Meeting Packet - Professions & Public Health Subcommittee (April 1, 2021)

Summary

Meeting packet of the Professions and Public Health Subcommittee for Thursday, April 1, 2021, 9:00 AM to 12:00 PM. The meeting notice lists HB 721 (Prohibited Acts by Health Care Practitioners), HB 949 (Communicable and Infectious Diseases), HB 1233 (Genetic Counseling Patient Protection Act) and HB 1345 (Pharmaceutical Products Containing Cannabis) for consideration, along with proposed committee substitutes including PCS for HB 361 (Consent for Pelvic Examinations). The staff analysis of PCS for HB 361 says the bill revises the definition of pelvic examination and the emergency exception to the written informed consent requirement. It states the bill has no fiscal impact on state or local government and provides an effective date of July 1, 2021.

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“Meeting Packet - Professions & Public Health Subcommittee (April 1, 2021).” Archived at Pandemic Darlings, https://pandemicdarlings.com/source-documents/2021-04-01-3093-professions-public-health-subcommittee-meeting-packets-7756da56ff/, SHA-256 f354c55cd31d46ebb666a7586f883e0df9238dfe652d288954735107765a2265.

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Professions and Public Health
Subcommittee
Thursday, April 1, 2021
9:00 AM – 12:00 PM
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: Thursday, April 01, 2021 09:00 am

End Date and Time: Thursday, April 01, 2021 12:00 pm

Location: Webster Hall (212 Knott)
Duration: 3.00 hrs

Consideration of the following bill(s):

HB 721 Prohibited Acts by Health Care Practitioners by Massullo
HB 949 Communicable and Infectious Diseases by Fetterhoff, Omphroy
HB 1045 Delegation of the Administration of Prescription Medications by Snyder
HB 1233 Genetic Counseling Patient Protection Act by Silvers
HB 1235 Fees by Silvers
HB 1345 Pharmaceutical Products Containing Cannabis by Persons-Mulicka, Learned

Consideration of the following proposed committee substitute(s):

PCS for HB 361 -- Consent for Pelvic Examinations
PCS for HB 463 -- Community Association Pools
PCS for HB 957 -- Hearing Aid Consultations and Sales
PCS for HB 1091 -- Relating to Substance Abuse Prevention

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 03/30/2021 4:22PM by Osborne.Erin

03/30/2021 04:22:11PM Leagis ® Page 1 of 1
PCS for HB 361
HOUSE OF REPRESENTATIVES STAFF ANALYSIS
BILL #: PCS for HB 361 Consent for Pelvic Examinations
SPONSOR(S): Professions & Public Health Subcommittee
TIED BILLS: IDEN./SIM. BILLS:

REFERENCE ACTION ANALYST STAFF DIRECTOR or
BUDGET/POLICY CHIEF

Orig. Comm.: Professions & Public Health Guzzo McElroy
Subcommittee

SUMMARY ANALYSIS
Informed consent is a process in which a health care provider educates a patient about the risks, benefits, and
alternatives of a given procedure or intervention. Such information enables a patient to make a competent
decision about whether to undergo a procedure or treatment.

Current law defines a pelvic examination as the series of tasks that comprise an examination of the vagina,
cervix, uterus, fallopian tubes, ovaries, rectum, or external pelvic tissue or organs using any combination of
modalities, which may include, but is not limited to, the health care provider’s gloved hand or instrumentation.
A health care practitioner must obtain a pelvic examination specific written informed consent from a patient
before performing a pelvic examination. A health care practitioner does not have to obtain such consent if the
pelvic examination is required by a court order or is immediately necessary to avert a serious risk of imminent
substantial and irreversible physical impairment of a major bodily function of the patient. Questions have arisen
within the medical community as to how to interpret the law’s requirements.

PCS for HB 361 revises the definition of pelvic examination to mean a manual examination of the organs of the
female reproductive system. The bill also revises the emergency exception to the informed consent
requirement allowing a health care practitioner to perform a pelvic examination without the written consent of
the patient if the pelvic examination is necessary for the provision of emergency services and care or the
patient has an emergency medical condition. These changes address questions raised by the medical
community regarding what constitutes a pelvic examination and when informed consent is required.

The bill has no fiscal impact on state or local government.

The bill provides an effective date of July 1, 2021.

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

Informed Consent

Informed consent for medical treatment is fundamental in both ethics and law. 1 Informed consent is a
process in which a health care provider educates a patient about the risks, benefits, and alternatives of
a given procedure or intervention. 2 A patient must be competent to make a voluntary decision about
whether to undergo a procedure. Foregoing the process of consent within medicine can result in
violations of both autonomy and basic rights, as well as trust. 3

The idea of informed consent was established in 1914, in a case in which a patient was operated on
without her consent. 4 In determining whether she had a cause of action against the hospital in which
the operation was formed, Judge Cardozo opined that “every human being of adult years and sound
mind has a right to determine what shall be done to his own body; and a surgeon who performs an
operation without his patient’s consent commits an assault, for which he is liable for damages.” 5

Pelvic Examinations

A pelvic examination involves the visual examination of the external genitalia and an internal visual
examination of the vaginal walls and cervix using a speculum and palpation of the pelvic organs. 6
Health care practitioners often perform pelvic examinations as a part of the annual well woman visit. 7 A
health care practitioner may also perform a pelvic examination to diagnose specific health conditions,
such as cancer and bacterial vaginosis. 8

Benefits of routine pelvic examinations include early detection of treatable gynecologic conditions
before symptoms occur and incidental findings such as dermatologic changes and foreign bodies. 9
These examinations also give the health care practitioner an opportunity to establish open
communication with the patient to answer specific questions and reassure her of normalcy. 10

New clinical guidelines have recommended against pelvic examinations on asymptomatic, non-
pregnant, adult women. 11 Routine pelvic examination has not been shown to benefit such women in

1 American Medical Association, Informed Consent: Code of Medical Ethics Opinion 2.1.1, available at https://www.ama-

assn.org/delivering-care/ethics/informed-consent (last visited Mar. 30, 2021).
2 William Gossman, Imani Thornton, John Hipskind, Informed Consent, (July 2019), available at

https://www.ncbi.nlm.nih.gov/books/NBK430827/ (last visited Mar. 30, 2021).
3 Phoebe Friesen, Educational Pelvic Exams on Anesthetized Women: Why Consent Matters (Abstract), 32 BIOETHICS 298 (June 2018),

available at https://onlinelibrary.wiley.com/doi/abs/10.1111/bioe.12441 (last visited Mar. 30, 2021).
4 Schloendorff v. Society of N.Y. Hosp., 105 N>E. 92, 93 (N.Y. 1914).
5 Id.
6 Id. A pelvic examination usually involves an examination of woman’s vulva, vagina, uterus, ovaries, and fallopian tubes. It may also

include examination of the bladder and the rectum. Melissa Conrad Stoppler, MD, Pelvic Exam, MedicineNet, available at
https://www.medicinenet.com/pelvic_exam/article.htm#why_is_a_pelvic_exam_performed (last visited Mar. 30, 2021).
7 Amir Qaseem, et al., Screening Pelvic Examination in Adult Women: A Clinical Practice Guideline from the American College of

Physicians, 161 Ann Intern Med 67 (2014), available at https://annals.org/aim/fullarticle/1884537/screening-pelvic-examination-adult-
women-clinical-practice-guideline-from-american?_ga=2.7498674.1663533724.1580510917-1215329083.1580510917 (last visited
Mar. 30, 2021).
8 Id.
9 American College of Obstetricians and Gynecologists, Committee on Gynecologic Practice, ACOG Committee Opinion, Number 754,

132(4) OBSTETRICS & GYNECOLOGY 174 (Oct. 2018), available at https://www.acog.org/Clinical-Guidance-and-Publications/Committee-
Opinions/Committee-on-Gynecologic-Practice/The-Utility-of-and-Indications-for-Routine-Pelvic-Examination?IsMobileSet=false (last
visited Mar. 30, 2021).
10 Id.
11 Supra note 7. This recommendation does not apply to pap smears.

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that it rarely detects important disease and does not reduce mortality. 12 Several harms have been
identified for the performance of pelvic examinations including fear, anxiety, embarrassment, pain, and
discomfort. 13 Other physical harms include urinary tract infections and symptoms such as dysuria and
frequent urination. 14

The American College of Obstetricians and Gynecologists finds that data is currently insufficient to
make a recommendation for or against routine pelvic examinations. 15 Therefore, it recommends that
pelvic examinations be performed when indicated by medical history or symptoms, such as abnormal
bleeding, pelvic pain, or urinary issues. 16

Florida Requirements for Informed Consent of Pelvic Examinations

Pursuant to Florida statutes, a pelvic examination is the series of tasks that comprise an examination of
the vagina, cervix, uterus, fallopian tubes, ovaries, rectum, or external pelvic tissue or organs using any
combination of modalities, which may include, but is not limited to the health care provider’s gloved
hand or instrumentation. 17

Current law prohibits a health care practitioner from performing a pelvic examination on a patient
without express written consent unless an exception applies. 18 A health care practitioner does not have
to obtain written consent if the pelvic examination is required by a court order or is immediately
necessary to avert a serious risk of imminent substantial and irreversible physical impairment of a
major bodily function of the patient. 19

Following the enactment of s. 456.51, F.S., questions arose within the medical community as to how to
interpret the law’s requirements, and a Petition for Declaratory Statement was filed with the Florida
Board of Medicine (BOM), requesting a determination of: 20

• Whether the definition of pelvic examination applies only to female patients or to males as well;
• Whether performance of surgery on the vagina, cervix, uterus, fallopian tubes, ovaries, rectum,
or external pelvic tissue or organs constitutes a pelvic examination;
• Whether a discrete visual examination of the vagina, cervix, uterus, fallopian tubes, ovaries,
rectum, or external pelvic tissue or organs constitutes a pelvic examination;
• Whether a pelvic examination requires separate written consents every time a pelvic
examination was performed during a course of treatment; and
• Whether a pelvic examination in emergent circumstances required a written consent when the
patient or a legal representative were unable to give consent.

12 American College of Physicians, American College of Physicians Recommends Against Screening Pelvic Examinations in Adult,

Asymptomatic, Average Risk, Non-Pregnant Women, (July 1, 2014), available at https://www.acponline.org/acp-newsroom/american-
college-of-physicians-recommends-against-screening-pelvic-examination-in-adult-asymptomatic (last visited on Mar. 30, 2021).
13 Id.
14 Id.
15 Id.
16 Id.
17 S. 456.51(1), F.S.
18 S. 456.51(2), F.S.
19 Id.
20 See Florida Department of Health, Board of Medicine, Final Order NO DOH-20-1553-DS-MQA filed Oct. 9, 2020, available at

https://s3.amazonaws.com/thenewsserviceofflorida/web/dist/downloads/2020/10/DOH_20-
1553_DS_Doug_Murphy__FMA__etc__1_.pdf (last visited Mar. 30, 2021).
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The BOM, in its Final Order, answered the above questions regarding what constitutes a pelvic
examination under s. 456.51, F.S., as follows: 21

• A pelvic examination applies only to female patients;
• Surgery on the vagina, cervix, uterus, fallopian tubes, ovaries, rectum, or external pelvic tissue
or organs does not constitute a pelvic examination; and
• Discrete visual examination of the vagina, cervix, uterus, fallopian tubes, ovaries, rectum, or
external pelvic tissue or organs does not constitute a pelvic examination.

The BOM declined to answer the questions regarding informed consent.

Effect of the Bill

• The pelvic examination is necessary for the provision of emergency services and care, as
defined in s. 395.002(9), F.S., 22 or
• The patient has an emergency medical condition, as defined in s. 395.002(8), F.S. 23

These changes address questions raised by the medical community regarding what constitutes a pelvic
examination and when informed consent is required.

The bill provides an effective date of July 1, 2021.

B. SECTION DIRECTORY:
Section 1: Amends s. 456.51, F.S., relating to consent for pelvic examinations.
Section 2: Provides an effective date of July 1, 2021.

II. FISCAL ANALYSIS & ECONOMIC IMPACT STATEMENT

A. FISCAL IMPACT ON STATE GOVERNMENT:

1. Revenues:
None.

2. Expenditures:
None.

B. FISCAL IMPACT ON LOCAL GOVERNMENTS:

21 Id.
22 S. 395.002(9), F.S. Emergency services and care means medical screening, examination, and evaluation by a physician, or, to the

extent permitted by applicable law, by other appropriate personnel under the supervision of a physician, to determine if an emergency
medical condition exists and, if it does, the care, treatment, or surgery by a physician necessary to relieve or eliminate the emergency
medical condition, within the service capability of the facility.
23 S. 395.002(8), F.S. Emergency medical condition means s medical condition manifesting itself by acute symptoms of sufficient

severity, which may include severe pain, such that the absence of immediate medical attention could reasonably be expected to result
in any of the following: serious jeopardy to patient health, including a pregnant woman or fetus; serious impairment to bodily functions;
serious dysfunction of any bodily organ or part; that there is inadequate time to effect safe transfer to another hospital prior to delivery;
that a transfer may pose a threat to the health and safety of the patient or fetus; or that there is evidence of the onset and persistence of
uterine contractions or rupture of the membranes.

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1. Revenues:
None.

2. Expenditures:
None.

C. DIRECT ECONOMIC IMPACT ON PRIVATE SECTOR:
None.

D. FISCAL COMMENTS:
None.

III. COMMENTS

A. CONSTITUTIONAL ISSUES:

1. Applicability of Municipality/County Mandates Provision:
Not applicable. The PCS does not appear to affect county or municipal governments.

2. Other:
None.

B. RULE-MAKING AUTHORITY:
No rule-making authority is necessary to implement the provisions of the bill.

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

PCS for HB 361 ORIGINAL 2021

1 A bill to be entitled
2 An act relating to consent for pelvic examinations;
3 amending s. 456.51, F.S.; revising the definition of
4 the term "pelvic examination"; revising the
5 circumstances under which a pelvic examination may be
6 performed without written consent; providing an
7 effective date.
8
9 Be It Enacted by the Legislature of the State of Florida:
10
11 Section 1. Section 456.51, Florida Statutes, is amended to
12 read:
13 456.51 Consent for pelvic examinations.—
14 (1) As used in this section, the term "pelvic examination"
15 means a manual the series of tasks that comprise an examination
16 of the vagina, cervix, uterus, fallopian tubes, ovaries, rectum,
17 or external pelvic tissue or organs of the female reproductive
18 system using any combination of modalities, which may include,
19 but need not be limited to, the health care provider's gloved
20 hand or instrumentation.
21 (2) A health care practitioner, a medical student, or any
22 other student receiving training as a health care practitioner
23 may not perform a pelvic examination on a patient without the
24 written consent of the patient or the patient's legal
25 representative executed specific to, and expressly identifying,

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PCS for HB 361.docx
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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

PCS for HB 361 ORIGINAL 2021

26 the pelvic examination, unless:
27 (a) A court orders performance of the pelvic examination
28 for the collection of evidence; or
29 (b) The pelvic examination is immediately necessary for
30 the provision of emergency services and care, as defined in
31 section 395.002(9), or the patient has an emergency medical
32 condition, as defined in section 395.002(8) to avert a serious
33 risk of imminent substantial and irreversible physical
34 impairment of a major bodily function of the patient.
35 Section 2. This act shall take effect July 1, 2021.

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PCS for HB 463
HOUSE OF REPRESENTATIVES STAFF ANALYSIS
BILL #: PCS for HB 463 Community Association Pools
SPONSOR(S): Professions & Public Health Subcommittee
TIED BILLS: IDEN./SIM. BILLS:

REFERENCE ACTION ANALYST STAFF DIRECTOR or
BUDGET/POLICY CHIEF

Orig. Comm.: Professions & Public Health Woodruff McElroy
Subcommittee

SUMMARY ANALYSIS
A homeowners’ association (HOA) is an association of residential property owners in which voting membership
is made up of parcel owners, membership is a mandatory condition of parcel ownership, and which is
authorized to impose assessments that, if unpaid, may become a lien on the parcel.

The Department of Health (DOH) is responsible for the oversight and regulation of water quality and safety of
public swimming pools in Florida. In order to operate or continue to operate a public swimming pool, a valid
operating permit from DOH must be obtained. DOH may, at any reasonable time, enter any and all parts of a
public swimming pool to examine and investigate the pool’s sanitary and safety conditions. County health
departments are responsible for the routine surveillance of water quality in all public swimming pools. Pools
that are used by condominiums or cooperatives with 32 units or less and which are not being operated as
public lodging establishes are exempt from DOH’s public pools requirements, except for maintaining water
quality standards. HOA pools are not exempt from DOH regulation even where the HOA has 32 homes or less.

HB 463 specifies that HOAs and other property associations with 32 units or less and which are not operated
as pubic lodging establishments are exempt from supervision under ch. 514, F.S., except for supervision
necessary to ensure water quality and under ss. 514.0315, 514.05, and 514.06, F.S.

There is an insignificant, negative fiscal impact on DOH. There is no fiscal impact on local governments.

The bill provides an effective date of July 1, 2021.

This document does not reflect the intent or official position of the bill sponsor or House of Representatives.
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DATE: 3/31/2021
FULL ANALYSIS

I. SUBSTANTIVE ANALYSIS

A. EFFECT OF PROPOSED CHANGES:
Background

Homeowners’ Associations

The Florida Division of Condominiums, Timeshares and Mobile Homes (Division), within the
Department of Business and Professional Regulation, provides consumer protection for Florida
residents living in regulated communities through education, complaint resolution, mediation and
arbitration, and developer disclosure. The Division has regulatory authority over Homeowners’
Associations (limited to arbitration of election and recall disputes).

A homeowners’ association (HOA) is an association of residential property owners in which voting
membership is made up of parcel owners, membership is a mandatory condition of parcel ownership,
and which is authorized to impose assessments that, if unpaid, may become a lien on the parcel. 1
Only HOAs whose covenants and restrictions include mandatory assessments are regulated by ch.
720, F.S. Like a condominium or cooperative, an HOA is administered by an elected board of directors.
The powers and duties of an HOA include the powers and duties provided in ch. 720, F.S., and in the
association’s governing documents, which include the recorded covenants and restrictions, together
with the bylaws, articles of incorporation, and duly adopted amendments to those documents. Current
law sets procedures and minimum requirements for HOA operation and provides for a mandatory
binding arbitration program, administered by the Division for certain election and recall disputes, but no
state agency has direct oversight of HOAs.

HOA Swimming Pools

The Department of Health (DOH) is responsible for the oversight and regulation of water quality and
safety of public swimming pools 2 in Florida under ch. 514, F.S. In order to operate or continue to
operate a public swimming pool, a valid operating permit from DOH must be obtained. If DOH
determines that the public swimming pool is, or may reasonably be expected, to be operated in
compliance with state laws and rules, DOH will issue a permit. However, if it is determined that the pool
is not in compliance with state laws and rules, the application for a permit will be denied. DOH is
authorized to establish a schedule of fees for plan approval and permitting. 3 Operating permits must be
renewed annually and may be transferred from one name or owner to another. 4

The Virginia Graeme Baker federal Pool and Spa Safety Act of 2007 5 implemented by the Consumer
Product Safety Commission, and duplicated in s. 514.0315, F.S., requires all public swimming pools to
assure compliance for anti-entrapment safety features to prevent drowning and entrapment injuries.

DOH may, at any reasonable time, enter any and all parts of a public swimming pool to examine and
investigate the pool’s sanitary and safety conditions. 6 County health departments are responsible for
the routine surveillance of water quality in all public swimming pools. 7

1 S. 720.301(9), F.S.
2 S. 514.011(2) defines “public swimming pool” or “public pool” to include a watertight structure of concrete, masonry, or other approved

materials which is located either indoors or outdoors, used for bathing or swimming by humans, and filled with a filtered and disinfected
water supply, together with buildings, appurtenances, and equipment used in connection therewith. A public swimming pool or public
pool means a conventional pool, spa-type pool, wading pool, special purpose pool, or water recreation attraction, to which admission
may be gained with or without payment of a fee and includes, but is not limited to, pools operated by or serving camps, churches, cities,
counties, day care centers, group home facilities for eight or more clients, health spas, institutions, parks, state agencies, schools,
subdivisions, or the cooperative living-type projects of five or more living units, such as apartments, boardinghouses, hotels, mobile
home parks, motels, recreational vehicle parks, and townhouses.
3 S. 514.033, F.S.
4 Ss. 514.031(2) and (3), F.S.
5 15 U.S.C. §8003

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Pools that are used by condominiums or cooperatives with 32 units or less and which are not being
operated as public lodging establishments are exempt from DOH’s public pools requirements, except
for maintaining water quality standards. 8 HOA pools are not exempt from DOH regulation, even where
the HOA has 32 homes or less.

DOH estimates that 200 public swimming pools would be effected if HOA pools were exempt from DOH
regulation. 9

Effect of Proposed Changes

HB 463 specifies that HOAs and other property associations which have no more than 32 units or
parcels and which are not operated as pubic lodging establishments are exempt from supervision
under ch. 514, F.S., except for:

• Supervision necessary to ensure water quality.
• Section 514.0315, F.S., related to required safety features for public swimming pools and spas.
• Section 514.05, F.S., related to denial, suspension, or revocation of permit; administrative fines.
• Section 514.06, F.S., related to injunction to restrain violations.

B. SECTION DIRECTORY:
Section 1: Amending s. 514.0115, F.S., related to exemptions from supervision or regulation; venues.
Section 2: Amending s. 553.77, F.S., related to specific powers of the commission.
Section 3: Provides an effective date.

II. FISCAL ANALYSIS & ECONOMIC IMPACT STATEMENT

A. FISCAL IMPACT ON STATE GOVERNMENT:

1. Revenues:
None.

2. Expenditures:
DOH estimates it could lose a total of $50,000 in annual operating permits if the 200 HOA public
swimming pools are exempt from DOH regulation. 10

B. FISCAL IMPACT ON LOCAL GOVERNMENTS:

1. Revenues:
None.

2. Expenditures:
None.

C. DIRECT ECONOMIC IMPACT ON PRIVATE SECTOR:
None.

6 S. 514.04, F.S.
7 S. 514.025, F.S.
8 S. 514.0115(2), F.S.
9 Email from Gary Landry, Florida Department of Health, re: data request, (Mar. 30, 2021)(on file with Professions & Public Health

Subcommittee staff).
10 Id.

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D. FISCAL COMMENTS:
None.

III. COMMENTS

A. CONSTITUTIONAL ISSUES:

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

2. Other:
None.

B. RULE-MAKING AUTHORITY:
The bill does not require rulemaking to implement the bill’s provisions.

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

PCS for HB 463 ORIGINAL 2021

1 A bill to be entitled
2 An act relating to community association pools;
3 amending s. 514.0015, F.S.; exempting certain
4 homeowners’ association pools from supervision by the
5 Department of Health; amending s. 553.77, F.S.;
6 conforming cross references; providing an effective
7 date.
8
9 Be It Enacted by the Legislature of the State of Florida:
10
11 Section 1. Subsections (3) through (7) of section
12 514.0114, Florida Statutes, are renumbered as subsections (4)
13 through (8), respectively, and a new subsection (3) is added to
14 that section to read:
15 514.0115 Exemptions from supervision or regulation;
16 variances.—
17 (3) Pools serving homeowners’ associations and other
18 property associations which have no more than 32 units or
19 parcels and which are not operated as public lodging
20 establishments are exempt from supervision under this chapter,
21 except for supervision necessary to ensure water quality and
22 compliance with s. 514.0315, and under ss. 514.05 and 514.06.
23 Section 2. Subsection (7) of section 553.77, Florida
24 Statutes, is amended to read:
25 (7) Building officials shall recognize and enforce

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PCS HB 463
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PCS for HB 463 ORIGINAL 2021

26 variance orders issued by the Department of Health under s.
27 514.0115(8) pursuant to s. 514.0115(7), including any conditions
28 attached to the granting of the variance.
29 Section 3. This act shall take effect July 1, 2021.

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PCS HB 463
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HB 721
HOUSE OF REPRESENTATIVES STAFF ANALYSIS
BILL #: HB 721 Prohibited Acts by Health Care Practitioners
SPONSOR(S): Massullo
TIED BILLS: IDEN./SIM. BILLS: SB 1142

REFERENCE ACTION ANALYST STAFF DIRECTOR or
BUDGET/POLICY CHIEF

1) Professions & Public Health Subcommittee Morris McElroy

2) Health & Human Services Committee

SUMMARY ANALYSIS
The Division of Medical Quality Assurance (MQA), within the Department of Health (DOH), has general
regulatory authority over health care practitioners. The MQA works in conjunction with 22 boards and four
councils to license and regulate seven types of health care facilities and more than 40 health care professions,
including allopathic physicians, osteopathic physicians, and dentists.

An unlicensed individual may be subject to administrative action or criminal penalties if the individual states or
otherwise implies that he or she is a licensed medical professional. This may include the use of certain terms
or titles that the public generally associates with a specific medical profession. DOH does not license a
physician’s specialty or sub-specialty based upon board certification, but does limit who can hold themselves
out as board-certified specialists.

HB 721 prohibits health care practitioners from making misleading, deceptive, or fraudulent representations
regarding a health care practitioner’s specialty designation. The bill prohibits a health care practitioner from
using the title “anesthesiologist” unless the health care practitioner is licensed as an allopathic physician under
chapter 458, F.S., an osteopathic physician under chapter 459, F.S., or a dentist under chapter 466, F.S. The
bill also prohibits a health care practitioner from using the title “dermatologist” unless the health care
practitioner is licensed as an allopathic physician under chapter 458, F.S., or an osteopathic physician under
chapter 459, F.S.

The bill requires DOH, rather than the boards, to enforce the bill’s provisions. The bill requires DOH to issue an
emergency order to cease and desist to a health care practitioner who violates the bill’s provisions. DOH must
issue an order imposing a citation and daily fine, reprimand or letter of concern, or suspension of license, if the
health care practitioner does not immediately correct the violation upon receipt of the emergency cease and
desist order.

The bill has an indeterminate, negative fiscal impact on DOH, which current resources are adequate to absorb.

The bill has no fiscal impact on local governments.

The bill takes effect upon becoming law.

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:
Present Situation

Licensure and Regulation of Physicians

The Division of Medical Quality Assurance (MQA), within the Department of Health (DOH), has general
regulatory authority over health care practitioners. 1 The MQA works in conjunction with 22 boards and
four councils to license and regulate seven types of health care facilities and more than 40 health care
professions, including Medical Doctors (allopathic physicians) and Doctors of Osteopathic Medicine
(osteopathic physicians). 2 Each profession is regulated by an individual practice act and by ch. 456,
F.S., which provides general regulatory and licensure authority for the MQA. MQA is statutorily
responsible for the following boards and professions established within the division: 3

• The Board of Acupuncture, created under ch. 457, F.S.;
• The Board of Medicine, created under ch. 458, F.S.;
• The Board of Osteopathic Medicine, created under ch. 459, F.S.;
• The Board of Chiropractic Medicine, created under ch. 460, F.S.;
• The Board of Podiatric Medicine, created under ch. 461, F.S.;
• Naturopathy, as provided under ch. 462, F.S.;
• The Board of Optometry, created under ch. 463, F.S.;
• The Board of Nursing, created under part I of ch. 464, F.S.;
• Nursing assistants, as provided under part II of ch. 464, F.S.;
• The Board of Pharmacy, created under ch. 465, F.S.;
• The Board of Dentistry, created under ch. 466, F.S.;
• Midwifery, as provided under ch. 467, F.S.;
• The Board of Speech-Language Pathology and Audiology, created under part I of ch. 468, F.S.;
• The Board of Nursing Home Administrators, created under part II of ch. 468, F.S.;
• The Board of Occupational Therapy, created under part III of ch. 468, F.S.;
• Respiratory therapy, as provided under part V of ch. 468, F.S.;
• Dietetics and nutrition practice, as provided under part X of ch. 468, F.S.;
• The Board of Athletic Training, created under part XIII of ch. 468, F.S.;
• The Board of Orthotists and Prosthetists, created under part XIV of ch. 468, F.S.;
• Electrolysis, as provided under ch. 478, F.S.;
• The Board of Massage Therapy, created under ch. 480, F.S.;
• The Board of Clinical Laboratory Personnel, created under part III of ch. 483, F.S.;
• Medical physicists, as provided under part IV of ch. 483, F.S.;
• The Board of Opticianry, created under part I of ch. 484, F.S.;
• The Board of Hearing Aid Specialists, created under part II of ch. 484, F.S.;
• The Board of Physical Therapy Practice, created under ch. 486, F.S.;
• The Board of Psychology, created under ch. 490, F.S.;
• School psychologists, as provided under ch. 490, F.S.;
• The Board of Clinical Social Work, Marriage and Family Therapy, and Mental Health
Counseling, created under ch. 491, F.S.; and

1 Pursuant to s. 456.001(4), F.S., health care practitioners are defined to include acupuncturists, physicians, physician assistants,

chiropractors, podiatrists, naturopaths, dentists, dental hygienists, optometrists, nurses, nursing assistants, pharmacists, midwives,
speech language pathologists, nursing home administrators, occupational therapists, respiratory therapists, dieticians, athletic trainers,
orthotists, prosthetists, electrologists, massage therapists, clinical laboratory personnel, medical physicists, dispensers of optical
devices or hearing aids, physical therapists, psychologists, social workers, counselors, and psychotherapists, among others.
2 Florida Department of Health, Division of Medical Quality Assurance, Annual Report and Long-Range Plan, Fiscal Year 2019-2020, p.

5, http://www.floridahealth.gov/licensing-and-regulation/reports-and-publications/_documents/2019-2020-annual-report.pdf (last visited
March 15, 2021).
3 S. 456.001(4), F.S; Id.

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• Emergency medical technicians and paramedics, as provided under part III of ch. 401, F.S.

Allopathic Physician Licensure

Chapter 458, F.S., provides for the licensure and regulation of the practice of medicine by the Florida
Board of Medicine (allopathic board) in conjunction with DOH. The chapter imposes requirements for
licensure examination and licensure by endorsement.

Allopathic Licensure Requirements

An individual seeking to be licensed by examination as an allopathic physician must, among other
things:

• Complete 2 years of post-secondary education which includes, at a minimum, courses in fields
such as anatomy, biology, and chemistry prior to entering medical school;
• Meet one of the following medical education and postgraduate training requirements:
o Graduate from an allopathic medical school recognized and approved by an accrediting
agency recognized by the U.S. Office of Education or recognized by an appropriate
governmental body of a U.S. territorial jurisdiction, and have completed at least one year
of approved residency training;
o Graduate from an allopathic foreign medical school registered with the World Health
Organization and certified pursuant to statute as meeting the standards required to
accredit U.S. medical schools, and have completed at least one year of approved
residency training; or
o Graduate from an allopathic foreign medical school that has not been certified pursuant
to statute; have an active, valid certificate issued by the Educational Commission for
Foreign Medical Graduates (ECFMG), 4 have passed that commission’s examination;
and have completed an approved residency or fellowship of at least 2 years in one
specialty area; and
• Obtain a passing score on:
o The United States Medical Licensing Examination (USMLE);
o A combination of the USMLE, the examination of the Federation of State Medical Boards
of the United States, Inc. (FLEX), or the examination of the National Board of Medical
Examiners up to the year 2000; or
o The Special Purpose Examination of the Federation of State Medical Boards of the
United States (SPEX), if the applicant was licensed on the basis of a state board
examination, is currently licensed in at least one other jurisdiction of the United States or
Canada, and has practiced for a period of at least 10 years. 5

An individual who holds an active license to practice medicine in another jurisdiction may seek
licensure by endorsement to practice medicine in Florida. 6 The applicant must meet the same
requirements for licensure by examination. To qualify for licensure by endorsement, the applicant must
also submit evidence of the licensed active practice of medicine in another jurisdiction for at least 2 of
the preceding 4 years, or evidence of successful completion of either a board-approved postgraduate
training program within 2 years preceding filing of an application or a board-approved clinical
competency examination within the year preceding the filing of an application for licensure.

Osteopathic Physician Licensure

4 A graduate of a foreign medical school does not need to present an ECFMG certification or pass its exam if the graduate received his

or bachelor’s degree from an accredited U.S. college or university, studied at a medical school recognized by the World Health
Organization, and has completed all but the internship or social service requirements, has passed parts I and II of the National Board
Medical Examiners licensing examination or the ECFMG equivalent examination. Section 458.311, F.S.
5 Section 458.311(1), F.S.
6 Section 458.313, F.S.

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Chapter 459, F.S., provides for the licensure and regulation of the practice of medicine by the Florida
Board of Osteopathic Medicine (osteopathic board) in conjunction with DOH. The chapter imposes
requirements for licensure by examination and licensure by endorsement.

