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DSCSA: Grandfathering Guidance

The comment period recently closed on the FDA’s grandfathering draft guidance. Here’s an expert’s take on how the guidance clears some of the confusion.

The FDA's Juпe issuance of а draft guidance, Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy, had drug manufacturers scratching their heads оп how and when to comply. In November 2017, the FDA published yet another draft guidance, Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier, which clears up some of the questions that we have all had on these issues.

Gordon Glass, Vice Presideпt Coпsulting, Excelis Health Solutions, adds some additional clarity to his earlier discourse with updates from the draft Grandfathering policy.

DSCSA non-enforcement draft guidance

The full compliance policy still hasn’t been published, as it’s going through review as a draft to accept challenges, recommendations and a critique (the comment period closed in January). The primary reason for seeking further guidance dealt with enforcement of DSCSA, specifically with regards to manufacturers applying serialization to products. The deadline for compliance here remains Nov. 27 of 2017, but in the draft the FDA states they will not enforce the manufacturers’ product identifier requirements under the DSCSA for another full year. While this buys some manufacturers, wholesalers, and repackagers some more time, it begged the question about what “introduced in a transaction into commerce before Nov. 26, 2018” meant.

Specifically, from lines 37-41 of the draft guidance:

‘In brief, FDA does not intend to take action against manufacturers who do not affix or imprint a product identifier to each package and homogeneous case of products intended to be introduced in a transaction into commerce before Nov. 26, 2018. This represents a one year delay in enforcement of the requirement for manufacturers to affix or imprint product identifiers.’

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