Manufacturer Operations, Replenishment, and DSCSA Support

AmerisourceBergen's Manufacturer Operations team works hand-in-hand with our manufacturer partners to ensure a smooth and efficient supply chain. By streamlining packaging/logistics guidelines for our manufacturer partners, we ensure sites of care receive their products quickly and safely. 
Healthcare providers and patients alike rely on our ability to receive your products, process and ship them quickly from our 30+ state-of-the-art distribution centers--and to do it in a manner that prioritizes patient safety and product access. 

 

Manufacturer Logistics Guide

The AmerisourceBergen Manufacturer Logistics Guide defines how to engage with AmerisourceBergen and our requirements for establishing and maintaining effective product movement. We have developed these guidelines with input from our trading partners, internal stakeholders and industry standards and alliance bodies.  As best practices evolve, this document will be revised.
View the guide

 

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.

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.  

 

2019 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. 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

GS1: Visit Here
HDA Saleable Returns Pilot: Read Here
2018 Exceptions Pilot: Download Now
Upcoming: FDA Pilots MediLedger and Xavier

 

Engage With Us Now to Ensure Compliance

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, and 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 Order.  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.

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 file

AmerisourceBergen Serialized Data Exchange Template

 

Replenishment Operations

Replenishment Operations (RO) buys and replenishes items for the AmerisourceBergen distribution center network. Our main focus is to ensure there is enough product in the DCs to service our end-customer: the patient. 

Contact Us

To start EPCIS onboarding, or to inquire about DSCSA or for any other related topics, our team is standing by to answer your questions

Email us