DSCSA Compliance Readiness Inches Along, Says HDA Survey


Latest Q4 2022 results show some progress, but 100% readiness by November looks doubtful.

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The Healthcare Distribution Alliance (HDA)’s quarterly update of industry readiness for compliance with the Drug Supply Chain Security Act (DSCSA) was up to 56% at the end of 2022, up five percentage points from the previous quarter. Directionally, that’s a positive sign; however, to get the industry fully ready by Nov. 27, when the is supposed to be fully in force, looks problematic.

“It is critical for the FDA to communicate how they plan to address the very real potential for product shortages and supply chain disruptions if trading partners are not ready by Nov. 27,” warns Perry Fri, EVP, industry relations for HDA. “To that end, HDA also reiterates its request for the agency not to exercise blanket enforcement discretion for DSCSA implementation”—i.e., that it allows more time before enforcement actions are taken against compliance laggards.

Nearly all manufacturers are barcoding their individual product units today, per an earlier deadline. The survey finds that 86% of respondents are using EPCIS 1.2, the preferred standard for communicating product data to trading partners. However, only 56% of that portion has successfully made connections to their downstream trading partners, while the portion of distributors who have made connections to small manufacturers 3PLs ranges from 33 to 56%. “Length of times to on-board trading partner” was listed as the No. 1 reason for the lack of connectivity. Another factor, not measured in the survey, is how many respondents have, or will, upgrade to EPCIS 1.3, which became available at the end of 2022.

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