A bill aimed to ensure the security of pharmaceuticals in the drug supply chain has passed the United States House of Representatives. The “Safeguarding America’s Pharmaceuticals Act of 2013” (HR 1919) would require Food and Drug Administration (FDA) to develop and implement regulations for tracking pharmaceutical products through each step of the drug distribution chain, from manufacture, to distribution, to dispensing. FDA would also be required to implement regulations for licensing “certain third parties that provide logistic services to support pharmaceutical manufacturers, wholesalers, and dispensers,” indicates the Congressional Budget Office in its analysis of the bill. The bill is sponsored by Congressman Bob Latta (R-OH). Another bill aimed to safeguard the pharmaceutical supply chain was introduced to the US Senate in May 2013. The Drug Supply Chain Security Act (S 957) would require FDA to establish a nationwide electronic tracking system to monitor the movement of drugs in the supply chain, and requires the system to be implemented within 10 years. A news release available on the Web site of Senator Michael F. Bennett (D-CO), the bill’s sponsor, states that the bill “establishes a workable pathway to unit-level tracing in a decade.”
To help protect the public from counterfeit, adulterated, and substandard drugs, National Association of Boards of Pharmacy® (NABP®) and the state boards of pharmacy established the Verified-Accredited Wholesale Distributors® (VAWD®) program in 2004 and the initiative received the support of FDA. Since its launch, over 560 facilities across the country have become VAWD accredited. Of the 21 states that recognize VAWD, Indiana, North Dakota, and Wyoming require VAWD accreditation as a component of licensure. The role of VAWD in helping to protect US patients from counterfeit and substandard drugs has been highlighted by the Institute of Medicine, which, in a recent report on counterfeit drugs, recommended that all state boards of pharmacy should require VAWD accreditation as a requisite for licensure. More information about the VAWD program is available in the Programs section of the NABP Web site.