HOUSE OF REPRESENTATIVES STAFF ANALYSIS
BILL #: CS/CS/HB 1063 Administration of Vaccines
SPONSOR(S): Health & Human Services Committee, Professions & Public Health Subcommittee,
Fernandez-Barquin
TIED BILLS: IDEN./SIM. BILLS: SB 898
REFERENCE ACTION ANALYST STAFF DIRECTOR or
BUDGET/POLICY CHIEF
1) Professions & Public Health Subcommittee 17 Y, 1 N, As CS Morris McElroy
2) Health & Human Services Committee 16 Y, 1 N, As CS Morris Calamas
SUMMARY ANALYSIS
Current law authorizes pharmacists and registered interns who meet certain educational requirements to
administer vaccines to adults within an established protocol with a supervising physician. A pharmacist may
administer:
Immunizations or vaccines listed on the U.S. Centers for Disease Control and Prevention (CDC) Adult
Immunization Schedule as of February 1, 2015;
Vaccines recommended by the CDC for international travel as of July 1, 2015;
Immunizations or vaccines approved by the Board of Pharmacy in rule; and
Immunizations or vaccines approved by the Board of Pharmacy in response to a state of emergency
declared by the Governor.
CS/CS/HB 1063 authorizes qualified Florida-licensed pharmacists or registered pharmacy interns to administer
any CDC-recommended vaccine or vaccine licensed in the United States by the U.S. Food and Drug
Administration (FDA) to an adult. The bill allows the Board of Pharmacy to authorize by rule additional
immunizations or vaccines, as they are recommended by the CDC, licensed by the FDA, that a qualified
pharmacist or registered pharmacy intern may administer. The bill authorizes a pharmacist, or a registered
intern under the supervision of a pharmacist, to administer vaccines authorized for emergency use by the FDA.
The bill also authorizes pharmacists to provide influenza vaccines to individuals age 7 and older.
The bill also repeals the specific statutory limitation to the 2015 CDC-recommended vaccines, effectively
updating the reference to the CDC-recommended vaccines as of the date of enactment.
Lastly, the bill increases the number of interns who administer vaccines that a pharmacist may supervise from
one to three.
The bill has an insignificant, negative fiscal impact on the Department of Health, which can be absorbed within
existing resources. 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: h1063b.HHS
DATE: 3/24/2021
FULL ANALYSIS
I. SUBSTANTIVE ANALYSIS
A. EFFECT OF PROPOSED CHANGES:
Present Situation
Vaccinations
CDC Immunizations Recommendations
The Advisory Committee on Immunization Practices (ACIP) is comprised of medical and public health
experts who develop recommendations on the use of vaccines in the United States.1 The ACIP works
with professional organizations, such as the American Academy of Pediatrics, the American Academy
of Family Physicians, the American College of Obstetricians and Gynecologists, and the American
College of Physicians to develop annual childhood and adult immunization schedules.2 The Centers for
Disease Control and Prevention (CDC) reviews the ACIP’s recommendations; and once approved, they
are published as the CDC’s official recommendations for immunizations of the U.S. population.3 The
current recommended immunization schedule for those ages 18 and under includes:4
Hepatitis B Rotavirus
Diphtheria, tetanus, & acellular pertussis Haemophilus influenza type b
Pneumococcal conjugate Inactivated poliovirus
Influenza Measles, mumps, rubella (MMR)
Varicella Hepatitis A
Meningococcal Human papillomavirus
Meningococcal B Pneumococcal polysaccharide
Tetanus, diphtheria, and acellular pertussis
The current recommended immunization schedule for adults includes:5
Influenza (annually) Varicella (if born in 1980 or later)
Measles, mumps, rubella Tetanus, diphtheria, pertussis (booster
every 10 years)
Zoster Human papillomavirus
Pneumococcal polysaccharide Pneumococcal conjugate
Haemophilus influenza type b Hepatitis A
Hepatitis B Meningococcal A, C, W, Y
Meningococcal B
New vaccines are considered for addition to the schedule after licensure by the United States Food and
Drug Administration.6 Not all newly licensed vaccines are added to the schedule. Some licensed
vaccines are only recommended for people who are traveling to areas where other vaccine preventable
1 Centers for Disease Control and Prevention, Advisory Committee on Immunization Practices (ACIP), General Committee-Related
Information, available at https://www.cdc.gov/vaccines/acip/committee/index.html (last visited March 16, 2021).
2 Centers for Disease Control and Prevention, Advisory Committee on Immunization Practices (ACIP), ACIP Recommendations,
available at https://www.cdc.gov/vaccines/acip/recommendations.html (last visited March 16, 2021).
