Meeting 2023 Requirements

AmerisourceBergen (AB) intends to be fully compliant with the enhanced unit level tracking requirements by November 2023. At this time, AB does not believe the Food and Drug Administration (FDA) will provide any additional enforcement discretion. In partnership with our manufacturer partners, there are several key milestones that AB must hit to meet the November 2023 deadline while not disrupting patient access 

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

2018 Serialization

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.  

Saleable Returns

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

DSCSA GTIN Data

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.  

 

DSCSA Pilot Activity

2015 GS1: Visit Here
2017 HDA Saleable Returns Pilot: Read 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.

Here are some useful links:

• To sign up for the Investigator Tool complete your Investigator Onboarding Form ASAP.
• Submit any questions you have about this process through this link: Questions
• Once you’ve signed up for onboarding, please Submit Product Identifier information for purpose of testing (repeat to submit more)

In 2020, AmerisourceBergen is sponsoring notification accounts for the top 100 suppliers in terms of saleable returns volume. To verify if you qualify for this, please check here Top 100 Inquiry Form

To register users for a notification account, please use the following links according to the option that is applicable to your company:

• Registration (Top 100)
• Registration (non-top 100 with credit card)
• Registration (non-top 100 without credit card)

 
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?

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.

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.

Inbound EDI Manufacturer Transaction Map Specifications 

• 810 Invoice - Drop Ship
• 810 Invoice - Trade
• 812 Credit Adjustment - Drop Ship
• 812 Credit Adjustment - Trade
• 855 Purchase Order Acknowledgement 
• 856 Advanced Ship Notification (includes DSCSA) 
• 845 Contracts/Price Authorization - Change
• 845 Contracts/Price Authorization - Original
  
• 849 Chargeback Response / Product Transfer Adjustment - Disputed
• 849 Chargeback Response / Product Transfer Adjustment - Undisputed

Outbound EDI Manufacturer Transaction Map Specifications 

• 850 Purchase Order 
• 820 Payment Order/Remittance Advice 
• 852 Product Activity Data 
• 867 Product Transfer and Resale Data 
• 844 Chargebacks/Product Transfer Adjustment

EPCIS Data Exchange Information

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