Drugs

Drug Compounding Actions Improved Public Health: FDA

In a three-year progress report on its regulation of drug compounding under the Drug Quality and Security Act of 2013, FDA says its oversight efforts have had a significant public health impact. The report lists these accomplishments:

significantly increased agency inspections of facilities where drugs are being compounded with appropriate regulatory actions taken in response to violations of law that put patients at risk;
issued numerous policy documents, including draft and final guidance documents and proposed and final regulations;
convened advisory committee meetings to obtain advice on scientific, technical, and medical issues concerning drug compounding;
obtained input from stakeholders through a variety of different mechanisms; and
worked closely with states to share drug information and coordinate efforts.

The report says that after FDA inspections and regulatory actions, many compounders have implemented corrective actions to address poor practices that could lead to quality problems that put patients at risk. Others, it says, have initiated voluntary drug recalls.

The agency says it continues to investigate many reports of serious adverse events associated with contaminated or otherwise poor quality compounded drugs, including sterile and non-sterile drugs that were thousands of times stronger than labeled. It says it also has identified insanitary conditions at most sterile drug compounders it has inspected since enactment of the law.

FDA says it “intends to build on its initial efforts to implement and enforce the compounding provisions of the law in the coming months and years. Maintaining vigorous oversight, continuing to explain regulatory requirements through policy development, and fostering collaboration with states and stakeholders are vital to achieving broader compliance with the provisions of federal law intended to help protect patients.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome