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七月 10, 2019
Intended Use and Packaging Risks for Compounding Pharmacies (503Bs)
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>

Amy Kim
Sr. Specialist, Scientific Communications, SA & TS
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以前的博客

六月 13, 2019
Key Takeaways from FDA Public Meeting on Outsourcing Facilities, cGMP and Office Stock

Melanie Prudom
Director, Market Insights, Pharma

五月 02, 2019
FDA Guidance Affecting cGMP Compounding Pharmacies (503Bs)

Amy Kim
Sr. Specialist, Scientific Communications, SA & TS