Osteopathic Licensure Requirements

An individual seeking to be licensed as an osteopathic physician must, among other things: 7

• Graduate from a medical college recognized and approved by the American Osteopathic
Association;
• Successfully complete a resident internship of at least 12 months in a hospital approved by the
Board of Trustees of the American Osteopathic Association or any other internship approved by
the osteopathic board; and
• Obtain a passing score, as established by rule of the osteopathic board, on the examination
conducted by the National Board of Osteopathic Medical Examiners or other examination
approved by the osteopathic board, no more than five years prior to applying for licensure. 8

If an applicant for a license to practice osteopathic medicine is licensed in another state, the applicant
must have actively practiced osteopathic medicine within the two years prior to applying for licensure in
this state.

Dentist Licensure

The Board of Dentistry, in conjunction with DOH, regulates dental practice in Florida, including dentists,
dental hygienists, and dental assistants under the Dental Practice Act. 9 A dentist is licensed to
examine, diagnose, treat, and care for conditions within the human oral cavity and its adjacent tissues
and structures. 10

Dental Licensure Requirements

Any person wishing to practice dentistry in this state must apply to DOH and meet specified
requirements. To qualify to take the Florida dental licensure examination, an applicant must be 18
years of age or older, be a graduate of a dental school accredited by the American Dental Association
or be a student in the final year of a program at an accredited institution, and have successfully
completed the NBDE dental examination.

Section 466.006, F.S., requires dentistry licensure applicants to sit for and pass the following licensure
examinations:

•The National Board of Dental Examiners dental examiner (NBDE);
•A written examination on Florida laws and rules regulating the practice of dentistry; and
•A practical examination, which is the American Dental Licensing Examination developed by the
American Board of Dental Examiners, Inc., and graded by a Florida-licensed dentist employed
by DOH for such purpose. 11
Board Certification and Florida Licensure

DOH does not license physicians by specialty or subspecialty; however, current law limits which
physicians may hold themselves out as board-certified specialists. An allopathic physician may not hold
himself or herself out as a board-certified specialist unless he or she has received formal recognition as
a specialist from a specialty board of the American Board of Medical Specialties (ABMS) or other

7 Section 459.0055(1), F.S.
8 However, if an applicant has been actively licensed in another state, the initial licensure in the other state must have occurred no more

than five years after the applicant obtained the passing score on the licensure examination.
9 Section 466.004, F.S.
10 Section 466.003(3), F.S.
11 A passing score is valid for 365 days after the date the official examination results are published. A passing score on an examination

obtained in another jurisdiction must be completed on or after October 1, 2011.
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recognizing agency 12 approved by the allopathic board. 13 Additionally, an allopathic physician may not
hold himself or herself out as a board-certified specialist in dermatology unless the recognizing agency,
whether authorized in statute or by rule, is triennially reviewed and reauthorized by the allopathic
board. 14 Similarly, an osteopathic physician may not hold himself or herself out as a board-certified
specialist unless he or she has successfully completed the requirements for certification by the
American Osteopathic Association (AOA) or the Accreditation Council on Graduate Medical Education
(ACGME) and is certified as a specialist by a certifying agency 15 approved by the board. 16

A dentist may not hold himself or herself out as a specialist, or advertise membership in or specialty
recognition by an accrediting organization, unless the dentist has completed a specialty education
program approved by the American Dental Association and the Commission on Dental Accreditation
and the dentist is: 17

• Eligible for examination by a national specialty board recognized by the American Dental
Association; or
• Is a diplomate of a national specialty board recognized by the American Dental Association.

If a dentist announces or advertises a specialty practice for which there is not an approved accrediting
organization, the dentist must clearly state that the specialty is not recognized or that the accrediting
organization has not been approved by the American Dental Association or the Florida Board of
Dentistry in capital letters. 18

Cease and Desist

Florida law prohibits an individual from practicing a regulated health care profession without a license.
An individual must meet minimum education and training requirements to become licensed and
practice a health care profession. 19 An unlicensed individual providing healthcare services is subject to
administrative and criminal penalties. Among other actions, DOH may issue a cease and desist letter to
such a person and impose, by citation, an administrative penalty of up to $5,000 per offense. 20

DOH is not authorized to issue a cease and desist letter to licensed health care practitioners for:

• Making misleading, deceptive, or fraudulent representations related to his or her licensed
profession or specialty designation;
• Using the title “anesthesiologist” if not licensed as an allopathic physician under chapter 458,
F.S., osteopathic physician under chapter 459, F.S., or dentist under chapter 466, F.S.; and
• Using the title “dermatologist” if not licensed as an allopathic physician under chapter 458, F.S.,
or an osteopathic physician under chapter 459, F.S.

DOH may also seek a civil penalty of up to $5,000 for each offense through the circuit court, in addition
to or in lieu of the administrative penalty. 21 An individual practicing, attempting to practice or offering to
practice, a health care profession without an active, valid Florida license is subject to criminal penalties,
in addition to any administrative and civil penalties incurred by the unlicensed individual. 22

12 The allopathic board has approved the specialty boards of the ABMS as recognizing agencies. Rule 64B8-11.001(1)(f), F.A.C.
13 Section 458.3312, F.S.
14 Id.
15 The osteopathic board has approved the specialty boards of the ABMS and AOA as recognizing agencies. Rule 64B15-14.001(h),

F.A.C.
16 Section 459.0152, F.S.
17 Section 466.0282, F.S. A dentist may also hold himself or herself out as a specialist if the dentist has continuously held himself or

herself out as a specialist since December 31, 1964, in a specialty recognized by the American Dental Association.
18 Section 466.0282(3), F.S.
19 Section 456.065(1), F.S.
20 Section 456.065, F.S. Each day that the unlicensed practice continues after issuance of a notice to cease and desist constitutes a

separate offense.
21 Section 456.065(2)(c), F.S.
22 Section 456.065(2)(d), F.S.

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Discipline of Health Care Practitioners

Section 456.072, F.S., authorizes a regulatory board or DOH, if there is no board, to discipline a health
care practitioner’s licensure for a number of offenses, including but not limited to:

• Making misleading, deceptive, or fraudulent representations in or related to the practice of the
licensee’s profession; or
• Failing to identify through writing or orally to a patient the type of license under which the
practitioner is practicing.

Making misleading, deceptive, or fraudulent representations related to a licensee’s specialty
designation or failing to identify such specialty designation to a patient is not ground for discipline under
current law.

If the board or DOH finds that a licensee committed a violation, the board or DOH may: 23

• Refuse to certify, or to certify with restrictions, an application for a license;
• Suspend or permanently revoke a license;
• Place a restriction on the licensee’s practice or license;
• Impose an administrative fine not to exceed $10,000 for each count or separate offense; if the
violation is for fraud or making a false representation, a fine of $10,000 must be imposed for
each count or separate offense;
• Issue a reprimand or letter of concern;
• Place the licensee on probation;
• Require a corrective action plan;
• Refund fees billed and collected from the patient or third party on behalf of the patient; or
• Require the licensee to undergo remedial education.

Investigations

DOH, on behalf of the professional boards, investigates any complaint that is filed against a health care
practitioner if the complaint is in writing, signed by the complainant, and legally sufficient. 24 A complaint
is legally sufficient if it contains allegations of ultimate facts that, if true, show that a regulated
practitioner has violated ch. 456, F.S., his or her practice act, or a rule of his or her board or the DOH. 25

The Consumer Services Unit within MQA receives the complaints and refers them to the closest
Investigative Services Unit (ISU) office. 26 The ISU investigates complaints against health care
practitioners. 27 Complaints that present an immediate threat to public safety are given priority; however,
all complaints are investigated as timely as possible. When the complaint is assigned to an investigator,
the complainant will be contacted and given the opportunity to provide additional information. A
thorough investigation will be conducted. The steps taken in the investigation are determined by the
specifics of the allegations, but generally include the following: 28

• Obtaining medical records, documents, and evidence;
• Locating and interviewing the complainant, the patient, the subject, and any witnesses; and
• Drafting and serving subpoenas for necessary information.

23 Section 456.073(1), F.S.
24 Section 456.073(1), F.S.
25 Id.
26 Department of Health, Consumer Services, http://www.floridahealth.gov/licensing-and-regulation/enforcement/admin-complaint-

process/consumer-services.html (last visited March 26, 2021).
27 Department of Health, Investigative Services, http://www.floridahealth.gov/licensing-and-regulation/enforcement/admin-complaint-

process/isu.html (last visited March 26, 2021).
28 Id.

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The ISU includes a staff of professional investigators and senior pharmacists who conduct interviews,
collect documents and evidence, prepare investigative reports for the Prosecution Services Unit (PSU),
and serve subpoenas and official orders for the DOH. 29

The PSU is responsible for providing legal services to the DOH in the regulation of all health care
boards and councils. 30 The PSU will review the investigative file and report from ISU and recommend a
course of action to the State Surgeon General (when an immediate threat to the health, safety, and
welfare of the people of Florida exists), the appropriate board’s probable cause panel, or the DOH, if
there is no board, which may include: 31

• Having the file reviewed by an expert;
• Issuing a closing order;
• Filing an administrative complaint; or
• Issuing an emergency order (emergency restriction order or emergency suspension order).

If the ISU investigative file received by PSU does not pose an immediate threat to the health, safety,
and welfare of the people of Florida, then the PSU attorneys review the file and determine, first,
whether expert review is required and, then, whether to recommend to the board’s probable cause
panel a closing order, an administrative complaint, or a letter of guidance. 32

Final DOH action, including all of the above, as well as cases where the subject has failed to respond to
an AC, are presented before the applicable board, or DOH if there is no board. The subject may be
required to appear. The complainant is notified of the date and location of the hearing and may attend.
If the subject is entitled to, and does, appeal the final decision, PSU defends the final order before the
appropriate appellate court. 33

If the ISU investigative file received by the PSU presents evidence of an immediate threat to the health,
safety, and welfare of the people of Florida, then PSU will present the file to the State Surgeon General
and recommend one of two types of emergency orders – emergency suspension order (ESO) or
emergency restriction order (ERO) – which are exclusively issued by the State Surgeon General
against licensees who pose such a threat to the people of Florida. 34

Whether the State Surgeon General issues an ERO or an ESO depends on the level of danger the
licensee presents because the DOH is permitted to use only the “least restrictive means” to stop the
danger. 35 The distinction between the two orders is: 36

• ESOs – Licensees are deemed to be a threat to the public at large; or
• EROs – Licensees are considered a threat to a segment of the population.

The emergency order process is carried out without a hearing, restricting someone’s right to work, and
when the order is served on the licensee, it must contain a notice to the licensee of his or her right to an
immediate appeal of the emergency order. 37 An ESO or ERO is not considered final agency action, and
the DOH must file an AC on the underlying facts supporting the ESO or ERO within 20 days of its

29 Id.
30 Department of Health, Prosecution Services, http://www.floridahealth.gov/licensing-and-regulation/enforcement/admin-complaint-

process/psu.html (last visited March 26, 2021).
31 Id.
32 Section 456.073(2), F.S. The DOH may recommend a letter of guidance in lieu of finding probable cause if the subject has not

previously been issued a letter of guidance for a related offense.
33 Supra note 27.
34 Section 456.073(8) and 120.60(6), F.S.
35 Section 120.60(6)(b), F.S.
36 Department of Health, Licensing and Regulation, Enforcement, Administrative Complaint Process, Prosecution Services, A Quick

Guide to the MQA Disciplinary Process Discretionary Emergency Orders – 3 Things to Know, http://www.floridahealth.gov/licensing-
and-regulation/enforcement/admin-complaint-process/_documents/a-quick-guide-to-the-mqa-disciplinary-process-discrtionary-
emergency-orders.pdf (last visited Mar. 26, 2021).
37 See Rule 28-106.501(3), F.A.C., and ss. 120.569(2)(n) or 120.60(6), F.S.

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issuance. 38 The appeal of the emergency order and the normal disciplinary process under the AC, and
regular prosecution can run simultaneously. 39

Mandatory EROs and ESOs

Section 456.074, F.S., directs that in certain cases, the DOH must issue an ESO or ERO to certain
licensed practitioners under certain circumstances. The State Surgeon General must issue an ESO to
certain practitioners if they have plead guilty to, been convicted of, found guilty of, or have entered a
plea of nolo contendere to, regardless of adjudication, Medicare fraud, Medicaid fraud, health care
fraud, or reproductive battery. 40 Such practitioners include: 41

• Allopathic physician, physician assistants, anesthesiologist assistants, medical assistants;
• Osteopathic physician, physician assistants, and anesthesiologist assistants;
• Chiropractic physician and physician assistants;
• Podiatric physicians;
• Naturopathic physicians;
• Optometrists - licensed and certified;
• Autonomous advanced practice registered nurses, advanced practice registered nurses,
registered nurses, licensed practical nurses and certified nursing assistants;
• Pharmacists and pharmacy technicians;
• Dentists, dental hygienist and dental laboratories; and
• Opticians.

DOH may issue an ESO or ERO if the Board of Medicine (BOM) or Board of Osteopathic Medicine
(BOOM) has previously found one of its physicians has committed medical malpractice, 42 gross
medical malpractice, or repeated medical malpractice, 43 and the probable cause panel again finds
probable of cause for another malpractice violation. In such cases, the State Surgeon General must
review the matter to determine if an ESO or ERO is warranted. 44

DOH may issue an ESO or ERO if any practitioner governed by ch. 456, F.S., tests positive for any
drug on any government or private sector pre-employment or employer-ordered confirmed drug test 45
when the practitioner does not have a lawful prescription and legitimate medical reason for using such
drug. 46

The DOH must issue an ESO if it receives information that a massage therapist, a person with an
ownership interest in the establishment, or a massage corporate establishment corporation whose
owners, officers, or individual are directly involved in the management of the establishment, has been
convicted of, found guilty of, or has entered a guilty or nolo contendere plea to, regardless of
adjudication, a felony under any of the following crimes anywhere: 47

• Prostitution; 48

38 Rule 28-106.501(3), F.A.C.
39 Section 120.60(6)(c), F.S.
40 Section 456.073(1), F.S.
41 Id.
42 Section 456.50(1)(g), F.S., “Medical malpractice” means the failure to practice medicine in accordance with the level of care, skill,

and treatment recognized in law related to health care licensure.
43 Id. “Repeated medical malpractice” is medical malpractice, and any similar wrongful act, neglect, or default committed in another

state or country which, if committed in this state, would have been considered medical malpractice, and will be considered medical
malpractice, if the standard of care and burden of proof applied in the other state or country equaled or exceeded that used in this state.
44 Section 456.074(2), F.S.
45 See s. 112.0445, F.S.
46 Section 456.074(3), F.S. The practitioner must be given 48 hours from the time of notification of the confirmed test results to produce

a lawful prescription for the drug before an emergency order is issued.
47 456.074(4), F.S.
48 Section 796.07(1)(a), F.S., “Prostitution” means the giving or receiving of the body for sexual activity for hire, but excludes sexual

activity between spouses. Prostitution that took place at massage establishment is reclassified to the next higher degree. See s.
796.07(2)(a), F.S., which is reclassified under s. 796.07(7), F.S.
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• Kidnapping; 49
• False imprisonment; 50
• Luring or enticing a child; 51
• Human trafficking; 52
• Human smuggling; 53
• Sexual battery; 54
• Female genital mutilation; 55
• Procuring a person under 18 for prostitution; 56
• Selling or buying of minors into prostitution; 57
• Forcing, compelling, or coercing another to become a prostitute; 58
• Deriving support from the proceeds of prostitution; 59
• Prohibiting prostitution and related acts; 60
• Lewd or lascivious offenses committed upon or in the presence of persons under 16; 61
• Lewd or lascivious offenses committed upon or in the presence of an elderly or disabled
person; 62
• Sexual performance by a child; 63
• Protection of minors; 64
• Computer pornography; 65
• Transmission of material harmful to minors, to a minor by electronic device or equipment; 66 and
• Selling or buying of minors. 67

DOH must issue an ESO if a BOM or BOOM probable cause panel determines that the following
constitutes a violation of the practice act and there exists an immediate danger to the public: 68

• The registered surgery office where office surgery liposuction, or Level II or Level III office
surgeries are being performed, or the physician practicing in the office, are not in compliance
with the standards of practice for office surgery set by statute and board rule; 69 or
• The physician is practicing beyond the scope of his or her education, training, and experience
and is performing procedures the licensee knows, or has reason to know, that he or she is not
competent to perform. 70

Due Process Under Chapter 120, F.S.

Chapter 120, F.S., known as the Administrative Procedure Act, (APA), provides uniform procedures for
the exercise of specified authority. Section 120.60, F.S., pertains to licensing and provides for due
process for persons seeking government-issued licensure or who have been granted such licensure.
Under the APA, no revocation, suspension, annulment, or withdrawal of any license is lawful unless,

49 Section 787.01, F.S.
50 Section 787.02, F.S.
51 Section 787.025, F.S.
52 Section 787.06, F.S.
53 Section 787.07, F.S.
54 Section 794.011, F.S.
55 Section 794.08, F.S.
56 Former s. 796.03, F.S.
57 Former s. 796.035, F.S.
58 Section 796.04, F.S.
59 Section 796.05, F.S.
60 Section 796.07(4)(a)3., F.S., relating to a felony of the third degree for a third or subsequent violation of s. 796.07, F.S.
61 Section 800.04, F.S.
62 Section 825.1025(2)(b), F.S.
63 Section 827.071, F.S.
64 Section 847.0133, F.S.
65 Section 847.0135, F.S.
66 Section 847.0138, F.S.
67 Section 847.0145, F.S.
68 Section 456.074(5), F.S.
69 Rules 64B-9.009 and 64B15-14.007, F.A.C.
70 Sections 458.331(1)(v) and 459.015(1)(z), F.S.

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prior to the entry of a final order, the governmental agency has served, by personal service or certified
mail, an administrative complaint which affords reasonable notice to the licensee of facts or conduct
which warrant the intended action and unless the licensee has been given an adequate opportunity to
request a hearing under ss. 120.569 and 120.57, F.S. 71

When personal service cannot be made and the certified mail notice is returned undelivered, the
agency must cause a short, plain notice to the licensee to be published once each week for four
consecutive weeks in a newspaper published in the county of the licensee’s last known address as it
appears on the records of the agency, or, if no newspaper is published in that county, the notice may
be published in a newspaper of general circulation in that county. 72

The APA provides a process for cases in which a governmental agency finds that immediate serious
danger to the public health, safety, or welfare requires emergency suspension, restriction, or limitation
of a license. 73 In such cases, the agency may take such action by any procedure that is fair under the
circumstances if: 74

• The procedure provides at least the same procedural protection as is given by other statutes,
the State Constitution, or the U.S. Constitution;
• The agency takes only that action necessary to protect the public interest under the emergency
procedure; and
• The agency states in writing at the time of, or prior to, its action the specific facts and reasons
for finding an immediate danger to the public health, safety, or welfare and its reasons for
concluding that the procedure used is fair under the circumstances. The agency’s findings of
immediate danger, necessity, and procedural fairness are judicially reviewable. Summary
suspension, restriction, or limitation may be ordered, but a suspension or revocation proceeding
pursuant to ss. 120.569 and 120.57, F.S., must also be promptly instituted and acted upon.

Effect of the Bill

HB 721 prohibits health care practitioners from making misleading, deceptive, or fraudulent
representations regarding a health care practitioner’s specialty designation. The bill prohibits a health
care practitioner from using the title “anesthesiologist” unless the health care practitioner is licensed as
an allopathic physician under chapter 458, F.S., an osteopathic physician under chapter 459, F.S., or a
dentist under chapter 466, F.S. The bill also prohibits a health care practitioner from using the title
“dermatologist” unless the health care practitioner is licensed as an allopathic physician under chapter
458, F.S., an osteopathic physician under chapter 459, F.S.

The bill requires DOH, rather than the boards, to enforce the bill’s provisions. The bill requires DOH to
issue an emergency order to cease and desist to a health care practitioner who violates the bill’s
provisions. DOH must send the emergency order to the health care practitioner’s email address and by
certified mail to the practitioner’s physical address, and to any other address at which the practitioner
may be reached. DOH must issue an order imposing a citation and daily fine, reprimand or letter of
concern, or suspension of license, if the health care practitioner does not immediately correct the
violation upon receipt of the emergency cease and desist order.

The bill takes effect upon becoming law.

B. SECTION DIRECTORY:
Section 1 Amends s. 456.072, F.S., relating to grounds for discipline; penalties; enforcement.
Section 2 Provides an effective date of upon becoming law.

71 Section 120.60(5), F.S.
72 Id.
73 Section 120.60(6), F.S.
74 Id.

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II. FISCAL ANALYSIS & ECONOMIC IMPACT STATEMENT

A. FISCAL IMPACT ON STATE GOVERNMENT:

1. Revenues:
None.

2. Expenditures:
DOH may experience a recurring increase in workload associated with additional complaints,
investigations, and prosecutions resulting from the bill. The extent to which such complaints,
investigations, and prosecutions may materialize is unknown; therefore, the fiscal impact is
indeterminate. 75

B. FISCAL IMPACT ON LOCAL GOVERNMENTS:

1. Revenues:
None.

2. Expenditures:
None.

C. DIRECT ECONOMIC IMPACT ON PRIVATE SECTOR:
Health care practitioners in violation of the restrictions in this bill may be subject to disciplinary actions
and fines.

D. FISCAL COMMENTS:
None.

III. COMMENTS

A. CONSTITUTIONAL ISSUES:

1. Applicability of Municipality/County Mandates Provision:
No applicable. The bill does not appear to affect county of municipal governments.

2. Other:
The bill’s requirement for DOH to enter an order imposing penalties if a person does not immediately
comply with an emergency cease and desist order, in a manner that differs from procedures that
provide due process under current law, may subject those provisions of the bill to challenge as a
violation of the licensee’s due process rights under the Florida Constitution and the United States
Constitution.

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

C. DRAFTING ISSUES OR OTHER COMMENTS:
DOH advises that while the bill focuses on a practitioner’s misuse of a specialty designation as grounds
for discipline, the term “specialty designation” is not defined in the bill or in existing statute and is not a
term used in the ordinary course of health care practitioner regulation. Absent a definition or guidelines
about what constitutes a misrepresentation, the bill’s new grounds for discipline are so vague as to be

75 Department of Health, Agency Analysis of 2021 House Bill 721 (March 20, 2021).

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unenforceable, according to DOH. While some physicians hold board certifications in their specialty
areas from the American Board of Medical Specialties or the American Osteopathic Association, not all
specialists hold or maintain such credentials. Health care providers who participate in Medicare
typically have a specialty designation under which they bill for payment. It is unclear to DOH what
credentials a practitioner must hold to use a “specialty designation” under the bill and when the use of
such designation would be considered misleading or fraudulent. 76

DOH also advises that, because the bill requires the department, not the applicable regulatory board, to
impose discipline for violations of ss. 456.072(1)(a) and (t), F.S., the bill will require the creation of a
new disciplinary process. DOH will need to create a unique procedure and tracking system for these
specific charges. For all other disciplinary grounds, it is the board that issued the license that takes
disciplinary action against that license. The bill would authorize DOH to suspend a practitioner’s license
without the involvement or input of the board that issued the license, which could be interpreted to
conflict with current law regarding practitioner discipline. 77

DOH further advises that, under the bill’s requirement for DOH to issue an emergency order to cease
and desist, the procedures for issuing such an order are unclear. Currently, when DOH issues an
emergency order, it must show that allowing the practitioner to continue to practice would constitute an
immediate serious danger to the health, safety, or welfare of the citizens of Florida and that nothing
short of the emergency action would protect citizens from that danger, as required under s. 120.60(6),
F.S. It is unclear to DOH how these requirements would be met under the circumstances specified in
the bill. 78

DOH further advises that the bill’s requirement for the department to enter an order imposing penalties
if a person does not immediately comply with an emergency cease and desist order may conflict with s.
456.073(5), F.S., which provides that a formal hearing must be held before an administrative law judge
in disciplinary matters if there are material issues of disputed fact. This portion of the bill may also
conflict with s. 120.60(5), F.S., which provides that no revocation, suspension, annulment, or
withdrawal of any license is lawful unless, prior to the entry of the order, the governmental agency has
served, by personal service or certified mail, an administrative complaint which affords reasonable
notice to the licensee of facts or conduct which warrant the intended action and the licensee has been
given an adequate opportunity to request a proceeding pursuant to ss. 120.569 and 120.57, F.S. 79

IV. AMENDMENTS/ COMMITTEE SUBSTITUTE CHANGES

76 Id.
77 Id. Sections 456.073(1) and (2), F.S., provide that the DOH investigates complaints and violations of the grounds for discipline and

provides the completed investigative report to the probable cause panel of the appropriate regulatory board. The statute provides for
the report to be sent to the department only when there is no board for the profession in question. Section 456.073(4), F.S., provides
that the determination of the existence of probable cause is made by the probable cause panel and that the DOH determines probable
cause only if there is no board. And, s. 456.073(6), F.S., provides that the appropriate board issues the final order in each health care
professional disciplinary case, unless there is no board, in which case the DOH would issue the final order.
78 Supra, note 75.
79 Id.

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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 721 2021

1 A bill to be entitled
2 An act relating to prohibited acts by health care
3 practitioners; amending s. 456.072, F.S.; prohibiting
4 specified acts by health care practitioners relating
5 to specialty designations; authorizing the Department
6 of Health to enforce compliance with the act;
7 authorizing the department to take specified
8 disciplinary action against health care practitioners
9 in violation of the act; specifying applicable
10 administrative penalties; providing an effective date.
11
12 Be It Enacted by the Legislature of the State of Florida:
13
14 Section 1. Paragraphs (a) and (t) of subsection (1) and
15 subsection (2) of section 456.072, Florida Statutes, are amended
16 to read:
17 456.072 Grounds for discipline; penalties; enforcement.—
18 (1) The following acts shall constitute grounds for which
19 the disciplinary actions specified in subsection (2) may be
20 taken:
21 (a) Making misleading, deceptive, or fraudulent
22 representations in or related to the practice of the licensee's
23 profession or specialty designation. The term "anesthesiologist"
24 may be used only if the practitioner is licensed as a physician
25 under chapter 458 or chapter 459 or as a dentist under chapter

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26 466, and the term "dermatologist" may be used only if the
27 practitioner is licensed as a physician under chapter 458 or
28 chapter 459.
29 (t) Failing to identify through written notice, which may
30 include the wearing of a name tag, or orally to a patient the
31 type of license or specialty designation under which the
32 practitioner is practicing. Any advertisement for health care
33 services naming the practitioner must identify the type of
34 license the practitioner holds. This paragraph does not apply to
35 a practitioner while the practitioner is providing services in a
36 facility licensed under chapter 394, chapter 395, chapter 400,
37 or chapter 429. The department shall enforce this paragraph Each
38 board, or the department where there is no board, is authorized
39 by rule to determine how its practitioners may comply with this
40 disclosure requirement.
41 (2)(a) When the board, or the department when there is no
42 board, finds any person guilty of the grounds set forth in
43 subsection (1) or of any grounds set forth in the applicable
44 practice act, including conduct constituting a substantial
45 violation of subsection (1) or a violation of the applicable
46 practice act which occurred before prior to obtaining a license,
47 it may enter an order imposing one or more of the following
48 penalties:
49 1.(a) Refusal to certify, or to certify with restrictions,
50 an application for a license.

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51 2.(b) Suspension or permanent revocation of a license.
52 3.(c) Restriction of practice or license, including, but
53 not limited to, restricting the licensee from practicing in
54 certain settings, restricting the licensee to work only under
55 designated conditions or in certain settings, restricting the
56 licensee from performing or providing designated clinical and
57 administrative services, restricting the licensee from
58 practicing more than a designated number of hours, or any other
59 restriction found to be necessary for the protection of the
60 public health, safety, and welfare.
61 4.(d) Imposition of an administrative fine not to exceed
62 $10,000 for each count or separate offense. If the violation is
63 for fraud or making a false or fraudulent representation, the
64 board, or the department if there is no board, must impose a
65 fine of $10,000 per count or offense.
66 5.(e) Issuance of a reprimand or letter of concern.
67 6.(f) Placement of the licensee on probation for a period
68 of time and subject to such conditions as the board, or the
69 department when there is no board, may specify. Those conditions
70 may include, but are not limited to, requiring the licensee to
71 undergo treatment, attend continuing education courses, submit
72 to be reexamined, work under the supervision of another
73 licensee, or satisfy any terms which are reasonably tailored to
74 the violations found.
75 7.(g) Corrective action.

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76 8.(h) Imposition of an administrative fine in accordance
77 with s. 381.0261 for violations regarding patient rights.
78 9.(i) Refund of fees billed and collected from the patient
79 or a third party on behalf of the patient.
80 10.(j) Requirement that the practitioner undergo remedial
81 education.
82
83 In determining what action is appropriate, the board, or
84 department when there is no board, must first consider what
85 sanctions are necessary to protect the public or to compensate
86 the patient. Only after those sanctions have been imposed may
87 the disciplining authority consider and include in the order
88 requirements designed to rehabilitate the practitioner. All
89 costs associated with compliance with orders issued under this
90 subsection are the obligation of the practitioner.
91 (b)1. When the department finds that a person has violated
92 paragraph (1)(a), the department must issue an emergency order
93 to the person to cease and desist the use of the name or title,
94 or any other words, letters, abbreviations, or insignia
95 indicating that he or she may practice under the specialty
96 designation. The department must send the emergency cease and
97 desist order to the person by certified mail and e-mail to the
98 person's physical address and e-mail address of record on file
99 with the department and to any other mailing address or e-mail
100 address through which the department believes the person may be

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101 reached.
102 2. If the person does not cease and desist his or her
103 actions in violation of paragraph (1)(a) immediately upon
104 receipt of the emergency cease and desist order, the department
105 must enter an order imposing any of the following penalties, or
106 a combination thereof, until the person complies with the cease
107 and desist order:
108 a. A citation and a daily fine.
109 b. A reprimand or a letter of concern.
110 c. Suspension of license.
111 Section 2. This act shall take effect upon becoming a law.

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COMMITTEE/SUBCOMMITTEE AMENDMENT
Bill No. HB 721 (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 Smith, C. offered the following:
4
5 Amendment (with directory amendment)
6 Between lines 40 and 41, insert:
7 (rr) Knowingly using the name or title "anesthetist"
8 unless that person is a certified registered nurse anesthetist
9 under s. 464.012.
10 Remove line 92 and insert:
11 paragraph (1)(a) or paragraph (1)(rr), the department must issue
12 an emergency order
13
14 -----------------------------------------------------
15 D I R E C T O R Y A M E N D M E N T
16 Remove line 15 and insert:
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Page 1 of 2
COMMITTEE/SUBCOMMITTEE AMENDMENT
Bill No. HB 721 (2021)
Amendment No. 1

17 subsection (2) of section 456.072, Florida Statutes, are
18 amended, and paragraph (rr) is added to subsection (1) of that
19 section,

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HB 949
HOUSE OF REPRESENTATIVES STAFF ANALYSIS
BILL #: HB 949 Communicable and Infectious Diseases
SPONSOR(S): Fetterhoff and Omphroy
TIED BILLS: IDEN./SIM. BILLS: HB 963, SB 1314, SB 1422

REFERENCE ACTION ANALYST STAFF DIRECTOR or
BUDGET/POLICY CHIEF

1) Government Operations Subcommittee 14 Y, 0 N Villa Smith

2) Professions & Public Health Subcommittee Guzzo McElroy

3) Appropriations Committee

4) State Affairs Committee

SUMMARY ANALYSIS
Any person employed full time by the state or a political subdivision as a firefighter, paramedic, emergency
medical technician, law enforcement officer, or correctional officer who suffers a condition caused by hepatitis,
meningococcal meningitis, or tuberculosis that results in total or partial disability or death is presumed to have
a disability suffered in-the-line-of-duty and is therefore entitled to certain higher benefits. This presumption can
be defeated by competent evidence to the contrary.

The bill adds an “infectious disease” to the list of diseases that, if suffered by an emergency rescue or public
safety worker, is presumed to have been suffered in-the-line-of-duty. The bill defines “infectious disease” to
mean any condition or impairment of health caused by a disease that has been declared a public health
emergency by the State Health Officer.

In order to be entitled to the presumption, the bill requires the emergency rescue or public safety worker to
submit a written declaration under penalty of perjury verifying that, to the best of his or her knowledge, he or
she contracted the infectious disease during a public health emergency and was not exposed to any person
known to have the infectious disease outside the scope of his or her employment.

The bill specifies that the vaccine or immunization that an emergency rescue or public safety worker may be
required by their employer to receive in order to enjoy the presumption must be approved by the United States
Food and Drug Administration.

The bill requires an emergency rescue or public safety worker to file an incident or accident report with his or
her employer for each instance of known or suspected occupational exposure to an infectious disease.

The bill may have a fiscal impact on the state and local governments. See Fiscal Comments section.

