APhA to FDA: As track and trace is implemented, consider disparities between supply chain participants

FDA is making progress on implementing the compounding, track-and-trace law

So much discussion of the new track-and-trace law has been focused on manufacturers and wholesalers, but components of the legislation will affect pharmacists. The track-and-trace law is part of the Drug Quality and Security Act, which is the compounding and track-and-trace legislation enacted in late 2013.

One component of the new law is the exchange of prescription drug change-of-ownership data. On May 8–9, FDA held a public workshop on that issue. On June 9, APhA responded by submitting written comments to the agency. Another component is the identification of suspect drug products in the supply chain. On June 10, FDA issued draft guidance on this issue; APhA plans to respond by the comment due date of August 11, 2014.

Key track-and-trace deadlines for pharmacists include January 1, 2015, and July 1, 2015. As of January 1, manufacturers and wholesale distributors can’t ship anything unless it has a transaction history in the form of paper documentation for each individual unit of a drug. If there’s a glitch, pharmacies can still accept the product until July 1, 2015. Starting on that date, following the 6-month grace period, pharmacists have to reject products without an accompanying transaction history.

FDA is making progress on implementing the law, and currently is collecting information and feedback from APhA and other stakeholders, according to Stacie Maass, BSPharm, JD, APhA Senior Vice President of Government Affairs and Pharmacy Practice.

The track-and-trace law—the Drug Supply Chain Security Act, which is Title II of the Drug Quality and Security Act of 2013—“outlines critical steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States,” according to the FDA website. In 10 years, “the system will facilitate the exchange of information at the individual package level about where a drug has been in the supply chain.”

FDA wrote that “drug manufacturers, wholesale drug distributors, repackagers, and many dispensers (primarily pharmacies) will be called on to work in cooperation with FDA to develop the new system over the next 10 years.” 

Exchange of prescription drug change-of-ownership data

In its June 9 comments on FDA’s public workshop on “developing standards for the interoperable exchange of information for tracing of human, finished, prescription drugs, in paper or electronic format,” APhA noted its appreciation of FDA’s effort to gather information and ideas for the exchange of the transaction information, transaction history, and transaction statement—but discussed several concerns.

The Association noted that “some dispensers may not have sophisticated inventory management systems in place, and these newly formed standards may create substantial financial and logistical challenges for [these] small businesses.” 

The Association also noted that “it may not be feasible for some [pharmacies] to store thousands of paper records, have access to an electronic inventory management system with the capability to store records, or install an electronic inventory management system that is interoperable with the upstream supply chain participant’s electronic system.” 

Because the new track-and-trace law affects all participants in the drug supply chain from global manufacturers to small pharmacies that serve underserved communities, APhA concluded its comments by asking FDA “to consider the disparities between the supply chain participants and their feasibility to implement new requirements.”

FDA is expected to issue draft guidance on this issue by November 27, 2014.

Identification of suspect drug products in the supply chain 

On June 10, FDA issued additional draft industry guidance as a result of the Drug Quality and Security Act on “identification of suspect product and notification.” (FDA has already released draft industry guidance related to compounding.) APhA is working with other stakeholders on feedback and comments by the August 11, 2014, deadline.

The draft guidance identifies specific scenarios that could increase the risk of a suspect product entering the pharmaceutical distribution supply chain, provides recommendations on how pharmacies can identify the product and determine whether the product is a suspect product as soon as practicable, and sets forth the process by which pharmacies should notify FDA of illegitimate product and how they must terminate the notifications in consultation with FDA, according to an analysis by Michael H Ghobrial, PharmD, JD, APhA Associate Director of Health Policy.