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Since the 2012 New England Compounding Center tragedy that linked a deadly fungal meningitis outbreak to a failure to use current good manufacturing practices (cGMP),1 compounding pharmacies have faced increasing scrutiny and regulation by the U.S. Food and Drug Administration (FDA). While registering with the FDA is still voluntary, only compounding pharmacies that register, and pass inspection, will be granted “503B” status as compounding outsourcing facilities under Section 503B of the Federal Food, Drug, and Cosmetic Act.2
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:
Understanding these new regulations, West can help minimize risk with the Integrated Solutions program to Simplify the Journey™ for customers by offering:
For more information visit the Integrated Solutions Program section of our website or contact an Account Manager or Technical Customer Support (TCS) representative.
Simplify the Journey™ is a trademark of West Pharmaceutical Services, Inc. in the United States and other jurisdictions.
In 2015, the FDA shed light on a problematic practice within the healthcare industry involving improper, off-label use of syringes as closed container storage systems for compounded or repackaged drugs. The incidents cited revealed that interaction with rubber plungers in syringes that were not cleared for the purpose of closed container storage resulted in the loss of potency of several drugs when administration was delayed.<sup>1</sup>
We are pleased to announce our recent publication in the November/December 2019 Issue of the International Journal of Pharmaceutical Compounding. In the article “How to Qualify Container Closure Systems, Part 1,” we address how compounding pharmacies (503Bs) can qualify systems for intended use via container closure integrity (CCI) to meet FDA Guidance requirements.<sup>1</sup>
With the May 21, 2019 meeting to review the FDA draft guidance governing 503B compounding pharmacies, it has become evident that sterility of drugs produced at such facilities is a major focus of the U.S. Food and Drug Administration (FDA).<sup>1</sup> The meeting discussed the importance of qualifying container closure systems and was aimed at providing more context on what compounding pharmacies need to do.
“Choosing the Right Components for Container Closure Systems,” the second part of our “How to Qualify Container Closure Systems” series, was recently published in the International Journal of Pharmaceutical Compounding. The article addresses ways in which packaging component selection is critical to ensuring that the closure container system will protect and maintain compounded drug quality.<sup>1</sup>
Members of the West Pharmaceutical Services, Inc. (West) Marketing Unit had the pleasure of attending the recent FDA Public Meeting on Tuesday, May 21, 2019 regarding 503B Compounding Pharmacies and the cGMP draft guidance, as well as office stock issues which had generated many comments.
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