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Navigating DSCSA compliance

What you need to know about the Drug Supply Chain Security Act (DSCSA)

Announcements

DSCSA live training webinars

Join our DSCSA-focused training webinars to master the ABC Order platform and stay compliant.

 
Announcements from the FDA

DSCSA updates as of October 9, 2024

The Food and Drug Administration (FDA) has issued an exemption to any product transacted by all eligible trading partners. Read the announcement below. 

Waivers and exemptions beyond the stabilization period

On June 12, 2024, the FDA announced exemptions for small dispensers from certain requirements of section 582 of the FD&C Act until November 27, 2026, while those who do not meet this exemption can request a waiver, exception, or exemption if they have concerns about readiness or patient access.

Stabilization period of DSCSA until November 2024

The FDA has announced it will not enforce DSCSA until November 27, 2024, allowing an additional year for manufacturers, distributors, dispensers, and trading partners to refine their systems and processes while continuing to show progress and prepare for compliance.

Preparing for the future of the supply chain

Dispenser impact checklist

Sample DSCSA Standard Operating Procedure Template

Understanding the Drug Supply Chain Security Act (DSCSA)

DSCSA frequently asked questions

Understanding GLN requirements

Suspect v. Illegitimate product

Understanding the new returns process


What dispensers should know about DSCSA

Global Location Number (GLN)

A Global Location Number (GLN) is the key to unique location identification. It is a unique number licensed by GS1 US that identifies a single location or business entity in the supply chain. A GLN is required for all locations. GLNs are used to meet the FDA tracing requirements from DSCSA. They also provide critical data in the EPCIS messaging standard that are used in DSCSA transactions. We are loading GLNs from GS1 now, if you don’t already have one, we will provide one. Cencora is actively participating in an industry-wide GLN cleanup led by GS1 to reconcile and remove duplicate GLNs created over the past year, and any changes to GLNs will be reflected in ABC Order.

DSCSA Reporting

Electronic Product Code Information Services (EPCIS), also known as the DSCSA report, file is the automated electronic, interoperable data exchange method for serialized data. By default, we will provide access to the DSCSA report in ABC Order for all Cencora customers. Alternatively, you can work with a third-party vendor solution to have the EPCIS file proactively sent.

Returns

There will be an added step to the returns process as distributors will only be able to accept returns purchased through that distributor originally. You will no longer be able to return bulk product that may have been purchased from multiple wholesalers. Returns will require Standardized Numerical Identifier (SNI). The new returns process still goes into effect August 27, 2025 despite any exemptions.

DSCSA standard operating procedures 

Consider establishing processes and procedures to investigate and properly handle suspect and illegitimate drugs. If you qualify for the small dispenser exemption or have submitted a Waiver, Exception, or Exemption (WEE) application, you have additional time for SOPs to be in place. 

DSCSA support for manufacturers

By streamlining packaging and logistics guidelines for our manufacturer partners, we ensure sites of care receive their products quickly and safely. We have created additional resources to help our
manufacturer partners prepare for the enhanced unit level tracking requirements effective November 2023.


How we are helping you prepare

Navigating DSCSA compliance

DSCSA: Are you ready for November 2024?

3 ways your distributor can help you prepare for DSCSA compliance

Matt Sample, SVP, Manufacturer
Operations,
discusses DSCSA requirements for dispensers


Additional resources as provided by the FDA

Drug Supply Chain Security Act

List of DSCSA policy documents

DSCSA requirements for pharmacists


DSCSA in the news

Drug Supply Chain Security Act: How Cencora supports compliance

The drug distributor is helping manufacturers tackle compliance with the long-awaited law’s implementation

HDA presents Cencora’s Matt Sample with DMA for industry leadership

Healthcare Distribution Alliance (HDA) interview with Matt Sample, SVP, Manufacturer and Replenishment Operations

Pharma industry shifts toward full activation

In the fourth part of her Pharma Commerce video interview, Heather Zenk, Cencora’s president of US supply chain, explores how public-private collaboration, smarter sourcing strategies, and long-term manufacturer support are helping to fortify pharmaceutical supply chains against future crises.

Understanding the FDA's exemption for DSCSA compliance 

The Pharmaceutical Commerce podcast featuring Matt Sample, SVP, Manufacturer and Replenishment Operations

The DSCSA clock is ticking

Medicine Maker interview with Matt Sample and Gregg Gorniak ahead of the fast-approaching implementation date

Pharmacy organizations raise alarms on DSCSA preparedness

Gregg Gorniak meets with Pharmacy Practice News to discuss the importance of knowing exactly who is responsible for DSCSA compliance in your organization

Prioritizing DSCSA adherence to protect patient safety

The FDA announces that it will delay its enforcement of DSCSA until November 2024

DSCSA delay: No time to take foot off the gas

Regulatory Focus interview with Matt Sample, SVP, Manufacturer and Replenishment Operations

What you need to know about the Drug Supply Chain Security Act before November’s deadline

Q&A with Matt Sample, SVP, Manufacturer and Replenishment Operations

Manufacturers an essential part of the DSCSA relay race

Regulatory Focus interview with Gregg Gorniak, Senior Director, Manufacturing Operations

The DSCSA overview

The Pharmaceutical Commerce podcast featuring Gregg Gorniak, Senior Director, Manufacturing Operations

Have additional questions or need assistance related to DSCSA?