Notice: Get a jump on 2015 — Pay your 2015 ASA membership dues now!




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


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



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

November 07, 2014

FDA MedWatch - Nellcor Puritan Bennett, 980 Ventilator System: Class I Recall - Software Issue May Stop Ventilator


FDA MedWatch Nellcor Puritan Bennett 980 Ventilator System Class I Recall



Add this product to your shopping cart

Self-Education and Evaluation (SEE) Program

SKU: 30701-14CE

... Read more »

Single Copies, Member Price: $360

FDA Issues Rule Tightening Drug Shortage Reporting

Thursday, December 15, 2011

In accordance with President Barack Obama’s Executive Order on drug shortages, the Food and Drug Administration (FDA) released an interim final rule tightening restrictions on the reporting of drug shortages by drugmakers. The interim final rule requires drugmakers who are the sole manufacturers of certain drugs to report all disruptions in production —temporary and permanent—by providing at least a six-month warning (situation-permitting) to the FDA. 

Covered drugs would include drugs that are “life supporting, life sustaining or intended for use in the prevention of debilitating disease or condition,” as determined by the FDA on a case-by-case basis.  This rule tightens previous references to temporary discontinuances by requiring disruption reporting “if the discontinuance could lead to a disruption in supply of the product.” 

Over the course of the last two years, ASA has actively led efforts to deal with the drug shortage issue on both the legislative and regulatory fronts.  Part of this effort included co-convening a Drug Shortage Workgroup Summit that issued five legislative and regulatory recommendations.  ASA was encouraged to see the inclusion of the Summit’s recommendation for reporting of interruptions and discontinuation of drugs at least six months in advance. 

Reveiw the FDA rule.

Department of Health and Human Service’s Fact Sheet.

Learn more about ASA’s work to combat drug shortages.

« Back to Washington Alerts