I have just returned from an all-day consultation audit of a compounding pharmacy. Our role is to perform a critical audit to help the firm identify the source of a fungal contaminate that was found in its sterile preparations. It is necessary to find the root cause and then the firm must institute both preventive and corrective actions.
We know that current good manufacturing practice regulations and FDA oversight are relatively new to the compounding pharmacy industry. We also all see firsthand how FDA and state Boards of Pharmacy are working closely together because of the tragedies that arose from the poor practices recently in Massachusetts [NECC].
The point of this blog is to let you know that we care about the survival of your industry. We want to work with pharmacies which have integrity about offering only safe scripts for their customers/patients. We can provide over 43 years of knowledge to help you adjust and forward your path to the new current expectations as relates to microbiological monitoring, facility design and training.