Sr. Specialist, Scientific Communications, SA & TS
May 02, 2019
With the need to achieve and maintain 503B status, compounding pharmacies will have to navigate the impending regulatory changes proposed in the December 2018 release of Revision 1 of the cGMP Guidance.2 This newly revised FDA Guidance treats compounding pharmacies increasingly like drug manufacturers. Here is what you need to know:
- 503B facilities, their equipment, and capabilities for stability testing, assignment of beyond-use-date (BUD) of products, and release testing will be held to FDA Guidance Requirements.
- FDA Guidance does allow compounders to rely upon suppliers, certificates of analysis (COAs), and third-party labs.
- Container closure systems must be tested to meet criteria for use, as well as be tested for integrity under appropriate storage conditions. Lots must be examined to verify identity, tested to ensure conformity with specifications, and protected from risk of contamination.
Understanding these new regulations, West can help minimize risk with the Integrated Solutions program to Simplify the Journey™ for customers by offering:
- Components/products that can meet 503B requirements.
- Analytical Support (West Analytical Services can design and execute studies, e.g., Container Closure Integrity (CCI) testing, BUD stability testing, and antimicrobial testing that meets FDA requirements).
- Regulatory support.
Simplify the Journey™ is a trademark of West Pharmaceutical Services, Inc. in the United States and other jurisdictions.