3 Id.
4 Centers for Disease Control and Prevention, Recommended Child and Adolescent Immunization Schedule for Ages 18 Years and
Younger, United States, 2021, available at https://www.cdc.gov/vaccines/schedules/hcp/imz/child-adolescent.html (last visited March
16, 2021). The schedule provides the recommended age, as well as the administration intervals for vaccines that require multiple
doses. Some vaccines are recommended only for populations with special situations that put these individuals at higher risk.
5 Centers for Disease Control and Prevention, Recommended Adult Immunization Schedule for Ages 19 Years or Older, United States,
2021, available at https://www.cdc.gov/vaccines/schedules/hcp/imz/adult.html (last visited March 16, 2021). The schedule provides the
recommended age, as well as the administration intervals for vaccines that require multiple doses. Some vaccines are recommended
only for populations with special situations that put these individuals at higher risk.
6 College of Physicians of Philadelphia, The History of Vaccines: The Development of the Immunization Schedule, available at
http://www.historyofvaccines.org/content/articles/development-immunization-schedule (last visited March 16, 2021).
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diseases occur, such as yellow fever, cholera, dengue, Japanese encephalitis, plague, rabies,
smallpox, and typhoid.7
CDC Health Information for International Travel
CDC’s Health Information for International Travel, commonly called the Yellow Book (Book), is
published biannually by the CDC as a reference for those who advise international travelers about
health risks.8 The Book includes the CDC’s most current travel health guidelines, including pre-travel
vaccine recommendations and destination-specific health advice. The Book is authored by subject-
matter experts both within and outside the CDC and the guidelines in the Book are evidence-based and
supported by best practices.9
Vaccinations are recommended by the CDC to protect international travelers from illness and prevent
the importation of infectious diseases across international borders. The Book recommends that persons
traveling internationally should be up to date on all CDC-recommended vaccines.10 Additionally, the
Book may recommend additional vaccinations based on traveler’s destination and other factors.
Examples of additional vaccines required for travelers based on the country of entry is yellow fever,
meningococcal, and polio.11 An example of a vaccine the CDC recommends travelers obtain to protect
their health, even if they aren’t required for entry into the country, is the typhoid vaccine.12
Emergency Use Authorizations
Emergency use authorization (EUA) allows the United States Food and Drug Administration (FDA) to
help strengthen the nation’s public health protections against chemical, biological, radiological, and
nuclear threats including infectious diseases, by facilitating the availability and use of medical
countermeasures need during public health emergencies.13 Under section 564 of the Federal Food,
Drug, and Cosmetic Act,14 when the Secretary of the United States Department of Health and Human
Services (HHS) declares that an emergency use authorization is appropriate, the FDA may authorize
unapproved medical products or unapproved uses of approved medical products to be used in an
emergency to diagnose, treat, or prevent serious life-threatening diseases or conditions caused by
chemical, biological, radiological, and nuclear threats.15
7 Id. For a complete list of FDA-licensed vaccines, see U.S. Food & Drug Administration, Vaccines Licensed for Use in the United
States, (last rev. Jan. 16, 2020), available at https://www.fda.gov/vaccines-blood-biologics/vaccines/vaccines-licensed-use-united-
states (last visited March 15, 2021).
8 Centers for Disease Control and Prevention. CDC Yellow Book 2020: Health Information for International Travel, available at
https://wwwnc.cdc.gov/travel/page/yellowbook-home (last visited March 16, 2021).
9 Id.
10 Id.
11 Centers for Disease Control and Prevention, Travelers’ Health Most Frequently Asked Questions, available at
https://wwwnc.cdc.gov/travel/page/faq (last visited March 16, 2021).
12 Id.
13 Food and Drug Administration, Emergency Use Authorization, https://www.fda.gov/emergency-preparedness-and-response/mcm-
legal-regulatory-and-policy-framework/emergency-use-authorization (last visited March 16, 2021). Medical countermeasures are FDA-
regulated products (biologics, drugs, and devices) that may be used in the event of a public health emergency.
14 21 U.S.C. § 360bbb-3.
15 Supra, note 13. A determination that a public health emergency exists does not enable the FDA to issue EUAs.
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Practice of Pharmacy
Licensure
Pharmacy is the third largest health profession behind nursing and medicine.16 The Board of Pharmacy
(Board), in conjunction with the Department of Health (DOH), regulates the practice of pharmacists
pursuant to ch. 465, F.S.17 To be licensed as a pharmacist, a person must:18
Complete an application and remit an examination fee;
Be at least 18 years of age;
Hold a degree from an accredited and approved school or college of pharmacy;19
Have completed a Board-approved internship; and
Successfully complete the Board-approved examination.
