Pharma Manufacturers Now Have FDA Draft Guidance on Securing the Drug Supply Chain

Agency issues new draft guidance to help companies comply with the 2013 Drug Supply Chain Security Act (DSCSA).

The 2013 Drug Supply Chain Security Act (DSCSA) was passed by Congress with the intention of establishing electronic systems for controlling the US drug supply chain. The law requires that a system for tracking and tracing prescription drugs as they travel through the supply chain be in place by 2023. The goal is to prevent counterfeiting of prescription drugs, as well as theft and contamination. Distributors must notify FDA and their trading partners within 24 hours if they find an illegitimate product. Requirements for tracing product information for different members of the supply chain are also established by the law. Manufacturers, re-packagers, wholesale drug distributors (WDDs), third-party logistics providers (3PLs) and dispensers are all impacted. FDA also must establish national standards for the licensing of WDDs and 3PLs.

The recent draft guidance, “Identifying Trading Partners Under the Drug Supply Chain Security Act," was issued by FDA to aid companies and governments in determining which categories different organizations fall into, according to the DSCSA, and which organizations must obtain licenses and comply with annual reporting requirements.

In the document, FDA notes that there has been confusion with respect to defining a wholesale distributor, wholesale distribution and a manufacturer’s affiliate. "For example, there has been confusion as to whether DSCSA licensure and reporting requirements apply to certain types of entities, such as but not limited to jobbers, brokers, and certain contractors and solution providers," FDA says, explaining when manufacturers, repackagers, WDDs, 3PLs and dispensers are considered trading partners under the DSCSA.

The agency notes that manufacturers, repackagers, WDDs, 3PLs and dispensers are considered trading partners when each "accepts or transfers direct ownership of a product from or to a manufacturer, repackager, wholesale distributor or dispenser. 

FDA will hold a total of three public meetings to discuss the provisions of the DSCSA and is expected to cover topics including supply chain security in 2023 and enhanced drug distribution needs. One meeting was held in August. Others are scheduled for early December 2017 and late February 2018.


Nigel Walker

Mr. Walker is the founder and managing director of That’s Nice LLC, a research-driven marketing agency with 20 years dedicated to life sciences. Nigel harnesses the strategic capabilities of Nice Insight, the research arm of That’s Nice, to help companies communicate science-based visions to grow their businesses. Mr. Walker earned a bachelor’s degree in graphic design with honors from London College of Communication, University of the Arts London, England.