9/2/2020

Laws and Rules Affecting

Pharmacy Practice

Goar Alvarez, Pharm.D.,C.Ph.,FASCP

Assistant Dean
NSU College of Pharmacy
FMR President – Florida Pharmacy Assoc.
FMR Member – Florida Board of Pharmacy

456.001 Definitions
 “Board”
 “Consumer member”
 “Department”
 “Health care practitioner”
 “License”
 “Licensee”
 “Profession”

456.0341 Requirements for instruction on human trafficking

• By January 1, 2021, each licensee … shall complete a board-

approved 1-hour continuing education course on human trafficking
• Poster

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456.054 Kickbacks prohibited

https://www.justice.gov/opa/pr/florida-compounding-
pharmacy-and-its-owners-pay-least-775000-resolve-
false-claims-act

• “kickback” means payment, by or on behalf of a provider of health care services or items, to

any person as an incentive or inducement to refer patients for past or future services or
items, when the payment is not tax deductible as an ordinary and necessary expense.

456.057 Penalty for giving false

information

456.063 Sexual misconduct; disqualification for license,

certificate, or registration

Sexual misconduct in the

practice of a health care
profession is prohibited.

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456.0635 Health care fraud; disqualification for license,

certificate, or registration

Health care fraud in the practice

of a health care profession is
prohibited.

456.065 Unlicensed practice of a health care profession; intent; cease

and desist notice: penalties; enforcement; citations; fees; allocation and
disposition of money collected

It is the intent of the Legislature that

vigorous enforcement of licensure
regulation for all health care
professions is a state priority in order
to protect Florida residents and
visitors.

456.073 Disciplinary proceedings

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456.076 Impaired practitioner

programs
1.Acknowledges the impairment
2.Voluntarily withdraws from practice or
restricts practice as prescribed by FL BOP
3.Participates in the program
4.Voluntarily allows progress reports to be
made available to FL BOP
5.Successfully completes the program

456.41 Complementary or
alternative health care treatments

LEGISLATIVE INTENT.—It is the intent of the Legislature that citizens

be able to make informed choices for any type of health care they deem
to be an effective option for treating human disease, pain, injury,
deformity, or other physical or mental condition.

456.42 Written prescription for

medicinal drugs

A written prescription for a medicinal drug issued by a health care

practitioner licensed by law to prescribe such drug must be legibly
printed or typed so as to be capable of being understood by the
pharmacist filling the prescription

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456.43 Electronic prescribing for

medical drugs

• Electronic prescribing shall not interfere with a patient’s

freedom to choose a pharmacy
• Expected to take effect in 2021
• Some exceptions may apply

456.44 Controlled substance

prescribing

Acute Pain
Acute Pain Exception
Non Acute Pain

456.47 Use of telehealth to provide

services

“Telehealth” means the use of synchronous or asynchronous telecommunications

technology by a telehealth provider to provide health care services, including, but
not limited to, assessment, diagnosis, consultation, treatment, and monitoring of a
patient; transfer of medical data; patient and professional health-related education;
public health services; and health administration.

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465.0252 Substitution of
interchangeable biosimilar products

465.026 Filling of certain prescriptions

Nothing contained in
this chapter shall be
construed to prohibit
a pharmacist licensed
in this state from
filling or refilling a
valid prescription
which is on file in a
pharmacy located in
this state or in
another state and has
been transferred
from one pharmacy
to another by any
means, including any
electronic means

465.0265 Centralized prescription

filling

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465.0266 Common database

Nothing contained in this chapter shall be construed to prohibit the

dispensing by a pharmacist licensed in this state or another state of a
prescription contained in a common database, and such dispensing shall not
constitute a transfer as defined in s. 465.026(1)-(6)

