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MEETINGS / EVENTS

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November 08 - 09 2014, 12:00 AM - 12:00 AM

ASA Quality Meeting 2014

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

ASA PRACTICE MANAGEMENT 2015

February 07 - 08 2015, 12:00 AM - 12:00 AM

ASA Certificate in Business Administration 2015

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FDA MEDWATCH ALERTS

October 16, 2014

FDA MedWatch - LifeCare Flexible Intravenous Solutions by Hospira, Inc.: Recall - Potential for Leakage

Summary:

FDA MedWatch LifeCare Flexible Intravenous Solutions by Hospira Inc

October 13, 2014

FDA MedWatch - CareFusion EnVe and ReVel Ventilators: Class 1 Recall - Power Connection Failure

Summary:

FDA MedWatch CareFusion EnVe and ReVel Ventilators

October 13, 2014

FDA MedWatch - ICU Medical ConMed Stat2 Flow Controller: Class 1 Recall - Delivers Higher Flow Rate than Intended

Summary:

FDA MedWatch ICU Medical ConMed Stat2 Flow Controller

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ASA FEATURED PRODUCT

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Self-Education and Evaluation (SEE) Program

SKU: 30701-14CE

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Single Copies, Member Price: $360

Congressional Report Details Regulatory Oversight of Compounding Pharmacies

Wednesday, October 31, 2012

This week, Congressman Edward J. Markey (D-Mass.) released a report, Compounding Pharmacies, Compounding Risk, which examines FDA and state Boards of Pharmacy regulation of compounding pharmacies.  According to the report, the FDA has attempted to rein in activities of compounding pharmacies by issuing warning letters, but the nature of regulatory oversight and gaps in legal authority have led to 23 deaths and at least 86 serious illnesses or injuries in 34 states (not including the most recent outbreak).  The report explained that state Boards of Pharmacy do not typically undertake enforcement actions that relate to the safety or scope of drugs made by compounding pharmacies.  In spite of this deficiency, "FDA’s efforts to assure the safety of compounding pharmacies have been challenged at every juncture by some members of the compounding pharmacy sector."  The report concluded:

This analysis makes clear that state regulators are not, or cannot, perform the same sort of safety-related oversight of compounding pharmacy practices that FDA has historically undertaken. But it is also clear that absent clear new statutory authority, FDA’s efforts will ultimately be constrained by gaps in regulatory authority and thwarted by an industry that has historically resisted a federal role for the oversight of its activities.

Read the report.

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