FDA To Publish Key Draft Guidance Tomorrow

This morning the FDA announced their intention to publish the long overdue draft guidance on Drug Supply Chain Security Act waivers, exceptions and exemptions tomorrow.  The timing of the publication of this particular draft guidance is critical to the FDA holding their current enforcement deadline for serialization and verification for manufacturers and repackagers.  In fact, if they had failed to meet their late May deadline for publication of this particular draft guidance (180 days before that enforcement, according to the DSCSA Section 582[a][3][C]), they would have been forced to delay enforcement again.  I’ve been watching this subtle deadline approaching and clearly the FDA has been too.

In fact, it has always been my contention that the delay of the serialization and verification for drug manufacturers that occurred last June was specifically because the FDA was unprepared to publish this draft guidance in time (see “FDA Tea Leaves: Are They About To Delay The November Deadline?”).  With that enforcement delay, they gave themselves another year to get it done, and they have now made their new cutoff by a couple of weeks (see “FDA Delays Enforcement of DSCSA November Deadline: What It Means”).  Shortly before the May deadline last year an FDA representative suggested that people who needed to apply for a waiver, exception or exemption could just send an email to the FDA and ask for one, as if the draft guidance wasn’t really necessary (see “Breaking: FDA Official Offers Advice In Absence Of DSCSA Waiver Guidance”).

Finally, the long awaited draft guidance will be published tomorrow, a few weeks before the 180 day deadline, which bolsters the ending of the enforcement delay for serialization and verification on November 27 this year.  What this means is, all statutory roadblocks to ending the enforcement delay on schedule have now been removed.  Don’t expect another delay.

I will review the new draft guidance on Monday.

Dirk.

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