The US Food and Drug Administration (FDA) has issued a draft guidance, Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification, which is intended to aid trading partners (manufacturers, repackagers, wholesale distributors, or dispensers) in identifying a suspect product and terminating notifications regarding illegitimate product. The FDA issued the draft guidance in line with its implementation efforts of the Drug Supply Chain Security Act (DSCSA), which was signed into law (Title II of Public Law 113-54) on November 27, 2013. The DSCSA outlines critical steps to build an electronic, interoperable system over the next 10 years that will identify and trace certain prescription drugs as they are distributed within the United States.
Under the draft guidance, beginning on January 1, 2015, a trading partner that determines that a product in its possession or control is an illegitimate product must notify the FDA and its immediate trading partners no later than 24 hours after making the determination. The draft guidance identifies specific scenarios that could significantly increase the risk of a suspect product entering the pharmaceutical distribution supply chain; provides recommendations on how trading partners can identify the product and determine whether the product is a suspect product as soon as practicable; and sets forth the process by which trading partners should notify FDA of illegitimate product and how they must terminate the notifications in consultation with the FDA.
The draft guidance specifies that beginning no later than January 1, 2015, trading partners must have systems in place that enable them, upon determining that a product in their possession or control is suspect or upon receiving a request for verification from the FDA, to quarantine suspect product and promptly conduct an investigation, in coordination with other trading partners, as applicable, to determine whether a suspect product is illegitimate.
The guidance does not address all provisions of the DSCSA related to suspect and illegitimate products. As the FDA works to implement other provisions of the DSCSA, the FDA says it intends to issue additional information to support efforts to develop standards, issue guidance and regulations, establish pilot programs, and conduct public meetings.
See related story, "FDA Begins Implementation Efforts for Drug Supply Chain Security Act"