physician
534 who is a board-certified pediatrician concurs with such
535 determination. A qualified physician may not issue a physician
536 certification for marijuana in a form for smoking to a patient
537 under 18 years of age unless the patient is diagnosed with a
538 terminal condition, the qualified physician determines that
539 smoking is the most effective route of administration for the
540 patient, and a second physician who is a board-certified
541 pediatrician concurs with such determination. Such
542 determinations determination and concurrences concurrence must
543 be documented in the patient's medical record and in the medical
544 marijuana use registry. The certifying physician must obtain the
545 written informed consent of such patient's parent or legal
546 guardian before issuing a physician certification to the patient
547 for marijuana or marijuana in a form for smoking. The qualified
548 physician must use a standardized informed consent form adopted
549 in rule by the Board of Medicine and the Board of Osteopathic
550 Medicine which must include information concerning the negative

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551 health effects of marijuana and smoking marijuana on persons
552 under 18 years of age and an acknowledgment that the qualified
553 physician has sufficiently explained the contents of the form.
554 (f) A qualified physician may not issue a physician
555 certification for more than three 70-day supply limits of
556 marijuana or more than six 35-day supply limits of marijuana in
557 a form for smoking. The department may shall quantify by rule a
558 daily dose amount with equivalent dose amounts for each
559 allowable form of marijuana dispensed by a medical marijuana
560 treatment center. A 35-day supply of marijuana may not exceed
561 15,000 milligrams of tetrahydrocannabinol The department shall
562 use the daily dose amount to calculate a 70-day supply.
563 1. A qualified physician may request an exception to the
564 daily dose amount limit, the 35-day supply limit of marijuana in
565 a form for smoking, and the 4-ounce possession limit of
566 marijuana in a form for smoking established in paragraph
567 (14)(a). The request shall be made electronically on a form
568 adopted by the department in rule and must include, at a
569 minimum:
570 a. The qualified patient's qualifying medical condition.
571 b. The dosage and route of administration that was
572 insufficient to provide relief to the qualified patient.
573 c. A description of how the patient will benefit from an
574 increased amount.
575 d. The minimum daily dose amount of marijuana that would

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576 be sufficient for the treatment of the qualified patient's
577 qualifying medical condition.
578 2. A qualified physician must provide the qualified
579 patient's records upon the request of the department.
580 3. The department shall approve or disapprove the request
581 within 14 days after receipt of the complete documentation
582 required by this paragraph. The request shall be deemed approved
583 if the department fails to act within this time period.
584 (g) A qualified physician may not issue a physician
585 certification for marijuana that has a tetrahydrocannabinol
586 potency, by weight or volume, of greater than 10 percent for
587 marijuana in a form for smoking or greater than 60 percent in
588 the final product for all other forms of marijuana, excluding
589 edibles. A qualified physician may certify marijuana with any
590 potency of tetrahydrocannabinol, if the qualified patient is
591 diagnosed with a terminal condition and the qualified physician
592 indicates such diagnosis on the physician certification.
593 (8) MEDICAL MARIJUANA TREATMENT CENTERS.—
594 (e) A licensed medical marijuana treatment center shall
595 cultivate, process, transport, and dispense marijuana for
596 medical use. A licensed medical marijuana treatment center may
597 not contract for services directly related to the cultivation,
598 processing, and dispensing of marijuana or marijuana delivery
599 devices, except that a medical marijuana treatment center
600 licensed pursuant to subparagraph (a)1. may contract with a

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601 single entity for the cultivation, processing, transporting, and
602 dispensing of marijuana and marijuana delivery devices. A
603 licensed medical marijuana treatment center must, at all times,
604 maintain compliance with the criteria demonstrated and
605 representations made in the initial application and the criteria
606 established in this subsection. Upon request, the department may
607 grant a medical marijuana treatment center a variance from the
608 representations made in the initial application. Consideration
609 of such a request shall be based upon the individual facts and
610 circumstances surrounding the request. A variance may not be
611 granted unless the requesting medical marijuana treatment center
612 can demonstrate to the department that it has a proposed
613 alternative to the specific representation made in its
614 application which fulfills the same or a similar purpose as the
615 specific representation in a way that the department can
616 reasonably determine will not be a lower standard than the
617 specific representation in the application. A variance may not
618 be granted from the requirements in subparagraph 2. and
619 subparagraphs (b)1. and 2.
620 1. A licensed medical marijuana treatment center may
621 transfer ownership to an individual or entity who meets the
622 requirements of this section. A publicly traded corporation or
623 publicly traded company that meets the requirements of this
624 section is not precluded from ownership of a medical marijuana
625 treatment center. To accommodate a change in ownership:

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626 a. The licensed medical marijuana treatment center shall
627 notify the department in writing at least 60 days before the
628 anticipated date of the change of ownership.
629 b. The individual or entity applying for initial licensure
630 due to a change of ownership must submit an application that
631 must be received by the department at least 60 days before the
632 date of change of ownership.
633 c. Upon receipt of an application for a license, the
634 department shall examine the application and, within 30 days
635 after receipt, notify the applicant in writing of any apparent
636 errors or omissions and request any additional information
637 required.
638 d. Requested information omitted from an application for
639 licensure must be filed with the department within 21 days after
640 the department's request for omitted information or the
641 application shall be deemed incomplete and shall be withdrawn
642 from further consideration and the fees shall be forfeited.
643
644 Within 30 days after the receipt of a complete application, the
645 department shall approve or deny the application.
646 2. A medical marijuana treatment center, and any
647 individual or entity who directly or indirectly owns, controls,
648 or holds with power to vote 5 percent or more of the voting
649 shares of a medical marijuana treatment center, may not acquire
650 direct or indirect ownership or control of any voting shares or

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651 other form of ownership of any other medical marijuana treatment
652 center.
653 3. A medical marijuana treatment center and any individual
654 or entity that directly or indirectly owns, controls, or holds
655 with power to vote 5 percent or more of the voting shares of a
656 medical marijuana treatment center may not employ a qualified
657 physician or have any direct or indirect economic interest in a
658 qualified physician's practice or a marijuana testing
659 laboratory.
660 4. A medical marijuana treatment center may not enter into
661 any form of profit-sharing arrangement with the property owner
662 or lessor of any of its facilities where cultivation,
663 processing, storing, or dispensing of marijuana and marijuana
664 delivery devices occurs.
665 5. All employees of a medical marijuana treatment center
666 must be 21 years of age or older and have passed a background
667 screening pursuant to subsection (9).
668 6. Each medical marijuana treatment center must adopt and
669 enforce policies and procedures to ensure employees and
670 volunteers receive training on the legal requirements to
671 dispense marijuana to qualified patients.
672 7. When growing marijuana, a medical marijuana treatment
673 center:
674 a. May use pesticides determined by the department, after
675 consultation with the Department of Agriculture and Consumer

