381.06014 Blood establishments. - Florida Statutes

381.06014 Blood establishments.

   (1) As used in this section, the term “blood establishment” means any person, entity, or organization, operating within the state, which examines an individual for the purpose of blood donation or which collects, processes, stores, tests, or distributes blood or blood components collected from the human body for the purpose of transfusion, for any other medical purpose, or for the production of any biological product.

   (2) Any blood establishment operating in the state may not conduct any activity defined in subsection (1) unless that blood establishment is operated in a manner consistent with the provisions of Title 21 parts 211 and 600-640, Code of Federal Regulations.

   (3) Any blood establishment determined to be operating in the state in a manner not consistent with the provisions of Title 21 parts 211 and 600-640, Code of Federal Regulations, and in a manner that constitutes a danger to the health or well-being of donors or recipients as evidenced by the federal Food and Drug Administration’s inspection reports and the revocation of the blood establishment’s license or registration shall be in violation of this chapter and shall immediately cease all operations in the state.

   (4) The operation of a blood establishment in a manner not consistent with the provisions of Title 21 parts 211 and 600-640, Code of Federal Regulations, and in a manner that constitutes a danger to the health or well-being of blood donors or recipients as evidenced by the federal Food and Drug Administration’s inspection process is declared a nuisance and inimical to the public health, welfare, and safety. The Agency for Health Care Administration or any state attorney may bring an action for an injunction to restrain such operations or enjoin the future operation of the blood establishment.

History. s. 1, ch. 2003-38; s. 38, ch. 2004-5.