Clarification of the Stability Clarification Front and Center!

I have been getting lots of calls and questions on my blog post of May 15, 2014 on clarification of the stability guidance particularly on the issue of primary stability batch packaging (here). Apparently, the Office of Generic Drugs (OGD) has also received e-mails on this issue as well.  So to clarify the clarification, here goes!

We all know that OGD used to require the packaging of at least 100,000 dosage units of solid oral dosage forms from a batch of at least 100,000dosage units and most firms made slightly more than that.  This has been OGD’s mantra ever since Hatch-Waxman passed in 1984.  The guidance now is that the 100,000 total packaged products can come from the three primary stability batches.  Today, it was learned after additional direct contact with OGD that the packaging issue outlined in my post of May 15, 2014 is correct but, in addition, packaging the smallest of the three exhibit batches fully will meet the guidance recommendation.

Thus, a total of 100,000 dosage units in total should be packaged, but it is recommended that the smallest of the three primary stability batches be fully packaged to meet the stability guidance requirements.  Take that into consideration when preparing for stability testing and packaging of the three primary stability batches.

For more information on stability or other regulatory issues please contact Joan Janulis at or one of our other regulatory experts at 516-222-6222.