The Compounding Pharmacy industry has recently been criticized by the FDA for mixing products that have caused considerable patient harm due to sterility. The guidance document put out describes conditions under which the agency considers insanitary. The agencies guidance is vague, it is up to Compounding Pharmacies to prevent any insanitary conditions and put the proper controls into place to prevent insanitary conditions from occurring. The webinar will help Compounding Pharmacies to understand what actions are needed in order to prevent insanitary conditions.
The FDA has recently been cracking down on Compounding Pharmacy facilities due to the fungal meningitis outbreak in 2012 that caused 60 deaths and 750 cases of infection. As a result of this, the Agency is not confident in the ability of Compounding Facilities to maintain a state of control on their facilities and the conditions under which the product is compounded. Many of the insanitary conditions described by the agency are outlined in this guidance document. By understanding and implementing the concepts described in the Aseptic Guidance document – Sep 2004, many of the conditions described can be eliminated and controlled.
Areas Covered in the Session:
A brief history of reason why the Compounding Pharmacy Guidance document is being implemented.
A brief overview of the Aseptic Processing Guidance Document – Sep 2004..
Reviewing the Aseptic Guidance document and how it implies to the insanitary conditions described in the proposed guidance document..
Examples on how the concepts outlined in the Aseptic Processing.