Earlier in the summer, the FDA issued a quartet of guidance documents setting forth the Agency’s plan for implementing requirements under the Drug Supply Chain Security Act (DSCSA). The DSCSA directs FDA to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States. It also requires that FDA establish national licensure standards for wholesale distributors and third-party logistics providers and establishes requirements for these entities to issue annual reports to FDA. Taken as a whole, these new guidances clarify FDA’s expectations for stakeholders to comply with the law to achieve a safer, more secure, and more trusted drug supply chain.
The DSCSA requires manufacturers and repackagers to put a product identifier on drug packages and homogenous cases. Product identifiers include the product national drug code (NDC), serial number, lot number, and expiration date, and, as clarified by FDA, are in addition to linear barcode requirements. The final guidance, Product Identifiers Under the Drug Supply Chain Security Act, Questions and Answers, sets forth requirements for the format of product identifiers under the DSCSA as well as procedures for implementing changes to incorporate identifiers. It clarifies FDA’s interpretation of these requirements, including what constitutes a package or homogenous case (here, the smallest saleable unit). The guidance also provides additional clarification on how to affix or imprint multiple barcodes on a label with sufficient space to avoid confusion in reading and scanning, and it states that suppliers with responsibility for affixing product identifiers must comply with current Good Manufacturing Practices.
Suspect and Illegitimate Products
The revised draft guidance, Definitions of Suspect Product and Illegitimate Product for Verification Obligation under DSCSA, defines “suspect” and “illegitimate” products. These include products that are “counterfeit,” “diverted,” part of a “fraudulent transaction,” or “unfit for distribution.” The revised guidance also adds a definition for a stolen product: “any product in its entirety (i.e., the prescription drug and its packaging) that has been taken or removed without permission of the owner of the product (e.g., a bottle and all of its content of drug are taken or removed from the trading partners, or product taken as the results of cargo theft, warehouse theft, or courier theft).” It also clarifies the definitions of “unfit for distribution” and “fraudulent transaction.” Specifically, the guidance clarifies that for a product to be “unfit for distribution,” not only must it violate the Federal Food, Drug, and Cosmetic Act (FFDCA), but there must also be “a reason to believe or credible evidence [to show] that the product would be reasonably likely to result in serious health consequences or death to humans.” For a product to be subject to a fraudulent transaction, the transaction documents must contain information that has been “knowingly” falsified by a trading partner.
Identification of Suspect Products and Notification to FDA
The final guidance, Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification, is intended to aid certain trading partners (manufacturers, repackagers, wholesale distributors, and dispensers) in identifying a suspect product, and to highlight situations that could increase the risk of a suspect product entering the pharmaceutical distribution supply chain. The guidance also outlines a process for trading partners to notify FDA and each other of suspect and illegitimate products. Updates made in the final guidance include
- clarification that trading partner notifications should generally be made to those entities to which a product was sold and, in some cases, those entities from which a product was received;
- the recommendation that when identifying whether a product may be suspect or illegitimate trading partners consult with the product manufacturer because the manufacturer is usually best able to assess product authenticity and quality;
- clarification regarding when a product may pose a “high risk of illegitimacy”;
- a statement that, when a product does not require DSCSA reporting but is otherwise violative of the FFDCA, FDA suggests that the trading partner report the product to FDA through the appropriate mechanisms.
Enhanced Drug Distribution Security
The new draft guidance, Enhanced Drug Distribution Security at the Package Level under DSCSA, is intended to assist supply chain stakeholders with compliance with the DSCSA’s requirements for enhanced drug distribution security at the package level, which will go into effect on November 27, 2023. The guidance addresses areas such as system attributes for the enhanced system, ways to meet system requirements (such as aggregation and inference), physical security features, data architecture for enhanced systems, data and system security recommendations, the protection of confidential commercial information and trade secrets, system access and data retrieval limits, and methods of enhanced product tracing and verification.
Although much of FDA’s efforts over the last year and a half has been focused on responding to the COVID-19 pandemic, FDA has not lost sight of other areas within its regulatory agenda. This suite of guidances indicates that FDA is looking past COVID-19 and preparing for future regulatory initiatives, including those that will not go into effect for several years. These guidances also show that FDA is responding to feedback it has received regarding its current DSCSA programs. Particularly, through the revision of the two guidances on suspect and illegitimate products, FDA is attempting to add more specificity to areas that have created uncertainty for trading partners over the last five years. Finally, through the guidances on suspect and illegitimate product reports, it appears that FDA is focusing its efforts and resources on those events that present more serious potential health issues and therefore demand more FDA concern and attention.