FDA Takes Efforts to Protect Patients from Potentially Harmful Compounded Drugs Through Finalizing Insanitary Conditions Guidance

FDA Statement

• For Immediate Release: November 06, 2020
• Statement From: Patrizia Cavazzoni,, M.D. ; Deputy Center Director for Operations - Center for Drug Evaluation and Research | CDER ; Acting Director - Center for Drug Evaluation and Research

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Based on comments to the revised draft guidance, we also added recommendations for compounders to use risk management tools to develop appropriate controls to prevent insanitary conditions at their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.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.