Summary
The rule implements the direct purchase pedigree provisions of Florida Session Law 2006-310; the rule provides for clarification on use of the pedigree and the content thereof, including but not limited to, the number of intracompany transfers allowed by use of the direct purchase pedigree. The rule deletes language related to deleted statutory pedigree requirements, found in subsection 16 of the rule. The rule allows Restricted Drug Distributor-Health Care Entity permitted prescription drug distributors to commingle drugs used for in house administration and for wholesale distribution. The rule adds restrictions to the documentation required for use of the “Emergency Distributions” distribution of prescription drugs without the passing of a pedigree. The rule clarifies the permitting requirements for third party logistics providers and the manufacturers they are contract distributors for, in order for the third party contract distributors to be exempt from licensure as wholesale distributors who would be required to pass pedigrees. The rule will require the contract distributor to be permitted at the distribution point as well as the manufacturer. In addition, the manufacturer will be required to be permitted at the location from which it is passing title to the prescription drugs. The rule provides the conditions under which a specified prescription drug can be can be returned and re-distributed.