465.189 Administration of vaccines

and epinephrine auto-injection

• Can administer adult CDC

vaccines as of Feb 2015 or
added by rule
• Can administer Epinephrine
• 20hr certificate
• 3hr bi-annual CE
• CPR
• Interns can immunize under
supervision 1:1
• Protocol by licensed physician
under chapter 458 or chapter
459
• Liability insurance
• Permission from pharmacy
owner

64B16-27.530 Duty of Pharmacists to Inform

Regarding Drug Substitution

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64B16-27.270 General Terms and Conditions to

Be Followed by a Pharmacist When Ordering and
Dispensing Approved Medical Drug Products

Pursuant to the authority of the Formulary Committee in Section 465.186, F.S., a

pharmacist may order the medicinal drug products listed in Rule 64B16-27.220,
F.A.C., subject to the following terms and limitations

64B16-28.108 All Permits- Labels

and Labeling of Medicinal Drugs

Each container of medicinal drugs dispensed shall have a label

or shall be accompanied by labeling.

64B16-28.1081 Regulation of Daily Operating

Hours: Commencement of Operations

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64B16-28.606 Remote Medication Order Processing for

Class II or Class III Institutional Pharmacies or Special
Pharmacy Permits Servicing Class I, Class II, Modified Class
II, Class III, and Special ALF

64B16-28.607 Automated Pharmacy System-

Long Term Care, Hospice, and Prison

64B16-28.608 Automated Filling

within a Pharmacy

“Automated filling system” means an automated system used within a

pharmacy to assist in filling a prescription drug order by selecting, labeling,
filling, or sealing medication for dispensing

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64B16-28.102 Sink and Running Water,

Sufficient Space, Refrigeration, Sanitation,
Equipment

64B16-28.2021 Change of Ownership

64B16-28.203 Transfer of Medicinal

Drugs; Change of Ownership; Closing
of a Pharmacy

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64B16-28.450 Centralized Prescription

Filling, Delivering and Returning

64B16-28.451 Pharmacy Common

Database; Exception for Prescription Drug
Processing Only Pharmacies

A pharmacy licensed under this chapter may perform prescription drug processing
for other pharmacies, provided that all pharmacies are under common ownership,
utilize a common database, and are properly licensed, permitted or registered in
this state or another state

64B16-27.300 Standard of Practice-

Continuous Quality Improvement
Program

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64B16-28.502 Class I, Class II and Class III

Institutional Permit- Labels and labeling of
Medicinal Drugs for Inpatients of a Nursing Home

64B16-27.210 General Terms and Conditions to Be

Followed by a Pharmacist When Ordering and
Dispensing Approved Medicinal Drug Products

64B16-28.202 Closing of a Pharmacy;

Transfer of Prescription Files

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64B16-28.118 Unit Dose and Customized

Patient Medication Package Returns by In-
patients

64B16-28.108 All Permits- Labels

and Labeling of Medicinal Drugs

Each container of medicinal drugs dispensed shall have a label

or shall be accompanied by labeling.

64B16-27.831 Standards of Practice for the Filling of

Controlled Substance Prescriptions; Electronic Prescribing;
Mandatory Continuing Education

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64B16-27.220 Medicinal Drugs May

Be Ordered by Pharmacists

64B16-31 Collaborative Practice

and Test and Treat Certifications

HB 389- Practice of Pharmacy

• Creates collaborative pharmacy practice agreement between pharmacist &

physician
• Requires agreements to be appropriate to training & scope of practice of
pharmacist & physician
• Requires maintenance of records & specified pharmacists to report certain
diseases of public health significance to DOH
• Authorizes pharmacists to test for & treat influenza & streptococcus
• Provides requirements for written protocol between pharmacist &
supervising physician

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HB-599 – Consultant Pharmacists

• Requires pharmacist to complete additional training for consultant

pharmacist licensure
• Authorizes consultant pharmacist to perform specified services

Questions about Self-Study material

will be addressed in Q&A Zoom
Session

Sept 21, 2020 11:00am -12:00pm

(see canvas for link)

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