The Global Language of Business

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The Global Language of Business

How to Identify your Location for DSCSA Requirements

When the U.S. Food and Drug Administration (U.S. FDA) enacted the Drug Supply Chain Security Act (DSCSA) in 2013, it aimed to create a fully interoperable U.S. supply chain - all the way from pharmaceutical manufacturers and wholesaler distributors down to pharmacy dispensers. To meet these requirements, industry leaders are endorsing a standardized approach to location identification with the GS1 Global Location Number (GLN).

A GLN is the globally unique GS1 Identification Number that can be used to identify the “Who” and “Where” of these product movement transactions. The GLN can be used to identify a legal entity (like a health system), a functional entity (like a pharmacy dispenser or accounting department), or a physical location (like a distribution center, hospital wing, loading dock door, storage location, or nursing station).

By creating GLNs, assigning locations to them, and sharing that information with trading partners - you will unlock the ability to fully track and trace your products, manage saleable returns, and other requirements of the DSCSA.

How to get a GLN

There are multiple ways to get a GLN, so we are here to help. The below Quick Start Guides were created to assist suppliers and dispensers in understanding the various options for getting a GLN and help them make the best decision for their business.

Quick Start Guide for Dispensers

The good news is you might already have a GLN if you are a hospital, retail pharmacy, home health agency, or long-term care facility. If you are a GS1 US member, you already have access to an entity GLN.

Also, if you work with AmerisourceBergen, Cardinal Health, McKesson, Smith Drug Company, HealthTrust, Premier, or Vizient, you may already have a GLN enumerated on your behalf. Review our options below to learn how you can determine if you already have a GLN or if needed, how you can get a GLN.

If your company already licenses a GS1 Company Prefix, these steps outline how to get, create, assign, and use your GLNs:

  1. Determine if there is an individual within your company who assigns GLNs

    Identify the person who manages your GS1 Company Prefix or subject matter expert (SME) on GLNs within the organization. This SME may be from your serialization, supply chain, regulatory, or other department within your organization.

  2. Assign GLNs

    As a member of GS1 US with a licensed GS1 Company Prefix, your company has access to the GS1 US Data Hub | Location® tool, which enables you to create and manage GLNs for your own locations, at no charge for a single user.
    • Your company’s Legal Entity GLN is preloaded in GS1 US Data Hub | Location and will serve as the top level of your GLN hierarchy.

      Helpful Hint: A legal entity is any business, government body, department, individual, or other institution that has standing in the eyes of the law and has the capacity to enter into agreements or contracts. A legal entity must be allocated its own GLN when its legal name and/or legal address and/or legal registration number is different from other legal entities and there is a business need to identify the legal entity across organizations.

    • If you have already assigned GLNs to your business locations and they are not in GS1 US Data Hub | Location, it is recommended you upload these locations before assigning new locations to avoid duplication. Uploading and managing your company locations in Data Hub allows industry supply chain partners access to view and use your location data.
    • Assign additional GLNs as business needs dictate using GS1 US Data Hub | Location.
    • Check the “Validate Location” box in GS1 US Data Hub | Location to show that you are regularly reviewing your GLNs.
    • Access the GS1 US Data Hub | Location User Guide to help with creating, managing, and sharing location data.
       

  3. View and use your trading partners’ GLNs

    If you wish to view and use GLNs from your trading partners, you should subscribe to the GS1 US Data Hub | Location View/Use option. Annual fees apply, based on the options you choose and the number of users. Users with access to GS1 US Data Hub can log in here.

    Helpful Hint: A View/Use subscription is required to view other companies’ location information, including Global Location Numbers and location organizational structure provided by location owners.

  1. Contact your GPO to find out the process to view and manage your organization’s GLNs in Data Hub | Location tool

    You can either obtain an Editor User ID for the GS1 US Data Hub | Location tool or request to Self-Manage your company's location data.

    An Editor Role means your locations are created and managed by your GPO on your company’s behalf, but you will have access to view and manage them.

    Self-Managed means you inherit the responsibility to create, manage, and share location data in GS1 US Data Hub | Location.

  2. Designate responsible party within your organization for GLN management (e.g., IT, Marketing, Supply Chain)

  3. Login to review your GLN hierarchy and refine as needed

    Using your Editor or Self-Managed credentials obtained from your participating GPO, you can:
    •  
      • Assume the approver role from the GPO.
      • Check the “Validated” box in GS1 US Data Hub | Location for GLNs you have verified as accurate.
      • Align your hierarchy with your GPO's roster.

  4. View and use your trading partners’ GLNs

    Self-Managed users have the ability to access trading partners’ GLN data to be used in transactions and applications, such as Verification Router Services (VRS), Electronic Product Code Information Services (EPCIS), applicable Electronic Data Interchange (EDI) transactions used, and the Global Data Synchronization Network™ (GDSN®).

  5. Share Data

    Self-Managed Users can access the GS1 US Data Hub | Location tool to share your location data before you transact with your trading partners (manufacturers and/or wholesale distributors) using GLNs.

     

  1. Contact your Wholesaler to obtain your company’s assigned Global Location Number.Designate responsible party within your organization for GLN management (e.g., IT, Marketing, Supply Chain)

  2. Designate responsible party within your organization for GLN management (e.g., IT, Marketing, Supply Chain, etc.).

  3. Share your location data with your trading partners (manufacturers and/or wholesale distributors) using GLNs.

  1. Your company has the option to license a GS1 Company Prefix or license an individual GLN to identify locations to meet trading partner needs

    If you have more than 9 locations to identify with a GLN, consider licensing a GS1 Company Prefix. Fees are based on the number of locations you need to identify. If you have less than 9 locations to identify with a GLN, you may license a single GLN for a small one-time fee.