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

Workers’ Compensation Insurance
Under ch. 440, F.S., which relates to workers’ compensation, an employer must pay compensation or
furnish benefits if an employee suffers an accidental compensable injury or death arising out of work
performed in the course and scope of employment. 1 The injury, its occupational cause, and any
resulting disability must be established to a reasonable degree of medical certainty, and the accidental
compensable injury must be the major contributing cause of any resulting injury. 2

Compensation for permanent total disability is equal to 66 2/3 percent of the employee’s average
weekly wages payable to the employee during the continuance of the total disability. 3 In addition, an
employee will generally receive an annual supplemental income benefit equal to 3 percent per year of
the compensation payment, multiplied by the number of calendar years since the date of the injury, until
age 62. 4

Compensation for temporary total disability is equal to 66 2/3 percent of the employee’s average
weekly wages payable to the employee during the continuance of the total disability, but payment may
not exceed 104 weeks. At the earlier of the 104th week or the employee reaching maximum medical
improvement, the temporary disability payment will cease and the injured employee’s permanent
impairment will be determined. 5

Where the disability or death of an employee results from an “occupational disease,” it will be treated
as an injury by accident. 6 The employee or his or her survivors will be entitled to compensation.
“Occupational disease” is defined to mean “only a disease for which there are epidemiological studies
showing that exposure to the specific substance involved, at the levels to which the employee was
exposed, may cause the precise disease sustained by the employee.” 7

An accidental compensable injury must be the major contributing cause of any resulting injury, meaning
that the cause must be more than 50 percent responsible for the injury as compared to all other causes
combined, as demonstrated by medical evidence only. For an injury or disease involving an
occupational disease or repetitive exposure, both causation and sufficient exposure to support
causation must be proven by clear and convincing evidence. 8

Florida Retirement System
The Florida Retirement System (FRS) was established in 1970 when the Legislature consolidated the
Teachers’ Retirement System, the State and County Officers and Employees’ Retirement System, and
the Highway Patrol Pension Fund. In 1972, the Judicial Retirement System was consolidated into the
FRS, and in 2007, the Institute of Food and Agricultural Sciences Supplemental Retirement Program
was consolidated into the FRS as a closed group. 9

1
Section 440.09(1), F.S.
2
Id.
3
Section 440.15(1)(a), F.S.
4
Section 440.15(1)(f), F.S.
5
Section 440.15(2)(a), F.S.
6
Section 440.151(1)(a), F.S.
7
Section 440.151(2), F.S.
8
Section 440.09(1), F.S.
9
Florida Retirement System Pension Plan and Other State Administered Systems Comprehensive Annual Financial Report Fiscal Year
2019-2020, at 35. A copy of the report can be found at:
https://www.dms.myflorida.com/workforce_operations/retirement/publications/annual_reports.
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The Florida Retirement System Act 10 governs the FRS, which is a multi-employer, contributory plan
that provides retirement income benefits to 644,338 active members, 11 432,258 annuitants, 15,512
disabled retirees, and 33,593 active participates of the Deferred Retirement Option Program. 12 It is the
primary retirement plan for employees of state and county government agencies, district school boards,
community colleges, and universities. Municipalities, independent special districts, metropolitan
planning districts, and public charter schools may elect to participate in the FRS. Such election is
irrevocable. 13 The FRS also serves as the retirement plan for participating employees of the 177 cities
and 149 special districts that have elected to join the system. 14

Membership in the FRS is compulsory for all full-time and part-time employees working in regularly
established positions for covered employers.

The FRS is managed by the Department of Management Services and the State Board of
Administration.

Class Structure
The membership of the FRS is divided into five membership classes. The five membership classes
include:
• Regular Class 15 has 557,754 members;
• Special Risk Class 16 has 76,343 members;
• Special Risk Administrative Support Class 17 has 108 members;
• Elected Officers’ Class 18 has 2,153 members; and
• Senior Management Service Class 19 has 7,980 members. 20

Each class is funded separately based upon the costs attributable to the members of that class.

Plan Options
Members of the FRS have two primary plan options available for participation:
• The investment plan, which is a defined contribution plan; and
• The pension plan, which is a defined benefit plan.

Regardless of whether the member elects to participate in the pension plan or the investment plan, the
member must contribute three percent of the member’s salary. 21

10
See ch. 121, F.S.
11
As of June 30, 2020, the FRS pension plan, which is a defined benefit plan, had 479,043 members, and the investment plan, which
is a defined contribution plan, had 165,295 members.
12
Annual Report, supra note 1, at 160.
13
See s. 121.051(2), F.S.
14
Annual Report, supra note 1, at 195.
15
Regular Class members are those members who do not qualify for membership in the other classes within the FRS. Section
121.021(12), F.S.
16
Special Risk Class members include law enforcement officers, firefighters, correctional officers, probation officers, paramedics, and
emergency medical technicians, among others. Section 121.0515, F.S.
17
Special Risk Administrative Support Class members are former members of the Special Risk Class who are transferred or
reassigned to an administrative support position in certain circumstances. Section 121.0515(8), F.S.
18
Membership in the Elected Officers’ Class is comprised of those participants who hold specified elective offices in either state or
local government. Section 121.052, F.S.
19
Senior Management Service Class members generally are high level executive and legal staff or as specifically provided in law.
Section 121.055, F.S.
20
All figures from Annual Report, supra note 3, at 161.
21
Prior to 1975, members of the FRS were required to make employee contributions of either 4 percent for Regular Class employees
or 6 percent for Special Risk Class members. Employees were again required to contribute to the system after July 1, 2011.
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Certain members, as specified by law, may, in lieu of FRS participation, participate in optional
retirement plans, which include the Senior Management Service Optional Annuity Program, State
Community College System Optional Retirement Program, and the State University System Optional
Retirement Program.

Special Risk Class
The Special Risk Class of the FRS consists of state and local government employees who meet the
criteria for special risk membership. The class covers persons employed in law enforcement,
firefighting, criminal detention, and emergency and forensic medical care who meet the statutory
criteria. 22

When originally establishing the Special Risk Class of membership in the FRS, the Legislature
recognized that persons employed in certain categories of positions:

are required as one of the essential functions of their positions to perform work
that is physically demanding or arduous, or work that requires extraordinary agility
and mental acuity, and that such persons, because of diminishing physical and
mental faculties, may find that they are not able, without risk to the health and
safety of themselves, the public, or their coworkers, to continue performing such
duties and thus enjoy the full career and retirement benefits enjoyed by persons
employed in other membership classes and that, if they find it necessary, due to
the physical and mental limitations of their age, to retire at an earlier age and
usually with less service, they will suffer an economic deprivation therefrom. 23

Compared to the Regular Class members, a person who is a member in the Special Risk Class earns a
higher annual service accrual rate, may retire at an earlier age, and is eligible to receive higher
disability and death benefits. As a result, the contribution rates to fund the normal cost of the special
risk benefits are higher than the contribution rates to fund the normal cost of the Regular Class
benefits. Similarly, the contribution rates to fund the unfunded liabilities of the Special Risk Class are
higher than those contribution rates for the Regular Class.

Disability Retirement Benefits for Special Risk Members of the FRS
There are two types of disability retirement available under the FRS: regular disability retirement and in-
the-line-of-duty disability retirement. To qualify for either type of disability retirement, members must be
totally and permanently disabled to the extent that they are unable to work. 24 An employee who is
physically or mentally unable to continue performing in his or her present occupation, but is able to
perform another type of work, will not qualify for disability benefits. 25

To be eligible for regular disability retirement under the FRS, a member must complete eight years of
creditable service. 26 Under the FRS Pension Plan, the minimum benefit under regular disability
retirement, regardless of class, is 25 percent of the employee’s average final compensation. 27 In
contrast, in-the-line-of-duty disability benefits are available to members on their first day of
employment. There is no vesting period. Special Risk Class members receive a minimum in-the-line-of-
duty disability benefit of 65 percent of their average final compensation. 28 Members in all other classes
are eligible to receive a minimum in-the-line-of-duty disability benefit of 42 percent of their average final
compensation. 29

22
See s. 121.0515, F.S.
23
Section 121.0515(1), F.S.
24
Section 121.091(4), F.S.
25
Florida Retirement System Employer Handbook, Disability Retirement, ch. 10, available at
https://www.rol.frs.state.fl.us/forms/EH_ch10.pdf.
26
Sections 121.091(4)(a) and 121.591(2)(b)2., F.S.
27
Section 121.091(4)(f), F.S.
28
Id.
29
Id.
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Under the FRS Investment Plan, the disability benefits are provided in lieu of the normal retirement
benefits (the accumulations of contributions and investment earnings in the member’s retirement
account). 30 To receive the disability benefits, the member must transfer all of his or her accumulations
to the investment plan disability account. The member will then receive a monthly benefit calculated the
same as a similarly situated pension plan member. 31

Death Benefits for Special Risk Members of the FRS
If a member of the FRS is terminated by reason of death prior to becoming vested in the FRS, the
member’s beneficiary is only entitled to the member’s accumulated contributions. 32 Under the pension
plan, if the member is vested at the time of his or her death, the member’s joint annuitant 33 is entitled to
receive the optional form 34 of payment for the annuitant’s lifetime. 35 If the designated beneficiary does
not qualify as a joint annuitant, the member’s beneficiary is only entitled to the return of the member’s
personal contributions, if any. 36

The FRS currently provides death benefits for surviving spouses and/or eligible dependents of active
members of the pension plan. Death benefits may be paid for an active member of the FRS Pension
Plan who dies before retirement due to an injury or illness. 37 If the injury or illness arises out of and in
the actual performance of duties required by a member’s job, the member’s surviving spouse and/or
eligible dependent(s) are entitled to in-the-line-of-duty death benefits. These in-the-line-of-duty death
benefits are also available to members of the investment plan if the member’s beneficiary elects to
transfer the accumulations in the member’s investment plan account to the pension fund. 38

If an FRS member who is not in the Special Risk Class dies in the line of duty, the surviving spouse of
the member is entitled to receive a monthly benefit equal to one-half of the monthly salary being
received by the member at the time of death for the rest of the surviving spouse’s lifetime. 39 If there is
no surviving spouse or the surviving spouse dies, the member’s children under 18 years of age and
unmarried may receive the benefits until the youngest child’s 18th birthday. 40

If an FRS member who is in the Special Risk Class dies in the line of duty, the member’s surviving
spouse and children are eligible to receive a monthly payment equal to the member’s total monthly
salary at the time of death. 41 These benefits may be extended to the 25th birthday of an unmarried
child enrolled as a full time student if there is no surviving spouse or the surviving spouse dies. 42

Presumptions and Burdens of Proof Relating to in-the-line-of-duty Disability and Death
An FRS member has the burden of proof when claiming in-the-line-of-duty disability or death benefits.
The member must show by competent medical evidence that the death or disability occurred in-the-
line-of-duty in order to receive the higher benefits. If the employee or the employee’s survivors cannot

30
Section 121.591(2), F.S.
31
Section 121.591(2)(g), F.S.
32
For purposes of disbursement of benefits, a member is considered retired as of the date of the death.
33
A joint annuitant is considered to be the member’s spouse, natural or legally adopted child who is either under age 25 or is
physically or mentally disabled and incapable of self-support (regardless of age), or any person who is financially dependent upon the
member for one-half or more of his or her support and is the member’s parent, grandparent, or person for whom the member is the
legal guardian. Section 121.021(28), F.S.
34
Under the pension plan, a member has a choice of payment options. If the member dies prior to retirement, the member’s joint
annuitant is entitled to select either to receive the member’s contributions or a reduced monthly benefit payment for life.
35
Section 121.091(7)(b)1., F.S.
36
Section 121.091(7)(b)2., F.S.
37
Section 121.091(7), F.S.
38
Section 121.591(4), F.S.
39
Section 121.091(7)(d)1., F.S.
40
Section 121.091(7)(d)2. and 3., F.S.
41
Section 121.091(7)(i), F.S.
42
Id.
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meet the burden of proof, the employee or the employee’s survivors are entitled only to the lesser
benefits available under regular death or disability

An FRS member employed as an emergency rescue or public safety worker 43 who suffers a condition
caused by hepatitis, meningococcal meningitis, or tuberculosis that results in total or partial disability or
death is presumed to have a disability suffered in-the-line-of-duty and to be entitled to the higher
benefits. 44 The presumption can be defeated by competent evidence to the contrary.

In order to be eligible for the presumption, the member, prior to diagnoses, must have undergone test
for the disease, which fail to indicate the presence of the infection. A prior negative test is not required,
however, in the case of meningococcal meningitis. In addition, the member must sign a written
declaration under penalty of perjury verifying he or she has not:
• In the case of a medical condition caused by hepatitis:
o Been exposed to any person known to have sickness or medical conditions derived from
hepatitis, outside the scope of his or her employment;
o Had a blood transfer, other than a transfusion arising out of an accident or injury
happening in connection with his or her employment;
o Engaged in unsafe sexual practices or other high-risk behavior; or
o Used intravenous drugs not prescribed by a physician.
• In the case of meningococcal meningitis, in the last 10 days, has not been exposed outside of
the scope of his or her employment to any person known to have meningococcal meningitis or
known to be an asymptomatic carrier of the disease; and
• In the case of tuberculosis, since the member’s last negative tuberculosis skin test, has not
been exposed outside of the scope of his or her employment to any person known by the
member to have tuberculosis. 45

If medically indicated in the given circumstances pursuant to the immunization policies established by
the Advisory Committee on Immunization Practices of the United States Public Health Service, 46
whenever a medically recognized vaccine or other form of immunization exists for the above mentioned
communicable diseases, the emergency rescue or public safety worker may be required by his or her
employer to undergo the immunization, unless the member’s physician determines in writing that the
immunization would pose a significant risk to the member’s health. 47 Absent such written declaration,
failure or refusal to undergo immunization disqualifies the member from the benefits of the
presumption.

An emergency rescue or public safety worker is required to file an incident report with his or her
employer for every known or suspected occupational exposure to hepatitis, meningococcal meningitis,
or tuberculosis. An employing agency must maintain a record of such exposures, and notify any
employee that may have been exposed. 48

43
“Emergency rescue or public safety worker” means any person employed full time by the state or any political subdivision of the
state as a firefighter, paramedic, emergency medical technician, law enforcement officer, or correctional officer who, in the course of
employment, runs a high risk of occupational exposure to hepatitis, meningococcal meningitis, or tuberculosis and who is not
employed elsewhere in a similar capacity. However, the term “emergency rescue or public safety worker” does not include any person
employed by a public hospital licensed under chapter 395 or any person employed by a subsidiary thereof. Section 112.181(1)(b), F.S.
44
Section 112.181(2), F.S.
45
Id.
46
The Advisory Committee on Immunization Practices comprises medical and public health experts who develop recommendations
on the use of vaccines in the civilian population of the United States. The recommendations stand as public health guidance for safe
use of vaccines and related biological products. Center for Disease Control and Prevention, Advisory Committee on Immunization
Practices (ACIP), https://www.cdc.gov/vaccines/acip/committee/index.html (last visited March 17, 2021).
47
Section 112.181(3), F.S.
48
Section 112.181(5), F.S.
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Effect of the Bill

The bill adds an “infectious disease” to the list of diseases that, if suffered by an emergency rescue or
public safety worker, is presumed to have been suffered in-the-line-of-duty thereby entitling the worker
to higher death or disability benefits, unless the contrary can be shown by competent evidence. The bill
defines “infectious disease” to mean any condition or impairment of health caused by a disease that
has been declared a public health emergency by the State Health Officer. 49

In order to be entitled to the presumption, the bill requires the emergency rescue or public safety
worker to submit a written declaration under penalty of perjury verifying that, to the best of his or her
knowledge, he or she contracted the infectious disease during a public health emergency declared by
the State Health Officer and was not exposed, outside of the scope of his or her employment, to any
person known to have the infectious disease.

The bill specifies that the vaccine or immunization that an emergency rescue or public safety worker
may be required by their employer to receive in order to enjoy the presumption must be approved by
the United State Food and Drug Administration.

The bill requires an emergency rescue or public safety worker to file an incident or accident report with
his or her employer for each instance of known or suspected occupational exposure to an infectious
disease.

The bill specifies that similar to meningococcal meningitis, an emergency rescue or public safety
worker is not required to undergo test, prior to diagnosis, which fail to indicate the presence of the
infection in order to enjoy the presumption.

B. SECTION DIRECTORY:
Section 1 amends s. 112.81, F.S., to add “infectious diseases” to the list of diseases that are presumed
to have been suffered in-the-line-of-duty for certain workers.

Section 2 provides an effective date of July 1, 2021.

II. FISCAL ANALYSIS & ECONOMIC IMPACT STATEMENT

A. FISCAL IMPACT ON STATE GOVERNMENT:

1. Revenues:
None.

2. Expenditures:
See fiscal comments.

B. FISCAL IMPACT ON LOCAL GOVERNMENTS:

49
The State Health Officer is responsible for declaring public health emergencies, issuing public health advisories, and ordering
isolation or quarantines. A “public health emergency” means any occurrence, or threat thereof, whether natural or manmade, which
results or may result in substantial injury or harm to the public health from infectious disease, chemical agents, nuclear agents,
biological toxins, or situations involving mass casualties or natural disasters. Before declaring a public health emergency, the State
Health Officer shall, to the extent possible, consult with the Governor and shall notify the Chief of Domestic Security. The declaration
of a public health emergency shall continue until the State Health Officer finds that the threat or danger has been dealt with to the
extent that the emergency conditions no longer exist and he or she terminates the declaration. However, a declaration of a public
health emergency may not continue for longer than 60 days unless the Governor concurs in the renewal of the declaration. Section
381.00315(1)(c), F.S.
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1. Revenues:
None.

2. Expenditures:
See fiscal comments.

C. DIRECT ECONOMIC IMPACT ON PRIVATE SECTOR:
None.

D. FISCAL COMMENTS:
The bill adds a new subset of diseases that are presumed to be suffered in-the-line-of-duty for certain
workers, thereby entitling those workers to higher disability and death benefits. Accordingly, more state
and local government employees may qualify for enhanced workers’ compensation or retirement
benefits. The fiscal impact on the state and local governments is unknown at this time.

III. COMMENTS

A. CONSTITUTIONAL ISSUES:

1. Applicability of Municipality/County Mandates Provision:
The county/municipality mandates provision of Art. VII, s. 18, of the Florida Constitution may apply
because this bill creates a new presumption for “infectious disease” that would be applicable to
workers’ compensation benefits paid to emergency rescue or public safety workers; however, an
exemption may apply if the fiscal impact of the bill is insignificant. In addition, an exception may
apply because all similarly situated state and local government employers of emergency rescue and
public safety workers are required to provide the workers’ compensation benefit. However, for this
exception to apply, the bill must declare that it fulfills an important state interest.

2. Other:
None.

B. RULE-MAKING AUTHORITY:
The bill does not confer rulemaking authority nor require rulemaking.

C. DRAFTING ISSUES OR OTHER COMMENTS:
None.

IV. AMENDMENTS/ COMMITTEE SUBSTITUTE CHANGES
None.

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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 949 2021

1 A bill to be entitled
2 An act relating to communicable and infectious
3 diseases; amending s. 112.181, F.S.; providing a
4 definition; providing a presumption to specified
5 workers that an impairment of health caused by an
6 infectious disease happened in the line of duty;
7 requiring certain actions in order to be entitled to
8 the presumption; requiring the United States Food and
9 Drug Administration to approve certain vaccines or
10 immunizations; providing an effective date.
11
12 Be It Enacted by the Legislature of the State of Florida:
13
14 Section 1. Section 112.181, Florida Statutes, is amended
15 to read:
16 112.181 Firefighters, paramedics, emergency medical
17 technicians, law enforcement officers, correctional officers;
18 special provisions relative to certain communicable and
19 infectious diseases.—
20 (1) DEFINITIONS.—As used in this section, the term:
21 (a) "Body fluids" means blood and body fluids containing
22 visible blood and other body fluids to which universal
23 precautions for prevention of occupational transmission of
24 blood-borne pathogens, as established by the Centers for Disease
25 Control and Prevention, apply. For purposes of potential

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26 transmission of meningococcal meningitis or tuberculosis, the
27 term "body fluids" includes respiratory, salivary, and sinus
28 fluids, including droplets, sputum, and saliva, mucous, and
29 other fluids through which infectious airborne organisms can be
30 transmitted between persons.
31 (b) "Emergency rescue or public safety worker" means any
32 person employed full time by the state or any political
33 subdivision of the state as a firefighter, paramedic, emergency
34 medical technician, law enforcement officer, or correctional
35 officer who, in the course of employment, runs a high risk of
36 occupational exposure to hepatitis, meningococcal meningitis, or
37 tuberculosis, or an infectious disease and who is not employed
38 elsewhere in a similar capacity. However, the term "emergency
39 rescue or public safety worker" does not include any person
40 employed by a public hospital licensed under chapter 395 or any
41 person employed by a subsidiary thereof.
42 (c) "Hepatitis" means hepatitis A, hepatitis B, hepatitis
43 non-A, hepatitis non-B, hepatitis C, or any other strain of
44 hepatitis generally recognized by the medical community.
45 (d) "High risk of occupational exposure" means that risk
46 that is incurred because a person subject to the provisions of
47 this section, in performing the basic duties associated with his
48 or her employment:
49 1. Provides emergency medical treatment in a non-health-
50 care setting where there is a potential for transfer of body

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51 fluids between persons;
52 2. At the site of an accident, fire, or other rescue or
53 public safety operation, or in an emergency rescue or public
54 safety vehicle, handles body fluids in or out of containers or
55 works with or otherwise handles needles or other sharp
56 instruments exposed to body fluids;
57 3. Engages in the pursuit, apprehension, and arrest of law
58 violators or suspected law violators and, in performing such
59 duties, may be exposed to body fluids; or
60 4. Is responsible for the custody, and physical restraint
61 when necessary, of prisoners or inmates within a prison, jail,
62 or other criminal detention facility, while on work detail
63 outside the facility, or while being transported and, in
64 performing such duties, may be exposed to body fluids.
65 (e) "Infectious disease" means any condition or impairment
66 of health caused by a disease that has been declared a public
67 health emergency in accordance with s. 381.00315.
68 (f)(e) "Occupational exposure," in the case of hepatitis,
69 meningococcal meningitis, or tuberculosis, or an infectious
70 disease, means an exposure that occurs during the performance of
71 job duties that may place a worker at risk of infection.
72 (2) PRESUMPTION; ELIGIBILITY CONDITIONS.—Any emergency
73 rescue or public safety worker who suffers a condition or
74 impairment of health that is caused by hepatitis, meningococcal
75 meningitis, or tuberculosis, or an infectious disease, that

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76 requires medical treatment, and that results in total or partial
77 disability or death is shall be presumed to have a disability
78 suffered in the line of duty, unless the contrary is shown by
79 competent evidence; however, in order to be entitled to the
80 presumption, the emergency rescue or public safety worker must,
81 by written affidavit as provided in s. 92.50, verify by written
82 declaration that, to the best of his or her knowledge and
83 belief:
84 (a) In the case of a medical condition caused by or
85 derived from hepatitis, he or she has not:
86 1. Been exposed, through transfer of bodily fluids, to any
87 person known to have sickness or medical conditions derived from
88 hepatitis, outside the scope of his or her employment;
89 2. Had a transfusion of blood or blood components, other
90 than a transfusion arising out of an accident or injury
91 happening in connection with his or her present employment, or
92 received any blood products for the treatment of a coagulation
93 disorder since last undergoing medical tests for hepatitis,
94 which tests failed to indicate the presence of hepatitis;
95 3. Engaged in unsafe sexual practices or other high-risk
96 behavior, as identified by the Centers for Disease Control and
97 Prevention or the Surgeon General of the United States, or had
98 sexual relations with a person known to him or her to have
99 engaged in such unsafe sexual practices or other high-risk
100 behavior; or

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101 4. Used intravenous drugs not prescribed by a physician.
102 (b) In the case of meningococcal meningitis, in the 10
103 days immediately preceding diagnosis he or she was not exposed,
104 outside the scope of his or her employment, to any person known
105 to have meningococcal meningitis or known to be an asymptomatic
106 carrier of the disease.
107 (c) In the case of tuberculosis, in the period of time
108 since the worker's last negative tuberculosis skin test, he or
109 she has not been exposed, outside the scope of his or her
110 employment, to any person known by him or her to have
111 tuberculosis.
112 (d) In the case of an infectious disease, he or she
113 contracted the infectious disease during a public health
114 emergency declared in accordance with s. 381.00315 and was not
115 exposed, outside of the scope of his or her employment, to any
116 person known to have the infectious disease.
117 (3) IMMUNIZATION.—Whenever any standard, medically
118 recognized vaccine, or other form of immunization or prophylaxis
119 exists for the prevention of a communicable or infectious
120 disease for which a presumption is granted under this section,
121 if medically indicated in the given circumstances under the
122 pursuant to immunization policies established by the Advisory
123 Committee on Immunization Practices of the United States Public
124 Health Service and if the vaccine or immunization has been
125 approved by the United States Food and Drug Administration, an

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126 emergency rescue or public safety worker may be required by his
127 or her employer to undergo the immunization or prophylaxis
128 unless the worker's physician determines in writing that the
129 immunization or other prophylaxis would pose a significant risk
130 to the worker's health. Absent such written declaration, failure
131 or refusal by an emergency rescue or public safety worker to
132 undergo such immunization or prophylaxis disqualifies the worker
133 from the benefits of the presumption.
134 (4) LIFE AND DISABILITY INSURANCE COVERAGE.—This section
135 does not apply to benefits payable under or granted in a
136 noncompulsory policy of life insurance or disability insurance,
137 unless the insurer and insured have negotiated for such
138 additional benefits to be included in the policy contract.
139 However, the state or any political subdivision of the state may
140 negotiate a policy contract for life and disability insurance
141 which includes accidental death benefits or double indemnity
142 coverage for any condition or impairment of health suffered by
143 an emergency rescue or public safety worker, which condition or
144 impairment is caused by a disease described in this section and
145 results in total or partial disability or death.
146 (5) RECORD OF EXPOSURES.—The employing agency shall
147 maintain a record of any known or reasonably suspected exposure
148 of an emergency rescue or public safety worker in its employ to
149 the diseases described in this section and shall immediately
150 notify the employee of such exposure. An emergency rescue or

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151 public safety worker shall file an incident or accident report
152 with his or her employer of each instance of known or suspected
153 occupational exposure to hepatitis infection, meningococcal
154 meningitis, or tuberculosis, or an infectious disease.
155 (6) REQUIRED MEDICAL TESTS; PREEMPLOYMENT PHYSICAL.—In
156 order to be entitled to the presumption provided by this
157 section:
158 (a) An emergency rescue or public safety worker must,
159 prior to diagnosis, have undergone standard, medically
160 acceptable tests for evidence of the communicable disease for
161 which the presumption is sought, or evidence of medical
162 conditions derived therefrom, which tests fail to indicate the
163 presence of infection. This paragraph does not apply in the case
164 of meningococcal meningitis or an infectious disease.
165 (b) On or after June 15, 1995, an emergency rescue or
166 public safety worker may be required to undergo a preemployment
167 physical examination that tests for and fails to reveal any
168 evidence of hepatitis or tuberculosis.
169 (7) DISABILITY RETIREMENT.—This section does not change
170 the basic requirements for determining eligibility for
171 disability retirement benefits under the Florida Retirement
172 System or any pension plan administered by this state or any
173 political subdivision thereof, except to the extent of affecting
174 the determination as to whether a member was disabled in the
175 line of duty or was otherwise disabled.

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176 Section 2. This act shall take effect July 1, 2021.

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PCS for HB 957
HOUSE OF REPRESENTATIVES STAFF ANALYSIS

BILL #: PCS for HB 957 Hearing Aid Consultations and Sales
SPONSOR(S): Professions & Public Health Subcommittee
TIED BILLS: IDEN./SIM. BILLS:

REFERENCE ACTION ANALYST STAFF DIRECTOR or
BUDGET/POLICY
CHIEF

Orig. Comm.: Professions & Public Health Guzzo McElroy
Subcommittee

SUMMARY ANALYSIS
A person who is not able to hear as well as someone with normal hearing, hearing thresholds of 20 decibels or
better in both ears, has hearing loss. In the United States, approximately 15% of adults (37.5 million) report
some difficulty hearing and 29 million adults could benefit from hearing aids. In 2019, there were 372,111
people with a hearing disability in Florida.

The Board of Speech-Language Pathology & Audiology within the Department of Health (DOH) is responsible
for licensing, monitoring, disciplining and educating audiologists. The practice of audiology includes the
application of principles, methods, and procedures for the prevention, identification, evaluation, consultation,
habilitation, rehabilitation, instruction, treatment, and research, relative to hearing and the disorders of hearing.

The Board of Hearing Aid Specialists within DOH is responsible for licensing, monitoring, disciplining and
educating hearing aid specialists. A licensed hearing aid specialist may practice the dispensing of hearing aids,
which includes: conducting and interpreting hearing tests for purposes of selecting suitable hearing aids;
making ear molds or ear impressions; providing appropriate counseling; and all acts pertaining to the selling,
renting, leasing, pricing, delivery, and warranty of hearing aids.

Audiologists and hearing aid specialists are authorized to conduct and interpret hearing tests and to dispense
hearing aids if necessary. Both audiologists and hearing aid specialists are authorized to utilize telehealth to
provide audiology services. However, current law prohibits any person from selling or distributing hearing aids
through the mail to the ultimate consumer. A violation of the mailing prohibition constitutes a second-degree
misdemeanor which is punishable by up to 60 days imprisonment and carries a fine of up to $500. This creates
a barrier for audiologists and hearing aid specialists to utilize telehealth to provide audiology services.

PCS for HB 957 repeals sections of law, s. 468.1265, F.S., and s. 484.054, F.S., that prohibit individuals from
selling or distributing hearing aids through the mail to the ultimate consumer. This removes a key barrier for
audiologists and hearing aid specialists to utilize telehealth to provide audiology services to individuals with
hearing loss.

The bill has no fiscal impact on state or local government.

The bill provides an effective date of July 1, 2021.

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

Hearing Loss

A person who is not able to hear as well as someone with normal hearing – hearing thresholds of 20
decibels or better in both ears – is said to have hearing loss. 1 There are four types of hearing loss: 2

• Conductive Hearing Loss – Occurs when something prevents sounds from getting through the
outer or middle ear.
• Sensorineural Hearing Loss - Occurs when there is a problem in the way the inner ear or
hearing nerve works.
• Mixed Hearing Loss - Hearing loss that includes both a conductive and a sensorineural
hearing loss.
• Auditory Neuropathy Spectrum Disorder - Hearing loss that occurs when sound enters the
ear normally, but because of damage to the inner ear or the hearing nerve, sound is not
organized in a way that the brain can understand.

In the United States, approximately 15% of adults (37.5 million) report some difficulty hearing and 29
million adults could benefit from hearing aids. 3 In 2019, there were 372,111 people with a hearing
disability in Florida. 4

Audiologists

The Board of Speech-Language Pathology & Audiology within the Department of Health (DOH) is
responsible for licensing, monitoring, disciplining and educating audiologists. 5 The practice of audiology
includes the application of principles, methods, and procedures for the prevention, identification,
evaluation, consultation, habilitation, rehabilitation, instruction, treatment, and research, relative to
hearing and the disorders of hearing.

In addition to conducting and interpreting hearing tests and dispensing hearing aids a licensed
audiologist may also: 6

• Offer, render, plan, direct, conduct, consult, or supervise certain services to individuals who
have or are suspected of having hearing disorders, including:
o Identification;
o Evaluation;
o Treatment;
o Consultation;
o Habilitation;

1 World Health Organization, Deafness and Hearing Loss, Mar. 2, 2021, available at https://www.who.int/news-room/fact-

sheets/detail/deafness-and-hearing-loss (last visited Mar. 29, 2021). “Disabling hearing loss” refers to hearing loss greater than 35
decibels in the better hearing ear.
2 Centers for Disease Control and Prevention, Types of Hearing Loss, available at https://www.cdc.gov/ncbddd/hearingloss/types.html

(last visited on March 30, 2021).
3 United States Department of Health and Human Services, National Institute of Deafness and Other Communication Disorders, Quick

Statistics About Hearing, available at https://www.nidcd.nih.gov/health/statistics/quick-statistics-hearing (last visited on March 30, 2021).
A hearing aid is a small electronic device that goes in or behind an individual’s ear to make sounds louder so the person can listen,
communicate, and participate more fully in daily activities.
4 Florida Department of Health – FLHealthCHARTS Community Health Assessment Resource Tool Set, Census Population Under 18

with Hearing Disability, Census Population 18-64 with Hearing Disability, Hearing Disability 65-74, and Hearing Disability 75+, available
at http://www.flhealthcharts.com/charts/SearchResult.aspx (last visited Mar. 29, 2021).
5 S. 468.1185, F.S.
6 S. 468.1125(6)(b), F.S.

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o Rehabilitation;
o Instruction; and
o Research.
• Participate in hearing conservation, evaluation of noise environments, and noise control.
• Habilitate and rehabilitate, including, but not limited to, hearing aid evaluation, prescription,
preparation, fitting, assistive listening device selection and orientation, auditory training, aural
habilitation and rehabilitation, speech conservation, and speechreading;
• Fabricate ear molds;
• Evaluate tinnitus; and
• Provide speech and language screening, limited to a pass/fail determination for identifying
individuals with disorders of communication.

