Guide

DSCSA resources

Ensuring a smooth and efficient supply chain

Clients count on our reimbursement and health policy expertise to develop strategies that adapt to the changing payer environment and ensure appropriate patient access. Whether it’s designing provider tools that break down complex billing and coding, or educating provider offices on how to proactively position for legislative and regulatory updates, AmerisourceBergen's RPI team has the knowledge, experience, and client service skills to create and implement effective strategies for success.

Manufacturer logistics

Our Manufacturer Logistics Guide defines how to engage with AmerisourceBergen and our requirements for establishing and maintaining effective product movement.

DSCSA support for customer/dispensers

High-level steps required for customer onboarding for serialized data exchange with Cencora.
 

On this page:


DSCSA support for manufacturers

We want to ensure your products are not only in compliance with DSCSA, but also, our distribution centers and pharmacy customers begin to use serialized products, that the barcodes and packaging can be scanned and utilized.  We also want to continue to support our trading partners as we reach new DSCSA milestones.

Cencora position on FDA October 2024 DSCSA Exemption announcement.

Cencora DSCSA August 2024 Position Letter addressing end of stabilization period.

September 13th, 2023: In light of the recent FDA announcement of a 1-year stabilization period, Cencora published an updated DSCSA position letter with modified dates. Please review the letter carefully to ensure operational alignment with implementation timeline.

Read the September 2023 DSCSA position letter

April 2023 DSCSA FAQs Document

HDA Best Practices Considerations for Manufacturer DSCSA Data Quality

AmerisourceBergen will accept un-serialized product for the foreseeable future under the Grandfathering Policy. It’s our policy to reference the manufacturer’s DSCSA transaction statement as proof that the manufacturer is complying with all legal requirements.

Starting November 27, 2019, all saleable returns from our customers must have the Product Identifier, if not grandfathered, verified with the original manufacturer. AmerisourceBergen manages over 13.5 million saleable returns a year and cannot rely on phone calls, emails or individual portals to execute verification requests. Please read the following related letters.

Preparing for Serialization: Read the letter

DSCSA 2020 Saleable Returns FDA Enforcement Discretion: Read the letter

As we transition to serialized data exchange and implement a VRS for 2019 Saleable Returns, we will need to collect all historical data about existing products and ensure that we collect accurate data for all new product launches going forward. We will be working with our trading partners to gather GTINs via HDA’s Origin, GDSN and other applicable methods to electronically collect this data.

2015 GS1: Visit Here

2018 Exceptions Pilot: Download Now

2019 MediLedger DSCSA FDA Pilot: Download Now

2019 Xavier End to End Serialization FDA Pilot: Download Now

LSPediA Investigator Tool

The LSPediA Investigator tool enables AmerisourceBergen to notify our manufacturer partners about suspect product and saleable returned product with non-response or negative verifications. This provides a way for the manufacturer partner to respond to these inquiries in a streamlined process with an audit trail.
Useful links:

We ask that every trading partner reach out to our Secure Supply Chain team now and let us know the following:


  1. What is your method for automating the 2019 Saleable Returns Verification (sending data, or VRS)?
  2. Do you want to know your average saleable return volume?
  3. How can we get your historic master data?
  4. Do you still need serialized labels reviewed?
  5. Do you want to pilot sending EPCIS data?
  6. Do you have any other general questions?
 

Product packaging and labeling

Product labeling and packaging is critical to ensure efficient and safe product movement through the supply chain. Just as important as the physical product packaging itself, logistics and transportation are also vital in ensuring the product arrives undamaged, and as efficiently as possible. As part of our Manufacturer Logistics guide, we examined industry best practices to outline both our requirements as well as what not to do. We expect our manufacturer trading partners to follow those guidelines and work with us in the unlikely event a problem arises.

Prescription drug packaging

For those manufacturers supplying prescription products, we require that all manufacturers follow the HDA Guidelines for Barcoding in the Pharmaceutical Supply Chain, which can be found here .

Consumer & medical device packaging

For those manufacturers supplying medical devices, or consumer products, we request that either GS1 or HIBCC identifiers are used and affixed in a barcode at all levels of product packaging.

Pharmaceutical contract manufacturer packaging requirements

For those partners providing contract packaging or manufacturing services to any of our AmerisourceBergen business units, including BluePoint, American Health Packaging or MWI, our packaging requirements can be found here .
 

Product setup and master data

Everything we do in our supply chain starts with accurate master product data.  Whether it be an inaccurate product identifier, missing hazmat values, or incorrect regulatory data missing or inaccurate master data can stop product movement through the supply chain.

Setup


AmerisourceBergen recently launched an interactive tool called ABC Setup that provides all manufacturers with an easy, automated interface for submitting new product information to AmerisourceBergen.   

ABC Setup can take consumer or medical device product data from a GS1 Data Synchronization Network (GDSN) or import the HDA New Product Form for prescription drug launches. Prior to submitting a new product request, ABC Setup will validate the key attributes and ensure that data errors aren’t passed downstream, resulting in hours of rework product stoppage.  

To get started, visit ABC Setup

We also continue to integrate key enhancements to ABC Setup that will allow us to receive a limited set of product changes (dimensions, quantities, etc.), further integrate the use of GDSN for DSCSA and potentially automate the HDA Rx New Product Form.

Useful links


GS1's Healthcare Global Trade Item Number™ (GTIN™) Allocation Rules
Explains when, how, and why Global Trade Item Numbers [GTINs] are created and assigned.  Anyone using GTINs or UPCs for product identification should review this document.

Healthcare Distribution Alliance (HDA) Rx Product Info Form
Current HDA New Product Form that must be used when uploading data into ABC Setup.  This form contains DSCSA and additional environment attributes required to safety move products.

GS1 US Implementation Guideline
This information covers implementing GS1 Standards, particularly the GS1 Electronic Product Code Information Services (EPCIS), for DSCSA lot-level management, serialization, and item-level traceability.

 

Manufacturer data exchange

AmerisourceBergen follows the American National Standards Institute X12 standard for EDI that complies with Healthcare Distribution Alliance (HDA) specifications. We support both the 4010 and 5010 versions of the standard as well as any new requirements or EDI document types that will emerge. As we lead the way in helping our manufacturer partners comply with DSCSA guidelines, we also support the evolving Electronic Product Code Information Services (EPCIS) standard for serialized data exchange.
AmerisourceBergen supports both EPCIS 1.1 and the newer EPCIS 1.2 for pharmaceutical products that have been assigned serial numbers (serialized) as DSCSA regulations require.


AmerisourceBergen Serialized Data Exchange Requirements


Sample EPCIS files
- Sample EPCIS 1.2 AmerisourceBergen

- Sample EPCIS 1.2 Cencora Global Procurement (CGP)

- Sample EPCIS 1.2 BluePoint Labs

- Sample EPCIS 1.2 AHP

- Sample EPCIS 1.2 MWI

AmerisourceBergen Location GLN/SGLN listing

AmerisourceBergen Serialization Master Data Template

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