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FEDERAL | ASPS Responds to FDA’s Pharmaceutical Compounding Draft Guidance

The U.S. Food and Drug Administration (FDA) has issued draft guidance for pharmaceutical compounders outlining insanitary conditions that put patients at risk for harm. It includes examples of conditions that its inspectors have observed during past inspections, such as the presence of vermin, visible microbial contamination and non-microbial contamination such as rust or hair in a drug production area. The draft guidance also describes procedures that will assist compounders in identifying insanitary conditions, plus actions that compounders should take if insanitary conditions are identified.

While contaminated drug products produced at compounding facilities have, in the past, caused numerous infections and death, this guideline extends the need for controls to a physician’s office.

In its response, ASPS took issue with the FDA’s statement that sterile compounding in a physician’s office is equally as dangerous as procedures performed in a compounding center and asked the Agency to perform an economic impact analysis to identify the financial ramification this guidance could have on physician practices.

ASPS’s Comments on Insanitary Conditions at Compounding Facilities