Audiologists are required to follow certain minimum procedures and conduct certain tests when fitting a
patient for a hearing aid, including: 7

• Pure tone audiometric testing by air and bone to determine the type and degree of hearing
deficiency when indicated;
• Effective masking when indicated; and
• Appropriate testing to determine speech reception thresholds, speech discrimination scores, the
most comfortable listening levels, uncomfortable loudness levels, and the selection of the best
fitting arrangement for maximum hearing aid benefit when indicated.

All audiometric tests must be conducted in a testing room that has been certified by DOH not to exceed
certain sound pressure levels and specified frequencies. 8 An audiologist is required to perform a final
fitting for a patient to ensure the physical and operational comfort of the hearing aid when indicated. 9

Hearing Aid Specialists

• Conducting and interpreting hearing tests for purposes of selecting suitable hearing aids.
• Making ear molds or ear impressions;
• Providing appropriate counseling; and
• All acts pertaining to the selling, renting, leasing, pricing, delivery, and warranty of hearing aids.

Hearing aid specialists are required to follow certain minimum procedures and conduct certain tests
when fitting a patient for a hearing aid, including: 11

• Pure tone audiometric testing by air and bone to determine the type and degree of hearing
deficiency;
• Effective masking when indicated; and
• Appropriate testing to determine speech reception thresholds, speech discrimination scores, the
most comfortable listening levels, uncomfortable loudness levels, and the selection of the best
fitting arrangement for maximum hearing aid benefit.

All audiometric tests must be conducted in a testing room that has been certified by DOH not to exceed
certain sound pressure levels and specified frequencies. 12 A hearing aid specialist is required to
perform a final fitting for a patient to ensure the physical and operational comfort of the hearing aid. 13

7 S. 468.1225(1), F.S.
8 S. 468.1225(6), F.S.
9 S. 468.1225(3), F.S.
10 S. 484.045, F.S.
11 S. 484.0501(1), F.S.
12 S. 484.0501(6), F.S.
13 S. 484.0501(3), F.S.

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Telehealth for Audiologists and Hearing Aid Specialists

Florida licensed and Florida registered out-of-state audiologists and hearing aid specialists are
authorized to utilize telehealth to provide audiology services. 14 However, current law prohibits any
person from selling or distributing hearing aids through the mail to the ultimate consumer. 15 A violation
of the mailing prohibition constitutes a second-degree misdemeanor which is punishable by up to 60
days imprisonment and carries a fine of up to $500. 16 This creates a barrier for audiologists and
hearing aid specialists to utilize telehealth to provide audiology services.

Effect of the Bill

PCS for HB 957 repeals the sections of law, s. 468.1265, F.S., and s. 484.054, F.S., that prohibit
individuals from selling or distributing hearing aids through the mail to the ultimate consumer. This
removes a key barrier for audiologists and hearing aid specialists to utilize telehealth to provide
audiology services to individuals with hearing loss.

The bill provides an effective date of July 1, 2021.

B. SECTION DIRECTORY:
Section 1: Repeals ss. 468.1265 and 484.054, F.S.
Section 2: Provides an effective date of July 1, 2021.

II. FISCAL ANALYSIS & ECONOMIC IMPACT STATEMENT

A. FISCAL IMPACT ON STATE GOVERNMENT:

1. Revenues:
None.

2. Expenditures:
None.

B. FISCAL IMPACT ON LOCAL GOVERNMENTS:

1. Revenues:
None.

2. Expenditures:
None.

C. DIRECT ECONOMIC IMPACT ON PRIVATE SECTOR:
It is possible that allowing audiologists and hearing aid specialists to sell and distribute hearing aids
through the mail will result in an indeterminate increase in their sales and revenue.

D. FISCAL COMMENTS:
None.

14 S. 456.47(1)(b), F.S.
15 SS. 468.1265, F.S., and 484.054, F.S.
16 Id., and ss. 775.082(4)(b), F.S., and 775.083(1)(e), F.S.

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III. COMMENTS

A. CONSTITUTIONAL ISSUES:

1. Applicability of Municipality/County Mandates Provision:
Not applicable. The PCS does not appear to affect county or municipal governments.

2. Other:
None.

B. RULE-MAKING AUTHORITY:
No rule-making authority is necessary to implement the provisions of the bill.

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

PCS for HB 957 ORIGINAL 2021

1 A bill to be entitled
2 An act relating to hearing aid sales; repealing ss.
3 468.1265 and 484.054, F.S., relating to the sale or
4 distribution of hearing aids through mail; providing
5 an effective date.
6
7 Be It Enacted by the Legislature of the State of Florida:
8
9 Section 1. Sections 468.1265 and 484.054, Florida
10 Statutes, are repealed.
11 Section 2. This act shall take effect July 1, 2021.

Page 1 of 1
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V
HB 1045
HOUSE OF REPRESENTATIVES STAFF ANALYSIS
BILL #: HB 1045 Delegation of the Administration of Prescription Medications
SPONSOR(S): Snyder
TIED BILLS: IDEN./SIM. BILLS: SB 1298

REFERENCE ACTION ANALYST STAFF DIRECTOR or
BUDGET/POLICY CHIEF

1) Professions & Public Health Subcommittee Rahming McElroy

2) Health Care Appropriations Subcommittee

3) Health & Human Services Committee

SUMMARY ANALYSIS
Certified nursing assistants (CNAs) and home-health aides (HHAs) assist older individuals and those with
disabilities with daily tasks, such as dressing, bathing, and eating. Under current law, a CNA or HHA may
administer oral, transdermal, ophthalmic, otic, rectal, inhaled, enteral, or topical prescription medications to a
patient of a home health agency if a registered nurse delegates such tasks and the CAN or HHA:

• Has completed a 6-hour training course approved by the Board of Nursing; and
• Has been found competent to administer medication to a patient in a safe and sanitary manner.

A registered nurse or physician must conduct the training and determine whether the CNA or HHA can
competently administer medication, and annually validate such competency. Current law requires the Board of
Nursing and the Agency for Health Care Administration (AHCA) to adopt rules, in consultation with each other,
on the standards and procedures that a CNA or HHA must follow for medication administration. Such rules
must address qualifications for trainers, medication label requirements, documentation and recordkeeping,
storage and disposal of medication, instructions for safe medication administration, informed consent, training
curriculum, and validation procedures.

A registered nurse is prohibited from delegating the administration of medications listed as Schedule II,
Schedule III, or Schedule IV controlled substances.

Under current law, a registered nurse is not authorized to delegate to a CNA or HHA medication administration
to a patient of a nurse registry.

A nurse registry is an agency licensed to secure employment for registered nurses, licensed practical nurses,
certified nursing assistants, home health aides, homemakers, and companions (caregivers) in a patient’s home
or with health care facilities or other entities. Caregivers referred for contract to a patient by a nurse registry are
independent contractors not employees of the nurse registry. Nurse registries must advise patients that
caregivers referred for contract are independent contractors and that the nurse registry is prohibited from
monitoring, supervising, managing, or training caregivers.

HB 1045 authorizes a registered nurse to delegate to a CNA or HHA medication administration to a patient of a
nurse registry. The bill requires the Board, in consultation with AHCA, to adopt rules on the standards and
procedures that a CNA must follow for medication administration to a patient of a nurse registry.

The bill has no fiscal impact on state or local governments.

The bill has an effective date of July 1, 2021.

This document does not reflect the intent or official position of the bill sponsor or House of Representatives.
STORAGE NAME: h1045.PPH
DATE: 3/31/2021
FULL ANALYSIS

I. SUBSTANTIVE ANALYSIS

A. EFFECT OF PROPOSED CHANGES:
Present Situation

Florida Direct Care Workers

Direct care workers assist older individuals and those with disabilities with daily tasks, such as
dressing, bathing, and eating. 1 They work in many different settings, such as private homes, group
homes, residential care facilities, assisted living facilities, skilled nursing facilities, and hospitals. 2 Direct
care workers account for 70 to 80 percent of all paid hands-on long-term care and personal assistance
for the elderly or disabled. 3

Nursing Assistants or Nursing Aides

Nursing assistants or nursing aides generally work in nursing homes, although some work in assisted
living facilities, other community-based settings, or hospitals. 4 The Florida Board of Nursing (Board),
within the Department of Health, certifies nursing assistants (CNAs) who must, among other things,
hold a high school diploma or equivalent, complete a 120-hour board-approved training program, and
pass a nursing assistant competency exam. 5 The Board establishes the general scope of practice for
CNAs, who perform services under the general supervision 6 of a registered nurse or licensed practical
nurse. 7 A CNA may not work independently and may not perform any tasks that require specialized
nursing knowledge, judgment, or skills. 8

Home Health Aides

Home health aides (HHA) provide essentially the same care and services as nursing assistants, but
they assist people in their homes or in community settings under the supervision of a nurse or a
physical, speech, occupational, or respiratory therapist. 9 In Florida, HHAs are not licensed or certified.
However, the Agency for Health Care Administration (AHCA) licenses home health agencies and
establishes training requirements for HHAs employed by home health agencies. A HHA must complete
at least 75 hours of training and/or successfully pass a competency evaluation by the home health
agency. 10 HHAs who work for a home health agency that is not certified by Medicare or Medicaid or
who work for a nurse registry must complete 40 hours of training or pass an AHCA-developed
competency examination. 11

Nurse Delegation of Duties

1 Paraprofessional Healthcare Institute, Understanding the Direct Care Workforce, available at https://phinational.org/policy-

research/key-facts-faq/ (last visited Mar. 28, 2021).
2 Paraprofessional Healthcare Institute, Direct Care Workforce 2018 Year in Review, https://phinational.org/resource/the-direct-care-

workforce-year-in-review-2018/ (last visited Mar. 28, 2021), and Paraprofessional Healthcare Institute, Who Are Direct-Care Workers?
https://phinational.org/wp-content/uploads/legacy/clearinghouse/NCDCW%20Fact%20Sheet-1.pdf (last visited Mar. 28, 2021).
3 Id.
4 Paraprofessional Healthcare Institute, Who Are Direct-Care Workers?, (Feb. 2011), available at https://phinational.org/wp-

content/uploads/legacy/clearinghouse/NCDCW%20Fact%20Sheet-1.pdf (last visited Mar. 28, 2021).
5 S. 464.203, F.S., and r. 64B9-15.006, F.A.C. Eighty hours must be classroom instruction and 40 hours must be clinical instruction, 20

of which must be in long term care clinical instruction in a licensed nursing home. 42 C.F.R. § 483.95 requires 75 hours of training;
Florida training requirements exceed the federal minimum training requirements.
6 Under general supervision, the registered nurse or licensed practical nurse does not need to be present but must be available for

consultation and advice, either in person or by a communication device. R. 64B9-15.001(5), F.A.C
7 R. 64B9-15.002, F.A.C.
8 Id.
9 Supra note 4. If the only service the home health agency provides is physical, speech, or occupational therapy, in addition to home

health aide or CNA services, a licensed therapist may provide supervision. R. 59A-8.0095, F.A.C.
10 Agency for Health Care Administration, Home Health Aides, available at

https://ahca.myflorida.com/MCHQ/Health_Facility_Regulation/Lab_HomeServ/HHA/Home_health_aides.shtml (last visited January 20,
2020).
11 Rules 59A-8.0095(5)

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Under current law, a registered nurse is authorized to delegate any task, including medication
administration, to a CNA or HHA, 12 if the registered nurse determines that the CNA or HHA is
competent to perform the task, the task is delegable under federal law, and the task: 13

• Is within the nurse’s scope of practice;
• Frequently recurs in the routine care of a patient or group of patients;
• Is performed according to an established sequence of steps;
• Involved little or no modification from one patient to another;
• May be performed with a predictable outcome;
• Does not inherently involve ongoing assessment, interpretation, or clinical judgement; and
• Does not endanger a patient’s life or well-being.

Medication Administration

Medication administration is to obtain and provide a single dose of a medication to a patient for his or
her consumption. 14 Currently, a CNA or HHA may administer oral, transdermal, ophthalmic, otic, rectal,
inhaled, enteral, or topical prescription medications to a patient of a home health agency if a registered
nurse delegates such tasks to the CNA and the CNA: 15

• Has completed a 6-hour training course approved by the Board of Nursing; and
• Has been found competent to administer medication to a patient in a safe and sanitary manner.

A registered nurse or physician must conduct the training and determine whether the CNA or HHA can
competently administer medication, and annually validate such competency. 16 Current law requires the
Board and the AHCA to adopt rules, in consultation with each other, on the standards and procedures
that a CNA or HHA must follow for medication administration to a patient of a home health agency. 17
Such rules must address qualifications for trainers, medication label requirements, documentation and
recordkeeping, storage and disposal of medication, instructions for safe medication administration,
informed consent, training curriculum, and validation procedures. 18

A registered nurse is prohibited from delegating the administration of medications listed as Schedule II,
Schedule III, or Schedule IV controlled substances. 19

Under current law, a registered nurse is not authorized to delegate to a CNA or HHA medication
administration to a patient of a nurse registry. Additionally, the Board and the AHCA are not required to
adopt rules on the standards and procedures that a CNA must follow for medication administration to a
patient of a nurse registry.

Nurse Registries

A nurse registry is an agency licensed to secure employment for registered nurses, licensed practical
nurses, certified nursing assistants, home health aides, homemakers, and companions (caregivers) in a
patient’s home or with health care facilities or other entities. 20 Nurse registries are governed by part II of
chapter 408, F.S., 21 associated rules in Chapter 59A-35, F.A.C., and the nurse registry rules in Chapter
59A-18, F.A.C. A nurse registry must be licensed by the AHCA to offer contracts in Florida. 22

12 Ss. 400.489 and 464.2035, F.S. Home health aide includes those CNAs who work in positions that work as home health aides or

equivalent positions.
13 Ss. 400.489 and 464.0156, F.S.
14 S. 465.003, F.S.
15 Ss. 400.489(1) and 464.2035(1), F.S.
16 Id.
17 Ss. 400.489(3) and 464.2035(3), F.S.
18 Id.
19 S. 464.0156(1), F.S
20 S. 400.462(21), F.S.
21 S. 400.506(2), F.S. A nurse registry is also governed by the provisions in s. 400.506, F.S.
22 S. 400.506(1), F.S.

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A caregiver referred by a nurse registry for contract in a private residences who is not a nurse licensed
under part I of chapter 464, such as a CNA or HHA, may only provide patient services or care for which
they have been certified or trained to perform under current law or rules of the AHCA or the Department
of Business and Professional Regulation. 23 Providing services beyond their authorized scope
constitutes the unauthorized practice of medicine or a violation of the Nurse Practice Act and is subject
to punishment as provided under current law.

A caregiver referred for contract to a patient by a nurse registry is an independent contractor not an
employee of the nurse registry. 24 Nurse registries must advise patients that a caregiver referred for
contract is an independent contractor and that the nurse registry is prohibited from monitoring,
supervising, managing, or training the caregiver. 25

Effect of Proposed Bill

HB 1045 authorizes a registered nurse to delegate to a CNA or HHA medication administration to a
patient of a nurse registry. The bill requires the Board, in consultation with AHCA, to adopt rules on the
standards and procedures that a CNA must follow for medication administration to a patient of a nurse
registry.

The bill has an effective date of July 1, 2021.

B. SECTION DIRECTORY:
Section 1: Amends s. 464.0156, relating to the delegation of duties.
Section 2: Amends s. 464.2035, relating to the administration of medication.
Section 3: Provides an effective date of July 1, 2021.

II. FISCAL ANALYSIS & ECONOMIC IMPACT STATEMENT

A. FISCAL IMPACT ON STATE GOVERNMENT:

1. Revenues:
None.

2. Expenditures:
None.

B. FISCAL IMPACT ON LOCAL GOVERNMENTS:

1. Revenues:
None.

2. Expenditures:
None.

C. DIRECT ECONOMIC IMPACT ON PRIVATE SECTOR:
None.

23 S. 400.506(7).
24 S. 400.506(6)(d).
25 S. 400.506(6)(e).

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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:
The bill provides sufficient rulemaking authority to implement the bill.

C. DRAFTING ISSUES OR OTHER COMMENTS:

IV. AMENDMENTS/ COMMITTEE SUBSTITUTE CHANGES

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DATE: 3/31/2021
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 1045 2021

1 A bill to be entitled
2 An act relating to delegation of the administration of
3 prescription medications; amending s. 464.0156, F.S.;
4 authorizing a registered nurse to delegate the
5 administration of certain duties for the care of a
6 patient of a nurse registry; amending s. 464.2035,
7 F.S.; authorizing certified nursing assistants to
8 administer certain medication to patients of nurse
9 registries under certain circumstances; conforming a
10 provision to changes made by the act; providing an
11 effective date.
12
13 Be It Enacted by the Legislature of the State of Florida:
14
15 Section 1. Subsection (2) of section 464.0156, Florida
16 Statutes, is amended to read:
17 464.0156 Delegation of duties.—
18 (2) A registered nurse may delegate to a certified nursing
19 assistant or a home health aide the administration of oral,
20 transdermal, ophthalmic, otic, rectal, inhaled, enteral, or
21 topical prescription medications to a patient of a home health
22 agency or nurse registry, if the certified nursing assistant or
23 home health aide meets the requirements of s. 464.2035 or s.
24 400.489, respectively. A registered nurse may not delegate the
25 administration of any controlled substance listed in Schedule

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hb1045-00
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 1045 2021

26 II, Schedule III, or Schedule IV of s. 893.03 or 21 U.S.C. s.
27 812.
28 Section 2. Subsections (1) and (3) of section 464.2035,
29 Florida Statutes, are amended to read:
30 464.2035 Administration of medication.—
31 (1) A certified nursing assistant may administer oral,
32 transdermal, ophthalmic, otic, rectal, inhaled, enteral, or
33 topical prescription medication to a patient of a home health
34 agency or nurse registry if the certified nursing assistant has
35 been delegated such task by a registered nurse licensed under
36 part I of this chapter, has satisfactorily completed an initial
37 6-hour training course approved by the board, and has been found
38 competent to administer medication to a patient in a safe and
39 sanitary manner. The training, determination of competency, and
40 initial and annual validation required under this section must
41 be conducted by a registered nurse licensed under this chapter
42 or a physician licensed under chapter 458 or chapter 459.
43 (3) The board, in consultation with the Agency for Health
44 Care Administration, shall establish by rule standards and
45 procedures that a certified nursing assistant must follow when
46 administering medication to a patient of a home health agency or
47 nurse registry. Such rules must, at a minimum, address
48 qualification requirements for trainers, requirements for
49 labeling medication, documentation and recordkeeping, the
50 storage and disposal of medication, instructions concerning the

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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 1045 2021

51 safe administration of medication, informed-consent requirements
52 and records, and the training curriculum and validation
53 procedures.
54 Section 3. This act shall take effect July 1, 2021.

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hb1045-00
COMMITTEE/SUBCOMMITTEE AMENDMENT
Bill No. HB 1045 (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 Snyder offered the following:
4
5 Amendment (with title amendment)
6 Between lines 14 and 15, insert:
7 Section 1. Subsection (7) of section 400.506, Florida
8 Statutes, is amended to read:
9 400.506 Licensure of nurse registries; requirements;
10 penalties.—
11 (7) A person who is referred by a nurse registry for
12 contract in private residences and who is not a nurse licensed
13 under part I of chapter 464 may perform only those services or
14 care to clients that the person has been certified to perform or
15 trained to perform as required by law or rules of the Agency for
16 Health Care Administration or the Department of Business and
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COMMITTEE/SUBCOMMITTEE AMENDMENT
Bill No. HB 1045 (2021)
Amendment No. 1

17 Professional Regulation. Providing services beyond the scope
18 authorized under this subsection constitutes the unauthorized
19 practice of medicine or a violation of the Nurse Practice Act
20 and is punishable as provided under chapter 458, chapter 459, or
21 part I of chapter 464. If a licensed nurse registry authorizes a
22 registered nurse to delegate tasks, including medication
23 administration, to a certified nursing assistant pursuant to
24 chapter 464 or to a home health aide pursuant to s. 400.490, the
25 licensed nurse registry must ensure that such delegation meets
26 the requirements of this chapter and chapter 464 and the rules
27 adopted thereunder.
28
29
30
31 -----------------------------------------------------
32 T I T L E A M E N D M E N T
33 Remove line 3 and insert:
34 prescription medications; amending s. 400.464, F.S.; requiring a
35 licensed nurse registry that authorizes a registered nurse to
36 delegate tasks to a certified nursing assistant or a home health
37 aide to ensure that certain requirements are met; amending s.
38 464.0156, F.S.;

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PCS for HB 1091
HOUSE OF REPRESENTATIVES STAFF ANALYSIS
BILL #: PCS for HB 1091 Relating to Substance Abuse Prevention
SPONSOR(S): Professions & Public Health Subcommittee
TIED BILLS: IDEN./SIM. BILLS:

REFERENCE ACTION ANALYST STAFF DIRECTOR or
BUDGET/POLICY CHIEF

Orig. Comm.: Professions & Public Health Woodruff McElroy
Subcommittee

SUMMARY ANALYSIS
An estimated 53 million people worldwide use opioids. An overabundance of opioids in the body can lead to a
fatal overdose. An opioid antagonist, such as Narcan, is a drug that blocks the effects of exogenously
administered opioids. Opioid antagonists are used in opioid overdoses to counteract life-threatening
depression of the central nervous system and respiratory system, allowing an overdose victim to breathe
normally. In 2019, Florida reported 5,268 opioid overdose deaths. This was the second highest overdose death
rate reported by any state.

Under current law, an authorized health care practitioner may prescribe and dispense an emergency opioid
antagonist to a patient or caregiver, and pharmacists may dispense an emergency opioid antagonist pursuant
to a prescription or pursuant to a non-patient-specific standing order. A patient or caregiver can store and
possess approved emergency opioid antagonists and, in an emergency, when a physician is not immediately
available, administer the emergency opioid antagonists to a person believed in good faith to be experiencing
an opioid overdose, regardless of whether that person has a prescription for an emergency opioid antagonist.
Emergency responders and crime laboratory personnel are authorized to possess, store, and administer
emergency opioid antagonists. Current law affords civil liability immunity to anyone who possess, administers,
prescribes, dispenses, or stores an approved emergency opioid antagonist.

Current law allows, rather than mandates, emergency medical technicians and paramedics who provide basic
and advanced life support services to report controlled substances overdoses to the Department of Health
(DOH).

HB 1091 amends s. 381.887, F.S., to reflect that the purpose of the section is for the prescribing, ordering, and
dispensing of emergency opioid antagonists. The bill requires DOH to develop and implement a statewide
awareness campaign to educate the public on opioid overdoses and the safe disposal of opioids. It allows a
pharmacist to order and dispense an emergency opioid antagonist to a patient or caregiver.

The bill expressly authorizes personnel of a law enforcement agency or other agency, including, correctional
probation officers and child protective investigators to possess, store, and administer emergency opioid
antagonists.

Finally, the bill amends s. 401.253, F.S., to require a basic life support service or advanced life support service
that treats and releases, or transports to a medical facility, a person in response to an emergency call for
suspected or actual overdose of a controlled substance to report such incidents to DOH.

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

The bill has an effective date of July 1, 2021.

This document does not reflect the intent or official position of the bill sponsor or House of Representatives.
STORAGE NAME: pcs1091.PPH
DATE: 3/31/2021
FULL ANALYSIS

I. SUBSTANTIVE ANALYSIS

A. EFFECT OF PROPOSED CHANGES:
Background

Opioids

Opioids are psychoactive substances derived from the opium poppy, or their synthetic analogues. 1
They are commonly used as pain relievers to treat acute and chronic pain. An individual experiences
pain because of a series of electrical and chemical exchanges among the individual’s peripheral
nerves, spinal cord, and brain. 2 Opioid receptors occur naturally and are distributed widely throughout
the central nervous system and in peripheral sensory and autonomic nerves. 3 When an individual
experiences pain, the body releases hormones, such as endorphins, which bind with targeted opioid
receptors. 4 This disrupts the transmission of pain signals through the central nervous system and
reduces the perception of pain. 5 Opioids function in the same way by binding to specific opioid
receptors in the brain, spinal cord and gastrointestinal tract, thereby reducing the perception of pain. 6

Opioids include prescription medications used to treat pain, as well as illegal drugs. Opioids include 7:

• Buprenorphine (Subutex, Suboxone)
• Codeine
• Fentanyl (Duragesic, Fentora)
• Heroin
• Hydrocodone (Vicodin, Lortab, Norco)
• Hydromorphone (Dilaudid, Exalgo)
• Meperidine
• Methadone
• Morphine
• Oxycodone (OxyContin, Percodan, Percocet)
• Oxymorphone
• Tramadol
• U-47700

It is estimated that 53 million people worldwide use opioids. 8 Opioids are commonly abused, with an
estimated 35.6 million people worldwide suffering from drug use dependence. 9 Opioids can create a
euphoric feeling because they affect the regions of the brain involved with pleasure and reward, which
can lead to abuse. 10 Continued use of these drugs can lead to the development of tolerance and

1 World Health Organization, Opioid Overdose, https://www.who.int/news-room/fact-sheets/detail/opioid-overdose (last visited Mar. 30,

2021).
2 Medical News Today, What is pain, and how do you treat it? (Sept. 7, 2020),

https://www.medicalnewstoday.com/articles/145750#:~:text=People%20feel%20pain%20when%20specific,immediate%20contraction%
20of%20the%20muscles (last visited Mar. 18, 2021).
3 Gjermund Henriksen, Frode Willoch, Imaging of Opioid Receptors in the Central Nervous System, Brain (2008) 131 (5): 1171-1196.
4 Id.
5 Id.
6 U.S. Department of Health and Human Services, Substance Abuse and Mental Health Services Administration, SAMHSA Opioid

Overdose Toolkit: Facts for Community Members (2018).
7 Florida Department of Law Enforcement, Drugs Identified in Deceased Persons by Florida Medical Examiners 2019 Report, (Nov.

2020).
8 United Nations Office on Drugs and Crime, World Drug Report 2019, Global Overview of Drug Demand and Supply (Jun. 2019),

https://wdr.unodc.org/wdr2019/prelaunch/WDR19_Booklet_2_DRUG_DEMAND.pdf (last visited Mar. 30, 2021).
9 Supra note 1.
10 National Institute on Drug Abuse, How Do Opioids Affect the Brain and Body?, (June 2020)

http://www.drugabuse.gov/publications/research-reports/prescription-drugs/opioids/how-do-opioids-affect-brain-body (last visited Mar.
18. 2021).
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psychological and physical dependence. 11 This dependence is characterized by a strong desire to take
opioids, impaired control over opioid use, persistent opioid use despite harmful consequences, a higher
priority given to opioid use than to other activities and obligations, and a physical withdrawal reaction
when opioids are discontinued. 12

An overabundance of opioids in the body can lead to a fatal overdose. In addition to their presence in
major pain pathways, opioid receptors are also located in the respiratory control centers of the brain. 13
Opioids disrupt the transmission of signals for respiration in the identical manner that they disrupt the
transmission of pain signals (figure 1). This leads to a reduction, and potentially cessation, of an
individual’s respiration. Oxygen starvation will eventually stop vital organs like the heart, then the brain,
and can lead to unconsciousness, coma, and possible death. 14 Within 3-5 minutes without oxygen,
brain damage starts to occur, soon followed by death. 15 However, this does not occur instantaneously
as people will commonly stop breathing slowly, minutes to hours after the drug or drugs were used. 16
An opioid overdose can be identified by a combination of three signs and symptoms referred to as the
“opioid overdose triad”: 17

• Pinpoint pupils.
• Unconsciousness.
• Respiratory depression.
Figure 1

Source: Maya Doe-Simkins, MPH, Boston Medical Center.

The rise in opioid overdose deaths can be outlines in three distinct waves:
1. The first wave began with increase prescribing of opioids in the 1990s, with overdose deaths
involving prescription opioids increasing since at least 1999.
2. The second wave began in 2010, with rapid increase in overdose deaths involving heroin.
3. The third wave began in 2013 with significant increases in overdose deaths involving synthetic
opioids, particularly those involving illicitly manufactured fentanyl. The market for illicitly
manufactured fentanyl continues to change, and it can be found in combination with heroin,
counterfeit pills, and cocaine. 18

11 Supra note 6.
12 Supra note 1.
13 Pattinson, K.T.S., Opioids and the Control of Respiration, BJA, Vol. 100, Issue 6, Pages 747-758.

http://bja.oxfordjournals.org/content/100/6/747.full (last visited Mar. 18, 2021).
14 Harm Reduction Coalition, Guide to Developing and Managing Overdose Prevention and Take-Home Naloxone Projects, (Aug. 31,

2020) http://harmreduction.org/our-work/overdose-prevention/ (last visited Mar. 18, 2021).
15 Id.
16 Id.
17 Supra note 1.
18 Centers for Disease Control and Prevention, Understanding the Epidemic, https://www.cdc.gov/drugoverdose/epidemic/index.html

(last visited Mar. 30, 2021).
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More than 70,000 Americans died from drug-involved overdose in 2019, including illicit drugs and
prescription opioids. 19 Overall, drug overdose deaths increased from 2018 to 2019 with 70,630 drug
overdoses reported in 2019. 20 The following graph provides information on the total number of U.S.
overdose deaths involving any opioid 21 from 1999 to 2019. 22 Opioid-involved overdose deaths
increased from 21,088 in 2010 to 47,600 in 2017 and remained steady in 2018 with 46,802. 23 This was
following by a significant increase in 2019 to 49,860 overdose deaths. 24

In 2019, Florida reported 5,268 opioid overdose deaths. 25 This was an 11.9 percent increase from
2018. 26 Florida also experienced 4,152 opioid and 10,464 all drug non-fatal overdoses between July
and September 2019. 27

Opioid Antagonist

An opioid antagonist, such as Narcan or Naloxone, is a drug that blocks the effects of exogenously
administered opioids. Opioid antagonists are used in opioid overdoses to counteract life-threatening
depression of the central nervous system and respiratory system, allowing an overdose victim to
breathe normally. 28 This occurs because opioid antagonists create a stronger bond with opioid
receptors than opioids. This forces the opioids from the opioid receptors and allows the transmission of
signals for respiration to resume. 29 This effect lasts only for a short period of time 30 with the narcotic

19 National institute on Drug Abuse, Overdose Death Rates, https://www.drugabuse.gov/drug-topics/trends-statistics/overdose-death-

rates (last visited Mar. 30, 2021).
20 Id.
21 Any opioid includes prescription opioids (natural and semi-synthetic opioids and methadone), heroin and synthetic opioids other than

methadone (primarily fentanyl).
22 Id.
23 Id.
24 Id.
25 Center for Disease Control and Prevention, Drug Overdose Deaths, https://www.cdc.gov/drugoverdose/data/statedeaths/drug-

overdose-death-2019.html (last visited Mar. 30, 2021).
26 Center for Disease Control and Prevention, 2018-2019 Drug Overdose Death Rate Increase,

https://www.cdc.gov/drugoverdose/data/statedeaths/drug-overdose-death-2019.html (last visited Mar. 30, 2021).
27 Florida Department of Health, Non-Fatal Opioid and All Drug Overdose Surveillance Report, Florida Q4-2019,

http://www.floridahealth.gov/statistics-and-data/fl-dose/_documents/non-fatal-od-2019-q4.pdf
28 Harm Reduction Coalition, Understanding Naloxone, (Sept. 8, 2020) http://harmreduction.org/issues/overdose-

prevention/overview/overdose-basics/understanding-naloxone/ (last visited Mar. 18, 2021).
29 Supra note 13.

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effect of the opioids returning if still present in large quantities in the body. In this scenario, additional
doses of an opioid antagonist would be required and it is why it is generally recommended that anyone
who has experienced an overdose seek medical attention.

In February 2019, Florida issued a statewide Standing Order for Naloxone. The Standing Order
authorizes pharmacists to dispense certain naloxone formulations to emergency responders for
administration to persons exhibiting signs of opioid overdose. 31 Under the Standing Order, emergency
responders, including law enforcement, firefighters, paramedics, and emergency medical technicians,
can go to a pharmacy or community-based program for training on opioid antagonist administration and
receive an opioid antagonist without a patient-specific prescription. Access to naloxone is available at
most pharmacies in Florida. The following map provides information on pharmacy locations where
naloxone is available with or without a prescription. 32

Florida law allows an authorized health care practitioner to prescribe and dispense an emergency
opioid antagonist to a patient or caregiver, and pharmacists may dispense an emergency opioid
antagonist pursuant to a prescription or to a non-patient-specific standing order. 33 Current law defines a
“caregiver” as a family member, friend, or person in a position to have recurring contact with a person
at risk of experiencing an opioid overdose. 34 Current law broadly defines a “person” to include

30 The half-life for a common opioid antagonist in adults ranged from 30 to 81 minutes. Acute opiate withdrawal is a potential side-effect

of naloxone; however, this would be time limited to the half-life of naloxone.
31 Florida Department of Health, State of Florida, Statewide Standing Order for Naloxone (Feb. 25, 2019),

http://www.floridahealth.gov/licensing-and-regulation/ems-system/_documents/standing-order-naloxone.pdf (last visited Mar. 30, 2021).
32 New America, National Naloxone Access Map,

https://opioidepidemic.maps.arcgis.com/home/item.html?id=153b0c32fefc432eae6a0e8439b9f56b (last visited Mar. 30, 2021). The
National Naloxone Map accumulates data from many difference sources, with participation from thousands of CVS, Walmart, and
Walgreens pharmacies, along with other independent distributors. The map is meant to be a community effort, and contributing
locations is encouraged to participate, to make it the best possible representation of resources. The map is not complete, and naloxone
prescription needs and costs vary by state, but this effort represents over 25,000 locations to obtain naloxone.
33 S. 381.887, F.S.
34 S. 381.887(1)(c), F.S.

