After nearly 10 years since the Drug Supply Chain Security Act (DSCSA) was signed into law, the deadline for tracking and tracing serialized pharmaceutical products across the US supply chain will come into force in November this year.

Most manufacturers have plans and ongoing activity in place to meet this deadline. However, some, often for very good reason, do not. If you fall into this latter category, read on. If you do have plans and activities in place, then chances are that you have worked with one of the Be4ward team at some point over the last 15 years in developing them.

DSCSA requires manufacturers to put in place several significant elements to help secure the US pharmaceutical drug supply chain:

• Formal procedures to manage suspect and illegitimate product, including quarantine, disposition, and reporting management.
• Ensuring you only trade with Authorized Trading Partners, including appropriately licenced 3rd Party Logistics organizations (3PL).
• Serializing commercial products with Product Identifiers at the smallest saleable unit and shippers, including aggregation.
• Electronic "T2" serialized product data exchange with downstream Authorized Trading Partners on the sale of products, which in turn often requires data exchange between internal supply chain partners.
• Having the ability to resolve issues in a timely manner, to ensure legitimate product flows as smoothly as possible across the end-to-end supply chain and that sales are made on time, in full.
• Being able to respond to legitimate requests for product verification and tracing information from Authorized Trading Partners, the Secretary or other appropriate Federal or State officials. Part of this activity includes ensuring the requesting party is legitimate.
• Keeping records of the above.

There are many ways to achieve the above, depending on the nature of your supply chain and the scale of your operations. For smaller manufacturers, this will often involve working closely with and coordinating activity across several internal functions, Contract Manufacturing/Packaging Organizations (CMO / CPO), 3rd Party Logistics organizations (3PL), Wholesalers or Specialty Pharmacies and product traceability system vendors.

If you are unsure that your company understands these requirements fully, or that your plans will get you to compliance on time, we are here to help.

Be4ward is one of the longest standing serialization and traceability consultancies, with a team of senior specialists that have worked with many manufacturers, industry groups and standards organizations over the last 15 years, delivering successful serialization solutions.