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676 Services, to be safely applied to plants intended for human
677 consumption, but may not use pesticides designated as
678 restricted-use pesticides pursuant to s. 487.042.
679 b. Must grow marijuana within an enclosed structure and in
680 a room separate from any other plant.
681 c. Must inspect seeds and growing plants for plant pests
682 that endanger or threaten the horticultural and agricultural
683 interests of the state in accordance with chapter 581 and any
684 rules adopted thereunder.
685 d. Must perform fumigation or treatment of plants, or
686 remove and destroy infested or infected plants, in accordance
687 with chapter 581 and any rules adopted thereunder.
688 8. Each medical marijuana treatment center must produce
689 and make available for purchase at least one low-THC cannabis
690 product.
691 9. A medical marijuana treatment center that produces
692 edibles must hold a permit to operate as a food establishment
693 pursuant to chapter 500, the Florida Food Safety Act, and must
694 comply with all the requirements for food establishments
695 pursuant to chapter 500 and any rules adopted thereunder.
696 Edibles may not contain more than 200 milligrams of
697 tetrahydrocannabinol, and a single serving portion of an edible
698 may not exceed 10 milligrams of tetrahydrocannabinol. Edibles
699 may have a potency variance of no greater than 15 percent of the
700 10 milligrams of tetrahydrocannabinol per single serving limit

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701 or 15 percent of the 200 milligrams of tetrahydrocannabinol per
702 product limit. Edibles may not be attractive to children; be
703 manufactured in the shape of humans, cartoons, or animals; be
704 manufactured in a form that bears any reasonable resemblance to
705 products available for consumption as commercially available
706 candy; or contain any color additives. To discourage consumption
707 of edibles by children, the department shall determine by rule
708 any shapes, forms, and ingredients allowed and prohibited for
709 edibles. Medical marijuana treatment centers may not begin
710 processing or dispensing edibles until after the effective date
711 of the rule. The department shall also adopt sanitation rules
712 providing the standards and requirements for the storage,
713 display, or dispensing of edibles.
714 10. Within 12 months after licensure, a medical marijuana
715 treatment center must demonstrate to the department that all of
716 its processing facilities have passed a Food Safety Good
717 Manufacturing Practices, such as Global Food Safety Initiative
718 or equivalent, inspection by a nationally accredited certifying
719 body. A medical marijuana treatment center must immediately stop
720 processing at any facility which fails to pass this inspection
721 until it demonstrates to the department that such facility has
722 met this requirement.
723 11. A medical marijuana treatment center that produces
724 prerolled marijuana cigarettes may not use wrapping paper made
725 with tobacco or hemp.

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726 12. When processing marijuana, a medical marijuana
727 treatment center must:
728 a. Process the marijuana within an enclosed structure and
729 in a room separate from other plants or products.
730 b. Comply with department rules when processing marijuana
731 with hydrocarbon solvents or other solvents or gases exhibiting
732 potential toxicity to humans. The department shall determine by
733 rule the requirements for medical marijuana treatment centers to
734 use such solvents or gases exhibiting potential toxicity to
735 humans.
736 c. Comply with federal and state laws and regulations and
737 department rules for solid and liquid wastes. The department
738 shall determine by rule procedures for the storage, handling,
739 transportation, management, and disposal of solid and liquid
740 waste generated during marijuana production and processing. The
741 Department of Environmental Protection shall assist the
742 department in developing such rules.
743 13. A medical marijuana treatment center must test
744 marijuana using a medical marijuana testing laboratory before it
745 is dispensed. Results must be verified and signed by two medical
746 marijuana treatment center employees. Before dispensing, the
747 medical marijuana treatment center must determine that the test
748 results indicate that low-THC cannabis meets the definition of
749 low-THC cannabis, the concentration of tetrahydrocannabinol
750 meets the potency requirements of this section, the labeling of

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751 the concentration of tetrahydrocannabinol and cannabidiol is
752 accurate, and all marijuana is safe for human consumption and
753 free from contaminants that are unsafe for human consumption.
754 The department shall determine by rule which contaminants must
755 be tested for and the maximum levels of each contaminant which
756 are safe for human consumption. The Department of Agriculture
757 and Consumer Services shall assist the department in developing
758 the testing requirements for contaminants that are unsafe for
759 human consumption in edibles. The department shall also
760 determine by rule the procedures for the treatment of marijuana
761 that fails to meet the testing requirements of this section, s.
762 381.988, or department rule. The department may select samples
763 of marijuana available in a cultivation facility, processing
764 facility, or for purchase in a dispensing facility which shall
765 be tested by the department to determine that the marijuana
766 meets the potency requirements of this section, is safe for
767 human consumption, and the labeling of the tetrahydrocannabinol
768 and cannabidiol concentration is accurate or to verify medical
769 marijuana testing laboratory results. The department may also
770 sample marijuana delivery devices from a dispensing facility to
771 determine that the marijuana delivery device is safe for use by
772 qualified patients. A medical marijuana treatment center may not
773 require payment from the department for the sample. A medical
774 marijuana treatment center must recall all marijuana which fails
775 to meet the potency requirements of this section, which is

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776 unsafe for human consumption, or for which the labeling of the
777 tetrahydrocannabinol and cannabidiol concentration is
778 inaccurate. The medical marijuana treatment center must retain
779 records of all testing and samples of each homogenous batch of
780 marijuana for at least 9 months. The medical marijuana treatment
781 center must contract with a marijuana testing laboratory to
782 perform audits on the medical marijuana treatment center's
783 standard operating procedures, testing records, and samples and
784 provide the results to the department to confirm that the
785 marijuana or low-THC cannabis meets the requirements of this
786 section and that the marijuana or low-THC cannabis is safe for
787 human consumption. A medical marijuana treatment center shall
788 reserve two processed samples from each batch and retain such
789 samples for at least 9 months for the purpose of such audits. A
790 medical marijuana treatment center may use a laboratory that has
791 not been certified by the department under s. 381.988 until such
792 time as at least one laboratory holds the required
793 certification, but in no event later than July 1, 2018.
794 14. When packaging marijuana, a medical marijuana
795 treatment center must:
796 a. Package the marijuana in compliance with the United
797 States Poison Prevention Packaging Act of 1970, 15 U.S.C. ss.
798 1471 et seq.
799 b. Package the marijuana in a receptacle that has a firmly
800 affixed and legible label stating the following information:

