• Drug Supply Chain Security Act

This post is Part 1 of the Series: Understanding The Drug Supply Chain Security Act and What it Means for Pharmaceutical Distribution Companies.  

If you’ve had any association with the pharmaceutical industry over the past 2-3 years, it would be a safe bet to say that you are probably “aware” of the FDA requirements “Drug Supply Chain Security Act (DSCSA)”, signed into law by President Obama in November 2013.

The DSCSA was written in an attempt to provide guidance to the pharmaceutical industry relating to the traceability of pharmaceutical products in the supply chain. The idea is to provide all trading partners the ability to easily identify and determine if product(s) in the supply chain are legitimate or have been injected into the system for illegitimate reasons. The DSCSA also provides requirements to help businesses in the distribution supply chain ensure all trading partners are legitimate, with active and non-revoked licenses.

Now, more than 3 years later, although most players in the pharmaceutical industry know about the Drug Supply Chain Security Act and general requirements, the specific details and timing of various phases are still a bit foggy.

As expertsin the industry, the FDA have put together many reports, presentations, slide shows etc. available on the topic for review by anyone interested.  However, many small pharmaceutical distribution businesses do not have the time or bandwidth to stay current with constantly changing regulations. To help summarize the DSCSA requirements and what it means to the pharmaceutical distribution industry, we will be writing a series of posts that summarize the important details and current implementation times.

Throughout the series, we will dissect the Drug Supply Chain Security Act and applicable information available, into reasonable segments and provide information needed to allow distributors to get a better understanding of the act and how it will impact their operations now and in the future.

Topics in the Series include:

  • Product Traceability (Transaction Report) – Requirements for tracking products and recording information as part of Transaction Reports (T3).
  • Suspect and Illegitimate Product Handling and Notification – What to look for now and in the future as product packaging changes.
  • Product Identification (Serialization) – Understanding the implementation of the Standardized Numerical Identifier (SNI) and how and when trading partners are required to comply.
  • Report Licensure – Requirements as to what information to submit to the FDA. Ability to track information pertaining to trading partners within the supply chain to ensure they have an active (not expired or revoked) license, for a specific location.
  • Managing the Data – What’s needed to manage all the information.

Stay tuned for the next post in the Series about Transaction Reports (T3) and be sure to subscribe to our blog for more information!

1 The content of the FDA presentations is intended only to provide a summary and general overview. They are not intended to be comprehensive nor do they constitute legal advice.

DSCSA Requirements