    You can apply for a GS1 US Company Prefix or license an individual GLN online at myGS1US.org.

    Establish your password to the GS1 US User Portal (our online member center) as soon as you receive your welcome email. This login credential also support access to GS1 US Data Hub.

  2. Create your GLN hierarchy in the GS1 US Data Hub | Location tool and check the “Validated” box

    When your company licenses a GLN, you will receive a free subscription for one user to GS1 US Data Hub® | Location, an online tool you can use to identify, manage, and share your location data.

  3. Designate responsible party within your organization for GLN assignment (e.g., IT, Marketing, Supply Chain)

  4. View and use your trading partners’ GLNs in business transactions

    If you wish to view and use GLNs from your trading partners, please subscribe to the GS1 US Data Hub | Location View/Use with the Export option. Annual fees apply, based on the options you choose and the number of users. Users with access to GS1 US Data Hub | Location can log in at https://www.gs1us.org/tools/gs1-us-data-hub/location.

    Helpful Hint: A View/Use subscription is required to view other companies’ location information, including GLNs and location organizational structure provided by location owners.

  5. Share Data

    Use the GS1 US Data Hub | Location tool to share your location data before you transact with manufacturers and/or wholesale distributors using GLNs.

Quick Start Guide for Suppliers

Pharmaceutical manufacturers and wholesale distributors may already have access to a GLN depending on their organization’s member status with GS1 US. Review our options below to learn how you can determine your member status and the steps needed to take to create and manage your GLN.

If your company already licenses a GS1 Company Prefix, these steps outline how to get, create, assign, and use your GLNs:

  1. Determine if there is an individual within your company who assigns GLNs

    Identify the person who manages your GS1 Company Prefix or subject matter expert (SME) on GLNs within the organization. This SME may be from your serialization, supply chain, regulatory, or other department within your organization.

  2. Assign GLNs

    As a member of GS1 US with a licensed GS1 Company Prefix, your company has access to the GS1 US Data Hub | Location® tool, which enables you to create and manage GLNs for your own locations, at no charge for a single user.
    • Your company’s Legal Entity GLN is preloaded in GS1 US Data Hub | Location and will serve as the top level of your GLN hierarchy.

      Helpful Hint: A legal entity is any business, government body, department, individual, or other institution that has standing in the eyes of the law and has the capacity to enter into agreements or contracts. A legal entity must be allocated its own GLN when its legal name and/or legal address and/or legal registration number is different from other legal entities and there is a business need to identify the legal entity across organizations.

    • If you have already assigned GLNs to your business locations and they are not in GS1 US Data Hub | Location, it is recommended you upload these locations before assigning new locations to avoid duplication. Uploading and managing your company locations in Data Hub allows industry supply chain partners access to view and use your location data.

    • Assign additional GLNs as business needs dictate using GS1 US Data Hub | Location

    • Check the “Validate Location” box in GS1 US Data Hub | Location to show that you are regularly reviewing your GLNs.

    • Access the GS1 US Data Hub | Location User Guide to help with creating, managing, and sharing location data.

  3. View and use your trading partners’ GLNs

    If you wish to view and use GLNs from your trading partners, you should subscribe to the GS1 US Data Hub | Location View/Use option. Annual fees apply, based on the options you choose and the number of users. Users with access to GS1 US Data Hub can log in here.

    Helpful Hint: A View/Use subscription is required to view other companies’ location information, including Global Location Numbers and location organizational structure provided by location owners.

  1. Your company has the option to license a GS1 Company Prefix or license an individual GLN to identify locations to meet trading partner needs

    If you have more than 9 locations to identify with a GLN, consider licensing a GS1 Company Prefix. Your GS1 Company Prefix can be used to enumerate additional locations or parties.

    If you have less than 9 locations to identify with a GLN, you may license a single GLN for a small one-time fee.

    Fees are based on the number of locations you need to identify. You can apply for a GS1 US Company Prefix or license an individual GLN online at myGS1US.org.

    Helpful Hint: Establish your password to the GS1 US User Portal (our online member center) as soon as you receive your welcome email. This login credential also support access to GS1 US Data Hub.

  2. Create your GLN hierarchy in the GS1 US Data Hub | Location tool and check the “Validated” box

    When your company licenses a GLN, you will receive a free subscription for one user to GS1 US Data Hub® | Location, an online tool you can use to identify, manage, and share your location data.

  3. Designate responsible party within your organization for GLN assignment (e.g., IT, Marketing, Supply Chain)

  4. View and use your trading partners’ GLNs in business transaction

    If you wish to view and use GLNs from your trading partners, please subscribe to the GS1 US Data Hub | Location View/Use with the Export option. Annual fees apply, based on the options you choose and the number of users. Users with access to GS1 US Data Hub | Location can log in at https://www.gs1us.org/tools/gs1-us-data-hub/location.

    Helpful Hint: A View/Use subscription is required to view other companies’ location information, including GLNs and location organizational structure provided by location owners.

  5. Share Data

    Use the GS1 US Data Hub | Location tool to share your location data before you transact with your trading partners using GLNs.

Need Additional Help?

If your company has no need to generate GLNs to identify locations, but still needs access to location data, you can still sign up for GS1 US Data Hub | Location as a View/Use subscriber. This allows you to search for and export GLN information for your business partners, who also use the tool. Annual fees apply, based on your subscription options and the number of users accessing the tool.

*For information about the act, see the 2013 Drug Supply Chain Security Act

Disclaimer: GS1 US is the local GS1 Member Organization that supports implementation of the GS1 System in the United States. GS1 US employees are not representatives or agents of the U.S. FDA, and the content herein has not been reviewed, approved, or authorized by the U.S. FDA.