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801 (I) The marijuana or low-THC cannabis meets the
802 requirements of subparagraph 13.
803 (II) The name of the medical marijuana treatment center
804 from which the marijuana originates.
805 (III) The batch number and harvest number from which the
806 marijuana originates and the date dispensed.
807 (IV) The name of the physician who issued the physician
808 certification.
809 (V) The name of the patient.
810 (VI) The product name, if applicable, and dosage form,
811 including concentration of tetrahydrocannabinol and cannabidiol.
812 The product name may not contain wording commonly associated
813 with products marketed by or to children.
814 (VII) The recommended dose.
815 (VIII) A warning that it is illegal to transfer medical
816 marijuana to another person.
817 (IX) A marijuana universal symbol developed by the
818 department.
819 15. The medical marijuana treatment center shall include
820 in each package a patient package insert with information on the
821 specific product dispensed related to:
822 a. Clinical pharmacology.
823 b. Indications and use.
824 c. Dosage and administration.
825 d. Dosage forms and strengths.

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826 e. Contraindications.
827 f. Warnings and precautions.
828 g. Adverse reactions.
829 16. In addition to the packaging and labeling requirements
830 specified in subparagraphs 14. and 15., marijuana in a form for
831 smoking must be packaged in a sealed receptacle with a legible
832 and prominent warning to keep away from children and a warning
833 that states marijuana smoke contains carcinogens and may
834 negatively affect health. Such receptacles for marijuana in a
835 form for smoking must be plain, opaque, and white without
836 depictions of the product or images other than the medical
837 marijuana treatment center's department-approved logo and the
838 marijuana universal symbol.
839 17. The department shall adopt rules to regulate the
840 types, appearance, and labeling of marijuana delivery devices
841 dispensed from a medical marijuana treatment center. The rules
842 must require marijuana delivery devices to have an appearance
843 consistent with medical use.
844 18. Each edible shall be individually sealed in plain,
845 opaque wrapping marked only with the marijuana universal symbol.
846 Where practical, each edible shall be marked with the marijuana
847 universal symbol. In addition to the packaging and labeling
848 requirements in subparagraphs 14. and 15., edible receptacles
849 must be plain, opaque, and white without depictions of the
850 product or images other than the medical marijuana treatment

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851 center's department-approved logo and the marijuana universal
852 symbol. The receptacle must also include a list of all the
853 edible's ingredients, storage instructions, an expiration date,
854 a legible and prominent warning to keep away from children and
855 pets, and a warning that the edible has not been produced or
856 inspected pursuant to federal food safety laws.
857 19. When dispensing marijuana or a marijuana delivery
858 device, a medical marijuana treatment center:
859 a. May dispense any active, valid order for low-THC
860 cannabis, medical cannabis and cannabis delivery devices issued
861 pursuant to former s. 381.986, Florida Statutes 2016, which was
862 entered into the medical marijuana use registry before July 1,
863 2017.
864 b. May not dispense more than two 35-day supplies a 70-day
865 supply of marijuana within any 70-day period to a qualified
866 patient or caregiver. May not dispense more than one 35-day
867 supply of marijuana in a form for smoking within any 35-day
868 period to a qualified patient or caregiver. A 35-day supply of
869 marijuana in a form for smoking may not exceed 15,000 milligrams
870 of tetrahydrocannabinol 2.5 ounces unless an exception to this
871 amount is approved by the department pursuant to paragraph
872 (4)(f).
873 c. Must have the medical marijuana treatment center's
874 employee who dispenses the marijuana or a marijuana delivery
875 device enter into the medical marijuana use registry his or her

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876 name or unique employee identifier.
877 d. Must verify that the qualified patient and the
878 caregiver, if applicable, each have an active registration in
879 the medical marijuana use registry and an active and valid
880 medical marijuana use registry identification card, the amount
881 and type of marijuana dispensed matches the physician
882 certification in the medical marijuana use registry for that
883 qualified patient, and the physician certification has not
884 already been filled.
885 e. May not dispense marijuana to a qualified patient who
886 is younger than 18 years of age. If the qualified patient is
887 younger than 18 years of age, marijuana may only be dispensed to
888 the qualified patient's caregiver.
889 f. May not dispense marijuana that has a
890 tetrahydrocannabinol potency, by weight or volume, of greater
891 than 10 percent for marijuana in a form for smoking or greater
892 than 60 percent in the final product for all other forms of
893 marijuana, excluding edibles, to a qualified patient or
894 caregiver, unless the qualified physician certification
895 indicates that the qualified patient has been diagnosed with a
896 terminal condition.
897 g.f. May not dispense or sell any other type of cannabis,
898 alcohol, or illicit drug-related product, including pipes or
899 wrapping papers made with tobacco or hemp, other than a
900 marijuana delivery device required for the medical use of

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HB 1455 2021

901 marijuana and which is specified in a physician certification.
902 h.g. Must, upon dispensing the marijuana or marijuana
903 delivery device, record in the registry the date, time,
904 quantity, and form of marijuana dispensed; the type of marijuana
905 delivery device dispensed; and the name and medical marijuana
906 use registry identification number of the qualified patient or
907 caregiver to whom the marijuana delivery device was dispensed.
908 i.h. Must ensure that patient records are not visible to
909 anyone other than the qualified patient, his or her caregiver,
910 and authorized medical marijuana treatment center employees.
911 (14) EXCEPTIONS TO OTHER LAWS.—
912 (a) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or
913 any other provision of law, but subject to the requirements of
914 this section, a qualified patient and the qualified patient's
915 caregiver may purchase from a medical marijuana treatment center
916 for the patient's medical use a marijuana delivery device and up
917 to the amount of marijuana authorized in the physician
918 certification, but may not possess more than two 35-day supplies
919 a 70-day supply of marijuana, or the greater of 4 ounces of
920 marijuana in a form for smoking or an amount of marijuana in a
921 form for smoking approved by the department pursuant to
922 paragraph (4)(f), at any given time and all marijuana purchased
923 must remain in its original packaging.