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individuals and children. 35 Therefore, an authorized health care practitioner may prescribed any person
falling under the definition an emergency opioid antagonist.

Any person prescribed an opioid antagonist, or distributed an emergency opioid antagonist pursuant to
a non-patient-specific standing order, may store and possess approved emergency opioid antagonists.
In an emergency, when a physician is not immediately available, that person may administer the
emergency opioid antagonists to an individual believed in good faith to be experiencing an opioid
overdose, regardless of whether that person has a prescription for an emergency opioid antagonist. 36
Current law also allows emergency responders and crime laboratory personnel to possess, store, and
administer emergency opioid antagonists.

A person who possess, administers, prescribes, dispenses, or stores an approved emergency opioid
antagonist is afforded the civil liability immunity protections under s. 768.13, F.S. (Good Samaritan Act).

Prescription Drug Disposal

Currently, the recommended method of disposing unused prescription medications is to take them to a
drug take-back location. 37 However, if there is not a drug take-back location in the area or if the person
cannot go to one promptly, the U.S. Food and Drug Administration (FDA) provides two
recommendations:

• That drugs on the drug flus list be disposed of immediately by being flushed down a toilet. The
FDA has identified and created a list of drugs that are either dangerous to be kept unused for an
extended period of time or are sought-after for their misuse and abuse potential. Many of the
drugs on the flush list are prescription opioids. 38
• If the drug is not on the flush list, the FDA recommends that the drug be mixed with an
unappealing substance in a sealed container and thrown away in the trash. 39
• In either case, the FDA also recommends that all personal information on the prescription label
be deleted before throwing away or recycling the drug container.

Drug Disposal Products

In April 2019, 70 percent of the U.S. population lived less than five miles from collection sites. 40 If
collection sites, take-back events, or mail-back programs are not feasible, commercial products to
facilitate in-home disposal exist for patients that may not want to dispose of products in the trash. There
are numerous drug disposal products available, many of which are sold directly to consumers. In-home
disposal products are proprietary substances that patients can mix with their unused drugs, including
opioids, before disposing them in the trash. 41 The products use a variety of method to dispose of drugs
and make them non-retrievable, including activated carbon, bentonite clay, mixtures of calcium
hypochlorite with other ingredients, and other proprietary methods not fully described by the products.
Vendors of in-home disposal products indicate the products can prevent misuse of opioids by rending
drugs non-retrievable and by motivating patients to dispose of unused opioids. 42

Emergency Response to Overdose

35 S. 1.01 (3), F.S.
36 Id.
37 Theriot, Jonathan, et al., Opioid Antagonists, (Jul. 27, 2020),

https://www.ncbi.nlm.nih.gov/books/NBK537079/#:~:text=3%5D%5B4%5D-
,The%20two%20most%20commonly%20used%20centrally%20acting%20opioid%20receptor%20antagonists,depression%20associate
d%20with%20opioid%20use (last visited Mar. 22, 2021).
38 U.S. Food and Drug Administration, Drug Disposal: FDA’s Flush List for Certain Medicines, (Oct. 1, 2020)

https://www.fda.gov/drugs/disposal-unused-medicines-what-you-should-know/drug-disposal-fdas-flush-list-certain-medicines (last
visited Mar. 22, 2021).
39 Id.
40 United States Government Accountability Office, Prescription Opioids, Patient Options for Safe and Effective Disposal of Unused

Opioids, (Sept. 2019), https://www.gao.gov/assets/gao-19-650.pdf (last visited Mar. 29, 2021).
41 Id.
42 Id.

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In 2017, U.S. drug overdose deaths increased 9.6% from 2016. Emergency departments treated
967,615 nonfatal drug overdoses in 2017. 43 From 2016 to 2017, rates for nonfatal overdoses increased
for those involving all drugs (4.3%), all opioids (3.1%), nonherion opioids (3.6%), heroin (3.6%), and
cocaine (32.9%). 44

The following table provides information on emergency department visits related to heroin and
nonmedical use of prescription opioids by age from April 2019 to December 2020. 45 Patients aged 26
to 45 accounted for more than half (52%) of emergency department visits related to non-medical use of
prescription opioids. 46

70%
63.90%
60%
51.50%
50%

40%
30.00%
30%
23.40%
20% 16.10%
12.30%
10%
0.30% 2.30%
0%
Heroin Nonmedical Use of Prescription Opioids
Under 18 18 to 25 26 to 45 Over 45

Florida Emergency Response to Overdoses Reporting Requirements

Current law allows emergency medical technician 47 (EMT) and paramedics 48 who provide basic and
advanced life support services to report controlled substances overdoses to the Department of Health
(DOH). A report must contain:

• The date and time of the overdose.
• The address of where the patient was picked up or where the overdose took place.
• Whether an emergency opioid antagonist was administered.
• Whether the overdose was fatal or non-fatal.

Additionally, the report must include the approximate age and gender of the patient and the suspected
controlled substance involved in the overdose only if permitted by its reporting mechanism. Reporters
must attempt to make the report within 120 hours.

43 Centers for Disease Control and Prevention, Nonfatal Drug Overdoses Treated in Emergency Departments – United States, 2016-

2017, (Apr. 3, 2020), https://www.cdc.gov/mmwr/volumes/69/wr/mm6913a3.htm (last visited Mar. 30, 2021).
44 Id.
45 U.S. Department of Health, Substance Abuse and Mental Health services Administration, DAWN: Heroin and Nonmedical Use of

Prescription Opioids, https://www.samhsa.gov/data/sites/default/files/reports/rpt32814/DAWN%20Opioids%20Profile.pdf (last visited
Mar. 22, 2021).
46 Id.
47 S. 401.23(11), F.S., defines an EMT as a person who is certified by DOH to perform basic life support.
48 S. 401.23(17), F.S., defines a paramedic as a person who is certified by DOH to perform basic and advanced life support.

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A report must be filed with DOH using the Emergency Medical Tracking and Reporting System
(EMSTARS), 49 the Washington/Baltimore High Intensity Drug Tracking Overdoes Detection Mapping
Application Program, 50 or other program identified by DOH in rule.

Reporting of such incidents is currently voluntary, and only about 30 percent of all emergency
responding units utilize it. 51

DOH established the Florida Drug Overdose Surveillance and Epidemiology (FL-DOSE) program using
federal grant funding from the Center for Disease Control and Prevention (CDC). 52 The FL-DOSE
program allows for a collaborative and targeted response to the growing drug overdose challenge
through timely dissemination of surveillance data. The program supports resources necessary to:

• Monitor non-fatal drug overdose visits at Florida’s emergency departments and hospitals.
• Leverage Florida’s existing incident-level Emergency Medical Services data collection system to
calculate drug overdose indicators.
• Collect, abstract, and input fatal overdose data from Florida’s Vital Statistics Death Certificates
and Medical Examiners’ reports for target counties into the CDC’s National Violence Death
Registry System’s State Unintentional Drug Overdose Reporting system.
• Communicate surveillance results to key stakeholders at state and local levels.

Opioid Public Education Campaigns

DOH, through Overdose Data to Action (OD2A) funding, recently launched a statewide media
campaign to increase awareness and education on overdose prevention utilizing campaign materials
from the Centers for Disease Control and Prevention Rx Awareness campaign. 53 This evidence-driven
campaign tells real stories of people whose lives have been torn apart by opioid use and abuse to raise
awareness. 54 In addition to state level efforts, these campaign materials are available and accessible to
County Health Departments in support of local initiatives and prevention efforts. 55 In addition to this
media campaign, there are various prevention efforts throughout Florida to increase education and
awareness about the risks of prescription drug and opioid misuse. Current statewide awareness
campaigns and initiatives include:

• The Department of Children and Families’ Opioid Overdose Prevention Awareness campaign,
launched in 2018, to educate the public on the signs and symptoms of opioid overdose, how to
use an opioid antagonist to reverse an opioid overdose, and where to access an opioid
antagonist in Florida.
• First Lady Casey DeSantis Hope for Healing Florida initiative, which is a multi-agency mental
health and substance abuse campaign.
• The Florida Dose of Reality website, launch by the Florida Office of Attorney General in
September 2018, provides information on the dangers of opioid misuse, safe storage of opioids,
advice for prescribing providers, students, teachers, parents, veterans, business owners and
others.

49 DOH maintains the EMSTARS to collect data and analyze the incident level data from EMS agencies for benchmarking and quality

improvement initiatives. The electronic patient care records submitted by licensed EMS agencies to EMSTARS are confidential and
exempt pursuant to s. 401.30(4), F.S.
50 The Washington/Baltimore High Intensity Drug Trafficking Area (HIDTA) is a federal grant program administered by the White House

Office of National Drug Control Policy which provides resources to assist federal, state, local, and tribal agencies coordinate activities
that address drug trafficking. HIDTA created an app, known as the Overdose Detection Mapping Application Program, which allows
EMS agencies to report overdose incidents that are then transmitted in real time with electronic map showing the location, date, time,
and incident type. The app does not allow EMS agencies to report on the patient’s age or gender or suspected controlled substance
involved in the overdose.
51 Florida Attorney General, Florida’s Opioid Epidemic: Recommendations and Best Practices (Jan. 25, 2021),

https://myfloridalegal.com/webfiles.nsf/WF/TDGT-B9UTV9/$file/AG+Opioid+Working+Group+Report+Final+2-28-2019.pdf (last visited
Mar. 30, 2021).
52 Florida Department of Health, Florida Drug Overdose Surveillance and Epidemiology (FL-DOSE),

http://www.floridahealth.gov/statistics-and-data/fl-dose/index.html (last visited Mar. 30, 2021).
53 Florida Department of Health, 2021 Agency Bill Analysis for HB 1091 (Mar. 12, 2021).
54 Id.
55 Id.

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Effect of Proposed Changes

HB 1091 amends s. 381.887, F.S., to specify that the purpose of the section is for the prescribing,
ordering, and dispensing of emergency opioid antagonists. The bill requires DOH to develop and
implement a statewide awareness campaign to educate the public regarding:

• Risk factors of opioid overdoses.
• Signs and symptoms of opioid overdoses.
• How to respond to opioid overdoses.
• Safe storage and administration of emergency opioid antagonists.
• Safe disposal of opioids including, but not limited to, permanent prescription drug donation
boxes and at-home drug deactivation and disposal systems.

The bill allows a pharmacist to order an emergency opioid antagonist with an autoinjection delivery
system or intranasal application delivery system for a patient or caregiver for use in accordance with s.
381.887, F.S. It further allows a pharmacist to dispense an emergency opioid antagonist pursuant to a
prescription by an authorized health care practitioner. Pharmacists may dispense an emergency opioid
antagonist with an autoinjection delivery system or intranasal application delivery system, which must
be appropriately labeled with instructions for use, pursuant to a pharmacist order or pursuant to a non-
patient standing order.

The bill expressly authorizes personnel of a law enforcement agency or other agency, including, but not
limited to, correctional probation officers and child protective investigators to possess, store, and
administer emergency opioid antagonists. Personnel of a law enforcement agency or other agency are
immune from civil liability or criminal liability as a result of administering an emergency opioid
antagonist.

The bill also amends s. 401.253, F.S., to require a basic life support service or advanced life support
service that treats and releases, or transports to a medical facility, a person in response to an
emergency call for suspected or actual overdose of a controlled substance to report such incident to
DOH.

B. SECTION DIRECTORY:
Section 1: Amending s. 381.887, F.S., relating to emergency treatment for suspected opioid overdose.
Section 2: Amending s. 401.253, F.S., relating to reporting of controlled substance.
Section 3: Providing an effective date.

II. FISCAL ANALYSIS & ECONOMIC IMPACT STATEMENT

A. FISCAL IMPACT ON STATE GOVERNMENT:

1. Revenues:
None.

2. Expenditures:
DOH will incur an insignificant fiscal impact to implement the bill’s provisions. DOH will incur both a
recurring and nonrecurring expense should the bill pass. DOH anticipates needing 2 FTEs at a total
costs of $231,582 in recurring costs for salaries and benefits to implement the bill’s provisions.
Additionally, DOH estimates $500,000 in non-recurring and $50,000 in recurring costs to implement
a statewide targeted awareness campaign.

B. FISCAL IMPACT ON LOCAL GOVERNMENTS:
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1. Revenues:
None.

2. Expenditures:
None.

C. DIRECT ECONOMIC IMPACT ON PRIVATE SECTOR:
None.

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:
DOH has sufficient rulemaking authority to implement the bill’s provisions.

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

PCS for HB 1091 2021

1 A bill to be entitled
2 An act relating to substance abuse prevention;
3 amending s. 381.887, F.S.; revising provisions
4 relating to the prescribing, ordering, and dispensing
5 of emergency opioid antagonists to certain persons;
6 requiring the Department of Health to develop and
7 implement a statewide awareness campaign to educate
8 the public regarding opioid overdoses, the safe
9 storage and administration of emergency opioid
10 antagonists, and the safe disposal of opioids;
11 authorizing a pharmacist to order an emergency opioid
12 antagonists; authorizing certain persons dispensed
13 opioid antagonists without a prescription to store and
14 possess and, in certain emergency situations, to
15 administer opioid antagonists; providing certain
16 authorized persons immunity from civil or criminal
17 liability for administering emergency opioid
18 antagonists under certain circumstances; authorizing
19 personnel of law enforcement agencies and other
20 agencies and certain other persons to administer
21 emergency opioid antagonists under certain
22 circumstances; amending s. 401.253, F.S.; requiring
23 basic life support services or advanced life support
24 services to report incidents involving a suspected or
25 actual overdose of a controlled substance; providing

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PCS for HB 1091 2021

26 an effective date.
27
28 Be It Enacted by the Legislature of the State of Florida:
29 Section 1. Subsections (2), (3), and (4) of section
30 381.887, Florida Statutes, are amended to read:
31 381.887 Emergency treatment for suspected opioid
32 overdose.—
33 (2)(a) The purpose of this section is to provide for the
34 prescribing, ordering, and dispensing prescription of emergency
35 opioid antagonists an emergency opioid antagonist to patients
36 and caregivers and to encourage the prescribing, ordering, and
37 dispensing prescription of emergency opioid antagonists by
38 authorized health care practitioners.
39 (b) The Department of Health shall develop and implement a
40 statewide awareness campaign to educate the public regarding:
41 1. Risk factors of opioid overdoses;
42 2. Signs and symptoms of opioid overdoses;
43 3. How to respond to opioid overdoses;
44 4. Safe storage and administration of emergency opioid
45 antagonists; and
46 5. Safe disposal of opioids including, but not limited
47 to, permanent prescription drug donation boxes and at-home drug
48 deactivation and disposal systems.
49 (3)(a) An authorized health care practitioner may
50 prescribe and dispense an emergency opioid antagonist, and a

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PCS for HB 1091 2021

51 pharmacist may order an emergency opioid antagonist with an
52 autoinjection delivery system or intranasal application delivery
53 system, to a patient or caregiver for use in accordance with
54 this section.
55 (b) A pharmacist may dispense an emergency opioid
56 antagonist pursuant to such a prescription by an authorized
57 health care practitioner. A pharmacist may dispense a
58 prescription or pursuant to a non-patient-specific standing
59 order for an emergency opioid antagonist with an autoinjection
60 delivery system or intranasal application delivery system, which
61 must be appropriately labeled with instructions for use,
62 pursuant to a pharmacist order or pursuant to a non-patient
63 standing order.
64 (c) A patient or caregiver is authorized to store and
65 possess emergency opioid antagonists and, in an emergency
66 situation when a physician is not immediately available,
67 administer the emergency opioid antagonist to a person believed
68 in good faith to be experiencing an opioid overdose, regardless
69 of whether that person has a prescription for an emergency
70 opioid antagonist.
71 (4) The following persons are authorized to possess,
72 store, and administer emergency opioid antagonists as clinically
73 indicated and are immune from any civil liability or criminal
74 liability as a result of administering an emergency opioid
75 antagonist:

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76 (a) Emergency responders, including, but not limited to,
77 law enforcement officers, paramedics, and emergency medical
78 technicians.
79 (b) Crime laboratory personnel for the statewide criminal
80 analysis laboratory system as described in s. 943.32, including,
81 but not limited to, analysts, evidence intake personnel, and
82 their supervisors.
83 (c) Personnel of a law enforcement agency or other agency,
84 including, but not limited to, correctional probation officers
85 and child protective investigators who, while acting within the
86 scope or course of employment, come into contact with a
87 controlled substance or a person who is at risk of experiencing
88 an opioid overdose.
89 Section 2. Paragraph (a) of subsection (1) of section
90 401.253, Florida Statutes, is amended to read:
91 401.253 Reporting of controlled substance overdoses.—
92 (1)(a) A basic life support service or advanced life
93 support service that which treats and releases, or transports to
94 a medical facility, a person in response to an emergency call
95 for a suspected or actual overdose of a controlled substance
96 must may report such incidents to the department. Such reports
97 must be made using the Emergency Medical Service Tracking and
98 Reporting System or other appropriate method with secure access,
99 including, but not limited to, the Washington/Baltimore High
100 Intensity Drug Trafficking Overdose Detection Mapping

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101 Application Program or other program identified by the
102 department in rule. If a basic life support service or advanced
103 life support service reports such incidents, it must shall make
104 its best efforts to make the report to the department within 120
105 hours after it responds to the incident.
106 Section 3. This act shall take effect July 1, 2021.
107

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HB 1233
HOUSE OF REPRESENTATIVES STAFF ANALYSIS
BILL #: HB 1233 Genetic Counseling Patient Protection Act
SPONSOR(S): Silvers
TIED BILLS: HB 1235 IDEN./SIM. BILLS: SB 1770

REFERENCE ACTION ANALYST STAFF DIRECTOR or
BUDGET/POLICY CHIEF

1) Professions & Public Health Subcommittee Morris McElroy

2) Health Care Appropriations Subcommittee

3) Health & Human Services Committee

SUMMARY ANALYSIS
The Division of Medical Quality Assurance (MQA), within the Department of Health (DOH), has general
regulatory authority over health care practitioners. The MQA works in conjunction with 22 boards and four
councils to license and regulate seven types of health facilities and more than 40 health care professions. Each
profession is regulated by an individual practice act and by ch. 456, F.S., which provides general regulatory
authority and licensure authority for MQA, including discipline of practitioners.

HB 1233 creates the “Genetic Counseling Patient Protection Act,” requiring DOH to regulate and license
genetic counselors. The bill:

• Creates requirements for initial licensure and renewal for genetic counselors;
• Authorizes DOH to adopt rules regarding continuing education requirements;
• Subjects genetic counselors to disciplinary action if they commit specified prohibited acts;
• Authorizes DOH to deny an application for licensure or impose penalties on a licensee who commits
specified prohibited acts; and
• Exempts active duty commissioned medical officers of the United States Armed Forces or Public Health
Service and licensed health care practitioners from the requirements of the genetic counselor practice
act.

The bill also makes technical and conforming changes.

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

The bill provides an effective date of July 1, 2021.

This document does not reflect the intent or official position of the bill sponsor or House of Representatives.
STORAGE NAME: h1233.PPH
DATE: 3/31/2021
FULL ANALYSIS

I. SUBSTANTIVE ANALYSIS

A. EFFECT OF PROPOSED CHANGES:
Current Situation

Health Care Professional Licensure

The Division of Medical Quality Assurance (MQA), within the Department of Health (DOH), has general
regulatory authority over health care practitioners. MQA works in conjunction with 22 boards and 4
councils to license and regulate 7 types of health care facilities and more than 40 health care
professions. 1 Each profession is regulated by an individual practice act and by ch. 456, F.S., which
provides general regulatory and licensure authority for MQA. MQA is statutorily responsible for the
following boards and professions established within the division: 2

Genetic Counseling

1 Florida Department of Health, Division of Medical Quality Assurance, Annual Report and Long-Range Plan, Fiscal Year 2019-2020, p.

6, http://www.floridahealth.gov/licensing-and-regulation/reports-and-publications/_documents/2019-2020-annual-report.pdf (last visited
on March 26, 2021).
2 Id.

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Advances in genetic technology and research have increased the amount of information available to
individuals and providers and increased the demand for genetic services, including genetic testing,
diagnosis and interpretation of test results, and genetic counseling. 3 Genetic test results can help
diagnose, confirm, or indicate increased risk for developing a particular condition, which genetic
counseling can help explain the results and available treatment options.

Genetic counseling gives individuals information about how genetic conditions might affect them or
their families. Genetic counselors collect personal and family history and use such information to
determine how likely it is that an individual or his or her family member has a genetic condition. Based
on such information, a genetic counselor helps an individual determine if a genetic test is suitable.
Genetic counseling after genetic testing can help an individual better understand his or her test results
and treatment options. 4

Individuals seek genetic counseling for multiple reasons, including to: 5

• Address prenatal concerns about factors that might affect a baby during infancy, including
genetic conditions and birth defects;
• Address concerns if a child is showing signs and symptoms of a genetic disorder, including
abnormal newborn screening results, intellectual or developmental disabilities, or birth defects;
• Determine if an individual is at risk of being affected by a health condition, including hereditary
breast and ovarian cancer, muscular dystrophy, Huntington’s disease, and sickle cell disease.

Genetic counselors who wish to become certified must pass a certification examination issued by the
American Board of Genetic Counseling (ABGC). 6 The primary qualification to sit for the certification
examination is a master’s degree in genetic counseling from a program accredited by the Accreditation
Council for Genetic Counseling. 7 States currently issuing a genetic counselor license require
individuals to pass the ABCG certification examination. 8

Genetic counselors primarily practice in hospital settings and can work in all medical specialties or
practice in one specialty area, such as pediatrics, oncology, or cardiology. 9 They assess individuals or
families with or at risk for genetic conditions, and provide counseling and education on test results.
Genetic counselors are not physicians; they typically work in conjunction with medical geneticists to
provide genetic services. 10 Medical geneticists will order genetic testing and interpret the results and a
genetic counselor will provide further education on the results and how they may affect an individual or
their family. 11

Twenty-nine states require licensure for genetic counselors. 12 Florida does not require licensure and
there are approximately 127 genetic counselors providing services in this state. 13

Sunrise Act

3 United States Government Accountability Office, Report to Congressional Committees: Genetic Services – Information on Genetic

Counselor and Medical Geneticist Workforces (July 2020), https://www.gao.gov/assets/gao-20-593.pdf (last visited March 26, 2021).
4 Centers for Disease Control and Prevention, Genetic Counseling, https://www.cdc.gov/genomics/gtesting/genetic_counseling.htm

(last visited March 26, 2021).
5 Id.
6 American Board of Genetic Counseling, Inc., Certification Qualifications, https://www.abgc.net/becoming-certified/do-i-qualify/ (last

visited March 26, 2021). Certification is valid for 5 years, after which time the genetic counselor must seek recertification.
The University of South Florida has the only certified genetic counseling training program in Florida.
7 Id.
8 Id.
9 Id.
10 Medical geneticists are physicians who specialist in medical genetics and conduct genetic testing and provide diagnoses.
11 Supra, note 6.
12 National Society of Genetic Counselors, States Issuing Licenses for Genetic Counselors, https://www.nsgc.org/Policy-Research-and-

Publications/State-Licensure-for-Genetic-Counselors/States-Issuing-Licenses (last visited March 26, 2021). States requiring licensure
of generic counselors include: Alabama, Arkansas, California, Connecticut, Delaware, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa,
Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Nebraska, New Hampshire, New Jersey, New Mexico, North Dakota, Ohio,
Oklahoma, Pennsylvania, South Dakota, Tennessee, Utah, Virginia, and Washington.
13 Department of Health, Agency Analysis of 2021 House Bill 1233 (March 22, 2021).
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Generally, a sunrise review is a formal process where a legislature scrutinizes legislation proposing to
regulate an unregulated profession or occupation by requiring a cost-benefit analysis before the
legislation is enacted. 14 The Sunrise Act requires the Legislature to consider certain factors before
determining whether to regulate an unregulated profession or occupation. 15 Proponents of regulation
must file information about the regulation’s potential impacts, costs, and benefits upon request. 16

Section 11.62, F.S., is Florida’s sunrise review, which is called the Sunrise Act. The Sunrise Act states
that regulation should not be adopted unless it is: 17

• Necessary to protect the public health, safety, or welfare from significant and discernible harm
or damage;
• Exercised only to the extent necessary to prevent the harm; and
• Limited so as not to unnecessarily restrict entry into the practice of the profession or adversely
affect public access to the professional services.

In determining whether to regulate a profession or occupation, the Sunrise Act requires the Legislature
to consider the following:

• Whether the unregulated practice of the profession or occupation will substantially harm or
endanger the public health, safety, or welfare, and whether the potential for harm is
recognizable and not remote;
• Whether the practice of the profession or occupation requires specialized skill or training and
whether that skill or training is readily measurable or quantifiable so that examination or training
requirements would reasonably assure initial and continuing professional or occupational ability;
• Whether the regulation will have an unreasonable effect on job creation or job retention in the
state or will place unreasonable restrictions on the ability of individuals who seek to practice or
who are practicing a given profession or occupation to find employment;
• Whether the public is or can be effectively protected by other means; and
• Whether the overall cost-effectiveness and economic impact of the proposed regulation,
including the indirect costs to consumers, will be favorable.

Genetic Counselor Sunrise Act Questionnaire

A Sunrise Act questionnaire has been completed by The Florida Association of Genetic Counselors
(FLAGC). 18 FLAGC is seeking licensure and regulation of genetic counselors to protect the health,
safety, and welfare of the public. 19 Florida does not license or regulate genetic counselors.

14 National Conference of State Legislatures, Improving Occupational Licensing with Sunrise and Sunset Review Acts,

https://www.ncsl.org/research/labor-and-employment/improving-occupational-licensing-with-sunrise-and-sunset-reviews.aspx (last
visited March 26, 2021).
15 S. 11.62, F.S.
16 S. 11.62(4), F.S.
17 S. 11.62(2), F.S.
18 The Florida Association of Genetic Counselors, Sunrise Review for Proposed Licensing of Genetic Counselors (on file with the

Professions and Public Health Subcommittee staff).
19 Id.

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Effect of the Bill

HB 1233 creates the “Genetic Counseling Patient Protection Act,” adding genetic counselors to the list
of health care practitioners requiring licensing and regulation by DOH.

The bill creates the scope of practice for genetic counselors, requiring them to advise individuals or
families affected by or at risk of genetic disorders. Genetic counselors may provide services to help an
individual or family:

• Understand a diagnosis and the probable cause and management of such diagnosis;
• Understand heredity and the risk of an occurring medical condition;
• Consider alternatives to genetic counseling for addressing the risk of an occurring medical
condition;
• Choose an appropriate course of action, taking into consideration the risks, family goals, and
ethical and religious standards, and to acting in accordance with that decision; and
• Adjust to a diagnosis and the risk of an occurring medical condition.

The bill creates requirements for licensure as a genetic counselor and requires DOH to issue a license
to an applicant who:

• Submits an application on a form approved by DOH;
• Is of good moral character;
• Has earned a:
o Master’s degree from a genetic counseling program or an equivalent program as
determined by the ABCG Counseling or the Canadian Association of Genetic
Counselors; or
o Doctoral degree from a medical genetics program accredited by the American Board of
Genetics and Genomics or the Canadian College of Medical Geneticists.
• Passes the examination for certification as:
o A genetic counselor by the ABCG, the American Board of Genetics and Genomics, or
the Canadian Association of Genetic Counselors; or
o A medical or clinical geneticist by the American Board of Medical Genetics and
Genomics or the Canadian College of Medical Geneticists.

The bill authorizes DOH to issue a temporary license for up to two years to applicants who meet all the
requirements for licensure, except for the examination requirement if the applicant is eligible to sit for
the next available certification examination issued by the American Board of Genetic Counseling.

The bill requires DOH to renew the license of a genetic counselor upon receipt of a renewal application.
The bill also requires DOH to adopt rules on continuing education requirements consistent with the
ABCG.

The bill prohibits a person from:

• Making a false or fraudulent statement in any application, affidavit, or statement presented to
DOH;
• Practicing genetic counseling, holding himself or herself out as a genetic counselor, or providing
genetic counseling services without obtaining a license from DOH; and
• Using the title “genetic counselor” or any other title, designation, words, letters, or abbreviations
which indicate a person is authorized to practice genetic counseling unless such person holds a
valid license or is exempt from such licensure.

The bill makes it a second degree misdemeanor to violate any of the above prohibitions, punishable by
a fine of up to $500 and imprisonment of up to 60 days. The bill authorizes DOH to discipline a genetic
counselor, or deny an application for licensure as a genetic counselor, if an applicant or licensee:

• Fraudulently attempts to obtain, obtains, or renews a license as a genetic counselor;
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• Has a license revoked, suspended, or otherwise acted against, including licensure denial, in
another jurisdiction;
• Is convicted, found guilty of, or pleads no contest to a crime in any jurisdiction that directly
related to the practice of genetic counseling, including violations of federal law;
• Makes or files a false report that the licensee knows is false;
• Intentionally or negligently fails to file a report required by state or federal law, or willfully
impedes, obstructs or induces another person to impede or obstruct such filing;
• Knowingly advertises genetic counseling services in a fraudulent, false, deceptive, or misleading
manner;
• Violates a DOH-issued disciplinary order or fails to comply with a DOH-issued subpoena;
• Practices with a revoked, suspended, or inactive license;
• Commits gross or repeated malpractice, or fails to deliver genetic counseling services at an
acceptable level of care;
• Displays unprofessional conduct, including failure to conform to minimum standards set by the
practice act and DOH rule, including:
o Practicing beyond the scope of practice of a genetic counselor;
o Failing to refer a patient to a health care practitioner if the licensed genetic counselor is
unwilling or unable to provide services;
o Failing to maintain confidentiality; and
o Financially exploiting the patient or his or her family.
• Violates the genetic counseling practice act.

The bill exempts active duty commissioned medical officers of the United States Armed Forces or the
United States Public Health Service and health care practitioners licensed in this state, other than
licensed genetic counselors, from the requirements of the genetic counseling practice act.

The bill makes conforming technical and conforming changes.

The bill provides an effective date of July 1, 2021.

B. SECTION DIRECTORY:
Section 1: Creates Part III of ch. 483, F.S., the “Genetic Counseling Patient Protection Act.”
Section 2: Amends s. 456.001, F.S., relating to definitions.
Section 3: Amends s. 20.43, F.S., relating to Department of Health.
Section 4: Provides an effective date of July 1, 2021.

II. FISCAL ANALYSIS & ECONOMIC IMPACT STATEMENT

A. FISCAL IMPACT ON STATE GOVERNMENT:

1. Revenues:
None.

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2. Expenditures:
DOH estimates a need for 3 FTE and 1 OPS positions to implement the bill. 20 The total estimated
cost for the first year is $225,876: $137,826 recurring FTE salary, $35,359 non-recurring OPS
costs, $33,878 recurring expenses, $17,716 non-recurring expenses, and $1,097 in human
resources costs. 21

DOH will experience an increase in workload associated with developing applications, rulemaking,
and technology updates which can be absorbed within current resources. 22

B. FISCAL IMPACT ON LOCAL GOVERNMENTS:

1. Revenues:
None.

2. Expenditures:
None.

C. DIRECT ECONOMIC IMPACT ON PRIVATE SECTOR:
Genetic counselors may incur costs associated with obtaining licensure by DOH.

