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MEETINGS / EVENTS

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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

June 26 - 28 2015, 12:00 AM - 12:00 AM

Annual Perioperative Surgical Home Summit

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FDA MEDWATCH ALERTS

December 18, 2014

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

Summary:

FDA MedWatch Recall - Particulate Matter

November 21, 2014

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

Summary:

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

Summary:

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

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Self-Education and Evaluation (SEE) Program

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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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