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HB 1455 2021

924 Section 3. Subsection (11) of section 381.988, Florida
925 Statutes, is renumbered as subsection (13), and new subsections
926 (11) and (12) are added to that section, to read:
927 381.988 Medical marijuana testing laboratories; marijuana
928 tests conducted by a certified laboratory.—
929 (11) A certified medical marijuana testing laboratory and
930 its officers, directors, and employees may not have a direct or
931 indirect economic interest in, or financial relationship with, a
932 medical marijuana treatment center. Nothing in this subsection
933 may be construed to prohibit a certified medical marijuana
934 testing laboratory from contracting with a medical marijuana
935 treatment center to provide testing services.
936 (12) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or
937 any other provision of law, but subject to the requirements of
938 this section, the department, including an employee of the
939 department acting within the scope of his or her employment, may
940 acquire, possess, test, transport, and lawfully dispose of
941 marijuana as provided in this section.
942 Section 4. Except as otherwise expressly provided in this
943 act, this act shall take effect July 1, 2021.

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COMMITTEE/SUBCOMMITTEE AMENDMENT
Bill No. HB 1455 (2021)
Amendment No. 1

COMMITTEE/SUBCOMMITTEE ACTION
ADOPTED (Y/N)
ADOPTED AS AMENDED (Y/N)
ADOPTED W/O OBJECTION (Y/N)
FAILED TO ADOPT (Y/N)
WITHDRAWN (Y/N)
OTHER

1 Committee/Subcommittee hearing bill: Professions & Public
2 Health Subcommittee
3 Representative Eskamani offered the following:
4
5 Amendment (with directory and title amendments)
6 Between lines 107 and 108, insert:
7 (7) IDENTIFICATION CARDS.—
8 (a) The department shall issue medical marijuana use
9 registry identification cards for qualified patients and
10 caregivers who are residents of this state, which must be
11 renewed every 2 years annually. The identification cards must be
12 resistant to counterfeiting and tampering and must include, at a
13 minimum, the following:
14 1. The name, address, and date of birth of the qualified
15 patient or caregiver.
16 2. A full-face, passport-type, color photograph of the
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COMMITTEE/SUBCOMMITTEE AMENDMENT
Bill No. HB 1455 (2021)
Amendment No. 1

17 qualified patient or caregiver taken within the 90 days
18 immediately preceding registration or the Florida driver license
19 or Florida identification card photograph of the qualified
20 patient or caregiver obtained directly from the Department of
21 Highway Safety and Motor Vehicles.
22 3. Identification as a qualified patient or a caregiver.
23 4. The unique numeric identifier used for the qualified
24 patient in the medical marijuana use registry.
25 5. For a caregiver, the name and unique numeric identifier
26 of the caregiver and the qualified patient or patients that the
27 caregiver is assisting.
28 6. The expiration date of the identification card.
29
30 -----------------------------------------------------
31 D I R E C T O R Y A M E N D M E N T
32 Remove line 55 and insert:
33 subsection (3), paragraph (a) of subsection (7), and paragraphs
34 (e) and (h) of subsection (8) are
35
36 -----------------------------------------------------
37 T I T L E A M E N D M E N T
38 Remove line 7 and insert:
39 exceptions; revising the frequency with which medical
40 marijuana use registry identification cards must be
41 renewed; prohibiting medical marijuana treatment
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COMMITTEE/SUBCOMMITTEE AMENDMENT
Bill No. HB 1455 (2021)
Amendment No. 2

COMMITTEE/SUBCOMMITTEE ACTION
ADOPTED (Y/N)
ADOPTED AS AMENDED (Y/N)
ADOPTED W/O OBJECTION (Y/N)
FAILED TO ADOPT (Y/N)
WITHDRAWN (Y/N)
OTHER

1 Committee/Subcommittee hearing bill: Professions & Public
2 Health Subcommittee
3 Representative Rayner offered the following:
4
5 Amendment (with directory and title amendments)
6 Between lines 107 and 108, insert:
7 (4) PHYSICIAN CERTIFICATION.—
8 (a) A qualified physician may issue a physician
9 certification only if the qualified physician:
10 1. Conducted a physical examination for the initial
11 patient visit while physically present in the same room as the
12 patient and a full assessment of the medical history of the
13 patient. Telehealth may be used to issue a physician
14 certification for an existing qualified patient with an existing
15 certification that was issued by that qualified physician

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COMMITTEE/SUBCOMMITTEE AMENDMENT
Bill No. HB 1455 (2021)
Amendment No. 2

16 without the need to conduct a physical examination while
17 physically present in the same room as the patient.
18 2. Diagnosed the patient with at least one qualifying
19 medical condition.
20 3. Determined that the medical use of marijuana would
21 likely outweigh the potential health risks for the patient, and
22 such determination must be documented in the patient's medical
23 record. If a patient is younger than 18 years of age, a second
24 physician must concur with this determination, and such
25 concurrence must be documented in the patient's medical record.
26 4. Determined whether the patient is pregnant and
27 documented such determination in the patient's medical record. A
28 physician may not issue a physician certification, except for
29 low-THC cannabis, to a patient who is pregnant.
30 5. Reviewed the patient's controlled drug prescription
31 history in the prescription drug monitoring program database
32 established pursuant to s. 893.055.
33 6. Reviews the medical marijuana use registry and
34 confirmed that the patient does not have an active physician
35 certification from another qualified physician.
36 7. Registers as the issuer of the physician certification
37 for the named qualified patient on the medical marijuana use
38 registry in an electronic manner determined by the department,
39 and:

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COMMITTEE/SUBCOMMITTEE AMENDMENT
Bill No. HB 1455 (2021)
Amendment No. 2

40 a. Enters into the registry the contents of the physician
41 certification, including the patient's qualifying condition and
42 the dosage not to exceed the daily dose amount determined by the
43 department, the amount and forms of marijuana authorized for the
44 patient, and any types of marijuana delivery devices needed by
45 the patient for the medical use of marijuana.
46 b. Updates the registry within 7 days after any change is
47 made to the original physician certification to reflect such
48 change.
49 c. Deactivates the registration of the qualified patient
50 and the patient's caregiver when the physician no longer
51 recommends the medical use of marijuana for the patient.
52 8. Obtains the voluntary and informed written consent of
53 the patient for medical use of marijuana each time the qualified
54 physician issues a physician certification for the patient,
55 which shall be maintained in the patient's medical record. The
56 patient, or the patient's parent or legal guardian if the
57 patient is a minor, must sign the informed consent acknowledging
58 that the qualified physician has sufficiently explained its
59 content. The qualified physician must use a standardized
60 informed consent form adopted in rule by the Board of Medicine
61 and the Board of Osteopathic Medicine, which must include, at a
62 minimum, information related to:
63 a. The Federal Government's classification of marijuana as
64 a Schedule I controlled substance.
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Bill No. HB 1455 (2021)
Amendment No. 2

