Guidance on Unsanitary Conditions at Compounding Facilities Gets Mixed Reviews

The FDA draft guidance on unsanitary conditions at drug compounding facilities got mixed reviews in comments on the draft.

One commenter questioned the need for the guidance, calling it an overreaction to the event that led to the guidance, a 2012 meningitis outbreak. The comment pointed to evidence that between 2000 and 2012 only 20 adverse events were linked to compounders that were not related to the New England Compounding Center, the source facility of the 2012 outbreak.

A second commenter said the guidance ignores other significant issues.

“The emphasis that this guidance document gives to the appearance of unsanitary conditions linked to potential microbial contamination at sterile compounding facilities downplays risks associated with bacterial endotoxin, super and sub potent preparations, chemical and physical contamination and use of inappropriate ingredients,” the commenter said.

The third and final comment said the guidance does not address the use of sterile versus non-sterile clothing except for gloves. Hoods, goggles, face masks, shoe covers and other items are not mentioned, and at a minimum, sterile sleeves should be addressed in the guidance, the commenter said.

The comments could be an indication that many in the compounding industry, especially in the U.S., aren’t worried about sanitation issues due to standards that are already in place and enforced. When it comes to overseas facilities, things could be different. 

The FDA does not inspect the vast majority of compounding facilities in the U.S. because they generally do not register with FDA unless they elect to become outsourcing facilities.

Therefore, FDA is often not aware of these facilities and potential problems with their drug products, or conditions and practices, unless it receives a complaint such as a report of a serious adverse event or visible contamination.

The guidance will assist compounding facilities in identifying insanitary conditions so that they can implement appropriate corrective actions. It also is expected to help state regulatory agencies in understanding some examples of what FDA considers insanitary conditions.

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