Published on: 4009512. The Department proposes to amend the rule to clarify the difference between a digital certificate and a digital signature, as well as correct some citations and term names within the rule.
Published on: 532838. The 2006 Florida legislature enacted session law 2006-310, amending Chapter 499, Part I, F.S., which changed requirements for prescription drug pedigrees in some instances; added a statutory provision authorizing drop shipment of prescription drugs in certain situations to allow an end user to obtain prescription drugs directly from the manufacturer without first obtaining a pedigree paper; authorized a cancer drug donation program. It is the purpose of this rule development process to enact rules to implement the changes to Chapter 499, Part I, F.S., made by session law 2006-310 (House Bill 371). Other changes or new text within the rule chapters listed above may also be addressed.
Published on: 292860. A proposed amendment to Rule 64F-12.012, F.A.C., requires an inventory of drugs at each wholesaler establishment, of drugs it has on hand as of June 30, 2006, so as to give the Department information useful to determining compliance as the drug pedigree law transitions effective July 1, 2006 from the requirements of Section 499.0121(6)(d) and (e), F.S., to Section 499.0121(6)(f), F.S. An additional proposed amendment to this rule would allow adjustments to the pedigree requirements for an emergency distribution, where a pharmacy or health care practitioner certifies to the wholesaler a need to treat a life threatening medical condition, or medical condition that will result in serious bodily harm, even if a drug pedigree compliant with Section 499.0121(6)(f), F.S. is not available.
Rule 64F-12.025, F.A.C., is proposed to establish standards for a certification authority to issue a digital certificate to an employee of a wholesale establishment, where the establishment employs this person to certify the accuracy and completeness of a pedigree paper. Through this rule the Department seeks to facilitate a self authenticating drug pedigree.