Electronic Safety Net — NABP Exploring the Creation of a Clearinghouse for Pedigree Data

November 16, 2004

Topics: Uncategorized

The National Association of Boards of Pharmacy® (NABP®) is pleased to announce that it is taking further steps to protect the public health and maintain the integrity of the United States drug supply. Earlier this year, NABP released its Model Rules for the Licensure of Wholesale Distributors. These Model Rules contain provisions requiring the documentation, recording, and maintenance of a pedigree (Chain of Custody Record) for each package of drugs. The Model Rules anticipate that these records will be created and stored electronically. We note that the states of Florida and California have passed laws that either require or allow electronic pedigree records.

NABP supports the Food and Drug Administration’s (FDA) policy that the use of radio frequency identification (RFID) technology is the best means to improve the security of the nation’s drug supply. Electronic pedigrees will track and trace a drug product through the distribution system, from the time it leaves a drug manufacturer until it is dispensed to a patient by a pharmacist. We also support the need for access to relevant pedigree information in order for regulators to conduct investigations.

To facilitate the collection and maintenance of electronic pedigree information, NABP is announcing that it will establish a Task Force of state regulators, manufacturers, wholesalers, retailers, government regulators, and information technology experts to explore the feasibility of creating and maintaining a clearinghouse for relevant information to establish an electronic pedigree. The Task Force will establish ways to facilitate the exchange of information in an effort to maintain the integrity and safety of the US drug distribution system. Additionally, the Task Force will work with EPC Global to create the necessary standards for the development of e-pedigree software. The NABP Task Force may also explore ways to establish an accreditation program for e-pedigree software platforms to assure connectivity of systems throughout the US that need to communicate to each other.

We would like to emphasize that NABP will act as an honest broker to facilitate the creation of policies and business rules for the exchange of information among trading partners. We envision that trading partners will make their own arrangements for exchange of information and use the advantages of the NABP Clearinghouse to improve these exchanges.

In February of this year, NABP released its revised Model Rules for the Licensure of Wholesale Distributors, which is part of the Association’s Model State Pharmacy Act and Model Rules. The Model Rules were developed through a broad consensus process involving state and federal regulators, wholesale drug industry experts, national pharmacy organizations, and consumer groups. The Model Rules focus on critical areas of the licensure and regulation of wholesale distributors, identified by FDA and the states, that are essential to combating counterfeit drugs. Included in the Model Rules are specific provisions concerning the documentation, recording, and maintenance of a pedigree for drugs distributed through the wholesale distribution system.

Therefore, today we are announcing a major initiative intended to realize these goals as e-pedigree information becomes more widely available over the next few years.

NABP is the independent, international, and impartial Association that assists its member boards and jurisdictions in developing, implementing, and enforcing uniform standards for the purpose of protecting the public health.