Are you an independent pharmacy seeking a reliable and unique solution to comply with the Drug Supply Chain Security Act (DSCSA) while ensuring the safety and authenticity of the drugs you dispense? The FDA recommends stores DO NOT DELAY DSCSA COMPLIANCE. IPC SecureLink ensures your pharmacy’s compliance with DSCSA track and trace requirements at the product level with access to all information for reporting and accessing required information in the event of an audit.
How IPC SecureLink Makes DSCSA Compliance Easy:
What does the FDA’s delay of enforcement of the DSCSA EDDs requirements mean to pharmacies?
The DSCSA act in and of itself has not been delayed; the FDA is allowing suppliers additional time to complete the conversion from current state transmission of ASN via EDI 856 to EPCIS file formats in what they term a “Stabilization Period.”
FDA generally expects trading partners to have the systems and processes in place to meet
the EDDS requirements as of November 27, 2023. Reference the FDA Guidance document.
What is DSCSA?
The Drug Supply Chain Security Act (DSCSA) is a critical piece of legislation enacted to enhance the security and traceability of pharmaceutical products as they move through the supply chain. It aims to safeguard the public health by identifying and eliminating counterfeit, adulterated, or stolen drugs from entering the market.
Get more answers to your questions with our FAQs list below.
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IPC GPO members can get started with IPC SecureLink by completing the form on the right.
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FAQ
General DSCSA Information
What is DSCSA?
The Drug Supply Chain Security Act (DSCSA) is a critical piece of legislation enacted to enhance the security and traceability of pharmaceutical products as they move through the supply chain. It aims to safeguard the public health by identifying and eliminating counterfeit, adulterated, or stolen drugs from entering the market.
What are the traceability changes that will be implemented?
Beginning on November 27, 2023, electronic-based approaches will be required to be used among all trading partners to meet the enhanced drug distribution security requirements, including electronic product tracing and verification of product at the package level (serialization).
How do I get my DSCSA data from IPC?
You can download it from our website. We can also send you an EPCIS file through a trading partner you choose.
EPCIS Files and Third-Party Partners
What is an EPCIS file?
Electronic Product Code Information Services (EPCIS) is a global GS1 Standard for creating and sharing visibility event data. It enables supply chain visibility by sharing data using a common language across, between, and within enterprises.
How can my pharmacy set up an EPCIS connection?
Email [email protected] with your request and let us know which third-party company you want to use. You will need to include your GLN (Global Location Number).
Do I need a third-party partner to follow the rules?
No. If you purchase from a single or dual source, you will be able to use those portals to get the information required. If you choose to use a 3rd party vendor, they can provide additional support including validating licenses, file formats, operational/audit support, etc. IPC GPO members have access to IPC SecureLink powered by PRS/Advasur.
GLN Information
What is a GLN?
Global Location Number – Uniquely identifies parties and locations to track products through the supply chain, assigned by GS1. GLNs are necessary for any EPCIS file transactions. GLNs are identifiers that can be shared with all trading partners and are not wholesaler specific.
How do I get a GLN?
McKesson will provide owners with 9 stores or less with GLN – Warehouse Customers should check with their primary wholesaler). You can purchase a GLN from GS1.
How can I determine if a distributor created a GLN for my pharmacy?
If you work with McKesson, AmerisourceBergen, Cardinal Health, Smith Drug Company, HealthTrust, Premier, or Vizient, you may already have a GLN enumerated on your behalf.
Do I need a GLN for my pharmacy?
You only need a GLN if you’re receiving EPCIS files.
Returns
Will the rules for returning products change?
Yes, there will be stricter rules based on the federal law. When you return a product, we’ll ask you to confirm its serial number and match it with our records. We’ll also need to make sure the returned product matches the original information from when it was sold.
Next Steps
What does the FDA’s delay of enforcement of the DSCSA EDDs requirements mean to pharmacies?
The DSCSA act in and of itself has not been delayed; the FDA is allowing suppliers additional time to complete the conversion from current state transmission of ASN via EDI 856 to EPCIS file formats in what they term a “Stabilization Period.”
FDA generally expects trading partners to have the systems and processes in place to meet
the EDDS requirements as of November 27, 2023. Reference the FDA Guidance document.
Can I delay compliance with DSCSA requirements since the latest FDA announcement on August 30th, 2023?
The FDA DOES NOT RECOMMEND DELAYING compliance with DSCSA requirements for product-level serialization. The 08/30/23 announcement states that the FDA is providing a “Stabilization Period” before it will enforce the Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act – Compliance Policies. Reference the Guidance Document DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs.
What changes should my pharmacy make?
Be ready to show information to the FDA or State BOP within 24 hours if they ask. Have a plan to keep suspicious products separate and report them to the FDA within a day. You can find more details from NCPA.
