Notice of Development of Rulemaking

DEPARTMENT OF HEALTH
Division of Family Health Services
Rule No.: RULE TITLE
64F-12.011: Wholesale Distribution of Prescription Drugs - Exceptions and Specific Distributions Authorized
PURPOSE AND EFFECT: The Department intends to review changes in this rule chapter for the purpose of better enabling the Department to provide for the movement of prescription drugs to areas, facilities and health care providers within the state to allow a more efficient response to natural disaster, communicable disease or other health care emergencies for which the Department has responsibility to protect the public health. This also includes enacting “rules established by the department” within the meaning of Section 499.003(54)(b). Florida Statutes. Finally, the Department will review this section for the possibility of rule changes for implementing Section 499.03, F.S. related to authorizing qualified persons engaged in research teaching and testing to lawfully possess prescription drugs.
SUBJECT AREA TO BE ADDRESSED: Exemption to the definition of “wholesale distribution” for emergency medical reasons; exemption letters to facilitate the lawful possession of prescription drugs for research teaching and testing.
SPECIFIC AUTHORITY: 499.003(54), 499.012, 499.03, 499.05 FS.
LAW IMPLEMENTED: 499.003(54), 499.012, 499.03, 499.05 FS.
IF REQUESTED IN WRITING AND NOT DEEMED UNNECESSARY BY THE AGENCY HEAD, A RULE DEVELOPMENT WORKSHOP WILL BE NOTICED IN THE NEXT AVAILABLE FLORIDA ADMINISTRATIVE WEEKLY.
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE DEVELOPMENT AND A COPY OF THE PRELIMINARY DRAFT, IF AVAILABLE, IS: Rebecca Poston, R. Ph., Executive Director, Drugs Devices and Cosmetics Program, 4052 Bald Cypress Way, Mail Bin #C04, Tallahassee, Florida 32399, (850)245-4292, or by email to Rebecca_Poston@doh.state.fl.us

THE PRELIMINARY TEXT OF THE PROPOSED RULE DEVELOPMENT IS NOT AVAILABLE.