65 b. The approval and oversight status of marijuana by the
66 Food and Drug Administration.
67 c. The current state of research on the efficacy of
68 marijuana to treat the qualifying conditions set forth in this
69 section.
70 d. The potential for addiction.
71 e. The potential effect that marijuana may have on a
72 patient's coordination, motor skills, and cognition, including a
73 warning against operating heavy machinery, operating a motor
74 vehicle, or engaging in activities that require a person to be
75 alert or respond quickly.
76 f. The potential side effects of marijuana use, including
77 the negative health risks associated with smoking marijuana.
78 g. The risks, benefits, and drug interactions of
79 marijuana.
80 h. That the patient's de-identified health information
81 contained in the physician certification and medical marijuana
82 use registry may be used for research purposes.
83
84 -----------------------------------------------------
85 D I R E C T O R Y A M E N D M E N T
86 Remove line 55 and insert:
87 subsection (3), paragraph (a) of subsection (4), and paragraphs
88 (e) and (h) of subsection (8) are
89
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COMMITTEE/SUBCOMMITTEE AMENDMENT
Bill No. HB 1455 (2021)
Amendment No. 2

90 -----------------------------------------------------
91 T I T L E A M E N D M E N T
92 Remove line 4 and insert:
93 definition; revising and providing conditions for a
94 qualified physician to issue a physician
95 certification; prohibiting qualified physicians from

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COMMITTEE/SUBCOMMITTEE AMENDMENT
Bill No. HB 1455 (2021)
Amendment No. 3

COMMITTEE/SUBCOMMITTEE ACTION
ADOPTED (Y/N)
ADOPTED AS AMENDED (Y/N)
ADOPTED W/O OBJECTION (Y/N)
FAILED TO ADOPT (Y/N)
WITHDRAWN (Y/N)
OTHER

1 Committee/Subcommittee hearing bill: Professions & Public
2 Health Subcommittee
3 Representative Eskamani offered the following:
4
5 Amendment (with directory and title amendments)
6 Between lines 457 and 458, insert:
7 (2) QUALIFYING MEDICAL CONDITIONS.—A patient must be
8 diagnosed with at least one of the following conditions to
9 qualify to receive marijuana or a marijuana delivery device:
10 (n) Addiction to or dependence on an opioid drug.
11
12 -----------------------------------------------------
13 D I R E C T O R Y A M E N D M E N T
14 Remove line 455 and insert:
15 amended, and a new paragraph (n) is added to subsection (2) and
16 a new paragraph (g) is added to subsection (4) of
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COMMITTEE/SUBCOMMITTEE AMENDMENT
Bill No. HB 1455 (2021)
Amendment No. 3

17
18 -----------------------------------------------------
19 T I T L E A M E N D M E N T
20 Remove line 3 and insert:
21 marijuana; amending s. 381.986, F.S.; providing that
22 addiction to or dependence on an opioid drug is a
23 qualifying condition to receive marijuana or a
24 marijuana delivery device; providing a

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COMMITTEE/SUBCOMMITTEE AMENDMENT
Bill No. HB 1455 (2021)
Amendment No. 4

COMMITTEE/SUBCOMMITTEE ACTION
ADOPTED (Y/N)
ADOPTED AS AMENDED (Y/N)
ADOPTED W/O OBJECTION (Y/N)
FAILED TO ADOPT (Y/N)
WITHDRAWN (Y/N)
OTHER

1 Committee/Subcommittee hearing bill: Professions & Public
2 Health Subcommittee
3 Representative Rayner offered the following:
4
5 Amendment (with directory and title amendments)
6 Between lines 457 and 458, insert:
7 (2) QUALIFYING MEDICAL CONDITIONS.—A patient must be
8 diagnosed with at least one of the following conditions to
9 qualify to receive marijuana or a marijuana delivery device:
10 (n) Sickle cell disease.
11
12 -----------------------------------------------------
13 D I R E C T O R Y A M E N D M E N T
14 Remove line 455 and insert:
15 amended, and a new paragraph (n) is added to subsection (2) and
16 a new paragraph (g) is added to subsection (4) of
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COMMITTEE/SUBCOMMITTEE AMENDMENT
Bill No. HB 1455 (2021)
Amendment No. 4

17
18 -----------------------------------------------------
19 T I T L E A M E N D M E N T
20 Remove line 3 and insert:
21 marijuana; amending s. 381.986, F.S.; providing that
22 sickle cell disease is a qualifying condition to
23 receive marijuana or a marijuana delivery device;
24 providing a

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COMMITTEE/SUBCOMMITTEE AMENDMENT
Bill No. HB 1455 (2021)
Amendment No. 5

COMMITTEE/SUBCOMMITTEE ACTION
ADOPTED (Y/N)
ADOPTED AS AMENDED (Y/N)
ADOPTED W/O OBJECTION (Y/N)
FAILED TO ADOPT (Y/N)
WITHDRAWN (Y/N)
OTHER

1 Committee/Subcommittee hearing bill: Professions & Public
2 Health Subcommittee
3 Representative Smith, C. offered the following:
4
5 Amendment (with directory and title amendments)
6 Remove lines 528-908 and insert:
7 use registry may be used for research purposes. The Office of
8 Program Policy Analysis and Government Accountability shall
9 research the use of high concentrate THC, including any adverse
10 patient outcomes recorded as a result of the use of THC using
11 existing data from the medical marijuana use registry and
12 patients' de-identified health information. The office shall
13 report its findings to the Governor, the President of the
14 Senate, and the Speaker of the House of Representatives by
15 October 1, 2021.
16 (d) A qualified physician may not issue a physician
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COMMITTEE/SUBCOMMITTEE AMENDMENT
Bill No. HB 1455 (2021)
Amendment No. 5

