Compounders are getting better but FDA is still concerned about this one thing…

Compounders are getting better but FDA is still concerned about this one thing…

In this FDA CDER conversation, Ian F. Deveau, Ph.D., Division Director at FDA CDER, discusses how the agency still continues to see harm come to patients due to improperly compounded drugs. While the New England Compounding Center (NECC) was the most infamous tragedy the compounding industry has seen to date, it is not the only incident on record. Dr. Deveau cites that from 1990 to 2005 there have been over 240 cases of adverse events and deaths linked to poor compounding practices. Today the compounding industry still faces many challenges in creating quality compounded preparations. One such challenge is that of insanitary conditions found at compounding facilities.

Examples of insanitary conditions include but are not limited to:

  • The presence of insect or animal infestations in the facility
  • The presence of viable and non-viable contaminants
  • Construction taking place near the compounding area
  • Standing water found in the cleanroom
  • Inadequate controls to prevent cross-contamination
  • Compounds made with ingredients having high levels of impurities

Why do insanitary conditions matter?

Although section 503A of the FD&C Act exempts compounding pharmacies from current good manufacturing practice (CGMP) requirements, they are not exempt from insanitary conditions.

A drug is deemed to be adulterated, “If it has been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.”

Federal Food Drug and Cosmetic Act (FD&C Act)

Today over 500 compounding establishments have been visited by the FDA. Many of these inspections have led to warning letters or recalls and it is no longer a safe assumption that the agency won’t inspect a pharmacy for compliance with insanitary conditions.

What can you do?

FDA urges compounders to be able to identify and correct insanitary conditions that may exist at their practice site. To learn more, read the final guidance on insanitary conditions and check out these courses related to heightened regulatory oversight of the compounding industry, insanitary conditions at compounding facilities, and contamination control strategies.

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