Capsule Newsletter, Issue 001, June 2006
Florida Pedigree Rules Made Final
In January 2006, the Florida Department of Health completed the pedigree regulations that go into effect on July 1. The final rules were developed through industry workshops in 2005 and establish procedures for electronic certification and authentication of pedigrees.
The Florida Prescription Drug Protection Act passed in 2003 requires all wholesale distributions of prescription drugs to include a pedigree for each salable item. The pedigree must describe the product and the details of each transfer of ownership. Drug manufacturers are not required to supply pedigrees, however they must make information available for downstream supply chain partners to authenticate the first sale transaction. Pharmacies, hospitals, and other distributors to pharmaceutical consumers must accept and retain pedigrees from wholesalers. Repackaging operations are considered to be a wholesale distribution and require pedigrees. All pedigrees must be stored for three years and be easily viewed and printed.
The digitally signed and self authenticating electronic pedigree specified by the Florida DoH increases the efficiency of pedigree operations by automating pedigree handling, verification, signing, and authentication. The digital Public Key Infrastructure (PKI) signatures used in pedigrees are accepted as legally binding and they verify that the content of the pedigree has not been altered. Florida pedigree regulations are the first in the U.S. to specify requirements for electronic pedigree and are likely to serve as a model for regulations outside the state.
The Florida legislature adopted a bill proposing adjustments for drop ship and specifying two additional types of pedigree. If this bill becomes law, it will require different types of pedigrees for different business operations and transactions.
SupplyScape is concerned about drop ship and working with industry to identify solutions and provide guidance on how the drop ship pedigree requirement can be accommodated within the existing law and within the constraints of the information availability and timing requirements.
Pedigree rule adjustments published by the Florida Department of Health are scheduled to become final rules before July 1, 2006. Reviewed at the public hearing on May 15, 2006, these rules allow the distribution and dispensing of drugs purchased before July 1, 2006 without pedigrees for a limited time, allow emergency distributions of a drug without a pedigree for a life-threatening medical condition, and clarify that a pharmaceutical company's third party contract manufacturers and contract distributors are not required to provide pedigrees. Rules for the certificate authority for digital certificates needed for the self-authenticating electronic pedigree were also addressed.
