If you have any questions, you can reach out to the BioCare DSCSA team at: DSCSA@biocaresd.com.
Q: What is DSCSA (Drug Supply Chain Security Act)?
A: DSCSA requires that all pharmaceutical products have a unique identifier and a standardized package label. The industry has chosen to use a GS1 (Global Standards 1) Data Matrix Barcode (aka 2D Barcode) to encode this data which consists of the GTIN (identifies the product), the unique Serial Number, the Expiration Date of the product and the Lot # at the unit of sale level. The act requires all participants in the drug supply chain to track and trace serialized products as they move through the supply chain.
Q: When does DSCSA go into effect?
A: DSCSA has been implemented in phases since its enactment in 2013. The deadline for compliance with the final phase is November 27, 2023, which involves the tracking of the serialized product as it moves through the supply chain. However, it’s important to note that the FDA has recently responded to the industry’s concerns about the need for extra time to stabilize and be fully interoperable for accurate, secure, and electronic data exchange. This additional period, referred to as the ‘Stabilization Period’ extends up to November 27, 2024.
Q: What is GS1 (Global Standards 1)?
A: GS1 is a not-for-profit international standards organization that defined the industry standards for DSCSA serialization. You will hear the following terms and this is what they mean:
- GLN (Global Location Number)* identifies the ‘Location’ of the Customer.
- GTIN (Global Trade Item Number) identifies the individual serialized ‘Products’. The NDC# is embedded in the GTIN.
- EPCIS (Electronic Product Code Information Systems) is the serialized data sent between trading partners.
*Check with your GPO to determine if they’ve purchased a GLN on your behalf. If not, you can obtain your GLN here.
Q: What is BioCare doing for DSCSA and Onboarding their Customers?
A: BioCare has chosen to use SAP’s ATTP (Advanced Track & Trace for Pharmaceuticals) to meet the serialization requirements in support of DSCSA. SAP’s ICH (Information Collaboration Hub) is our solution to send the serialized data to our customers. Customers can accept the serialized data directly into their Track & Trace systems, or they can sign into the ICH User Interface and pull the related DSCSA information for a shipment, which can be in the form of a pdf file.
To kickstart the onboarding process with customers, BioCare will send customers the necessary onboarding documents. OnceBioCare receives the onboarding documents back, they will 1) guide the customer through ICH onboarding, and 2) test with the customer to ensure they are receiving the serialized data. This will ensure compliance with DSCSA.
Q: What should Customers do to prepare for DSCSA?
A: You can prepare for DSCSA by reviewing the requirements of the act and assessing your compliance. FDA Guidance for Industry: Standards for Securing the Drug Supply Chain – SNI for Prescription Drug Packages (FDA, 2010).