June 03, 2021

The following quote is attributed to Donald D. Ashley, J.D., Director of the Office of Compliance for FDA’s Center for Drug Evaluation and Research

“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. Illegitimate and unsafe products must be kept out of the U.S. drug supply chain.

Since 2013, when the FDA began phasing in new requirements added by the Drug Supply Chain Security Act (DSCSA), we have helped create a supply chain that is better at preventing and detecting the introduction of illegitimate products. The new requirements can also enable stakeholders and the FDA to respond rapidly when such products are found.

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. We are also soliciting feedback for further improving the way our drug supply chain operates within the DSCSA framework. We view these guidance recommendations as an important part of implementing the robust enhanced system envisioned under DSCSA.

We look forward to continuing open conversations on DSCSA-related issues and providing future guidance to stakeholders as part of our efforts to protect American patients and the drug supply chain we all rely on.”

Additional Information

• Today, the U.S. Food and Drug Administration is finalizing two guidance documents and making available two draft guidance documents to help ensure that prescription drugs are identified and traced properly as they move through the supply chain. These guidance documents lay out the FDA’s recommendations for how to comply with applicable DSCSA requirements, including those for enhanced drug distribution security at the package level that go into effect in November 2023.
• As part of the DSCSA, manufacturers and repackagers are required to put a product identifier on drug packages. This includes the product national drug code (NDC), serial number, lot number and expiration date on each package and homogenous case of product, in human- and machine-readable form. The machine-readable form is generally a two-dimensional data matrix barcode. Industry questions are clarified in the final guidance, Product Identifiers Under the Drug Supply Chain Security Act, Questions and Answers.
• Additionally, the final guidance Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification is intended to aid certain trading partners in identifying a suspect product and specific scenarios that could significantly increase the risk of a suspect product entering the pharmaceutical distribution supply chain. The guidance also describes how trading partners should notify the FDA of illegitimate product and sets forth a process for terminating notifications of illegitimate product in consultation with the FDA. In addition, this guidance describes when manufacturers should notify the FDA of a high risk that a product is illegitimate. This guidance responds to comments from stakeholders to clarify certain points and finalizes the remaining draft portion of the otherwise final guidance for industry, Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification issued in December 2016.
• The revised draft guidance, Definitions of Suspect Product and Illegitimate Product for Verification Obligation under DSCSA, lays out the FDA’s current understanding of terms used to define “suspect” and “illegitimate” products. These include “counterfeit,” “diverted,” “stolen,” “fraudulent transaction” and “unfit for distribution.” In response to comments received from stakeholders, this draft guidance revises the March 2018 draft guidance.
• The new draft guidance, Enhanced Drug Distribution Security at the Package Level under DSCSA, is intended to assist supply chain stakeholders, particularly trading partners, with requirements for enhanced drug distribution security at the package level that go into effect on November 27, 2023. This guidance provides recommendations on the system attributes necessary for enabling the secure tracing of product at the package level.
• Congress enacted the Drug Supply Chain Security Act on November 27, 2013. DSCSA outlines steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States. Additionally, DSCSA directs the FDA to establish national licensure standards for wholesale distributors and third-party logistics providers and requires these entities to report licensure and other information to the FDA annually.

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.