Federal Track-and-Trace Legislation Imminent

By Milenkovich, Ned | Drug Topics, November 2013 | Go to article overview

Federal Track-and-Trace Legislation Imminent


Milenkovich, Ned, Drug Topics


Congressional leaders agree on bicameral legislation

As both federal and state legislation concerning track and trace continues to evolve, a closer look at pending federal legislation becomes increasingly appropriate. As is well settled, California's electronic pedigree requirement will begin in 2015, absent implementation by Congress of a national prescription chug track-and-trace law. Proposed federal legislation would generally preempt or supplant any state legislation, including that of California.

In June 2013, the House passed H.R. 1919, which would create a national track-and-trace system. The Senate passed a similar bill in the form of S. 959. Most recently, on September 25, 2013, Senate and House committee leadership agreed on bicameral legislation that would amend the Federal Food, Drug, and Cosmetic Act to address the issue of compounding pharmacies while also incorporating a national prescription-chug track-and-trace system. The House passed the bicameral legislation, in the form of H.R. 3204, on September 28, 2013.

Stakeholder requirements

The bicameral legislation provides specific requirements for all stakeholders in the drug-distribution supply chain. This includes manufacturers, wholesalers, repackagers, and pharmacies.

The current Senate bill requires third-party logistics providers ("3PL") to be responsible for drug pedigrees, while the bicameral legislation does not.

The bicameral legislation requires manufacturers to provide product identifiers on prescription-drug products produced within four years of enactment of the law, while repackagers are required to include it within five years. However, the bicameral legislation mandates that manufacturers, wholesalers and repackagers, provide and/or receive drug pedigrees by January 1, 2015, while dispensers must do so by July 1,2015. In addition, within six years wholesalers must accept and distribute only prescription chugs containing product identifiers, and within seven years dispensers may receive only prescription drugs with product identifiers.

Legitimation

The bicameral legislation also requires supply-chain distribution stakeholders to implement a system that ensures the legitimacy of a prescription chug, in order to minimize counterfeiting, adulteration, or introduction of prescription chugs into commerce by illegitimate means. …

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