FDA Releases DSCSA Data Exchange Guidance
The FDA today released their long-awaited Data Exchange Guidance for DSCSA. The short summary? No new news - HDMA ASN, GS1
Entitled "DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs: How to Exchange Product Tracing Information", it has two sections.
First, the coverage of the Guidance with respect to DSCSA Implementation:
- Organizations covered by the Guidance: Basically any manufacturers, wholesale distributors, repackagers and dispensers that have a DSCSA compliance requirement.
- Products covered by the Guidance: Basically the products defined in DSCSA section 581(13) as having a DSCSA compliance requirement.
- Transaction covered by the Guidance: Basically all transactions as defined under DSCSA section 581(13) not explicitly exempted in the law
Second, FDA's thoughts on data exchange methods to meet the Product Tracing regulations of DSCSA:
- Interoperability between trading partners is crucial and flexibility is key given the diversity of partners and systems
- Companies may utilize current electronic or paper-based methodologies as long as these methods meet all provisions of DSCSA Tracing regulations
- Methods documented in the guidance include: EDI ASN (such as the HDMA ASN), EPCIS (such as the GS1 EPCIS v1.1), web portals, paper (such as packing slips or invoices)
The FDA also reinforced that whatever method(s) are chosen, the information must be captured, maintained and provided in full compliance with all provisions of the Tracing and Verification regulations in DSCSA section 582.
The Guidance doesn't address any additional requirements that a company may have due to trade partner requirements for DSCSA data exchange. For example, suppliers or trading partners may not accept paper DSCSA compliance documents to meet the regulatory requirements.