Tele: 561.316.3330
Breaking Medical Device News

Wednesday, October 20, 2021

MEDICAL DEVICE NEWS MAGAZINE

A DIGITAL PUBLICATION FOR THE PRACTICING MEDICAL SPECIALIST, INDUSTRY EXECUTIVE AND INVESTOR
HomeFDAProtecting Patients from Potentially Harmful Compounded Drugs Through Finalizing Insanitary Conditions Guidance:...

Protecting Patients from Potentially Harmful Compounded Drugs Through Finalizing Insanitary Conditions Guidance: FDA Takes Efforts

The Following Is Attributed to Patrizia Cavazzoni, M.D., Acting Director, FDA Center for Drug Evaluation and Research

November 6, 2020

Protecting patients from exposure to poor quality compounded drugs is a fundamental part of the U.S. Food and Drug Administration’s drug compounding program, and we are committed to protecting patients.

While compounded drugs can serve an important role for patients whose medical needs cannot be met by an FDA-approved drug product, these drugs have not been reviewed by the FDA for safety, effectiveness, or quality. The FDA through its oversight of compounded drugs strives to help improve the quality of compounded drugs and reduce risk to patients.

Under federal law, a drug is considered adulterated if it is prepared, packed or held under insanitary conditions that could cause the drug to become contaminated with filth or rendered injurious to health. While some compounders work hard to meet quality standards, too often, FDA investigators continue to observe poor conditions at compounding facilities that impact drug quality and have the potential to harm patients who use the drugs. These insanitary conditions include dirt, mold, insects, trash, peeling paint, unclean exhaust vents and dirty high-efficiency particulate air (HEPA) filters, among many other examples. Numerous compounders have voluntarily recalled drug products intended to be sterile, and also temporarily or permanently stopped sterile operations because of these inspectional observations. The FDA has also taken regulatory and enforcement actions when we observe these insanitary conditions.

Because of these and other concerning examples, we have witnessed, today we’re releasing a final guidance to further our efforts to help compounders identify and prevent insanitary conditions at their facilities. The final guidance provides recent examples of insanitary conditions that we’ve observed at compounding facilities and details corrective actions that facilities should take when they identify these conditions.

Based on comments to the revised draft guidance, we also added recommendations for compounders to use risk management tools to develop appropriate controls to prevent insanitary conditions at their facilities. Additionally, the guidance addresses the regulatory actions that the FDA may take in response to insanitary conditions. Through our oversight and regulatory actions, we address insanitary conditions at compounders’ facilities across the country. We will continue to take appropriate action to protect patients from poor quality drugs made in facilities that have insanitary conditions. And our collaborative work with states and the Department of Justice remains ongoing.

Both traditional compounders and outsourcing facilities should take measures to avoid insanitary conditions. We urge compounders to use this valuable resource to better understand insanitary conditions and take necessary actions to avoid such issues for the safety of the patients who receive their drugs.

Additional Resources:

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

Stay Connected

spot_img

Don't Miss

Contraline Closes $10.7 Million Series A Financing to Become a Clinical Stage Company

This infusion of capital will support the initiation of a first-in-human trial of ADAM™, the world’s first hydrogel implant designed to provide long-lasting, non-permanent contraception for men.

Adam S. Epstein New CEO of AliMed, Inc.

In his prior role as Chief Commercial Officer, Epstein directed all customer-facing, demand generation and product development activities. Under his new leadership, AliMed will continue to build a robust portfolio of contracted positions with major, national GPO’s, IDN’s, and Distribution partners to drive sales growth.

Tony Collins Appointed CFO of Xenter

“Xenter is building a platform for medical innovations that is transformational. The only way we can achieve our objectives is if we have great leaders like Tony Collins leading our company,” stated Richard J. Linder, Founder, Chairman & CEO of Xenter, Inc. “Tony brings incredible depth and experience to his new role as Chief Financial Officer.

Scott Sexton Appointed President at FIGUR8

"Scott brings to FIGUR8 30 years of workers' compensation, casualty, disability, and commercial health experience, most recently serving as a market leader for CorVel's national carrier practice sales team," said Nan-Wei Gong, CEO, and co-founder of FIGUR8.

Insulet Announces Board of Director Changes with Appointment of Luciana Borio, M.D. and Retirement of Sally W. Crawford

Luciana Borio MD is a respected physician with vast experience in advancing major regulatory and policy agendas for the United States.

Ganymed Robotics Awarded a €2.5M Grant from the EC through the EIC Accelerator Program

Ganymed Robotics is developing a radically new approach to surgical robotics by combining computer vision, a branch of artificial intelligence, and mechatronics.

By using this website you agree to accept Medical Device News Magazine Privacy Policy