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Latest Post

July 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

Amy Kim

Sr. Specialist, Scientific Communications, SA & TS

Previous Posts
Introducing Integrated Solutions

May 02, 2019

FDA Guidance Affecting cGMP Compounding Pharmacies (503Bs)

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Amy Kim

Sr. Specialist, Scientific Communications, SA & TS

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Overcoming Challenges Associated with Biologic Drug Formulation and Development

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Selecting the Right Package for a Drug Product

Page McAndrew

T. Page McAndrew

Director, Scientific Communications

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