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November 18, 2019

Ready Pack™ Sterile Component Solutions for Compounding Pharmacy

The FDA recognizes that compounded drugs serve an important role for patients whose medical needs cannot be met by FDA-approved drugs. However, compounded drugs are not approved by the FDA and therefore, have not been evaluated for safety or efficacy. Poor compounding practices or unsuitable manufacturing conditions can lead to serious adverse effects, or even patient death. Over the past few years, the FDA has taken significant steps to modernize and clarify policies related to the quality of compounding in an effort to ensure continued access to compounded drugs, while also protecting patients from the risks of contaminated or otherwise harmful products<sup>1</sup>. FDA Draft Guidances<sup>2, 3</sup> help to clarify applicable regulatory requirements and specifically address the use and handling of container closure systems.
Amy Kim

Amy Kim,

Sr, Specialist, Scientific Communications

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