17 certification to a patient under 18 years of age for marijuana,
18 except for low-THC cannabis, unless the qualified physician
19 determines that marijuana other than low-THC cannabis is the
20 most effective treatment for the patient and a second physician
21 who is a board-certified pediatrician concurs with such
22 determination. A qualified physician may not issue a physician
23 certification for marijuana in a form for smoking to a patient
24 under 18 years of age unless the patient is diagnosed with a
25 terminal condition, the qualified physician determines that
26 smoking is the most effective route of administration for the
27 patient, and a second physician who is a board-certified
28 pediatrician concurs with such determination. Such
29 determinations determination and concurrences concurrence must
30 be documented in the patient's medical record and in the medical
31 marijuana use registry. The certifying physician must obtain the
32 written informed consent of such patient's parent or legal
33 guardian before issuing a physician certification to the patient
34 for marijuana or marijuana in a form for smoking. The qualified
35 physician must use a standardized informed consent form adopted
36 in rule by the Board of Medicine and the Board of Osteopathic
37 Medicine which must include information concerning the negative
38 health effects of marijuana and smoking marijuana on persons
39 under 18 years of age and an acknowledgment that the qualified
40 physician has sufficiently explained the contents of the form.
41 (f) A qualified physician may not issue a physician
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COMMITTEE/SUBCOMMITTEE AMENDMENT
Bill No. HB 1455 (2021)
Amendment No. 5

42 certification for more than three 70-day supply limits of
43 marijuana or more than six 35-day supply limits of marijuana in
44 a form for smoking. The department may shall quantify by rule a
45 daily dose amount with equivalent dose amounts for each
46 allowable form of marijuana dispensed by a medical marijuana
47 treatment center. A 35-day supply of marijuana may not exceed
48 54,250 milligrams of tetrahydrocannabinol The department shall
49 use the daily dose amount to calculate a 70-day supply.
50 1. A qualified physician may request an exception to the
51 daily dose amount limit, the 35-day supply limit of marijuana in
52 a form for smoking, and the 4-ounce possession limit of
53 marijuana in a form for smoking established in paragraph
54 (14)(a). The request shall be made electronically on a form
55 adopted by the department in rule and must include, at a
56 minimum:
57 a. The qualified patient's qualifying medical condition.
58 b. The dosage and route of administration that was
59 insufficient to provide relief to the qualified patient.
60 c. A description of how the patient will benefit from an
61 increased amount.
62 d. The minimum daily dose amount of marijuana that would
63 be sufficient for the treatment of the qualified patient's
64 qualifying medical condition.
65 2. A qualified physician must provide the qualified
66 patient's records upon the request of the department.
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COMMITTEE/SUBCOMMITTEE AMENDMENT
Bill No. HB 1455 (2021)
Amendment No. 5

67 3. The department shall approve or disapprove the request
68 within 14 days after receipt of the complete documentation
69 required by this paragraph. The request shall be deemed approved
70 if the department fails to act within this time period.
71 (8) MEDICAL MARIJUANA TREATMENT CENTERS.—
72 (e) A licensed medical marijuana treatment center shall
73 cultivate, process, transport, and dispense marijuana for
74 medical use. A licensed medical marijuana treatment center may
75 not contract for services directly related to the cultivation,
76 processing, and dispensing of marijuana or marijuana delivery
77 devices, except that a medical marijuana treatment center
78 licensed pursuant to subparagraph (a)1. may contract with a
79 single entity for the cultivation, processing, transporting, and
80 dispensing of marijuana and marijuana delivery devices. A
81 licensed medical marijuana treatment center must, at all times,
82 maintain compliance with the criteria demonstrated and
83 representations made in the initial application and the criteria
84 established in this subsection. Upon request, the department may
85 grant a medical marijuana treatment center a variance from the
86 representations made in the initial application. Consideration
87 of such a request shall be based upon the individual facts and
88 circumstances surrounding the request. A variance may not be
89 granted unless the requesting medical marijuana treatment center
90 can demonstrate to the department that it has a proposed
91 alternative to the specific representation made in its
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COMMITTEE/SUBCOMMITTEE AMENDMENT
Bill No. HB 1455 (2021)
Amendment No. 5

92 application which fulfills the same or a similar purpose as the
93 specific representation in a way that the department can
94 reasonably determine will not be a lower standard than the
95 specific representation in the application. A variance may not
96 be granted from the requirements in subparagraph 2. and
97 subparagraphs (b)1. and 2.
98 1. A licensed medical marijuana treatment center may
99 transfer ownership to an individual or entity who meets the
100 requirements of this section. A publicly traded corporation or
101 publicly traded company that meets the requirements of this
102 section is not precluded from ownership of a medical marijuana
103 treatment center. To accommodate a change in ownership:
104 a. The licensed medical marijuana treatment center shall
105 notify the department in writing at least 60 days before the
106 anticipated date of the change of ownership.
107 b. The individual or entity applying for initial licensure
108 due to a change of ownership must submit an application that
109 must be received by the department at least 60 days before the
110 date of change of ownership.
111 c. Upon receipt of an application for a license, the
112 department shall examine the application and, within 30 days
113 after receipt, notify the applicant in writing of any apparent
114 errors or omissions and request any additional information
115 required.
116 d. Requested information omitted from an application for
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COMMITTEE/SUBCOMMITTEE AMENDMENT
Bill No. HB 1455 (2021)
Amendment No. 5

117 licensure must be filed with the department within 21 days after
118 the department's request for omitted information or the
119 application shall be deemed incomplete and shall be withdrawn
120 from further consideration and the fees shall be forfeited.
121
122 Within 30 days after the receipt of a complete application, the
123 department shall approve or deny the application.
124 2. A medical marijuana treatment center, and any
125 individual or entity who directly or indirectly owns, controls,
126 or holds with power to vote 5 percent or more of the voting
127 shares of a medical marijuana treatment center, may not acquire
128 direct or indirect ownership or control of any voting shares or
129 other form of ownership of any other medical marijuana treatment
130 center.
131 3. A medical marijuana treatment center and any individual
132 or entity that directly or indirectly owns, controls, or holds
133 with power to vote 5 percent or more of the voting shares of a
134 medical marijuana treatment center may not employ a qualified
135 physician or have any direct or indirect economic interest in a
136 qualified physician's practice or a marijuana testing
137 laboratory.
138 4. A medical marijuana treatment center may not enter into
139 any form of profit-sharing arrangement with the property owner
140 or lessor of any of its facilities where cultivation,
141 processing, storing, or dispensing of marijuana and marijuana
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COMMITTEE/SUBCOMMITTEE AMENDMENT
Bill No. HB 1455 (2021)
Amendment No. 5

