FDA drops some long-awaited DSCSA guidance documents

With the deadline for full medicines traceability in the US approaching its 2023 deadline, the FDA has released guidance documents to help supply chain partners prepare.

The regulator has finalised two guidance documents and published draft versions of two more that will be used to phase in the stepwise requirements of the 2013 Drug Supply Chain Security Act (DSCSA), which required a full track-and-trace system for medicines distributed in the US market to be in place within 10 years.

The DSCSA expects pharmaceutical manufacturers to assign unique identifiers to pharmaceuticals and have interoperable systems in place with trading partners so they can be tracked through the supply chain by November 27, 2023, to prevent drug counterfeiting and diversion and increase traceability.

The framework requires aggregation – linking each medicine pack to the case or pallet it is shipped in – as well as inference systems to allow trading partners to infer the contents of a pack case or pallet without having to open it. It also mandates electronic systems for verifying returned products from wholesale distributors that can be resold.

The two finalised guidance documents include one covering identification of suspect product and notification – issued in draft form in 2016 – while the second is a question and answer document about the use of produce identifiers.

The suspect product document is intended to aid certain trading partners in identifying a suspect product in the supply chain and details scenarios that could significantly increase the risk of encountering one, and also describes how they should notify the FDA when illegitimate product is identified.

The Q&A document meanwhile answers industry queries about the product identifier, which comprises the product national drug code (NDC), serial number, lot number and expiration date on each package and homogenous case of product, in both human- and machine-readable form.

The first of the new draft guidances is a revision of the definitions of suspect product and illegitimate product for verification obligations first published in 2018, and lays out the FDA's current understanding of terms like "counterfeit," "diverted," "stolen," "fraudulent transaction" and "unfit for distribution."

The brand new draft guidance meanwhile is entitled enhanced drug distribution security at the package level under DSCSA, and as its name suggested provides recommendations on the system attributes necessary for enabling the secure tracing of product at the package level.

It covers system structure including data architecture, incorporation of the product ID into tracing information, and enhanced verification of distributed and saleable returned products as well as alerts for illegitimate packs that will become mandatory in 2023.

"Ensuring the quality of prescription drugs and safeguarding the integrity of pharmaceutical distribution are crucial roles the FDA plays in protecting the health of the American public," said Donald Ashley, director of the FDA's Office of Compliance.

"To help our stakeholders understand these requirements, we are issuing guidance documents intended to assist trading partners in complying with the law and achieving a safer, more secure and more trusted drug supply chain," he added.

"We are also soliciting feedback for further improving the way our drug supply chain operates within the DSCSA framework."

Comments can be submitted on the two draft guidances until August 3.