OTC Stability Program for FDA Compliance

David E. Wiggins

Course description

In 2006, FDA withdrew both their approved 1987 Stability Guideline and their draft 1998 Stability Guidance and referred industry to the ICH Stability Guidances. With the ICH guidance documents covering New Chemical Entities (NCEs) and their associated drug products, there was no guidance provided for OTC drugs covered by an ANDA or an OTC monograph. In 2014, FDA issued Guidance for Stability testing requirements for all drug products covered by an ANDA, but no guidance has been provided for OTC monograph drug products.

As a result, strictly following the ICH stability guidance for NCEs is unwarranted and ignores the significant database of information that is typically available for OTC drug products. For OTC drug products covered by an OTC monograph, there is frequently years of proven experience with the drug substance as well as the drug product. It is this body of data that can often be used to justify a pre-market stability program.

This accredited course will provide an understanding of how the pre-market stability programs can be successfully managed while minimizing the overall timeline. Lectures will address the seven key GMP aspects of a stability program along with all of the relevant stability guidelines that cover drug product stability. Accelerated testing that allows the marketing of a new OTC drug product prior to the generation of long-term, real-time stability data and confirmation of the stability projections will also be covered.

Upon completion of this course, you will be able to:

• Establish the stability of an OTC drug product following a fully GMP compliant program
• Describe how the stability would be established for an OTC drug product covered by an OTC Monograph
• Prepare stability protocols that incorporate all cGMP requirements and are consistent with the intended purpose