Washington, DC – December 4, 2013 – Bryan Cave LLP’s Government Affairs Team, led by Senior Policy Advisors Bill Applegate and Chris Rorick in the firm’s Washington, D.C., office, helped secure passage of H.R. 3204, the Drug Quality and Security Act, which establishes a strong, uniform federal prescription drug-tracing standard, on behalf of the Health Industry Distributors Association (HIDA). The bill was signed into law by President Barack Obama on Nov. 29.
The passage of this bill marks a milestone in the industry’s efforts to create a uniform, national pedigree solution. Congress passed the Prescription Drug Marketing Act (PDMA) in 1987, creating a chain of custody tracking requirements for distributors of prescription drugs and related products. These tracking requirements, known as product “pedigrees,” were intended to ensure the safety and integrity of the pharmaceutical supply chain, a multistep distribution process that ensures providers and patients receive the wide range of life-saving medical-surgical products they require.
However, there was no national standard pedigree, leading to confusion in the industry. Currently, there are also 29 states that have passed pedigree laws of their own, adding to the patchwork of competing and overlapping legislation and regulation. Complying with a quickly expanding list of individual state requirements is costly, onerous and inefficient, especially for small businesses that distribute prescription products in order to serve their customers’ unique needs.
H.R. 3204 creates a national pedigree standard that will help secure the drug supply chain and ease the burden of compliance on distributors. The act establishes requirements that allow for the tracing of prescription drug products through the pharmaceutical supply distribution chain. The new “track-and-trace” requirements are expected to help prevent contaminated or counterfeit drugs from entering the supply chain and to allow for the faster recall of tainted products. At full implementation, the law will require each package of drugs to be electronically traceable throughout the supply chain.
Bryan Cave and the HIDA collaborated with other stakeholders, including the Pharmaceutical Distribution Security Alliance (PDSA), to urge Congress to pass this legislation.
The HIDA is the premier trade association representing medical products distribution. HIDA members primarily serve the nation’s hospital, long-term care and physician/alternative care markets.
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