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CMS updated guidance for the nursing service regulatory requirements [§482.23(c)(1), (c)(1)(i) & (c)(2)], concerning medication administration to clarify that hospitals must ensure staff adherence to accepted standards of practice in those limited instances when Compounded Sterile Preparations (CSPs) may be prepared outside of the pharmacy.

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A video crew followed Donna Reich through a shift as a Sterile Processing Technician at PeaceHealth Southwest Medical Center (at the time of recording, it wa...

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A harmonized standard for Limits for Non-Sterile Products has been approved by the Pharmacopeial Discussion Group (PDG) as described in its PDG Sign-Off Cover Page. Since there was no web posting at the time of sign-off of this chapter, all previous PDG sign-offs and postings are summarized as below:

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Advice to the pharmaceutical industry regarding the chemistry, manufacturing, and controls and microbiology (sterility assurance) information to be included in regulatory submissions to the Center for Drug Evaluation and Research (CDER) can be found in the pertinent statutes, regulations, and guidances. The primary statute is the Federal Food, Drug and Cosmetic Act (the Act); applicable ...

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compounding area for sterile products. ⚠ Any other person who enters the sterile compounding area or who is involved in sterile compounding processes must be adequately trained and comply with specific policies and procedures. ⚠ All personnel assigned to the compounding of sterile preparations must

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to ensure a low bioburden of finished dosage forms by implementing current guidelines on good manufacturing practice (GMP) during the manufacture, storage and distribution of pharmaceutical preparations. Microbial examination of non-sterile products is performed according to the methods given in the texts on 3.3.1 Microbial

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