Purpose
The Department intends to enact rules that implement the pedigree provisions of Florida Session Law 2006-310 concerning implementing the direct purchase statement pedigree related provisions of that session law. The Department intends to provide clarification as to when wholesale distributions of prescription drugs are eligible for the direct purchase pedigree, as well as conditions on content of the direct purchase pedigree. The Department intends to revise the rule chapter to delete outdated pedigree language for pedigree requirements that were deleted from Chapter 499, Florida Statutes, effective July 1, 2006. The Department intends to make changes regarding when the operating systems of businesses licensed under Chapter 499, Florida Statutes, are required to be maintained separately for each type of business. The Department also intends to make changes to the emergency distributions paragraph within this rule, changing the documentation requirements for use of this provision. The Department intends to make changes to the requirements for permitting for contract distributors of prescription drugs on behalf of manufacturers, who do not have to pass pedigrees. The Department proposes to provide additional language regarding the requirements for returns of prescription drugs to wholesalers.