Florida Regulations
Department of Health/Division of Disease Control
Vol. 47, Issue 56, Florida Administrative Register 2021-03-23
PUBLICATION DATE: 03/23/2021
ACTION DATE: 03/19/2021
EFFECTIVE DATE: 03/17/2021
EXPIRATION DATE: 06/15/2021
PUBLICATION TYPE: Register
REGISTER SOURCE: Vol. 47, Issue 54, Florida Administrative Register 2021-03-19 pp.1423-1424
PUBLICATION DATE: 03/19/2021
ACTION DATE: 03/19/2021
EFFECTIVE DATE: 03/17/2021
EXPIRATION DATE: 06/15/2021
PUBLICATION TYPE: Register

Notice of Emergency Rule

DEPARTMENT OF HEALTH

Division of Disease Control

RULE NO.: RULE TITLE:

64DER21-5 COVID-19 Vaccine Redistribution Requirements

SPECIFIC REASONS FOR FINDING AN IMMEDIATE DANGER TO THE PUBLIC HEALTH, SAFETY OR WELFARE: Novel Coronavirus Disease 2019 (COVID-19) is a severe acute respiratory illness that can spread among humans through respiratory transmission and presents with symptoms similar to those of influenza. COVID-19 is a communicable disease with significant morbidity and mortality. As a result, it presents a severe danger to public health. In furtherance of state and federal government response efforts, the Florida Department of Health and the Centers for Disease Control and Prevention (CDC) seek to permit the redistribution of COVID-19 vaccine beyond the primary CDC ship-to-sites. Tracking the redistribution of COVID-19 vaccines in Florida is paramount to controlling this communicable disease and to ensure proper oversight by the CDC. Therefore, there is an immediate need to adopt rules setting forth the continued procedure for providers to request to redistribute COVID-19 vaccine in order to control the spread of COVID-19 to protect the health, safety and welfare of Florida's citizens.

REASON FOR CONCLUDING THAT THE PROCEDURE USED IS FAIR UNDER THE CIRCUMSTANCES: COVID-19 presents a public health threat to the state of Florida. The Surgeon General has declared a statewide Public Health Emergency due to the spread of COVID-19. There is an immediate need to set forth the continued procedures for the tracking of vaccine redistribution between enrolled COVID-19 vaccine providers in the effort to control this communicable disease in the State of Florida.

SUMMARY OF THE RULE: Emergency rule 64DER21-5 sets forth the continued requirements to permit the redistribution of COVID-19 vaccines between enrolled COVID-19 vaccine providers.

THE PERSON TO BE CONTACTED REGARDING THE EMERGENCY RULE IS: Carina Blackmore, Florida Department of Health, 4052 Bald Cypress Way, Tallahassee, Florida 32399-1703, (850)245-4732.

THE FULL TEXT OF THE EMERGENCY RULE IS:

THIS RULE TAKES EFFECT UPON BEING FILED WITH THE DEPARTMENT OF STATE UNLESS A LATER TIME AND DATE IS SPECIFIED IN THE RULE.

EFFECTIVE DATE: March 17, 2021

64DER21-5 COVID-19 Vaccine Redistribution Requirements

(1) Prior to any redistribution of COVID-19 vaccines between COVID-19 vaccine provider sites, all COVID-19 vaccine redistributions require approval from the Florida Vaccines for Children and Adults (VFC/VFA) Program.

(2) All COVID-19 vaccine redistributions must be to providers who are fully enrolled in the Florida State Health Online Tracking System (Florida SHOTS) and the VFC/VFA Program. In addition, all providers must have completed both sections A and B of the "CDC COVID-19 Vaccination Program Provider Agreement" (09/14/2020) which is available through the provider's Florida SHOTS account at http://www.flshotsusers.com/.

(3) In order to redistribute any COVID-19 vaccine product to an enrolled COVID-19 Vaccine Program outside of the provider's organization, a provider must complete a "CDC Supplemental COVID-19 Vaccine Redistribution Agreement" (09/29/20) which is incorporated by reference and available at http://www.floridahealth.gov/programs-and-services/immunization/COVID-19VaccineInfo/index.html. A copy of the completed redistribution agreement must be sent to the VFC/VFA program at FloridaVFC@flhealth.gov no less than 24 hours before the anticipated redistribution.

(4) A redistribution agreement is not required if the redistribution will occur between enrolled COVID-19 Vaccine Program providers within the same organization.

(5) A Florida SHOTS Vaccine Transfer form (09/15) must be completed and signed by both the redistributing provider and the receiving provider for all vaccine redistributions. The transfer form is available through the provider's Florida SHOTS account at http://www.flshotsusers.com/. The completed form must be sent to the VFC/VFA program at FloridaVFC@flhealth.gov no less than 24 hours before the anticipated redistribution.

Rulemaking Authority 381.003(2), 381.0031(8), 381.005(3) FS. Law Implemented 381.0011(3), (4), 381.003(1), 381.0031, 381.005(1) FS. History - New 3-17-21.