NABP and FDA Partner on Combating Counterfeit Drugs

February 18, 2004 12:00 AM

The National Association of Boards of Pharmacy® (NABP®) participated in a press conference in Washington, DC, on Wednesday, February 18, 2004, convened by United States Department of Health and Human Services Secretary Tommy G. Thompson and Food and Drug Administration (FDA) Commissioner Mark McClellan to discuss strategies for ensuring that the US medication distribution system remains the most secure and protected in the world. The press conference concluded months of discussions and investigations by FDA to address challenges to maintaining the integrity of the US medication distribution system.

In a report released at the press conference, FDA recognized the important role states play in regulating wholesale drug distributors and supported NABP's efforts, and corresponding efforts of the states, to adopt and implement NABP's revised Model Rules for the Licensure of Wholesale Distributors, which is a part of the Model State Pharmacy Act and Model Rules of the National Association of Boards of Pharmacy.

NABP convened a task force in October 2003 to revise its Model Rules on the Licensure of Wholesale Distributors. The Task Force proposed major revisions to the Model Rules through an intense effort that focused on regulatory actions in Florida and Nevada and involved all aspects of the wholesale distribution industry, as well as federal and state regulators. The NABP Executive Committee approved the revised Model Rules, which include more stringent licensing requirements — background checks and extensive disclosure, reduced incentives to counterfeit through more complete pedigrees and accountability of responsible personnel, inspections and due diligence procedures prior to transactions, development and maintenance of a national list of susceptible products, electronic pedigree requirements by 2007, implementation of trace and track technologies, random and for cause authentications of pedigrees, and tougher administrative and criminal penalties for violations.

NABP believes that only through a partnership of federal and state regulators and the wholesale drug industry can the US distribution system retain its integrity and continue to serve as the standard by which other medication distribution systems in the world are compared. NABP President Donna S. Wall commented that, "Today marks another historic achievement for the FDA and NABP and a demonstration that a federal-state partnership works and provides the most effective means for combating counterfeit drugs. Patients in the US can rest assured that the medication distribution system remains safe and will improve as new technologies are implemented."

NABP will be releasing its revised Model Rules on Friday, February 20, and will work with its member state boards and the wholesale drug industry to adopt and implement the revised Model Rules. Adoption of the Model Rules by the state boards of pharmacy will provide national and uniform regulation for the licensure of wholesale distributors. NABP will also be releasing a List of Susceptible Drug Products next week to avoid the need for individual states to develop their own list of drug products that are susceptible to counterfeiting.

The NABP Wholesale Distributor Clearinghouse, created to accredit wholesale distributors for the states, will be operational by mid 2004. NABP President Wall addressed the role of NABP and its Wholesale Distributor Clearinghouse, asking states "to adopt the Model Rules and recognize the NABP Wholesale Distributors Clearinghouse as the means for establishing uniform licensure requirements that will prevent illicit operators from locating in a state with the less stringent requirements. States supporting NABP and its Wholesale Distributor Clearinghouse will create uniform standards and regulation for a safe and productive environment for the wholesale distribution of medications."

Renee Renganathan