A pharmacist must complete at least 30 hours of Board-approved continuing education during each
biennial renewal period.20 Pharmacists who are certified to administer vaccines or epinephrine
autoinjections must complete a 3-hour continuing education course on the safe and effective
administration of vaccines and epinephrine injections as a part of the biennial licensure renewal.21
Pharmacists who administer long-acting antipsychotic medications must complete an approved 8-hour
continuing education course as a part of the continuing education for biennial licensure renewal.22
Scope of Practice
In Florida, the practice of the profession of pharmacy includes:23
Compounding, dispensing, and consulting concerning contents, therapeutic values, and uses of
a medicinal drug;
Consulting concerning therapeutic values and interactions of patent or proprietary preparations;
Monitoring a patient’s drug therapy and assisting the patient in the management of his or her
drug therapy, including the review of the patient’s drug therapy and communication with the
patient’s prescribing health care provider or other persons specifically authorized by the patient,
regarding the drug therapy;
Transmitting information from prescribers to their patients;
Administering vaccines to adults;24
Administering epinephrine injections;25 and
Administering antipsychotic medications by injection.26
16 American Association of Colleges of Pharmacy, About AACP, available at https://www.aacp.org/about-aacp (last visited March 16,
2021).
17 Sections 465.004 and 465.005, F.S.
18 Section 465.007, F.S. DOH may also issue a license by endorsement to a pharmacist who is licensed in another state upon meeting
the applicable requirements set forth in law and rule. See s. 465.0075, F.S.
19 If the applicant has graduated from a 4-year undergraduate pharmacy program of a school or college of pharmacy located outside
the United States, the applicant must demonstrate proficiency in English, pass the board-approved Foreign Pharmacy Graduate
Equivalency Examination, and complete a minimum of 500 hours in a supervised work activity program within Florida under the
supervision of a DOH-licensed pharmacist
20 Section 465.009, F.S.
21 Section 465.009(6), F.S.
22 Section 465.1893, F.S.
23 Section 465.003(13), F.S.
24 See s. 465.189, F.S.
25 Id.
26 Section 465.1893, F.S.
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Pharmacy Interns
A pharmacy intern is a person enrolled in a college of pharmacy and actively pursuing a pharmacy
degree. To become a pharmacy intern, a person must be certified by the Board as enrolled in an intern
program at an accredited school or college of pharmacy or as a graduate of an accredited school or
college of pharmacy and not yet licensed as a pharmacist in Florida.27 The Board’s rules outline the
registration process for pharmacy interns and the internship program requirements for U.S. pharmacy
students or graduates and foreign pharmacy graduates.28
A pharmacist is responsible for any delegated act performed by a registered pharmacy intern employed
or supervised by the pharmacist.29
Pharmacist Vaccine Administration
Current law authorizes a pharmacist, or a registered pharmacy intern under the supervision of a
certified pharmacist at a ratio of 1:1, to administer immunizations and vaccines to adults within an
established protocol under a licensed supervising physician.30 The protocol between the pharmacist
and the supervising physician dictates which types of patients to whom the pharmacist may administer
allowable vaccines.31 The terms, scope, and conditions set forth in the protocol must be appropriate to
the pharmacist’s training and certification. A supervising physician must review the administration of
vaccines by the pharmacist.32
To be certified to administer vaccines, a pharmacist or registered pharmacy intern must successfully
complete a Board-approved vaccine administration certification program. The certification program
requires a pharmacist or registered intern to complete 20 hours of Board-approved continuing
education that addresses:33
Mechanisms of action for vaccines, contraindications, drug interactions, and monitoring after
vaccine administration;
Immunization schedules;
Immunization screening questions, provision of risk/benefit information, informed consent,
recordkeeping, and electronic reporting into the state immunization registry;
Vaccine storage and handling;
Bio-hazardous waste disposal and sterile technique;
Entering, negotiating, and performing pursuant to physician oversight protocols;
Community immunization resources and programs;
Identifying, managing and responding to adverse incidents including but not limited to potential
allergic reactions associated with vaccine administration;
Procedures and policies for reporting to the Vaccine Adverse Event Reporting System;
Reimbursement procedures and vaccine coverage by federal, state, and local governmental
jurisdictions and private third party payers;
Administration techniques;
Administration of epinephrine using an autoinjector delivery system;
The February 1, 2015, CDC Recommended Adult Immunization Schedule;
The immunizations or vaccines recommended for international travel as of July 1, 2015, found in
the