142 delivery devices occurs.
143 5. All employees of a medical marijuana treatment center
144 must be 21 years of age or older and have passed a background
145 screening pursuant to subsection (9).
146 6. Each medical marijuana treatment center must adopt and
147 enforce policies and procedures to ensure employees and
148 volunteers receive training on the legal requirements to
149 dispense marijuana to qualified patients.
150 7. When growing marijuana, a medical marijuana treatment
151 center:
152 a. May use pesticides determined by the department, after
153 consultation with the Department of Agriculture and Consumer
154 Services, to be safely applied to plants intended for human
155 consumption, but may not use pesticides designated as
156 restricted-use pesticides pursuant to s. 487.042.
157 b. Must grow marijuana within an enclosed structure and in
158 a room separate from any other plant.
159 c. Must inspect seeds and growing plants for plant pests
160 that endanger or threaten the horticultural and agricultural
161 interests of the state in accordance with chapter 581 and any
162 rules adopted thereunder.
163 d. Must perform fumigation or treatment of plants, or
164 remove and destroy infested or infected plants, in accordance
165 with chapter 581 and any rules adopted thereunder.
166 8. Each medical marijuana treatment center must produce
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Bill No. HB 1455 (2021)
Amendment No. 5

167 and make available for purchase at least one low-THC cannabis
168 product.
169 9. A medical marijuana treatment center that produces
170 edibles must hold a permit to operate as a food establishment
171 pursuant to chapter 500, the Florida Food Safety Act, and must
172 comply with all the requirements for food establishments
173 pursuant to chapter 500 and any rules adopted thereunder.
174 Edibles may not contain more than 200 milligrams of
175 tetrahydrocannabinol, and a single serving portion of an edible
176 may not exceed 10 milligrams of tetrahydrocannabinol. Edibles
177 may have a potency variance of no greater than 15 percent of the
178 10 milligrams of tetrahydrocannabinol per single serving limit
179 or 15 percent of the 200 milligrams of tetrahydrocannabinol per
180 product limit. Edibles may not be attractive to children; be
181 manufactured in the shape of humans, cartoons, or animals; be
182 manufactured in a form that bears any reasonable resemblance to
183 products available for consumption as commercially available
184 candy; or contain any color additives. To discourage consumption
185 of edibles by children, the department shall determine by rule
186 any shapes, forms, and ingredients allowed and prohibited for
187 edibles. Medical marijuana treatment centers may not begin
188 processing or dispensing edibles until after the effective date
189 of the rule. The department shall also adopt sanitation rules
190 providing the standards and requirements for the storage,
191 display, or dispensing of edibles.
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Bill No. HB 1455 (2021)
Amendment No. 5

192 10. Within 12 months after licensure, a medical marijuana
193 treatment center must demonstrate to the department that all of
194 its processing facilities have passed a Food Safety Good
195 Manufacturing Practices, such as Global Food Safety Initiative
196 or equivalent, inspection by a nationally accredited certifying
197 body. A medical marijuana treatment center must immediately stop
198 processing at any facility which fails to pass this inspection
199 until it demonstrates to the department that such facility has
200 met this requirement.
201 11. A medical marijuana treatment center that produces
202 prerolled marijuana cigarettes may not use wrapping paper made
203 with tobacco or hemp.
204 12. When processing marijuana, a medical marijuana
205 treatment center must:
206 a. Process the marijuana within an enclosed structure and
207 in a room separate from other plants or products.
208 b. Comply with department rules when processing marijuana
209 with hydrocarbon solvents or other solvents or gases exhibiting
210 potential toxicity to humans. The department shall determine by
211 rule the requirements for medical marijuana treatment centers to
212 use such solvents or gases exhibiting potential toxicity to
213 humans.
214 c. Comply with federal and state laws and regulations and
215 department rules for solid and liquid wastes. The department
216 shall determine by rule procedures for the storage, handling,
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COMMITTEE/SUBCOMMITTEE AMENDMENT
Bill No. HB 1455 (2021)
Amendment No. 5

217 transportation, management, and disposal of solid and liquid
218 waste generated during marijuana production and processing. The
219 Department of Environmental Protection shall assist the
220 department in developing such rules.
221 13. A medical marijuana treatment center must test
222 marijuana using a medical marijuana testing laboratory before it
223 is dispensed. Results must be verified and signed by two medical
224 marijuana treatment center employees. Before dispensing, the
225 medical marijuana treatment center must determine that the test
226 results indicate that low-THC cannabis meets the definition of
227 low-THC cannabis, the concentration of tetrahydrocannabinol
228 meets the potency requirements of this section, the labeling of
229 the concentration of tetrahydrocannabinol and cannabidiol is
230 accurate, and all marijuana is safe for human consumption and
231 free from contaminants that are unsafe for human consumption.
232 The department shall determine by rule which contaminants must
233 be tested for and the maximum levels of each contaminant which
234 are safe for human consumption. The Department of Agriculture
235 and Consumer Services shall assist the department in developing
236 the testing requirements for contaminants that are unsafe for
237 human consumption in edibles. The department shall also
238 determine by rule the procedures for the treatment of marijuana
239 that fails to meet the testing requirements of this section, s.
240 381.988, or department rule. The department may select samples
241 of marijuana available in a cultivation facility, processing
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Bill No. HB 1455 (2021)
Amendment No. 5

242 facility, or for purchase in a dispensing facility which shall
243 be tested by the department to determine that the marijuana
244 meets the potency requirements of this section, is safe for
245 human consumption, and the labeling of the tetrahydrocannabinol
246 and cannabidiol concentration is accurate or to verify medical
247 marijuana testing laboratory results. The department may also
248 sample marijuana delivery devices from a dispensing facility to
249 determine that the marijuana delivery device is safe for use by
250 qualified patients. A medical marijuana treatment center may not
251 require payment from the department for the sample. A medical
252 marijuana treatment center must recall all marijuana which fails
253 to meet the potency requirements of this section, which is
254 unsafe for human consumption, or for which the labeling of the
255 tetrahydrocannabinol and cannabidiol concentration is
256 inaccurate. The medical marijuana treatment center must retain
257 records of all testing and samples of each homogenous batch of
258 marijuana for at least 9 months. The medical marijuana treatment
259 center must contract with a marijuana testing laboratory to
260 perform audits on the medical marijuana treatment center's
261 standard operating procedures, testing records, and samples and
262 provide the results to the department to confirm that the
263 marijuana or low-THC cannabis meets the requirements of this
264 section and that the marijuana or low-THC cannabis is safe for
265 human consumption. A medical marijuana treatment center shall
266 reserve two processed samples from each batch and retain such
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Amendment No. 5

