Insanitary Conditions Guidance from the FDA Finalized

In 2012, an outbreak of fungal meningitis was traced back to the now-defunct New England Compounding Center. Ever since then, the Food and Drug Administration (FDA) has taken measures to improve sanitary conditions as compounding pharmacies. The FDA has now taken another step in that process, and pharmacies all across the nation need to be aware of these changes.

The FDA Finalizes New Insanitary Conditions Guidance

Sometimes an FDA-approved drug does not meet all the needs of certain patients. In these instances, licensed pharmacists and physicians, or a properly supervised facility, can produce an alternative mixed compound. These compounds combine, mix or alter ingredients of drugs to create a tailored medication for certain patient needs. However, when prepared in an insanitary environment, these compounded medications can have dire effects.

In 2012, one incident involving a contaminated compound took the lives of 64 people and caused infections in 800 others. The FDA wants to avoid another such tragedy.

Unlike FDA-approved drugs, these medical compounds are not subjected to the same rigorous testing as a normal drug. However, they must be unadulterated to protect the safety of patients. Any such drug prepared in insanitary conditions should be considered adulterated. Insanitary conditions include the presence of insects, mold, dirt, peeling paint, trash, dirty HEPA filters, and unclean exhaust vents.

Contaminated drugs can cause serious harm to patients and even death. Compounding pharmacies have a responsibility to ensure that the drugs they mix are reliable and safe for consumer use. To further this effort, the FDA released final guidance on November 6. All compounding pharmacies need to be aware of these rules and do their part to ensure the sterility and safety of their products.

This message was brought to you by Ross Caputo, Ph.D. and President of Eagle. Eagle provides analytical and microbiological testing services to compounding pharmacies and other facilities. We help you maintain sterile conditions and protect your patients, as well as your business. Please contact Eagle if you have more questions about how we can help.