Randy Hoggle Advasur DSCSA Track and Trace Compliance Costs
J. Randall Hoggle, B.Pharm., D.Ph., M.B.A

AS YOU PROBABLY KNOW, THE NEXT requirements of the Drug Supply Chain Security Act (DSCSA) “track and trace” are coming soon, and pharmacies must be prepared for and compliant with these new reporting requirements by Nov. 27, 2023.

That means starting now to ensure you are compliant, if you are not already. Please see the action steps that I outline here to be able to receive Electronic Product Code Information Services (EPCIS) advance shipment notices as product leaves your supplier’s warehouse to ensure you accurately receive the prescription products you ordered.

Soon after the DSCSA was enacted, the pharmaceutical supply chain industry came together in many different forums and agreed on using GS1 standards as the platform for DSCSA compliance efforts, a practical decision based on the need for trading partners from manufacturers to pharmacies to use one set of common standards.

You need to register your pharmacy with GS1 to set up a Global Location Number (GLN) and Serialized GLN (SGLN).

The GLN and SGLN will be needed for three reasons:

  1. DSCSA-compliant EPCIS transmissions require your supplier to have your GLN/SGLN or they cannot forward those transmissions for your purchases from that supplier.
  2. The GLN and SGLN will be needed to send salable returns back through the supplier’s verification router service.
  3. The GLN and SGLN can be used as dispenser validation credentials.

GS1 is a not-for-profit international organization developing and maintaining its own standards for barcodes and the corresponding issue company prefixes. The best known of these standards is the barcode, a symbol printed on products that can be scanned electronically.

Here are the action steps you need to take with GS1 over the next couple of weeks:

  1. Register with GS1 to set up your Global Location Number (GLN), which is required of all pharmacies for current DSCSA compliance components and conversion from advance ship notices (ASN) format to EPCIS format. See “Steps to complete GS1 registration of your pharmacy” below.
  2. Once you have received your GS1 registration information to set up your GLN and SGLN, forward it to your DSCSA compliance service provider, if you have one, to assist you in completing the process. Otherwise, just contact Advasur and we will assist you, as this is mission critical to your practice and business.
  3. Once you complete your sign-up with your DSCSA compliance service provider, you can respond to your supplier’s request to test EPCIS transmissions; all such tests require you to have a GLN/SGLN to do an EPCIS transmission test. Once the test is successful you or your DSCSA compliance service provider will start to receive EPCIS rather than ASNs.

Steps to complete GS1 registration of your pharmacy:

Starting in early 2023, the data format used by suppliers for sharing ASNs will be migrating from EDI 856 to EPCIS. Advanced ship notices are the digital data files that each dispenser should be receiving from their suppliers (not printed packing slips) at the time of order shipment. Dispensers (pharmacies) are required to retain these transaction documents for a full six years to achieve full DSCSA compliance.

To receive EPCIS files for advanced ship notices, all trading partners (including dispensers) will now be required to obtain a Global Location Number (GLN) from GS1.org. This requirement is based on the FDA guidance for DSCSA compliance requirements. Most dispensers have not yet created their location number, but it is going to be a must.

Follow this GS1 website link if you have a single pharmacy and pay the one-time fee of $30 at the time of checkout.

If you don’t have a DSCSA compliance services provider and cannot set up the GLN and SGLN yourself, then GS1 offers an option to set those up for you for a higher initial fee and an annual maintenance fee.

If you are a multipharmacy owner, go to this GS1 website registration link. The initial pricing for multipharmacy locations is shown in the table, with initial and annual renewal fees.

[supsystic-tables id=27]

GS1’s website often refers to GLNs interchangeably with the term barcodes. You will not need to purchase a company prefix from GS1. Just pay the fee to set up the GLN. If you purchase the prefixes too, then prefixes would require registration fees and renewal fees every year.

Visit The GS1 US DSCSA Implementation Suite

With suppliers (direct-selling manufacturers and wholesalers) already starting to test EPCIS transmissions with some dispensers, time is of the essence to complete the GS1 registration and GLN/ SGLN setup.

I am always available to assist my pharmacy colleagues who are trying to be compliant with these regulations. My email is r.hoggle@advasur.com. I will try to respond to any questions within one workday for ComputerTalk readers. CT

J. Randall Hoggle, B.Pharm., D.Ph., M.B.A., is the managing director of Advasur, LLC, the Advasur Audit & Supply Chain Resource Center in Rockville, Md.