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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 550+ 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.

Precious Parcels: Smarter Shipping Preserves Health and Safety Around the Globe

As the coronavirus pandemic continues to take a toll on people and businesses worldwide, Logistyx remains committed to serving as a trusted advisor to our customers as they adjust their parcel shipping strategies to sustain the health and safety of the global populations they serve. In awe of what’s being done, we think this great work deserves some recognition.

Investigational Coronavirus Treatment Reaches Patients Faster

Leading biopharmaceutical company, Gilead Sciences, has been contributing towards the global effort to fight the pandemic with its investigational drug which is currently being trialed against the novel coronavirus that causes COVID-19.

ebook logistyx quadrant Choosing a TMS for Parcel ShippingWhat better way to ship a medicine quickly than using Logistyx’s technology? To more promptly move shipments of this investigational medicine past holding at points of entry, Gilead called on Logistyx to add a new medically approved carrier service to its network to fast track the process. After reconfiguring codes within the Logistyx system to print carrier-compliant service labels, Gilead was able to quickly test print and integrate the labels to rapidly increase delivery speed of this medicine from its manufacturing location to medical facilities in need around the globe.

We commend Gilead for shipping swiftly to positively contribute to the fight against COVID-19. While this pandemic is grueling for all businesses, those that successfully reorganize to evolve along with the marketplace can help customers persevere, adapt and ultimately thrive.

To see how your company can efficiently modify shipping strategies to manage the impact of COVID-19 and prepare for its future effects, contact us today.

Logistyx TMS Streamlines Shipping

Bausch + Lomb standardizes distribution – improving end-to-end visibility and saving at least half a day in labor costs every week.

As one of the most highly respected and well known healthcare brands in the world, Bausch + Lomb need to ensure the distribution of their products is smooth and seamless to maintain their integrity in the industry and keep their customers happy.However, a complex in-house system combined with huge growth within the organization was making this difficult to achieve. Having developed their own distribution tool in an attempt to streamline the order process, Bausch + Lomb were faced with all sorts of problems soon after implementation.


Carrier Management and Compliance – Bausch + Lomb was using 25 different carriers, each with their own different services and types of barcodes, which were not always compatible with Bausch + Lomb’s software. Label maintenance for this large number of carriers was extremely labor-intensive and was costing the company a lot of money. They needed a system that could link all of their carriers and enforce carrier compliance.

Tracking – Before adopting the Logistyx TMS for parcel shipping solution, Bausch + Lomb had to track thousands of items, all on different carrier sites, every week. This was extremely time consuming and costly. The system was unable to track orders all the way through the delivery process and Bausch + Lomb couldn’t confidently inform customers of exact delivery times. They needed to streamline their processes so that they could efficiently manage distribution and improve the information flow.


The Logistyx TMS for parcel shipping supports the tariffs, services and special fees for all carriers and links the information so that it is accessible via one system. This eliminates the need to work on different carrier sites and in different languages. The Logistyx TMS produces all of the appropriate shipping documentation including labels, manifests and commercial invoices, eliminating manual document production.The Logistyx TMS reporting capabilities allow Bausch + Lomb to access all of the necessary performance data to provide the right information to the right people when they need it.


The Logistyx TMS has standardized Bausch + Lomb’s distribution. Operations are much more seamless and efficient. The company has reduced shipping costs while improving shipping visibility. The system:

  • Provides full visibility from order to delivery, all on one platform. This has saved Bausch + Lomb a lot of time, as previously they were tracking orders on each individual carrier site.
  • Helps Bausch + Lomb increase productivity, saving at least half a day in labor costs every week.
  • Provides tracking to provide customers with shipping status updates. As a result, Bausch + Lomb has improved customer satisfaction rates.

Please contact us for a complimentary consultation today. You can contact us by phone at 877-755-2374 or via email at info@logistyx.com.