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On Oct. 9, 2024, the Food and Drug Administration (FDA) announced new deadlines for DSCSA compliance for eligible manufacturers, distributors and pharmacies (FDA Exemption). The FDA Exemption describes criteria and conditions for manufacturers, distributors and pharmacies to be eligible for new deadlines for DSCSA compliance.

The FDA Exemption applies to in-scope products transacted by “eligible trading partners,” as described and subject to the conditions in the FDA Exemption. McKesson intends to utilize the FDA exemption as a wholesale distributor, as permitted by the FDA exemption.

FDA Granted Exemptions

For eligible trading partners that meet the FDA Exemption’s conditions, the FDA granted exemptions from certain DSCSA requirements until the following dates:

  • For manufacturers and repackagers, May 27, 2025. 
  • For wholesale distributors, Aug. 27, 2025, 
  • For dispensers with 26 or more pharmacists and technicians, Nov. 27, 2025. 

Dispensers with 25 or fewer pharmacists and technicians were previously exempted until November 2026. 

Overview:

  1. What is GLN?
  2. How do I obtain my GLN number?
  3. How do I create a GLN number?
  4. How do I submit my GLN number to McKesson?
  5. Ready to submit your GLN?

Preparing For DSCSA – serialized transaction information

photo of 3 workers in a distribution warehouse, looking over a clipboard and surrounded by labeled parcels

A GLN, or Global Location Number, is a unique identifier that lets businesses know who is involved in transactions and where things are located throughout the supply chain. McKesson is in the process of gathering our customers’ GLNs and loading them into our systems.

Establishing and submitting your GLN number(s) is imperative to continue to conduct business with McKesson. We are requesting all customers to have one or more GLNs on file with McKesson to allow the parties in the supply chain to mature and test their systems and processes.

Global Location Numbers (GLNs) are typically created by the organization that is being identified by subscribing to a license from GS1. To aid in the adoption of GLNs for DSCSA purposes, McKesson and other distributors have purchased a group license from GS1 for the identification of independent and small customers. A cross-functional team is working to collect and enter all customer account data into the GS1 system.

All customers must provide two GLN numbers to designate their status:

  • Sold to- represents the party acquiring ownership of the DSCSA in-scope product shipped.
  • Shipped to- represents the physical location where the DSCSA in-scope products are being delivered.

These numbers may be the same for some customers if their sold-to and ship-to addresses are identical.

In the instance you do not have a GLN, it can be created by visiting the GS1 website at gs1us.org. Please be aware that a small registration fee is involved.

Following are more details about the GLN retrieval process for each customer segment.

  1. Independent Pharmacies and PractitionersIf you are unsure whether or not your business location has GLNs, we highly recommend you that you visit the GS1 website at gs1us.org to search for, and if needed, create your GLNs. After locating or creating GLNs, please send to GLNsubmissions@mckesson.com and include the account number(s) the GLNs should be associated to.
  2. Health Systems and ClinicsMany health systems implemented the use of GLNs through their GPOs years ago. If the GLN information is available in the GS1 Data Hub and the name and address match a McKesson “Bill To” or “Ship To” name and address, we have already retrieved and loaded this data for you. You can search for and create GLNs at gs1us.org. If you have valid GLNs for your physical location that you would like to submit, please send to GLNSubmissions@mckesson.com and include the account numbers the GLNs should be associated to.
  3. National Retail Chains Most National Chains can generate GLNs using their Global Company Prefix (GCP) from GS1. Customers with their own GCP can contact GS1 for assistance in generating their GLNs if they do not already have their locations listed with GLNs. We are currently collecting GLN information from our National Chain partners. If you have valid GLNs for your physical location that you would like to submit, please send to GLNSubmissions@mckesson.com and include the account numbers the GLNs should be associated to.
  4. Federal and State CustomersIf you are unsure whether or not your location has GLNs, we highly recommend you that you visit the GS1 website at gs1us.org to search for, and if needed, create your GLNs. After locating or creating GLNs, please send to GLNsubmissions@mckesson.com and include the account number(s) the GLNs should be associated to.

Global Location Numbers (GLNs) are typically created by the organization that is being identified by subscribing to a license from GS1. If you know your GLN or GLNs, you can submit that information via this form or email to GLNSubmissions@mckesson.com and our team will upload it to our data systems.

In your email, please include the following information:

  • Business Name
  • Business Address
  • Business Phone Number
  • Business Contact Name
  • Bill To McKesson Account Number
  • Sold to GLN
  • Ship To McKesson Account Number
  • Ship to GLN

Please see the information below that describes the account numbers and an example of where they can be found on an invoice. If you have any questions, please contact your sales representative.

DataWhat is this?DataWhat is this?DataWhat is this?
Sold To/Bill To
McKesson Account Number
The account number representing the legal entity taking control of the product. The Sold To and Ship To can match if they are the same physical location.Ship To McKesson Account NumberThe account number representing the physical location the product is shipping to. The Sold To and Ship To can match if they are the same physical locationGLN (Global Location Number)The fourteen digit numeric number used to designate a legal entity and/or physical location that will be used to track serialization data for this location and/or legal entity.

GLN numbers can be obtained at this link: https://www.gs1us.org/industries-and-insights/standards/global-location-number/get-a-global-location-number
graphic image of an Example McKesson invoice where bill to number and ship to number is circled - 

MCKESSON
McKesson Medical-Surgical
Minnesota Supply Inc.
9954 Mayland Drive, Ste. 5176A
Henrico, VA 23233
Bill To: 12345678

BILLING NAME
1234 BILLING STREET
CITY, ST, ZIP

Invoice
Page 1 of 2

Shipped From:
MCKESSON MEDICAL-SURGICAL INC (TEMPE)
7343-A SOUTH HARDY DRIVE
TEMPE, AZ 85283

Shipped To: 87654321

SHIPPING NAME
1234 SHIPPING STREET
CITY, ST, ZIP

© 2023 McKesson Medical-Surgical Inc.

McKesson is here to support you during this transition by providing guidance and assistance where possible. We are not able to take action for you. Additional information for dispensers from NACDS, NCPA, HDA and NABP about dispenser requirements is available at www.dscsa.pharmacy.


McKesson response to FDA announcement of DSCSA compliance policy

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