D. FISCAL COMMENTS:
None.

III. COMMENTS

A. CONSTITUTIONAL ISSUES:

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

2. Other:
None.

B. RULE-MAKING AUTHORITY:
The bill provides sufficient rulemaking authority to implement its provisions.

C. DRAFTING ISSUES OR OTHER COMMENTS:
None.

IV. AMENDMENTS/ COMMITTEE SUBSTITUTE CHANGES

20 Supra, note 13.
21 Id.
22 Id.

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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 1233 2021

1 A bill to be entitled
2 An act relating to Genetic Counseling Patient
3 Protection Act; creating part III of ch. 483, F.S.,
4 titled "Genetic Counseling"; providing a short title,
5 legislative findings and intent, and definitions;
6 providing licensure and licensure renewal
7 requirements; requiring the Department of Health to
8 adopt by rule continuing education requirements;
9 prohibiting certain acts; providing penalties and
10 grounds for disciplinary action; authorizing the
11 department to enter an order denying licensure or
12 imposing other penalties; providing exemptions;
13 amending s. 456.001, F.S.; revising the definition of
14 the term "health care practitioner" to include
15 licensed genetic counselors; amending s. 20.43, F.S.;
16 correcting a cross-reference relating to the
17 department's responsibilities for health care
18 practitioners; providing an effective date.
19
20 Be It Enacted by the Legislature of the State of Florida:
21
22 Section 1. Part III of chapter 483, Florida Statutes,
23 consisting of sections 483.911, 483.912, 483.913, 483.914,
24 483.915, 483.916, 483.917, and 483.918, is created to read:
25

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26 PART III
27 GENETIC COUNSELING
28 483.911 Short title.—This part may be cited as the
29 "Genetic Counseling Patient Protection Act."
30 483.912 Legislative findings and intent.—The sole
31 legislative purpose for enacting this part is to ensure that
32 every genetic counselor practicing in this state meets minimum
33 requirements for safe practice. The Legislature finds that the
34 delivery of genetic counseling services by unskilled and
35 incompetent persons presents a danger to public health and
36 safety. Because it is difficult for the public to make informed
37 choices related to genetic counseling services and since the
38 consequences of uninformed choices can seriously endanger public
39 health and safety, it is the intent of the Legislature to
40 prohibit the delivery of genetic counseling services by persons
41 who are determined to possess less than minimum competencies or
42 who otherwise present a danger to the public.
43 483.913 Definitions.—As used in this part, the term:
44 (1) "Department" means the Department of Health.
45 (2) "Genetic counselor" means a person licensed under this
46 part to practice genetic counseling.
47 (3) "Practice of genetic counseling" means the process of
48 advising an individual or family affected by or at risk of
49 genetic disorders, including services to help an individual or
50 family:

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51 (a) Understand a diagnosis, the probable cause, and
52 available management.
53 (b) Understand how heredity contributes and the risk of
54 occurrence.
55 (c) Consider alternatives to genetic counseling for
56 addressing the risk of occurrence.
57 (d) Choose a course of action appropriate to the
58 individual or family, taking into consideration their risks,
59 family goals, and ethical and religious standards, and to act in
60 accordance with that decision.
61 (e) Adjust to a diagnosis and the risk of occurrence.
62 483.914 Licensure requirements.—
63 (1) A person desiring to be licensed as a genetic
64 counselor under this part must apply to the department on a form
65 approved by the department.
66 (2) The department shall issue a license to each applicant
67 who:
68 (a) Has completed an application.
69 (b) Is of good moral character.
70 (c) Provides satisfactory documentation of having earned:
71 1. A master's degree from a genetic counseling training
72 program or an equivalent program as determined by the American
73 Board of Genetic Counseling, Inc., or the Canadian Association
74 of Genetic Counsellors; or
75 2. A doctoral degree from a medical genetics training

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76 program accredited by the American Board of Medical Genetics and
77 Genomics or the Canadian College of Medical Geneticists.
78 (d) Has passed the examination for certification as:
79 1. A genetic counselor by the American Board of Genetic
80 Counseling, Inc., the American Board of Medical Genetics and
81 Genomics, or the Canadian Association of Genetic Counsellors; or
82 2. A medical or clinical geneticist by the American Board
83 of Medical Genetics and Genomics or the Canadian College of
84 Medical Geneticists.
85 (3) The department may issue a temporary license for up to
86 2 years to an applicant who meets all of the requirements for
87 licensure except for the examination requirement in this section
88 and is eligible to sit for the next available certification
89 examination administered by the American Board of Genetic
90 Counseling, Inc.
91 483.915 Licensure renewal and continuing education
92 requirements.—
93 (1) The department shall renew a license upon receipt of a
94 renewal application.
95 (2) The department shall adopt by rule continuing
96 education requirements consistent with nationally accepted
97 standards of the American Board of Genetic Counseling, Inc.
98 483.916 Prohibitions; penalties.—
99 (1) A person may not:
100 (a) Make a false or fraudulent statement in any

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101 application, affidavit, or statement presented to the
102 department.
103 (b) Practice genetic counseling or hold himself or herself
104 out as a genetic counselor or as being able to practice genetic
105 counseling or to render genetic counseling services without a
106 license issued under this part, unless exempt from licensure
107 under this part.
108 (c) Use the title "genetic counselor" or any other titles,
109 designations, words, letters, abbreviations, or devices tending
110 to indicate that the person is authorized to practice genetic
111 counseling, unless that person holds a current license as a
112 genetic counselor issued under this part or is exempt from
113 licensure under this part.
114 (2) A person who violates this section commits a
115 misdemeanor of the second degree, punishable as provided in s.
116 775.082 or s. 775.083.
117 483.917 Grounds for disciplinary action; penalties.—
118 (1) The following acts constitute grounds for denial of a
119 license or disciplinary action, as specified in s. 456.072(2):
120 (a) Attempting to obtain, obtaining, or renewing a license
121 under this part by fraudulent misrepresentation.
122 (b) Having a license revoked, suspended, or otherwise
123 acted against, including the denial of licensure in another
124 jurisdiction.
125 (c) Being convicted or found guilty of, or entered a plea

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126 of nolo contendere to, regardless of adjudication, a crime in
127 any jurisdiction that directly relates to the practice of
128 genetic counseling, including a violation of any federal law or
129 regulation regarding genetic counseling.
130 (d) Making or filing a report or record that the licensee
131 knows is false, intentionally or negligently failing to file a
132 report or record required by state or federal law, willfully
133 impeding or obstructing such filing, or inducing another person
134 to impede or obstruct such filing. Such reports or records
135 include only reports or records that are signed by a person who
136 is licensed under this part.
137 (e) Knowingly advertising services related to genetic
138 counseling in a fraudulent, false, deceptive, or misleading
139 manner.
140 (f) Violating a previous order of the department entered
141 in a disciplinary hearing or failing to comply with a subpoena
142 issued by the department.
143 (g) Practicing with a revoked, suspended, or inactive
144 license.
145 (h) Gross or repeated malpractice or the failure to
146 deliver genetic counseling services with that level of care and
147 skill which is recognized by a reasonably prudent licensed
148 genetic counselor as being acceptable under similar conditions
149 and circumstances.
150 (i) Unprofessional conduct, including any departure from

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151 or failure to conform to the minimal prevailing standards of
152 acceptable practice under this part and department rule such as:
153 1. Practicing or offering to practice beyond the scope
154 permitted by law or accepting and performing genetic counseling
155 services the licensee knows, or has reason to know, the licensee
156 is not competent to perform.
157 2. Failing to refer a patient to a health care
158 practitioner as defined in s. 456.001 if the licensee is unable
159 or unwilling to provide genetic counseling services to the
160 patient.
161 3. Failing to maintain the confidentiality of any
162 information received under this part or failing to maintain the
163 confidentiality of patient records pursuant to s. 456.057,
164 unless such information or records are released by the patient
165 or otherwise authorized or required by law to be released.
166 4. Exercising influence on the patient or family in such a
167 manner as to exploit the patient or family for financial gain of
168 the licensee.
169 (j) Violating this part or chapter 456, or any rules
170 adopted pursuant thereto.
171 (2) The department may enter an order denying licensure or
172 imposing penalties against an applicant for licensure or a
173 licensee who is found guilty of violating subsection (1) or s.
174 483.916.
175 483.918 Exemptions.—This part does not apply to:

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176 (1) A commissioned medical officer of the United States
177 Armed Forces or the United States Public Health Service while on
178 active duty or while acting within the scope of his or her
179 military or public health responsibilities.
180 (2) A health care practitioner as defined in s. 456.001,
181 other than a genetic counselor licensed under this part, who is
182 practicing within the scope of his or her training, education,
183 and licensure, and who is doing work of a nature consistent with
184 such training, education, and licensure.
185 Section 2. Subsection (4) of section 456.001, Florida
186 Statutes, is amended to read:
187 456.001 Definitions.—As used in this chapter, the term:
188 (4) "Health care practitioner" means any person licensed
189 under chapter 457; chapter 458; chapter 459; chapter 460;
190 chapter 461; chapter 462; chapter 463; chapter 464; chapter 465;
191 chapter 466; chapter 467; part I, part II, part III, part V,
192 part X, part XIII, or part XIV of chapter 468; chapter 478;
193 chapter 480; part I, or part II, or part III, of chapter 483;
194 chapter 484; chapter 486; chapter 490; or chapter 491.
195 Section 3. Subsection (8) of section 20.43, Florida
196 Statutes, is amended to read:
197 20.43 Department of Health.—There is created a Department
198 of Health.
199 (8) The department may hold copyrights, trademarks, and
200 service marks and enforce its rights with respect thereto,

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201 except such authority does not extend to any public records
202 relating to the department's responsibilities for health care
203 practitioners regulated under part II of chapter 456 455.
204 Section 4. This act shall take effect July 1, 2021.

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COMMITTEE/SUBCOMMITTEE AMENDMENT
Bill No. HB 1233 (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 Silvers offered the following:
4
5 Amendment
6 Remove lines 30-90 and insert:
7 483.912 Legislative findings and intent.—The sole
8 legislative purpose for enacting this part is to ensure that
9 every genetic counselor practicing in this state meets minimum
10 requirements for safe practice. The Legislature finds that the
11 delivery of genetic counseling services by unskilled and
12 incompetent persons presents a danger to public health and
13 safety. Because it is difficult for the public to make informed
14 choices related to genetic counseling services and since the
15 consequences of uninformed choices can seriously endanger public
16 health and safety, it is the intent of the Legislature to
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COMMITTEE/SUBCOMMITTEE AMENDMENT
Bill No. HB 1233 (2021)
Amendment No. 1

17 prohibit the delivery of genetic counseling services by persons
18 who are determined to possess less than minimum competencies or
19 who otherwise present a danger to the public.
20 483.913 Definitions.—As used in this part, the term:
21 (1) "Department" means the Department of Health.
22 (2) "Genetic counselor" means a person licensed under this
23 part to practice genetic counseling.
24 (3) "Scope of practice of genetic counseling" means the
25 process of advising an individual or a family affected by or at
26 risk of genetic disorders, including:
27 (a) Obtaining and evaluating individual and family medical
28 histories to determine risk for genetic or medical conditions
29 and diseases in an individual, his or her offspring, and other
30 family members.
31 (b) Discussing the clinical features, family history,
32 means of diagnosis, genetic and environmental factors, and
33 management of risk for genetic or medical conditions and
34 diseases.
35 (c) Identifying, ordering, and coordinating genetic
36 laboratory tests and other diagnostic studies as appropriate for
37 the genetic assessment.
38 (d) Integrating genetic laboratory test results and other
39 diagnostic studies with individual and family medical histories
40 to assess and communicate risk factors for genetic or medical
41 conditions and diseases.
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COMMITTEE/SUBCOMMITTEE AMENDMENT
Bill No. HB 1233 (2021)
Amendment No. 1

42 (e) Explaining the clinical implications of genetic
43 laboratory tests and other diagnostic studies and the results.
44 (f) Evaluating the individual's or the family's responses
45 to the condition or risk of recurrence and provide client-
46 centered counseling and anticipatory guidance.
47 (g) Identifying and utilizing community resources that
48 provide medical, educational, financial, and psychosocial
49 support and advocacy.
50 (h) Providing written documentation of medical, genetic,
51 and counseling information for individuals, families, and health
52 care professionals.
53 (i) Referring individuals to a physician for diagnosis and
54 treatment.
55 483.914 Licensure requirements.—
56 (1) A person desiring to be licensed as a genetic
57 counselor under this part must apply to the department on a form
58 approved by the department.
59 (2) The department shall issue a license, valid for a
60 period of 2 years after the date of issuance, to each applicant
61 who:
62 (a) Has completed an application.
63 (b) Is of good moral character.
64 (c) Provides satisfactory documentation of having earned:
65 1. A master's degree from a genetic counseling training
66 program or an equivalent program as determined by the
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COMMITTEE/SUBCOMMITTEE AMENDMENT
Bill No. HB 1233 (2021)
Amendment No. 1

67 Accreditation Council of Genetic Counseling or its successor or
68 equivalent; or
69 2. A doctoral degree from a medical genetics training
70 program accredited by the American Board of Medical Genetics and
71 Genomics or the Canadian College of Medical Geneticists.
72 (d) Has passed the examination for certification as:
73 1. A genetic counselor by the American Board of Genetic
74 Counseling, Inc., the American Board of Medical Genetics and
75 Genomics, or the Canadian Association of Genetic Counsellors; or
76 2. A medical or clinical geneticist by the American Board
77 of Medical Genetics and Genomics or the Canadian College of
78 Medical Geneticists.
79 (3) The department may issue a temporary license for up to
80 2 years to an applicant who meets all of the requirements for
81 licensure except for the examination requirement in this section
82 and is eligible to sit for the next available certification
83 examination.

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HB 1235
HOUSE OF REPRESENTATIVES STAFF ANALYSIS
BILL #: HB 1235 Fees
SPONSOR(S): Silvers
TIED BILLS: HB 1233 IDEN./SIM. BILLS: SB 1772

REFERENCE ACTION ANALYST STAFF DIRECTOR or
BUDGET/POLICY CHIEF

1) Professions & Public Health Subcommittee Morris McElroy

2) Health Care Appropriations Subcommittee

3) Health & Human Services Committee

SUMMARY ANALYSIS
Genetic counselors provide individuals information about how genetic conditions might affect them or their
families. Genetic counselors collect personal and family history and use such information to determine how
likely it is that an individual or his or her family member has a genetic condition. Genetic counselors are not
licensed or regulated in this state.

HB 1233 creates the “Genetic Counseling Patient Protection Act,” requiring the Department of Health (DOH) to
regulate and license genetic counselors.

HB 1235, which is linked to HB 1233, requires DOH to adopt rules relating to the issuance and annual renewal
of genetic counselor licenses. The bill authorizes DOH to charge an application fee of $25 for a genetic
counselor license. The bill also authorizes an annual renewal fee not to exceed $25. The bill allows DOH to
waive the fee by rule. Proceeds from the collected fees must be deposited into the DOH Administrative Trust
Fund and used for the administration of genetic counselor licensure.

The bill will have an indeterminate, positive fiscal impact on DOH.

The bill will be effective on the same date that HB 1233 or similar legislation takes effect.

This bill authorizes a new state fee, requiring a two-thirds vote of the membership of the House. See
Section III.A.2. of the analysis.

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:
Current Situation

Legislation Imposing or Raising State Fees or Taxes

The Florida Constitution provides that no state tax or fee may be imposed, authorized, or raised by the
Legislature except through legislation approved by two-thirds of the membership of each house of the
Legislature. 1 For purposes of this requirement, a “fee” is any charge or payment required by law,
including any fee or charge for services and fees or costs for licenses and to “raise” a fee or tax means
to: 2

• Increase or authorize an increase in the rate of a state tax or fee imposed on a percentage or
per mill basis;
• Increase or authorize an increase in the amount of a state tax or fee imposed on a flat or fixed
amount basis; or
• Decrease or eliminate a state tax or fee exemption or credit.

A bill that imposes, authorizes, or raises any state fee or tax may only contain the fee or tax
provision(s) and may not contain any other subject. 3

The constitutional provision does not authorize any state tax or fee to be imposed if it is otherwise
prohibited by the constitution and does not apply to any tax or fee authorized or imposed by a county,
municipality, school board, or special district. 4

Health Practitioner Licensure Fees

The Division of Medical Quality Assurance (MQA), within the Department of Health (DOH), has general
regulatory authority over health care practitioners. 5 The MQA works in conjunction with 22 boards and
four councils to license and regulate seven types of health care facilities and more than 40 health care
professions. 6 Each profession is regulated by an individual practice act and by ch. 456, F.S., which
provides general regulatory and licensure authority for the MQA.

Under current law, the costs of regulation of health care practitioners must be borne by the licensees
and licensure applicants. 7 Regulatory boards, in consultation with DOH, must set renewal fees by rule
that must be: 8

• Based on revenue projections prepared using generally accepted accounting practices;
• Adequate to cover all expenses relating to that board;
• Reasonable, fair, and not serve as a barrier to licensure;
• Be based on potential earnings from working under the scope of the license;

1 Fla. Const. art. VII, s. 19(a)-(b). The amendment appeared on the 2018 ballot as Amendment 5.
2 Fla. Const. art. VII, s. 19(d).
3 Fla. Const. art. VII, s. 19(e).
4 Fla. Const. art. VII s. 19(c).
5 Pursuant to s. 456.001(4), F.S., health care practitioners are defined to include acupuncturists, physicians, physician assistants,

chiropractors, podiatrists, naturopaths, dentists, dental hygienists, optometrists, nurses, nursing assistants, pharmacists, midwives,
speech language pathologists, nursing home administrators, occupational therapists, respiratory therapists, dieticians, athletic trainers,
orthotists, prosthetists, electrologists, massage therapists, clinical laboratory personnel, medical physicists, dispensers of optical
devices or hearing aids, physical therapists, psychologists, social workers, counselors, and psychotherapists, among others.
6 Florida Department of Health, Division of Medical Quality Assurance, Annual Report and Long-Range Plan, Fiscal Year 2019-2020,

http://www.floridahealth.gov/licensing-and-regulation/reports-and-publications/_documents/2019-2020-annual-report.pdf (last visited
March 26, 2021).
7 Section 456.025(1), F.S.
8 Id.

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• Similar to fees imposed on similar licensure types; and
• No more than 10 percent greater than the actual cost to regulate that profession for the previous
biennium.

Genetic Counselors

Genetic counselors provide individuals information about how genetic conditions might affect them or
their families. Genetic counselors collect personal and family history and use such information to
determine how likely it is that an individual or his or her family member has a genetic condition. Based
on such information, a genetic counselor helps an individual determine if a genetic test is suitable.
Genetic counseling after genetic testing can help an individual better understand his or her test results
and treatment options. 9

Currently, genetic counselors are not licensed or regulated in this state and no fees are assessed for
initial licensure or renewal.

Effect of the Bill

HB 1235, which is linked to HB 1233, authorizes DOH to adopt rules relating to the procedures for
issuance and annual renewal of genetic counselor licenses, including an application and renewal fee
not to exceed $25. The bill authorizes DOH to waive such fees by rule. Proceeds from collected fees
must be deposited in the Administrative Trust Fund within DOH and used for the regulation of genetic
counselors.

The bill becomes effective on the same date as HB 1233 or similar legislation.

B. SECTION DIRECTORY:
Section 1: Creates s. 483.919, F.S., relating to licensure of genetic counselors.
Section 2: Provides an effective date of the same date that HB 1233 or similar legislation takes
effect.

II. FISCAL ANALYSIS & ECONOMIC IMPACT STATEMENT

A. FISCAL IMPACT ON STATE GOVERNMENT:

1. Revenues:
Genetic counselor applicants for licensure will be assessed an application fee of up to $25 for
issuance and annual renewal of a license. The total amount of revenue DOH will receive from such
fees is indeterminate because the number of genetic counselors who will apply for licensure is not
predictable.

2. Expenditures:
DOH will incur costs associated with the regulation of licensees, rulemaking, and technology
updates, the impact of which is indeterminate. 10

9 Centers for Disease Control and Prevention, Genetic Counseling, https://www.cdc.gov/genomics/gtesting/genetic_counseling.htm

(last visited March 26, 2021).
10 Department of Health, Agency Analysis of 2021 House Bill 1235 (March 22, 2021).

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B. FISCAL IMPACT ON LOCAL GOVERNMENTS:

1. Revenues:
None.

2. Expenditures:
None.

C. DIRECT ECONOMIC IMPACT ON PRIVATE SECTOR:
Genetic counselor license applicants will have to pay an application fee and annual renewal fee. The
bill authorizes DOH to set the application and annual renewal fees, but neither fee may exceed $25.

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:
Article VII, s. 19 of the Florida Constitution requires the imposition, authorization, or raising of a state
tax or fee be contained in a separate bill that contains no other subject and be approved by two-
thirds of the membership of each house of the Legislature. As such, the bill appears to implicate Art.
VII, s. 19 of the Florida Constitution because the bill authorizes a state fee.

B. RULE-MAKING AUTHORITY:
The bill provides sufficient rulemaking needed for implementation.

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 1235 2021

1 A bill to be entitled
2 An act relating to fees; creating s. 483.919, F.S.;
3 requiring the Department of Health to adopt by rule
4 procedures for the issuance and annual renewal of
5 genetic counselor licenses, including a specified
6 application fee; authorizing the department to waive
7 payment of the fee by rule; providing for the deposit
8 and use of fee proceeds; providing a contingent
9 effective date.
10
11 Be It Enacted by the Legislature of the State of Florida:
12
13 Section 1. Section 483.919, Florida Statutes, is created
14 to read:
15 483.919 Licensure of genetic counselors.—The department
16 shall adopt by rule procedures for the issuance and annual
17 renewal of a genetic counselor license, including an application
18 fee not to exceed $25 for such issuance and annual renewal. The
19 department may waive payment of the fee by rule. Proceeds from
20 fees collected pursuant to this section shall be deposited in
21 the Administrative Trust Fund within the Department of Health
22 and used for the administration of genetic counselor licensure.
23 Section 2. This act shall take effect on the same date
24 that HB 1233 or similar legislation takes effect if such
25 legislation is adopted in the same legislative session or an

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26 extension thereof and becomes a law.

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HB 1345
HOUSE OF REPRESENTATIVES STAFF ANALYSIS
BILL #: HB 1345 Pharmaceutical Products Containing Cannabis
SPONSOR(S): Persons-Mulicka and others
TIED BILLS: IDEN./SIM. BILLS: SB 1738

REFERENCE ACTION ANALYST STAFF DIRECTOR or
BUDGET/POLICY CHIEF

1) Criminal Justice & Public Safety Subcommittee 16 Y, 0 N Padgett Hall

2) Professions & Public Health Subcommittee Guzzo McElroy

3) Judiciary Committee

SUMMARY ANALYSIS
Federal and state law both classify controlled substances into five schedules. The scheduling determination for
a controlled substance is based on a substance’s potential for abuse, accepted medical use, and potential for
addiction. The classifications range from a Schedule I substance, which has a high potential for abuse, with no
accepted medical use, and high potential for addiction; to a Schedule V substance, which has a low potential
for abuse, an accepted medical use, and a mild potential for addiction. With the exception of Epidiolex, which is
the only pharmaceutical product derived from the cannabis plant approved for medical use by the U.S. Food
and Drug Administration (FDA), cannabis and compounds derived from cannabis are listed in Schedule I of
both federal and Florida law.

HB 1345 amends s. 893.03(1)(c)7., F.S., to exclude from Schedule I any pharmaceutical product containing
cannabis that has been approved by the FDA. The Legislature retains the authority to schedule a
pharmaceutical product through future legislation, including as a Schedule I controlled substance.

Although there are currently no other FDA approved pharmaceutical products besides Epidiolex derived from
the cannabis plant, the bill would prevent any future pharmaceutical product from being automatically placed in
Schedule I, which includes controlled substances that have no currently accepted medical use.

Preventing an FDA approved pharmaceutical product derived from the cannabis plant from being automatically
included in Schedule I could increase the availability of the product to Florida residents, and allow doctors and
pharmacies to prescribe and dispense such a product without burdensome regulations and reporting
requirements.

The bill does not appear to have a fiscal impact on state or local governments.

The bill is effective upon becoming a law.

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

Florida Law

Controlled Substances

Chapter 893, F.S., the Florida Comprehensive Drug Abuse Prevention and Control Act, classifies
controlled substances into five categories, called schedules. These schedules regulate the
manufacture, distribution, preparation, and dispensing of the substances listed therein. The
distinguishing factors between the different drug schedules are the “potential for abuse” 1 of the
substance and whether there is a currently accepted medical use for the substance. 2

The controlled substance schedules are as follows:
• Schedule I substances have a high potential for abuse and currently have no accepted medical
use in the United States, including substances such as cannabis and heroin. 3
• Schedule II substances have a high potential for abuse and have a currently accepted but
severely restricted medical use in the United States, including substances such as raw opium,
fentanyl, and codeine. 4
• Schedule III substances have a potential for abuse less than the substances contained in
Schedules I and II and have a currently accepted medical use in the United States, including
substances such as stimulants and anabolic steroids. 5
• Schedule IV substances have a low potential for abuse relative to substances in Schedule III
and have a currently accepted medical use in the United States, including substances such as
benzodiazepines and barbiturates. 6
• Schedule V substances have a low potential for abuse relative to the substances in Schedule IV
and have a currently accepted medical use in the United States, including substances such as
mixtures that contain small quantities of opiates, narcotics, or stimulants. 7

A prescriber 8 or dispenser 9 of controlled substances in Florida is required to consult the Prescription
Drug Monitoring Program (PDMP) system each time a controlled substance is prescribed or dispensed
to a patient age 16 or over unless a statutory exemption applies. 10 A dispenser is required to report to
the PDMP each time a controlled substance in schedules II, III, IV, and V are dispensed to a patient. 11

Attorney General

1 S. 893.035(3)(a), F.S., defines “potential for abuse” to mean that a substance has properties as a central nervous system stimulant or

depressant or a hallucinogen that create a substantial likelihood of its being: 1) used in amounts that create a hazard to the user’s
health or safety of the community; 2) diverted from legal channels and distributed through illegal channels; or 3) taken on the user’s
own initiative rather than on the basis of professional medical advice.
2 See s. 893.03, F.S.
3 S. 893.03(1), F.S.
4 S. 893.03(2), F.S.
5 S. 893.03(3), F.S.
6 S. 893.03(4), F.S.
7 S. 893.03(5), F.S.
8 “Prescriber” means a prescribing physician, prescribing practitioner, or other prescribing health care practitioner authorized by the

laws of this state to order controlled substances. S. 893.055(1)(k), F.S.
9 “Dispenser” means a dispensing health care practitioner, pharmacy, or pharmacist licensed to dispense controlled substances in or

into this state. S. 893.055(1)(e), F.S.
10 S. 893.055, F.S.
11 S. 893.055(3), F.S. Schedule I substances are not included because, by definition, a Schedule I substance has no accepted medical

use and therefore is not prescribed or dispensed.
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The Legislature delegated to the Florida Attorney General the authority to adopt rules rescheduling or
deleting controlled substances from a schedule if reduced control of a substance is in the best interest
of the public. 12 In making this determination, the Attorney General is required to give great weight to the
scheduling of the substance under federal law and consider scientific evidence of a substance’s
medical benefits. 13 The Attorney General also has the authority to schedule or reschedule any
substance which is not already controlled under s. 893.03, F.S., if the substance has the potential for
abuse. 14

Federal Law

The Federal Controlled Substances Act 15 (CSA) also classifies controlled substances into schedules
based on the potential for abuse and whether there is a currently accepted medical use for the
substance. The Drug Enforcement Administration (DEA) is required to consider the following when
determining where to schedule a substance: 16
• The substance’s actual or relative potential for abuse;
• Scientific evidence of the substance’s pharmacological effect, if known;
• The state of current scientific knowledge regarding the substance;
• The substance’s history and current pattern of abuse;
• The scope, duration, and significance of abuse;
• What, if any, risk there is to public health;
• The substance’s psychic or physiological dependence liability; and
• Whether the substance is an immediate precursor of a substance already controlled.

A controlled substance subject to regulation under the CSA is subject to strict distribution and inventory
controls. The CSA requires a controlled substance to be tracked and inventoried from the time it is
manufactured or imported until it is dispensed to a patient. 17 Additionally, the CSA also restricts how
specified controlled substances may be prescribed, requires minimum security precautions for
controlled substances, and requires each person or entity authorized to handle a controlled substance
to register with the DEA. 18

Epidiolex

Epidiolex, which is currently the only prescription pharmaceutical approved by the U.S. Food and Drug
Administration (FDA) containing cannabidiol, a non-psychoactive compound derived from the cannabis
plant, is used to treat seizures associated with Lennox-Gastaut syndrome or Dravet syndrome. 19 Since
Epidiolex is derived from the cannabis plant, it would have been designated a Schedule I controlled
substance under state and federal law. However, on June 25, 2018, the FDA approved Epidiolex for
use in patients two years of age or older. 20 The DEA responded by rescheduling Epidiolex in schedule
V of the federal Controlled Substances Act effective September 27, 2018. 21 Although Epidiolex was still
subject to the requirements under the CSA, the rescheduling allowed doctors to legally prescribe
Epidiolex to patients. In 2018, the Florida Attorney General rescheduled Epidiolex by emergency rule 22
as a Schedule V controlled substance, and in 2019, the Legislature formally rescheduled Epidiolex in
statute as a Schedule V controlled substance. 23

12 S. 893.0355, F.S.
13 Id.
14 S. 893.035, F.S.
15 21 U.S.C. § 812.
16 21 U.S.C. § 811(c).
17 21 U.S.C. §827.
18 21 U.S.C. Part C.
19 Greenwich Biosciences, The Epidiolex Story, https://www.epidiolex.com/about-epidiolex/story (last visited Mar. 20, 2021).
20 U.S. Food and Drug Administration, FDA approves first drug comprised of an active ingredient derived from marijuana to treat rare,

severe forms of epilepsy, https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm611046.htm (last visited Mar. 16,
2021).
21 United State Drug Enforcement Administration, FDA-approved drug Epidiolex placed in schedule V of Controlled Substance Act,

https://www.dea.gov/press-releases/2018/09/27/fda-approved-drug-epidiolex-placed-schedule-v-controlled-substance-act (last visited
Mar. 20, 2021).
22 Office of the Attorney General, Findings of the Attorney General in Support of Emergency Rule 2ER18-1, F.A.C. (Oct. 31, 2018).
23 Ch. 19-166, Laws of Florida.

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On April 6, 2020, the DEA announced it was removing Epidiolex from Schedule V and descheduling it
entirely, meaning Epidiolex is no longer subject to the CSA and its tracking and monitoring
requirements. 24 Epidiolex remains a Schedule V controlled substance under Florida law. 25

Effect of Proposed Changes

HB 1345 amends s. 893.03(1)(c)7., F.S., to exclude from Schedule I any pharmaceutical product
containing cannabis that has been approved by the FDA. The Legislature retains the authority to
schedule a pharmaceutical product through future legislation, including as a Schedule I controlled
substance.

Although there are currently no other FDA approved pharmaceutical products derived from the
cannabis plant besides Epidiolex, the bill would prevent any future pharmaceutical product from being
automatically placed in Schedule I, which includes controlled substances that have no currently
accepted medical use.

The bill is effective upon becoming a law.

B. SECTION DIRECTORY:
Section 1: Amends s. 893.03, F.S., relating to standards and schedules.
Section 2: Provides the bill is effective upon becoming a law.

II. FISCAL ANALYSIS & ECONOMIC IMPACT STATEMENT

A. FISCAL IMPACT ON STATE GOVERNMENT:

1. Revenues:
None.

2. Expenditures:
None.

B. FISCAL IMPACT ON LOCAL GOVERNMENTS:

1. Revenues:
None.

2. Expenditures:
None.

C. DIRECT ECONOMIC IMPACT ON PRIVATE SECTOR:
Preventing an FDA approved pharmaceutical product derived from the cannabis plant from being
automatically included in Schedule I could increase the availability of the product to Florida residents,
and allow doctors and pharmacies to prescribe and dispense such a product without burdensome
regulations and reporting requirements.

24 GW Pharmaceuticals, GW Pharmaceuticals plc and Its U.S. Subsidiary Greenwich Biosciences, Inc. Announce That Epidiolex

(cannabidiol) Oral Solution Has Been Descheduled And Is No Longer A Controlled Substance, April 6, 2020,
https://ir.gwpharm.com/news-releases/news-release-details/gw-pharmaceuticals-plc-and-its-us-subsidiary-greenwich-1 (last visited Mar.
20, 2021)
25 S. 893.03(5)(d), F.S.

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D. FISCAL COMMENTS:
None.

