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January 23 - 25 2015, 12:00 AM - 12:00 AM


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Annual Perioperative Surgical Home Summit



December 18, 2014

0.9 Percent Sodium Chloride Injection USP in 100 mL MINI-BAG PLUS Container by Baxter: Recall - Particulate Matter


FDA MedWatch Recall - Particulate Matter

November 21, 2014

FDA MedWatch - Respironics California, Esprit V1000 and V200 Ventilators: Class I Recall - Power Failure May Occur


FDA MedWatch Respironics California Esprit V1000 and V200 Ventilators Class I Recall

November 21, 2014

FDA MedWatch - Highly Concentrated Potassium Chloride Injection, 10 mEq per 100 mL by Baxter: Recall - Mislabeled


Highly Concentrated Potassium Chloride Injection 10 mEq per 100 mL by Baxter Recall Mislabeled



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Bipartisan and Bicameral Compounding Legislation Clears House of Representatives

Tuesday, October 01, 2013

On September 28th, the U.S. House of Representatives passed by a voice vote H.R. 3204, the Drug Quality and Security Act, a bill to enhance regulation of compounding pharmacies.  This bipartisan and bicameral compromise bill is in response to the fatal outbreak of fungal meningitis last year.


The bill would create a new category of compounders known as outsourcing facilities.  Under the legislation, compounding pharmacies may elect to register with the Food and Drug Administration (FDA) as outsourcing facilities.  As part of the registration, the outsourcing facility voluntarily agrees to subject itself to certain requirements similar to those that currently govern traditional drug manufacturers. 

Under the new regulatory structure, the FDA will have information regarding where outsourcing facilities are located and what drugs  are being compounding.  Additionally, the FDA will receive adverse event reports about compounded drugs, and will have the authority to conduct risk-based inspections.   

Compounders that decline to register as outsourcing facilities will not be penalized under this legislation.


The proponents of this new framework argue that this market-based approach to regulation will allow hospitals and other end users the opportunity to purchase from an FDA-regulated outsourcing facility or a facility that has elected not to register with the FDA.

Authors of the legislation claim it is crafted to maintain the status quo in regards to physician offices.     

The bill now moves to the Senate where passage is considered likely. 


ASA will continue to closely monitor this legislation.


Review the Drug Quality and Security Act.

House Energy and Commerce Committee Fact Sheet.

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