The Federal Food and Drug Administration (“FDA”) recently published a draft guidance to assist industry and State and local governments in understanding how to categorize entities in the drug supply chain in accordance with the Drug Supply Chain Security Act (“DSCSA”). The DSCSA establishes product tracing, licensure, reporting, and other requirements for certain trading partners in the drug supply chain, including manufacturers, repackagers, wholesale distributors, dispensers, and third-party logistics providers or 3PLs.

Since November 2013, when the DSCSA became law, many clients have been concerned about whether and the extent to which the DSCSA applies to certain segments of the pharmaceutical supply chain industry. Other clients have been concerned about how to satisfy applicable DSCSA requirements for being considered an “authorized” trading partner, and whether some partners – such as solutions providers and logistics and administrative services contractors – should be considered a DSCSA trading partner at all.

The FDA’s draft guidance helps to address many of these concerns. Among other things, it clarifies the applicability of DSCSA requirements to entities that take part in the distribution of prescription drugs in the United States. It also explains when and whether such entities are engaged in activities that require licensure and annual reporting, as well as other requirements related to being an “authorized” trading partner in the drug supply chain, as defined by the DSCSA.