Ensure Compliance with the U.S. Drug Supply Chain Security Act (DSCSA)

 

Signed into Federal Law in 2013, the DSCSA is a critical piece of legislation enacted in the United States to safeguard the integrity of the pharmaceutical supply chain. Its primary goal is to protect patients from potentially harmful drugs by ensuring that only genuine and safe medications reach the market.


To achieve this, the DSCSA mandates the implementation of an interoperable electronic system that allows for the tracking and tracing of prescription drugs as they move through the supply chain. Every organization in the pharmaceutical industry must comply with the DSCSA:

  • Manufacturers
  • Distributors
  • Repackagers
  • Dispensers
  • Third Party Logistics Providers (3PLs)

Looking for more information on DSCSA requirements? Speak with one of our industry experts.

DSCSA Requirements

The act established the following requirements:

  Every organization is required to ensure that all prior transaction information is provided at each transfer of ownership.

  In the event of a recall or for the purpose of investigating a suspect product or an illegitimate product, all organizations are required to provide the applicable transaction documentation upon request.

  Manufacturers and repackagers are required to affix or imprint a product identifier on each package and homogeneous case intended to be introduced in a transaction into commerce except for products that are required to have a standardized numerical identifier.

  Every organization is required to ensure that each of their trading partners are authorized.

  Every organization is required to implement systems to:

     Investigate suspect products; and
     Handle illegitimate products, including through quarantine, disposal, & appropriate notice.

  Manufacturers, wholesale distributors, and repackagers are required to verify returned products before further distribution.

Are You Prepared?

DSCSA Interoperability Mandate:

Where we are today
DSCSA requirements
Steps to take in advance of deadline
 
 Stay up to date on compliance.
 
Serialization-by-Covectra

DSCSA Timeline

2013 DSCSA is signed into law by the U.S. Congress.

2015 Initial requirements of the DSCSA, such as product tracing, start to take effect.

2017 Manufacturers must serialize products at the package level, adding unique identifiers and product tracing information.

2018 Wholesale distributors are required to transmit lot level product data. In addition, distributors must verify and authenticate returned drugs (enforcement delayed).

2019 Dispensers, including health system pharmacies, are required to verify and authenticate products before dispensing them to patients.

2020 DSCSA pilot program for enhanced drug distribution security begins.

August 25, 2023 FDA announced an extended stabilization period, which postponed the upcoming enforcement deadline by one year.

November 27, 2023 Full DSCSA implementation enforcement was scheduled to take effect, with comprehensive serialization and tracing requirements.

November 27, 2024 End of stabilization period, full DSCSA compliance enforcement begins.

 

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Connect with Us Today to Get Started

Discover how Covectra's suite of AuthentiTrack serialization products can help your company adapt to the upcoming changes in the U.S. drug supply chain and ensure compliance with the DSCSA.

Stay ahead of industry changes with Covectra's AuthentiTrack serialization. While the FDA recently extended the DSCSA enforcement deadline to November 27th, 2024, it's crucial for all stakeholders to remain proactive in their preparations. Our interoperable software solution and turnkey hardware are your key to ensuring compliance and safeguarding the U.S. drug supply chain.

Covectra stands out by providing comprehensive serialization solutions for all levels of serializations (L1 – L5) encompassing software, hardware, and gateway integration.

 

At Covectra, we understand that staying ahead of regulatory changes and industry challenges is paramount. Our serialization solutions are designed to adapt and evolve alongside the shifting landscape of pharmaceutical regulations, providing you with a future-proof investment in supply chain security.

With Covectra as your partner, you can confidently navigate the complexities of serialization, uphold the highest standards of product safety, and ensure the integrity of your pharmaceutical supply chain. Join us in shaping a safer and more secure future for the pharmaceutical industry.

Get started with Covectra today.

 

Covectra, Inc.