This article is not intended as legal advice and should not be used as such. When legal questions arise, pharmacists should consult with attorneys familiar with the relevant drug and pharmacy laws.
Ned Milenkovich is chair of the Healthcare Law practice
The bicameral legislation provides specific requirements for all stakeholders in the drug-distribution supply chain, including manufacturers, wholesalers, repackagers, and pharmacies.
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 drug 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-drug track and trace system. The House passed the bicameral legislation, in the form of H.R. 3204, on September 28, 2013.
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 drugs containing product identifiers, and within seven years dispensers may receive only prescription drugs with product identifiers.
The bicameral legislation also requires supply-chain distribution stakeholders to implement a system that ensures the legitimacy of a prescription drug, in order to minimize counterfeiting, adulteration, or introduction of prescription drugs into commerce by illegitimate means. If a drug product is suspected to be illegitimate, stakeholders are required to take action to eliminate it from the supply chain.
The federal legislation allows for transmission and recordkeeping of drug pedigrees to occur by either paper or electronic means. However, an “interoperable electronic system” must be implemented within 10 years of the new law.
The Food and Drug Administration (FDA) is very likely to issue compliance policy guides in connection with the various track and trace legislative requirements. FDA will also be tasked with establishing pilot programs in order to evaluate various methods of increasing safety and security of the prescription-drug distribution supply chain.
Of note, the bicameral legislation contains wholesaler and 3PL licensing requirements. If states do not mandate licensing provisions, the bicameral legislation provides for the creation of national wholesaler and 3PL licenses. Fees for licensing in the states will still inure to the benefit of the states.
In addition to the licensing requirements, beginning on January 1, 2015, a wholesaler and 3PL must submit annual reports to the FDA. The reporting requirements include: information regarding each state of wholesaler or 3PL licensure; name and address of each facility; and contact information.
The proposed bicameral legislation is currently bound to the compounding federal legislation. Nevertheless, it appears to have broad support from both Congressional chambers, as well as bipartisan political support. With House passage already a reality, and the Senate set to vote on it, it would appear that federal prescription-drug track and trace law is imminent.
This article is current as of press time. Due to the fluid nature of HR 3204, it may have become law by the time the November 2013 issue of Drug Topics is published.