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Drug Supply Chain Security Act: Working with Trusted Partners to Ensure Industry Compliance

In 2013, the US Food and Drug Administration (FDA) signed the Drug Supply Chain Security Act (DSCSA) into law, establishing requirements for manufacturers, distributors and other entities involved in the drug supply chain for product tracing, product identifiers, authorized trading partners and product verification. With implementation over a 10-year period, the DSCSA enhances the FDA’s ability to help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated or otherwise harmful. The system also improves detection and removal of potentially dangerous drugs from the drug supply chain to protect U.S. consumers.

Since its signing in 2013, the DSCSA has presented significant challenges for the pharmaceutical industry. To help the industry meet DSCSA requirements, companies throughout the supply chain have developed technology to ensure safety and security measures can be properly achieved in accordance with the FDA’s industry guidance.

Logistyx helps shippers in the pharma industry ensure that every parcel ships with the correct label and documentation, no matter the carrier, destination or product. Logistyx has integrated with a worldwide network of 8,500+ carrier services to provide regulatory compliance and certification for each shipment. When shipping a specialized product like pharmacological drugs that require extra documentation, Logistyx provides the necessary documents to comply with complex regulations like those required by the DSCSA.

While full implementation of the DSCSA goes into effect on November 27, 2023, the next major milestone for pharmaceutical companies and all trading partners within the pharmaceutical supply chain is coming up on November 27, 2020. As of that date, the FDA will enforce wholesalers to only accept and sell serialized products and verify the serialized number on all saleable returns, and dispensers to only accept serialized product.

For medical drug manufacturers and others involved in the pharma supply chain, it is critical to begin preparing their company for the next phase of DSCSA readiness and compliance, as well as asking questions of their strategic partners.

As stated in the FDA’s guidance document, “Identifying Trading Partners Under the Drug Supply Chain Security Act,” while serving as a solution provider that offers software or systems solutions to help achieve compliance with the requirements under DSCSA, Logistyx does not:

  • take ownership of the product nor direct the sale or disposition of a product
  • provide or coordinate warehousing
  • accept or transfer direct possession of the product

Therefore, Logistyx is not considered a 3PL under the DSCSA and is thus not required to be compliant with DSCSA regulations. However, we would advise shippers and suppliers of medical treatments and drugs in the pharma industry to ensure that certain types of partners are indeed compliant, if they may fit the 3PL licensure requirements under DSCSA in accordance with these guidelines.

To help manage the details of your specialized shipping needs and all the necessary labels, documents, and procedures to ensure compliance, contact us today.