267 samples for at least 9 months for the purpose of such audits. A
268 medical marijuana treatment center may use a laboratory that has
269 not been certified by the department under s. 381.988 until such
270 time as at least one laboratory holds the required
271 certification, but in no event later than July 1, 2018.
272 14. When packaging marijuana, a medical marijuana
273 treatment center must:
274 a. Package the marijuana in compliance with the United
275 States Poison Prevention Packaging Act of 1970, 15 U.S.C. ss.
276 1471 et seq.
277 b. Package the marijuana in a receptacle that has a firmly
278 affixed and legible label stating the following information:
279 (I) The marijuana or low-THC cannabis meets the
280 requirements of subparagraph 13.
281 (II) The name of the medical marijuana treatment center
282 from which the marijuana originates.
283 (III) The batch number and harvest number from which the
284 marijuana originates and the date dispensed.
285 (IV) The name of the physician who issued the physician
286 certification.
287 (V) The name of the patient.
288 (VI) The product name, if applicable, and dosage form,
289 including concentration of tetrahydrocannabinol and cannabidiol.
290 The product name may not contain wording commonly associated
291 with products marketed by or to children.
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292 (VII) The recommended dose.
293 (VIII) A warning that it is illegal to transfer medical
294 marijuana to another person.
295 (IX) A marijuana universal symbol developed by the
296 department.
297 15. The medical marijuana treatment center shall include
298 in each package a patient package insert with information on the
299 specific product dispensed related to:
300 a. Clinical pharmacology.
301 b. Indications and use.
302 c. Dosage and administration.
303 d. Dosage forms and strengths.
304 e. Contraindications.
305 f. Warnings and precautions.
306 g. Adverse reactions.
307 16. In addition to the packaging and labeling requirements
308 specified in subparagraphs 14. and 15., marijuana in a form for
309 smoking must be packaged in a sealed receptacle with a legible
310 and prominent warning to keep away from children and a warning
311 that states marijuana smoke contains carcinogens and may
312 negatively affect health. Such receptacles for marijuana in a
313 form for smoking must be plain, opaque, and white without
314 depictions of the product or images other than the medical
315 marijuana treatment center's department-approved logo and the
316 marijuana universal symbol.
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317 17. The department shall adopt rules to regulate the
318 types, appearance, and labeling of marijuana delivery devices
319 dispensed from a medical marijuana treatment center. The rules
320 must require marijuana delivery devices to have an appearance
321 consistent with medical use.
322 18. Each edible shall be individually sealed in plain,
323 opaque wrapping marked only with the marijuana universal symbol.
324 Where practical, each edible shall be marked with the marijuana
325 universal symbol. In addition to the packaging and labeling
326 requirements in subparagraphs 14. and 15., edible receptacles
327 must be plain, opaque, and white without depictions of the
328 product or images other than the medical marijuana treatment
329 center's department-approved logo and the marijuana universal
330 symbol. The receptacle must also include a list of all the
331 edible's ingredients, storage instructions, an expiration date,
332 a legible and prominent warning to keep away from children and
333 pets, and a warning that the edible has not been produced or
334 inspected pursuant to federal food safety laws.
335 19. When dispensing marijuana or a marijuana delivery
336 device, a medical marijuana treatment center:
337 a. May dispense any active, valid order for low-THC
338 cannabis, medical cannabis and cannabis delivery devices issued
339 pursuant to former s. 381.986, Florida Statutes 2016, which was
340 entered into the medical marijuana use registry before July 1,
341 2017.
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342 b. May not dispense more than two 35-day supplies a 70-day
343 supply of marijuana within any 70-day period to a qualified
344 patient or caregiver. May not dispense more than one 35-day
345 supply of marijuana in a form for smoking within any 35-day
346 period to a qualified patient or caregiver. A 35-day supply of
347 marijuana in a form for smoking may not exceed 54,250 milligrams
348 of tetrahydrocannabinol 2.5 ounces unless an exception to this
349 amount is approved by the department pursuant to paragraph
350 (4)(f).
351 c. Must have the medical marijuana treatment center's
352 employee who dispenses the marijuana or a marijuana delivery
353 device enter into the medical marijuana use registry his or her
354 name or unique employee identifier.
355 d. Must verify that the qualified patient and the
356 caregiver, if applicable, each have an active registration in
357 the medical marijuana use registry and an active and valid
358 medical marijuana use registry identification card, the amount
359 and type of marijuana dispensed matches the physician
360 certification in the medical marijuana use registry for that
361 qualified patient, and the physician certification has not
362 already been filled.
363 e. May not dispense marijuana to a qualified patient who
364 is younger than 18 years of age. If the qualified patient is
365 younger than 18 years of age, marijuana may only be dispensed to
366 the qualified patient's caregiver.
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367 f. May not dispense or sell any other type of cannabis,
368 alcohol, or illicit drug-related product, including pipes or
369 wrapping papers made with tobacco or hemp, other than a
370 marijuana delivery device required for the medical use of
371 marijuana and which is specified in a physician certification.
372 g. Must, upon dispensing the marijuana or marijuana
373 delivery device, record in the registry the date, time,
374 quantity, and form of marijuana dispensed; the type of marijuana
375 delivery device dispensed; and the name and medical marijuana
376 use registry identification number of the qualified patient or
377 caregiver to whom the marijuana delivery device was dispensed.
378 h. Must ensure that patient records are not visible to
379
380 -----------------------------------------------------
381 D I R E C T O R Y A M E N D M E N T
382 Remove lines 450-456 and insert:
383 Section 2. Effective July 1, 2022, paragraphs (a), (d),
384 and (f) of subsection (4), paragraph (e) of subsection (8), and
385 paragraph (a) of subsection (14) of s. 381.986, Florida
386 Statutes, are amended to read:
387
388 -----------------------------------------------------
389 T I T L E A M E N D M E N T
390 Remove lines 26-41 and insert:

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Amendment No. 5

391 dispose of marijuana; requiring the Office of Program
392 Policy Analysis and Government Accountability to
393 research the use of high concentrate THC and report
394 its findings to the Governor and Legislature by a
395 specified date; prohibiting a qualified physician from
396 issuing a physician certification to a minor patient
397 for marijuana, except for low-THC cannabis; providing
398 an exception; revising the supply limits of marijuana
399 for which a physician certification may be issued;
400 limiting the potency of tetrahydrocannabinol in such
401 supply; prohibiting a medical marijuana treatment
402 center from dispensing a certain daily supply within a
403 specified period to conform to changes made by the
404 act; amending s. 381.988, F.S.; prohibiting a

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