III. COMMENTS

A. CONSTITUTIONAL ISSUES:

1. Applicability of Municipality/County Mandates Provision:
Not applicable.

2. Other:
None.

B. RULE-MAKING AUTHORITY:
Not applicable.

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 1345 2021

1 A bill to be entitled
2 An act relating to pharmaceutical products containing
3 cannabis; amending s. 893.03, F.S.; excluding from
4 Schedule I cannabis if it is contained within a
5 pharmaceutical product approved by the United States
6 Food and Drug Administration; providing an effective
7 date.
8
9 Be It Enacted by the Legislature of the State of Florida:
10
11 Section 1. Paragraph (c) of subsection (1) of section
12 893.03, Florida Statutes, is amended to read:
13 893.03 Standards and schedules.—The substances enumerated
14 in this section are controlled by this chapter. The controlled
15 substances listed or to be listed in Schedules I, II, III, IV,
16 and V are included by whatever official, common, usual,
17 chemical, trade name, or class designated. The provisions of
18 this section shall not be construed to include within any of the
19 schedules contained in this section any excluded drugs listed
20 within the purview of 21 C.F.R. s. 1308.22, styled "Excluded
21 Substances"; 21 C.F.R. s. 1308.24, styled "Exempt Chemical
22 Preparations"; 21 C.F.R. s. 1308.32, styled "Exempted
23 Prescription Products"; or 21 C.F.R. s. 1308.34, styled "Exempt
24 Anabolic Steroid Products."
25 (1) SCHEDULE I.—A substance in Schedule I has a high

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26 potential for abuse and has no currently accepted medical use in
27 treatment in the United States and in its use under medical
28 supervision does not meet accepted safety standards. The
29 following substances are controlled in Schedule I:
30 (c) Unless specifically excepted or unless listed in
31 another schedule, any material, compound, mixture, or
32 preparation that contains any quantity of the following
33 hallucinogenic substances or that contains any of their salts,
34 isomers, including optical, positional, or geometric isomers,
35 homologues, nitrogen-heterocyclic analogs, esters, ethers, and
36 salts of isomers, homologues, nitrogen-heterocyclic analogs,
37 esters, or ethers, if the existence of such salts, isomers, and
38 salts of isomers is possible within the specific chemical
39 designation or class description:
40 1. Alpha-Ethyltryptamine.
41 2. 4-Methylaminorex (2-Amino-4-methyl-5-phenyl-2-
42 oxazoline).
43 3. Aminorex (2-Amino-5-phenyl-2-oxazoline).
44 4. DOB (4-Bromo-2,5-dimethoxyamphetamine).
45 5. 2C-B (4-Bromo-2,5-dimethoxyphenethylamine).
46 6. Bufotenine.
47 7. Cannabis, except if it is contained within a
48 pharmaceutical product approved by the United States Food and
49 Drug Administration.
50 8. Cathinone.

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51 9. DET (Diethyltryptamine).
52 10. 2,5-Dimethoxyamphetamine.
53 11. DOET (4-Ethyl-2,5-Dimethoxyamphetamine).
54 12. DMT (Dimethyltryptamine).
55 13. PCE (N-Ethyl-1-phenylcyclohexylamine) (Ethylamine
56 analog of phencyclidine).
57 14. JB-318 (N-Ethyl-3-piperidyl benzilate).
58 15. N-Ethylamphetamine.
59 16. Fenethylline.
60 17. 3,4-Methylenedioxy-N-hydroxyamphetamine.
61 18. Ibogaine.
62 19. LSD (Lysergic acid diethylamide).
63 20. Mescaline.
64 21. Methcathinone.
65 22. 5-Methoxy-3,4-methylenedioxyamphetamine.
66 23. PMA (4-Methoxyamphetamine).
67 24. PMMA (4-Methoxymethamphetamine).
68 25. DOM (4-Methyl-2,5-dimethoxyamphetamine).
69 26. MDEA (3,4-Methylenedioxy-N-ethylamphetamine).
70 27. MDA (3,4-Methylenedioxyamphetamine).
71 28. JB-336 (N-Methyl-3-piperidyl benzilate).
72 29. N,N-Dimethylamphetamine.
73 30. Parahexyl.
74 31. Peyote.
75 32. PCPY (N-(1-Phenylcyclohexyl)-pyrrolidine) (Pyrrolidine

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76 analog of phencyclidine).
77 33. Psilocybin.
78 34. Psilocyn.
79 35. Salvia divinorum, except for any drug product approved
80 by the United States Food and Drug Administration which contains
81 Salvia divinorum or its isomers, esters, ethers, salts, and
82 salts of isomers, esters, and ethers, if the existence of such
83 isomers, esters, ethers, and salts is possible within the
84 specific chemical designation.
85 36. Salvinorin A, except for any drug product approved by
86 the United States Food and Drug Administration which contains
87 Salvinorin A or its isomers, esters, ethers, salts, and salts of
88 isomers, esters, and ethers, if the existence of such isomers,
89 esters, ethers, and salts is possible within the specific
90 chemical designation.
91 37. Xylazine.
92 38. TCP (1-[1-(2-Thienyl)-cyclohexyl]-piperidine)
93 (Thiophene analog of phencyclidine).
94 39. 3,4,5-Trimethoxyamphetamine.
95 40. Methylone (3,4-Methylenedioxymethcathinone).
96 41. MDPV (3,4-Methylenedioxypyrovalerone).
97 42. Methylmethcathinone.
98 43. Methoxymethcathinone.
99 44. Fluoromethcathinone.
100 45. Methylethcathinone.

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101 46. CP 47,497 (2-(3-Hydroxycyclohexyl)-5-(2-methyloctan-2-
102 yl)phenol) and its dimethyloctyl (C8) homologue.
103 47. HU-210 [(6aR,10aR)-9-(Hydroxymethyl)-6,6-dimethyl-3-
104 (2-methyloctan-2-yl)-6a,7,10,10a-tetrahydrobenzo[c]chromen-1-
105 ol].
106 48. JWH-018 (1-Pentyl-3-(1-naphthoyl)indole).
107 49. JWH-073 (1-Butyl-3-(1-naphthoyl)indole).
108 50. JWH-200 (1-[2-(4-Morpholinyl)ethyl]-3-(1-
109 naphthoyl)indole).
110 51. BZP (Benzylpiperazine).
111 52. Fluorophenylpiperazine.
112 53. Methylphenylpiperazine.
113 54. Chlorophenylpiperazine.
114 55. Methoxyphenylpiperazine.
115 56. DBZP (1,4-Dibenzylpiperazine).
116 57. TFMPP (Trifluoromethylphenylpiperazine).
117 58. MBDB (Methylbenzodioxolylbutanamine) or (3,4-
118 Methylenedioxy-N-methylbutanamine).
119 59. 5-Hydroxy-AMT (5-Hydroxy-alpha-methyltryptamine).
120 60. 5-Hydroxy-N-methyltryptamine.
121 61. 5-MeO-MiPT (5-Methoxy-N-methyl-N-isopropyltryptamine).
122 62. 5-MeO-AMT (5-Methoxy-alpha-methyltryptamine).
123 63. Methyltryptamine.
124 64. 5-MeO-DMT (5-Methoxy-N,N-dimethyltryptamine).
125 65. 5-Me-DMT (5-Methyl-N,N-dimethyltryptamine).

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126 66. Tyramine (4-Hydroxyphenethylamine).
127 67. 5-MeO-DiPT (5-Methoxy-N,N-Diisopropyltryptamine).
128 68. DiPT (N,N-Diisopropyltryptamine).
129 69. DPT (N,N-Dipropyltryptamine).
130 70. 4-Hydroxy-DiPT (4-Hydroxy-N,N-diisopropyltryptamine).
131 71. 5-MeO-DALT (5-Methoxy-N,N-Diallyltryptamine).
132 72. DOI (4-Iodo-2,5-dimethoxyamphetamine).
133 73. DOC (4-Chloro-2,5-dimethoxyamphetamine).
134 74. 2C-E (4-Ethyl-2,5-dimethoxyphenethylamine).
135 75. 2C-T-4 (4-Isopropylthio-2,5-dimethoxyphenethylamine).
136 76. 2C-C (4-Chloro-2,5-dimethoxyphenethylamine).
137 77. 2C-T (4-Methylthio-2,5-dimethoxyphenethylamine).
138 78. 2C-T-2 (4-Ethylthio-2,5-dimethoxyphenethylamine).
139 79. 2C-T-7 (4-(n)-Propylthio-2,5-dimethoxyphenethylamine).
140 80. 2C-I (4-Iodo-2,5-dimethoxyphenethylamine).
141 81. Butylone (3,4-Methylenedioxy-alpha-
142 methylaminobutyrophenone).
143 82. Ethcathinone.
144 83. Ethylone (3,4-Methylenedioxy-N-ethylcathinone).
145 84. Naphyrone (Naphthylpyrovalerone).
146 85. Dimethylone (3,4-Methylenedioxy-N,N-
147 dimethylcathinone).
148 86. 3,4-Methylenedioxy-N,N-diethylcathinone.
149 87. 3,4-Methylenedioxy-propiophenone.
150 88. 3,4-Methylenedioxy-alpha-bromopropiophenone.

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151 89. 3,4-Methylenedioxy-propiophenone-2-oxime.
152 90. 3,4-Methylenedioxy-N-acetylcathinone.
153 91. 3,4-Methylenedioxy-N-acetylmethcathinone.
154 92. 3,4-Methylenedioxy-N-acetylethcathinone.
155 93. Bromomethcathinone.
156 94. Buphedrone (alpha-Methylamino-butyrophenone).
157 95. Eutylone (3,4-Methylenedioxy-alpha-
158 ethylaminobutyrophenone).
159 96. Dimethylcathinone.
160 97. Dimethylmethcathinone.
161 98. Pentylone (3,4-Methylenedioxy-alpha-
162 methylaminovalerophenone).
163 99. MDPPP (3,4-Methylenedioxy-alpha-
164 pyrrolidinopropiophenone).
165 100. MDPBP (3,4-Methylenedioxy-alpha-
166 pyrrolidinobutyrophenone).
167 101. MOPPP (Methoxy-alpha-pyrrolidinopropiophenone).
168 102. MPHP (Methyl-alpha-pyrrolidinohexanophenone).
169 103. BTCP (Benzothiophenylcyclohexylpiperidine) or BCP
170 (Benocyclidine).
171 104. F-MABP (Fluoromethylaminobutyrophenone).
172 105. MeO-PBP (Methoxypyrrolidinobutyrophenone).
173 106. Et-PBP (Ethylpyrrolidinobutyrophenone).
174 107. 3-Me-4-MeO-MCAT (3-Methyl-4-Methoxymethcathinone).
175 108. Me-EABP (Methylethylaminobutyrophenone).

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176 109. Etizolam.
177 110. PPP (Pyrrolidinopropiophenone).
178 111. PBP (Pyrrolidinobutyrophenone).
179 112. PVP (Pyrrolidinovalerophenone) or
180 (Pyrrolidinopentiophenone).
181 113. MPPP (Methyl-alpha-pyrrolidinopropiophenone).
182 114. JWH-007 (1-Pentyl-2-methyl-3-(1-naphthoyl)indole).
183 115. JWH-015 (1-Propyl-2-methyl-3-(1-naphthoyl)indole).
184 116. JWH-019 (1-Hexyl-3-(1-naphthoyl)indole).
185 117. JWH-020 (1-Heptyl-3-(1-naphthoyl)indole).
186 118. JWH-072 (1-Propyl-3-(1-naphthoyl)indole).
187 119. JWH-081 (1-Pentyl-3-(4-methoxy-1-naphthoyl)indole).
188 120. JWH-122 (1-Pentyl-3-(4-methyl-1-naphthoyl)indole).
189 121. JWH-133 ((6aR,10aR)-6,6,9-Trimethyl-3-(2-
190 methylpentan-2-yl)-6a,7,10,10a-tetrahydrobenzo[c]chromene).
191 122. JWH-175 (1-Pentyl-3-(1-naphthylmethyl)indole).
192 123. JWH-201 (1-Pentyl-3-(4-methoxyphenylacetyl)indole).
193 124. JWH-203 (1-Pentyl-3-(2-chlorophenylacetyl)indole).
194 125. JWH-210 (1-Pentyl-3-(4-ethyl-1-naphthoyl)indole).
195 126. JWH-250 (1-Pentyl-3-(2-methoxyphenylacetyl)indole).
196 127. JWH-251 (1-Pentyl-3-(2-methylphenylacetyl)indole).
197 128. JWH-302 (1-Pentyl-3-(3-methoxyphenylacetyl)indole).
198 129. JWH-398 (1-Pentyl-3-(4-chloro-1-naphthoyl)indole).
199 130. HU-211 ((6aS,10aS)-9-(Hydroxymethyl)-6,6-dimethyl-3-
200 (2-methyloctan-2-yl)-6a,7,10,10a-tetrahydrobenzo[c]chromen-1-

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201 ol).
202 131. HU-308 ([(1R,2R,5R)-2-[2,6-Dimethoxy-4-(2-
203 methyloctan-2-yl)phenyl]-7,7-dimethyl-4-bicyclo[3.1.1]hept-3-
204 enyl] methanol).
205 132. HU-331 (3-Hydroxy-2-[(1R,6R)-3-methyl-6-(1-
206 methylethenyl)-2-cyclohexen-1-yl]-5-pentyl-2,5-cyclohexadiene-
207 1,4-dione).
208 133. CB-13 (4-Pentyloxy-1-(1-naphthoyl)naphthalene).
209 134. CB-25 (N-Cyclopropyl-11-(3-hydroxy-5-pentylphenoxy)-
210 undecanamide).
211 135. CB-52 (N-Cyclopropyl-11-(2-hexyl-5-hydroxyphenoxy)-
212 undecanamide).
213 136. CP 55,940 (2-[3-Hydroxy-6-propanol-cyclohexyl]-5-(2-
214 methyloctan-2-yl)phenol).
215 137. AM-694 (1-(5-Fluoropentyl)-3-(2-iodobenzoyl)indole).
216 138. AM-2201 (1-(5-Fluoropentyl)-3-(1-naphthoyl)indole).
217 139. RCS-4 (1-Pentyl-3-(4-methoxybenzoyl)indole).
218 140. RCS-8 (1-(2-Cyclohexylethyl)-3-(2-
219 methoxyphenylacetyl)indole).
220 141. WIN55,212-2 ((R)-(+)-[2,3-Dihydro-5-methyl-3-(4-
221 morpholinylmethyl)pyrrolo[1,2,3-de]-1,4-benzoxazin-6-yl]-1-
222 naphthalenylmethanone).
223 142. WIN55,212-3 ([(3S)-2,3-Dihydro-5-methyl-3-(4-
224 morpholinylmethyl)pyrrolo[1,2,3-de]-1,4-benzoxazin-6-yl]-1-
225 naphthalenylmethanone).

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226 143. Pentedrone (alpha-Methylaminovalerophenone).
227 144. Fluoroamphetamine.
228 145. Fluoromethamphetamine.
229 146. Methoxetamine.
230 147. Methiopropamine.
231 148. Methylbuphedrone (Methyl-alpha-
232 methylaminobutyrophenone).
233 149. APB ((2-Aminopropyl)benzofuran).
234 150. APDB ((2-Aminopropyl)-2,3-dihydrobenzofuran).
235 151. UR-144 (1-Pentyl-3-(2,2,3,3-
236 tetramethylcyclopropanoyl)indole).
237 152. XLR11 (1-(5-Fluoropentyl)-3-(2,2,3,3-
238 tetramethylcyclopropanoyl)indole).
239 153. Chloro UR-144 (1-(Chloropentyl)-3-(2,2,3,3-
240 tetramethylcyclopropanoyl)indole).
241 154. AKB48 (N-Adamant-1-yl 1-pentylindazole-3-
242 carboxamide).
243 155. AM-2233(1-[(N-Methyl-2-piperidinyl)methyl]-3-(2-
244 iodobenzoyl)indole).
245 156. STS-135 (N-Adamant-1-yl 1-(5-fluoropentyl)indole-3-
246 carboxamide).
247 157. URB-597 ((3′-(Aminocarbonyl)[1,1′-biphenyl]-3-yl)-
248 cyclohexylcarbamate).
249 158. URB-602 ([1,1′-Biphenyl]-3-yl-carbamic acid,
250 cyclohexyl ester).

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251 159. URB-754 (6-Methyl-2-[(4-methylphenyl)amino]-1-
252 benzoxazin-4-one).
253 160. 2C-D (4-Methyl-2,5-dimethoxyphenethylamine).
254 161. 2C-H (2,5-Dimethoxyphenethylamine).
255 162. 2C-N (4-Nitro-2,5-dimethoxyphenethylamine).
256 163. 2C-P (4-(n)-Propyl-2,5-dimethoxyphenethylamine).
257 164. 25I-NBOMe (4-Iodo-2,5-dimethoxy-[N-(2-
258 methoxybenzyl)]phenethylamine).
259 165. MDMA (3,4-Methylenedioxymethamphetamine).
260 166. PB-22 (8-Quinolinyl 1-pentylindole-3-carboxylate).
261 167. Fluoro PB-22 (8-Quinolinyl 1-(fluoropentyl)indole-3-
262 carboxylate).
263 168. BB-22 (8-Quinolinyl 1-(cyclohexylmethyl)indole-3-
264 carboxylate).
265 169. Fluoro AKB48 (N-Adamant-1-yl 1-
266 (fluoropentyl)indazole-3-carboxamide).
267 170. AB-PINACA (N-(1-Amino-3-methyl-1-oxobutan-2-yl)-1-
268 pentylindazole-3-carboxamide).
269 171. AB-FUBINACA (N-(1-Amino-3-methyl-1-oxobutan-2-yl)-1-
270 (4-fluorobenzyl)indazole-3-carboxamide).
271 172. ADB-PINACA (N-(1-Amino-3,3-dimethyl-1-oxobutan-2-yl)-
272 1-pentylindazole-3-carboxamide).
273 173. Fluoro ADBICA (N-(1-Amino-3,3-dimethyl-1-oxobutan-2-
274 yl)-1-(fluoropentyl)indole-3-carboxamide).
275 174. 25B-NBOMe (4-Bromo-2,5-dimethoxy-[N-(2-

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276 methoxybenzyl)]phenethylamine).
277 175. 25C-NBOMe (4-Chloro-2,5-dimethoxy-[N-(2-
278 methoxybenzyl)]phenethylamine).
279 176. AB-CHMINACA (N-(1-Amino-3-methyl-1-oxobutan-2-yl)-1-
280 (cyclohexylmethyl)indazole-3-carboxamide).
281 177. FUB-PB-22 (8-Quinolinyl 1-(4-fluorobenzyl)indole-3-
282 carboxylate).
283 178. Fluoro-NNEI (N-Naphthalen-1-yl 1-
284 (fluoropentyl)indole-3-carboxamide).
285 179. Fluoro-AMB (N-(1-Methoxy-3-methyl-1-oxobutan-2-yl)-1-
286 (fluoropentyl)indazole-3-carboxamide).
287 180. THJ-2201 (1-(5-Fluoropentyl)-3-(1-
288 naphthoyl)indazole).
289 181. AM-855 ((4aR,12bR)-8-Hexyl-2,5,5-trimethyl-
290 1,4,4a,8,9,10,11,12b-octahydronaphtho[3,2-c]isochromen-12-ol).
291 182. AM-905 ((6aR,9R,10aR)-3-[(E)-Hept-1-enyl]-9-
292 (hydroxymethyl)-6,6-dimethyl-6a,7,8,9,10,10a-
293 hexahydrobenzo[c]chromen-1-ol).
294 183. AM-906 ((6aR,9R,10aR)-3-[(Z)-Hept-1-enyl]-9-
295 (hydroxymethyl)-6,6-dimethyl-6a,7,8,9,10,10a-
296 hexahydrobenzo[c]chromen-1-ol).
297 184. AM-2389 ((6aR,9R,10aR)-3-(1-Hexyl-cyclobut-1-yl)-
298 6a,7,8,9,10,10a-hexahydro-6,6-dimethyl-6H-dibenzo[b,d]pyran-1,9
299 diol).
300 185. HU-243 ((6aR,8S,9S,10aR)-9-(Hydroxymethyl)-6,6-

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301 dimethyl-3-(2-methyloctan-2-yl)-8,9-ditritio-7,8,10,10a-
302 tetrahydro-6aH-benzo[c]chromen-1-ol).
303 186. HU-336 ((6aR,10aR)-6,6,9-Trimethyl-3-pentyl-
304 6a,7,10,10a-tetrahydro-1H-benzo[c]chromene-1,4(6H)-dione).
305 187. MAPB ((2-Methylaminopropyl)benzofuran).
306 188. 5-IT (2-(1H-Indol-5-yl)-1-methyl-ethylamine).
307 189. 6-IT (2-(1H-Indol-6-yl)-1-methyl-ethylamine).
308 190. Synthetic Cannabinoids.—Unless specifically excepted
309 or unless listed in another schedule or contained within a
310 pharmaceutical product approved by the United States Food and
311 Drug Administration, any material, compound, mixture, or
312 preparation that contains any quantity of a synthetic
313 cannabinoid found to be in any of the following chemical class
314 descriptions, or homologues, nitrogen-heterocyclic analogs,
315 isomers (including optical, positional, or geometric), esters,
316 ethers, salts, and salts of homologues, nitrogen-heterocyclic
317 analogs, isomers, esters, or ethers, whenever the existence of
318 such homologues, nitrogen-heterocyclic analogs, isomers, esters,
319 ethers, salts, and salts of isomers, esters, or ethers is
320 possible within the specific chemical class or designation.
321 Since nomenclature of these synthetically produced cannabinoids
322 is not internationally standardized and may continually evolve,
323 these structures or the compounds of these structures shall be
324 included under this subparagraph, regardless of their specific
325 numerical designation of atomic positions covered, if it can be

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326 determined through a recognized method of scientific testing or
327 analysis that the substance contains properties that fit within
328 one or more of the following categories:
329 a. Tetrahydrocannabinols.—Any tetrahydrocannabinols
330 naturally contained in a plant of the genus Cannabis, the
331 synthetic equivalents of the substances contained in the plant
332 or in the resinous extracts of the genus Cannabis, or synthetic
333 substances, derivatives, and their isomers with similar chemical
334 structure and pharmacological activity, including, but not
335 limited to, Delta 9 tetrahydrocannabinols and their optical
336 isomers, Delta 8 tetrahydrocannabinols and their optical
337 isomers, Delta 6a,10a tetrahydrocannabinols and their optical
338 isomers, or any compound containing a tetrahydrobenzo[c]chromene
339 structure with substitution at either or both the 3-position or
340 9-position, with or without substitution at the 1-position with
341 hydroxyl or alkoxy groups, including, but not limited to:
342 (I) Tetrahydrocannabinol.
343 (II) HU-210 ((6aR,10aR)-9-(Hydroxymethyl)-6,6-dimethyl-3-
344 (2-methyloctan-2-yl)-6a,7,10,10a-tetrahydrobenzo[c]chromen-1-
345 ol).
346 (III) HU-211 ((6aS,10aS)-9-(Hydroxymethyl)-6,6-dimethyl-3-
347 (2-methyloctan-2-yl)-6a,7,10,10a-tetrahydrobenzo[c]chromen-1-
348 ol).
349 (IV) JWH-051 ((6aR,10aR)-9-(Hydroxymethyl)-6,6-dimethyl-3-
350 (2-methyloctan-2-yl)-6a,7,10,10a-tetrahydrobenzo[c]chromene).

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351 (V) JWH-133 ((6aR,10aR)-6,6,9-Trimethyl-3-(2-methylpentan-
352 2-yl)-6a,7,10,10a-tetrahydrobenzo[c]chromene).
353 (VI) JWH-057 ((6aR,10aR)-6,6,9-Trimethyl-3-(2-methyloctan-
354 2-yl)-6a,7,10,10a-tetrahydrobenzo[c]chromene).
355 (VII) JWH-359 ((6aR,10aR)-1-Methoxy-6,6,9-trimethyl-3-
356 (2,3-dimethylpentan-2-yl)-6a,7,10,10a-
357 tetrahydrobenzo[c]chromene).
358 (VIII) AM-087 ((6aR,10aR)-3-(2-Methyl-6-bromohex-2-yl)-
359 6,6,9-trimethyl-6a,7,10,10a-tetrahydrobenzo[c]chromen-1-ol).
360 (IX) AM-411 ((6aR,10aR)-3-(1-Adamantyl)-6,6,9-trimethyl-
361 6a,7,10,10a-tetrahydrobenzo[c]chromen-1-ol).
362 (X) Parahexyl.
363 b. Naphthoylindoles, Naphthoylindazoles,
364 Naphthoylcarbazoles, Naphthylmethylindoles,
365 Naphthylmethylindazoles, and Naphthylmethylcarbazoles.—Any
366 compound containing a naphthoylindole, naphthoylindazole,
367 naphthoylcarbazole, naphthylmethylindole,
368 naphthylmethylindazole, or naphthylmethylcarbazole structure,
369 with or without substitution on the indole, indazole, or
370 carbazole ring to any extent, whether or not substituted on the
371 naphthyl ring to any extent, including, but not limited to:
372 (I) JWH-007 (1-Pentyl-2-methyl-3-(1-naphthoyl)indole).
373 (II) JWH-011 (1-(1-Methylhexyl)-2-methyl-3-(1-
374 naphthoyl)indole).
375 (III) JWH-015 (1-Propyl-2-methyl-3-(1-naphthoyl)indole).

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376 (IV) JWH-016 (1-Butyl-2-methyl-3-(1-naphthoyl)indole).
377 (V) JWH-018 (1-Pentyl-3-(1-naphthoyl)indole).
378 (VI) JWH-019 (1-Hexyl-3-(1-naphthoyl)indole).
379 (VII) JWH-020 (1-Heptyl-3-(1-naphthoyl)indole).
380 (VIII) JWH-022 (1-(4-Pentenyl)-3-(1-naphthoyl)indole).
381 (IX) JWH-071 (1-Ethyl-3-(1-naphthoyl)indole).
382 (X) JWH-072 (1-Propyl-3-(1-naphthoyl)indole).
383 (XI) JWH-073 (1-Butyl-3-(1-naphthoyl)indole).
384 (XII) JWH-080 (1-Butyl-3-(4-methoxy-1-naphthoyl)indole).
385 (XIII) JWH-081 (1-Pentyl-3-(4-methoxy-1-naphthoyl)indole).
386 (XIV) JWH-098 (1-Pentyl-2-methyl-3-(4-methoxy-1-
387 naphthoyl)indole).
388 (XV) JWH-116 (1-Pentyl-2-ethyl-3-(1-naphthoyl)indole).
389 (XVI) JWH-122 (1-Pentyl-3-(4-methyl-1-naphthoyl)indole).
390 (XVII) JWH-149 (1-Pentyl-2-methyl-3-(4-methyl-1-
391 naphthoyl)indole).
392 (XVIII) JWH-164 (1-Pentyl-3-(7-methoxy-1-
393 naphthoyl)indole).
394 (XIX) JWH-175 (1-Pentyl-3-(1-naphthylmethyl)indole).
395 (XX) JWH-180 (1-Propyl-3-(4-propyl-1-naphthoyl)indole).
396 (XXI) JWH-182 (1-Pentyl-3-(4-propyl-1-naphthoyl)indole).
397 (XXII) JWH-184 (1-Pentyl-3-[(4-methyl)-1-
398 naphthylmethyl]indole).
399 (XXIII) JWH-193 (1-[2-(4-Morpholinyl)ethyl]-3-(4-methyl-1-
400 naphthoyl)indole).

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401 (XXIV) JWH-198 (1-[2-(4-Morpholinyl)ethyl]-3-(4-methoxy-1-
402 naphthoyl)indole).
403 (XXV) JWH-200 (1-[2-(4-Morpholinyl)ethyl]-3-(1-
404 naphthoyl)indole).
405 (XXVI) JWH-210 (1-Pentyl-3-(4-ethyl-1-naphthoyl)indole).
406 (XXVII) JWH-387 (1-Pentyl-3-(4-bromo-1-naphthoyl)indole).
407 (XXVIII) JWH-398 (1-Pentyl-3-(4-chloro-1-
408 naphthoyl)indole).
409 (XXIX) JWH-412 (1-Pentyl-3-(4-fluoro-1-naphthoyl)indole).
410 (XXX) JWH-424 (1-Pentyl-3-(8-bromo-1-naphthoyl)indole).
411 (XXXI) AM-1220 (1-[(1-Methyl-2-piperidinyl)methyl]-3-(1-
412 naphthoyl)indole).
413 (XXXII) AM-1235 (1-(5-Fluoropentyl)-6-nitro-3-(1-
414 naphthoyl)indole).
415 (XXXIII) AM-2201 (1-(5-Fluoropentyl)-3-(1-
416 naphthoyl)indole).
417 (XXXIV) Chloro JWH-018 (1-(Chloropentyl)-3-(1-
418 naphthoyl)indole).
419 (XXXV) Bromo JWH-018 (1-(Bromopentyl)-3-(1-
420 naphthoyl)indole).
421 (XXXVI) AM-2232 (1-(4-Cyanobutyl)-3-(1-naphthoyl)indole).
422 (XXXVII) THJ-2201 (1-(5-Fluoropentyl)-3-(1-
423 naphthoyl)indazole).
424 (XXXVIII) MAM-2201 (1-(5-Fluoropentyl)-3-(4-methyl-1-
425 naphthoyl)indole).

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426 (XXXIX) EAM-2201 (1-(5-Fluoropentyl)-3-(4-ethyl-1-
427 naphthoyl)indole).
428 (XL) EG-018 (9-Pentyl-3-(1-naphthoyl)carbazole).
429 (XLI) EG-2201 (9-(5-Fluoropentyl)-3-(1-
430 naphthoyl)carbazole).
431 c. Naphthoylpyrroles.—Any compound containing a
432 naphthoylpyrrole structure, with or without substitution on the
433 pyrrole ring to any extent, whether or not substituted on the
434 naphthyl ring to any extent, including, but not limited to:
435 (I) JWH-030 (1-Pentyl-3-(1-naphthoyl)pyrrole).
436 (II) JWH-031 (1-Hexyl-3-(1-naphthoyl)pyrrole).
437 (III) JWH-145 (1-Pentyl-5-phenyl-3-(1-naphthoyl)pyrrole).
438 (IV) JWH-146 (1-Heptyl-5-phenyl-3-(1-naphthoyl)pyrrole).
439 (V) JWH-147 (1-Hexyl-5-phenyl-3-(1-naphthoyl)pyrrole).
440 (VI) JWH-307 (1-Pentyl-5-(2-fluorophenyl)-3-(1-
441 naphthoyl)pyrrole).
442 (VII) JWH-309 (1-Pentyl-5-(1-naphthalenyl)-3-(1-
443 naphthoyl)pyrrole).
444 (VIII) JWH-368 (1-Pentyl-5-(3-fluorophenyl)-3-(1-
445 naphthoyl)pyrrole).
446 (IX) JWH-369 (1-Pentyl-5-(2-chlorophenyl)-3-(1-
447 naphthoyl)pyrrole).
448 (X) JWH-370 (1-Pentyl-5-(2-methylphenyl)-3-(1-
449 naphthoyl)pyrrole).
450 d. Naphthylmethylenindenes.—Any compound containing a

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451 naphthylmethylenindene structure, with or without substitution
452 at the 3-position of the indene ring to any extent, whether or
453 not substituted on the naphthyl ring to any extent, including,
454 but not limited to, JWH-176 (3-Pentyl-1-
455 (naphthylmethylene)indene).
456 e. Phenylacetylindoles and Phenylacetylindazoles.—Any
457 compound containing a phenylacetylindole or phenylacetylindazole
458 structure, with or without substitution on the indole or
459 indazole ring to any extent, whether or not substituted on the
460 phenyl ring to any extent, including, but not limited to:
461 (I) JWH-167 (1-Pentyl-3-(phenylacetyl)indole).
462 (II) JWH-201 (1-Pentyl-3-(4-methoxyphenylacetyl)indole).
463 (III) JWH-203 (1-Pentyl-3-(2-chlorophenylacetyl)indole).
464 (IV) JWH-250 (1-Pentyl-3-(2-methoxyphenylacetyl)indole).
465 (V) JWH-251 (1-Pentyl-3-(2-methylphenylacetyl)indole).
466 (VI) JWH-302 (1-Pentyl-3-(3-methoxyphenylacetyl)indole).
467 (VII) Cannabipiperidiethanone.
468 (VIII) RCS-8 (1-(2-Cyclohexylethyl)-3-(2-
469 methoxyphenylacetyl)indole).
470 f. Cyclohexylphenols.—Any compound containing a
471 cyclohexylphenol structure, with or without substitution at the
472 5-position of the phenolic ring to any extent, whether or not
473 substituted on the cyclohexyl ring to any extent, including, but
474 not limited to:
475 (I) CP 47,497 (2-(3-Hydroxycyclohexyl)-5-(2-methyloctan-2-

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476 yl)phenol).
477 (II) Cannabicyclohexanol (CP 47,497 dimethyloctyl (C8)
478 homologue).
479 (III) CP-55,940 (2-(3-Hydroxy-6-propanol-cyclohexyl)-5-(2-
480 methyloctan-2-yl)phenol).
481 g. Benzoylindoles and Benzoylindazoles.—Any compound
482 containing a benzoylindole or benzoylindazole structure, with or
483 without substitution on the indole or indazole ring to any
484 extent, whether or not substituted on the phenyl ring to any
485 extent, including, but not limited to:
486 (I) AM-679 (1-Pentyl-3-(2-iodobenzoyl)indole).
487 (II) AM-694 (1-(5-Fluoropentyl)-3-(2-iodobenzoyl)indole).
488 (III) AM-1241 (1-[(N-Methyl-2-piperidinyl)methyl]-3-(2-
489 iodo-5-nitrobenzoyl)indole).
490 (IV) Pravadoline (1-[2-(4-Morpholinyl)ethyl]-2-methyl-3-
491 (4-methoxybenzoyl)indole).
492 (V) AM-2233 (1-[(N-Methyl-2-piperidinyl)methyl]-3-(2-
493 iodobenzoyl)indole).
494 (VI) RCS-4 (1-Pentyl-3-(4-methoxybenzoyl)indole).
495 (VII) RCS-4 C4 homologue (1-Butyl-3-(4-
496 methoxybenzoyl)indole).
497 (VIII) AM-630 (1-[2-(4-Morpholinyl)ethyl]-2-methyl-6-iodo-
498 3-(4-methoxybenzoyl)indole).
499 h. Tetramethylcyclopropanoylindoles and
500 Tetramethylcyclopropanoylindazoles.—Any compound containing a

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501 tetramethylcyclopropanoylindole or
502 tetramethylcyclopropanoylindazole structure, with or without
503 substitution on the indole or indazole ring to any extent,
504 whether or not substituted on the tetramethylcyclopropyl group
505 to any extent, including, but not limited to:
506 (I) UR-144 (1-Pentyl-3-(2,2,3,3-
507 tetramethylcyclopropanoyl)indole).
508 (II) XLR11 (1-(5-Fluoropentyl)-3-(2,2,3,3-
509 tetramethylcyclopropanoyl)indole).
510 (III) Chloro UR-144 (1-(Chloropentyl)-3-(2,2,3,3-
511 tetramethylcyclopropanoyl)indole).
512 (IV) A-796,260 (1-[2-(4-Morpholinyl)ethyl]-3-(2,2,3,3-
513 tetramethylcyclopropanoyl)indole).
514 (V) A-834,735 (1-[4-(Tetrahydropyranyl)methyl]-3-(2,2,3,3-
515 tetramethylcyclopropanoyl)indole).
516 (VI) M-144 (1-(5-Fluoropentyl)-2-methyl-3-(2,2,3,3-
517 tetramethylcyclopropanoyl)indole).
518 (VII) FUB-144 (1-(4-Fluorobenzyl)-3-(2,2,3,3-
519 tetramethylcyclopropanoyl)indole).
520 (VIII) FAB-144 (1-(5-Fluoropentyl)-3-(2,2,3,3-
521 tetramethylcyclopropanoyl)indazole).
522 (IX) XLR12 (1-(4,4,4-Trifluorobutyl)-3-(2,2,3,3-
523 tetramethylcyclopropanoyl)indole).
524 (X) AB-005 (1-[(1-Methyl-2-piperidinyl)methyl]-3-(2,2,3,3-
525 tetramethylcyclopropanoyl)indole).

