FDA finalises DSCSA verification systems guidance

The FDA has published the final version of a guidance document covering verification systems used by supply chain partners under the Drug Supply Chain Security Act (DSCSA).

The new document – Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs; Guidance for Industry; Availability – covers the verification systems that manufacturers, repackagers, wholesale distributors, and dispensers of prescription medicines must have in place when the DSCSA is fully implemented next year.

Specifically, the guidance covers the statutory verification systems requirements that include the quarantine and investigation of a product determined to be suspect and the quarantine and disposition of a product determined to be illegitimate, according to the FDA. It updates a draft document published last year, which in turn updated a version released in 2018.

It also lays out the processes needed to meet the statutory requirement for notification to the FDA of a product that has been cleared by a trading partner after a suspect product investigation because it is determined that the product is not an illegitimate product, as well as the requirement for responding to requests for verification and processing saleable returns.

Among the changes included in the final version is the removal of a clause saying that a trading partner would have to quarantine any product suspected of being illegitimate if it does not receive a response to a trading partner enquiry within 24 hours.

Other changes include clarification that dispensers need not provide transaction information for saleable return product, and that “verification” involves confirming that the product identifier affixed or imprinted upon a package or homogeneous case corresponds to the Standardized Numerical Identifier (SNI) or lot number and expiration date assigned to the product.

The DSCSA was scheduled to go into full implementation on November 27 this year, but the FDA responded to pleas for more time with a new deadline set for the same date in 2024 after what it called a “stabilisation period” that should be used to “implement, troubleshoot and mature" the systems that will need to be in place. It is widely anticipated that there will not be any further delay.

The legislation is now approaching a decade in the implementation phase since it was enacted in 2013, and requires trading partners in the pharma supply chain from manufacturers to pharmacies to install traceability systems that allow prescription medicines to be tracked at the pack level, using serialised codes.

The objective is that manufacturers can respond in real-time to queries about the legitimacy of a product, to improve the security of the supply chain and prevent counterfeit and otherwise illicit medicines reaching patients.