Our View: HDA DSCSA Readiness Survey Shows Possible Gaps

HDA DSCSA Survey Shows Possible Gaps

The Healthcare Distribution Alliance (HDA) Research Foundation published the results of a DSCSA serialization readiness survey in October of 2016.  The survey was conducted during August and September of 2016.  HDA Research Foundation surveys are particularly credible because the industry organization maintains close relationships with the supply chain departments of most drug manufacturers.  Those responding to the survey take it seriously so they tend to put more time and effort into their responses than for third-party commercial surveys.  Because of this, there is a high response rate and high-level of accuracy.

The full survey results were made public in the Foundation’s “Manufacturer Serialization Readiness Survey Executive Summary.”  It revealed several surprising facts:

No significant difference between brand and generic drug portfolios:
The Foundation found no significant difference between the readiness of the brand and generic drug portfolios.  Many people have assumed that generic drug manufacturers will be less prepared for meeting the DSCSA serialization requirements on-time due to their lower profit margins.  This survey seems to indicate that there is no significant difference between brand and generic.

Ten percent of manufacturers will not ship any serialized product early:
Ten percent of the manufacturers responding said that they will not begin shipping serialized product before the DSCSA deadline of November 27, 2017.  There is no indication of what percentage of those respondents will miss the deadline entirely and what percentage will just barely meet it.

Forty percent of respondents had “concerns” about the approaching deadline:
Of those who had concerns that could impact their ability to meet the deadline, the top 3 concerns were:

  1. CMO readiness (62%)
  2. Lack of FDA Guidance on serialization (62%)
  3. Absence of FDA mandated guidance on waivers, exemptions and exceptions (48%)

DSCSA Serialization Solution

Clearly, there are readiness problems and concerns that could impact the availability of some products after the serialization deadline.  Fortunately, Systech offers Rapid Compliance.  This solution allows companies to serialize their packaging lines in 90 days.  Our full 90-day compliance solution includes:

  • Multi-level serialization
  • Site and line management configuration
  • A built-in foundation for future lines
  • Factory Acceptance Testing (FAT)
  • Site Acceptance Testing (SAT)

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