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May 20, 2013

All Sterile Drug Products Made and Distributed By NuVision Pharmacy Dallas Facility: Recall - Lack Of Sterility Assurance

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All Sterile Drug Products Made and Distributed By NuVision Pharmacy Dallas Facility

May 14, 2013

Zolpidem Containing Products: Drug Safety Communication - FDA Requires Lower Recommended Doses

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Zolpidem Containing Products Drug Safety Communication

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The Compounding Shop: FDA News Release - Lack of Sterility Assurance of Drug Products

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The Compounding Shop FDA News Release Lack of Sterility

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ASA Scores Major Victory on Labor Epidural Supervision

Friday, January 21, 2011

CMS recently issued revised Interpretative Guidelines (IGs) to the Hospital Conditions of Participation that contain major victories for ASA’s regulatory lobbying efforts.  These guidelines revise major sections of the December 2009 CMS Hospital Interpretative Guidelines and are effective immediately.

CMS has removed language specifically exempting labor epidurals from the physician supervision requirements.  Hospitals are now required to “establish policies and procedures, based on nationally recognized guidelines, that address whether specific clinical situations involved anesthesia versus analgesia,” as well as, “the minimum qualifications and supervision requirements for each category of practitioner who is permitted to provide analgesia services.”  

When the 2009 IGs were released, ASA developed a comprehensive regulatory lobbying strategy, involving comment letters, meetings and discussions with appropriate CMS officials, with the goal of making substantive changes to the IGs.  ASA’s focus in all of its efforts was consistently on patient safety and quality of care coupled with emphasis on anesthesia as a continuum with no clear boundaries.  The strategy worked.  

Click here for updates on other victories ASA achieved in the new IGs.

Click here to read the CMS issued Revised Interpretive Guidelines.

Click here to read a memo from CMS on the Revised Interpretive Guidelines.

Click here to read FAQs released by CMS on the Revised Interpretive Guidelines.

 

 

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