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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:
Simplify the Journey™ is a trademark of West Pharmaceutical Services, Inc. in the United States and other jurisdictions.
Take an in-depth look at the science behind containment & delivery of injectable medicines in the West Knowledge Center.