Category Archives: DSCSA

Decoding The FDA’s DSCSA Timeline

FDA DSCSA Implementation Plan.shrunkMany RxTrace readers probably saw the FDA press release last week that included the timeline chart called “Summary of Planned Implementation Timeframes for the Drug Supply Chain Security Act”.  If you did not see it, here is the link.  I found the text to be too small so I reproduced the chart using a larger font size.  See that version below.  Click on it to enlarge the image.  You might find this version better for inclusion in Powerpoint slides.

This is the FDA’s interpretation of their obligations under the Drug Supply Chain Security Act (DSCSA), which is Title II of the Drug Quality and Security Act (DQSA) that was signed into law last November (see “It’s Official, President Obama Signs H.R. 3204, DQSA, Into Law”).  There really are not any surprises in their interpretation, but there are a few interesting things to notice in this timeline and the associated table of target dates that accompanied it.  I have also reproduced the FDA’s deliverable table, but my version is sorted by the estimated target date column to make it easier to see what they plan to do in time sequence.

The first thing to notice about the timeline is Continue reading Decoding The FDA’s DSCSA Timeline