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526 i. Adamantoylindoles, Adamantoylindazoles, Adamantylindole
527 carboxamides, and Adamantylindazole carboxamides.—Any compound
528 containing an adamantoyl indole, adamantoyl indazole, adamantyl
529 indole carboxamide, or adamantyl indazole carboxamide structure,
530 with or without substitution on the indole or indazole ring to
531 any extent, whether or not substituted on the adamantyl ring to
532 any extent, including, but not limited to:
533 (I) AKB48 (N-Adamant-1-yl 1-pentylindazole-3-carboxamide).
534 (II) Fluoro AKB48 (N-Adamant-1-yl 1-
535 (fluoropentyl)indazole-3-carboxamide).
536 (III) STS-135 (N-Adamant-1-yl 1-(5-fluoropentyl)indole-3-
537 carboxamide).
538 (IV) AM-1248 (1-(1-Methylpiperidine)methyl-3-(1-
539 adamantoyl)indole).
540 (V) AB-001 (1-Pentyl-3-(1-adamantoyl)indole).
541 (VI) APICA (N-Adamant-1-yl 1-pentylindole-3-carboxamide).
542 (VII) Fluoro AB-001 (1-(Fluoropentyl)-3-(1-
543 adamantoyl)indole).
544 j. Quinolinylindolecarboxylates,
545 Quinolinylindazolecarboxylates, Quinolinylindolecarboxamides,
546 and Quinolinylindazolecarboxamides.—Any compound containing a
547 quinolinylindole carboxylate, quinolinylindazole carboxylate,
548 isoquinolinylindole carboxylate, isoquinolinylindazole
549 carboxylate, quinolinylindole carboxamide, quinolinylindazole
550 carboxamide, isoquinolinylindole carboxamide, or

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551 isoquinolinylindazole carboxamide structure, with or without
552 substitution on the indole or indazole ring to any extent,
553 whether or not substituted on the quinoline or isoquinoline ring
554 to any extent, including, but not limited to:
555 (I) PB-22 (8-Quinolinyl 1-pentylindole-3-carboxylate).
556 (II) Fluoro PB-22 (8-Quinolinyl 1-(fluoropentyl)indole-3-
557 carboxylate).
558 (III) BB-22 (8-Quinolinyl 1-(cyclohexylmethyl)indole-3-
559 carboxylate).
560 (IV) FUB-PB-22 (8-Quinolinyl 1-(4-fluorobenzyl)indole-3-
561 carboxylate).
562 (V) NPB-22 (8-Quinolinyl 1-pentylindazole-3-carboxylate).
563 (VI) Fluoro NPB-22 (8-Quinolinyl 1-(fluoropentyl)indazole-
564 3-carboxylate).
565 (VII) FUB-NPB-22 (8-Quinolinyl 1-(4-fluorobenzyl)indazole-
566 3-carboxylate).
567 (VIII) THJ (8-Quinolinyl 1-pentylindazole-3-carboxamide).
568 (IX) Fluoro THJ (8-Quinolinyl 1-(fluoropentyl)indazole-3-
569 carboxamide).
570 k. Naphthylindolecarboxylates and
571 Naphthylindazolecarboxylates.—Any compound containing a
572 naphthylindole carboxylate or naphthylindazole carboxylate
573 structure, with or without substitution on the indole or
574 indazole ring to any extent, whether or not substituted on the
575 naphthyl ring to any extent, including, but not limited to:

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576 (I) NM-2201 (1-Naphthalenyl 1-(5-fluoropentyl)indole-3-
577 carboxylate).
578 (II) SDB-005 (1-Naphthalenyl 1-pentylindazole-3-
579 carboxylate).
580 (III) Fluoro SDB-005 (1-Naphthalenyl 1-
581 (fluoropentyl)indazole-3-carboxylate).
582 (IV) FDU-PB-22 (1-Naphthalenyl 1-(4-fluorobenzyl)indole-3-
583 carboxylate).
584 (V) 3-CAF (2-Naphthalenyl 1-(2-fluorophenyl)indazole-3-
585 carboxylate).
586 l. Naphthylindole carboxamides and Naphthylindazole
587 carboxamides.—Any compound containing a naphthylindole
588 carboxamide or naphthylindazole carboxamide structure, with or
589 without substitution on the indole or indazole ring to any
590 extent, whether or not substituted on the naphthyl ring to any
591 extent, including, but not limited to:
592 (I) NNEI (N-Naphthalen-1-yl 1-pentylindole-3-carboxamide).
593 (II) Fluoro-NNEI (N-Naphthalen-1-yl 1-
594 (fluoropentyl)indole-3-carboxamide).
595 (III) Chloro-NNEI (N-Naphthalen-1-yl 1-
596 (chloropentyl)indole-3-carboxamide).
597 (IV) MN-18 (N-Naphthalen-1-yl 1-pentylindazole-3-
598 carboxamide).
599 (V) Fluoro MN-18 (N-Naphthalen-1-yl 1-
600 (fluoropentyl)indazole-3-carboxamide).

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601 m. Alkylcarbonyl indole carboxamides, Alkylcarbonyl
602 indazole carboxamides, Alkylcarbonyl indole carboxylates, and
603 Alkylcarbonyl indazole carboxylates.—Any compound containing an
604 alkylcarbonyl group, including 1-amino-3-methyl-1-oxobutan-2-yl,
605 1-methoxy-3-methyl-1-oxobutan-2-yl, 1-amino-1-oxo-3-
606 phenylpropan-2-yl, 1-methoxy-1-oxo-3-phenylpropan-2-yl, with an
607 indole carboxamide, indazole carboxamide, indole carboxylate, or
608 indazole carboxylate, with or without substitution on the indole
609 or indazole ring to any extent, whether or not substituted on
610 the alkylcarbonyl group to any extent, including, but not
611 limited to:
612 (I) ADBICA, (N-(1-Amino-3,3-dimethyl-1-oxobutan-2-yl)-1-
613 pentylindole-3-carboxamide).
614 (II) Fluoro ADBICA (N-(1-Amino-3,3-dimethyl-1-oxobutan-2-
615 yl)-1-(fluoropentyl)indole-3-carboxamide).
616 (III) Fluoro ABICA (N-(1-Amino-3-methyl-1-oxobutan-2-yl)-
617 1-(fluoropentyl)indole-3-carboxamide).
618 (IV) AB-PINACA (N-(1-Amino-3-methyl-1-oxobutan-2-yl)-1-
619 pentylindazole-3-carboxamide).
620 (V) Fluoro AB-PINACA (N-(1-Amino-3-methyl-1-oxobutan-2-
621 yl)-1-(fluoropentyl)indazole-3-carboxamide).
622 (VI) ADB-PINACA (N-(1-Amino-3,3-dimethyl-1-oxobutan-2-yl)-
623 1-pentylindazole-3-carboxamide).
624 (VII) Fluoro ADB-PINACA (N-(1-Amino-3,3-dimethyl-1-
625 oxobutan-2-yl)-1-(fluoropentyl)indazole-3-carboxamide).

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626 (VIII) AB-FUBINACA (N-(1-Amino-3-methyl-1-oxobutan-2-yl)-
627 1-(4-fluorobenzyl)indazole-3-carboxamide).
628 (IX) ADB-FUBINACA (N-(1-Amino-3,3-dimethyl-1-oxobutan-2-
629 yl)-1-(4-fluorobenzyl)indazole-3-carboxamide).
630 (X) AB-CHMINACA (N-(1-Amino-3-methyl-1-oxobutan-2-yl)-1-
631 (cyclohexylmethyl)indazole-3-carboxamide).
632 (XI) MA-CHMINACA (N-(1-Methoxy-3-methyl-1-oxobutan-2-yl)-
633 1-(cyclohexylmethyl)indazole-3-carboxamide).
634 (XII) MAB-CHMINACA (N-(1-Amino-3,3-dimethyl-1-oxobutan-2-
635 yl)-1-(cyclohexylmethyl)indazole-3-carboxamide).
636 (XIII) AMB (N-(1-Methoxy-3-methyl-1-oxobutan-2-yl)-1-
637 pentylindazole-3-carboxamide).
638 (XIV) Fluoro-AMB (N-(1-Methoxy-3-methyl-1-oxobutan-2-yl)-
639 1-(fluoropentyl)indazole-3-carboxamide).
640 (XV) FUB-AMB (N-(1-Methoxy-3-methyl-1-oxobutan-2-yl)-1-(4-
641 fluorobenzyl)indazole-3-carboxamide).
642 (XVI) MDMB-CHMINACA (N-(1-Methoxy-3,3-dimethyl-1-oxobutan-
643 2-yl)-1-(cyclohexylmethyl)indazole-3-carboxamide).
644 (XVII) MDMB-FUBINACA (N-(1-Methoxy-3,3-dimethyl-1-
645 oxobutan-2-yl)-1-(4-fluorobenzyl)indazole-3-carboxamide).
646 (XVIII) MDMB-CHMICA (N-(1-Methoxy-3,3-dimethyl-1-oxobutan-
647 2-yl)-1-(cyclohexylmethyl)indole-3-carboxamide).
648 (XIX) PX-1 (N-(1-Amino-1-oxo-3-phenylpropan-2-yl)-1-(5-
649 fluoropentyl)indole-3-carboxamide).
650 (XX) PX-2 (N-(1-Amino-1-oxo-3-phenylpropan-2-yl)-1-(5-

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651 fluoropentyl)indazole-3-carboxamide).
652 (XXI) PX-3 (N-(1-Amino-1-oxo-3-phenylpropan-2-yl)-1-
653 (cyclohexylmethyl)indazole-3-carboxamide).
654 (XXII) PX-4 (N-(1-Amino-1-oxo-3-phenylpropan-2-yl)-1-(4-
655 fluorobenzyl)indazole-3-carboxamide).
656 (XXIII) MO-CHMINACA (N-(1-Methoxy-3,3-dimethyl-1-oxobutan-
657 2-yl)-1-(cyclohexylmethyl)indazole-3-carboxylate).
658 n. Cumylindolecarboxamides and Cumylindazolecarboxamides.—
659 Any compound containing a N-(2-phenylpropan-2-yl) indole
660 carboxamide or N-(2-phenylpropan-2-yl) indazole carboxamide
661 structure, with or without substitution on the indole or
662 indazole ring to any extent, whether or not substituted on the
663 phenyl ring of the cumyl group to any extent, including, but not
664 limited to:
665 (I) CUMYL-PICA (N-(2-Phenylpropan-2-yl)-1-pentylindole-3-
666 carboxamide).
667 (II) Fluoro CUMYL-PICA (N-(2-Phenylpropan-2-yl)-1-
668 (fluoropentyl)indole-3-carboxamide).
669 o. Other Synthetic Cannabinoids.—Any material, compound,
670 mixture, or preparation that contains any quantity of a
671 Synthetic Cannabinoid, as described in sub-subparagraphs a.-n.:
672 (I) With or without modification or replacement of a
673 carbonyl, carboxamide, alkylene, alkyl, or carboxylate linkage
674 between either two core rings, or linkage between a core ring
675 and group structure, with or without the addition of a carbon or

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676 replacement of a carbon;
677 (II) With or without replacement of a core ring or group
678 structure, whether or not substituted on the ring or group
679 structures to any extent; and
680 (III) Is a cannabinoid receptor agonist, unless
681 specifically excepted or unless listed in another schedule or
682 contained within a pharmaceutical product approved by the United
683 States Food and Drug Administration.
684 191. Substituted Cathinones.—Unless specifically excepted,
685 listed in another schedule, or contained within a pharmaceutical
686 product approved by the United States Food and Drug
687 Administration, any material, compound, mixture, or preparation,
688 including its salts, isomers, esters, or ethers, and salts of
689 isomers, esters, or ethers, whenever the existence of such salts
690 is possible within any of the following specific chemical
691 designations:
692 a. Any compound containing a 2-amino-1-phenyl-1-propanone
693 structure;
694 b. Any compound containing a 2-amino-1-naphthyl-1-
695 propanone structure; or
696 c. Any compound containing a 2-amino-1-thiophenyl-1-
697 propanone structure,
698
699 whether or not the compound is further modified:
700 (I) With or without substitution on the ring system to any

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701 extent with alkyl, alkylthio, thio, fused alkylenedioxy, alkoxy,
702 haloalkyl, hydroxyl, nitro, fused furan, fused benzofuran, fused
703 dihydrofuran, fused tetrahydropyran, fused alkyl ring, or halide
704 substituents;
705 (II) With or without substitution at the 3-propanone
706 position with an alkyl substituent or removal of the methyl
707 group at the 3-propanone position;
708 (III) With or without substitution at the 2-amino nitrogen
709 atom with alkyl, dialkyl, acetyl, or benzyl groups, whether or
710 not further substituted in the ring system; or
711 (IV) With or without inclusion of the 2-amino nitrogen
712 atom in a cyclic structure, including, but not limited to:
713 (A) Methcathinone.
714 (B) Ethcathinone.
715 (C) Methylone (3,4-Methylenedioxymethcathinone).
716 (D) 2,3-Methylenedioxymethcathinone.
717 (E) MDPV (3,4-Methylenedioxypyrovalerone).
718 (F) Methylmethcathinone.
719 (G) Methoxymethcathinone.
720 (H) Fluoromethcathinone.
721 (I) Methylethcathinone.
722 (J) Butylone (3,4-Methylenedioxy-alpha-
723 methylaminobutyrophenone).
724 (K) Ethylone (3,4-Methylenedioxy-N-ethylcathinone).
725 (L) BMDP (3,4-Methylenedioxy-N-benzylcathinone).

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726 (M) Naphyrone (Naphthylpyrovalerone).
727 (N) Bromomethcathinone.
728 (O) Buphedrone (alpha-Methylaminobutyrophenone).
729 (P) Eutylone (3,4-Methylenedioxy-alpha-
730 ethylaminobutyrophenone).
731 (Q) Dimethylcathinone.
732 (R) Dimethylmethcathinone.
733 (S) Pentylone (3,4-Methylenedioxy-alpha-
734 methylaminovalerophenone).
735 (T) Pentedrone (alpha-Methylaminovalerophenone).
736 (U) MDPPP (3,4-Methylenedioxy-alpha-
737 pyrrolidinopropiophenone).
738 (V) MDPBP (3,4-Methylenedioxy-alpha-
739 pyrrolidinobutyrophenone).
740 (W) MPPP (Methyl-alpha-pyrrolidinopropiophenone).
741 (X) PPP (Pyrrolidinopropiophenone).
742 (Y) PVP (Pyrrolidinovalerophenone) or
743 (Pyrrolidinopentiophenone).
744 (Z) MOPPP (Methoxy-alpha-pyrrolidinopropiophenone).
745 (AA) MPHP (Methyl-alpha-pyrrolidinohexanophenone).
746 (BB) F-MABP (Fluoromethylaminobutyrophenone).
747 (CC) Me-EABP (Methylethylaminobutyrophenone).
748 (DD) PBP (Pyrrolidinobutyrophenone).
749 (EE) MeO-PBP (Methoxypyrrolidinobutyrophenone).
750 (FF) Et-PBP (Ethylpyrrolidinobutyrophenone).

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751 (GG) 3-Me-4-MeO-MCAT (3-Methyl-4-Methoxymethcathinone).
752 (HH) Dimethylone (3,4-Methylenedioxy-N,N-
753 dimethylcathinone).
754 (II) 3,4-Methylenedioxy-N,N-diethylcathinone.
755 (JJ) 3,4-Methylenedioxy-N-acetylcathinone.
756 (KK) 3,4-Methylenedioxy-N-acetylmethcathinone.
757 (LL) 3,4-Methylenedioxy-N-acetylethcathinone.
758 (MM) Methylbuphedrone (Methyl-alpha-
759 methylaminobutyrophenone).
760 (NN) Methyl-alpha-methylaminohexanophenone.
761 (OO) N-Ethyl-N-methylcathinone.
762 (PP) PHP (Pyrrolidinohexanophenone).
763 (QQ) PV8 (Pyrrolidinoheptanophenone).
764 (RR) Chloromethcathinone.
765 (SS) 4-Bromo-2,5-dimethoxy-alpha-aminoacetophenone.
766 192. Substituted Phenethylamines.—Unless specifically
767 excepted or unless listed in another schedule, or contained
768 within a pharmaceutical product approved by the United States
769 Food and Drug Administration, any material, compound, mixture,
770 or preparation, including its salts, isomers, esters, or ethers,
771 and salts of isomers, esters, or ethers, whenever the existence
772 of such salts is possible within any of the following specific
773 chemical designations, any compound containing a phenethylamine
774 structure, without a beta-keto group, and without a benzyl group
775 attached to the amine group, whether or not the compound is

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776 further modified with or without substitution on the phenyl ring
777 to any extent with alkyl, alkylthio, nitro, alkoxy, thio,
778 halide, fused alkylenedioxy, fused furan, fused benzofuran,
779 fused dihydrofuran, or fused tetrahydropyran substituents,
780 whether or not further substituted on a ring to any extent, with
781 or without substitution at the alpha or beta position by any
782 alkyl substituent, with or without substitution at the nitrogen
783 atom, and with or without inclusion of the 2-amino nitrogen atom
784 in a cyclic structure, including, but not limited to:
785 a. 2C-B (4-Bromo-2,5-dimethoxyphenethylamine).
786 b. 2C-E (4-Ethyl-2,5-dimethoxyphenethylamine).
787 c. 2C-T-4 (4-Isopropylthio-2,5-dimethoxyphenethylamine).
788 d. 2C-C (4-Chloro-2,5-dimethoxyphenethylamine).
789 e. 2C-T (4-Methylthio-2,5-dimethoxyphenethylamine).
790 f. 2C-T-2 (4-Ethylthio-2,5-dimethoxyphenethylamine).
791 g. 2C-T-7 (4-(n)-Propylthio-2,5-dimethoxyphenethylamine).
792 h. 2C-I (4-Iodo-2,5-dimethoxyphenethylamine).
793 i. 2C-D (4-Methyl-2,5-dimethoxyphenethylamine).
794 j. 2C-H (2,5-Dimethoxyphenethylamine).
795 k. 2C-N (4-Nitro-2,5-dimethoxyphenethylamine).
796 l. 2C-P (4-(n)-Propyl-2,5-dimethoxyphenethylamine).
797 m. MDMA (3,4-Methylenedioxymethamphetamine).
798 n. MBDB (Methylbenzodioxolylbutanamine) or (3,4-
799 Methylenedioxy-N-methylbutanamine).
800 o. MDA (3,4-Methylenedioxyamphetamine).

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801 p. 2,5-Dimethoxyamphetamine.
802 q. Fluoroamphetamine.
803 r. Fluoromethamphetamine.
804 s. MDEA (3,4-Methylenedioxy-N-ethylamphetamine).
805 t. DOB (4-Bromo-2,5-dimethoxyamphetamine).
806 u. DOC (4-Chloro-2,5-dimethoxyamphetamine).
807 v. DOET (4-Ethyl-2,5-dimethoxyamphetamine).
808 w. DOI (4-Iodo-2,5-dimethoxyamphetamine).
809 x. DOM (4-Methyl-2,5-dimethoxyamphetamine).
810 y. PMA (4-Methoxyamphetamine).
811 z. N-Ethylamphetamine.
812 aa. 3,4-Methylenedioxy-N-hydroxyamphetamine.
813 bb. 5-Methoxy-3,4-methylenedioxyamphetamine.
814 cc. PMMA (4-Methoxymethamphetamine).
815 dd. N,N-Dimethylamphetamine.
816 ee. 3,4,5-Trimethoxyamphetamine.
817 ff. 4-APB (4-(2-Aminopropyl)benzofuran).
818 gg. 5-APB (5-(2-Aminopropyl)benzofuran).
819 hh. 6-APB (6-(2-Aminopropyl)benzofuran).
820 ii. 7-APB (7-(2-Aminopropyl)benzofuran).
821 jj. 4-APDB (4-(2-Aminopropyl)-2,3-dihydrobenzofuran).
822 kk. 5-APDB (5-(2-Aminopropyl)-2,3-dihydrobenzofuran).
823 ll. 6-APDB (6-(2-Aminopropyl)-2,3-dihydrobenzofuran).
824 mm. 7-APDB (7-(2-Aminopropyl)-2,3-dihydrobenzofuran).
825 nn. 4-MAPB (4-(2-Methylaminopropyl)benzofuran).

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826 oo. 5-MAPB (5-(2-Methylaminopropyl)benzofuran).
827 pp. 6-MAPB (6-(2-Methylaminopropyl)benzofuran).
828 qq. 7-MAPB (7-(2-Methylaminopropyl)benzofuran).
829 rr. 5-EAPB (5-(2-Ethylaminopropyl)benzofuran).
830 ss. 5-MAPDB (5-(2-Methylaminopropyl)-2,3-
831 dihydrobenzofuran),
832
833 which does not include phenethylamine, mescaline as described in
834 subparagraph 20., substituted cathinones as described in
835 subparagraph 191., N-Benzyl phenethylamine compounds as
836 described in subparagraph 193., or methamphetamine as described
837 in subparagraph (2)(c)5.
838 193. N-Benzyl Phenethylamine Compounds.—Unless
839 specifically excepted or unless listed in another schedule, or
840 contained within a pharmaceutical product approved by the United
841 States Food and Drug Administration, any material, compound,
842 mixture, or preparation, including its salts, isomers, esters,
843 or ethers, and salts of isomers, esters, or ethers, whenever the
844 existence of such salts is possible within any of the following
845 specific chemical designations, any compound containing a
846 phenethylamine structure without a beta-keto group, with
847 substitution on the nitrogen atom of the amino group with a
848 benzyl substituent, with or without substitution on the phenyl
849 or benzyl ring to any extent with alkyl, alkoxy, thio,
850 alkylthio, halide, fused alkylenedioxy, fused furan, fused

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851 benzofuran, or fused tetrahydropyran substituents, whether or
852 not further substituted on a ring to any extent, with or without
853 substitution at the alpha position by any alkyl substituent,
854 including, but not limited to:
855 a. 25B-NBOMe (4-Bromo-2,5-dimethoxy-[N-(2-
856 methoxybenzyl)]phenethylamine).
857 b. 25B-NBOH (4-Bromo-2,5-dimethoxy-[N-(2-
858 hydroxybenzyl)]phenethylamine).
859 c. 25B-NBF (4-Bromo-2,5-dimethoxy-[N-(2-
860 fluorobenzyl)]phenethylamine).
861 d. 25B-NBMD (4-Bromo-2,5-dimethoxy-[N-(2,3-
862 methylenedioxybenzyl)]phenethylamine).
863 e. 25I-NBOMe (4-Iodo-2,5-dimethoxy-[N-(2-
864 methoxybenzyl)]phenethylamine).
865 f. 25I-NBOH (4-Iodo-2,5-dimethoxy-[N-(2-
866 hydroxybenzyl)]phenethylamine).
867 g. 25I-NBF (4-Iodo-2,5-dimethoxy-[N-(2-
868 fluorobenzyl)]phenethylamine).
869 h. 25I-NBMD (4-Iodo-2,5-dimethoxy-[N-(2,3-
870 methylenedioxybenzyl)]phenethylamine).
871 i. 25T2-NBOMe (4-Methylthio-2,5-dimethoxy-[N-(2-
872 methoxybenzyl)]phenethylamine).
873 j. 25T4-NBOMe (4-Isopropylthio-2,5-dimethoxy-[N-(2-
874 methoxybenzyl)]phenethylamine).
875 k. 25T7-NBOMe (4-(n)-Propylthio-2,5-dimethoxy-[N-(2-

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876 methoxybenzyl)]phenethylamine).
877 l. 25C-NBOMe (4-Chloro-2,5-dimethoxy-[N-(2-
878 methoxybenzyl)]phenethylamine).
879 m. 25C-NBOH (4-Chloro-2,5-dimethoxy-[N-(2-
880 hydroxybenzyl)]phenethylamine).
881 n. 25C-NBF (4-Chloro-2,5-dimethoxy-[N-(2-
882 fluorobenzyl)]phenethylamine).
883 o. 25C-NBMD (4-Chloro-2,5-dimethoxy-[N-(2,3-
884 methylenedioxybenzyl)]phenethylamine).
885 p. 25H-NBOMe (2,5-Dimethoxy-[N-(2-
886 methoxybenzyl)]phenethylamine).
887 q. 25H-NBOH (2,5-Dimethoxy-[N-(2-
888 hydroxybenzyl)]phenethylamine).
889 r. 25H-NBF (2,5-Dimethoxy-[N-(2-
890 fluorobenzyl)]phenethylamine).
891 s. 25D-NBOMe (4-Methyl-2,5-dimethoxy-[N-(2-
892 methoxybenzyl)]phenethylamine),
893
894 which does not include substituted cathinones as described in
895 subparagraph 191.
896 194. Substituted Tryptamines.—Unless specifically excepted
897 or unless listed in another schedule, or contained within a
898 pharmaceutical product approved by the United States Food and
899 Drug Administration, any material, compound, mixture, or
900 preparation containing a 2-(1H-indol-3-yl)ethanamine, for

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901 example tryptamine, structure with or without mono- or di-
902 substitution of the amine nitrogen with alkyl or alkenyl groups,
903 or by inclusion of the amino nitrogen atom in a cyclic
904 structure, whether or not substituted at the alpha position with
905 an alkyl group, whether or not substituted on the indole ring to
906 any extent with any alkyl, alkoxy, halo, hydroxyl, or acetoxy
907 groups, including, but not limited to:
908 a. Alpha-Ethyltryptamine.
909 b. Bufotenine.
910 c. DET (Diethyltryptamine).
911 d. DMT (Dimethyltryptamine).
912 e. MET (N-Methyl-N-ethyltryptamine).
913 f. DALT (N,N-Diallyltryptamine).
914 g. EiPT (N-Ethyl-N-isopropyltryptamine).
915 h. MiPT (N-Methyl-N-isopropyltryptamine).
916 i. 5-Hydroxy-AMT (5-Hydroxy-alpha-methyltryptamine).
917 j. 5-Hydroxy-N-methyltryptamine.
918 k. 5-MeO-MiPT (5-Methoxy-N-methyl-N-isopropyltryptamine).
919 l. 5-MeO-AMT (5-Methoxy-alpha-methyltryptamine).
920 m. Methyltryptamine.
921 n. 5-MeO-DMT (5-Methoxy-N,N-dimethyltryptamine).
922 o. 5-Me-DMT (5-Methyl-N,N-dimethyltryptamine).
923 p. 5-MeO-DiPT (5-Methoxy-N,N-Diisopropyltryptamine).
924 q. DiPT (N,N-Diisopropyltryptamine).
925 r. DPT (N,N-Dipropyltryptamine).

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926 s. 4-Hydroxy-DiPT (4-Hydroxy-N,N-diisopropyltryptamine).
927 t. 5-MeO-DALT (5-Methoxy-N,N-Diallyltryptamine).
928 u. 4-AcO-DMT (4-Acetoxy-N,N-dimethyltryptamine).
929 v. 4-AcO-DiPT (4-Acetoxy-N,N-diisopropyltryptamine).
930 w. 4-Hydroxy-DET (4-Hydroxy-N,N-diethyltryptamine).
931 x. 4-Hydroxy-MET (4-Hydroxy-N-methyl-N-ethyltryptamine).
932 y. 4-Hydroxy-MiPT (4-Hydroxy-N-methyl-N-
933 isopropyltryptamine).
934 z. Methyl-alpha-ethyltryptamine.
935 aa. Bromo-DALT (Bromo-N,N-diallyltryptamine),
936
937 which does not include tryptamine, psilocyn as described in
938 subparagraph 34., or psilocybin as described in subparagraph 33.
939 195. Substituted Phenylcyclohexylamines.—Unless
940 specifically excepted or unless listed in another schedule, or
941 contained within a pharmaceutical product approved by the United
942 States Food and Drug Administration, any material, compound,
943 mixture, or preparation containing a phenylcyclohexylamine
944 structure, with or without any substitution on the phenyl ring,
945 any substitution on the cyclohexyl ring, any replacement of the
946 phenyl ring with a thiophenyl or benzothiophenyl ring, with or
947 without substitution on the amine with alkyl, dialkyl, or alkoxy
948 substituents, inclusion of the nitrogen in a cyclic structure,
949 or any combination of the above, including, but not limited to:
950 a. BTCP (Benzothiophenylcyclohexylpiperidine) or BCP

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951 (Benocyclidine).
952 b. PCE (N-Ethyl-1-phenylcyclohexylamine)(Ethylamine analog
953 of phencyclidine).
954 c. PCPY (N-(1-Phenylcyclohexyl)-pyrrolidine)(Pyrrolidine
955 analog of phencyclidine).
956 d. PCPr (Phenylcyclohexylpropylamine).
957 e. TCP (1-[1-(2-Thienyl)-cyclohexyl]-piperidine)(Thiophene
958 analog of phencyclidine).
959 f. PCEEA (Phenylcyclohexyl(ethoxyethylamine)).
960 g. PCMPA (Phenylcyclohexyl(methoxypropylamine)).
961 h. Methoxetamine.
962 i. 3-Methoxy-PCE ((3-Methoxyphenyl)cyclohexylethylamine).
963 j. Bromo-PCP ((Bromophenyl)cyclohexylpiperidine).
964 k. Chloro-PCP ((Chlorophenyl)cyclohexylpiperidine).
965 l. Fluoro-PCP ((Fluorophenyl)cyclohexylpiperidine).
966 m. Hydroxy-PCP ((Hydroxyphenyl)cyclohexylpiperidine).
967 n. Methoxy-PCP ((Methoxyphenyl)cyclohexylpiperidine).
968 o. Methyl-PCP ((Methylphenyl)cyclohexylpiperidine).
969 p. Nitro-PCP ((Nitrophenyl)cyclohexylpiperidine).
970 q. Oxo-PCP ((Oxophenyl)cyclohexylpiperidine).
971 r. Amino-PCP ((Aminophenyl)cyclohexylpiperidine).
972 196. W-15, 4-chloro-N-[1-(2-phenylethyl)-2-
973 piperidinylidene]-benzenesulfonamide.
974 197. W-18, 4-chloro-N-[1-[2-(4-nitrophenyl)ethyl]-2-
975 piperidinylidene]-benzenesulfonamide.

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976 198. AH-7921, 3,4-dichloro-N-[[1-
977 (dimethylamino)cyclohexyl]methyl]-benzamide.
978 199. U47700, trans-3,4-dichloro-N-[2-
979 (dimethylamino)cyclohexyl]-N-methyl-benzamide.
980 200. MT-45, 1-cyclohexyl-4-(1,2-diphenylethyl)-piperazine,
981 dihydrochloride.
982 Section 2. This act shall take effect upon becoming a law.

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