Did You Know?
FDA Takes OTC Accelerated Stability Data Very Seriously
The FDA expects all drug products to bear an expiration date that is backed by scientifically sound data and projections, regardless of whether that drug is an NDA, ANDA or Over the Counter (OTC) monograph product. Under the FDA’s current expectations, OTC monograph drugs are provided a rare opportunity to leverage projected data rather than actual data to set the expiry periods. That is of course, provided the data follows the rules of well recognized accelerated stability models.
Unfortunately, inadequate stability is consistently ranked in the top five of FDA observations, demonstrating the OTC drug industry does not understand the fundamentals of accelerated stability, what the program requires and how to set up a meaningful approach that will satisfy the Agency. As part of GMP methodology, stability, including the validity, usefulness and limitations of accelerated data almost seems like a gray area when it comes to products manufactured under monographs – not an ICH, but also not an ANDA.
Do you understand how to set up a meaningful accelerated stability program for the establishment of an expiration date for OTC monograph drug products?