Quality and regulatory

DSCSA compliance

The Drug Supply Chain Security Act (DSCSA) changes how trading partners trace, verify, receive, and return prescription drugs.

What DSCSA means across the pharmaceutical supply chain

The Drug Supply Chain Security Act establishes an electronic, interoperable system for tracing certain prescription drugs at the package level across the U.S. supply chain. For dispensers, this includes working with authorized trading partners, receiving and maintaining serialized product data, verifying eligible saleable returns, and investigating suspect or illegitimate products.

Most requirements are now in effect. Small dispensers have an exemption from certain requirements until November 27, 2027. Whether you qualify or not, the goal is the same: keep your patients supplied without interruption while you meet compliance.

Improved patient safety

Validates product integrity to help protect patients from counterfeit, stolen, or otherwise illegitimate products entering the supply chain.

Enhanced supply chain security

Increased visibility and traceability through serialization and electronic data exchange helps prevent counterfeiting, theft, and unauthorized product movement.

Getting started with DSCSA

We can walk you through what to set up first — confirming authorized trading partners, getting your account ready to receive serialized data, and registering your GLN — so you can meet the requirements without slowing down day-to-day dispensing. 

Here’s a quick DSCSA readiness checklist

  •  Confirm authorized trading partners.
  •  Register and maintain your GLN.
  •  Maintain access to serialized transaction data, including EPCIS.
  •  Have a process to quarantine and report suspect or illegitimate product.

  •  Keep a written standard operating procedure (SOP) your team can follow

  •  Know how to verify a saleable return before it goes back out.
  •  Confirm whether the small dispenser exemption applies.
  •  Keep SOPs current as requirements or processes change.

Exemptions, waivers, and key dates

The FDA exempted small dispensers from certain DSCSA requirements until November 27, 2027. If you are not a small dispenser, or you need more time, you can request a waiver, exception, or exemption (WEE) if you have concerns about readiness or patient access. We can help you understand which path applies to you and what to document.

Manufacturers and repackagers

Exemption ended May 27, 2025

Manufacturers and repackagers should be ready to comply with DSCSA requirements and understand what steps may be needed next.

Wholesale distributors

Exemption ended August 27, 2025

Wholesale distributors should confirm their readiness and identify any remaining actions needed to support DSCSA compliance.

Dispensers

Exemption ended November 27, 2025

Dispensers should review their current readiness and prepare the documentation and processes needed to move forward.

Small dispensers

Exempt from certain requirements until November 27, 2027

Small dispensers have additional time to prepare for certain DSCSA requirements and strengthen their readiness approach.

Waivers, exceptions, and exemptions (WEE) are Food and Drug Administration-approved pathways that allow certain authorized trading partners or products to be excluded from specific Drug Supply Chain Security Act (DSCSA) requirements in limited situations. If you need help identifying, quarantining and investigating suspect product, or notifying FDA of illegitimate product, use our SOP template.

Waiver, exception, and exemption resources

These three resources can help you understand waiver, exception, and exemption requirements, review approved waiver, exception, and exemption status, and support suspect and illegitimate product procedures under the DSCSA.

WEE requests

Learn when trading partners may request a waiver, exception, or exemption for certain Drug Supply Chain Security Act requirements.

WEE report

Learn how we manage FDA-approved waiver, exception, and exemption status for eligible products in the U.S. supply chain.

SOP template

Use this sample template to help identify, quarantine, and investigate suspect product, and notify the FDA and trading partners of illegitimate product.
All available in English only

Returns and claims under DSCSA

Saleable returns must be verified before they re-enter the supply chain. We have updated our returns and claims process to handle this for you, so eligible product moves back efficiently, and the required checks happen behind the scenes.

For product invoiced on or after August 27, 2025, returns are verified against serialized data. Your team generates a return authorization by selecting the invoice and serial number in ABC Order. Products that were not originally sold to your account may be denied return credit. Product invoiced before that date follows the prior returns process.

Helpful guidance for DSCSA requirements

Suspect or illegitimate product

DSCSA requires you to act when a product may be suspect or illegitimate. That means quarantining the product, investigating, and notifying the right parties on time. In our guide, we explain the difference between suspect and illegitimate product and walk through the steps, so your team can respond quickly and correctly.
View guide
Available in English only

Drop-shipped products

Drop-shipped products still require DSCSA data. That information may be provided by Cencora through Electronic Product Code Information Services (EPICS), or by the manufacturer through its own portal. If the data is missing, we can help you access it.

GLN requirements

A Global Location Number (GLN) identifies each of your locations in the supply chain. Accurate GLNs keep serialized data flowing to the right place and are part of staying compliant. Keep yours up to date as your locations change. If you need help understanding where to find a GLN, you can review GS1’s helpful guide.

Access your DSCSA report and training materials

Sign in to ABC Order to access your DSCSA report tailored to your account. You can also find previous DSCSA training materials and recordings in ABC Order to reference as needed.

Learn how serialization and NDC12 are changing distribution

DSCSA depends on serialization, and the move to 12-digit National Drug Codes (NDC12) is coming soon. Learn how the pieces fit together and how we can help.

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Connect with our supply chain team

Our team of supply chain experts is here to assist you with DSCSA readiness for your pharmacy, practice, or health system. Whether you have questions or need more details, we are here to help.

Or, if you need general support or additional contact information, visit our Contact us page.