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Previous Blogs

Daikyo Crystal Zenith Insert Needle Syringe
Compounding Pharmacy 503B Outsourcing Facilities
Intended Use and Packaging Risks for Compounding Pharmacies (503Bs)

By Amy Kim

July 10, 2019

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.1

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clinical researcher engaged in drug safety, safeguarding, compliance
CGMP Outsourcing Facilities 503B Compounding Pharmacy
Key Takeaways from FDA Public Meeting on Outsourcing Facilities, cGMP and Office Stock

By Melanie Prudom

June 13, 2019

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of attending the recent FDA Public Meeting on Tuesday, May 21, 2019 regarding 503B Compounding Pharmacies and the cGMP draft guidance, as well as office stock issues which had generated many comments.

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